Advancements in Cardiac Surgery

2013 Cardiac Operations

Combined Valve

(No Aorta)

Isolated

Valve

Other

Isolated CABG

Aorta

13%16%

27%

22%

N = 4,405

18%

4%

Peds Congenital

*107 Adult Congenital Heart Surgeries distributed among the adult operations

US Cardiac Surgery

Cuyahoga

County

15%

Cardiothoracic Surgery

National Volume

Cardiothoracic Surgery

National Volume

20 County

30%

Cardiothoracic Surgery

National Volume

Ohio

9%

United States

42%

Cardiothoracic Surgery

National Volume

Patients from 76 Countries Outside the US

came for their Cardiovascular Care

0

1

2

3

4

5

6

7

8

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

0.00%

2.00%

4.00%

6.00%

8.00%

1975 90 93 96 99 2

2005

2008

Cardiovascular Surgery

Mortality8

6

4

2

0

%

2010 2011 UHC

Expected

2009 2012 2013

3 Stars in All 3 STS Categories!

Min89.3

10th

93.150th

96.790th

97.9Max98.9

Rating

Overall

CCF

CABG

Min85.2

10th

92.250th

94.890th

96.5Max98.2

Overall

CCF

AVR

Min78.7

10th

87.850th

91.690th

94.4Max97.0

Overall

CCF

AVR + CABG

Quality:

Measure of Excellence

“We are what we repeatedly do.

Excellence, then,

is not an act, but a habit.”

Aristotle, 384-322 BC

Value is driven by provider experience,

scale, and learning at the medical

condition level

“21st century care should

be innovative.”

“Collaborative care is

essential.”

Isolated Aortic

Isolated Tricuspid

1%

IsolatedMitral

14%

20%

Valves

N = 2,852

65%

Combined

Evolution of Surgical

Technique

• Full median sternotomy

• Upper hemi-sternotomy

• Mini right anterior thoracotomy

• Transapical valve

• Transfemoral valve

Safety must be maintained

Operative Approach – Isolated Valve

Transcatheter

Placement

Full

Conventional

Sternotomy

N = 960

32%

27% Mini

Sternotomy

10%19%

Mini

Thoracotomy

Robotic12%

Robotically-assisted Cardiac Surgery l November 3, 2014 l 19

Median

SternotomyMini

Thoracotomy

Totally

Endoscopic

Robotic

>450 procedures >150 procedures >150 procedures

Robotically-assisted Cardiac Surgery l November 3, 2014 l 20

4th intercostal

space is ideal

Camera

Port

Service

Port

Robotically-assisted Cardiac Surgery l November 3, 2014 l 21

SERVICE

PORT

Robotically-assisted Cardiac Surgery l November 3, 2014 l 22

Isolated Mitral Valve Mortality

%

6

4

2

00%.3%

STS Expected

STS Expected

ReplaceRepair*

*2013 only

1

2

3

4

0 50 100 150 200 250 300

Net Cost of Care

Co

st

Ra

tio

No. of Patients / Year

Robot vs. Sternotomy

AVR Volume Trend

400

#

300

200

02009 2012 20132010 2011

100

Primary

Reoperation

Aortic Valve Mortality

Isolated Combined

Primary

Reoperation

0% 2.1% 1.4% 3.7%

STS

Expected

%

10

6

4

0

2

8

STS

Expected UHC

Expected

UHC

Expected

Works well in larger patients

Traditional Aortic Valve

Choices

Mechanical Stented

xenograftStentless

xenograft

Homograft Autograft

(Ross)

0

20

40

60

80

100

2001 2002 2003 2004 2005 2006

Bioprostheses

Mechanical

Homograft

100

80

60

40

20

CCF Aortic Valve Replacements

Prosthesis Choice

%

1994 1998 20102002 20061990

Long Term Valve Outcomes

12,569 Perimount (CE) implants

1981-2011

30 yrs of data

3

6

9

12

15

40 50 60 70 80 90

Risk of Explant for SVD

Age (years)

%

Actual Risk within 20 years

New Valves

TAVR

Edwards - S3

Direct Flow - Salus

St Jude’s - Portico

Boston Scientific

- Sadra

Medtronic - CoreValve

TAVR over 400

• TA – TAVR, TAO

− N = 135

• 5 Deaths (3.8%)

• TF – TAVR

− N = 257

• Conversion 11 (5 TA, 2 Open AVR Rup)

(4.2%)

• 1 Death (0.4%)

• 2 Strokes (0.8%)

TAO Insertion

Transcatheter Mitral Valved Stent

Trans-Apical Mitral VaIve Implant

Delivery Systems

Echo images of valve

implanted in swine

Mitral Valved Stent

New Cleveland Clinic Valve Treatment

(GLX)

GLX Valve

Commence Trial

Univ of Maryland

St. Vincent’s Hosp – Indiana

Univ of Florida at Shands

Columbia University

Cleveland Clinic

Spectrum Health

Baylor St. Luke’s Houston

Univ of S. California

Emory Univ Hospital

Mt Sinai Medical Center

Univ of Kansas Med Ctr

0 5 10 15 20 25 30 35 40

CCF Valve Exchange Vitality45 Patients, European CE Label

Baylor Plano

Florida Hospital

Univ. Penn/Presby

Northwestern

Cleveland Clinic

Univ. of Michigan

ECHI

St. Luke’s

Pinnacle Health

Barnes Jewish

Swedish

Duke

Medical City Dallas

Mission

New York Univ.

Good Samaritan

Northshor/Lenox Hil

UPMC

UCLA

St. Tomas

Hoag

Beth Israel

Baptist

Cooper

0 10 20 30 40 50 60

EDWARDS INTUITY Overview

EDWARDS INTUITY Valve Flexible shaft delivery system

Note: EDWARDS INTUITY Valve System is not available for commercial distribution in the United States or Canada.

Note: EDWARDS INTUITY Valve System is not available for commercial distribution in the United States or Canada.

Procedure Overview

Perceval - Sutureless Valve

Prediction: In 10 Years:

• Percutaneous Valves, ASDs, Aortas,

PCI

− Outpatients

− Echo

− Local Anesthetic

Aortic Surgery

%

2,000

1,000

500

0

Open Asc Arch Repair

Open Des Thor Repair

Endo Des Thor Repair/TAA

Open Abd Repair/TAAA

Endo Abd Repair

2010 2011 20122009 2013

1,5001,178

6

Mortality

Aorta Surgery

%

Observed

4

2

0Expected

University HealthSystem Consortium (UHC) Comparative Database, January through November 2013 discharges

O/E Ratio = 0.8

2.8% 3.6%

Descending Thoracic Endovascular

Repairs: Proven Technology

Current Device Choices

Gore

Cook

Medtronic

Survival after Thoracic

Aneurysm Repair

365 730300

1.0

.8

.6

.4

.2

0

Open Surgical Control

Endograft

P=0.48

Days since treatment

Pro

ba

bilit

y o

f S

urv

ival

Bavaria. JTCVS, 2007.

The New Frontier:

Thoracoabdominal Aortic

Aneurysms

Acute Mortality: 7.4 –17%

• Older Age

• Co-morbid conditions

− COPD

− CRI

− CAD

− Frail

The Visceral Segment

0%

5%

10%

15%

Infrarenal Supraceliac

The more proximal the clamp,

the greater the mortality risk.

The greater the mortality risk,

the more benefit may be realized from

a minimally invasive procedure.

Thoracoabdominal Aneurysms

Standard Repair

Circa 1999

TAA - EVAR

Soltesz, Greenberg. Op Tech Thor and Card Surg, 2011.

Device Construct

Mortality for CCF TAAA 2008-

2011

2.8% 3.1%

Disasters occur when Hazards

meet Vulnerability

Cardiogenic shock

Progress

1980

Now

Left to die

Survival improving

with prompt therapy and

newer devices

Emergency Circulatory Support

ECMO

Tandem HeartImpella

Emergency Circulatory Support

ECMO

Tandem HeartImpella

ECMO

• Blood pump

• Rotaflow centrifugal pump

• Low cost, small size

• 0-10 L/min

• Oxygenator

• Quadrox D

• Minimal plasma leak

• Long-lasting

ECMOCleveland Clinic Experience

ECMOModes of Support

Veno-arterial

• Extracorporeal axial flow

pump: 0 - 5L/min

• Inflow: left atrium via

trans-septal puncture

• Outflow: femoral artery

• LAP and PCWP

• Myocardial oxygen

demand

• MAP and CO

Tandem Heart

Tandem Heart

Tandem Heart VersatilityConversion to ECMO

Tandem Heart VersatilityConversion to ECMO

EZ Tandem EZ Tandem with Transseptal

TH-021

1

2

3

• 21F micro-axial flow pump

• 9F peripheral insertion

• Flow: 0 - 5L/min

• Duration of support: 7 days

• Fully unloads left ventricle

Impella 5.0

Impella 2.5 and 5.0

Impella Positioning

~240 Million Population ≥ age 20 years old

HF=2.6 % Population* or

6.24 Million Total

~50 % Preserved Systolic Function 3.12 M

~50 % Systolic HF

3.12 Million

Advanced Stage C and Stage D ≥ age 20 years old

109,200 – 280,800

Advanced Stage C / NYHA class IIIB

93,600-124,800

80-85% Stage A-B

0.5-5 % Stage D

Stage D / NYHA functional class IV

15,600-156,000

15-20% Stage C (3-4% advanced

Stage C)

Chronic Heart Failure in the US

0

20

40

60

80

100

Leukemia Lung CA PancreaticCA

NYHA IVHF

%

1 year mortality

Chronic Heart FailureMortality Rate Similar to Aggressive Malignancies

1 Rose, Gelijns, Moskowitz, et al. NEJM. 345:1435-43, 2001. 2 Rogers, Butler, Lansman, et al. J Am Coll Cardiol. 50:741-47, 2007.

3 Hershberger, Nauman, Walker, et al. J Card Fail. 22:616-24, 2003.4 Gorodeski, Chu, Reese, et al. Circ Heart Fail. 2:320-24, 2009.

5 Data on file. Pleasanton, Calif: Thoratec Corp.

Risk factor reduction, patient and family education

Treat HTN, DM, CAD, dyslipidemia. ACEI or ARB

ACEI, BB in all. Is patient candidate for surgery?

Sodium restriction, diuretics

Aldosterone antagonists

Digoxin

Inotrope, nesiritide

VAD, TX

Stage A

High risk

with no

symptoms

CRT, ICD if applicable

Stage B

Structural

heart

disease,

no

symptoms

Stage C

Structural

disease,

prior or

current

symptoms

Stage D

Refractory

symptoms

requiring

special

intervention

Stages & steps:

treatment of

systolic HF

Hospice

Brief inotrope or nesiritide

ACEI, ARB’s if intolerant of ACEI, BB if MI or low LVEF

Biologic or Mechanical

Replacement

“Proposing heart transplantation to cure heart

failure is analogous to proposing the lottery to

cure poverty.” LW Stevenson, MD

“Cardiac transplantation is ‘epidemiologically trivial’ solution.”

Eric Rose, MD

5/4/2014 – 3,972 awaiting heart transplantation

2013 Transplant Activity

Transplants 44

Listed 73

Referrals 242

Full evaluations 182

Heart Transplant

#

100

80

60

40

0

20

2009 2010 2011 2012 2013

Centers within a 500 mile radius

For a sample of transplant programs

Depending on the geographic location of the center, the 500 mile radius for

each program includes from 4 to 67 other transplant programs

Number of Candidates Ever Actively

Waiting (2010-2012)

Each symbol represents one transplant center, with the size of the

symbol proportional to the number of centers within 500 miles

CC Heart Transplant TrendsMedian Wait Months

5.4

1.8

7.5

8.6

9.7

2005 2008 2011 2012 2013

12

10

8

6

4

2

0

Mo

nth

s

Slide Courtesy of Dr. Randall Starling

13.8

22.8

44.6 44.2

57.9

2005 2008 2011 2012 2013

12

10

8

6

4

2

0

CC Heart Transplant TrendsBridge to Transplant

Devic

es %

VAD Implants

2001 2003 2005 2007 2009 2011

80

60

40

20

0

#

Bridge to Decision

Destination Therapy

Bridge to Transplantation

2013

2000

3000

4000

5000

1975 78 81 84 87 90 93

1996

1999

2002

2005

2008

LVAD In Hospital Mortality

50

40

10

0

30

20

76 51#VAD pt’s/yr 56

Mortality

UHC expected

2010 2011 20122009 2013

66

%

66University HealthSystem Consortium (UHC) Comparative Database, January through November 2013 discharges

%

VAD Complications

40

30

20

10

0Re-op for Bleeding

RenalFailure

Stroke DeepWound

Infection

201120122013

AnyRe-op

CC Primary LVAD by Era

Months

after 2010-

Device <2010 2011 2012-13

Implant % % (Jan-Sep)

1 93 91 993 87 83 95

6 80 83 91

12 74 78 8624 51 61

SEvent: Death (censored at transplant or recovery)

At Risk

83 53 22 5

54 39 28 24 16 13 6 1

71 42 30 20 15 13 11 9 6

P (log-rank) = 0.0746

HeartMate II HeartWare HVAD

CE Mark, FDA Approved

BTT

DT

CE Mark, FDA approved

BTT

DT clinical trial

LVAD Technology

CircuLite Synergy Subcutaneous LVAD

Partial Support 2.5 to 3.5 L/min

CCF Total

Artificial Heart

Heart Transplantation2014

• Most patients who get a transplant will

be Status 1

• Majority will be on an LVAD

• Status 2 patients are unlikely to receive

a transplant but are unlikely to die

waiting

• LVAD survival very close to transplant

survival

www.heartware.com

54 gm

EU late 2013

US 2014

Trial design:

all comers

HVAD and MVAD

Side-by-Side Comparison

CAUTION – Investigational Device. Limited by United States law to investigational use.

Exclusively for Clinical Investigations.

Parameter HVAD MVAD

Pump Type Centrifugal Axial

Weight 160 g 58 g

Pericardial Volume 50 cc 15 cc

Priming Volume 15 cc 5 cc

Inflow OD Same Same

HeartMate III*

Hematologically Friendly, Proven Full

Magnetically Levitated VAD

“Artificial pulse”

Transplant Advancments:Transmedics Organ Care System

• Broaden retrieval distances/locations

• Increase marginal donor supply

Convergence: Hybrid Operating Room

Value

Best Quality

+

Highest capabilities

+

Competitive costs