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Will Heart Transplantation Become Obsolete?

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Will Heart Transplantation Become Obsolete? Dan M. Meyer, MD 2011 Donald and Lois Roon Visiting Lectureship Wednesday, Sept. 28, 2011 William Pierce, MD What ever happened to the artificial heart? MechanicalMechanical supportsupport ofof thethe failingfailing heart:heart: WillWill heartheart transplantationtransplantation becomebecome obsolete?obsolete? Dan M. Meyer, MD The 20thth Annual Donald and Lois Roon Visiting Lectureship Scripps Green Hospital September 28, 2011 Jack Copeland, MD Surgical treatment of advanced heart disease Charles Lindbergh Heart Transplantation Heart Transplantation History History Lower + Shumway James Hardy Stanford Univ USA, 1918-2003 First long term successful heart transplant (4th) Univ Mississippi Surg Forum 11:18 1960 1964 First Human 5 dogs survived 6-21 d Orthotopic HTx N=97 HTx 1968-1975 Xenograft (Chimp) Surv-1 yr = 49% 1968 Surv-1 = 22% JAMA 188:1132-40, 1974 Surv-1 = 62% 1964 Surv-5 yr = 23% Dan M. Meyer, MD 2011 Donald and Lois Roon Visiting Lectureship Wednesday, Sept. 28, 2011 Heart Transplantation Life Magazine – Dec. 15, 1967 History 1968 102 heart transplants worldwide 17 countries 52 medical centers median survival = 29 days 1969 Fewer than 50 heart transplants 1970-1975 Fewer than 20 heart transplants per year Stanford (Shumway) Medical College of Virginia (Lower) Life Magazine - Sept. 17, 1971 HeartMate IP LVAD Dan M. Meyer, MD 2011 Donald and Lois Roon Visiting Lectureship Wednesday, Sept. 28, 2011 LVADs as Destination Therapy REMATCH Update 1.00 1 year LVAD vs. 0.90 VE LVAS (n=71) OMM survival = 0.80 OMM (n=61) 0.70 P=0.0012 53.5% vs. 26.5% 0.60 2 year LVAD vs. 0.50 P=0.0004 0.40 OMM survival = 0.30 P=0.0063 32% vs. 8.2% 0.20 0.10 3 year LVAD vs. 0.00 0 6 12 18 24 30 36 42 48 54 OMM survival = Months Post Enrollment 15.9% vs. 2% (NS) REMATCH Update (as of April 2004) – Source Thoratec Registry Improving Outcomes BEYOND REMATCH The Problem 100 Half-life =9.1 years HTx Conditional Half-life = 11.6 years The number of patients with end-stage CHF 80 Actuarial Survival (1982-2000) increasing (Stage D), ~500,000 in the US LVAD 60 “ IMPROVEMENTS with: LDSH ~ 10% of patients >65yo LV dysfunction - DEVICES N=52,195 40 - MANAGEMENT LVAD This number is expected to double in 25 yrs Survival (%) Survival LESS ADVANCED Illness 20 (Patient Selection) The number of available donors are not OMM expected to increase, numbering 2200 in US 0 01234567891011121314151617 Years Post-Transplantation Heart Failure Expected to Become More Treatment Options Common as Population Ages Common as Population Ages End-Stage Heart Failure Medical management - limited by poor outcomes Cardiac transplantation - limited by donor shortage Mechanical circulatory support devices Left ventricular assist device (LVAD) Heart Failure‐Epidemiology Forecasts to 2015. Datamonitor 2002 Dan M. Meyer, MD 2011 Donald and Lois Roon Visiting Lectureship Wednesday, Sept. 28, 2011 Congestive Heart Failure HEART TRANSPLANTATION Medical Rx Survival Kaplan-Meier Survival (1/1982-6/2008) 100 Half-life = 10.0 years Conditional Half-life = 13.0 years 80 60 HEARTN=80,038 TRANSPLANTATION Kaplan-Meier40 Survival (1/1982-6/2005) N at risk at 23 years = 124 Survival (%) (%) Survival 20 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 Years ISHLT 2010 Gorodeski et al. Circ Heart Fail 2009;2:320-324 J Heart Lung Transplant. 2010 Oct; 29 (10): 1083-1141 Loss of Pulsatility with Increased RPM Thoratec HeartMate II LVAD Pump Worldwide Clinical Experience HeartMate II BTT Long-term Results (n=281) More than 8,000 patients worldwide have now been implanted with the HeartMate II LVAS. Patients supported ≥ 1 year: 2978 . Patients supported ≥ 2 years: 1108 . Patients supported ≥ 3 years: 300 . Patients supported ≥ 4 years: 136 . Patients supported ≥ 5 years: 33 . Patients supported ≥ 6 years: 9 As of Sept 2011 23 25 JAAC 2009;54(4):312-21. Dan M. Meyer, MD 2011 Donald and Lois Roon Visiting Lectureship Wednesday, Sept. 28, 2011 Kaplan-Meier Survival (n=281) HeartWare LVAD HVAD miniaturized implantable blood pump Provides up to 10 L/min of flow Centrifugal design, continuous flow Hybrid magnetic / hydrodynamic impeller suspension Optimizes flow, pump surface washing, and hemocompatibility Pagani F, Miller L, Russell S, JAAC: Vol 54, No 4, 2009. ADVANCE Trial Secondary Outcome: Survival Indications for LVAD Placement 100 Bridge to Decision HVA Bridge to Transplant 90 D Destination Therapy Control Bridge to Recovery 80 Days Post Treatment Control Implant p = .39 30 98.6% 96.6% % Survival % 90 95.6% 93.6% 70 Event: Death (censored at 180 93.9% 90.2% transplant or recovery) 360 90.6% 85.7% ITT Population 60 0 60 120 180 240 300 360 Days Post Implant Patients Treatment 140 128 108 92 63 36 26 at Risk Control 499 440 370 305 228 176 127 Patient Selection/Stabilization Timing of LVAD is Key to Survival Too Late Futile Implants 1-Year Survival Operative 19% Risk Death Successful 1-Year Survival Implants 69% Worsening nutritional, end-organ, and RV function Lietz et al. Circulation. 2007;116(5):497 Dan M. Meyer, MD 2011 Donald and Lois Roon Visiting Lectureship Wednesday, Sept. 28, 2011 INTERMACS Profiles Level Key feature of level Descriptive label 1 Critical cardiogenic shock “Crash and burn” 2 Progressive decline Inotropes, slipping 3 Stable but inotropic dependent Inotropes, stable 4 Recurrent decompensations “Frequent flyer” 5 Exertion intolerant Housebound 6 Exertion limited “Walking wounded” (fatigue within minutes) 7 NYHA IIIA Too well for VAD/Transplant Stevenson L, et al JACC, 2007 Clinical Outcomes National Shift in Timing of Implants INTERMACS Profile Length of Stay Post-VAD Actuarial Survival Post-VAD Less acutely ill, ambulatory patients in INTERMACS profiles 4–7 had better survival and reduced length of stay compared to patients who were more accurately ill in profiles 1–3. Group 1: INTERMACS 1 Group 2: INTERMACS 2–3 Group 3: INTERMACS 4–7 Boyle, Ascheim, Russo, et al. JHLT. 2011;30:4. Current research efforts Assessment of sympathetic nerve activity in non-pulsatile systems Non-invasive monitoring of the LVAD patient Clinical studies LVAD and ventricular arrythmias LVAD and renal recovery LVAD and gastrointestinal bleeding Dan M. Meyer, MD 2011 Donald and Lois Roon Visiting Lectureship Wednesday, Sept. 28, 2011 Study Protocol Study Protocol Phase 1 Phase 2 Instrumentation ECG/HR BP Instrumentation cuff (Korotkoff /Doppler) ECG/HR beat-by-beat finger arterial BP (Nexfin) BP cuff (Korotkoff /Doppler) TCD recording from a non-pulsatile LVAD beat-by-beat finger arterial BP (Nexfin) patient Microneurography (MSNA) Sympathetic multiunit activity occurs as “bursts” peroneal nerve Transcranial Doppler (TCD) burst recordings Sitting/Standing Maneuvers – 0.05 Hz Head up tilting supine, 30°, and 60° Transfer function estimation – cross spectral method of gain, phase, Cardiac output and coherence acetylene rebreathing technique TCD recording from a pulsatile LVAD patient An LVAD patient undergoing head up tilting Total study time: approximately 6-7 hours involving about Total study time is approximately 6-7 hours involving about 15 investigators Sympathetic and Cardiovascular Responses During Bolus Injection of Nitroprusside and Phenylephrine in a Nonpulsatile Patient 130 120 110 HR 100 HR 90 80 70 Nitroprusside Phenylephrine 30 s 120 110 100 90 80 BP (mmHg) BP 70 60 50 0.2 0.0 -0.2 MSNA -0.4 -0.6 -0.8 Conclusions Clinical Implications Non-pulsatile LVAD patients have dramatically higher sympathetic activity than pulsatile patients and controls, Higher sympathetic activity could lead to adverse presumably due to greater baroreceptor unloading (impaired baroreceptor function) events in these patients over time: CV events, stroke, high blood pressure, renal effects Cerebral autoregulation does not seem to be significantly affected in nonpulsatile devices, at least at It may be possible to develop surrogate measures of the frequency of normal activity sympathetic activity to guide therapy in these Variability in CBFV and BP during sit-stand is relatively low in nonpulsatile devices compared to pulsatile patients There may need to be some “built in” pulsatility in More data and larger studies are needed to further define devices that are primarily non-pulsatile: the physiology of nonpulsatility with change in speed, devices that are primarily non-pulsatile: position, exercise, and device optimization How to do that? What frequency? What duration? Dan M. Meyer, MD 2011 Donald and Lois Roon Visiting Lectureship Wednesday, Sept. 28, 2011 Nexfin - Blood pressure measurement Nexfin integrative hemodynamics One screen: Blood pressure + Cardiac Output Brachial pressure + Hemodynamics + ECG Touch screen user interface Finger pressure Brachial pressure 9/28/2011 43 9/28/2011 44 A Study of Blood Pressure Measurement in Patients Increased LVAD Utilization with Non-pulsatile Left Ventricular Assist Devices Findings: In the first 10 subjects, correlation of BMEYE with A-line measurements is stronger than Doppler with A-line measurements. Doppler and A- BMEYE and A- line line Pearson’s 0.8 0.9 coefficient Interclass 0.861 0.911 correlation LVAD Program Growth Dan M. Meyer, MD 2011 Donald and Lois Roon Visiting Lectureship Wednesday, Sept. 28, 2011 Quality Program Details Intermacs Quality Assurance Report Performance Measures Adverse Events Baylor University Medical Center INTERMACS Adverse Events #%#% Bleeding 104 23 4317 17.5 Cardiac Arrhythmia 15 3.3 1591 6.4 Death 14 3.1 747 3 Device Malfunction 37 8.2 712 2.8 NeurologicInfection 30 6.6 3472 14 Dysfunction 14 3.1 687 2.7 Psychiatric Episode 24 5.9 396 1.6 Rehospitalization 81 17.9 4774 19.3 July 2011 CMS Eligibility Criteria DT Gaining Popularity Destination Therapy Class III-IV CHF EF < 25% Significant functional limitations despite OMM for at least 60 days VO2max < 12 ml/kg/min or inotrope dependent Inability to tolerate OMM No conditions which limit life expectancy Acceptable surgical risk (nutrition, organ function) Stewart G, et al Circ 2011;123:1559-68.
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