Advance Heart Failure Therapy

Susan George, APRN- CNP, CCNS, CCRN, CHFN

Epidemiology of Heart Failure

6 More deaths from heart failure (HF )than from all forms of cancer combined

4.9 million symptomatic patients; estimated 10 million in 2037

Incidence: About 550,000 new cases/year

Mortality: 10% within 1st year & 50% within 5yrs

The total estimated cost in 2009 was $27.9 billions

1991 2000 2005 2037

Hea

rt F

ailu

re P

atie

nts

in U

S(m

illio

ns)

3.54.8

4.9

10

Heart Disease and Stroke Statistics—2012 Update

Prevalence of HF

Heart Disease and Stroke Statistics—2012 Update

Hospital discharges for HF

Medicare Expenditures for Heart Failure

It is a complex clinical syndrome that can

result from any structural or functional cardiac disorders that impairs ability of the left ventricle to fill with or ejects blood

Definition of HF

Systolic dysfunction: Left ventricular ejection fraction

(LVEF) of less than 40% and is generally due to left ventricular enlargement.

Diastolic dysfunction: Impaired ventricular relaxation and distensibility resulting in an increase in ventricular filling pressures.

HF: Systolic v. Diastolic

Functional classification: NYHA class (I-IV)

Staging of HF: ACC/AHA stages (A,B,C,D)

Classification of Heart Failure

ACC/AHA staging of HF

NEJM. 2003;Volume 348:2007-2018

Life style modification Medications Electrical Therapy Advanced HF therapy - Transplant/ Mechanical

circulatory support (MCS).

Management of HF

Patients with HF have limited exercise capacity because of

dyspnea and fatigue. End stage HF patients have structural and functional

abnormality in skeletal muscle secondary to chronic hypoperfusion and physical deconditioning

Skeletal muscle dysfunction involving the respiratory muscles may contribute to dyspnea.

Heart failure patients have skeletal muscle atrophy and intrinsic skeletal muscular metabolic defects, leading to less efficient use high energy phosphates and more rapid accumulation of lactic acid

Exercise intolerance is also caused by hemodynamic disorders

Heart failure and exercise intolerance

Studies have shown that exercise leads to functional, pathophysiological, and hemodynamic improvement Enhanced peak/maximum VO2 (VO2 max) and

possibly peak cardiac output due to a higher workload achieved, and leg blood flow during exercise

Improved muscle energetics so that oxygen utilization becomes more efficient

Improvement in HF symptoms such as dyspnea and fatigue

Effects of exercise training in HF

Restoring autonomic cardiovascular control towards normal

by reducing sympathetic tone and increasing vagal tone Reduced neurohormaonal activity Improvement in endothelial function leading to vasodilation

of skeletal muscle blood vessel, possibly leading to increase in exercise capacity

Reduction in total peripheral resistance Reduction in plasma brain natriuretic peptide values Significant improvement in six-minute walk distance Significant improvement in NYHA functional class Exercise training may reduce HF related hospitalization and

improve health related quality of life

Effects of exercise training in HF

Advanced/End Stage HF Patient

• Severe exercise intolerance

• Heart failure wasting syndrome

• Cardiorenal syndrome

• Right heart failure

• Inotrope dependence

It is characterized by the presence of structural

myocardial disease and symptoms that limit daily activity (NYHA III/IV or stage D)

300,000 to 800,000 advance HF patients in US 20% stage D patients are younger than 65yrs- that is at

least 60,000 patients Cardiac transplantation provides increased longevity

and symptomatic relief Only 2200 organ donors in US Mechanical circulatory support with LVADs is a rapidly

evolving field and is a life saving therapy for patients with advanced heart failure

Advanced/End Stage HF

Transplant- When conventional medical

therapies are unsuccessful, cardiac transplantation is an option for treatment and to prolong life. Unfortunately, only 2200 patients each year receive heart transplants, because the number of patients awaiting transplants far exceeds the number of organs available.

Mechanical Circulatory support

Advanced HF therapy

Cardiopulmonary exercise testing: VO2 max

<14ml/kg/min if patients intolerant to BB; <12ml/kg/min in the presence of BB; or <50% of predicted VO2 in young patients (<50yrs) and women.

Acceptable pulmonary artery pressure Age <70 Diabetes well controlled Absence on neoplasm Psychosocial support

Listing criteria for Heart transplantation

Bridge to transplantation Bridge to decision Destination therapy Bridge to recovery

MCS Applications

REMATCH (The Randomized Evaluation of

Mechanical Assistance for the Treatment of Congestive Heart Failure) trial was the landmark study that approved the benefit of mechanical support for patients with end stage HF.

LVAD group showed significant improvement in survival and quality of life

MCS landmark Study

Non-reversible systolic HF- NYHA class IV Inotropic support, if tolerated No contraindication for listing as status 1A or

status 1B meet the following - Pulmonary capillary wedge pressure (PCWP) or pulmonary artery diastolic pressure (PAD) >20 mm Hg - Cardiac index < 2.2L/min/m or SBP <90 mm Hg Body surface area >1.2m

Indication for BTT

Advanced HF symptoms (class IIIB or IV) with one of

the following: - On optimal management, but failing to respond - Class III or IV HF and dependent on IABP and/or inotropes - Intolerant to ACE/ARB or BB Body surface are (BSA) >1.2 m Ineligible for cardiac transplant VO2 max <14ml/kg/min or <50% predicted VO2 max LVEF <25%

Indication for DT

Active systemic infection Uncorrectable aortic insufficiency Renal insufficiency that may require dialysis in

the near future History of cardiac transplant Any condition, other than heart failure, which

is expected to limit survival to less than 2 years

Exclusion Criteria

Pre-op MCS evaluation

Assessment of RV function

Nutrition Hemodynamics Renal function Gastrointestinal Hepatic function Hematology Coagulation

Peripheral vascular disease

Pulmonary function Infection Neurologic Psychosocial Psychiatric

MCS pre-op evaluation data is presented to a

multidisciplinary team and the candidacy s determined by the team.

MCS candidacy

Short-term MCS: intended to support a patient

with acute decompensated HF until patient recovers or until further long-term therapy is indicated based on recovery of end-organ function. Usually for few hour to days to less than 2wks.

Long-term MCS

Types of Devices

Left ventricular assist device (LVAD) Biventricular support (BiVAD) Total artificial heart (TAH)

Types of Long-term MCS

Thoratec Paracorporeal VAD (P-VAD) – BTT- for

patients with severe biventricular failure

Biventricular support (BiVAD)

Syncardia TAH – BTT- for patients with

severe biventricular failure

Total artificial heart (TAH)

1st generation- Pulsatile positive displacement

pumps- HeartMate XVE and Thoratec paracorporeal ventricular assist device (PVAD)

2nd generation: Continuous flow axial blood pump with an internal rotor- HeartMate II LVAD

Third generation- currently in development

Evolution of Devices

First generation pumps: HeartMate XVE

Second generation pumps: HeartMate II

HeartMate II is currently FDA approved for BTT and DT

Axial-flow, rotary ventricular assist system

Capable of flows up to 10 liters per minute

HeartMate II

High Speed Rotary Long Life Small Flexible Driveline Quiet Valveless Textured Blood

Contacting Surface Cost Effective

1

HeartMate II

Percutaneous Cable Connection

Bend Relief

Outflow Cannula

Blood Pump

Flex Section

Inflow Cannula

HeartMate II

Flow

Outflow Stator

Outflow Bearings

Rotor

Inflow Bearings

Inflow Stator

HeartMate II

More than 13,000 patients worldwide have now been implanted with the HeartMate II® LVAS.Over 5,500 patients on ongoing support Patients supported ≥ 1 year: 1,576 Patients supported ≥ 2 years: 883 Patients supported ≥ 3 years: 412 Patients supported ≥ 4 years: 161 Patients supported ≥ 5 years: 121 Patients supported ≥ 6 years: 26 Patients supported ≥ 7 years: 11 Patients supported ≥ 8 years: 1

HeartMate II

HM II system Controller

Microprocessor that: Delivers power to the pump Controls pump speed and

power Monitors, interprets &

responds to system performance

Performs diagnostic monitoring Indicates hazard and advisory

alarms Provides complete backup

system Automatic event recording Data logger capabilities

Power sources

- Power Module - Batteries

System Monitor Display Module Battery Charger

Common HM II Externals

ICU stay- 3-5 days IMC/Tele- 7-14 days Rehab- some patients will need inpatient

rehab

HM II Post-op period

Extensive patient and family education

regarding equipment handling and driveline exit site dressing change

Patient completes 7 modules and signs contracts of commitment and understanding

Aggressive PT/OT/Cardiac rehab Stabilize INR Dietary monitoring Set up home health if needed Discharge planning for community training

Post-op period

The HeartMate II is continuous flow, therefore

you may not feel a pulse Heart rate- only detectable by telemetry-

there may not be a palpable pulse! Blood pressure- may or may not be detected

with automatic BP cuff Arterial line monitoring or Doppler At each office visit check mean BP by Doppler Goal blood pressure is 70-90mmHg

HeartMate II

Transportation/Ambulation

Change patient to batteries

Take the black bag, which includes: Charged batteries-

minimum of one pair

Backup system controller

Disposable stethoscope

Many patients will need inpatient rehab Sternal precaution for 3 months No driving for 3 months No shower for 3 months No lifting over 5-10lbs for 2 months; then gradually

increasing Encourage regular exercise but avoid very strenuous

exercise Encourage patients get back to their regular hobbies No swimming or water aerobics Battery and controller should be secured well at all times

Activity instructions

Medications

Aspirin – prevents platelet aggregation Persantine – prevents platelet aggregation Plavix/Effient- occasionally used for platelet

inhibition Antiplatelets are adjusted based thrombo-

elastography (TEG) Coumadin- required, goal INR depends on

patients underlying comorbidities

Anti-Coagulation Guidelines

Bleeding Pump thrombus/Hemolysis Infection Stroke- Ischemic or hemorrhagic Right hear failure- usually immediate post-op

period

Complication