Ventricular Assist Devices for Chronic Heart Failure
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1 Ventricular Assist Devices for Chronic Heart Failure Σ.Γ.Δράκος, Επικ. Καθ/τής Medical Director, Cardiac Mechanical Support Program Investigator, Molecular Medicine Program University of Utah
2 Heart Failure: The Final Cardiovascular Disease Chronic Heart Failure: Global Epidemic Coronary deaths are down by half But heart failure has almost tripled % 350 of population in 5 over Coronary Deaths - Most common hospital admission diagnosis Heart Failure Enhanced survival in other CV diseases leads to expansion of HF Population Source: National Hospital Discharge Survey data. Centers for Disease Control and Prevention/National Center for Health Statistics and National Heart, Lung, and Blood Institute.
3 Advanced Heart Failure Therapies: Heart Transplantation cannot meet the need Number of Transplants , , , , , , , , , , , , , , , , , , , , , , , , , Stehlik J et al. ISHLT Registry; J Heart Lung Transpl 2011
4 Chronic Mechanical Circulatory Support 1. Βridge to Transplant (BTT) 2. Destination Therapy (DT) 3. Bridge to Recovery (BTR)
5 Chronic Mechanical Circulatory Support 1. Βridge to Transplant (BTT) 2. Destination Therapy (DT) 3. Bridge to Recovery (BTR)
6 Bridge to Heart Transplant Proportion of patients surviving to Transplant LVAD Medical Therapy Aaronson K, et al, JACC 2002 Frazier O, et al, JTCS 2001
7 Bridge to Heart Transplant VAD effects Prior to Transplant: HLA sensitization IVIG No IVIG Pulsatile flow VAD Continuous flow VAD Drakos S,, Renlund D. J Thorac Cardiovasc Surg 2006 Drakos S,, Renlund Drakos D. SG, J Heart et al. J Lung Heart Transpl Lung Transpl
8 Bridge to Heart Transplant Survival After Transplant UTAH program n=278 Bridged to Tx with LVAD Bridged to Tx with Medical Therapy Drakos SG, et al. J Heart Lung Transpl 2006
9 Bridge to Heart Transplant Survival After Transplant ISHLT Registry Bridged to Tx with LVAD Bridged to Tx with Medical Therapy 2 nd Era Pulsatile LVAD 2 nd Era Continuous LVAD Nativi JN, Drakos SG, et al. J Heart Lung Transpl 2011
10 Chronic Mechanical Circulatory Support 1. Βridge to Transplant (BTT) 2. Destination Therapy (DT) 3. Bridge to Recovery (BTR)
11 Destination Therapy (DT): Landmark Trials REMATCH N=130 end stage HF patients - Randomization: LVAD (1 st generation) vs Optimal Medical Therapy LVAD Pulsatile, 1 - Too old or too sick for heart transplant st generation - Age 68 - NYHA Class IV - LVEF 17% - Wedge 25mmHg - Cardiac Index IV Inotrope dependent 72% Medical therapy Disadvantages of 1 st Generation, Pulsatile LVADs 1. Large Size Morbidity / Infections 2. Engineering Malfunctions after months
12 Landmark REMATCH Trial: Late VS. Early Results: UTAH contribution Park S, et al, J. Thor Cardiovasc Surg 2005
13 Destination Therapy (DT): Landmark Trials REMATCH II 2009 LVAD 1st generation, Pulsatile-flow LVAD 2 nd generation, Continuous-flow Advantages of 2 nd Generation, Continuous-flow LVADs 1. No Engineering Malfunctions Extended Durability (>10 years) 2. Small Size Decreased Perioperative Morbidity / Infections
14 REMATCH II Trial: Complications Meta to Quality of Life tha akolouthisoun ta complications Not everything is perfect
15 REMATCH II Trial: Complications Meta to Quality of Life tha akolouthisoun ta complications Not everything is perfect
16 Survival The Field Is Evolving 100% 3 rd generation VAD 90% 80% 70% 60% 50% 40% 1. Technological Advances 2 nd generation VAD INTERMACS 2011, n= Patient Management VAD Arm of REMATCH 2001 (1st generation) TRANSPLANT ISHLT Registry n>40,000 30% 20% 3. Patient Selection 10% Medical Therapy Arm of REMATCH 0% Months post LVAD implant
17 Technology evolves 1. Size matters! 2. Wireless energy transfer = elimination of percutaneous abdominal exit site (3-5 years away from clinic)
18 The Field Is Evolving 1. Technological Advances 2. Patient Management 3. Patient Selection
19 Balance Anticoagulation Between Wever O, Drakos SG. Pharmacol & Ther 2011
20 The Field Is Evolving 1. Technological Advances 2. Patient Management 3. Patient Selection
21 the optimal time for referral in an individual patient s course of progressive HF is an art and a science James Fang, NEJM 2009
22 Strong Indication Operative and Risk The Right Time for LVAD Implantation Optimal Window Referred to HF program for VAD/ Tx evaluation if: a) NYHA III or IV b) two of the following: - Serum sodium < 136 mmol/l Moderate - Creatinine Indication > 1.8mg/dl - Intolerant or refractory to ACE/ARB/BB - Diuretic Too dose early > 1.5 mg/kg/d - Heart failure-related hospital admissions - QRS > 140 ms refractory to CRT therapy - Hematocrit < 35% Too late Right heart failure End-organ dysfunction Cachexia Aaronson K, et al. Eur J Heart Fail 2010 Russell S, Miller L, Pagani F. Congestive AHA statement, Heart Failure Circ
23 Patient Selection to Prevent Post LVAD Implantation Right Ventricular Failure Right Ventricular Failure Risk Score Drakos SG, et al. Am J Cardiol 2010
24 Quality of Life Dick Cheney Πρόγραμμα Χρ. Mητ. Υποβ. Noζοκ. Eσαγγελιζμoύ - Γ Καρδιολογικής Κλινικής Παν/μίοσ Αθηνών Who has LVAD?
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26 Theoretical No. of Adults With Advanced HF in US - Potential LVAD candidates for BTT or DT ~240 Million Population age 20 years old ~50 % Preserved Systolic Function 3.12 Million HF=2.6 % Population* or 6.24 Million 80-85% Stage A-B 30 BTT or ~50 DT % Systolic LVADs HF / 3.12 Million % Stage D 100,000 population Advanced Stage C / NYHA class IIIB 124, % Stage C (3-4% advanced Stage C) Stage D / NYHA functional class IV 156,000 Advanced Stage C and Stage D age 20 years old 280,800 ~ 30% = ~ 90,000 accessible patients Modified after permission from: Starling R, O Connell J
27 U.S. VAD Implants for currently approved indications (BTT, DT) 3,200 3,000 2,800 2,600 2, ,200 2,000 1,800 1,600 1,400 1,200 1,
28 Chronic Mechanical Circulatory Support 1. Βridge to Transplant (BTT) 2. Destination Therapy (DT) 3. Bridge to Recovery (BTR)
29 Load Drives Cardiac Remodeling and HF progression LV Function Initial Insult LV Hypothesis: LOAD Load Removal via LVAD= LV Reverse Remodeling? LV Structure T LV Cardiac Recovery? Cardiac Remodeling Trajectory
30 LVAD Unloading: Reverse Remodeling? Harefield Athens Recovery Program (HARP),00,00 90 what: edd Sympathetic innervation LV End-diastolic Diameter (mm) MIBG imaging QTc QRS who al ax kaz par,00 80 Pre LVAD Post LVAD,00 70,00 60,00 50 Pre LVAD pre dur when Post LVAD post Drakos Drakos Drakos SG, S,,, Yacoub S,..., Yacoub MH, M, Nanas M, Nanas JN. J. Ann JACC J. Thor Eur Imaging Heart Surg 2008; J 2008: 2007;28: 91: 3: Dimopoulos S,, Nanas S. J Heart Lung Transpl 2010
31 Cardiac Recovery? Harefield Athens Recovery Program LVAD Weaning? Fascinating and Rare Anecdote? Vs. Consistent and Real Phenomenon? Drakos S, et al, Circulation 2012
32 LVAD Induced Cardiac Recovery Fascinating Reasons Anecdote for Variable Vs. Real Results Phenomenon? Study Design Issues 1. Small Numbers, Retrospective Design 2. Heart Function Monitoring 3. Concurrent Drug Therapy 4. Variable Explantation Criteria (Recovery definition ) 5. Patients Diversity in Recovery Propensity - HF etiologies - extent of pre-lvad pathologic changes Drakos SG, Circulation, et al. Circulation July
33 What Does the Field Need to Advance? Large- scale, Prospective, Translational Programs: 1. Evaluate Extent of functional Recovery 2. Investigate mechanisms of Recovery
34 Utah LVAD Recovery Program Clinical Component HF/ Tx/ VAD Programs Basic Science Component Molecular Medicine Program Two-phase Translational Program Started in 2008
35 Utah LVAD Recovery Program 1 st Phase (Years 1 and 2): Standardization of Tissue Protocols Fibrosis Evaluation Hypertrophy Evaluation Microvascular Evaluation Drakos,, Li DY. JACC 2010; 56:
36 Post LVAD Turn-Down echo Utah LVAD Recovery Program 1 st Phase (Years 1 and 2): Imaging Protocols Standardization Post LVAD echo Pre LVAD echo
37 Utah LVAD Recovery Program 2 nd Phase (Year 3): Apply Protocols at Full Scale Prospective Translational Program: 1. Evaluate Extent of functional Recovery 2. Investigate mechanisms of Recovery
38 Utah LVAD Recovery Program Prospective Translational Program: 1. Evaluate Extent of functional Recovery 2. Investigate mechanisms of Recovery
39 Utah LVAD Recovery Program Evaluate Extent of functional Recovery 1. Infrastructure / Recruit Patients 2. Control for Confounders & Limitations 3. Serial Monitoring of Functional Recovery
40 Utah LVAD Recovery Program Evaluate Extent of functional Recovery 1. Infrastructure / Recruit Patients 2. Control for Confounders & Limitations 3. Serial Monitoring of Functional Recovery
41 Utah LVAD Recovery Program Infrastructure/ Recruit Patients Progress so far (Tissue & Clinical data): LVAD pts prospectively enrolled Utah - 26 Donors (not allocated for Tx)
42 Utah LVAD Recovery Program Determine Extent of functional Recovery 1. Infrastructure / Recruit Patients 2. Control for Confounders & Limitations - Concurrent drug therapies - Duration of unloading 3. Serial Monitoring of Functional Recovery
43 Utah LVAD Recovery Program Determine Extent of functional Recovery 1. Infrastructure / Recruit Patients 2. Control for Confounders & Limitations - Concurrent drug therapies - Duration of unloading 3. Serial Monitoring of Functional Recovery - Echo evaluation - Hemodynamic evaluation
44 Utah LVAD Recovery Program Patient A Improved Cardiac Function= RESPONDER Pre LVAD Post LVAD ( Turn-Down echo)
45 Utah LVAD Recovery Program Patient B DID NOT Improve= NON RESPONDER Despite Same Unloading duration, HF duration, HF etiology Pre LVAD Post LVAD ( Turn-Down echo)
46 Utah LVAD Recovery Program LV Functional Responders : 19% of pts Relative LVEF Increase: % (echo results on 90 prospectively enrolled pts) Drakos SG, et al. JACC In Press Drakos SG, et al. JACC In Press
47 Utah LVAD Recovery Program Time Course of Unloading- induced Functional Response Drakos SG, et al. JACC in press
48 LVAD Induced Recovery? Fascinating Anecdote Vs. Real Phenomenon? - Single-program, large-scale Utah LVAD Preliminary Data - LVEF degree of improvement superior Pharmac./Regenerative trials - Burned-out HF exciting implications for less advanced HF
49 LVAD Induced Recovery? Fascinating Anecdote Vs. Real Phenomenon? - Single-program, large-scale Utah LVAD Preliminary Data - LVEF degree of improvement superior Pharmac./Regenerative trials - Burned-out HF exciting implications for less advanced HF -Revisit view: human heart incapable of repair/ recovery - Opportunity understand human heart s potential to respond to injury/death
50 Utah LVAD Recovery Program Prospective Translational Program: 1. Determine Extent of functional Recovery 2. Investigate mechanisms of Recovery
51 Utah LVAD Recovery Program
52 Utah LVAD Recovery Program Recovery Mechanisms: More Energy Efficient Metabolism? unpublished data
53 Utah LVAD Recovery Program Recovery Mechanisms: Regeneration? Cell cycle reentry unpublished data
54 Utah LVAD Recovery Program Opportunity to Transform HF Biology and HF Clinical Practice HF patients Optimal Medical Therapy Surgical Therapies Stem cells LVAD Bridge to Heart Recovery Heart Transplant
55 Clinical Basic Science Research Fellows Nikos Diakos Omar Wever Abdul Saidi Div Verma Chi Yen
56 LVAD Unloading & Recovery What are the Future Research Targets? Drakos SG, et al. Circulation 2012
57 Guest Faculty David Kass, MD, Johns Hopkins Douglas Mann, MD, Washington Univ. Joseph Hill, MD, PhD, Univ. Texas Southwestern Michael Givertz, MD, Harvard Univ. Joseph Rogers, MD, DUKE Univ. Roger Hajjar, MD, Mount Sinai Simon Maybaum, MD, Albert Einstein College of Medicine Evangelia Kranias, PhD, Univ. of Cincinnati Mark Slaughter, MD, Univ. of Louisville Francis Spinale, MD, MUSC Evgenij Potapov, MD, Berlin Heart Institute, Germany John V. Terrovitis, MD, University of Athens, Greece
58 Summary - Bridge to Transplant, Destination Therapy: 1 st line therapeutic options for selected HF patients - Room for Improvement / Decrease Complications: 1. Technological Advances, 2. Patient Management, 3. Patient Selection
59 Summary Research in LVAD Recovery field: - Revisit view: human heart incapable of repair/ recovery - Transform role of LVAD from BTT to enabler of cardiac recovery? - Redirect Basic Science of cardiac recovery by focusing the field on basic pathways relevant to humans (i.e. biomarkers derived from LVAD Responders )
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61 Funding Sources for UTAH Recovery Program 1. VA Merit Award 2. American Heart Association 3. CTSA/NIH Award 4. Deseret Foundation 5. U of U Molecular Medicine (U2M2) 6. Intermountain Health Care
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63 2 nd Generation, Continuous-flow VADs: Concerns due to non- pulsatile/ non- physiologic blood flow pattern Importance of Pulse in Flow both for the Peripheral Organs and the Heart?
64 Short-term Support: Pulse in Flow Does Matter! Porcine model of ACUTE HF Coronary Flow Non-Pulsatile flow Pulsatile flow Cardiac Output Aortic Pressure Right Atrial Pressure Drakos S, Ntalianis A,, Nanas J. ASAIO J 2002
65 Long-term Support: Pulse Less Crucial? Animal data suggested adaptation to the non physiologic/ non-pulsatile flow over a period of few weeks Jett, et al, ASAIO J 1999 Saito, et al, Ann Thor Surg 2002 Tominaga, et al, J Thorac Cardiovasc Surg 1996
66 Long-term support: Human Peripheral Organs Adapt to Non Pulsatile flow
67 Increased GI Bleeding with Non-Pulsatile LVADs? Crow et al. J Thorac Cardiovasc Surg 2009
68 LVAD Unloading & Recovery: Future Directions Optimal Type of Unloading? Drakos, Kfoury,..., Li. Circulation 2012, In Press
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