1. The End Stage Heart Disease Jennifer Ellis, M.D., FACS The Washington Hospital Center November 9, 2010

2. Background Cardiovascular disease (CVD) is the #1 killer of Americans. 1 Blacks hospitalized with the most common type of stroke are less likely than white or Hispanic patients to receive evidence-based stroke care. 2 Even when they have insurance and are of the same social class, minorities often receive a lower quality of care than do their white counterparts. 4 It is the number one killer of women, blacks and Latinos. 1 Currently 1/3 the US Population is minority and by 2042 minorities will become majority! 3 1 American Heart Association, Heart Disease and Stroke Statistics Update 2008 2. Circulation: Journal of the American Heart Association 3. CNN Aug 2008 4. Alliance for Health Care Reform ” Racial and Ethnic Disparities in Health Care” Publication November 2006

3. Black Americans are more likely to have heart failure and suffer more severely from it 1 Black Americans are also more likely than other groups to: 1 develop symptoms at an earlier age have their heart failure get worse faster have more hospital visits die from heart failure Black Americans between the ages of 45 and 64 are 2.5 times more likely to die from heart failure than Caucasians in the same age range 2 African Americans and Heart Disease 1 National Heart Lung & Blood Institute: Heart Failure: Who is at Risk? 2 National Minority Quality Forum. Heart Failure in African Americans.

4. Latinos and Heart Disease Like other Americans CVD is the # 1 killer of Latino Americans 1 It is estimated that one out of every four Latino males – and one of every three Latino females – will die from heart disease and stroke 2 Latinos are hospitalized more often for heart attack 2 At least 65% of people with diabetes die from heart disease and stroke. Yet, only 1 in 4 Latinos with diabetes know that they are at risk for heart disease 3 1 American Heart Association: Heart Facts 2007 Latino/Hispanic Americans. 2 American Heart Association. Hispanic Heritage Month 3 National Diabetes Education Program. The Link Between Diabetes and Cardiovascular Disease.

5. Asian/Pacific Islander Americans South Asian Americans have highest rates of CAD worldwide Heart disease in young Indians is severe and diffuse Asian Americans have low awareness of the benefits of blood cholesterol testing CAD is more prevalent among South Asian American women

6. Limited-English-Proficient Americans Many non-English speakers are not provided with an interpreter at their healthcare visits Spanish-speaking Hispanics are among the least likely to know the symptoms of heart attack and stroke Spanish-speaking Latinos experience less access to health services than English-speaking Latinos

7. Figure 1 Evidence of Racial/Ethnic Differences in Cardiac Care, 1984–2001 What’s the Evidence? Disparities persist across many clinical settings and conditions Even after adjusting for: –Age –Health insurance –Socioeconomic status –Severity of conditions Source: Kaiser Family Foundation/American College of Cardiology Foundation, Racial/Ethnic Differences in Cardiac Care: The Weight of the Evidence, 2002 2 Studies Find the Racial/Ethnic Minority Group More Likely Than Whites to Receive Appropriate Care (2%) Total = 81 Studies 68 Studies Find Racial/Ethnic Differences in Care (84%) 11 Studies Find No Racial/Ethnic Differences in Care (14%)

8. The Cardiovascular Disparity Gap Cardiac Interventions among Medicare Patients with Acute MI by Race/Ethnicity Equally likely as white patients Odds ratio < 1.0 indicates group is less likely to undergo procedure compared to white patients * Difference is statistically significant after adjustment. Note: Odds ratios are adjusted for age, sex, insurance, health status, and disease severity. Data: Ford et al. 2000. Source: Kaiser Family Foundation, Key Facts: Race, Ethnicity and Medical Care, June 2003.

9. 2004 Survey of Cardiologists 69% 33% 12% 5% 0 10 20 30 40 50 60 70 80 90 100 % Agree That There Are Racial/Ethnic Disparities in Their Hospital Agree That There Are Racial/Ethnic Disparities in Cardiac Care Agree That There Are Disparities in Health Care By Insurance Status Agree That There Are Racial/Ethnic Disparities in Their Practice Source: Lurie, et al., Racial and Ethnic Disparities in Care: The Perspectives of Cardiologists, Circulation, March 15, 2005.

10. Disparities in Device Utilization Based on a study published in 2005 of the Medicare Population there are significant differences in treatment rates based on Gender and Race for patient groups we serve Source: Racial Trends in the use of Major Procedures among the Elderly NEJM 353;7 August 18,2005

11. Access Equalization Source: Calculated from Racial Trends in the use of Major Procedures among the Elderly NEJM 353;7 August 18,2005 Achieving equality in treatment rates would provide therapy for an additional 500,000+ patients In the Medicare Population + 3% for AAA +70% for CABG +8% for Valves +30% for Angioplasty

12. Left Ventricular Assist Devices (LVADs) Acute Cardiogenic Shock Historically: –Pharmacological agents –IABP –Abiomed BVS New Frontiers: –Abiomed AB Ventricle –Impella Recover System –Levitronix CentriMag Historically: –Pharmacological agents –IABP –Abiomed BVS New Frontiers: –Abiomed AB Ventricle –Impella Recover System –Levitronix CentriMag

13. Acute Cardiogenic Shock BVS® 5000 Limitations Essentially 5-7 day device Preload and gravity dependent (minimal vacuum assisted filling) Bedrest restricted Console supports BVS only

14. 2.5 lpm flow Up to 5 days support EU indications: AMI, high risk PCI Impella® Recover LP 2.5 System Percutaneous Pump Configuration Percutaneous placement 9F proximal, 12F distal 0.014” guidewire Blood inlet Blood outlet 9F catheter Pump

15. Destination Therapy LVADs “Heart Transplant-Equivalency” 1 st Generation  Large  “Pulsatile”  Moving parts  Large driveline  Limited life  BTT, DT 1 st Generation  Large  “Pulsatile”  Moving parts  Large driveline  Limited life  BTT, DT 2 nd Generation  Small  Continuous flow  Conventional wearing bearings wearing bearings  Smaller driveline  Limited life  Clinical trials in progress in progress 2 nd Generation  Small  Continuous flow  Conventional wearing bearings wearing bearings  Smaller driveline  Limited life  Clinical trials in progress in progress 3 rd Generation  Smallest  Continuous flow  Magnetically suspended suspended  Smallest driveline  Unlimited life  Clinical trials in progress in progress 3 rd Generation  Smallest  Continuous flow  Magnetically suspended suspended  Smallest driveline  Unlimited life  Clinical trials in progress in progress

16. Mechanical Circulatory Assist Devices Device Terminology Total artificial heart –Replace native heart Ventricular assist devices –Volume displacement pump Pulsatile flow: pusher-plate vs pneumatic First generation pump –Rotary pump Continuous flow Second generation: axial flow Third generation: centrifugal flow

17. Rotary Pumps Third Generation: Centrifugal Pumps VentrAssist (Ventracor) Coraide (Arrow) HVAD (HeartWare) DuraHeart (Terumo) Evaheart LVAS (Evaheart Medical) Rotary VAD (World Heart) HeartMate III (Thoratec)

18. VentrAssist™ LVAS Device Overview Weight: 298 g Diameter: 6 cm Diamond-like carbon- coated surfaces Hydrodynamically suspended rotor Low thrombosis rate Insignificant hemolysis 10 lpm at 120 mmHg Weight: 298 g Diameter: 6 cm Diamond-like carbon- coated surfaces Hydrodynamically suspended rotor Low thrombosis rate Insignificant hemolysis 10 lpm at 120 mmHg

19. HeartWare HVAD Pump Characteristics Small wearless, centrifugal pump, ~2” outside diameter Full output device with up to 10L/min flow capacity Only one moving part designed > 10 years of clinical use Integrated inflow cannula allowing pericardial implantation High reliability: dual stators, passive impeller suspension Small driveline designed to minimize exit site infections

20. Left Ventricular Assist Devices (LVADs) Overview Augment or replace native LV function Native heart remains “intact” Indications: refractory left heart failure –Bridge to transplant –Bridge to recovery –Lifetime therapy (ineligible for heart transplant)

21. End-Stage Systolic Heart Failure Ultimate Therapy Totally implanted, mini-centrifugal pump Passively, magnetically suspended Sealless No man-made contacting surfaces ? Intravascular

22. LVAD Current Limitations Limitations of currently available VADs Risk of thromboembolic events Risk of infection, especially due to percutaneous control or drive lines Limited durability Large device size Limited physiological control strategies during prolonged use Uncertainty about the long-term consequences of non-pulsatile flow Adverse effects on gastrointestinal system with abdominal wall device placement Substantial invasive surgery High costs Department Health and Human Services, National Institues of Health National Heart Lng and Blood Institute Working Group