Heart Transplantation is Dead

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Brett Gregory
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1 Heart Transplantation is Dead Alternatives to Transplantation in Heart Failure Sagar Damle, MD University of Colorado Health Sciences Center Grand Rounds September 8, 2008

2 Outline Why is there a debate? The numbers. Heart Tx: The truth about outcomes and complications. Alternatives to Heart Transplantation New Medical Therapy Ventricular Remodeling Mechanical Devices as Destination Therapy Mechanical Devices as Bridge to Recovery Conclusions

3 The Numbers Heart Failure Affects ~ 5 million Americans Incidence ~ 500,000 cases/ year UNOS Data Usually transplant ~2400 hearts per year Only 887 tx this year thus far ~ 1400 this year Median wait time At least 10-15% of patients DIE while waiting.

4 Who is NOT a Candidate? Contraindication (Absolute): Fixed pulmonary hypertension Malignancy Irreversible liver/kidney dysfunction Relative Age Reversible organ dysfunction HIV+

5 If you get a heart, what can you look forward to? Adverse Events with Heart Tx Early Mortality Late Cancers (Esp lymphomas and skin tumors) Accounts for >35% of late deaths 1 Accelerated coronary disease (CAV) 1yr, 5 yrs, 8 yrs 2 Worse prognosis afterwards 2 Neurological Problems 20% Periop, up to 70% long-term 3 1 J Heart Lung Tx 27(5):486-93, Circulation 117(16): , Arch Neuro 65(2):226-31, 2008

6 If you get a heart, what can you look forward to? Episodes of rejection On average, 1 q3 yrs 1 Post-Tx Diabetes Up to 1/3 of patients 2 Graft failure Chronic Renal Failure 1 NEED FOR RE-TRANSPLANT! As high as 6% in some studies. 1 J Heart Lung Tx 27(5):486-93, Clin Res Car 95S1:i48-53, 2006.

7 Survival After Tx: UNOS 1 Month 1 Year 3 Years Transplants (n=number) Graft Survival (%) Observed Number of Graft Failures South Carolina

8 Location Survival After Heart Tx Vienna, Italy1 Nantes, France2 Bad Oeynhausen, Germany3 Montreal, Canada4 Years Patients yr yr yr Clin Trans:81-97, J Heart Lung Tx 27:486-93, Int Heart J 49(2):213-20, Cand J Card 24(3):217-21, 2008

9 Alternative 1 New Medicines

10 Current Medical Regimen Rivals Heart Tx Most Difference: B-blocker and spironolactone J Am Coll Cardiol 43(5):787-93, 2004.

11 Alternative 2 Ventricular Restoration

12 Ventricular Restoration Concept: Remove akinetic/dysfunctional portions of LV wall for restoration of LV anatomy. Patients: Usually dilated cardiomyopathy and post-infarct Procedures: Multiple types Contraindications: severely depressed right ventricular function lack of ischemic areas suitable for revascularization lack of contraction improvement of basal segments during dobutamine echo First question, does it work?

13 Outcomes Following Surgical Ventricular Restoration for Patients With Clinically Advanced Congestive Heart Failure (New York Heart Association Class IV) Baltimore, MD Retrospective review, 3 yrs, NYHC IV pts (vs. NYHC II/III. 78 pts total) Surgery: SVR with intraventricular sizer +/- CABG +/- MVR Results EF pre-op ~23% => 36% post-op 65% of pts improved to class II post-op Survival: ~75%, 1 and 3 yrs Next Question: Is it comparable to transplant? Journal of Cardiac Failure 13(6): , 20

14 Treatment of Extensive Ischemic Cardiomyopathy: Quality of Life Following Two Different Surgical Strategies Naples, Italy Single-center, retrospective, 7 years Inclusion: ESHF, ESVI >50ml/m2, EF <35% 111 patients total SVR Group: 42 pts (mean age 62) HTx Group: 69 pts (mean age 54) Euro J Cardio-thoracic Surg 27: , 2005.

15 Treatment of Extensive Ischemic Cardiomyopathy: Quality of Life Following Two Different Surgical Strategies Naples, Italy Results Pre-op Most patients were NYHC III Tx Group ~ 10 yrs younger SVR Group: More NYHC IV (14 vs. 7 %) Post-op SVR longer ICU stay (1 day), more IABP Immed Mortality: 19% vs 9% (not significant) Euro J Cardio-thoracic Surg 27: , 2005.

16 Treatment of extensive ischemic cardiomyopathy: quality of life following two different surgical strategies Naples, Italy Delayed Results (Starting from 1 M post-op) No difference in 5 yrs QOL Measures Physical capacity better in HTx Psychological and social better in SVR HTx SVR SVR HTx Euro J Cardio-thoracic Surg 27: , 2005.

17 Functional Outcomes of SVR Single-center, prospective Outcomes: MVO2, mortality SVR (35 pts, 63 yo) vs. HTx (40 pts, 56 yo) Results Hospital Mortality Same: 11% vs 8% SVR HTx Pre Post Pre Post MVO2 (ml /kg/min) EF (%) CI (L/min/m2) JTCVS 135(5): , 2008

18 Conclusions about SVR Tailored approach is better Low-rate of tx-related deaths in survivors of SVR Good QOL Essentially EQUIVALENT to Heart Tx

19 Alternative 3 Ventricular Assist Devices as Destination Therapy (DT)

20 History 1962: LVAD created by Dr. Liotta 1963: First clinical use of LVAD by Dr. Liotta. Pt survives 4 days. 1966: First successful BTR LVAD (Debakey) 1969: First TAH as BTT (4 days) (Cooley) 1982: First TAH as DT (112 days)

21 History of LVADs Generation 1: Pulsatile flow Generation 2: Axial flow Generation 3: Hydrodynamic or electromagnetic suspension

22 Long-term use of LVAD for ESHF (REMATCH) 129 patients, RCT, LVAD vs. OMM Inclusion: Chronic ESHF with C/I to transplant Age, CRI, DM with end-organ damage => exclusion Results 1 yr survival: 52% vs. 25% < 60yo: 1 yr survival of 74 % with LVAD Death in OMM: Mostly cardiac failure Death in LVAD: Sepsis (41%) and VAD failure (17%) NEJM 345(20): , 200

23 Recent LVAD as DT: Utah Single-center; 23 patients Inclusion similar to REMATCH Excluded HTx candidates Pts: NYHC IV, mvo2 <12, LVEF < 25% VAD: Heartmate XVE Results Periop Mortality: 8.7% Survival: 1 yr, 2 yrs! Infections: Reduced vs REMATCH (28% vs. 31%) Con t mechanical problems. JTCVS 135(6): ,2008.

24 Heartmate II, Texas Heart 43 patients. (26 BTT and 17 DT) Results 81% of patients survived operation and were d/c d home in NYHC I. 1 year ~80% Patient 1: 749 days 4 patients explanted for recovery 1 yr and 2 yrs) Tex Heart Inst J 34:275-81, 2007.

25 Alternative 4 Ventricular Assist Devices as Bridge to Recovery (BTR)

26 Bridge to Recovery Concept: Heart failure is a syndrome involving multiple neurohormonal alterations which lead to myocardial remodeling. Myocyte activity Structure of myocardium LV chamber size and shape Presumption: Unloading heart and improving HD status leads to reverse remodeling.

27 LVAD-induced myocardial changes. Estimates of 5-10% of patients could be explanted of device once healed. Reverse Remodeling with VAD Decreased LV diameter and increased LV wall thickness Decreased cardiomyocyte diameter Decreased interstitial fibrosis Improved EF (possible correlation to biopsy) Multiple molecular changes also Cardiovas Res 68:376-87, 2005.

28 Left ventricular assist device and drug therapy for the reversal of heart failure. UK 15 pts, non-ischemic dilated cardiomyopathy, without myocarditis (subset of 24 pts) Pre-op: NYHC IV, dilated LV, EF ~12, CI 1.8 (on inotropes) Tx: Heartmate I then 2 phases of medical therapy Phase 1: lisinopril, carvedilol, spironolactone, losartan Phase 2 (once maximal regression achieved: clenbuterol and change carvedilol to bisoprolol Close monitoring Eventually, with echo and cath with device off NEJM 355: , 2006.

29 Left ventricular assist device and drug therapy for the reversal of heart failure. UK Results 73% met criteria for explantation Mean duration of therapy:320 days Survival 91% and 82% at 1 and 4 yrs postexplantation. Freedom from recurrence 4 yrs No infectious deaths QOL: improved mental and physical health which was better than matched transplant pts 2 NEJM 355: , J Heart Lung Transplant 27:165-72, 2008

30 Issues Specialized procedures Data represents best-of-best Patient Populations VAD patients typically sicker (more CRF) and older US vs. Europe Comorbid conditions reduce life in VAD patients (cancers, organ failure, age) Devices continuously evolving Need new studies every few years (minimal long-term data) Topics not covered: Pediatric heart failure Specific patient populations in heart transplant

31 Conclusions Why is heart transplantation not a viable longterm solution? 1. Not enough donors Problem will worsen with LVADs as BTT 2. Good alternatives are available 3. Improved meds Future? New devices with better longevity Improved technology Better selection for reverse remodeling New meds on horizon?

Surgical Options for Advanced Heart Failure

Surgical Options for Advanced Heart Failure Benjamin Medalion, MD Director, Transplantation and Heart Failure Surgery Department of Cardiothoracic Surgery Rabin Medical Center, Beilinson Hospital Heart