9/30/15. Epidemiology. Management of Left Ventricular Assist Devices in Heart Failure Patients. Jennifer Mazzoni, DO FACC. I have no disclosures

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1 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) 1

2 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) 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 2

3 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 (logrank, 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: ) in patients with preserved EF heart failure. ACCF/AHA Classification 2013 Objective NYHA Subjective ACE or ARB B-Blocker Aldosterone blocker 3

4 Diagnosis 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 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 Beta Blockers Chronic CHF Medical Regimen Target Doses Metoprolol XL 200mg QD Carvedilol 25 mg BID Bisoprolol 10 mg QD Aldosterone agents Spironolactone 25 mg QD/BID Eplerenone 25 mg QD/BID ACE Captopril 50 mg TID Enalapril 20 mg BID Lisinopril 40 mg QD Quinapril Fosinopril 40 mg QD ARB OR DIG mg QD monitor in women >1.2 ng/dl Class 2A evidence B Candesartan 32 mg QD Valsartan 160 mg BID Losartan 50 mg QD 4

5 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) 5

6 REMATCH NEJM 2001 Survival 6

7 LVAD Trials INTERMACS INTERMACS Classifications 7

8 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) 8

9 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 9

10 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 (3/24/04) HeartMate II LVAD Anatomical Placement of HeartMate II LVAD 10

11 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 11

12 Specific Patient Conditions/Events: Changes Seen Power Flow (reading) PI or no change in Aortic pulse pressure Possible Causes to Evaluate Thrombus on stator or rotor Power Flow PI No change in Aortic pulse pressure Evaluate for suction event Suction event will present as pump speed suddenly dropping to auto speed low limit from the higher, fixed speed. 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 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 12

13 Hemodynamics CVP PA pressures Cardiac output O2 saturation Blood pressure Intake and output Anti-Coagulation HMII: - Warfarin to maintain INR 2 +/ ASA mg May see patients or reduced or no anticoagulation due issues with GI bleeding. Postoperative Complications Infection Assessment WBC, temperature Hypotension Sinus tachycardia SVR pump flow Redness or drainage from lines or incisions Culture and sensitivity Management 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 13

14 Hypotension SOB, Mental Evaluate Decrease Inflow 9/30/15 Postoperative Complications Infection: Percutaneous Lead Assessment Exit site care technique & immobilizing percutaneous lead per protocol Trauma to exit site Erythema or drainage from exit site Culture and sensitivity Management 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 ECG Assessment Heart failure symptoms pulmonary edema deterioration Potential PI events Decrease pump flow, power, PI Management Treat electrolyte imbalances Remove PA catheter and wean inotropes Consider anti-arrhythmic medications ECHO pump speed for excessive unloading pump speed if arrhythmias occur with PI events cannula position contact with septum or LV wall Carefully assess RV function Consider cardioversion, defibrillation ICD turned on Consider ICD 14

15 3 chamber-long axis view TEE 2 chamber view TEE Mitral valve 4 chamber view TEE INFLOW CANNULA 15

16 CT image of LVAD INFLOW CANNULA ECHO/CT LVAD Thrombosed Thank you!! 16