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Management of Left Ventricular Assist Devices in Heart Failure Patients

Jennifer Mazzoni, DO FACC Attending Cardiologist,

Deborah Heart and Lung Center

❖  I have no disclosures

Epidemiology ❖ The leading causes of death in the United States

are: • Heart disease (631,636 deaths per year) •  Cancer (559,888 deaths per year) •  Stroke (137,119 deaths per year) •  Chronic respiratory diseases (124,583 deaths per year) •  Accidents (121,599 deaths per year) •  Diabetes (72,449 deaths per year) •  Alzheimer’s disease (72,432 deaths per year) •  Influenza and Pneumonia (56,326 deaths per year) •  Kidney Diseases (45,344 deaths per year) •  Septicemia (34,234 deaths per year)

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Epidemiology

❖  Heart Failure(HF) affects approximately 6 million in US ❖  Current data reveals almost half is diastolic dysfunction with

preserved ejection fraction other half systolic dysfunction- about equal mortality

❖  Prevalence increases with age and after 80 years more women

than men are affected Go, AS et al Circulation 2013;127:e6 –e245.

Cost Analysis

❖  The estimated health cost for cardiovascular disease is 350 million annually.

❖ The estimated cost for congestive heart

failure is estimated $32 billion annually. Heidenreich et al. Circulation 2011; 123(8) 933-44.

Etiology

❖  Cardiomyopathy- Disease of Heart Muscle ❖  Ischemic- Coronary Disease-- #1 in US

•  Diabetic Microvascular Disease ❖  Non-ischemic

•  Hypertensive, Arrhythmogenic •  Valvular AS, AR, MR, MS, TR, PS, PR •  Viral •  Post- Partum •  Chemotherapy/Radiation •  Congenital including: Hypertrophic Cardiomyopathy, LV Non-

Compaction, Genetic- Idiopathic Dilated LV •  Arrythmogenic Right Ventricular Dysplasia •  Infiltrative Heart Disease

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Prognosis EF <40%

❖  The ADHERE heart failure registry has a prognostic chart which demonstrates the prognosis declines yearly and reaches 40% risk of mortality in patients with an EF less than 40% after 5 years from diagnosis.

Prognosis- Diastolic Dysfunction

(Circulation. 2007;116:II_597.) Patients with E/E’ > 15 at follow-up showed significantly lower cardiac event-free survival than in patients with E/E’ < 15 at follow-up (log-

rank, p=0.005). By multivariate logistic regression analysis, E/E’> 15 at follow-up was the only independent predictor of cardiac events (p=0.037, RR=6.1, 95% CI: 1.12–33.3) in patients with preserved EF heart failure.

ACCF/AHA Classification 2013

NYHA

Objective

Subjective

ACE or ARB B-Blocker Aldosterone blocker

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❖  History and Physical- Clinical diagnosis •  S3 gallop is a poor prognostic sign •  Rales, edema with JVD •  Lab Data-- BNP and Sodium, Potassium, Creatinine Clearance,

Magnesium, Chest X-Ray, CBC ❖  Echocardiography with/without Dysynchrony ❖  Cardiac Catheterization

•  Right and Left for Pulmonary Wedge Pressure and Cardiac Index/Output

❖  Myocardial Perfusion Imaging ❖  Cardiac CT and MRI

❖  Vo2 Exercise Test <10 ml/kg/min •  for prognosis and referral for transplant

evaluation

Diagnosis

Pharmacological Treatment- Evidence Based

❖  ACE (angiotensin-converting enzyme inhibitor) EF% •  SOLVD Prevention and Treatment(enalapril)35%, •  SAVE(captopril post-MI).40%, V-HeFT II,III(enalapril)45%, ATLAS(lisinopril)

30%, •  Prevention-HOPE(ramipril)>40%

❖  ARB(angiotensin II-receptor blocker) •  CHARM(candesartan)40% and CHARM-added, Val(sartan)-HeFT,40% •  ELITE, ELITEII(losartan)40%

❖  Beta Blocker •  COPERNICUS(carvedilol), MERIT-HF(metoprolol succinate),RESOLVD •  CIBIS II-Europe-(bisoprolol) •  CAPRICORN(carvedilol post- MI),US Carvedilol •  COMET(carvedilol vs metoprolol tartrate)Europe

Chronic CHF Medical Regimen Target Doses

Beta Blockers ❖  Metoprolol XL 200mg QD ❖  Carvedilol 25 mg BID ❖  Bisoprolol 10 mg QD ❖  Aldosterone agents Spironolactone 25 mg QD/BID Eplerenone 25 mg QD/BID ❖  DIG 0.125 mg QD

monitor in women >1.2 ng/dl Class 2A evidence B

ACE ❖  Captopril 50 mg TID ❖  Enalapril 20 mg BID ❖  Lisinopril 40 mg QD ❖  Quinapril ❖  Fosinopril 40 mg QD OR ARB ❖  Candesartan 32 mg QD ❖  Valsartan 160 mg BID ❖  Losartan 50 mg QD

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Treatment - Acute CHF

❖  No prospective, double-blind, placebo-controlled studies that show

benefit of any medication used in the treatment of acutely decompensated HF patients to improve 1-, 3-, or 5-year mortality. This includes inotrope therapy which is palliative therapy.

❖  The lack of answers to questions, i.e. initial dose and type of diuretics,

the optimal method of volume removal, and the role of vasodilators or inotropes, undermines our ability to institute effective therapy.

❖  May require lower doses of beta blocker and ACE in acute HF due to low

cardiac output with hypotension.

Major Device Treatments HF ❖  COMPANION Trial ❖ NICM and ICM ❖  EF < 35% QRS >120ms and NYHA Class 3-4 ❖ On Optimal Medical Treatment ❖  Bi-Ventricular Device and AICD ❖  19%(CRT), 43%(CRT-D) reduction in all cause mortality ❖  SCD-HFT ❖ NICM and ICM ❖  EF < 35% and NYHA Class 2 and 3 ❖  Single lead AICD ❖  23% reduction in all cause mortality

Treatment for End Stage

❖  LVAD for advanced HF- FDA approved (Left Ventricular Assist Device)

Candidates are refractory to medical/device treatment •  Heart Mate(HM) and

HMII and Heart Ware •  Destination therapy- (Class

IIa level of evidence B)

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REMATCH NEJM 2001

Survival

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LVAD Trials

INTERMACS

INTERMACS Classifications

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Longterm Implantable Durable Devices

VAD: Ventricular Assist Device •  A VAD is a mechanical circulatory assist device that is

used to partially or completely replace the function of a failing heart

•  Goal of device: to direct blood away from the failing

ventricle (Left and/or Right) and provide flow to the circulation (Systemic and/or Pulmonary)

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Indications for Use ❖  Bridge to Transplant

•  Non-reversible left heart failure •  Imminent risk of death •  Candidate for cardiac transplantation

❖  Destination Therapy •  NYHA Class IIIB or IV heart failure •  Optimal medical therapy 45 of last 60

days •  Not candidate for cardiac

transplantation

❖  For in-patient and out-patient use •  May be transported via ground

ambulance, fixed wing aircraft or helicopter

Considerations

❖ Contraindication: •  Inability to tolerate anticoagulation

❖ Other considerations •  Limited data on BSA < 1.3 m², use medical judgment •  Limited data on pediatric patients (Age < 18 years) •  Social support •  Acceptance of blood products •  Pregnancy •  Nonreversible end organ failure

VAD system: basic features

❖  Pump (VAD) –  Internal or external

placement ❖  Wearable or portable control system ❖  Power source

–  AC power or battery power that is outside of the body

❖  The pump can vary in method of operation, size and placement

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Key Design Features of HeartMate II LVAD

❖ Blood pump rotor is the only moving part ❖ Rotor spins on blood-lubricated bearings

designed for long life ❖ Blood pump is driven by an integrated electric

motor ❖ All motor drive and control electronics are

outside of the implanted blood pump ❖ Speed range: 6,000 to 15,000 rpm ❖ Flow range: 3 – 10 L/min

Rev. 12.0 (3/24/04)

HeartMate II LVAD

Anatomical Placement of HeartMate II LVAD

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Common HeartMate Peripherals ❖  Power sources

-Power Base Unit or Power module and Battery charger •  Batteries & clips

❖ Display Module

Patient Assessment ❖ Vital signs, fluid status, chest tube output ❖ Heart rate & rhythm ❖ Assess peripheral circulation for adequate perfusion ❖ Neuro checks ❖ 12 lead EKG ❖ ECHO ❖ Lab work

•  Chemistry profile •  Liver functions •  PTT, PT, INR •  CBC

Monitors…

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Specific Patient Conditions/Events: Changes Seen Possible Causes to Evaluate

➢  Thrombus on stator or rotor

➢  Evaluate for suction event ➢  Suction event will present as pump speed suddenly dropping to auto speed low limit from the higher, fixed speed.

Power

Flow (reading)

PI

or no change in Aortic pulse pressure

Power

Flow

PI

No change in Aortic pulse pressure

↔

Patient Management ❖ Measures to reduce pump pressures:

Maintain MAP 70-80mmHg (no higher then 90mmHg) with HM II.

**Continous flow pumps are pre-load dependent and afterload sensitive**

**Manual BP by Doppler is Gold standard for measurement**

•  Fixed mode only with HM II •  Maintain good blood glucose control

❖  Assess infection risks ❖  Nothing replaces a thorough patient assessment…look at the patient

first!

Blood Pressure Monitoring ❖  Due to the continuous-flow nature of the HeartMate II, it is often

difficult to find a pulse and measure blood pressure by the usual physical examination techniques

❖  Blood pressure measurement •  Arterial line early post-op •  Doppler ultrasound once A-line removed •  Automatic cuffs are inaccurate

❖  Targeting MAP with a goal of: •  Mean ≈ 70-80 mmHg •  Mean < 90 mmHg & SBP < 120 mmHg

❖  Hypertension •  Effects on pump support

–  May decrease forward flow –  Decrease in pump flow and power –  Increase in PI

•  In anti-coagulated patients, may increase risk of hemorrhagic stroke

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Hemodynamics

❖ CVP ❖ PA pressures ❖ Cardiac output ❖ O2 saturation ❖ Blood pressure ❖ Intake and output

Anti-Coagulation HMII:

- Warfarin to maintain INR 2 +/- 0.5 - ASA 81-325mg May see patients or reduced or no anti-

coagulation due issues with GI bleeding.

Postoperative Complications Infection

Assessment Management ·  ↑ WBC, temperature

·  Hypotension

·  Sinus tachycardia

·  ↓ SVR

·  ↑ pump flow

·  Redness or drainage from lines or incisions

·  Culture and sensitivity

·  Administer antibiotics targeted at culture results

·  Good hand washing!

·  Extubate and mobilize early

·  Remove invasive lines as soon as possible

·  Monitor CBC & temperature

·  Culture blood, urine, sputum for Temp. > 38.3° C

·  Drug therapy to increase SVR & treat hypotension

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Postoperative Complications Infection: Percutaneous Lead

Assessment Management ·  Exit site care technique &

immobilizing percutaneous lead per protocol

·  Trauma to exit site

·  Erythema or drainage from exit site

·  Culture and sensitivity

·  Administer antibiotics

·  Follow sterile technique when performing percutaneous lead exit site care and immobilization lead

–  Re-educate patient & staff on proper technique

·  Consider wound VAC for significant wound healing issues

Ventricular Arrhythmias Risk Factors

❖ Myocardial ischemia ❖ Drug toxicity ❖ Irritability or manipulation of natural ventricle ❖ Electrolyte imbalance ❖ Response to systemic problem ❖ Monitoring lines

Postoperative Complications Arrhythmias

Assessment Management ·  ECG

·  Heart failure symptoms

•  Hypotension •  SOB, pulmonary edema

•  Mental deterioration

·  Potential PI events

·  Decrease pump flow, power, PI

·  Treat electrolyte imbalances

·  Remove PA catheter and wean inotropes

·  Consider anti-arrhythmic medications

·  ECHO

•  Evaluate pump speed for excessive unloading

•  Decrease pump speed if arrhythmias occur with PI events

•  Inflow cannula position – contact with septum or LV wall

·  Carefully assess RV function

·  Consider cardioversion, defibrillation

·  ICD turned on

·  Consider ICD

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3 chamber-long axis view TEE

2 chamber view TEE Mitral valve

4 chamber view TEE

INFLOW CANNULA

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CT image of LVAD INFLOW CANNULA

ECHO/CT LVAD Thrombosed

Thank you !!