One Heart Magazine 2012

ONE HEART MAGAZINE Globa l Card iovascu lar A l l i ance

A UNITED FRONTTEAMING UP TO FIGHT CVD AROUND THE WORLD

One HeartGlobal CardiovascularAl l iance

A mission to save more than a thousand lives

Ever since BIOTRONIK developed the very fi rst German-engineered pacemaker almost 50 years ago, our focus has been to provide safe, innovative solutions for unmet clinical needs. We work closely together with patients and practitioners to identify and solve these needs, further innovation by collaborating with universities, and fund selected health and education programs on an ongoing basis.

As many as three million people each year suffer needlessly because they cannot afford a life-saving pacemaker or implantable cardioverter-defi brillator (ICD). In our commitment to tackle this inequality in cardiovascular care, BIOTRONIK has formed a strong, strategic alliance with Heartbeat International Foundation (HBI).

www.biotronik.com

Saving and improving lives by providing access to care

BIOTRONIK actively supports HBI by donating devices free of charge and helps to set up new heart centers and education programs around the globe. To date, the HBI network of volunteer doctors and hospitals are saving lives in 14 countries.

Heart centers using BIOTRONIK donated devices.

charitable support forquality care

Quality prevails throughout BIOTRONIK‘s company culture. It also means living up to our own high standards and remembering the people we help. We therefore believe that it is our corporate responsibility to provide access to high quality care for everyone in need of it – especially those who are most vulnerable because they cannot afford it.

„

„– Christoph Böhmer, Managing Director, BIOTRONIK

Bard Peripheral Vascular, Inc.

1 800 321 4254 www.bardpv.com1625 W. 3rd Street Tempe, AZ 85281

A leader in providing the tools physicians need to treat peripheral vascular disease

Bard is a trademarks and/or registered trademarks of C. R. Bard, Inc.Copyright © 2012, C. R. Bard, Inc. All Rights Reserved.

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Bard, Crosser, LifeStent, Solo and VascuTrak are trademarks and/or registared trademarks of C. R. Bard, Inc. or an affi liate. Copyright © 2012, C. R. Bard, Inc. All Rights Reserved.

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Get the facts. it just may save your life.Recent studies also show that 50% of those who have a heart attack or stroke have “normal” cholesterol

levels. This suggests that many individuals at risk are presumed low-risk because they have normal

cholesterol levels. Thus, routine cholesterol tests are failing to identify people at risk for heart attack and

stroke. With a focus on prevention and wellness, Cleveland HeartLab, Inc. designed the CVD Infl ammation

Profi le™ to more accurately estimate cardiovascular risk for patients who may warrant more aggressive and

comprehensive therapy. In particular, this profi le is focused on managing and reducing infl ammation. We

also offer an array of standard and advanced tests that physicians can choose from.

Please read our feature on the “Clinical Utility of Infl ammation Testing” in this issue of One Heart Magazine.

Contact Cleveland HeartLab today at 866.358.9828 or www.clevelandheartlab.com.

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For 30% of those who have a myocardial infarction, their fi rst symptom is death.

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TABLE OF CONTENTS

16A United Front Against CVDHBI’s Global Cardiovascular Alliance brings together governments, industry, charities

Beyond Its BordersAmerican Heart Association doesn’t confine efforts to just the U.S.

29

Fighting Heart Disease in China

46

www.heartbeatsaveslives.org ONE HEART MAGAZINE 7

Cardiovascular Credentialing International

24

Corporate Headquarters4302 Henderson Blvd., Ste 102

Tampa, Florida 33629, USATel. (813) 261-2127




PublishersAdam LongakerEdward Suyak

Chairman Heartbeat International Foundation

Dr. Benedict S. Maniscalco

Executive Vice President Heartbeat International Foundation

Laura Maniscalco DeLise

Vice President of Business Development

Johnathan Hartmand

AccountingLeanne RaganoCharles Stevens

Advertising AssociatesJason EastonPenn MillsGage Pierce

Creative DirectorBryan Clapper

Editorial DirectorKevin Anderson

Sales Support StaffMichelle SantiagoAlfredo Escandion

Contributing WritersStephanie RickerGordon F. Tomaselli, M.D.Marc S. Penn, M.D.Michelle Beidelschies, Ph.D.Dayi HuJanet Wright, M.D.Nadeem Afridi, M.D., FACCSidney Smith et al

Non-Profit LiaisonLaura Maniscalco DeLise

Heartbeat International Support StaffGeorgina CroninChristine ConleyMichael Maniscalco

Production AssociateMichael Johns

Legal CounselAlbert Salem, Esquire

Special ThanksBerlin HeartAmerican Heart AssociationCleveland Heart LabWater Beach Club HotelChina Medical AssociationMillion Hearts InitiativeAmerican College of CardiologyBiotronikAssociation of Pakistani-Descent Cardiologists of North AmericaWorld Heart FederationWorld Health Organization

©Copyright 2012 Heartbeat International Foundation. All rights reserved. Reproduction of editorial content in whole or in part without written permission is prohibited.

Heartbeat International Foundation does not assume responsibility for the advertisements, nor any representation made therein, nor the quality or deliverability of the products themselves. Reproduction of articles and photographs, in whole or in part, contained herein is prohibited without expressed written consent of the publisher, with the exception of reprinting for news media use. Printed in the United States of America.


AdvertisersName Pages

Accumetrics 18

Atricure 49

Bard Peripheral Vascular 4-5

Berlin Heart 20

Biotronik 2-3, 40-41, 84

Boston Scientific 54

CardioComm Solutions 30

CardioTek 36

Cardiovascular Credentialing International 28

Cleveland Heart Lab 6

Defy Medical 67

ECA Medical Instruments 37

Ecoventura 79

Eli Lilly 12-15

Foundation for Medical Education and Research 31

Old Bahama Bay 68

Pace Medical 78

Point Grace 34

Regent Palms 56-57

Shape 53

The Meridian Club 60

TYRX 10

Vasomedical 47, 73

Water Beach Club Hotel 25

Zoll 64


TABLE OF CONTENTS

A Million HeartsGalvanizing clinicians and communities to prevent U.S. heart attacks and strokes

58

Advances in Inflammatory Biomarker Testing to define cardiovascular risk

38

Making a global difference74

Keeping pacewith the worldBiotronik travel guide gives patients ease of mind

80

A callto action

65 Just therightsize

21

Fighting NCDs in Pakistan61

1. Hanna et al. Journal of Clinical Oncology; 2004; 22(15): 3163-3171 2. Leon et al. Intensive Care Medicine; 2004; 30(10): 1891-1899 3. Zabramski et al. Journal of Neurosurgery; 2003; 98(4): 725-730 4. Chatzinikolaou et al. American Journal of Medicine; 2003; 115(5): 352-357 5. Raad et al. Annals of Internal Medicine; 1997; 127(4): 267-274 6. Bloom et al. Pacing Clinical Electrophysiol; 2011; 34(2):133-142 CAUTION: Federal law limits the device to sale by, or on the order of, a licensed practitioner. For full prescribing information, including indications, warnings, cautions and contraindications, see instructions for use.

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Welcome

T he inaugural edition of ONE HEART was met with enthusiastic reviews and

we are pleased and humbled by its acceptance from our readers. Thank you all for the comments and support for our efforts.

This second edition reports on initiatives of organizations which were featured in our first edition and content from others who have worked in the cardiovascular arena around the globe addressing the growing problems associated with cardiovascular disease.

In the inaugural issue Dr Mendes of the World Health Organization discussed the magnitude of the world wide problem of cardiovascular disease as well as the enormous burden of other chronic non-communicable diseases. The Non-Communicable Disease Alliance (NCDA) was presented in great detail and Heartbeat International Foundation announced the start of the One Heart Global Cardiovascular Alliance and called upon interested parties to join us in pursuit of opportunities and initiatives in the developing world. Many have done so and others are now in conversation with us and coming on board.

We are grateful to those companies, organizations, and individuals who have supported this project and the publication of ONE HEART. We particularly are grateful to all who have provided content and discussions of the missions of their organizations. We hope you will enjoy this second edition and learn about the dedication and initiatives in the fight against cardiovascular diseases around the globe. We encourage your comments and participation and would welcome learning about your organization and its missions around the world.

Sincerely,

Benedict S. Maniscalco, M.D.Chairman, C.E.O.Heartbeat International Foundation, Inc.

ABOUT DR. BENEDICT S. MANISCALCO

Dr. Benedict S. Maniscal-co, chairman and CEO of Heartbeat International, has been a private practitioner specializing in cardiovas-cular diseases since 1976. In addition to his work in preventive and consultative cardiology, he serves as medical advisor to multiple companies involved in medically related business. Well regarded as an innovator and educator in cardiovascular medicine, Dr. Maniscalco has been engaged with the American College of Cardiology at the local, state, and national levels, serving in leadership roles that have directly influenced healthcare practices and policy.

After graduating from the Duke Univer-sity School of Medicine, Dr. Maniscalco interned at Grady Memorial Hospital in Atlanta and did his junior and senior residencies at Emory University and its af-filiated hospitals, and followed that with a fellowship in cardiovascular diseases from 1973–1975. He served on the faculty at the University of South Florida School of Medicine before leaving to found the St. Joseph’s Heart Institution in Tampa, Florida. He is a member of the American Medical Association, American Heart Association and a Fellow of the American Heart Association, the American College of Cardiology, the American College of Physicians, the American College of Chest Physicians, and the Society for Cardiac Angioplasty.





Trapped

IS YOUR ACS-PCI PATIENT AT HIGH RISK FOR FUTURE THROMBOTIC CV EVENTS?

INDICATIONS AND USAGEEffient® (prasugrel) is indicated to reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows: [1] patients with unstable angina (UA) or non–ST-elevation myocardial infarction (NSTEMI); [2] patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI. The loading dose (LD) of Effient is 60 mg and themaintenance dose (MD) is 10 mg once daily. Effient is available in 5-mg and 10-mg tablets.

IMPORTANT SAFETY INFORMATION

WARNING: BLEEDING RISKEffient® (prasugrel) can cause significant, sometimes fatal, bleeding.Do not use Effient in patients with active pathological bleeding or a history of transient ischemic attack or stroke.In patients ≥75 years of age, Effient is generally not recommended, because of the increased risk of fatal and intracranial bleeding and uncertain benefit, except in high-risk situations (patients with diabetes or a history of prior myocardial infarction [MI]) where its effect appears to be greater and its use may be considered.Do not start Effient in patients likely to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue Effient at least 7 days prior to any surgery.Additional risk factors for bleeding include:

body weight <60 kg propensity to bleed concomitant use of medications that increase the risk of bleeding (eg, warfarin, heparin, fibrinolytic therapy, chronic use of nonsteroidal anti-inflammatory drugs [NSAIDs])

Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of Effient.If possible, manage bleeding without discontinuing Effient. Discontinuing Effient, particularly in the first few weeks after acute coronary syndrome, increases the risk of subsequent cardiovascular events.

CONTRAINDICATIONS Effient is contraindicated in patients with active pathological bleeding, such as from a peptic ulcer or intracranial hemorrhage (ICH), or a history of transient ischemic attack (TIA) or stroke, and in patients with hypersensitivity to prasugrel or any component of the product

WARNINGS AND PRECAUTIONS Patients who experience a stroke or TIA while on Effient generally should have therapy discontinued. Effient should also be discontinued for active bleeding and elective surgery Premature discontinuation of Effient increases risk of stent thrombosis, MI, and death Thrombotic thrombocytopenic purpura (TTP), a rare but serious condition that can be fatal, has been reported with Effient, sometimes after a brief exposure (<2 weeks), and requires urgent treatment, including plasmapheresis Hypersensitivity, including angioedema, has been reported in patients receiving Effient, including patients with a history of hypersensitivity reaction to other thienopyridines

ADVERSE REACTIONS Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction

Please see Brief Summary of Prescribing Information, including Boxed Warning regarding bleeding risk, on subsequent pages.

FOR MORE INFORMATION, CALL YOUR EFFIENT REPRESENTATIVE OR VISIT EFFIENTHCP.COM TODAY!

®Effient and the Effient logo are registered trademarks of Eli Lilly and Company.Copyright © 2012 Daiichi Sankyo, Inc. and Lilly USA, LLC. All Rights Reserved. PG75240. PGHCPISI03Oct2011. Printed in USA. January 2012.

*Data include refill prescriptions.

*1

183_29934_JrnlAd-PB Trapped

IS YOUR ACS-PCI PATIENT AT HIGH RISK FOR FUTURE THROMBOTIC CV EVENTS?

INDICATIONS AND USAGEEffient® (prasugrel) is indicated to reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows: [1] patients with unstable angina (UA) or non–ST-elevation myocardial infarction (NSTEMI); [2] patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI. The loading dose (LD) of Effient is 60 mg and themaintenance dose (MD) is 10 mg once daily. Effient is available in 5-mg and 10-mg tablets.

IMPORTANT SAFETY INFORMATION

WARNING: BLEEDING RISKEffient® (prasugrel) can cause significant, sometimes fatal, bleeding.Do not use Effient in patients with active pathological bleeding or a history of transient ischemic attack or stroke.In patients ≥75 years of age, Effient is generally not recommended, because of the increased risk of fatal and intracranial bleeding and uncertain benefit, except in high-risk situations (patients with diabetes or a history of prior myocardial infarction [MI]) where its effect appears to be greater and its use may be considered.Do not start Effient in patients likely to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue Effient at least 7 days prior to any surgery.Additional risk factors for bleeding include:

body weight <60 kg propensity to bleed concomitant use of medications that increase the risk of bleeding (eg, warfarin, heparin, fibrinolytic therapy, chronic use of nonsteroidal anti-inflammatory drugs [NSAIDs])

Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of Effient.If possible, manage bleeding without discontinuing Effient. Discontinuing Effient, particularly in the first few weeks after acute coronary syndrome, increases the risk of subsequent cardiovascular events.

CONTRAINDICATIONS Effient is contraindicated in patients with active pathological bleeding, such as from a peptic ulcer or intracranial hemorrhage (ICH), or a history of transient ischemic attack (TIA) or stroke, and in patients with hypersensitivity to prasugrel or any component of the product

WARNINGS AND PRECAUTIONS Patients who experience a stroke or TIA while on Effient generally should have therapy discontinued. Effient should also be discontinued for active bleeding and elective surgery Premature discontinuation of Effient increases risk of stent thrombosis, MI, and death Thrombotic thrombocytopenic purpura (TTP), a rare but serious condition that can be fatal, has been reported with Effient, sometimes after a brief exposure (<2 weeks), and requires urgent treatment, including plasmapheresis Hypersensitivity, including angioedema, has been reported in patients receiving Effient, including patients with a history of hypersensitivity reaction to other thienopyridines

ADVERSE REACTIONS Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction

Please see Brief Summary of Prescribing Information, including Boxed Warning regarding bleeding risk, on subsequent pages.

FOR MORE INFORMATION, CALL YOUR EFFIENT REPRESENTATIVE OR VISIT EFFIENTHCP.COM TODAY!

®Effient and the Effient logo are registered trademarks of Eli Lilly and Company.Copyright © 2012 Daiichi Sankyo, Inc. and Lilly USA, LLC. All Rights Reserved. PG75240. PGHCPISI03Oct2011. Printed in USA. January 2012.

*Data include refill prescriptions.

*1

183_29934_JrnlAd-PB

Effient® (prasugrel) tablets Brief Summary of Prescribing InformationBRIEF SUMMARY: Please see Full Prescribing Information for additional information about Effient.

WARNING: BLEEDING RISKEffient can cause significant, sometimes fatal, bleeding [see Warnings and Precautions (5.1 and 5.2) and Adverse Reactions (6.1)].Do not use Effient in patients with active pathological bleeding or a history of transient ischemic attack or stroke [see Contraindications (4.1 and 4.2)].In patients ≥75 years of age, Effient is generally not recommended, because of the increased risk of fatal and intracranial bleeding and uncertain benefit, except in high-risk situations (patients with diabetes or a history of prior MI) where its effect appears to be greater and its use may be considered [see Use in Specific Populations (8.5)].Do not start Effient in patients likely to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue Effient at least 7 days prior to any surgery.Additional risk factors for bleeding include:

<60 kg

bleeding (e.g., warfarin, heparin, fibrinolytic therapy, chronic use of non-steroidal anti-inflammatory drugs [NSAIDs])

Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of Effient.If possible, manage bleeding without discontinuing Effient. Discontinuing Effient, particularly in the first few weeks after acute coronary syndrome, increases the risk of subsequent cardiovascular events [see Warnings and Precautions (5.3)].

1 INDICATIONS AND USAGE1.1 Acute Coronary Syndrome: Effient® is indicated to reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows:

managed with primary or delayed PCI.Effient has been shown to reduce the rate of a combined endpoint of cardiovascular death, nonfatal myocardial infarction (MI), or nonfatal

driven predominantly by MI, with no difference on strokes and little difference on CV death [see Clinical Studies (14)].It is generally recommended that antiplatelet therapy be administered promptly in the management of ACS because many cardiovascular events occur within hours of initial presentation. In the clinical trial that established the efficacy of Effient, Effient and the control drug were not

established. For the small fraction of patients that required urgent CABG after treatment with Effient, the risk of significant bleeding was substantial [see Warnings and Precautions (5.2)]. Because the large majority of patients are managed without CABG, however, treatment can be considered before determining coronary anatomy if need for CABG is

must then be balanced against the increased rate of bleeding in patients who do need to undergo urgent CABG.2 DOSAGE AND ADMINISTRATION

then continue at 10 mg orally once daily. Patients taking Effient should also take aspirin (75 mg to 325 mg) daily [see Drug Interactions (7) and Clinical Pharmacology (12.3)]. Effient may be administered with or without food [see Clinical Pharmacology (12.3) and Clinical Studies (14)].Dosing in Low Weight Patients: Compared to patients weighing ≥60 kg, patients weighing <60 kg have an increased exposure to the active metabolite of prasugrel and an increased risk of bleeding on a 10 mg once daily maintenance dose. Consider lowering the maintenance dose to 5 mg in patients <have not been prospectively studied.4 CONTRAINDICATIONS4.1 Active Bleeding: Effient is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].4.2 Prior Transient Ischemic Attack or Stroke: Effient is contraindicated in patients with a history of prior transient ischemic

ial to Assess Improvement in ptimizing Platelet InhibitioN with Prasugrel),

>3 months prior to enrollment) had a higher rate of stroke on Effient (6.5%; of which 4.2% were thrombotic stroke and 2.3% were intracranial hemorrhage [ICH]) than on clopidogrel (1.2%; all thrombotic). In patients without such a history, the incidence of stroke was 0.9% (0.2% ICH) and 1.0% (0.3% ICH) with Effient and clopidogrel, respectively. Patients with a history of ischemic stroke within 3 months of screening and patients with a

generally should have therapy discontinued [see Adverse Reactions (6.1) and Clinical Studies (14)].4.3 Hypersensitivity: Effient is contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to prasugrel or any component of the product [see Adverse Reactions (6.2)].5 WARNINGS AND PRECAUTIONS5.1 General Risk of Bleeding:

overt bleeding associated with a fall in hemoglobin ≥5 g/dL, or

a fall in hemoglobin of ≥3 g/dL but <5 g/dL) bleeding events were more common on Effient than on clopidogrel [see Adverse Reactions (6.1)].

450 days; inset shows events through 7 days).Figure 1: Non-CABG-Related TIMI Major or Minor Bleeding Events.

Non-

CABG

-Rel

ated

TIM

I M

ajor

or M

inor

Ble

edin

g Ev

ents

(%)

2

3

4

5

1

018090 270 360 450

Clopidogrel

Effient

Days from RandomizationNumber at risk:Effient 6741 6042 5707 4813 4078 2747Clopidogrel 6716 6023 5764 4883 4138 2792

0

3

2

1

010 2 4 63 5 7

Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, PCI, CABG, or other surgical procedures even if the patient does not have overt signs of bleeding.

[see Contraindications (4.1 and 4.2)].

≥75 years. Because of the risk of bleeding (including fatal bleeding) and uncertain effectiveness in patients ≥75 years of age, use of Effient is generally not recommended in these patients, except

infarction) where its effect appears to be greater and its use may be considered [see Adverse Reactions (6.1), Use in Specific Populations (8.5), Clinical Pharmacology (12.3), and Clinical Trials (14)].

[see Warnings and Precautions (5.2)].

[see Dosage and Administration (2), Adverse Reactions (6.1), Use in Specific Populations (8.6)].

recurrent gastrointestinal (GI) bleeding, active peptic ulcer disease, or severe hepatic impairment) [see Adverse Reactions (6.1) and Use in Specific Populations (8.8)].

e.g., oral

drugs [NSAIDs], and fibrinolytic agents). Aspirin and heparin were [see Drug Interactions (7),

Clinical Studies (14)].

bleeding event or the risk of bleeding associated with an invasive

relative to the lifetime of the platelet, it may be possible to restore hemostasis by administering exogenous platelets; however, platelet transfusions within 6 hours of the loading dose or 4 hours of the maintenance dose may be less effective.5.2 Coronary Artery Bypass Graft Surgery-Related Bleeding:risk of bleeding is increased in patients receiving Effient who undergo CABG. If possible, Effient should be discontinued at least 7 days prior to CABG.

Effient group and 4.5% in the clopidogrel group [see Adverse Reactions (6.1)]persisted up to 7 days from the most recent dose of study drug. For patients receiving a thienopyridine within 3 days prior to CABG, the

patients) in the Effient group, compared with 5.0% (3 of 60 patients) in the clopidogrel group. For patients who received their last dose of thienopyridine within 4 to 7 days prior to CABG, the frequencies

related bleeding may be treated with transfusion of blood products, including packed red blood cells and platelets; however, platelet transfusions within 6 hours of the loading dose or 4 hours of the maintenance dose may be less effective.5.3 Discontinuation of Effient: Discontinue thienopyridines, including

duration of thienopyridine therapy is unknown. In patients who are managed with PCI and stent placement, premature discontinuation of any antiplatelet medication, including thienopyridines, conveys an increased risk of stent thrombosis, myocardial infarction, and death. Patients who require premature discontinuation of a thienopyridine will be at increased risk for cardiac events. Lapses in therapy should be avoided, and if thienopyridines must be temporarily discontinued because of an adverse event(s), they should be restarted as soon as possible [see Contraindications (4.1 and 4.2) and Warnings and Precautions (5.1)]. 5.4 Thrombotic Thrombocytopenic Purpura:

serious condition that can be fatal and requires urgent treatment,

by thrombocytopenia, microangiopathic hemolytic anemia (schistocytes [fragment red blood cells] seen on peripheral smear), neurological findings, renal dysfunction, and fever [see Adverse Reactions (6.2)].5.5 Hypersensitivity Including Angioedema: Hypersensitivity including angioedema has been reported in patients receiving Effient, including patients with a history of hypersensitivity reaction to other thienopyridines [see Contraindications (4.3), Adverse Reactions (6.2)].6 ADVERSE REACTIONS6.1 Clinical Trials Experience:are also discussed elsewhere in the labeling:

[see Boxed Warning and Warnings and Precautions (5.1, 5.2)]

[see Warnings and Precautions (5.4)]

Safety in patients with ACS undergoing PCI was evaluated in a

population treated with Effient was 27 to 96 years of age, 25% female,

loading dose and 75 mg once daily.Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials cannot be directly compared with the rates observed in other clinical trials of another drug

Drug Discontinuationbecause of adverse reactions was 7.2% for Effient and 6.3% for clopidogrel. Bleeding was the most common adverse reaction leading to study drug discontinuation for both drugs (2.5% for Effient and 1.4% for clopidogrel).Bleeding: Bleeding Unrelated to CABG Surgery

to coronary artery bypass graft surgery (CABG) were significantly higher

Table 1: Non-CABG-Related Bleedinga (TRITON-TIMI 38)Effient (%) (N=6741)

Clopidogrel (%) (N=6716) p-value

4.5 3.4 p=0.002b 2.2 1.7 p=0.029

1.3 p=0.015Fatal 0.3 0.1Symptomatic intracranial hemorrhage (ICH) 0.3 0.3

Requiring inotropes 0.3 0.1Requiring surgical intervention 0.3 0.3

Requiring transfusion (≥4 units) 0.7 0.5

b 2.4 1.9 p=0.022a Patients may be counted in more than one row.b See 5.1 for definition.

42108_AT-183_29934_PI 1 12/16/11 9:56 AM

to 7) [see Warnings and Precautions (5.1)].Bleeding rates in patients with the risk factors of age ≥75 years and weight <Table 2: Bleeding Rates for Non-CABG-Related Bleeding by Weight and Age (TRITON-TIMI 38)

Major/Minor FatalEffient

(%)Clopidogrel

(%)Effient

(%)Clopidogrel

(%)Weight <Effient, N=356 clopidogrel) 10.1 6.5 0.0 0.3

Weight ≥60 kg (N=6373 Effient, N=6299 clopidogrel) 4.2 3.3 0.3 0.1

Age < 2.9 0.2 0.1

Age ≥ 9.0 6.9 1.0 0.1

Bleeding Related to CABG

bleeding adverse reactions in patients treated with Effient persisted up to 7 days from the most recent dose of study drug.Table 3: CABG-Related Bleedinga (TRITON-TIMI 38)

Effient (%) (N=213)

Clopidogrel (%)(N=224)

14.1 4.511.3 3.6

Fatal 0.9 0Reoperation 0.5

≥5 units 6.6 2.2Intracranial hemorrhage 0 0

0.9a Patients may be counted in more than one row.Bleeding Reported as Adverse Reactions

and clopidogrel, respectively: epistaxis (6.2%, 3.3%), gastrointestinal hemorrhage (1.5%, 1.0%), hemoptysis (0.6%,

hemorrhage (0.5%, 0.2%), retroperitoneal hemorrhage (0.3%, 0.2%), pericardial effusion/hemorrhage/tamponade (0.3%, 0.2%), and retinal hemorrhage (0.0%, 0.1%).Malignancieswere reported in 1.6% and 1.2% of patients treated with prasugrel and

related or are random occurrences.

respectively: severe thrombocytopenia (0.06%, 0.04%), anemia (2.2%, 2.0%), abnormal hepatic function (0.22%, 0.27%), allergic reactions

the adverse events reported by at least 2.5% of patients.Table 4: Non-Hemorrhagic Treatment Emergent Adverse Events Reported by at Least 2.5% of Patients in Either Group

Effient (%) (N=6741)

Clopidogrel (%) (N=6716)

Hypertension 7.5 7.1Hypercholesterolemia/Hyperlipidemia 7.0 7.4Headache 5.5 5.3Back pain 5.0 4.5Dyspnea 4.9 4.5Nausea 4.6 4.3Dizziness 4.1 4.6Cough 3.9 4.1Hypotension 3.9Fatigue 3.7

3.1 3.5Atrial fibrillation 2.9 3.1Bradycardia 2.9 2.4Leukopenia (<4 x 109 WBC/L) 3.5Rash 2.4Pyrexia 2.7 2.2Peripheral edema 2.7 3.0Pain in extremity 2.6 2.6Diarrhea 2.3 2.6

6.2 Postmarketing Experience:have been identified during post approval use of Effient. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.Blood and lymphatic system disorders —

[see Warnings and Precautions (5.4) and Patient Counseling Information (17.3)]Immune system disorders — Hypersensitivity reactions including anaphylaxis [see Contraindications (4.3)]7 DRUG INTERACTIONS7.1 Warfarin: Coadministration of Effient and warfarin increases the risk of bleeding [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)].7.2 Non-Steroidal Anti-Inflammatory Drugs: Coadministration of Effient and NSAIDs (used chronically) may increase the risk of bleeding [see Warnings and Precautions (5.1)].7.3 Other Concomitant Medications: Effient can be administered with drugs that are inducers or inhibitors of cytochrome P450 enzymes [see Clinical Pharmacology (12.3)].Effient can be administered with aspirin (75 mg to 325 mg per day), heparin, GPIIb/IIIa inhibitors, statins, digoxin, and drugs that elevate gastric pH, including proton pump inhibitors and H2 blockers [see Clinical Pharmacology (12.3)].8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy: Pregnancy Category B

and developmental toxicology studies in rats and rabbits at doses of up to 30 times the recommended therapeutic exposures in humans (based on plasma exposures to the major circulating human metabolite) revealed no evidence of fetal harm; however, animal studies are not always predictive of a human response. Effient should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.In embryo fetal developmental toxicology studies, pregnant rats and rabbits received prasugrel at maternally toxic oral doses equivalent to more than 40 times the human exposure. A slight decrease in pup body weight was observed; but, there were no structural malformations in either species. In prenatal and postnatal rat studies, maternal treatment with prasugrel had no effect on the behavioral or reproductive development of the offspring at doses greater than 150 times the human exposure [see Nonclinical Toxicology (13.1)].8.3 Nursing Mothers: It is not known whether Effient is excreted in human milk; however, metabolites of Effient were found in rat milk. Because many drugs are excreted in human milk, prasugrel should be used during nursing only if the potential benefit to the mother justifies the potential risk to the nursing infant.8.4 Pediatric Use: Safety and effectiveness in pediatric patients have not been established [see Clinical Pharmacology (12.3)].8.5 Geriatric Use: ≥65 years of age and 13.2% were ≥increased with advancing age in both treatment groups, although the relative risk of bleeding (Effient compared with clopidogrel) was similar across age groups.Patients ≥75 years of age who received Effient had an increased risk of fatal bleeding events (1.0%) compared to patients who received clopidogrel (0.1%). In patients ≥75 years of age, symptomatic intracranial

patients (0.3%) who received clopidogrel. Because of the risk of bleeding, and because effectiveness is uncertain in patients ≥75 years of age [see Clinical Studies (14)], use of Effient is generally not

and past history of myocardial infarction) where its effect appears to be greater and its use may be considered [see Warnings and Precautions (5.1), Clinical Pharmacology (12.3), and Clinical Studies (14)].8.6 Low Body Weight:with Effient had body weight <60 kg. Individuals with body weight <60 kg had an increased risk of bleeding and an increased exposure to the active metabolite of prasugrel [see Dosage and Administration (2), Warnings and Precautions (5.1), and Clinical Pharmacology (12.3)].

prospectively studied.8.7 Renal Impairment: No dosage adjustment is necessary for patients

stage renal disease [see Clinical Pharmacology (12.3)].8.8 Hepatic Impairment: No dosage adjustment is necessary in

patients with severe hepatic disease have not been studied, but such patients are generally at higher risk of bleeding [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)].8.9 Metabolic Status: In healthy subjects, patients with stable atherosclerosis, and patients with ACS receiving prasugrel, there was no relevant effect of genetic variation in CYP2B6, CYP2C9, CYP2C19, or

inhibition of platelet aggregation.10 OVERDOSAGE10.1 Signs and Symptoms: Platelet inhibition by prasugrel is rapid and irreversible, lasting for the life of the platelet, and is unlikely to be increased in the event of an overdose. In rats, lethality was observed after administration of 2000 mg/kg. Symptoms of acute toxicity in dogs included emesis, increased serum alkaline phosphatase, and hepatocellular atrophy. Symptoms of acute toxicity in rats included mydriasis, irregular respiration, decreased locomotor activity, ptosis, staggering gait, and lacrimation.10.2 Recommendations about Specific Treatment: Platelet

is not likely to be removed by dialysis.13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenesis

(>100 times the recommended therapeutic exposures in humans (based on plasma exposures to the major circulating human

(hepatocellular adenomas) in mice exposed for 2 years to high doses (>250 times the human metabolite exposure).Mutagenesis in vitro tests (Ames bacterial gene mutation test, clastogenicity assay in Chinese hamster fibroblasts) and in one in vivo test (micronucleus test by intraperitoneal route in mice).Impairment of Fertility

major metabolite exposure at daily dose of 10 mg prasugrel).17 PATIENT COUNSELING INFORMATIONSee Medication Guide17.1 Benefits and Risks

of Effient.

with the physician who prescribed Effient.

17.2 Bleeding: Inform patients that they:

blood in their stool or urine.17.3 Other Signs and Symptoms Requiring Medical Attention

been reported with Effient.

any of the following symptoms that cannot otherwise be explained: fever, weakness, extreme skin paleness, purple skin patches, yellowing of the skin or eyes, or neurological changes.

including rash, angioedema, anaphylaxis, or other manifestations. Patients who have had hypersensitivity reactions to other thienopyridines may have hypersensitivity reactions to Effient.

17.4 Invasive Procedures: Instruct patients to:

invasive procedure is scheduled.

prescribing health care professional before stopping Effient.17.5 Concomitant Medications: Ask patients to list all prescription

are taking or plan to take so the physician knows about other treatments that may affect bleeding risk (e.g., warfarin and NSAIDs).Literature Revised: September 27, 2011Effient® is a registered trademark of Eli Lilly and Company.Manufactured by Eli Lilly and Company, Indianapolis, IN 46285Marketed by Daiichi Sankyo, Inc. and Lilly USA, LLCCopyright © 2009, 2011 Daiichi Sankyo, Inc. and Eli Lilly and Company. All rights reserved.

Reference: 1. Data on file: #EFF20110809a: DSI/Lilly.

42108_AT-183_29934_PI 2 12/16/11 9:56 AM

As of publication of this One Heart magazine, Heartbeat International has secured the commitment of nine partners, with more than 15 others in the review process. Our committed partners have agreed to work with us in achieving the primary goals of the One Heart Global Cardiovascular Alliance:

1. Identify specific cardiovascular health needs of indigent populations in countries served by the GCA Partner or an HBI Heart Center or in other developing countries in which they may work together to establish new Heart Centers.

2. Design programs to address the needs identified above. Such program will be operated over a period of time sufficient to make a measurable and meaningful impact on the cardiovascular health of the targeted recipients and provide a meaningful opportunity for in-country medical personnel to acquire the knowledge, skills and experience that will allow them to continue to address the targeted medical need after a program has been completed.

3. Raise the financial resources needed to carry out selected programs.

4. Raise funds to acquire the equipment or devices, medical or otherwise, to carry out selected programs.

5. Identify and secure the participation or approval of any governmental organizations, charitable organizations,

business organizations or individuals that may be required to most effectively carry out intended programs.

6. Funds, devices, equipment or other assets associated with a program shalt by managed by the parties by mutual agreement in a manner that most effectively supports the relevant program.

Inaugural Partners of the One Heart Global Cardiovascular Alliance:

The American Heart Association states that the ultimate goal of its international activities is “to reduce the global burden of cardiovascular disease and stroke.” This mission “requires a multifaceted approach, including efforts aimed at young and old, healthy and at-risk, researchers, clinicians, academicians, healthcare administrators, and government agencies.” The American Heart Association knows that they alone can not achieve this lofty goal and have committed

AUnited FRONT AGAINST CVDHeartbeat International has spent the

last year deliberating, collaborating and developing, with its partners

as described below, the One Heart Global Cardiovascular Alliance; a project aimed at bringing governments, Industry, Heartbeat International’s Heart Centers, and other charitable organizations together to deliver cardiovascular health services and needed equipment to larger populations in need throughout the developing world. We have reached out to the many organizations and societies working in the cardiovascular field securing their commitment to assist Heartbeat International in its vision and mission of saving lives globally.

16 ONE HEART MAGAZINE www.heartbeatsaveslives.org

to “forging partnerships with like-minded organizations, healthcare entities and corporations around the world.” (AHA Global Strategies Brochure) Heartbeat International is proud to call the American Heart Association one of our inaugural partners in the One Heart Global Cardiovascular Alliance.

Cardiovascular Credentialing International is a non profit corporation established for the purpose of administering credentialing examinations as an independent credentialing agency. CCI offers eight credentials which, when earned, demonstrate that the registrant holds fundamental knowledge in the particular cardiovascular specialty. With our partnership in CCI, the One Heart Global Cardiovascular Alliance will work to transfer the skills and experience to in-country medical personnel needed to address the cardiovascular challenges and aid in health systems strengthening initiatives in each location. CCI and the Alliance will work together to build capacity in cardiovascular care globally.

The Caribbean Cardiac Society is a non profit organization comprised of medical professionals, including physicians, surgeons, nurses and technologists, who are involved in the treatment of supporting services to cardiac patients in the Caribbean region. Their mission is to improve the health of the Caribbean people through the advancement of cardiovascular knowledge and practice. Past CCS President, Dr. Raymond Massey, expressed the support of the Alliance by stating: “Heartbeat International’s work has always been consistent with the mission of the CCS. We are certain that the launch and success of the One Heart Global Cardiovascular Alliance will greatly enhance this contribution.”

CardioStart International is a 501c3 charity using a global network of volunteer effort, and the collective skills of experts in healthcare to provide free heart surgery and associated medical care to children and adults living in underserved regions of the world. CardioStart and its worldwide volunteers conduct two-week missions in such countries as Peru, Haiti, Uganda and Vietnam. To date, CardioStart has completed 55 comprehensive missions in 27 countries. Through the One Heart Global Cardiovascular Alliance, CardioStart and Heartbeat International will expand services and training to both CardioStart and Heartbeat International global locations.

Christian Medical Ministry to Cambodia/Jeremiah’s Hope is a nondenominational, international, Christian mission dedicated to providing excellent medical care to the poor and quality medical education to the healthcare community

AUnited FRONT AGAINST CVD


“The One Heart program and Global Cardiovascular

Alliance are vibrant, compassionate and

compelling programs to help the world’s poor

and underserved achieve improved quality of life.

ECA Medical Instruments, a 33 year partner in the

cardiovascular industry is pleased to support and be a member of this vital industry

group.” —James B. SchultzEXECUTIVE VICE PRESIDENT

ECA

To find out more, visit www.accumetrics.com/oneheart

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of Cambodia. The One Heart Global Cardiovascular Alliance will work to expand the services and training Jeremiah’s Hope can take to Cambodia.

ECA Medical Instruments manufactures a broad range of high-quality, robust precision torque wrenches and elegant custom instrument solutions which have become the gold standard in Cardiac and Neuro surgery. The commitment of ECA to the Alliance furthers trainings and transfer of knowledge to those in the developing world enabling better care of their citizens; a primary goal of the One Heart Global Cardiovascular Alliance.

The Goodwin Group International works to overcome geographic, linguistic, and technological barriers to connect physicians and care providers around the world with the very best in clinical practice. At its core, The Goodwin Group works to publish MD Conference Express; a highlights publication designed to bring the most clinically-relevant findings from major medical conferences to physicians around the world. This proprietary report is published in more than 20 countries and in more than six different languages. Working with The Goodwin Group allows the Alliance a global audience in the promotion and marketing of its services. Further, it serves to attract additional volunteer organizations and volunteers.

The International Academy of Cardiovascular Sciences has been developing collaborations around the world to make more effective our vision as expressed by our Founding President Dr. Howard Morgan. “The challenge for the Academy and its members is to adopt a mind-set, which continuously raises the question of how new and

existing knowledge, can be translated into prevention, improved diagnosis and therapy of cardiovascular disease. This approach offers the hope of a continued reduction in morbidity and mortality due to cardiovascular diseases.”

The Marafie Foundation in Pakistan has focused its attention on health and education working towards sustainable progress in the community and the availability of treatment to those is need. Along with the Heartbeat International Heart Center of Pakistan, the Alliance will work with the Marafie Foundation in the cardiovascular education, training, screening and treatment in the hopes that sustainable health is achieved.

Cardiovascular Disease is the world’s number one killer, and its impact on the developing world is growing rapidly. The One Heart Global Cardiovascular Alliance, including all its partners, aims to establish and operate long-term programs to provide needed assistance tailored to specific countries to both provide needed services and education related to cardiovascular health. Alliance partners agree and understand that the challenges posed by cardiovascular disease are too immense and complicated for a single organization to address. They further agree that by working together, and with others, they can each make a more significant impact in the fight against cardiovascular disease, for this reason we have all come together for the launch of the One Heart Global Cardiovascular Alliance. All Alliance partners share in goal of working together to fulfill the mission and vision of the Alliance and its promise to the people of the underserved populations.

The Joint Board for Heartbeat International Foundation and Heartbeat International Worldwide. From left to right, Joseph Messer, MD, Albert Salem, JD, Mo Kasti (Strategic Planning Facilitator, CTI), Peter Nagle (Carlton & Co.), Anthony Reece, JD, Jennifer Goodwin Schunemann, Federico Alfaro, MD, Basha Mohammed, Wit Ostrenko, Sandra Kreul, ARNP, Thomas Piemonte, MD, Andres Baffigo, Benedict Maniscalco, MD, Art Noriega

HEADQUARTERSBerlin Heart GmbHWiesenweg 10D-12247 Berlin (Steglitz)Germany

Telephone: +49 30 8187-2600Email: [email protected]

NORTH AMERICABerlin Heart Inc.200 Valleywood, Suite A500The Woodlands, Texas 77380USA

Telephone: 281-863-9700Email: [email protected]

Berlin Heart GmbH is the only company worldwide that develops, produces, and distributes implantable and external ventricular assist devices for patients of every age and body size. The devices INCOR®, EXCOR® Adult and EXCOR® Pediatric can support failing hearts short-, mid- and long-term and therefore offer a life-saving therapy. Customers moreover benefit from clinical and technical support by Berlin Heart VAD specialists who are available 7-24. INCOR® and EXCOR® Adult are not FDA-approved, but widely used in Europe. The company is the market leader in Germany and Europe.

Since 1988, EXCOR® has been implanted in more than

3,000 patients worldwide


In 1984, nearly 20 years later, the first successful infant heart transplant was performed by Dr Denton Cooley and his colleagues on an 8-month-old girl at Texas Children’s Hospital. Since the 1980s, pediatric heart transplantation has become the safe, effective and an accepted management strategy for pediatric patients with end-stage heart failure resulting from cardiomyopathy or inoperable congenital heart disease. Since 1982, more than 6,000 pediatric heart transplants have been performed, with consistent improvement in survival. Improving survival in pediatric cardiac transplantation is predominately related to increased early survival. Increasing early survival, most likely a manifestation of the advancements in perioperative management has been the driving force improving outcomes.

While survival has steadily improved after heart transplantation, waitlist mortality, the period of time between official listing for transplant and the heart transplant procedure itself, remains a major problem in the current era. In data analyzed from the United Network for Organ Sharing, it was observed that between January 1999 and July 2006, more than 500 children died on the heart transplant list before a suitable donor could be identified. This highlighted the need for novel therapies to treat children with or in need of a heart transplant.

When Dr. Charles D. Fraser, Jr. arrived at Texas Children’s Hospital in 1995 to take up his new position as chief of congenital heart surgery, he had a plan to build a surgical team that would provide the finest heart surgery for

SizeJust the rightFormer Berlin Heart patient Brady Burch visits Dr Charles Fraser.

BERLIN HEART PROVIDES BRIDGE TO TRANSPLANT FOR CHILDREN

On December 6, 1967, Dr Adrian Kantrowitz and his associates in Brooklyn, New York, performed the first pediatric heart transplant on a 17-day-old infant with Ebstein anomaly. This occurred just three days

after Dr Christian Barnard’s first human-to-human transplant on Dec. 3, 1967, in South Africa.


children with the best long-term outcomes. He succeeded in his plan, but one challenge bothered him consistently—babies and young children with heart failure awaiting heart transplantation. Often he or his colleagues would have to stand at the bedside of a languishing baby and tell the parents that nothing else could be done to save their child unless a tiny donor heart became available immediately.

Dr. Fraser felt frustrated that multiple assist devices existed for adults with failing hearts, but none of those heart pumps were small enough to serve an infant population. He and other pediatric cardiovascular colleagues around the country had to rely on ECMO and centrifugal pumps—neither of which was designed for long-term support. So without an appropriate-sized, long-term device, babies and young children often died as they waited for a donor heart to become available.

In Germany, engineers at the Berlin Heart Institute had developed a pediatric ventricular assist device for older children which they first used in 1990. By 1994, they offered a scaled-down version for infants. Over the years, the pump was used successfully in Germany and other parts of Europe, but was not FDA-approved for use in the United States. The early European experience suggested the Berlin Heart VAD could provide stable circulatory support for up to 421 days in children as small as 3 kilograms. Furthermore, the experience indicated that many EXCOR® Pediatric subjects could be weaned and extubated from mechanical ventilation, discontinue sedation/paralysis, transition from parenteral to enteral nutrition, and even become ambulatory –clinical benefits widely considered infeasible with currently available options, and beneficial to continued suitability for transplant while waiting for a transplant.

Between 2000 and 2004, two hospitals used the scaled-down heart pump in infants for the first time in the U. S. under the FDA’s Humanitarian Device Exemption program for a “compassionate use.” The device took over the heart’s pumping action and improved blood circulation as the babies waited for donor hearts to become available. The news accounts of these uses piqued interest among pediatric

heart surgeons around the country. In 2005, Dr. Fraser, who had long been an advocate for

small heart assist devices, implanted the Berlin Heart into a three-month-old baby at Texas Children’s Hospital. The child had been born with a failing heart and transferred from another city to Texas Children’s in Houston. After attempting all other possible treatments for the baby without success, the Hospital petitioned the FDA for a “compassionate use”

of the Berlin Heart. The baby did well after the surgery and soon went on to receive a donor heart. The child, 7 years old now, started school

last year. Encouraged by the successful

implantation, Dr. Fraser accompanied Berlin Heart representatives to

Washington, D. C., requesting that the FDA allow an investigational device exemption (IDE) study. The FDA took the information under consideration and later agreed to a “Conditional IDE approval” that opened the door

for a multi-center study, allowing clinical trials to begin in late 2007.

As previously mentioned, the first successful infant heart transplant was performed at Texas Children’s Hospital.

Fittingly, in January, 2008, Texas Children’s Heart Center was chosen by Berlin Heart Incorporated to serve as the national lead center of a first ever, prospective multi-center, North American clinical trial on a pediatric heart pump, the Berlin Heart EXCOR Pediatric Ventricular Assist Device (VAD). Dr. Charles D. Fraser, Jr was named the National Principal Investigator who would coordinate the multi-center IDE study on the safety and efficacy of the Berlin Heart VAD as a bridge to cardiac transplantation. Once the study began, investigators around the country were able to enroll patients,

implant the device and keep children alive while they waited for heart transplantation.

At the end of the 3-year clinical trial, Dr. Fraser and his study colleagues took the

Berlin Heart results before a 22-member FDA advisory panel comprised of pediatric and adult cardiovascular experts. The panel’s goal was to review the clinical data from the trial and to make recommendations to the FDA concerning the safety and probable benefit of the EXCOR VAD as it pertains to an application for Humanitarian Device Exemption

The Berlin Heart EXCOR is a ventricular assist device that supports the hearts of children awaiting a heart transplant.

(HDE) approval. At the end of a challenging day of questions about the study evidence, the panel members voted unanimously to recommend to the FDA that they grant HDE approval. The FDA considered the recommendation and by Dec. 16, 2011, the device received FDA approval for the EXCOR to be used in U.S. children as a bridge to heart transplantation.

For Dr. Fraser and his colleagues from the 17 hospitals who participated in the North American study, this was a landmark event for babies and older children suffering from severe heart failure and needing heart transplantation. They felt this approval ushered in a new era for children with terminal heart failure. It meant that the pediatric medical community could now offer this life-saving device to support dying children who might not otherwise survive while awaiting donor hearts. This first-ever perspective clinical trial conducted to investigate the safety and benefit of a pediatric VAD involved an incredible effort from 15 U.S. hospitals and two Canadian centers with extensive experience in pediatric heart failure and transplantation.

Since 2005, when Texas Children’s implanted its first Berlin Heart, Dr. Fraser and his surgical team have implanted this life-saving device into 30 pediatric heart patients, most of which have gone on to receive a transplanted donor heart.

The following story illustrates the foremost benefit to having a device in several sizes to fit young children and an infant population. The device is changing lives of newborns and giving parents the delight of rearing a baby who can enjoy the activities of a normal child.

Leanny Rodriguez, Berlin Heart babyWhen Leanny’s parents brought their daughter home

from the hospital, she seemed to be a healthy, happy baby. Then her health took a dramatic turn. Within three months, Leanny was fighting for her life at Texas Children’s Heart Center.

Leanny’s problem started with an upset stomach and fussiness that lasted a few days. Soon she was unable to eat, was vomiting and had a noticeably pale color. A worried mom took her to the ER at a local hospital.

Doctors diagnosed her with pneumonia. But the following day, they realized the problem was more complex.

They arranged for a helicopter to transport Leanny to Texas Children’s Hospital

There cardiac specialists told Leanny’s parents that she had a serious heart problem called dilated cardiomyopathy. It meant that her heart was enlarged—particularly the left ventricle-- and was too weak to pump blood to the body’s organs. The parents were shocked when heart doctors said their 3-month-old baby needed a heart transplant.

With a failing heart, time was not on the baby’s side. Her doctors recommended that Leanny have a Berlin Heart implanted – a pump developed in Germany that could be attached to her own heart by tubes that would assist her circulation. The device, which rests outside the body, could support Leanny’s heart and buy her more time as she waited for a donor heart to become available. Pediatric heart surgeons implanted Leanny with the Berlin Heart during an eight-hour operation.

The device improved Leanny’s circulation, and she grew stronger each day. She was able to be an active baby and meet developmental milestones such as crawling, standing alone and walking. By the time she received a donor heart four months later, she was a healthy candidate for the transplant surgery.

Now with a new heart beating in her chest, the 4-year-old participates in normal childhood activities.



By Stephanie Ricker

A shared vision is a powerful motivating force. It serves as a call to action, it lends strength

and encouragement, and it has the capability to forge a partnership that is greater than the sum of its parts. Cardiovascular Credentialing International (CCI) shares Heartbeat International’s vision to save lives through education, prevention, and treatment of cardiovascular diseases. In our 44 years of operation, CCI has built relationships with countless organizations to unite in common goals, and we are thrilled to become a partner with Heartbeat International as a member of the Global Cardiovascular Alliance. We are honored to join Heartbeat International’s worldwide battle against cardiovascular diseases, and we are grateful for the opportunity to contribute to One Heart Magazine and its synthesis of industry and philanthropy.

CCI is a not-for-profit credentialing body with a vision to promote international awareness of its cardiovascular credentialing programs. We seek to be the globally recognized

cardiovascular technology credentialing agency by providing competency-based examinations in a variety of cardiovascular specialties. Our innovation, driven by professional ethics and integrity, has placed us at the forefront of worldwide cardiovascular credentialing, and we are striving to increase that international presence even more in the near future. Current CCI President Doug Passey states, “We have always had aspirations to broaden our global awareness and acceptance, and we have found that there is a dire need for educational support and a desire for recognition through credentialing, especially in emerging countries and medically underserved populations.”

CCI began as the National Society of Cardiopulmonary Technology (NSCPT), which was a professional society that administered its first credentialing examinations in 1968. The American Medical Association officially recognized the

Cardiovascular Credentialing International Joins Forces with Heartbeat International to Combat Cardiovascular Diseases

Photos courtesy of Lancaster General Hospital

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cardiovascular technology profession in 1984. After merging with several other organizations, the society officially changed its name to Cardiovascular Credentialing International in 1988. CCI is governed by a Board of Trustees and is advised on matters pertaining to the cardiovascular field by its Board of Advisors. The Board of Advisors consists of representatives in each cardiovascular specialty field, as nominated by the following professional societies: American College of Cardiology, American College of Phlebology, American Society of Echocardiography, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, Society of

Invasive Cardiovascular Professionals, Society of Diagnostic Medical Sonography, and Society for Vascular Ultrasound. Currently, CCI administers two certificate-level and six registry-level credentialing examinations:

• Certified Cardiographic Technician (CCT)• Certified Rhythm Analysis Technician (CRAT)• Registered Congenital Cardiac Sonographer (RCCS)• Registered Electrophysiology Specialist (RCES)• Registered Cardiovascular Invasive Specialist (RCIS)• Registered Cardiac Sonographer (RCS)• Registered Phlebology Sonographer (RPhS)• Registered Vascular Specialist (RVS)

CCI’s Board of Trustees is investigating opportunities and the international need for further credentials in the cardiovascular field. All credentialing programs administered by CCI have gained ISO/IEC 17024 accreditation by the American National Standards Institute (ANSI). Accreditation was awarded to the RCES, RCIS, RCS, and RVS examinations

in 2008, and to the CCT, CRAT, RCCS, and RPhS examinations in 2011. Founded in 1918, ANSI accredits developers of standards for a multitude of personnel certification programs and industries, both nationally and internationally. Nearly one million professionals hold credentials in ANSI-accredited organizations, and ANSI accreditation is widely acknowledged as the foremost personnel certification accreditation body in the United States.

ANSI is the United States representative of the International Organization of Standardization (ISO), which is the global developer of international standards dedicated

to eliminating obstacles to international trade. ISO standards are established with worldwide consensus, providing rigorous guidelines for products, services, and sound practice. CCI recognizes that accreditation through these bodies is vital to creating an international credentialing presence. Reciprocity is essential for international relationships and a shared vision that transcends geographic and socioeconomic borders. ISO standards encourage open exchange while providing the necessary regulation to ensure structure and mutual accountability. In such a context, reciprocal benefits can be offered by two or more international partners without fear.

In an effort to promote global awareness of its internationally recognized

credentials, CCI exhibited for the first time at the World Congress of Cardiology (WCC) in Dubai, UAE in April of this year. Attendees demonstrated great interest in cardiovascular professional credentialing, and ISO recognition of CCI’s credentials played a vital role in communicating the validity of our programs. Meeting our international colleagues and our registrants (professionals who hold CCI credentials) is part of CCI’s ongoing research into uncovering and providing for the needs of our international constituents. For example, CCI is currently investigating the possibilities of altering our international fee structure according to World Health Organization guidelines so that the economic constraints of certain countries are taken into consideration when determining examination and renewal fees.

At the WCC, representatives of CCI were struck anew by the desire the international attendees expressed for educational opportunities in the cardiovascular field. The attendees saw the value of credentialing programs, but they also consistently emphasized the desperate need

Photo courtesy of Alta Bates Summit Medical Center


for education for associate professionals as a key step in combating cardiovascular disease. Meeting our international colleagues from a wide variety of countries including the UAE, Saudi Arabia, India, Pakistan, Sudan, Nigeria, Tanzania, and Kenya renewed our drive to fulfill these needs in the worldwide cardiovascular field.

CCI’s primary mission is dedicated to the credentialing of cardiovascular professionals, but we as an organization know that education is the vital first step on the road to credentialing. “CCI has always been of the belief that within the cardiovascular profession there is a triad of specialties that works to ensure the success of the profession,” says President Passey. “The triad consists of those who educate, those who credential, and the professional society that represents the members of the profession. All are important, and without any one component the profession would falter.” For this reason, CCI is working to develop an educators’ foundation, called the Cardiovascular Education and Research Foundation (CERF), as a 501(c)(3). This foundation will enable CCI to contribute to the profession by providing resources to aid future generations of cardiovascular educators and students. In keeping with Heartbeat International’s vision of philanthropy, CERF will provide a vehicle for individuals and corporations to make charitable contributions to a vitally important cause. Passey states, “CERF gives us the opportunity to support worthwhile educational endeavors, both locally and abroad. In the future, CCI would like to become involved in educational initiatives that extend to those areas of the world that have limited opportunities for education and training.”

CCI also demonstrated its commitment to education by holding the first annual Cardiovascular Educators’ Forum in Las Vegas, Nevada during March of this year. Fifty-five educators representing 35 schools and colleges attended, representing cardiac sonography, vascular ultrasound, cardiac catheterization, and cardiac electrophysiology programs. Speakers presented on a variety of topics, including accreditation, credentialing qualifications, teaching challenges, and education in the new millennium. Educators discussed how to nurture the professional development of their students and shared effective strategies and techniques in discussion.

Kathy Ozols, BS, RRT, CPFT, NPS, RCS, an educator for Central Florida Institute, said, “Participating in the conference, openly sharing ideas with other educators across the country, and listening to presentations from the speakers exceeded all of my expectations. I have never attended a conference that allowed the attendees to interact more positively and productively. I returned to my job inspired, motivated, and

with a better understanding of commonly shared issues among healthcare educators.” CCI hopes that this forum will continue to be a useful resource for educators, and in the future CERF is expected to be a valuable funding source for the endeavor.

The Global Cardiovascular Alliance founded by Heartbeat International is the next logical step in the fight against cardiovascular diseases. Created through individual strategic partnerships, the Alliance maximizes cooperation to expand services. The Alliance unifies members with a common goal and offers the opportunity for collaboration in Heartbeat International’s three goals of education, prevention, and treatment, thus addressing all aspects of humanitarian efforts against cardiovascular diseases. Each organization in the Alliance, whether it is a charity, society, school, industry, or government, brings its own contributions to the battle.

Heartbeat International’s existing structure and newly expanded Heart Center network is the key to the approach, bringing cardiac care to entire populations. However, the Heart Centers need educated health care professionals who are prepared for the onslaught of patients headed their way.

This is where CCI steps onto the battlefield as part of the Alliance. CCI is forming a partnership with Heartbeat International to build the framework of certification programs through the Alliance. Doug Passey describes the

Alliance as “a great opportunity for CCI to partner with other cardiovascular organizations for the purpose of working with the governments of medically underserved populations to help provide much needed resources in the education, prevention,

diagnosis, and treatment of cardiovascular disease.” The education programs will provide cardiovascular health instruction for cardiovascular professionals preparatory to these professionals becoming credentialed through CCI. These programs will be designed to ensure a lasting, meaningful impact in the targeted areas and will provide the knowledge and experience that in-country professionals require to meet the cardiovascular health needs of the area long after the programs have been completed.

A single organization cannot hope to surmount the challenges presented by cardiovascular diseases worldwide. Such a task requires cooperation, a shared vision, and a deeply rooted commitment to our common goals. Together, as members of the Global Cardiovascular Alliance, we have even greater power to effect permanent, significant change in the lives of people around the world. CCI is proud of to be a member of this Alliance, creating educational opportunities and supporting our colleagues around the world.

“ ”“CCI has always been of the belief that

within the cardiovascular profession there is a triad of specialties that works to ensure the

success of the profession.”—Doug Passey

PRESIDENTCARDIOVASCULAR CREDENTIALING INTERNATIONAL

Photo courtesy of Morrison Vein Institute and Compudiagnostics

• Certified Cardiographic Technician (CCT)

• Certified Rhythm Analysis Technician (CRAT)

• Registered Congenital Cardiac Sonographer (RCCS)

• Registered Cardiac Electrophysiology Specialist (RCES)

• Registered Cardiovascular Invasive Specialist (RCIS)

• Registered Cardiac Sonographer (RCS)

• Registered Phlebology Sonographer (RPhS)

• Registered Vascular Specialist (RVS)

Credentials administered by CCI are accredited by the American National Standards Institute (ANSI) based on the ISO/IEC 17024 Accreditation Standard.

For more information about CCI and examinations offered call 1-800-326-0268 or visit www.cci-online.org

Cardiovascular Credentialing International

Credentialing Cardiovascular Professionals since 1968

Photo courtesy of Lancaster General Hospital

Photo courtesy of Saint Francis Hospital and Medical Center

See article on page 24


By Gordon F. Tomaselli, M.D.President, American Heart Association

Founded in 1924, the American Heart Association has long been the United States’ oldest and largest volunteer health organization dedicated to fighting

heart disease and stroke — our No. 1 and No. 4 causes of death.

What many people don’t know is that the association also is waging battle on these diseases beyond national borders.

Our volunteers and employees are working on various fronts around the globe to reduce cardiovascular disease —the leading cause of death in the world. It’s part of our mission: building healthier lives, free of cardiovascular diseases and stroke.

“We are committed to forwarding the mission around the world that fosters prevention and early intervention,” said Vincent Bufalino, M.D., chairman of the American Heart Association’s International Committee and senior vice

president of the Cardiovascular Institute and senior medical director of cardiology for the Advocate Medical Group in Chicago.

“We think there are tremendous opportunities for us to bring some of our science and programs to areas where the population is underserved.”

The organization’s international focus was highly visible as recently as late April, when the American Heart Association joined other leading cardiovascular health organizations at the 2012 World Congress of Cardiology in Dubai, calling for the adoption of a global goal to reduce premature non-communicable disease mortality by 25 percent by 2025.

Adopting those targets “is the first and most important

AMERICAN HEART ASSOCIATION DOESN’T CONFINE EFFORTS TO JUST THE U.S.

Gordon F. Tomaselli, M.D.

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step in creating global change,” said American Heart Association Chief Executive Officer Nancy Brown.

Here is a brief look at some of the many other areas where the American Heart Association is focusing its international efforts:

» Emergency Cardiovascular Care – Of the more than 13 million people the American Heart Association trains in CPR and first aid annually, about 430,000 are in 400 international centers in 140 countries, including priority locations Brazil, China, India and the Middle East. With more than 280,000 instructors around the world, the association’s goal is to train 20 million people by 2020.

» Consumer Education – The association uses emergency cardiovascular care training as a platform to expand its consumer health initiatives internationally, including Go Red For Women, a heart-disease awareness campaign that a number of countries have adapted to their culture. The association has also partnered with the World Health Federation to share Go Red For Women through its member national heart foundations.

» Scientific Conferences and Meetings – The American Heart Association’s annual Scientific Sessions and International Stroke Conference are incubators for global collaboration, attracting the world’s leading scientists and clinicians who debut groundbreaking findings in heart and stroke research. Scientific Sessions is the world’s largest cardiovascular science meeting and is No. 10 worldwide in professional attendance among all scientific meetings. Of the 15,553 professionals who attended the last conference in November 2011, 7,422 (47 percent) were from more than 100 other countries. The 2012 International Stroke Conference included 693 professionals from 49 countries. The association conducts other specialty conferences that attract thousands from around the world. For the many unable to attend, the association reprises key presentations in venues outside the United States and provides

key portions of content on its websites and email newsletters.

» Professional Journals – Published in more than 10 languages and in about 50 countries, the 12 scientific journals provide subscribers the latest groundbreaking laboratory discoveries, results of key clinical trials and global perspectives through editorials and reviews by thought leaders in science and medicine. Four of the journals — Circulation, Hypertension, Stroke and Arteriosclerosis, Thrombosis and Vascular Biology — are ranked No. 1 worldwide in their subject categories based on impact factor rating.

» International Partnerships – The American Heart Association is a founding member of the World Heart Federation and a member of the World Stroke Organization. It also founded the InterAmerican Heart Foundation, which focuses on cardiovascular diseases and stroke in Latin America.

» Professional Membership and Education – About 21 percent of the more than 28,000 member clinicians and researchers are from countries outside the United States who network and have access to an array of resources.

» Non-communicable Diseases – A member of the Non-Communicable Disease Alliance, the association was part of the U.S. delegation at the United Nations summit in New York in September 2011, when world health leaders approved a political declaration to address non-communicable diseases. The American Heart Association was also part of the U.S. delegation at the World Health Organization’s First Global Ministerial Conference on Non-Communicable Diseases, held in Moscow in April 2011.

» Heart Doctors Without Borders – The association’s clearing house for volunteer activities around the world helps train physicians in new techniques.

By Gordon F. Tomaselli, M.D.President, American Heart Association

The key to our international efforts — and all of our lifesaving work — is the dedication of our volunteers. Their efforts to defeat cardiovascular disease and stroke ignite the American Heart Association.

Here’s a look at one of those volunteers. Dr. Vemuri S. Murthy, who practices medicine in Oak Park, Ill., is highly committed to serving our mission in his native India. He is one of thousands of our volunteers serving in our global battle against cardiovascular disease, the world’s No. 1 cause of death.

When Dr. Vemuri Murthy returns each year to his native Andhra

Pradesh, India, he is on a mission.“My vision, my ambition is for every

medical student, every doctor in India to have the basic cardiovascular emergency skills and guidelines of the American Heart Association,” he said. “Having spent 28 years of my life in India, I am quite passionate about developing countries like India, where people don’t have access to basic medical help.”

His dream is gradually becoming a reality.

For the past eight years, armed with the American Heart Association’s emergency cardiovascular care courses and guidelines, Murthy has been developing

high-quality training programs in medical colleges in Andhra Pradesh. He hopes to help start similar programs in all medical colleges throughout India. He has also conducted countless training sessions and coordinated several initiatives that have affected thousands of healthcare providers and patients.

As chairman of the Emergency Medical Care Educational Committee of the Federation of the Andhra Pradesh Medical Graduates in USA, he is leading efforts to have physicians in all medical colleges and hospitals in the state trained in resuscitation science. The organization has signed an agreement with the government and the NTR Medical University in Andhra Pradesh to offer needed help to establish

A DOCTOR ON A MISSION

Dr. Vemuri Murthy

resuscitation science courses in the medical college curriculum with assistance from AHA-trained instructors.

“Even though we have a lot of medical colleges, the basic education doesn’t cover skills like CPR,” said Murthy, who graduated from Guntur Medical College and All India Institute of Medical Sciences in New Delhi. “When it comes to emergency cardiovascular care, they are not armed with evidence-based knowledge and skills that we have in America.”

The main goals of the ambitious project, which Murthy initiated, are to:

» Disseminate American Heart Association training information to save lives.

» Train and retrain physicians with basic CPR skills.

» Eventually expand the knowledge and information in every home in India.

“We’re bringing AHA courses to the door steps of colleges,” Murthy said. “We train. We provide manpower.”

Murthy is quite an active volunteer for the American Heart Association in Illinois as well. In addition to being an anesthesiologist in active private practice, he is a regional faculty and member of the Emergency Cardiovascular Care Committee of Illinois. He is also an American Heart Association speaker on resuscitation science and participates in various community health education programs.

“Since I came to the United States in

1980, I have found a need and am quite passionate about getting myself involved with the American Heart Association,” Murthy said. “It’s the only organization taking education to the global arena, reaching out with basic emergency skills.”

And it is those skills developed here that he is taking back home.

“We have a long way to go,” he said, “and my passion is to get every doctor in India to be capable of delivering emergency medical care.”

His passion is the American Heart Association’s mission.

“ ”“It’s the only organization taking education to the global arena, reaching out with basic emergency skills.”

—Dr. Vemuri Murthy


What do you need in a vacation? Comfort without fuss? Warmth mixed with refreshing trade winds? Natural beauty? Excellence in service performed at a relaxed pace with a certain charm? Then make some time for the Turks & Caicos Islands, where your pulse rate is sure to slow down.

Turks and Caicos is actually made up of over 40 islands and cays east south east of the Bahamas, spanning a distance of less than 100 miles from east to west and even fewer north to south. Just eight are inhabited, each reflecting distinct natural beauty, history and culture. Most visitors spend their time on Providenciales, the perfect place to unwind, but trips to the outer islands are highly recommended if you are looking to get a better impression of this small lively nation. Scheduled air flights and well organized excursions are readily available.

Providenciales’ Grace Bay Beach consistently receives accolades as the world’s best beach. It was named after Grace Hutchings, an early visitor in 1892, in honor of her beauty, style and of course grace. This pristine 12 mile beach seems to have that perfect combination of fine white powder sand, expansive vistas, constant breezes and yet no crowds. The sea colors will stay with you forever; shades of Tiffany blue, turquoise, cobalt and more; and the sunsets are not to be missed. Many of the country’s most luxurious resorts are here, making for easy movement between one world class refreshment experience to another. Of course there’s nothing like becoming a ‘local’ in your own luxury resort, and one that has received the World Travel Award for the Caribbean’s Leading Boutique Hotel from 2005 to 2010 is Point Grace, Luxury Resort & Spa. The resort is appropriately named as it sits on the ‘point’ half way along Grace Bay Beach where with it’s expanse of white sand and untamed beauty you feel like you are on your own desert island. The resort’s magnificent suites, restaurants and spa are all inspired by classic turn-of-the-century British Colonial architecture creating a West Indian setting untouched by time.

The islands are a divers feast with close to shore wall drops of up to 8,000 feet. Humpback whales pass by during Spring whaling season. Nature can be found in many forms from turtles to osprey eagles. Fitness lovers will find quality gyms, classes and water-sports with expert tuition. Kite-boarding, triathlons, 5/10K runs, sea-swims are all pursuits to join in. Tennis, golf and horse-back riding are all catered for, again with experts on hand. Fishing from bone fishing to deep sea fishing is world class. There is plenty to do if you are looking to be active.

World class chefs seek to impress you with their signature dishes creating a cosmopolitan fare, but Caribbean and native-style dishes abound with the fresh catch of the day and the country’s own Conch. Dining is everything from a simple to luxurious experience. You’ll find a huge selection of wines and drinks on offer too. Point Grace’s elegant gourmet restaurant, Grace’s Cottage, has specialized in pairing fine wines with inspired cuisine for many years now. Come, take time to enjoy cuisine at it’s best, in the best possible settings.

Your body and soul have already entered a new dimension, where you feel energized but utterly peaceful. The Point Grace Thalasso Spa is all you need to further the restoration process. Treatments are European in style; Thalassotherapy using the islands natural resources and Thalgo products. The setting is truly West Indian; white washed exquisite cottages just set back from the natural beach dunes with inspiring sea views and breezes.

Turks and Caicos is very accessible with many international flights. It’s just over an hour from Miami and two and a half hours from New York amongst many routes. Your first vision of the islands from the plane will be awe inspiring. You’ll finally know you are on vacation. Getting through the soon to be expanded small airport terminal is fine but a discrete courteous fast track VIP Flyers service is available; Turks and Caicos will give you the luxury you desire at every step.

Those that live in the islands keep their history and culture close to their hearts, but they also move with the times and going-green, ecotourism and government-reform are all hot topics. There is certainly a pride in the islands that we do things our way, we don’t just follow others, and that gives the islands a spirit all to their own. If you chose to visit Turks and Caicos you’d very likely become one of our many return visitors, so we hope to see you very soon.

Luxury getaway on the world’s best beach



Marc S. Penn, MD, PhD, FACC, Director of Research, Summa Cardiovascular Institute, Summa Health System, Professor of Medicine and Integrated Medical Sciences, Skirball Laboratory of Cardiovascular Cellular Therapeutics, Northeast Ohio Medical University, Chief Medical Officer, Cleveland HeartLab, Inc.

Michelle Beidelschies, PhDClinical Liaison, Cleveland HeartLab, Inc.

The statistics for incident cardiovascular disease (CVD) continue to rise and will ultimately affect medical costs substantially. At present, approximately 37 percent of the US population has some form of CVD and the real total direct medical costs related to this disease are approximately $272 billion1. By the year 2030, 40 percent of the U.S. population is projected to have some form of CVD and the real total direct medical costs related to this disease are expected to triple to approximately $818 billion1. As a result of these outstanding statistics, the medical field is beginning to shift its way of thinking from responding to the presence of CVD to preventing the onset of CVD.

Our increasing understanding of the role of inflammation is changing the way medicine approaches chronic diseases such as CVD, and several studies suggest that monitoring inflammation may be an efficacious strategy to monitor the progression or even prevent the onset of chronic disease. Originally proposed over 35 years ago by Dr. Russell Ross, a vascular biologist, the “Response to Injury Hypothesis” has now become a well-recognized concept for chronic disease progression as it underscores the importance of inflammation in the development of atherosclerosis2,3. In short, the body responds to vascular injury by mounting an immune response which is a tightly regulated and orchestrated response. However, when the injury is chronic, or the tissue cannot be healed, this process can become dysregulated and persists as chronic inflammation. This continuous or episodic recurrence of the positive feedback loop can become detrimental to an individual’s health.

ADVANCES IN INFLAMMATORY BIOMARKER TESTING TO DEFINE CARDIOVASCULAR RISK


With the advent of various types of statin therapies aimed at lowering LDL cholesterol (LDL-C) levels, physicians are now able to substantially reduce the incidence of injury to the vasculature, and ultimately an individual’s risk for CVD. Statin therapy is an important treatment option that has contributed to the >50 percent decrease in the prevalence of ST elevation myocardial infarction in the United States over the past 15 years. However, the landmark JUPITER (Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin) trial recently published in the New England Journal of Medicine, suggests that lowering LDL-C levels alone may not be enough4. The trial enrolled

over 17,800 individuals without a history of cardiovascular disease who exhibited LDL-C levels <130 mg/dL and hsCRP (high-sensitivity C-reactive protein) levels ≥2 mg/dL. These individuals were randomly assigned rosuvastatin therapy (20 mg/daily; Crestor, AstraZeneca) or placebo and monitored for incident vascular events. The trial was actually stopped early due to an overwhelming benefit to individuals taking rosuvastatin therapy who experienced less vascular events (a 54 percent reduction in myocardial infarction and a 48 percent reduction in stroke). These benefits also paralleled the individuals’ laboratory results (50 percent reduction in LDL-C and 37 percent reduction in hsCRP). Interestingly, a maximum benefit was seen in individuals who had significant reductions in both LDL-C and hsCRP ultimately underscoring the importance of reducing inflammation alongside LDL-C levels. The results of the JUPITER trial have ultimately led to the relabeling of rosuvastatin and increased interest in utilizing hsCRP in the clinical setting.

Since the JUPITER trial, the use of inflammatory biomarkers in the clinical setting to assess CV risk has significantly increased especially since biomarker testing is quite simple and inexpensive compared to more invasive tests such as angiography or coronary artery calcium scoring. However, certain biomarker tests do have their limitations as well. In particular, hsCRP testing is useful for measuring systemic inflammation, but lacks specificity for vascular injury suggesting that it is more of a measure of the initiation and development of CVD or plaque burden, rather than for plaque activity5.

For this purpose, there is a more vascular-specific biomarker of vulnerable plaque formation called myeloperoxidase, or MPO, that can be easily measured in the bloodstream. MPO is an enzyme released from white blood cells during the inflammatory process, and its

pathophysiology is well-documented in the literature6. Clinically, free MPO levels in the bloodstream can be

measured to examine the release of MPO by white blood cells in response to vulnerable plaque/erosions/fissures in the artery wall. This was documented in a landmark study in 2003 when Brennan and colleagues looked at a large group of individuals who reported to the emergency room with chest pain5. The investigators found that individuals at admission with the highest MPO levels, even if they were persistently negative for Troponin T, were almost 4 times more likely to require revascularization due to vulnerable plaque rupture soon after admission than those with the lowest levels5. Thus, the investigators concluded that free MPO in the bloodstream was a biomarker that could identify the presence of vulnerable plaque.

Since this seminal report, over 100 manuscripts have been published on the clinical utility of MPO outside of the acute care setting. Among the middle-aged, healthy individuals in the MONICA/KORA Ausburg study, individuals with the highest levels of MPO at baseline were almost twice as likely to have a cardiac event over the ensuing 10 years7. In a slightly older population, increased MPO levels at baseline were associated with an increased risk of cardiovascular events, especially fatal events, particularly among individuals who had normal LDL-C, HDL-C, and CRP levels8. These studies highlight the utility of MPO testing to identify patients who have vulnerable plaque even in individuals who are negative for traditional risk factors and may inappropriately be assumed to be at low or intermediate risk.

Overall, the great interest in inflammatory biomarkers such as MPO is in large part due to the fact that traditional risk factors, such as LDL-C, fail to identify the majority of individuals at risk of developing CVD and adverse cardiac events as was demonstrated by the JUPITER trial. In fact, physicians may be missing approximately 50% of the patient population at risk for a heart attack or stroke if basing risk solely on ‘normal’ LDL-C. Therefore, a closer examination of residual risk due to inflammation through the measurement of MPO as well as other novel biomarkers may result in better prognostication and risk stratification which may ultimately reduce long-term medical costs and the incidence of CVD.

REFERENCES1. Heidenreich PA et al. Forecasting the future of cardiovascular disease

in the United States: A policy statement from the American Heart Association. Circulation. 2011; 123: 933-944.

2. Ross R and Glomset JA. The pathogenesis of atherosclerosis (First of two parts). N Engl J Med. 1976; 295: 369-377.

3. Ross R and Glomset JA. The pathogenesis of atherosclerosis (Second of two parts). N Engl J Med. 1976; 295: 420-425.

4. Ridker PM et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008; 359: 2195-2207.

5. Brennan ML et al. Prognostic value of myeloperoxidase in patients with chest pain. N Engl J Med. 2003; 349: 1595-1604.

6. Nicholls SJ and Hazen SL. Myeloperoxidase and cardiovascular disease. Arterioscler Thromb Vasc Biol. 2005; 25: 1102-1111.

7. Karakas M et al. Myeloperoxidase is associated with incident coronary heart disease independently of traditional risk factors: results from the MONICA/KORA Ausburg Study. J Intern Med. 2012; 271: 43-50.

8. Meuwese MC et al. Serum myeloperoxidase levels are associated with the future risk of coronary artery disease in apparently healthy individuals. The EPIC-Norfolk Prospective Population Study. J Am Coll Cardiol. 2007; 50: 159-165.

THERE IS A MORE VASCULAR-SPECIFIC BIOMARKER OF VULNERABLE PLAQUE

FORMATION CALLED MYELOPEROXIDASE, OR MPO, THAT CAN BE EASILY MEASURED IN THE

BLOODSTREAM.

www.biotronik.com

Geraldine Ariana Suarez, a little girl who was born in Saltillo, Mexico, in December 2010, faced many challenges already in her fi rst years. Not only was she born with Down syndrome and an atrioventricular (AV) block, but the federal government’s health care program under which she was receiving health care would not cover the cost of implanting a life-saving pacemaker. Since her mother was single and unemployed, Geraldine and her family were left helpless.

“When she was born, we thought we were going to lose her,” said Geraldine’s mother, Ana Gabriela Suarez. “At the hospital they told us her heart was asleep. It was just so painful because for us she was a little angel arriving into our lives.” In line with its commitment to provide access to life-saving cardiac care for the most vulnerable people, BIOTRONIK formed an alliance with Heartbeat International Foundation (HBI) in 2010. The goal of the alliance is to donate new implantable cardiac devices to economically disadvantaged patients at HBI Heart Centers in Mexico and all around the globe. To date more than 1000 devices have been donated by BIOTRONIK.

“Our products, aside from everything else, save patients lives. We are strongly committed to increasing access to life-saving cardiovascular treatment for economically disadvantaged people and wholeheartedly support HBI’s program,” says Christoph Böhmer, Managing Director of BIOTRONIK.

“A little girl was dying,” explained Ariel Garcia, Heartbeat International Foundation (HBI) Chairman of the Saltillo Heart Center in northeastern Mexico. “Geraldine Ariana Suarez, 11 months old at the time, had been born with and

suffered from AV block, a form of bradycardia heart disease. They were looking for help everywhere.”

“She fi nally received a BIOTRONIK pacemaker, and now she’s doing just fi ne,” continued Garcia. “She’s laughing, she’s happy, and she’s starting to talk. Her grandparents and her mother cry with joy almost every day.”

“You have returned the light to our lives,” said Geraldine’s mother. “It is incredible that the sum of the wills of BIOTRONIK, Heartbeat International and the group of Rotarians who run the Saltillo Heart Center have made it possible to save her life. God bless all who have given me the greatest gift in life – the health of my daughter.”

Cardiovascular diseases are the world’s number one killer, and for people in developing countries without the resources to take advantage of today’s advanced medical technologies, their prognosis is poor. This can be especially true in places like Mexico, where government spending per capita is low –with the total expenditure on health as a percentage of gross domestic product (GDP) is just 6.5% compared with countries like the United States and Germany where rates are 16.2% and 11.4% respectively.1

In Mexico, federal government programs offer assistance to patients with cardiac problems. The cost of a required pacemaker implantation, however, is not covered – meaning that many patients do not receive the treatment they need.

“In Mexico, there are so many people who cannot afford to buy a pacemaker. At the hospital, they are offered no option other than to go home – and most of them die a sudden death,” said Dr. Jorge Bahena, Medical Director of Mexico National Heart Centers. “With HBI’s program, this scenario has turned completely around. Patients do not go home because they cannot afford an implantable cardiac device. In our heart center alone we have saved more than 100 lives with outstanding support from BIOTRONIK.”

Comprised almost completely of volunteers, including 120 physicians, social workers, administrators, support staff and other medical professionals, Heartbeat International´s Heart Centers are running in fi ve locations in Mexico: Aguascalientes, Mexico City, Monterrey, Puebla and Saltillo. A sixth location is scheduled to open soon in Guadalajara.

“The commitment BIOTRONIK made at the end of 2010 to help Heartbeat International save 1000 lives with BIOTRONIK devices by 2013 has set a high standard,” explained Benedict S. Maniscalco, MD, Chairman and CEO of Heartbeat International Foundation. “BIOTRONIK’s donation goal has already been exceeded – one year early. We would like to use this opportunity to appeal to others to follow their lead and join our cause to fi ght against the socioeconomic disparity of patients who desperately need care.”

Improving access to life-saving cardiovascular treatment in MexicoCollaboration between BIOTRONIK and Heartbeat International saves 11-month-old girl with Down syndrome

World Health Organization statistics, 2009.1

The power of an industry commitmentto HBI’s Global Cardiovascular Alliance

350

300

250

200

150

100

50

02010 2011 2012

(Jan.-May)

110136

194200 202

310

200

128

2 5

Units Shipped

329 334

Pacemakers ICDs Pacemaker-Leads ICD-Leads Programmers

“As a leading global manufacturer of cardiovascular therapies, we fi rmly believe that it is our responsibility to be at the forefront with initiatives to increase patient access to life-saving, high quality care. While proud of our

mutual achievement, our work is far from done. We look forward to strengthening our strategic alliance with HBI in the months and years to come.”

Christoph BöhmerManaging Director, BIOTRONIK


Puerto Rico, officially the Commonwealth of Puerto Rico, is an unincorporated territory of the United States. It is located in the northeastern Caribbean, east of the

Dominican Republic and west of both the U.S. Virgin Islands and the British Virgin Islands.

Puerto Rico is only 100 miles long by 35 miles wide, making it the smallest island of the Greater Antilles. Puerto Rico (Spanish for “rich port”) consists of an archipelago that includes several striking islands, such as the main island, Vieques, Culebra, Mona, and numerous islets.

It is said to be the best of the Caribbean with over 270 miles of white-sand beaches, consistent warm temperatures throughout the year, tropical flavors and rhythms and, of course, plenty of rum! The Island stands out even amongst its fellow Caribbean Island inhabitants.

Puerto Rico’s culture is a colorful, festive fusion of Taíno, African, and Spanish influences. Every day is a celebration of the diversity of cultures that have shaped the island for over 1,000 years through rich cuisine, distinctive arts and crafts, vibrant music, and traditional festivals and parades. There is always a spot

to hear the beating of the drums to salsa, bomba and plenas. These percussion-driven musical traditions keep the people of Puerto Rico ready to congregate, dance and celebrate! Puerto Rico is inhabited by extremely proud people and they love to show their island off to visitors. Great pride, humility and passion run through the veins of Puerto Ricans. Puerto Rico is a paradise retreat 24/7, 365 days a year. Visit historic El Morro Fort on the northwestern tip of the island and learn how it defended the city of Old San Juan from seaborne enemies. Explore lush foliage, waterfalls and rivers at El Yunque Rainforest and national park. The rainforest has a number of trails to walk, hike, and climb. Take an eco-tour of the fascinating and beautiful bioluminescent Vieques Bay where water microorganisms emit a flash of bluish light when agitated at night. Adventure seekers may even dare to experience the intense water sports offered right off the shore. These are all excursions that should be placed on your to-do list while visiting Puerto Rico.

Isla Verde is one of the many sensational areas to visit while in Puerto Rico. This area is a district of Carolina which borders the Atlantic Ocean, south of Gurabo, east of San Juan, and west of

Puerto Rico THE BEST OF THE CARIBBEAN


Canovanas. Isla Verde is a destination unto itself. Over a mile-long strip of some the most beautiful white sand beaches and generally calm water make it a perfect playground for water sports, swimming, and of course sunbathing. This strip plays host to some of the largest luxury resorts and casinos, filled with plenty of boutique shops and divine restaurants. Isla Verde is perfect for leisure and extremely welcoming for business.

With some of the largest resorts and casinos taking up much of the real estate along the beachfront on Isla Verde Beach, one might miss the hidden gem of the area. Located directly across from one Puerto Rico’s most pristine beaches, the San Juan Water Beach Club Hotel is truly a David amongst several large Goliaths. This chic property brings the transparent waters of the Caribbean Sea flowing through the hotel. A cool mix of blues that swirl, ripple, and cascade throughout the sleek, modern building play point with brilliant shades of white, to a soundtrack all its own. With its new renovation complete, this hotel is perfect for a leisure fantasy escape or company retreat. Trip Advisor awarded the San Juan Water Beach Club Hotel the 2012 Certificate of Excellence as well as the 2012 Travelers’ Choice Award.

The San Juan Water Beach Club Hotel offers executive services with an intimate Caribbean flare. The hotel has an oceanfront business center and indoor and outdoor function venues for board meetings, corporate training, or special corporate functions. At your disposal, the hotel offers an executive boardroom, state-of-the-art audio/visual and telecommunications equipment, and other technology you may need upon request.

Whether you are here for leisure or business, your stay will be first class. With the hotel located only five minutes from the Luis Muñoz Marin International Airport, it is extremely easy to bring larger groups or plan a stay for two on a romantic getaway. From the moment you disembark your transportation, you are greeted and pampered by the Beach Club staff. Every thought to make your stay more pleasurable is taken into consideration and executed by all staff members. Give them one day, and not only will they know your name, they will also personalize their service based on your desires. No detail is missed—and a few might be added, based on your individual needs. No matter what you set your heart on while visiting Puerto Rico—a day at the beach, a couples massage on the beach, a tour of old San Juan, zip-lining on one of the longest lines in the United Sates, water sports, fishing, salsa dancing, trying your luck at one of the many outstanding casinos, exploring the rain forest, viewing a waterfall (and these are just the tip of things to do)—the Beach Club staff will make it their mission to fulfill your every request.

The hotel has 80 rooms and suites that feature floor-to-ceiling windows with views of the tropical Atlantic and San Juan’s finest beach. When you decide to finally sleep, you will rest on


a pillow-top mattress and snuggle up in fine linens. Your room comes with complimentary high-speed internet access, LCD flat screen TVs, an iHOME docking station, in-room safe, telescope, nightly turn-down service, plush towels, calming bath amenities, and of course coffee service with Puerto Rican Yaucono coffee for when you arise. Once you work up an appetite, you have two first-class dining options from which to choose.

The San Juan Water Beach Club Hotel has two spectacular restaurants under the helm of local celebrity executive Raul Correa. Located on the rooftop of the hotel, Mist is the renowned hot spot for locals and tourists. Mist offers comfortable white plush couch- and bed-style seating areas, as well as dining tables facing the pristine water and scenic view of the Puerto Rican Mountain range. Words cannot describe the ambiance in this setting. The menu boasts an Island-Italian-Spanish fusion flare, featuring “socializers”—or small plates—that you can share, all prepared with fresh, locally grown ingredients. Once you’re done dining, grab one of their signature cocktails and take a dip in the rooftop pool overlooking the Atlantic Ocean. When you feel satisfied and have made every attempt to overindulge yourself at the rooftop oasis, you might check out the second restaurant on the main level. Zest is an avant-garde culinary experience that takes you beneath the waves, with special visual effects including dancing ripples on the walls, an ocean surface simulation on the

ceiling, illuminated floors, and a cascading waterfall adjacent the bar. Zest is an amazing sub-aquatic atmosphere with a mouthwatering modern-Latino cuisine, prepared using only sustainable local ingredients. Executive Chef Raul Correa’s unique style of cooking embraces both the sensory and scientific qualities of food, as he infuses each dish with a distinct panache designed to stimulate every sense. This executive chef is hands-on, and it is very likely that when your taste buds explode with one of his dynamite dishes, he will soon be table-side making sure your experience is like no other.

After a long day taking in all that the Beach Club has to offer, it’s time to relax in your luxury room. No need to go to sleep, because the party on Isla Verde’s trendiest favorite night spot is just above you on the roof top lounge. Mist offers nightly DJs who spin a variety of music to get you out of your seat and onto the dance floor. Dance the night away, and get ready to do it all again tomorrow.

There is so much to do and see while staying in the Isla Verde area of Puerto Rico, not to mention on Puerto Rico as a whole. The only way to really experience, enjoy, and absorb it all is to stop reading this article and book your trip to Puerto Rico! Isla Verde should be a definite stop while exploring the island, and the San Juan Water Beach Club Hotel should be your destination of choice.


ChinaFIGHTING HEART DISEASE IN

By Dayi HuChina Medical Association

Two generations of my family have desired to serve as volunteers. Now, at the age of 95, my mother is still working in a community in Zhengzhou, China, and goes to serve the outpatients every morning. She is the oldest

“young volunteer.”

I have deep feelings for the Chinese countryside that are related to my upbringing. In 1965, I was admitted by Beijing Medical University while reading Mao Zedong’s Instruction on 26 June 1965. In that year, Chairman Mao proposed to “lay stress of medical work on the countryside” and build the “barefoot doctor” system, a great creation. In such a large and

EECP Therapy: A Treatment for Heart Failure via Improvementin Endothelial Dysfunction Gregory W. Barsness, MD, Division of Cardiovascular Disease and Internal Medicine, Mayo Clinic, Rochester, Minnesota, USA.

Enhanced external counterpulsation (EECP) is a noninvasive outpatient therapy cleared for marketing by the US FDA for the treatment of chronic angina and heart failure. EECP treatment produces an acute hemodynamic effect similar to that produced by the invasive intra-aortic balloon pump. Cuffs on the calves, the lower thighs, and upper thighs are sequentially inflated with compressed air during the diastolic phase of the cardiac cycle and are simultaneously deflated in early systole. This rapid inflation and deflation raises diastolic aortic pressure to increase coronary perfusion, provides afterload reduction and increases venous return, resulting in an increase in cardiac output. The safety and efficacy of EECP therapy for angina and heart failure have been well documented in several large international studies.

Several investigators have studied the mechanisms of action of EECP therapy, including the endothelial function effects of increased systemic blood flow velocity and beneficial shear stress forces. The observed endothelial function improvement is associated with an observed increase in the release of endothelial nitric oxide synthase (eNOs) and the vasodilator nitric oxide (NO), as well as suppression of the vasoconstrictor endothelin (ET-1). There are also published studies demonstrating that EECP therapy is effective in stimulating the endothelium to release vascular endothelial growth factor and, together with the mechanical pressure gradient generated during EECP, to potentially promote coronary collateral flow, coronary fractional flow reserve and increase microcirculatory density. In addition, EECP therapy decreases circulating levels of inflammatory cytokines and activates endothelial progenitor stem cells to replace and repair endothelium apoptosis, thereby enhancing endothelial function and slowing down the atherosclerotic process and the progression of cardiovascular disease.

The beneficial actions of EECP therapy to inhibit the progression of disease can be illustrated in its use as a treatment of heart failure with positive results from a randomized, controlled clinical trial entitled Prospective Evaluation of EECP in Congestive Heart Failure (PEECH™), in which 187 heart failure patients with NYHA II or III classification were randomized into either EECP + pharmacologic therapy (PT) or PT alone. The results of the PEECH™ trial showed a significant portion (35%) of EECP treated patients achieving a 60-second or more increase in exercise duration versus

25% in the PT control group at 6 months post treatment, with a 25 second increase in average exercise duration for the EECP group verses a 10 second decrease for the control group, 6 months post treatment. This trial demonstrated more significant improvements in favor of EECP therapy for the subgroup of patients 65 years or older, including improvements in exercise duration, peak volume of oxygen uptake, symptom status and quality of life. Patients in the trial who had an ischemic etiology (i.e. pre-existing coronary artery disease) demonstrated a greater response to EECP therapy than those who had an idiopathic (non-ischemic) etiology.

The confluence of these effects is manifest in endothelial dysfunction as a predictor of future major adverse cardiovascular events in patients suffering from heart failure, especially those patients with ischemic heart disease. Given the strong evidence that EECP is effective in improving endothelial dysfunction, the potential use and benefit of EECP in patients with heart failure is an attractive consideration.

Currently in the United States, EECP therapy is reimbursed as a covered benefit by the Centers for Medicare and Medicaid Service (CMS) and many private insurance companies for the treatment of patients with disabling angina. Many of these patients, however, present with concomitant symptoms of ischemic heart failure. The safety and efficacy of EECP in this patient subset has been confirmed among 8,000 patients enrolled in the International EECP Patient Registry™ (IEPR). University of Pittsburgh investigators found that approximately one-third of patients treated for angina with EECP also have a history of heart failure. Among this group, approximately 70% to 80% have demonstrated positive outcomes from EECP therapy.

EECP therapy remains an important therapeutic tool for the safe and effective outpatient treatment of a broad spectrum of symptomatic cardiovascular disorders. Investigation into likely therapeutic mechanisms, such as improved vascular endothelial function, along with exploration of benefit in new patient subgroups, such as those with heart failure, continues, while the application of this novel treatment modality remains ever increasing as the observed benefits become more apparent.

one_heart_ad.indd 2 3/25/2011 3:35:15 PM

FIGHTING HEART DISEASE IN


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is safe and effective when performed during open heart procedures?

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Only 1 in 10

ONLY 1, 2

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2. Niv Ad, MD, et al. J Thorac Cardiovasc Surg 2012;143:936-944.

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PERSISTENT AF TREATMENTpoor country as China, medical security for the majority of people in rural areas has been solved with relatively low cost, and has resulted in the realization of a basically fair medical service. When I was studying, I helped to build the medical system through the countryside. Since the 1970s, I have engaged in medical work and participated in the Hexi Corridor Medical Team and Tibetan Ali Medical Team appointed by Premier Zhou that year, walking the whole Hexi Corridor on foot. Back then, Ali was called the “roof of the roof, snowland of snowland, and plateau of

plateau.” In Ali, I came to recognize five “extreme” spirits that characterize the region and the task of establishing the volunteer medical sytem: most hard-working, most patient, most dedicated, most united, and most fighting. These spirits were the spiritual support of the Ali liberation army and medical team that year.

After completing Ali medical assistance and returning to Beijing, I continued to engage in work related to cardiovascular disease treatment. In the early 1990s, I developed technology for treating tachyarrhythmias with radiofrequency catheter ablation in China, and held seminars to promote its application. I founded the Great Wall International Congress of Cardiology (GWICC), introduced and initiated the technology, trained medical personnel, and explored and established the “green channel” service mode for acute myocardial infarction. In 2002, I began to pay attention to congenital heart disease treatment. As both the radiofrequency ablation of cardiac arrhythmia and interventional therapy of congenital heart disease were radical cure technologies, I was lucky in my life to promote and apply these two technologies to benefit chronic patients. In that year, I opened two outpatient departments for congenital heart disease, in Peking University People’s Hospital and Beijing Tongren Hospital. The incidence rate of congenital heart disease in China was nearly 7 percent, and there were nearly four million patients with congenital heart disease. However, in 2002, only a few dozen patients went to the outpatient department. I asked myself, why did the hospital have a large sign there, if it had no patients?

In the long “May Day” holiday after the SARS outbreak in 2003, I led a medical team to Anhui Taihe County for free medical service, which was an impoverished area in central China. During the five-day holiday, we screened more than 400 children with congenital heart disease. Bian Hong, a young doctor in our team, said, “Mr. Hu, I see not only the congenital heart disease encyclopedia, but also the health status encyclopedia in China in these five days, which is never seen in Beijing before and is very astonishing.”

Most astonishing was that: 1) Disease that could have been radically cured was delayed in treatment to the point of being an incurable disease. Congenital heart disease could be radically cured when the patient is 3 years old, but would difficult to cure when the patient is 13 years old, and could not be cured when the patient is 30 years old. Many people eventually fell within the range of incurable disease. 2) Very few of these children went elsewhere to treat the disease, because of poverty. During the “May Day” holiday, the weather was not very warm, children slept all over the ground, and they could not afford to live in even the cheapest guest house. 3) Lack of fundamental knowledge. One child with congenital defects suffered from blood poisoning due to the bacterial infection in his blood, but his father tried to save his life by giving him a wedding to counteract bad luck. This would never have been seen in the city.

As a result, I concluded that our health care system had problems at the time. I called it “watching the fire from the other side of the river.” Advanced technology made enormous progress on one side of the river, which was

The incidence rate of congenital heart disease in China was nearly 7 percent, and there were nearly four million patients with

congenital heart disease.

Did you know...

is safe and effective when performed during open heart procedures?

AF patients receive complete Maze IV during open heart procedure?

AtriCure offers training to CV surgeons on the FDA approved device for persistent AF treatment?

Maze IV

Only 1 in 10

ONLY 1, 2

1. ABLATE Trial G070080

2. Niv Ad, MD, et al. J Thorac Cardiovasc Surg 2012;143:936-944.

84% of persistent AF patients are with no increase in perioperative risk?

(1) ABLATE Trial G070080, (2) Niv Ad, MD, et al. J Thorac Cardiovasc Surg 2012;143:936-944. AtriCure Synergy OLL2/OSL2 clamps that are approved to ablate cardiac tissue for the treatment of PAF or LSP AF in patients who are undergoing open concomitant CABG and/or valve replacement or repair. MKT-1642A-G

AF free

First in Surgical AF Treatment

Is your CV surgeon offering the Maze IV procedure?

Do you want to get them trained?

Visit www.TargetAF.com to learn more

PERSISTENT AF TREATMENT


wonderful; numerous patients to be treated were on the other side, however, and were very helpless. The technology could not reach the patient to be treated—it was rendered “reachless,” without value. In response, I immediately organized and established the “volunteer service team” and initiated the “Loving Care Project.” My only goal was to achieve three tasks through the “Loving Care Project” activities: 1) keep going, do “addition or subtraction,” and reduce healthcare costs through utilizing the nearest local screening and treatment facilities; 2) develop health knowledge lectures to disseminate health knowledge and promote a healthy lifestyle; and 3) carry out medical technical training and establish medical teams that would not leave local districts. Such work was especially favored by grassroots supporters.

In 2007, supported by the Chinese Red Cross, the “Loving Care Project of the Chinese Red Cross—Hu Dayi volunteer service team” was set up. When we went to the rural areas, we had a volunteer flag, a “100-word declaration,” and a flag-giving ceremony very rich with content. The “100-word declaration” included “acting as a volunteer with a public spirit,” “tempering in rural areas and communities,” and more.

Do “addition or subtraction” and locally treat patients in the nearest facilities. Why was the nearest local treatment necessary? Because there was not enough time to travel in cases of acute disease, impoverished people did not have enough money to treat diseases elsewhere, and it was not cost efficient to treat frequently-occurring diseases elsewhere. Many patients with congenital heart disease did not have money and could not go to the city with large hospitals; how much more challenged were patients with acute myocardial infarction? In such a district as Xinjiang Hetian, a patient with myocardial infarction could not go to Beijing, and did not have enough time to go to Urumqi. Therefore, we needed to help strengthen the grassroots medical institutions of the county and city so

that the disease could be locally treated. I suggested doing “addition or subtraction.” What was addition or subtraction? “Subtraction” referred to accessing the nearest local treatment, providing convenience for the masses, and cost reduction. “Addition” started with sporadic things, mobilizing various social resources, organizing beneficent funds, caring for parents’ love, and returning healthy hearts to the children. “Addition” allowed more children to be treated.

Carry out training of grassroots physicians, and establish medical teams that would not leave. We emphasized that health was fair and attainable, medical service should be fair, and it was necessary to make grassroots medical institutions stronger. If the grassroots system was not strong, it would be hard to solve the difficulty of going to see a doctor. The most serious problem of grassroots hospitals was backward technology. In the year our medical team went to Ali and the Hexi Corridor, Premier Zhou Enlai repeatedly exhorted us that the most important goal was to establish medical teams that would not leave. This point remained most crucial: we should leave behind technology and medical teams that would not leave local districts. Through utilizing the nearest local treatment centers, “practical experience” was given to grassroots medical personnel and technology was left for them. Our experts operated at the grassroots level, allowing grassroots doctors to participate in the practical training, who were sure to learn through teach-by-doing! This was my experience as a doctor and a teacher for many years. Grassroots treatment was not only convenient for the patients but also saved on costs, and more importantly was establishing medical teams that would not leave the area.

Establish health care lectures and guarantee people’s health and warmth. I think that the greatest value a doctor can learn in medicine is to prevent disease and allow fewer people to fall ill. Do not allow serious disease to occur, and promptly treat it when it does. At present, our cardiovascular disease assumes the trend of “well blowout.” In order to achieve early success in the two inflection points of disease


control and medical cost reduction, it is very important to promote health nationwide. Therefore, my approach is to try to change the doctors’ concept, and extensively promote activities whereby everyone pays attention to health and participates in health promotion. Therefore, in our volunteer activities, we established health care lectures, guaranteed people’s health and warmth, told the public about disease prevention knowledge, and advocated a healthy and civilized lifestyle so that thousands of households were healthy. The public was in favor of the activities. Each time, a large cinema or a hall was packed out, which showed that the masses longed for health.

By now, we have established cooperative relationships with 75 hospitals in 24 provinces, held more than 200 large-scale free medical service and health care lectures, screened nearly 200,000 people, guided and carried out 6,120 operations, and raised nearly 30 million yuan of beneficent funds and equipment. What was particularly important was that our volunteer service team went to the grassroots hospitals in the county and city to provide the nearest local treatment for patients, trained grassroots doctors, and left behind medical teams that would not leave. As a result, many medical institutions have become regional cardiovascular disease treatment centers, and together formed a congenital heart disease treatment network and system in China. For example, the Anhui Taihe Hospital of Traditional Chinese Medicine developed into a national

third-grade class-A hospital of traditional Chinese medicine; the First Hospital of Nanchang increased its capacity for congenital heart disease treatment, from more than 200 cases four years ago to 1,000 cases; and Xinjiang Hetian People’s Hospital established emergency green channels, significantly improved its capacity for cardiovascular disease treatment, and realized the objective of establishing medical teams that would not leave local districts.

In addition to the above activities, we actively promoted standardized treatment of congenital heart disease and organized experts to study and formulate the Common Knowledge about the Interventional Therapy of Frequent Congenital Heart Diseases among Chinese Experts; at the same time, at the Great Wall International Congress of Cardiology, we organized a special forum of structural cardiology and promoted academic exchanges and technical popularization. We cooperated with famous foreign institutions and established the “International Training Base for Congenital Heart Disease.” Such work has vigorously promoted the popularization of technology needed to treat congenital heart disease in China.

Driven by the Loving Care Project, the government and all social circles pay attention to congenital heart disease treatment. In 2010, the Ministries of Health and of Civil Affairs of the People’s Republic of China developed a related policy for congenital heart disease treatment which was integrated into the social security treatment system. Seventy

In 2010, the Ministries of Health and of Civil Affairs of the People’s Republic of China developed a related policy for congenital heart disease treatment which was integrated into

the social security treatment system. Seventy to ninety percent of the treatment cost can be reimbursed in various regions, which was an important measure to treat poor youth patients

with congenital heart disease.


to ninety percent of the treatment cost can be reimbursed in various regions, which was an important measure to treat poor youth patients with congenital heart disease.

In April 2011, based on the Loving Care Project volunteer service team for treatment of the children patients with congenital heart disease, I organized more than 150 experts in various medical fields to establish the “general service team for medical volunteers.” Medical volunteers were not limited to congenital heart disease treatment, but included a number of other medical fields. Volunteers operated regardless of borders, with “all for the people’s health” as the mission, “excellent doctors having perfect skills and absolute sincerity” as the tenet, and followed the volunteer spirit of “dedication, love, mutual help, and progress.” The majority of physicians were asked to go to places where they were most needed by the state, society, and patients. There, they exchanged technical knowledge with grassroots physicians, guaranteed the health and warmth of the masses, and advanced the physician volunteers’ operation to a new stage. Medical volunteers follow the concept that “great doctors walk on the road, great doctors offer great love, great doctors advocate great virtue, and great doctors act as important persons.”

Volunteers dedicate their love. In the past 20 years, I seldom rest on weekends and holidays, and I spend most of my time helping the academic and general promotion of grassroots medical technology. After the setup of a general volunteer team, I devoted a lot of time to volunteer work and led the team to develop relevant work in order to promote medical technology in western China and underdeveloped grassroots regions. In 2011, these activities required more than 410 hours of my volunteer service, including health lectures; free medical service; ward inspection, guidance and assistance; training, fundraising and donation of instruments and medicines; etc. Through volunteer assistance, we explored a feasible volunteer service model, namely: small action + many people + standardization = great

difference. A number of expert volunteers from various hospitals all over the country shared the tasks and provided centralized assistance, rapidly achieved medical technology promotion in assisted areas, and trained medical teams that would not leave local districts.

Under the current background of momentous medical reform in China, volunteers of the Loving Care Project cooperate with the government from the point of view of an NGO, carrying out a series of very fruitful tasks centering on the overall grassroots objective. The essence of the volunteer spirit is dedication, love, mutual help, and progress. What we do is to repay our motherland. The doctors can neither grow nor become experts without our national culture, social support, and patients. We go to places where we are most needed by the state, society, and patients; share our knowledge and technology; exchange technology and knowledge with the grassroots doctors; and guarantee health and warmth of the masses, so that more patients and more people benefit from our operation, thereby realizing both a harmonious doctor-patient relationship and harmonious society. The above work is highly praised by the government, society, media, and service interests.

I often advise people to have a healthy and happy life, and to take the opportunity to do the right thing. What is the right thing? I think that the right thing should take into account not only the interests of numerous people, but also the law of the development of things. Carrying out the Loving Care Project volunteer service is a right thing. At present, development of the grassroots medical technology in China is not balanced and needs to be enhanced. Promoting fair and attainable medical service still has a long way to go, and a number of poor patients in underdeveloped areas need to be treated. We also need to appeal to more expert teams to participate in and support the volunteer service work. I believe that as a way of life and a life attitude, volunteer service is bound to be accepted by more and more people. In conclusion: we are walking on the road!

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Americans share something that cuts across race, gender and politics:

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The Turks and Caicos has been heralded by many as the perfect Caribbean destination for those

looking to relax, be pampered, and get away from it all. Turks and Caicos is located south east of the Bahamas and is made up of forty islands, although only eight are inhabited. Providenciales is the most developed of all the islands and is home to an international air hub, making it easily accessible from anywhere. Flights from Miami arrive in about an hour and a half and from New York it takes less than three hours.

Providenciales is also home to the world’s most beautiful beach. Grace Bay Beach has been named the world’s best beach several times and is consistently recognized as one of the most beautiful beaches by Conde Nast’s “Best in the World” polls. The flawless white sand stretches on for 12 miles and is known for its impossibly blue water and vibrant coral reefs. Situated at the heart of the exquisite Grace Bay Beach, the Regent Palms fuses traditional Caribbean hospitality with prestigious amenities and guest services, to deliver all the charm of the Caribbean with five star luxury and comfort. Boundless ocean views from stylishly-appointed suites ensure peace and tranquility.

The 72-suite Regent Palms resort in Turks and Caicos is one of the Caribbean’s best-kept secrets, however this year it was awarded the coveted ‘Hotel of The Year’ Award by the Turks and Caicos Hotel and Tourism Association. This is a testament not only to the splendor of the hotel, but also to the attentiveness of the staff that will go out of their way to pamper and indulge you. Often lauded as the Turks and Caicos’ best property, the Regent Palms Spa has been listed by Conde’ Nast Traveler as the #2 in the Caribbean for the second year in a row.

Regent Palms’s signature dining experience at Parallel 23, an award winning AAA 3-Diamond restaurant was also honored as the Turks and Caicos number one restaurant last year. Parallel23 restaurant combines the best of Caribbean fusion cuisine with today’s more casual restaurant ambiance. Endless full-height French doors and a hi-tech display kitchen with wow-factor wood-burning oven invite diners to enjoy the theatre of food preparation, while an extensive boutique wine list introduces even the most knowledgeable guest to a new

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By Janet Wright, MD, FACCExecutive Director

Million Hearts™ Initiative

Cardiovascular disease is the leading cause of death for men and women of all races and ethnicities in the United States. Every day, nearly

5,500 Americans have a heart attack or stroke and more than 2,000 die from heart disease and stroke. What’s more, treatment of these diseases accounts for about $1 of every $6 spent on health care.

We have the science and the tools to fight heart disease and stroke and we have seen improvements, but we could prevent much more disability and save many more lives. That’s why in September 2011, the U.S. Department of Health and Human Services launched the Million HeartsTM initiative—a national effort by leaders in the public and private sectors to address the critical threat that cardiovascular disease poses to the nation.

Million Hearts™ is focused on preventing one million heart attacks and strokes by 2017. The initiative will achieve this goal through clinical and community prevention. Through community prevention, we will reduce the number of people who need treatment; through clinical prevention, we will optimize care for those who do need treatment.

Over the past few months, we have brought together an unprecedented commitment from partners across the government, and across society, to put those tools to use like never before for a common purpose.

Within the U.S. federal government, this effort is led by the Centers for Disease Control and Prevention and the Centers for Medicare & Medicaid Services. However, this commitment goes beyond the federal government to include a broad range of medical and public health associations, non-profits, foundations, community organizations, government agencies, and businesses. By bringing their ingenuity, their resources, and their leadership to this effort we will have a much greater impact than if the government acted alone.

Specifically, the initiative focuses on improving the ABCS (Aspirin for those at risk, Blood pressure control, Cholesterol management, Smoking cessation) to prevent one million heart attacks and strokes in the United States by the end of 2016.

To reach that goal, we are taking steps to help: » 10 million more Americans with high blood pressure

bring it under control » 5 million more Americans with high cholesterol bring

it under control » 4 million Americans quit smoking » Reduce the average sodium intake by 20% » Reduce the average trans fat intake by 50%

We’re early in our journey and we know that the road ahead will present many challenges. But in its first year, the Million Hearts™ initiative has made tremendous progress in raising awareness among health care professionals, patients, and communities about how they can help reach the goal of preventing a million heart attacks and strokes. For example, we emphasized the importance of blood pressure control through a number of activities:

» Million Hearts™ promoted the Community Preventive Services Task Force new recommendation that team-based care (TBC) improves blood pressure

Million Hearts™GALVANIZING CLINICIANS AND COMMUNITIES TO PREVENT U.S. HEART ATTACKS AND STROKES

Janet Wright, MD, FACC


control. The Task Force’s review of 77 studies showed that patients’ control of blood pressure improved when their care was provided by a team of health professionals—including nurses and pharmacists—rather than by a single physician.

» CDC, co-lead of the initiative, published the latest data on the toll that hypertension takes among Americans. Vital Signs: Awareness and Treatment among US Adults with Uncontrolled Blood Pressure stated strongly that there are many missed opportunities for blood pressure control. A collaborative effort and increased focus on blood pressure from individuals, healthcare providers and healthcare systems is key to better control and reduced risk for heart attack and stroke.

» CDC also launched the “Team Up. Pressure Down” campaign in support of Million Hearts™ to increase the number of pharmacists who provide advice, especially tips on taking blood pressure medications as prescribed, to their customers with high blood pressure. The campaign also is working to increase

consumers’ awareness about the importance of asking the pharmacist for help with taking medications.

Million Hearts™ public and private partners in 2012 also contributed to growing awareness of and engagement with the initiative through a variety of activities, including educating consumers about heart health; sharing lessons learned about integrating heart health into state and local programs, clinical practices and health systems; and providing blood pressure screenings and referrals for treatment when needed.

In future years of the initiative, we will be able to share reports on progress in attaining our goal. We will report on improvements on the ABCS every one to two years through surveillance and surveys and on deaths annually through the vital statistics system. The initiative continually seeks information about best practices and results from “high performers” that can be shared broadly for maximum impact.

Over time, Million Hearts™ expects to be able to share its experience globally. It’s no secret that cardiovascular disease is the world’s leading cause of death. As news has spread about the U.S. effort, other countries have expressed interest in the Million Hearts™ framework as they develop their own initiatives to reduce cardiovascular disease within their borders. Just as this initiative seeks to share best practices domestically, Million Hearts™ leaders have engaged in conversations with Ministries of Health in other countries about their efforts to document and monitor the burden of cardiovascular disease and set achievable targets.

The U.S. government has a long history of engaging with the global community on a variety of communicable and noncommunicable diseases, including cardiovascular disease. Besides providing expert guidance on disease surveillance and research priority setting, the U.S. government has provided faculty to teach cardiovascular disease epidemiology and prevention to increase the numbers of people worldwide who can conduct epidemiologic studies and strengthen other efforts to prevent cardiovascular disease. To date, more than 1,300 physicians and scientists from more than 100 nations have participated in more than 40 seminars. The U.S. government has also collaborated on cardiovascular disease prevention, including reducing sodium consumption and improving high blood pressure control, with Australia, China, the United Kingdom, India, the European Union, and countries in Africa, the Americas, and Southeast Asia. These experiences have taught us that the public health learning community is not limited by national boundaries. We have been pleased to share our experiences and technical expertise and have also learned from the best practices of other countries.

I look forward to the day when we see a sustained decline in the number of the world’s citizens who are disabled or who die as a result of heart disease and stroke. To be successful, every nation’s clinicians, health systems, communities, corporations, employers, and citizens must work together to improve their ABCS and realize the benefits for individuals and society of living a healthier lifestyle.

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imploding diseases

Intersection of

By Nadeem Afridi, MD, FACCSecretary, APCNA

NCD’s (non communicable diseases) are threatening the physical health and economic

security of many lower and middle-income countries (LMIC). In southeast Asia, it has been estimated that the share of death from NCD’s will increase from 51 percent to 72 percent of all deaths by 2030. In the Pakistan region, 1.3 billion people are at risk.

In most LMIC, there is wide spread prevalence of communicable diseases like malaria and tuberculosis. Now these populations face a “double burden” of disease with the onslaught of NCD’s.

There is emerging evidence that due to infectious disease related inflammatory burden plus the prevalence of risk factors for NCD’s and heart disease is emerging

at a much younger age. Another factor exacerbating the problem is that large populations are now living in poorly structured cities with congested housing, narrow streets and lack of open space for physical activity. This problem is far more severe for women since in many such societies women are expected to remain indoors. Consequently obesity, diabetes and hypertension have risen at an alarming rate for women in their 30’s and 40’s. This has lead to a higher burden of heart attacks and strokes which makes heart disease the number one killer for women internationally.

By 2030, it is estimated the population of Pakistan will exceed 245 million. Due to the Pakistani population transitioning from rural to urban areas, 60 percent of the population will be living in large cities. The infrastructure to accommodate such populations from rural area is lacking. This will continue to lead people to compete for fewer resources, increase stress, raise tobacco consumption and reduce mobility with diets that are calorie dense as well as rich in sugars.

Limited access to healthcare, lack of understanding of diseases processes along with the inability to afford medical care, puts such populations at a high risk of developing NCD’s that remain undetected until it is too late. In addition, health insurance is not accessible to a large majority of our population. This leaves 80 percent to 90 percent of all health care being paid as an out of pocket expense in this group.

There is now ample evidence, that once the breadwinner

and the will to tackle them

Nadeem Afridi, MD, FACC

In southeast Asia, it has been estimated that the share of death from NCD’s will increase from 51 percent to 72 percent of all deaths by 2030. In the Pakistan region, 1.3 billion

people are at risk.


in a household becomes ill, (earning less than $1,000 a year), the entire family is affected. Money has to be borrowed for treatment, children have to leave schools to join the work force at an early age and women have to sacrifice health for food. These circumstances are the factors that continue this vicious cycle of “poverty and ill health.” They will never be able to beat poverty therefore generations have to work their whole life to pay back debt.

Much of the rise in NCD’s in low to middle income countries is attributable to modifiable risk factors such as physical inactivity, unhealthy diet (including excessive sugars, fats and salt), tobacco use and exposure to environmental pollution. There is evidence to suggest that half of the burden of the NCD’s may be reduced through effective health promotion and disease prevention programs.

Most countries in this region lack the means to “treat there way out” of the NCD challenge (as seen in the West). To achieve MDG’s (Millennium Development Goals), strategies have to be devised that emphasize prevention and health promotion along with targeted screening and treatments. All strategies going forward have to be evidence based, context specific and cost effective. Community involvement, political will and multi-sector response are essential ingredients for such strategic planning. Targeted health system adaptations can stem the tide of uncontrolled, NCD related and outcomes.

The role of the health sector is to assess the magnitude of the problem. First, present the evidence to society at large, help shape interventions, monitor and evaluate the outcome.

To generate evidence of prevalence of life style, vascular risk factors and disease, Association of Pakistani-Decent Cardiologist of North America (APCNA) with its partners (IRD Research, Indus Hospital and University of Texas) conducted a population based study and randomly selected a cohort in a poor suburb of Karachi, Pakistan. Our goal was to assess the prevalence of life style risk factors that were leading to physical and biochemical changes which lead to predisposing the population to NCD’s

Ours is the first study among randomly selected households in a transition population in Karachi and provides evidence that Karachi, one of the largest and fastest growing Asian megacities, has both high rates of anthropometric and biological markers for NCD risk factors and infectious diseases. Our study identified 20 percent of the population was overweight and 8 percent obese, while 18 percent of the participants had hypertension, 8 percent were diabetic and 16 percent had borderline-to-high cholesterol. We also found that 23 percent of the population was underweight, 24 percent

of the population had been exposed to hepatitis B virus, and 8 percent were positive for hepatitis C virus. Our findings confirm that Karachi is experiencing a classic demographic and epidemiological transition with an increasing burden of over-nutrition and NCD’s adding

to an existing burden of under-nutrition and infectious diseases. We believe that

our findings highlight the need for longitudinal research in high-

burden transition communities and the urgency of public

health intervention programs tailored for these transition communities.

Despite the enormity of the problem especially in the low income communities, funding for NCD research and intervention is lagging. To conduct long term

surveillance work and devise cost effective interventions,

consortiums and collaborations have to be built such that stake

holders with common interests can pool there resources (both technical

and financial) together. This would allow supervision, targeted, contest specific,

cost effective interventions. Later, policy work can be conducted with governments to apply these learned lessons to larger populations.

Areas that need immediate attention include, community screening for disease and its risk factors (60 percent of hypertensive’s and 40 percent of diabetics, who have disease and do not know that they have disease), health education at schools on NCD’s at grades eight to twelve (including exercise, sweet drinks, and tobacco prevention), health promotion at the work place (educating tobacco abstinence, diet rich in fruits and vegetables). Community profiling including play grounds, stake holders, healthy food availability, accessibility to tobacco for kids under 18, has to be developed to devise a comprehensive response (Matrix of NCD). Most importantly, strategies have to be devised to educate and provide avenues for exercise for women, who are home bound (culturally promoted), giving the greatest sacrifices for the family and now getting afflicted by a higher share of the burden of NCD.

Heartbeat International Foundation and APCNA, along with groups with shared interests in combating NCD’s in LMIC, is embarking on a challenging task to prevent heart disease and promote health. Although the distances are long and Pakistan is a tougher environment to work in, it is these very populations that need the most help to beat the cycle of poverty of disease and ill health. With our previously built networks (pacemaker bank initiative), extensive knowledge of people and language, and recently completed survey work, the ground has been laid to tackle NCD’s at its roots.


Karachi is experiencing a classic demographic and epidemiological transition with an increasing burden of over-nutrition and NCD’s adding to an existing burden of under-nutrition and infectious diseases.

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Worldwide, the aging population, globalization, rapid urbanization, and population growth have fundamentally changed disease patterns.

Noncommunicable diseases (NCDs), of which cardiovascular disease (CVD) accounts for nearly half, have overtaken communicable diseases as the world’s major disease burden. CVD remains the No. 1 global cause of death, accounting for 17.3 million deaths per year, a number that is expected to grow to >23.6 million by 2030. Increasingly, the populations affected are those in low- and middle-income countries, where 80% of these deaths occur, usually at younger ages than in higher-income countries, and where the human and financial resources to address them are most limited [1].

The epidemiological transition occurring is exacerbated by the lack of vital investment in sustainable health policies to address and curtail the risk factors associated with CVD and NCDs. Recognizing the profound mismatch between the need for investment in the prevention and control of CVD at the global and national level and the actual resources allocated, the international CVD community, under the umbrella of the World Heart Federation, joined the NCD community to call for a United Nations (UN) High-level Meeting on Non-communicable Diseases, held in September 2011. At this meeting, heads of state signed a Political Declaration that committed governments to the development of 4 specific measures to address the

Our Time:

A CALL TO SAVE PREVENTABLE DEATH FROM CARDIOVASCULAR DISEASE (HEART DISEASE AND STROKE)

Writing Committee: Sidney C. Smith, Jr, MD, FACC, FAHA, FESC, Chair, Amy Collins, MA, Roberto Ferrari, MD, PhD, FESC, David R. Holmes, Jr, MACC, FAHA, FESC, Susanne Logstrup, Cand. Jur., MBA, FESC, Diana Vaca McGhie, MPA, Johanna Ralston, MA, MSc, Ralph L. Sacco, MS, MD, FAAN, FAHA, Hans Stam, PhD, Kathryn Taubert, PhD, FAHA, David A. Wood, MSc, FRCP, FRCPE, FFPHM, FESC, William A. Zoghbi, MD, FACC, FAHA The writing committee members represent the following participating organizations: World Heart Federation (S.C.S., A.C., J.R., K.T.), American Heart Association (D.V.M., R.L.S.), American College of Cardiology Foundation (D.R.H., W.A.Z.), European Heart Network (S.L., H.S.), and European Society of Cardiology (R.F., D.A.W.).


NCD burden in a specific timeline: (1) Recommendations for a global monitoring framework that included NCD targets to be completed by the end of 2012; (2) development of a plan for an effective multisector partnership by the end of 2012; (3) national NCD plans by 2013; and (4) a comprehensive review to evaluate progress, to take place in 2014 [2].

CELEBRATING THE 2025 GLOBAL NCD MORTALITY TARGET

Celebrating the 1-year anniversary of the passage of the UN Political Declaration, it is timely that our respective organizations speak with a single voice to advocate for a set of public health interventions that have the potential to mitigate and reverse the rising rates of CVD and NCDs. In May 2012, during the World Health Assembly, Ministers of Health took the first critical step by agreeing to adopt a global target to reduce premature NCD mortality 25% by 2025, a target the global CVD community has been advocating since the UN High-level Meeting on Non-communicable Diseases [3]. We applaud the World Health Assembly for reaching a consensus on this bold goal.

The UN Political Declaration on NCDs and the recent resolution to reduce premature NCD deaths by 25% are landmark achievements for the health and CVD community. For the first time in history, NCDs have been recognized as a development issue. These targets and indicators have the potential to address longstanding health challenges, including the fragmentation of health funding, gaps in the healthcare infrastructure, and the lack of local and reliable data, and will address the growing demand for integrated disease management. As the Millennium Development Goals come to a close in 2015, the CVD community is set to ensure that the single largest cause of death—CVD—is addressed. As such, all relevant stakeholders need to be part of the process, putting optimal health at the cornerstone of development.

It is our desire to see heart disease and stroke receive the attention they deserve. We recognize that the process is complex and the time is short, but we have an opportunity to ensure that the commitments made in September 2011 translate into real global, and thus national, action for years to come. Collaboration among appropriate stakeholders will

be necessary to address this emerging 21st century global health priority and begin to reverse the devastating toll of CVD and NCDs in our communities.

MAINTAINING THE MOMENTUM TO ADDRESS OTHER TARGETS

A first step toward global action has been the passage of the global mortality target, which will provide a shared vision on NCDs for all stakeholders and ensure that all targets are appropriately developed to achieve this overarching goal. As the leading organizations that represent thousands of members in nearly every country, and for the millions of individuals with, or at risk of CVD, we are aligning with the broader NCD community in support of a comprehensive set of additional targets that will ensure this global reduction is achieved.

The challenge faced by countries will be to reach agreement concerning the additional targets and indicators to be part of the comprehensive monitoring framework to achieve the overarching global mortality target. In the summer of 2010, a World Health Organization (WHO) technical working group developed 10 proposed global targets (Appendix A), which remained virtually unchanged until the spring of 2012 [4]. At that time, Member States, civil society organizations, and other relevant stakeholders were asked to comment on and make specific recommendations regarding the global monitoring framework for NCDs and the specific targets and indicators that would be used to guide countries and measure progress. The original set of 10 targets was reduced before completion of regional consultations and with limited input of Member

person, this translates to <US$1 a day (US$0.43-US$0.90) across low-income countries and<US$3 a day (US$0.54-US$2.93) across middle-income countries [11].

Several of the 10 targets being supported by theNCD community have been identified within thiscore set of “Best Buy” interventions and are at riskof failing to be adopted as global targets, includingthe evidence-based drug therapy regimen to addressthose at highest risk for developing CVD. Studieshave indicated that nearly 17.9 million deaths couldbe averted over a 10-year period with the implemen-tation of multidrug therapy [11]. The cost wouldamount to just over US$1 a day annually. Beyondthe lives saved and the life-years extended, reducingthe mortality rate for ischemic heart disease andstroke by 10% would also reduce economic lossesin low- and middle-income countries by an esti-mated US$25 billion per year [12]. Drug therapy,singly or in combination with multiple drugs, isdocumented to be a concrete investment and shouldbe a target to be accomplished.

As Member States look to finalize targets in thecoming months, doubt regarding country-levelcompliance in the implementation of NCD inter-ventions, as a result of underdeveloped monitoringand surveillance systems, must not overshadow thereal, cost-effective, and feasible solutions offeredby the WHO “Best Buys.” Collection of data, forall targets, remains a critical issue that can, andshould, be addressed through the Global Moni-toring Framework. It is recognized that target levels

may vary slightly in different regions of the world.As such, when considering national NCD actionplans, all targets will require adequate and well-developed indicators that encourage the improve-ment of data at the country level and provide animpetus to countries that have the tools to collectand monitor data. Moreover, improved healthcaredelivery and an expanded health workforce withcoordination of local and national approaches areparamount in building comprehensive healthsystems to achieve this end.

GLOBA L CARD I OVA S CU LARTA S K FORC E SUMMARY PO S I T I ON :P R E V EN T I ON , R I S K FA C TOR S , ANDT R EA TMENT

Member States have taken the first step and seta bold overarching goal of reducing mortality fromNCDs by 25% by 2025. We now have the opportu-nity to make meaningful changes in our countries byadopting evidence-based targets and implementingtactics that will guide health policy, chronic diseaseplans and, ultimately, resources for national publichealth interventions. Many of these are feasibleand cost-effective. Reducing NCDs are central toa country’s economic growth. As such, we respect-fully request Member States to consider our recom-mendations and adopt the evidence-based targets toaddress CVD and NCDs and avert millions ofdeaths by 2025.

Table 2. Proposed Targets and Indicators to Address NCDs With Some Support (See Appendix C)

Proposed Target

Best

Buy

Recommendation to

Member States

5 Saturated fat intake: 15% Relative reduction in mean proportion of total energy intake from

saturated fatty acids (SFA), with aim of achieving a recommended level of <10% of total energy

intake

U Adopt with modification

6 Obesity: Halt the rise in obesity prevalence Adopt

7 Alcohol: 10% Relative reduction in overall alcohol consumption (especially hazardous, excessive, and

harmful drinking)

U Adopt with modification

8 Raised cholesterol: 20% Relative reduction in prevalence of raised total cholesterol Adopt

9 Drug therapy to prevent heart attacks and strokes: 50% Of eligible people receive drug therapy to

prevent heart attacks and strokes, and counseling

U Adopt

10 Essential NCD medicines and basic technologies to treat major NCDs: 80% Availability of basic

technologies and generic essential medicines required to treat major NCDs in both public and

private facilities

Adopt

NCDs indicate noncommunicable diseases.

Smith et al. G L O B A L H E A R T , V O L . - , N O . - , 2 0 1 2

A Call to Save Preventable Death From CVD- 2 0 1 2 : 1 – 9

4

are to be noted as the list of recommended targetsfor adoption includes 10 strong, evidence-basedstrategies. Together, the Global CardiovascularDisease Taskforce calls on the CVD communityto endorse and support the top 4 widely supportedexposure targets (Table 1) on physical inactivity,hypertension/blood pressure, dietary salt intake,and tobacco as those required to achieve the over-arching goal of a 25% reduction in prematuremortality by 2025.

Other, originally proposed targets to addressNCDs that were dropped in the second WHOdiscussion paper include evidence-based targets onobesity, trans fat/fat intake, alcohol, and multidrugtherapy to prevent and treat CVD (Table 2) [7].Although these targets have been included in themost recent discussion paper, they have been iden-tified as having limited support and will needfurther advocacy to ensure their adoption [7]. Inaddition to supporting the NCD community intheir call for Member States to agree on this globalset of 10 voluntary targets, we also explicitly call forMember States to be ambitious and ensure that theyaddress those persons at highest risk now by adopt-ing the additional exposure and health systemstargets currently under consideration.

To halt and reverse the NCD epidemic, it isparamount that the CVD burden be adequatelyaddressed, which requires that those living withCVD and at highest risk of developing CVD haveaccess to treatment and care. The 2011 report bythe WHO, Scaling Up Action Against Noncommuni-cable Diseases: How Much Will It Cost?, details a coreset of low-cost strategies, identified as “Best Buys”that all countries can implement to prevent and treatNCDs. This list includes population-basedmeasures to address risk factors and specific indi-vidual-based interventions, including a multidrugtherapy regimen of aspirin, a statin, and blood pres-sure-lowering agents to prevent heart disease and

stroke and to treat those with, or at highest riskof, heart disease and stroke [8]. As Member Statesdetermine how best to achieve this global target,the global CVD community looks to this packageof the WHO’s “Best Buys” as a critical way forward.

CVD AND THE WHO B E S T BUY S

With CVD as the largest single contributor toglobal mortality, accounting for nearly half of the36 million NCD deaths, and with a global cost ofnearly US $863 billion, achieving the global targetto reduce premature NCD deaths by 25% requiresthat CVD and its risk factors be adequatelyaddressed [9]. The Global Cardiovascular Taskforcesupports the set of recommendations identified bythe WHO as “Best Buys,” feasible and cost-effectiveinterventions that can be undertaken regardless ofthe income level of a country. This core set of inter-ventions are recommended at 2 levelsepopulation-wide measures to reduce exposure to risk factorsand interventions targeting individuals who alreadyhave NCDs or are at high risk of developingthemeand are implemented through a systematiclayered approach. Regarding population-wide riskfactor measures, the WHO has identified “BestBuys” in the areas of tobacco use, harmful use ofalcohol, salt intake, physical activity, and replace-ment of trans fat with polyunsaturated fat. Interven-tions targeting individuals include evidence-based,cost-effective medical therapies alongside coun-seling, as well as aspirin therapy for acute myocardialinfarction [10].

On the occasion of the UN High-level Meetingin September 2011, the WHO introduced a tool forlow-, middle-, and high-income countries to guideand estimate the feasibility of the implemention ofthis core set of NCD interventions [8]. The costof the interventions is <US$11.4 billion per yearin low- and middle-income settings. Yearly, per

Table 1. Suggested Global Targets to Address NCDs With Wide Support (See Appendix C)

Proposed Target

Best

Buy

Recommendation to

Member States

1 Physical inactivity: 10% Relative reduction in prevalence of insufficient physical activity U Adopt

2 Raised blood pressure: 25% Relative reduction in prevalence of raised blood pressure U Adopt

3 Salt/sodium intake: 30% Relative reduction in mean population intake of salt, with aim of achieving

recommended level of <5 g/d (2000 mg of sodium)

U Adopt

4 Tobacco: 30% Relative reduction in prevalence of current tobacco smoking U Adopt

NCDs indicate noncommunicable diseases.

G L O B A L H E A R T , V O L . - , N O . - , 2 0 1 2 Smith et al.- 2 0 1 2 : 1 – 9

A Call to Save Preventable Death From CVD

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States (Appendix B) [5]. Calls to action from the CVD, NCD, and specific risk-factor communities did, however, lead to positive changes within this reduced set of targets and included the insertion of a new target on physical activity. The inclusion of this target in the list of recommendations was a milestone in NCD advocacy efforts, ensuring that each of the major risk factors leading to NCDs was addressed. With the release of the third WHO discussion paper [6], the NCD community’s advocacy efforts are to be noted as the list of recommended targets for adoption includes 10 strong, evidence-based strategies. Together, the Global Cardiovascular Disease Taskforce calls on the CVD community to endorse and support the top 4 widely supported exposure targets (Table 1) on physical inactivity, hypertension/blood pressure, dietary salt intake, and tobacco as those required to achieve the overarching goal of a 25% reduction in premature mortality by 2025.

Other, originally proposed targets to address NCDs that were dropped in the second WHO discussion paper include evidence-based targets on obesity, trans fat/fat intake, alcohol, and multidrug therapy to prevent and treat CVD (Table 2) [7]. Although these targets have been included in the most recent discussion paper, they have been identified as having limited support and will need further advocacy to ensure their adoption [7]. In addition to supporting the NCD community in their call for Member States to agree on this global set of 10 voluntary targets, we also explicitly call for Member States to be ambitious and ensure that they address those persons at highest risk now by adopting the additional exposure and health systems targets currently under consideration.

To halt and reverse the NCD epidemic, it is paramount that the CVD burden be adequately addressed, which requires that those living with CVD and at highest risk of developing CVD have access to treatment and care. The 2011 report by the WHO, Scaling Up Action Against Noncommunicable Diseases: How Much Will It Cost?, details a core set of low-cost strategies, identified as “Best Buys” that all countries can implement to prevent and treat

APP END I X A . O R I G I NA L S E T O FTA RG E T S

Outcome Targets Indicator Source

Premature mortality from NCDs Unconditional probability of dying between

ages 30 and 70 y from CVD, cancer, dia-

betes, or chronic respiratory disease

Civil registration system, with medical

certification of cause of death, or survey

with verbal autopsy

25% Relative reduction in overall

mortality from CVD, cancer, diabetes,

or chronic respiratory disease

Diabetes Age-standardized prevalence of diabetes

mellitus among persons age �25 y (defined

as fasting plasma glucose �7.0 mmol/L

[126 mg/dL] or on treatment for diabetes)

National survey (with measurement)

10% Relative reduction in the prevalence

of diabetes mellitus (elevated blood

glucose level �7.0 mmol/L [26 mg/dL]

or on treatment for diabetes)

Exposure Targets

Tobacco smoking Age-standardized prevalence of current

tobacco smoking among persons age �15 y

National survey

40% Relative reduction in prevalence of

current tobacco smoking

Alcohol Per capita consumption of pure liters of

alcohol among persons age �15 y

Official statistics and reporting systems for

production, import, export, and sale or

taxation data and national survey

10% Relative reduction in alcohol per

capita consumption among persons

age �15 y

Dietary salt intake Age-standardized mean population intake

of salt per day in grams


Mean adult population intake of salt

<5 g/d (2000 mg of sodium)

Blood pressure/hypertension National survey (with measurement)


of elevated blood pressure (defined as

systolic blood pressure �140 mm Hg and/

or diastolic blood pressure �90 mm Hg)

Obesity Age-standardized prevalence of obesity

(defined as BMI �30 kg/m2) in persons age

�25 y


No increase in obesity prevalence

Prevention of heart attack and stroke Percentage of people age �30 y with a 10-y

risk of heart attack or stroke �30%, or

existing CVD who are currently on multi-

drug therapy (including glycemic control)


80% Coverage of multidrug therapy

(including glycemic control) for people

age �30 y with a 10-y risk of heart attack

or stroke �30%, or existing CVD

Cervical cancer screening Prevalence of women between ages 30 and

49 y screened for cervical cancer at least

once

National survey; health facility data

80% Of women between ages 30 and

49 y screened for cervical cancer at least

once

Elimination of industrially produced trans

fatty acids (PHVO) from the food supply

Adoption of national policies that eliminate

PHVOs in the food supply

Policy review

NCDs indicate noncommunicable diseases; CVD, cardiovascular disease; BMI, body mass index; and PHVO, partially hydrogenated vegetable oil.



6

AP P END I X B . R EDUC ED L I S T O FTA RG E T S

A P P END I X C . C U R R EN T S E T O FTA RG E T S

Outcome Targets Indicator Data Source(s)

Mortality from NCDs Unconditional probability of dying

between ages 30 and 70 y from CVD,

cancer, diabetes, or chronic respiratory

disease

Civil registration system, with medical certifi-

cation of cause of death, or survey with verbal

autopsy




Blood pressure/hypertension 25% relative reduction in the prevalence


systolic blood pressure �140 mm Hg and/or

diastolic blood pressure �90 mm Hg)




systolic blood pressure �140 mm Hg

and/or diastolic blood pressure

�90 mm Hg)


tobacco smoking among persons

age �15 y

National survey

40% Relative reduction in prevalence

of current tobacco smoking

Dietary salt intake Age-standardized mean population

intake of salt per day in grams


Mean adult population intake of

salt <5 g/d (2000 mg of sodium)

Physical inactivity Age-standardized prevalence of obesity

(defined as BMI �30 kg/m2) in persons

age �25 y

National survey


of insufficient physical activity in adults

aged �18 y

NCDs indicate noncommunicable diseases; CVD, cardiovascular disease; and BMI, body mass index.



ages 30-70 y from CVD, cancer, diabetes, or

chronic respiratory disease



autopsy




Exposure Targets

Alcohol Total (recorded and unrecorded) alcohol

per capita (�15 y) consumption within

a calendar year in liters of pure alcohol


production, import, export, and sales or taxa-

tion data

10% Relative reduction in overall alcohol

consumption (including hazardous and

harmful drinking)

Fat intake Age-standardized mean proportion of

total energy intake from saturated fatty

acids (SFA) in adults aged �18 y

National survey

15% Relative reduction in mean

proportion of total energy intake from

saturated fatty acids (SFA), with aim of

achieving recommended level of

<10% of total energy intake


among adults aged �18 y


Halt the rise in obesity prevalence

Physical inactivity Age-standardized prevalence of insufficient

physical activity in adults aged �18 y

National survey


of insufficient physical activity

(continued on next page)



7


NCDs. This list includes population-based measures to address risk factors and specific individual-based interventions, including a multidrug therapy regimen of aspirin, a statin, and blood pressure-lowering agents to prevent heart disease and stroke and to treat those with, or at highest risk of, heart disease and stroke [8]. As Member States determine how best to achieve this global target, the global CVD community looks to this package of the WHO’s “Best Buys” as a critical way forward.

CVD AND THE WHO BEST BUYSWith CVD as the largest single

contributor to global mortality, accounting for nearly half of the 36 million NCD deaths, and with a global cost of nearly US $863 billion, achieving the global target to reduce premature NCD deaths by 25% requires that CVD and its risk factors be adequately addressed [9]. The Global Cardiovascular Taskforce supports the set of recommendations identified by the WHO as “Best Buys,” feasible and cost-effective interventions that can be undertaken regardless of the income level of a country. This core set of interventions are recommended at 2 levelsepopulationwide measures to reduce exposure to risk factors and

interventions targeting individuals who already have NCDs or are at high risk of developing themeand are implemented through a systematic layered approach. Regarding population-wide risk factor measures, the WHO has identified “Best Buys” in the areas of tobacco use, harmful use of alcohol, salt intake, physical activity, and replacement of trans fat with polyunsaturated fat. Interventions targeting individuals include evidence-based, cost-effective medical therapies alongside counseling, as well as aspirin therapy for acute myocardial infarction [10].

On the occasion of the UN High-level Meeting in September 2011, the WHO introduced a tool for low-, middle-, and high-income countries to guide and estimate the feasibility of the implemention of this core set of NCD interventions [8]. The cost of the interventions is <US$11.4 billion per year in low- and middle-income settings. Yearly, per person, this translates to <US$1 a day (US$0.43- US$0.90) across low-income countries and <US$3 a day (US$0.54-US$2.93) across middleincome countries [11].

Several of the 10 targets being supported by the NCD community have been identified within this core set of “Best Buy” interventions and are at risk of failing to be adopted as global targets, including the evidence-based drug therapy regimen to address those at highest risk for developing CVD. Studies have indicated that nearly 17.9 million deaths could be averted over a 10-year period with the implementation of multidrug therapy [11]. The cost would amount to just over US$1 a day annually. Beyond the lives saved and the life-years extended, reducing the mortality rate for ischemic heart disease and stroke by 10% would also reduce economic losses in low- and middle-income countries by an estimated US$25 billion per year [12]. Drug therapy, singly or in combination with multiple drugs, is documented to be a concrete investment and should be a target to be accomplished.

As Member States look to finalize targets in the coming months, doubt regarding country-level compliance in the implementation of NCD interventions, as a result of underdeveloped monitoring and

AP P END I X B . R EDUC ED L I S T O FTA RG E T S

A P P END I X C . C U R R EN T S E T O FTA RG E T S


Mortality from NCDs Unconditional probability of dying

between ages 30 and 70 y from CVD,

cancer, diabetes, or chronic respiratory

disease



autopsy




Blood pressure/hypertension 25% relative reduction in the prevalence


systolic blood pressure �140 mm Hg and/or

diastolic blood pressure �90 mm Hg)




systolic blood pressure �140 mm Hg

and/or diastolic blood pressure

�90 mm Hg)



age �15 y

National survey



Dietary salt intake Age-standardized mean population

intake of salt per day in grams


Mean adult population intake of

salt <5 g/d (2000 mg of sodium)

Physical inactivity Age-standardized prevalence of obesity

(defined as BMI �30 kg/m2) in persons

age �25 y

National survey


of insufficient physical activity in adults

aged �18 y

NCDs indicate noncommunicable diseases; CVD, cardiovascular disease; and BMI, body mass index.



ages 30-70 y from CVD, cancer, diabetes, or

chronic respiratory disease



autopsy




Exposure Targets

Alcohol Total (recorded and unrecorded) alcohol

per capita (�15 y) consumption within

a calendar year in liters of pure alcohol


production, import, export, and sales or taxa-

tion data

10% Relative reduction in overall alcohol

consumption (including hazardous and

harmful drinking)

Fat intake Age-standardized mean proportion of

total energy intake from saturated fatty

acids (SFA) in adults aged �18 y

National survey


proportion of total energy intake from

saturated fatty acids (SFA), with aim of

achieving recommended level of

<10% of total energy intake


among adults aged �18 y


Halt the rise in obesity prevalence

Physical inactivity Age-standardized prevalence of insufficient

physical activity in adults aged �18 y

National survey


of insufficient physical activity

(continued on next page)



7

R E F E R E N C E S

1. World Health Organization, WorldHeart Federation, World StrokeOrganization. Global atlas on cardio-vascular disease prevention andcontrol: policies, strategies, and inter-ventions. Published 2011. Availableat: http://www.who.int/cardiovascular_diseases/publications/atlas_cvd/en/. Accessed August 7,2012.

2. United Nations General Assembly.Resolution adopted by the GeneralAssembly: 66/2: Political Declarationof the High-level Meeting of theGeneral Assembly on the Preventionand Control of Non-communicableDiseases. Adopted September 19,2011; published January 24, 2012.Available at: http://www.who.int/nmh/events/un_ncd_summit2011/political_declaration_en.pdf.Accessed June 26, 2012.

3. World Health Organization. 65thWorld Health Assembly document

A65/54: Second report of CommitteeA. Published May 25, 2012. Availableat: http://apps.who.int/gb/ebwha/pdf_files/WHA65/A65_54-en.pdf.Accessed August 7, 2012.

4. World Health Organization. WHOdiscussion paper: a comprehensiveglobal monitoring framework andvoluntary global targets for theprevention and control of NCDs.Updated December 21, 2011. Avail-able at: http://www.who.int/nmh/events/2011/consultation_dec_2011/WHO_Discussion_Paper_FINAL.pdf. Accessed August 7, 2012.

5. World Health Organization. WHOdiscussion paper: summary of feed-back from member states on the firstdiscussion paper on the proposedglobal monitoring framework andindicators and targets for the preven-tion and control of noncommunicablediseases. Published March 22, 2012.Available at: http://www.who.int/

nmh/events/2012/targets_feedback_summary_22032012.pdf. AccessedAugust 7, 2012.

6. World Health Organization. Revised[third] WHO discussion paper on thedevelopment of a comprehensive globalmonitoring framework, including indi-cators, and a set of voluntary globaltargets for the prevention and controlof NCDs. Published July 2012. Avail-able at: http://www.who.int/nmh/events/2012/ncd_discussion_paper/en/index.html. Accessed July 25, 2012.

7. World Health Organization. SecondWHO discussion paper: a comprehen-sive global monitoring frameworkincluding indicators and a set ofvoluntary global targets for the preven-tion and control of noncommunicablediseases. Published March 22, 2012.Available at: http://www.who.int/nmh/events/2012/discussion_paper2_20120322.pdf. Accessed August 7,2012.

continued


Raised blood pressure Age-standardized prevalence of raised

blood pressure among adults aged �18 y



of raised blood pressure

Raised cholesterol Age-standardized prevalence of raised total

cholesterol among adults aged �18 y



of raised total cholesterol

Salt/sodium intake Age-standardized mean adult (aged �18 y)

population intake of salt per day



population intake of salt, with aim

of achieving recommended level of

<5 g/d (2000 mg of sodium)

Tobacco Age-standardized prevalence of current


aged �15 y

National survey



Health Systems Response Targets

Drug therapy to prevent heart attacks

and strokes

Drug therapy to prevent heart attacks and

strokes (including glycemic control), and

counseling for people aged �40 y with

a 10-year cardiovascular risk �30% (includes

those with existing cardiovascular disease)

National survey

50% Of eligible people receive drug

therapy to prevent heart attacks and

strokes, and counseling

Essential NCD medicines and basic

technologies to treat major NCDs

Availability of basic technologies and

generic essential medicines required to

treat major NCDs in public and private

sector facilities, including primary care

facilities

Facility data

80% Availability of basic technologies

and generic essential medicines required

to treat major NCDs in both public and

private facilities

NCDs indicate noncommunicable diseases; CVD, cardiovascular disease.



8


surveillance systems, must not overshadow the real, cost-effective, and feasible solutions offered by the WHO “Best Buys.” Collection of data, for all targets, remains a critical issue that can, and should, be addressed through the Global Monitoring Framework. It is recognized that target levels may vary slightly in different regions of the world. As such, when considering national NCD action plans, all targets will require adequate and welldeveloped indicators that encourage the improvement of data at the country level and provide an impetus to countries that have the tools to collect and monitor data. Moreover, improved healthcare delivery and an expanded health workforce with coordination of local and national approaches are paramount in building comprehensive health systems to achieve this end.

GLOBAL CARDIOVASCULAR TASKFORCE SUMMARY POSITION: PREVENTION, RI S K FACTORS, ANDTREATMENT

Member States have taken the first step and set a bold overarching goal of reducing mortality from NCDs by 25% by 2025. We now have the opportunity to make meaningful changes in our countries by adopting evidence-based targets and implementing tactics that will guide health policy, chronic disease plans and, ultimately, resources for national public health interventions. Many of these are feasible and cost-effective. Reducing NCDs are central to a country’s economic growth. As such, we respectfully request Member States to consider our recommendations and adopt the evidence-based targets to address CVD and NCDs and avert millions of deaths by 2025.

REFERENCES1. World Health Organization, World Heart Federation, World Stroke

Organization. Global atlas on cardiovascular disease prevention and control: policies, strategies, and interventions. Published 2011. Available at: http://www.who.int/cardiovascular_diseases/publications/atlas_cvd/en/. Accessed August 7, 2012.

2. United Nations General Assembly. Resolution adopted by the General Assembly: 66/2: Political Declaration of the High-level Meeting of the General Assembly on the Prevention and Control of Non-communicable

Diseases. Adopted September 19, 2011; published January 24, 2012. Available at: http://www.who.int/nmh/events/un_ncd_summit2011/political_declaration_en.pdf. Accessed June 26, 2012.

3. World Health Organization. 65th World Health Assembly document A65/54: Second report of Committee A. Published May 25, 2012. Available at: http://apps.who.int/gb/ebwha/pdf_files/WHA65/A65_54-en.pdf. Accessed August 7, 2012.

4. World Health Organization. WHO discussion paper: a comprehensive global monitoring framework and voluntary global targets for the prevention and control of NCDs. Updated December 21, 2011. Available at: http://www.who.int/nmh/events/2011/consultation_dec_2011/WHO_Discussion_Paper_FINAL.pdf. Accessed August 7, 2012.

5. World Health Organization. WHO discussion paper: summary of feedback from member states on the first discussion paper on the proposed global monitoring framework and indicators and targets for the prevention and control of noncommunicable diseases. Published March 22, 2012. Available at: http://www.who.int/nmh/events/2012/targets_feedback_summary_22032012.pdf. Accessed August 7, 2012.

6. World Health Organization. Revised [third] WHO discussion paper on the development of a comprehensive global monitoring framework, including indicators, and a set of voluntary global targets for the prevention and control of NCDs. Published July 2012. Available at: http://www.who.int/nmh/events/2012/ncd_discussion_paper/en/index.html. Accessed July 25, 2012.

7. World Health Organization. Second WHOdiscussion paper: a comprehensive global monitoring framework including indicators and a set of voluntary global targets for the prevention and control of noncommunicable diseases. Published March 22, 2012. Available at: http://www.who.int/nmh/events/2012/discussion_paper2_20120322.pdf. Accessed August 7, 2012.

8. World Health Organization, 2011. Scaling up action against noncommunicable diseases: how much will it cost? Published September 2011. Available at: http://www.who.int/nmh/publications/cost_of_inaction/en/. Accessed August 7, 2012.

9. Bloom DE, Cafiero ET, Jané-Llopis E, Abrahams-Gessel S, Bloom LR, Fathima S, Feigl AB, Gaziano T, Mowafi M, Pandya A, Prettner K, Rosenberg L, Seligman B, Stein AZ, Weinstein C. The Global Economic Burden of Non-communicable Diseases. Geneva, Switzerland: World Economic Forum; 2011.

10. World Health Organization. Global status report on noncommunicable diseases 2010. Published April 2011. Available at: http://www.who.int/nmh/publications/ncd_report2010/en/. Accessed August 7, 2012.

11. World Economic Forum and World Health Organization. From burden to “best buys”: reducing the economic impact of non-communicable diseases in low- and middle-income countries. Published September 2011. Available at: http://www.who.int/nmh/publications/best_buys_summary/en/index.html. Accessed August 7, 2012.

12. Lim SS, Gaziano TA, Gakidou E, Reddy KS, Farzadfar F, Lozano R, Rodgers A. Prevention of cardiovascular disease in high-risk individuals in low-income and middle-income countries: health effects and costs. Lancet 2007;370:2054–62.


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GlobalDifference

AMERICAN COLLEGE OF CARDIOLOGY EXPANDS INTERNATIONAL FOCUS THROUGH EDUCATION, PRACTICE

STANDARDS INITIATIVES, COMMUNICATIONS


To these ends, the American College of Cardiology (ACC) has developed a comprehensive international strategy focused on expanding international participation in educational activities, furthering international knowledge exchange, encouraging international participation in practice standards and quality initiatives, and increasing communications around international issues and activities.

TAKING EDUCATION GLOBALOn the education front, the College’s international

leaders have spent the last several years enhancing the breadth of the ACC’s international education activities. Meetings like the ACC’s Annual Scientific Sessions and others held by national societies around the world are important for bringing together cardiovascular professionals, promoting knowledge exchange, and providing information on the latest evidence-based science. Ever-increasing web and video access make these meetings more globally accessible, particularly to those in countries with greater deprivation or conflict.

Among the changes, the ACC has developed a comprehensive international track at its own annual meeting with popular lunchtime symposia highlighting international society efforts on various topics of import to their respective communities. For example, with imaging and patient selection top of mind for physicians using catheter-based and minimally invasive surgeries, the joint ACC session with the Canadian Cardiovascular Society (CCS) focused on three-dimensional echocardiographic imaging, minimally invasive mitral repair, transcatheter aortic valve intervention, periprosthetic regurgitation closure and structural heart disease interventions. A Joint Session of the ACC and the Saudi Heart Association (SHA) featured representatives from the U.S. and the Kingdom of Saudi Arabia comparing and contrasting their countries’ registries and the patient experience.

In an interview during the conference, Huon Gray, M.D., chair of the ACC Assembly of International Governors (AIG) at the time and consultant cardiologist at the University of Southampton in the United Kingdom, explained the importance of these joint international sessions the best: “Cardiovascular diseases are conditions with global relevance,” he said, “and whilst their underlying causes are broadly the same the world over, the approach that countries take to their prevention and management vary significantly.”

In addition to the ACC’s annual scientific session, ACC faculty attends over 50 meetings each year around the world. The College also partners with international organizations to host innovative events abroad. After each year’s Scientific Sessions, a condensed “Best of ACC” program has attracted large audiences when presented in countries overseas. The ACC Cardiovascular Symposium, featuring Valentin Fuster and hosted in conjunction with the Brazilian Society of Cardiology (SBC), was another highly popular international presentation which drew 2,000 attendees in Sao Paulo in 2012.

The College has also tailored its Cardiovascular Leadership Institute program for international audiences. In February 2012, the ACC held its first-ever international program for Cardiovascular Trainees in Mexico. This two-day program featured case presentations and was hosted by the ACC Mexico Chapter. ACC’s international efforts also include cross-sectorial collaboration. One such initiative is the new ACC and ACC China Chapter atrial fibrillation (AFib) training program sponsored by Boehringer Ingelheim. This one-day program will be delivered at 10 different hospitals across China in 2013 and will help educate approximately 3,500 Chinese physicians.

SHARED KNOWLEDGE LEADS TO BETTER OUTCOMES

With nearly 1 in 4 cardiologists in the U.S. being

C ardiovascular disease (CVD) has no borders. It remains the number one cause of death around the globe. According to the World Health Organization, deaths from CVD and stroke currently account for 30% of global death and are expected to

reach more than 20 million within the next decade and 24 million by 2030.

Given these statistics, there is no denying room for considerable improvement in care. There is also a unique opportunity, particularly given today’s mobile and digital technologies, for cardiovascular professionals around the world to come together to help ease this global burden through the sharing of education and knowledge. Comparisons across the globe of issues and approaches to treating and preventing cardiovascular disease can provide important insights, unattainable within any one homogeneous group.


foreign medical graduates, it is natural for us to reach across national borders to improve cardiovascular care through the sharing of information. Knowledge exchange is a key tenet for improving global cardiovascular health.

A great example of collaboration is the “Twinning Program” partnerships between several ACC chapters in the United Sates and international societies. The Twinning project between the ACC California Chapter and the British Cardiovascular Society (BCS) is the longest running of the programs. Despite being more than 5,000 miles apart, the program provides many opportunities for collaboration on educational programs, resources, and participation in institutional visits, lecture tours, and observerships. Other Twinning programs between Pennsylvania and Italy, and most recently Florida and the Spanish Cardiology Society, are also currently underway.

“ACC’s international strategy has been immensely successful over the last several years,” said John Gordon Harold, M.D., ACC’s incoming president-elect, who launched the Twinning program with BCS. “It has stimulated the Twinning initiative, and created over 20 international chapters, the creation of the AIG, international fellowships, and many highly rewarding personal relationships that might never have come to be without the drive and support of ACC state chapters.”

Sharing knowledge with the next generation of cardiovascular professionals is also of vital importance. The ACC is working both within the United States and with several international chapters to develop mentoring programs for Fellows in Training (FITs). Currently, ACC’s FIT network consists of 825 young cardiologists from around the world. The ACC’s Mexico Chapter is one of the most active when it comes to mentoring FITs and finding innovative ways to integrate them into the chapter. In fact, the Mexico Chapter recently sponsored a FIT to attend the College’s 2012 Legislative Conference in Washington, D.C., in order to better understand the policymaking process in the United States and take back lessons learned to Mexico.

Of course, sharing information with patients is another important element. The ACC’s public-facing CardioSmart initiative aims to involve patients in their own care and educate them about heart disease and healthy lifestyle choices. Currently the majority of CardioSmart content is available in English and Spanish, but plans are in the works to translate the material into Arabic, Mandarin Chinese, and Portuguese as well. CardioSmart content in Mandarin will be featured prominently in the patient education event to be held at the 23rd Great Wall International Congress of Cardiology in Beijing.

QUALITY KNOWS NO BOUNDARIESQuality improvement is also an area in which

international collaboration can go a long way toward improving global health statistics. Online communities, such as the ACC’s Door-to-Balloon (D2B) Alliance, Hospital to Home (H2H), and Imaging in FOCUS communities, can now provide important forums for sharing best practices, raising questions about challenging cases, and providing information on local, regional, and/or country-specific

activities. Other, more public online communities like Facebook, Twitter and LinkedIn are also proving to be popular distribution channels for updates on the latest research and evidence-based guidelines, international activities, and opportunities to participate in case studies. Currently, the ACC’s social media properties have more international than U.S. followers.

Registry participation is also a growing area internationally that can also help with quality improvement. The ACC is exploring international participation in the National Cardiovascular Data Registry (NCDR) with several international hospitals from the United Arab Emirates,

THE COLLEGE HAS LAUNCHED ITS OUTPATIENT PINNACLE REGISTRY IN INDIA AND WILL LAUNCH IN BRAZIL LATER THIS YEAR, FOLLOWED BY CHINA IN 2013.


Saudi Arabia, Brazil, and India. The College has launched its outpatient PINNACLE Registry in India and will launch in Brazil later this year, followed by China in 2013. Using standardized, clinically-relevant data elements, international use of NCDR registries can potentially help reduce wasteful or inefficient clinical practices. The NCDR has made a considerable contribution toward improving the quality of cardiac care in the United States, and there is tremendous potential internationally to use registries to identify global gaps in care and help providers develop global best practices related to cardiovascular outcomes.

The College is also collaborating with its international counterparts on clinical documents and research. Most recently, the ACC was involved in developing an updated universal definition of myocardial infarction (MI), incorporating new developments related to cardiac biomarkers, more sensitive imaging techniques, and improvements in the management of patients with MI. The definition also distinguishes the various settings in which MI occurs, such as “spontaneous” and “procedure-related” MI.

“This is a truly global document that will be used worldwide. It will help doctors diagnose their patients so that they can provide the most appropriate treatment, and help researchers design clinical trials with standardized endpoints,” said Kristian Thygesen, M.D., co-chair of the document task force, upon the document’s release.

SHAPING GLOBAL HEALTH POLICYGlobal health policy is another

important focus of the ACC’s international efforts. Last year, in collaboration with the World Heart Federation, the American Heart Association, and the European Society of Cardiology, the ACC launched an advocacy effort during the first United Nations Summit on Non-Communicable Diseases (NCDs). The result was the publication of a U.N. Political Declaration that frames the

global effort to combat NCDs, and in May 2012, the World Health Organization (WHO) approved the goal of reducing mortality from NCDs by 25 percent by 2025.

Currently, the ACC and its partner organizations are calling on governments and the cardiovascular community to accelerate the progress on the commitments made last year and support the 10 evidence-based prevention targets, including the top four exposure targets on physical activity, tobacco, dietary salt intake, and hypertension/blood pressure. Additionally, the ACC is strongly urging the WHO to adopt treatment targets to treat the millions in

global cities who are already burdened with cardiovascular disease. In September, the Global Cardiovascular Disease Taskforce, a group of experts representing the ACC Foundation (ACCF), World Heart Federation, American Heart Association, European Heart Network, and European Society of Cardiology, jointly released a health policy statement urging timely global action to save preventable death from cardiovascular disease, including heart disease and stroke.

Among the recommendations: uptake of a set of interventions designed by the WHO which include cost-effective treatments that can be delivered regardless of the income level of a country. These include the widespread adoption of multidrug therapy regiment of aspirin, a statin, and blood pressure-lowering agents to prevent heart disease and stroke and to treat those with, or at high risk of, heart disease and stroke.

THE ROAD AHEADAs a result of the ACC’s successes in implementing

its international strategies to date, the ACC’s international member group is the fastest growing member segment in the College with representation in 125 countries. To meet the growing global needs of these members, the ACC recently transformed its international leadership structure, from an International Council to an Assembly of International Governors (AIG) made up of all of the governors from the more than 20 new international chapters. The AIG includes a steering committee made up of leaders representing the Americas, Asia, Europe, and the Middle East/Africa.

The goal of the AIG is to ensure a more efficient engagement with international members and encourage greater participation in the College’s activities. “We want to create a United Nations of cardiologists by tackling some of the worldwide challenges in heart health care through concerted action and, above all, through education,” said AIG Chair Christoph Bode, M.D. “Education is essential for the development of mankind and we want to contribute by expanding our knowledge of the heart through research, as well as translating the results into better prevention of and care for heart disease.”

There is still much to learn about the treatment of cardiovascular disease. Disease type, occurrence, and treatment vary with many factors. Yet, as a disease category, cardiovascular disease is unquestionably a leading cause of morbidity and mortality around the world. Moving forward, the ACC will continue to make progress toward:

» increasing international participation in educational activities,

» increasing international knowledge exchange, » increasing international participation in practice

standards and quality initiatives, and » increasing communication on international activities.

These goals are driven by the seriousness of the challenges we face. As the world seems to get smaller, there has never been a time of greater opportunity to forge stronger personal and professional relationships. We look forward to joining forces with our international partners and celebrating our shared progress.

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Many patients with an implanted cardiac device are concerned about whether or not they can travel. Activity and travel restrictions usually result from underlying medical problems and not from the device itself. With the right preparation and after consulting with their physician, patients should encounter no problems travelling with an implanted cardiac device. However, unforeseeable events may occur and with the new BIOTRONIK Travel Guide, which details hospitals for possible unexpected device follow up in countries all over the world, patients will have ease of mind during their travels.

By always carrying the patient and implantable cardiac device identification card, given at the time of the implantation, patients can have their device check up done in almost any part of the world. The new BIOTRONIK® Travel Guide now provides patients with a tool to find hospitals that offer support for BIOTRONIK devices at their holiday destination all over the world.

The Travel Guide can be found in the patient section of the BIOTRONIK web site. To find a device check up clinic for BIOTRONIK implants, the patient just needs to select the country and city of destination from the drop-down menu and the tool will give an overview of the closest clinic and how to reach it.

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it is an ICD, pacemaker or CRT device – was, with the right preparation, already safe from a device point of view. Unless patients with an implanted cardiac device are restricted by an underlying medical condition, patients can, after consultation with their physician, now enjoy their holidays, even during a longer stay or at (more) remote destinations.

The new Travel Guide now allows patients to travel fully prepared for unexpected situations, having the information about hospitals that offer support for BIOTRONIK implanted devices in more than 100 countries at their fingertips.

Due to the sensitive nature of active implantable devices, there are a few things that patients need to keep in mind when preparing for travel:

» Talk to your physician about your travel plans to ensure everything is fine with your implanted device in relation to the activities you plan to undertake.

» If you have a Cardio Messenger for Home Monitoring®, ask your doctor about taking it abroad.

» Ask your physician for a printout of your medical status, for example, a print-out report from the last device follow-up as well as for your medication.

» Make sure you pack your medication and your BIOTRONIK pacemaker / ICD identification card. You will need it at the airport security and it provides important information about your device if you should need a medical check-up during your holiday.

» While metal detectors will not interfere with your implanted device, it is advisable to not lean on or stand near metal detectors for any extended period of time. Instead ask the security personal for a private search instead of going through the detectors.

BIOTRONIK GmbH & Co. KGAs one of the world’s leading manufacturers of

cardiovascular medical devices, with several million devices implanted, BIOTRONIK is represented in over 100 countries by its global workforce of more than 5,600 employees. Known for having its finger on the pulse of the medical community, BIOTRONIK assesses the challenges physicians face and provides the best solutions for all phases of patient care, ranging from diagnosis to treatment to patient management. Quality, innovation and reliability define BIOTRONIK and its growing success—and deliver confidence and peace of mind to physicians and their patients worldwide. For more information, visit www.biotronik.com

For more information about the Travel Guide, to register your clinic or have your clinic’s details updated, please visit the patient section of the BIOTRONIK web site. We suggest bookmarking the page for easy and quick access during your travels.

The patient can search for clinics that offer support for BIOTRONIK® implanted devices all over the world. The simple lay-out and drop-down menu make the tool easy to use.

quality andprotection

quality andprotection

quality and

www.biotronik.com

Living with a BIOTRONIK cardiac device

Our patient-fi rst attitude motivates us to provide customers and their families with an ever-increasing sense of security. Therefore BIOTRONIK’s quality standards not only are among the highest in the industry, but we take great pride in exceeding them.

Eleven-month-old baby girl with Down syndrome saved by a clinical team using a pacemaker donated by BIOTRONIK.

One Heart Magazine 2012

Documents

Transcript of One Heart Magazine 2012