3/1/2017. Chronic Mechanical Support for Heart Failure. Heart Failure is a major driver of morbidity and mortality in the US 1-7

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1 Chronic Mechanical Support for Heart Failure Margarita Camacho MD, FACS Surgical Director Cardiac Transplant and Mechanical Assist Device Program RWJ/Barnabas Health Heart Centers at Newark Beth Israel Medical Center Newark, NJ Disclosures Sunshine Heart, Inc. Consultant Heart Failure is a major driver of morbidity and mortality in the US 1-7 Heart failure is a growing issue in the US ~6.0 million adults (2.8%) in the US have heart failure 670,000 new cases each year #1 reason for hospitalization in people >65 After 4 hospitalizations, median survival is <6 months 1. JACC HF. 2013;1: Rose EA, et al. Long-term mechanical left ventricular assistance for end-stage heart failure. N Engl J Med. Nov. 2001;5;345(20): Rogers, Butler, Lansman, et al. J Am Coll Cardiol. 2007;50: Hershberger, Nauman, Walker, et al. J Card Fail. 2003;22: Gorodeski, Chu, Reese, et al. Circ Heart Fail. 2009;2: Data on file. Pleasanton, Calif: Thoratec Corp. More costly than all forms of cancer combined 1

Transplants are considered the gold standard, but the supply of donor hearts is limited 1 Proposing heart transplantation to cure heart failure is analogous to proposing the lottery to

Current estimates of adult patients with advanced heart failure (HF) in the United States, with projected left ventricular assist device (LVAD) candidates. U.S. population estimate is derived from U.

Advanced Heart Failure Therapies Forum, Atlanta. 2013.

2 Transplants are considered the gold standard, but the supply of donor hearts is limited 1 Proposing heart transplantation to cure heart failure is analogous to proposing the lottery to cure poverty. LW Stevenson Current estimates of adult patients with advanced heart failure (HF) in the United States, with projected left ventricular assist device (LVAD) candidates. U.S. population estimate is derived from U.S. Census data. Estimate of HF prevalence is derived from latest American Heart Association (AHA) statistics. 2. UNOS Website: 3. O Connell. Advanced Heart Failure Therapies Forum, Atlanta HEART TRANSPLANTS Kaplan-Meier Survival (Transplants: January June 2010) N = 96,273 N at risk at 25 years = 112 ISHLT 2012 Survival is based on adult and J Heart Lung Transplant Oct; 31(10): pediatric transplant recipients Adult Heart Transplants % of Patients Bridged with Mechanical Circulatory Support* (Transplants: January 2000 December 2013) 2015 * LVAD, RVAD, TAH, ECMO JHLT Oct; 34(10): 33(10):

Timing earlier referral is best Identify candidates who will benefit from MCS Avoid end-organ damage Improve quality of life More rapid post-operative recovery if referred before co-morbidities begin

3 Timing earlier referral is best Identify candidates who will benefit from MCS Avoid end-organ damage Improve quality of life More rapid post-operative recovery if referred before co-morbidities begin to appear, i.e. renal dysfunction If referred earlier, they can be kept on the radar and receive timely intervention, rather than no intervention due to too late referral Avoid patients who are too sick to benefit BTT vs. DT 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 Not candidate for cardiac transplantation Bridge to Recovery Young patients with myocarditis or post-partum cardiomyopathy 3

limited Comfortable at rest and with ADL.

4 Profiling the patient with severe heart failure Profile 1: Cardiogenic shock Profound hypotension despite rapidly escalating inotropic support; acidosis; crash and burn Profile 2: Progressive decline Declining function despite IV inotropes, possible worsening renal function; sliding on inotropes Profile 3: Stable but inotrope-dependent Continuous IV inotropes +/- IABP or other mechanical supposrt, unable to be weaned Profiling the Patient. Profile 4: Resting symptoms Daily congestion at rest or during ADL (activities of daily living) Profile 5: Exertion intolerant Comfortable at rest or with ADL, but unable to engage in any other activity, living predominantly within house Profile 6: Exertion limited Comfortable at rest and with ADL. Profile 7: Advanced NYHA III Living comfortably with meaningful activity limited to mild physical exertion Mechanical Circulatory Support (MCS) Mechanical pumps using either axial or centrifugal flow that supplement or replace the blood flow generated by the native heart First generation HM XVE Second generation HM II Third generation HM 3/ HVAD 4

5 Indications for LVAD Placement NYHA FC IV Life expectancy <2 years Failure to respond to optimal medical management LVEF 25% Refractory cardiogenic shock or cardiac failure VO2 12 ml/kg / min Need for IV inotropes therapy Recurrent symptomatic sustained VT or VF in the presence of an untreatable arrhythmogenic substrate Relative contraindications Age >75 years CKDz with creatinine > 2.5 mg/dl Severe chronic malnutrition (BMI <21 (M) / <19 (F) Morbid obesity (BMI >40 kg/m2) Mechanical ventilation Severe mitral stenosis or moderate to severe aortic insufficiency Contraindications Potentially reversible cause of heart failure High surgical risk for successful implantation Recent or evolving stroke Neurological deficits impairing the ability to manage device Coexisting terminal condition (eg, metastatic cancer, cirrhosis) Abdominal aortic aneurysm 5 cm Biventricular failure in patients older than 65 years Active systemic infection or major chronic risk for infection 5

6 Contraindications Fixed pulmonary or portal hypertension Severe pulmonary dysfunction (eg, FEV1 <1 L) Impending renal or hepatic failure Multisystem organ failure Significant underlying psychiatric illness or lack of social support that may impair ability to maintain and operate VAD 6

7 VAD Complications Right ventricular (RV) failure Aortic insufficiency GI bleed Pump thrombosis and hemolysis Drive line infections (very rare in our institution) = 0.06% ( compared to the 20% in INTERMACS data) 7

Ventricular device innovation dramatically improves outcomes for patients with advanced heart failure HeartMate XVE Pulsatile

Technology Investigational* FDA Approved 2008 FDA Approved 2001 HeartMate SNAP-VE LVAD External control system promotes

to 10 liters per minute HeartMate Patients can ambulate and attend exercise classes Patients can be discharged home Important

8 Ventricular device innovation dramatically improves outcomes for patients with advanced heart failure HeartMate XVE Pulsatile Technology HeartMate II Continuous Flow Technology: Axial Design HeartMate 3 Continuous Flow Technology: Full MagLev Technology Investigational* FDA Approved 2008 FDA Approved 2001 HeartMate SNAP-VE LVAD External control system promotes patient discharge and mobility Textured surfaces minimize thromboembolic events and anti-coagulation therapy Able to supply up to 10 liters per minute HeartMate Patients can ambulate and attend exercise classes Patients can be discharged home Important reduction in the complications of bed rest Pulmonary insufficiency Bone demineralization Reduced muscular tone Decreased activity tolerance 8

9 REMATCH Long-Term Use of a Left Ventricular Assist Device for End-Stage Heart Failure N Engl J Med 2001; 345: , Nov 15, 2001 REMATCH Results (2-year follow-up) 54/61 (88%) medical patients died 41/68 (60%) LVAD patients died From extended follow-up (up to four years) of REMATCH patients: LVAD therapy renders significant survival and quality of life benefits compared with optimal medical management for patients with end-stage heart failure. Park SJ, Tector A, Piccioni W, Raines E, Geljins A, Moskowitz A, Rose E, Holman W, Furukawa S, Frazier OH, Dembitsky W: Left ventricular assist devices as destination therapy: a new look at survival. J Thorac Cardiovasc Surg 2005 Jan;129(1);9-17 9

10 REMATCH HeartMate Patients HeartMate Destination Patients HeartMate II Design Features Inflow Cannula Inserted into the apex of the left ventricle Outflow Graft Outflow Graft Anastomosed to the ascending aorta Bend Relief Preload Dependent is important for VAD patients Afterload Sensitive Maintain blood pressure MAP mmhg Volume Inflow Conduit Blood Pump 10

Functional Status NYHA Class I or II 98 percent of patients were

11 Contemporary Destination Therapy Results Park SJ. AHA Scientific Sessions, November Functional Status NYHA Class I or II 98 percent of patients were NYHA Class IV at baseline. 83% 82% 59% 0% n= Pagani F, Miller L, Russell S, JAAC: Vol 54, No 4,

Adverse Event Rates HM II Pilot Study vs HeartMate I (Events / Patient Year) HM II Pilot (n=46) HM I BTT Study (n=280) Bleeding* 0.7 1.5 Driveline Infection 0.3 0.8 Stroke 0.1 0.4 TIA 0.1 0.2 Other Neuro 0.

12 Adverse Event Rates HM II Pilot Study vs HeartMate I (Events / Patient Year) HM II Pilot (n=46) HM I BTT Study (n=280) Bleeding* Driveline Infection Stroke TIA Other Neuro *Defined as bleeding events that require surgery to resolve bleed or result in death Improved Survival in High-Risk Patients with Smaller Implantable LVAD s: Single-Center Experience over 3 Years M. Camacho M.D., D.A. Baran M.D., A. Martin NP, M.J. Zucker, M.D Newark Beth Israel Medical Center, Newark, NJ Purpose Materials & Methods Results Results The availability of smaller implantable left ventricular assist devices (LVAD s) is associated with decreased in-hospital mortality despite no decrease in Materials the acuity & Methods of this patient population. Materials & Methods The single-institution, singlesurgeon experience is reported over the past three years, from August 2005 to September Seventy-one implantable LVAD s were implanted (30 Heartmate XVE s, 34 Heartmate II s, 2 MicroMed DeBakey, 4 VentrAssist). The majority of these devices were placed as destination therapy. All patients were inpatients at the time of surgery. 14% of the patients were on ventilatory support pre-operatively (4 in 2006, 3 in 2007, 3 in 2008) and 50% were in cardiogenic shock on both intra-aortic balloon and inotropic support prior to LVAD implant. Results: Graphs The overall hospital mortality in this high-risk group of patients was 24.6%, with a significant decrease in mortality From 33% in 2005 to 12.5% in This coincided with a trend towards the use of smaller implantable LVAD s (22.2% in 2005 vs. 83.3% in 2008). While the hospital survival in patients on ventilatory support preoperatively (3 with Heartmate XVE, 7 with Heartmate II) was better than overall survival (80% vs. 74.4%), the two deaths in this group occurred in two of the three Heartmate XVE patients. The hospital mortality after Heartmate XVE implant was more than double that after Heartmate II implant (26.7% vs. 11.8%). No deaths were attributed to device malfunction or failure. Causes of death included prolonged sepsis with death greater than one month postoperatively (5), respiratory arrest (4), coagulopathy (2), progressive multi-organ failure (2), hepatic failure (1), renal failure due to atheroembolism (1), intracranial hemorrhage (1), depression and failure-to-thrive (1). Conclusion A large single-center, singlesurgeon experience suggests that the use of smaller implantable LVAD s is associated with significantly improved hospital survival despite little or no change in acuity of this patient the population 12

Driveline HeartHMate 3 Design Features Inflow Conduit Inserted into the apex of the left

important for VAD patients Afterload Sensitive Maintain blood pressure <90 mmhg Outflow

System Three important feature design: 1) True magnetic levitation 2) Artificial pulse

13 Driveline HeartHMate 3 Design Features Inflow Conduit Inserted into the apex of the left ventricle Outflow Graft Anastomosed to the ascending aorta Preload Dependent Volume is important for VAD patients Afterload Sensitive Maintain blood pressure <90 mmhg Outflow Graft Inflow Conduit Blood Pump Fully Magnetically Levitated Left Ventricular Assist System Three important feature design: 1) True magnetic levitation 2) Artificial pulse 3) Internal sintering with textured titanium microsphere to allow for a biocompatible surface 13

Conversely, hydrodynamic bearings are typically operated with much smaller gaps, 0.05 of a millimeter or so. ~ 0.5 mm along the side ~ 1.

14 HeartMate III*: Full MagLev Technology Key Design Benefits: Optimized Geometry HeartMate III secondary flow paths are ~0.5 mm along the side, and ~1.0 mm pump above and below the rotor. Conversely, hydrodynamic bearings are typically operated with much smaller gaps, 0.05 of a millimeter or so. ~ 0.5 mm along the side ~ 1.0 mm top and bottom *In development. Not approved for clinical use Fully Magnetically Levitated Left Ventricular Assist System Augmenting the pulsatility might benefit in AI/ bleeding/ thrombogenesis System Monitor Clinical Screen Heart Mate II Heart Mate III 14

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or TIA : 8% Momentum 3 Trial The MOMENTUM 3 U.S.

16 Bleeding: 38 % - post-op : 30% - GI bleed: 8% (vs25%) Infection: 36% - respiratory: 28% - sepsis: 16% - drive line: 10% Stroke: 12% (higher than expected) - ischemic: 8% - hemorrhagic: 4% Mild neuro: SZ or TIA : 8% Momentum 3 Trial The MOMENTUM 3 U.S. IDE Clinical Trial is a prospective, multi-center, unblinded randomized study comparing the HeartMate 3 LVAS to the HeartMate II LVAS in advanced stage heart failure patients (cls III/IV) as a non-inferiority trial Primary Endpoint Composite of survival to transplant/ recovery/ 6/ 24- months of LVAD support free of debilitating stroke or reoperation to replace the pump 16

17 HM3 Inflow cannula HM3 Outflow cannula 17

18 HM3 3D Inflow cannula HM3 3D Inflow color cannula 18

19 HM3 HM3 DeBakey VAD 19

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22 Adult and Pediatric Size Jarvik 2000 Hearts Jarvik 2000 FlowMaker Before-implant After-implant 22

Pericardial benefits No abdominal surgery No pump

redundant stators (dual motors) Designed to function

connector, or driveline circuitry failure.

Pump The HeartWare Ventricular Assist System Up to

moving part Hybrid magnetic / hydrodynamic

23 Pericardial benefits No abdominal surgery No pump pocket Pump Motor Construction HVAD Pump contains redundant stators (dual motors) Designed to function on a single stator without loss of therapeutic support. mitigates pump stoppage due to motor, pump connector, or driveline circuitry failure. Redundant Dual Motor Stators Cutaway of the HVAD Pump The HeartWare Ventricular Assist System Up to 10 liters of flow Advanced Impeller is the only moving part Hybrid magnetic / hydrodynamic suspension Wear-less system Two motors designed to provide power redundancy Thin (4.2 mm), flexible driveline with fatigue resistant cables 23

24 Pericardial Placement of HVAD Pump HeartWare System Peripherals IN THE HOSPITAL HeartWare Monitor with pump parameters & flow waveforms AT HOME HeartWare Controller with LCD display, audible alarms and 30 day data storage HeartWare Batteries & Charger: 2 Li-ION batteries last up to 12 hours Cardiowest Total Artificial Heart 24

htee IN MECHANICAL CIRCULATORY SUPPORT: A

Advanced Heart Failure and Heart Filling

25 htee IN MECHANICAL CIRCULATORY SUPPORT: A COLLABORATIVE APPROACH MARGARITA CAMACHO MD Surgical Director, Cardiac Transplantation and Mechanical CLAUDIA GIDEA MD Attending, Advanced Heart Failure and Heart Filling and Function are the Keys to Cardiac Performance 25

26 Post-Op Management Wean nitric oxide if used Plasma-free hemoglobin (normal less than 0.03) to rule out hemolysis Extubate after diuresis OOB in chair, and ambulate when Swan removed Aggressive physical mobilization LVAD-only or RVAD-only support: judicious weaning of inotropes HeartMate Fully Implantable System* Breakthrough technology to advance mechanical circulatory support. Mobile Tethered Free Forgiving Energy Transfer High-efficiency, user-friendly wireless energy transfer across a distance Designed for Advanced Implantation and Robust Battery Technology Flexible Lifestyle Eliminates the driveline and around the clock worn equipment. Custom battery technology Expected to last >3 yrs Slow degradation Reduced size Increased reliability of electronics *In development. Not approved for clinical use. Much improved but far from perfect GI Bleeding Von Willebrand factor deficiency Does non-pulsatility compromise vascular integrity? Pump Thrombosis Increasing incidence? (in the news.) Aortic Insufficiency High-risk re-operation to replace aortic valve Infection Less driveline (fixation/immobilization), occasional pocket 26

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Ventricular Assist Devices for Permanent Therapy: Current Status and Future

Ventricular Assist Devices for Permanent Therapy: Current Status and Future Prospects Francis D. Pagani MD PhD Professor of Cardiac Surgery University of Michigan April 28 th, 2012 Disclosures NHLBI and