1. Heart Failure and VADsBridges for Broken Hearts Priya Gaiha MD MBA May 26th 2010 University of Kentucky Grand Rounds

2. Objectives • What is the pathophysiology of heart failure? • Why is heart failure relevant? • What is the history of mechanical circulatory support? • What are the various types of ventricular assist devices (VADs)? • How and when are VADs used? • What is the next generation of VADs?

3. Etiologies of cardiac failure • Coronary artery disease • Idiopathic cardiomyopathy • Peripartumcardiomyopathy • Dilated cardiomyopathy • Ischemic cardiomyopathy • Acute valvular disease • Arrhythmia (supraventricular or ventricular) • Myocarditis • Congenital heart disease • Drug induced • Diabetes mellitus • Hypertension

4. Pathogenesis of Heart Failure Mann, D. Circulation 1999;100;999-1008

5. NYHA classes

6. Relevance

9. CVD deaths vs. cancer deaths by age (US) NCHS 2006

10. CVD and other major causes of death for all males and females A CVD B Cancer C Accidents D Chronic Lower Respiratory Diseases E Diabetes Mellitus F Alzheimer’s Disease NCHS and NHLBI 2006

11. Hospital Discharges (in millions) for the 10 Leading diagnostic Groups NHDS/NCHS and NHLBI 2006

12. Economic Ramifications www.americanheart.org

13. Options for Advanced CHF • Transplant ($$$$$$) • Assist Device ($$$) • Die($) • Preceded by 6-12 months of medical therapy • Multiple hospital re-admissions • Hospice ($$$)

14. Transplant

16. UK

17. ADULT HEART TRANSPLANTATIONKaplan-Meier Survival by Era (Transplants: 1/1982 – 6/2005) Survival (%) ISHLT 2007 J Heart Lung Transplant 2007;26: 769-781

18. ADULT HEART RECIPIENTSFunctional Status of Surviving Recipients(Follow-ups: 1995 - June 2008) ISHLT 2009

19. Historical Events 1953: Gibbon’s heart-lung machine successfully used during ASD repair 1950 1960 1970 1980 1990 2000 2010

20. John Gibbon • Born in 1903 in Philadelphia • 4th generation physician • 1931: watched a young woman postop from cholecystectomy die from PE • Worked for 20 years on dogs to refine bypass machine • Received financial and technical support from Thomas Watson of IBM • 1953: first successful use of machine on patient during ASD repair

21. Historical Events 1953: Gibbon’s heart-lung machine successfully used during ASD repair 1963: DeBakey implants first VAD in patient with postcardiotomy shock 1950 1960 1970 1980 1990 2000 2010

22. Historical Events 1953: Gibbon’s heart-lung machine successfully used during ASD repair 1963: DeBakey implants first VAD in patient with postcardiotomy shock 1950 1960 1970 1980 1990 2000 2010 1967: Barnard performs first heart transplant

23. Christian Barnard • Born in South Africa in 1922 • Studied heart surgery at the University of Minnesota then returned to set up a cardiac unit in Cape Town. • December 1967: transplanted the heart of a road accident victim into a 59 year old patient • Patient only survived 18 days due to infectious complications

24. Historical Events 1953: Gibbon’s heart-lung machine successfully used during ASD repair 1963: DeBakey implants first VAD in patient with postcardiotomy shock 1968: Shumway performs first heart transplant in US 1950 1960 1970 1980 1990 2000 2010 1967: Barnard performs first heart transplant

25. Norm Shumway • Stanford University • 1959: transplanted the heart of a dog into a 2-year-old mongrel • 1968: performed the first heart transplant in the US on a 54 year old steel worker who lived 14 days • Pioneered immunosuppression • 1981: performed the world’s first successful heart-lung transplant

26. Historical Events 1953: Gibbon’s heart-lung machine successfully used during ASD repair 1963: DeBakey implants first VAD in patient with postcardiotomy shock 1968: Shumway performs first heart transplant in US 1950 1960 1970 1980 1990 2000 2010 1969: Cooley implants VAD as bridge to transplant 1967: Barnard performs first heart transplant

27. Willem Kolff • “Father of artificial organs” • 1911: Born in the Netherlands • 1940: Established the first blood bank in Europe • 1943: Developed the first artificial kidney • 1957: Developed the first artificial heart that was successfully transplanted into an animal

28. Historical Events 1953: Gibbon’s heart-lung machine successfully used during ASD repair 1984: implantation of Jarvik-7 artificial heart by DeVries 1963: DeBakey implants first VAD in patient with postcardiotomy shock 1968: Shumway performs first heart transplant in US 1950 1960 1970 1980 1990 2000 2010 1969: Cooley implants VAD as bridge to transplant 1967: Barnard performs first heart transplant

29. William DeVries • Born in 1943 • Trained at the University of Utah and Duke University • Worked with Kolff to implant artificial heart in animals • 1982: Implanted first artificial heart into Seattle dentist Barney Clark • 1985: Implanted 2nd Jarvik into Bill Schroeder in Louisville KY

30. Historical Events 1953: Gibbon’s heart-lung machine successfully used during ASD repair 1984: implantation of Jarvik-7 artificial heart by DeVries 1963: DeBakey implants first VAD in patient with postcardiotomy shock 1994: FDA approval of LVAD as bridge to transplant 1968: Shumway performs first heart transplant in US 1950 1960 1970 1980 1990 2000 2010 1969: Cooley implants VAD as bridge to transplant 1967: Barnard performs first heart transplant

31. Historical Events 1953: Gibbon’s heart-lung machine successfully used during ASD repair 1984: implantation of Jarvik-7 artificial heart by DeVries 1963: DeBakey implants first VAD in patient with postcardiotomy shock 1994: FDA approval of LVAD as bridge to transplant 1968: Shumway performs first heart transplant in US 1950 1960 1970 1980 1990 2000 2010 1969: Cooley implants VAD as bridge to transplant 2004: REMATCH trial 1967: Barnard performs first heart transplant

32. Historical Events 1953: Gibbon’s heart-lung machine successfully used during ASD repair Heart mate II approved for destination therapy 1984: implantation of Jarvik-7 artificial heart by DeVries 1963: DeBakey implants first VAD in patient with postcardiotomy shock 1994: FDA approval of LVAD as bridge to transplant 1968: Shumway performs first heart transplant in US 1950 1960 1970 1980 1990 2000 2010 1969: Cooley implants VAD as bridge to transplant 2004: REMATCH trial 1967: Barnard performs first heart transplant

35. Criteria for patient selection • Class IV HF • Failing hemodynamics • Persistent pulmonary edema • Neurologic impairment or renal failure due to low perfusion • Fluid and electrolyte imbalance related to low cardiac output • Severe arrhythmias despite medical therapy

36. Indications for support • SBP<80 mm Hg • MAP<65 mm Hg • CI<2.0 L/min/m2 • PCWP>20 mm Hg • SVR>2100 dynes-sec/cm Circulation 2005; 112: 438-448

37. INTERMACS: Patient Selection Patient Profile/ Status:INTERMACS Levels • 1. Critical cardiogenic shock • Progressive decline • Stable but inotrope dependent • Recurrent advanced HF • Exertion intolerant • Exertion limited • Advanced NYHA III

39. INTERMACS Profiles Inotrope Dependent 2006-2007 data

40. Short term Device options ECMO IABP Tandem Heart Bridge to recovery Bridge to decision Centrimag AbioMed 5000 Impella Circulation 112 (3): 438

41. Intraaortic Balloon Pump (IABP) • Developed in late 1960s • Counterpulsation is synchronized to the EKG or arterial waveforms • Increase coronary perfusion • Decrease left ventricular stroke work and myocardial oxygen requirements • Most widely used form of mechanical circulatory support • Indications for its use include • Failure to wean from cardiopulmonary bypass • Cardiogenic shock after MI • Heart failure • Refractory ventricular arrhythmias with ongoing ischemia

42. Bridge to bridge: ECMO • Immediately stabilize circulation • Improve end organ perfusion • Overall survival comparable between ECMO + LVAD versus LVAD alone • Clinical indicators of poor outcome after ECMO: consider VAD implantation carefully • Elevated blood lactate levels • Elevated LFTs Pagani et al. Ann Thorac Surg 2000; 70:1977-85

43. Case #1 • 57 yo male • Transferred to UK for cardiogenic shock secondary to heart failure • Taken to cath lab for emergent IABP placement • EF<10% • Sv02 20s • Maximal inotropic support: 4 pressors • Stabilized on VA-ECMO • Supported for 7 days • Improvement in hepatic and renal dysfunction • Heartmate II implanted

44. Centrifugal pumps • Acute hemodynamic support • Continuous flow • Extracorporeal • LV, RV or biventricular support • Wide availability • Ease of use • Relatively low cost • Limited duration of support • Bridge to recovery • Bridge to decision Hoy et al. Ann Thorac Surg 2000; 70:1259-63

45. Tandem hearts • Acute hemodynamic support • Centrifugal pump • Percutaneous placement • LV support via transseptal cannula • Used in high risk cardiac catheterization procedures • Risk of vascular injuries due to cannula size

46. Levitronix Centrimag • Newer generation • Centifugal pump • Continuous flow • Extracorporeal • Impellar within the pump rotates in contact-free manner • Increased durability • Minimal thrombus formation and hemolysis of RBCs

47. Abiomed 5000 • Extracorporeal • Pneumatic pulsatile pumps • Uni- or biventricular support • Bridge to transplant • Easy to insert and operate so used in community hospitals • Flows 6L/min Circulation. 2005;112:438-448.

48. Impella • Axial flow pumps • Acute hemodynamic support • Miniaturized impellar pump in catheter • Helical catheter tip placed across aortic valve and left ventricle • Percutaneous or direct placement • Flow 4.5L/min • Bridge to recovery

49. Case #2 • 54 yo male • Postcardiotomy cardiogenic shock after mitral valve repair and CABGx 4v • Came off CPB but then decompensated • Initially treated with Impella placement • Developed hemolysis: converted to Abiomed 5000 BVS pump 48hrs later • Transferred to UK • Successfully explanted after 7 days of support • Functional at home, EF~45%

50. Long term Device options Heartmate II Heartmate XVE Bridge to transplant Thoratec CardioWest TAH Jarvik 2000 Circulation 112 (3): 438