Advanced Heart Failure and the Role of Mechanical Circulatory Support

Megan Shifrin, RN, MSN, ACNP-BCVanderbilt University

Objectives• Review current recommendations for advanced heart

failure management• Identify the different types of VADs currently in use• Identify the indications and contraindications for

placement• Overview of immediate post-operative management

and potential complications

Why Should I Care About Heart Failure or LVADs?

• Prevalence – According to the American Heart Association, there are close to 6 million Americans living with heart failure. • Incidence – Almost 550,000 new cases are diagnosed

annually. • About 300,000 people die each year of heart-failure related causes.

• Heart failure is the single most common cause of hospitalization in the United States for people over the age of 65. • In 2012 alone, there were 2,066 permanent LVADs placed in

patients.• These patients live in your community.

The Cost of Heart Failure Management in the United States

10.5%

9.7%8.2%

6.4%

11.9%

53.3%

Hospitalization$20.9

Lost Productivity/Mortality*

$4.1Home Healthcare

$3.8

Drugs/Other Medical Durables

$3.2

Physicians/Other Professionals

$2.5

Nursing Home$4.7

Total Cost

$39.2 billion

Heart Disease and Stroke Statistics—2010 Update: A Report From the AHA

Circulation, Feb 2010; 121: e46 - e215

Etiologies of Heart Failure• Non-ischemic cardiomyopathy

• Valvular disease• Viral/bacterial cardiomyopathy• Peripartum cardiomyopathy• Idiopathic/familial cardiomyopathy• Myocarditis• Connective tissue disorders• Drugs/Toxins• Alcohol

• Ischemic cardiomyopathy• Hypertension• Coronary artery

disease • Myocardial infarction

Increasing Severity

Class I

• Cardiac disease

• No symptoms• No limitation

in ordinary physical activity

Class II• Mild

symptoms (mild shortness of breath and/or angina)

• Slight limitation during ordinary activity

Class IIIa and IIIb• Marked

limitation in activity due to symptoms

• Comfortable only at rest

Class IV

• Severe limitations

• Symptoms even while at rest

• Mostly bedbound patients

New York Heart Association Functional Classification of Heart Failure

Goals of Heart Failure Management

1. Improving symptoms and quality of life

2. Slowing the progression or reversing cardiac and peripheral dysfunction

3. Reducing mortality

Addressing Heart Failure in 2013

Katz AM

Heart Failure

Pharmacologic Optimization of the Heart Failure Patient with LVEF <40%

(Strength of Evidence = A)• ACE inhibitors

• ARBs• To be utilized when intolerant to

ACE inhibitors due to angioedema or cough

• Patients intolerant to ACE-I due to renal insufficiency or hyperkalemia are likely to experience the same effects with ARBs

• Warfarin• In patients with atrial fibrillation,

pulmonary embolism, or TIA

• Beta Blockers

• Aldosterone Antagonists

• Hydralazine and Isosorbide Dinitrate• In African American population

with stage III and IV heart failure, strength of evidence = A

• Loop DiureticsLindenfeld, J, et al.J Card Failure2010; 6, 486-491

Pharmacologic Optimization of the Heart Failure Patient with LVEF <40%

Strength of Evidence = B• Antiplatelet agents

(Aspirin)• Ischemic etiology of HF

• Digoxin• In stage II and III HF

• Thiazide diuretics• Warfarin

• MI patients with LV thrombus

Strength of Evidence = C• Digoxin• In stage IV HF

• Metalazone

Lindenfeld, J, et al.J Card Failure2010; 6, 486-491

Pharmacologic Optimization of the Heart Failure Patient with LVEF <40%

Inotropes• Commonly used on an outpatient basis for stage IIIb – IV

heart failure• Milrinone and Dobutamine are the only FDA approved

drugs for outpatient use• Not recommended for acute heart failure exacerbations in

ischemic patients• Probable benefit in non-ischemic exacerbations

• OPTIME-CHF JAMA 2002; 287:1541-7

Non-pharmacologic Optimization of the Heart Failure Patient with Low LVEF

Cardiac Resynchronization Therapy (CRT)• LVEF <35%• NYHA class III – IV• QRS > 120 ms• Optimal medical therapy

Non-pharmacologic Optimization of the Heart Failure Patient with Low LVEF

Implantable Cardiac Defibrillators• Ischemic Etiology • (Strength of Evidence = A)

• Non-ischemic Etiology • (Strength of Evidence = B)

• Primary prevention of ventricular arrhythmias• LVEF <35% Lindenfeld, J, et al.

J Card Failure2010; 6, 486-491

Evidence of Progressing Heart Failure

Decreased end organ perfusion• Renal function• Liver function• Pulmonary function

We need more support!

Ventricular Assist Device (VAD)

Long-Term LVADImplanted surgically with

the intention of support for months to years

Short-Term LVADUtilized for urgent/

emergent support over the course of days to weeks

A mechanical circulatory device used to partially or completely replace the function of either the left

ventricle (LVAD); the right ventricle (RVAD); or both ventricles (BiVAD)

Things to Consider Before Placing ANY type of VAD Support

• Are there any contraindications to VAD support?• End-stage lung, liver, or renal disease• Metastatic disease • Medical non-adherence or active drug addiction• Active infectious disease• Inability to tolerate systemic anticoagulation (recent CVA, GI

bleed, etc.,)• Moderate to severe RV dysfunction for some LVADs

• What are our other issues in this particular patient?• What are the patient’s goals? What are our goals? • What happens if we don’t meet our goals?

Lietz and Miller Curr Opin Cardiol 2009, 24:246–251

INTERMACS SCOREInteragency Registry for Mechanically Assisted Circulatory

Support Long-Term LVAD

Ideal candidates are INTERMACS classes 3-4Short-Term LVAD

Candidates are INTERMACS

classes 1-2Not a LVAD Candidate

INTERMACS 1 or those with multisystem organ failure

Destination Therapy vs. Bridge to TransplantationLong-term placement

Destination Therapy (DT)• Not a heart transplant

candidate• NYHA IV• LVEF <25%• Maximized medical

therapy >45 of 60 days; IABP for 7 days; OR 14 days

• Functional limitation with a peak oxygen consumption of less than or equal to 14 ml/kg/min

• Life expectancy < 2 years

Bridge to Transplantation (BTT)

• Patient is approved and currently listed for transplant

• NYHA IV• Failed maximized medical

therapy

http://www.cms.gov/medicare-coverage-database

Adult FDA Approved LVADs

Bridge to Transplantation (BTT)

HeartMate II (Thoratec)HeartWare (HeartWare)

PVAD (Thoratec)IVAD (Thoratec)

Destination Therapy (DT)HeartMate II (Thoratec)

HeartMate II (Thoratec)

Basics of HM IIPump Speed (RPM) – How quickly the pump rotates

Pump Power (Watts) – Measure of motor voltage and current

Pump Flow (L/min) - Estimated value of the volume running through the pump

Pulsitility Index – The measure of the left ventricular pressure during systole

Immediate Post-op Management

VS

Management Considerations• Typically pulseless

• Use a doppler or arterial line for BP assessment (Target MAP 60-80)

• Afterload sensitive • An increase against pump propulsion is reflected in decreased

pump flow

• Preload sensitive• Anticoagulation status

• Correction of coagulopathy immediately post-operatively• At 24-48 hours, Warfarin with goal INR 2-3 +/- Aspirin, Dipiridamole,

Clopidogrel

• Should not receive chest compressions during an arrest• Patients still have heart failure

Potential Device Complications

Inflow cannula (poor position, obstruction)

Pump/rotor dysfunction (thrombus)

Battery dysfunction

Outflow graft (kink, leak)

Drive line infection / fracture

Controller malfunction

Hematologic Long-Term Complications

•GI bleed • 13-40% of LVAD patients• Constitute 9.8% of LVAD readmissions

• CVA (embolic and hemorrhagic) • 17% of patients who survived 24 months post-

implant

•Hemolysis • Increases rate of mortality by 25% over six months

“However beautiful the strategy, you should occasionally look at the results.”

Winston Churchill

Medical Management vs. LVAD

Rose, EA; et alNEJM 2001; 345:1435-1443

Survival Rates

Kirkland, JK, et. alJHLT 2013; 32:141-156

ADLs of DT Patients

Kirkland, JK, et. alJHLT 2013; 32:141-156

What Happens to These Patients?

• Shock Team Evaluation for mechanical circulatory support (MCS)

• Try to avoid the bridge to decision or the bridge to nowhere

Variations of Short-Term VADs

• Impella 2.5 and 5.0•Tandem Heart•CentriMag•ECMO (V-A)

Impella 2.5 and 5.0• Utilized for LV support only; not

appropriate to use with RV failure• Impella 2.5 can be inserted through

the femoral artery during a standard catheterization procedure; provides up to 2.5 L of flow

• Impella 5.0 inserted via femoral or axillary artery cut down; provides up to 5L of flow

• The catheter is advanced through the ascending aorta into the left ventricle

• Pulls blood from an inlet near the tip of the catheter and expels blood into the ascending aorta

• FDA approved for support of up to 6 hours

TandemHeart pVAD• Used for LV support; not

appropriate in RV failure• Cannulas are inserted

percutaneously through the femoral vein and advanced across the intraatrial septum into the left atrium

• The pump withdraws oxygenated blood from the left atrium and returns it to the femoral arteries via arterial cannulas

• Provides up to 5L/min of flow

• Can be used for up to 14 days

CentriMag

• Can be used for LV and/or RV support

• Cannula are typically inserted via a midline sternotomy

• Capable of delivering flows up to 9.9 L/min

• Can be used for up to 30 days

ECMO (VA)• Used for patients with a

combination of acute cardiac and respiratory failure

• A cannula takes deoxygenated blood from a central vein or the right atrium, pumps it past the oxygenator, and then returns the oxygenated blood, under pressure, to the arterial side of the circulation

• Can be used for days to weeks

Summary• The management of advanced heart failure is a

dynamic process that requires frequent re-evaluation

• Timing of LVAD placement is critical

• LVADs for DT have been shown to improve mortality rates and quality of life

• There are short-term VAD options available for emergent situations