Advanced Heart Failure and the Role of Mechanical Circulatory Support Megan Shifrin, RN, MSN, ACNP-BC Vanderbilt 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 Hospitalization $20.9 Total Cost $39.2 billion 53.3% Nursing Home $4.7 11.9% 6.4% 10.5% Physicians/Other Professionals $2.5 8.2% Lost Productivity/ Mortality* $4.1 9.7% Drugs/Other Medical Durables $3.2 Home Healthcare $3.8 Heart Disease and Stroke Statistics—2010 Update: A Report From the AHA Circulation, Feb 2010; 121: e46 - e215

Etiologies of Heart Failure Ischemic cardiomyopathy Hypertension Coronary artery disease Myocardial infarction Non-ischemic cardiomyopathy Valvular disease Viral/bacterial cardiomyopathy Peripartum cardiomyopathy Idiopathic/familial cardiomyopathy Myocarditis Connective tissue disorders Drugs/Toxins Alcohol

New York Heart Association Functional Classification of Heart Failure Increasing Severity Class I Class II Class IIIa and IIIb Class IV Cardiac disease No symptoms No limitation in ordinary physical activity Mild symptoms (mild shortness of breath and/or angina) Slight limitation during ordinary activity Marked limitation in activity due to symptoms Comfortable only at rest Severe limitations Symptoms even while at rest Mostly bedbound patients

Goals of Heart Failure Management 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 Diuretics Lindenfeld, J, et al. J Card Failure 2010; 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 Failure 2010; 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 Failure 2010; 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) 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) Long-Term LVAD Implanted surgically with the intention of support for months to years Short-Term LVAD Utilized for urgent/ emergent support over the course of days to weeks

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?

Interagency Registry for Mechanically Assisted Circulatory Support INTERMACS SCORE Interagency Registry for Mechanically Assisted Circulatory Support Long-Term LVAD Ideal candidates are INTERMACS classes 3-4 Short-Term LVAD Candidates are INTERMACS classes 1-2 Not a LVAD Candidate INTERMACS 1 or those with multisystem organ failure Lietz and Miller Curr Opin Cardiol 2009, 24:246–251

Destination Therapy vs. Bridge to Transplantation Long-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 Destination Therapy (DT) HeartMate II (Thoratec) Bridge to Transplantation (BTT) HeartMate II (Thoratec) HeartWare (HeartWare) PVAD (Thoratec) IVAD (Thoratec)

HeartMate II (Thoratec)

Basics of HM II Pump 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 Outflow graft (kink , leak) Inflow cannula (poor position, obstruction) Drive line infection / fracture Pump/rotor dysfunction (thrombus) Controller malfunction Battery dysfunction

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 al NEJM 2001; 345:1435-1443

Survival Rates Kirkland, JK, et. al JHLT 2013; 32:141-156

ADLs of DT Patients Kirkland, JK, et. al JHLT 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