Advances in Advanced Heart Failure Therapies. Disclosures. Management Algorithm for Patients in Cardiogenic Shock

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Dominick Marsh
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1 Advances in Advanced Heart Failure Therapies 9 th Annual Dartmouth Conference on Advances in Heart Failure Therapies Dartmouth-Hitchcock Medical Center May 20, 2013 Joseph G. Rogers, M.D. Associate Professor of Medicine Senior Vice Chief for Clinical Affairs, Division of Cardiology Medical Director, Cardiac Transplant and Mechanical Circulatory Support Program Duke University Disclosures Consultant: Thoratec Corporation Principal nvestigator, HeartWare ENDURANCE trial Management Algorithm for Patients in Cardiogenic Shock Rogers JG, Milano CA, The role for mechanical support in cardiogenic shock, AHA Publication, 2009

The Problem of Acute Cardiogenic Shock ABP SHOCK

move forward with the understanding that a

2012;367:1287-96 Novel Mechanical Approaches to

clinical trials of novel mechanical circulatory

$with refractory cardiogenic shock Nearly 50% had$ just received or were receiving CPR Mean support

2 The Problem of Acute Cardiogenic Shock ABP SHOCK Trial On the basis of the ABP-Shock trial, we must move forward with the understanding that a cardiovascular condition with a 40% mortality at 30- days is unacceptable. New Eng J Med 2012;367: New Engl J Med 2012;367: Novel Mechanical Approaches to Treat Acute Cardiogenic Shock Need controlled clinical trials of novel mechanical circulatory assist devices for acute heart failure TandemHeart in Cardiogenic Shock: TH Experience 118 patients with refractory cardiogenic shock Nearly 50% had just received or were receiving CPR Mean support duration = 5.8 days Am Heart J 2006;152:469 Artificial Organs 2006;30: J Am Coll Cardiol 2011;57:688-96

Mechanical Right Heart Support Two limbs in trial: 1) Post M RV failure; 2) Post heart surgery The Stage D Heart

options Percent Survival 1.00 0.90 0.80 0.70 0.60 0.50 0.40 0.30 0.20 0.10 0.

Making Advanced HF Symptoms Severe LV Dysfunction Standard Therapies Utilized Pt wishes to proceed Viable candidate

3 Mechanical Right Heart Support Two limbs in trial: 1) Post M RV failure; 2) Post heart surgery The Stage D Heart Failure Patient 5% of the heart failure population ntolerable symptoms Frequent hospitalizations Limited therapeutic options Percent Survival Months Post Enrollment N Engl J Med 2001; 345: Advanced Heart Failure Decision Making Advanced HF Symptoms Severe LV Dysfunction Standard Therapies Utilized Pt wishes to proceed Viable candidate Yes Management of Co-morbidities Tailored Medical Therapy/PAC Suitable improvement No Palliative Care Hospice Yes Continue No Continuous infusion inotropes LVAD Transplant

mpact of notropes on Survival Mortality (%) 100 80 60 40 20 0 0 3 6 9 12 Mo on notropic Therapy Placebo Randomized V notropes

TRANSPLANTS BY YEAR AND LOCATON J Heart Lung Transplant.

4 mpact of notropes on Survival Mortality (%) Mo on notropic Therapy Placebo Randomized V notropes Uncontrolled V notrope Oral Milrinone Class V REMATCH notrope Dependent Oregon Series Circulation 2003; 108: NUMBER OF HEART TRANSPLANTS BY YEAR AND LOCATON J Heart Lung Transplant Oct; 31(10): ADULT HEART TRANSPLANTS Patients Bridged with Mechanical Circulatory Support* (Transplants: January 2000 December 2010) * LVAD, RVAD, TAH J Heart Lung Transplant Oct; 31(10):

HEART TRANSPLANTS Kaplan-Meier Survival (Transplants: January

Status of Surviving Recipients (Follow-ups: January 2000 June

5 HEART TRANSPLANTS Kaplan-Meier Survival (Transplants: January June 2010) N = 96,273 N at risk at 25 years = 112 J Heart Lung Transplant Oct; 31(10): ADULT HEART RECPENTS Functional Status of Surviving Recipients (Follow-ups: January 2000 June 2011) J Heart Lung Transplant Oct; 31(10): VAD mplantation in the US J Heart Lung Transplant 2013;32:141-56

P < 0.001 log-rank test Post-Trial (N=1496) Trial (N=486) 85% 76% At Risk: 281 133 215 95 Early trial = 2.0 ± 1.6 years (longest: 5.

4 years) 74 ± 3% 68 ± 4% 188 82 Mid trial (N=281) Early trial (N=133) 167 69 64 ± 3% 58 ± 4% 94 62 Mechanically Assisted Circulation:

Mode: fixed speed Mechanically Assisted Circulation: Contemporary Devices and Outcomes Percent Survival 100 90 80 70 60 50 40 Bridge to

NYHA CLASS 100 90 80 70 60 50 40 30 20 10 0 Destination Therapy P(log-rank) = 0.134 P(adjusted for BSA) = 0.

trials using MCS in non-inotrope dependent, ambulatory heart failure REVVE-T ROADMAP Sponsor NH, Thoratec Thoratec Design Randomized

6 P < log-rank test Post-Trial (N=1496) Trial (N=486) 85% 76% At Risk: Early trial = 2.0 ± 1.6 years (longest: 5.5 years) Mid trial = 1.5 ± 1.0 years (longest: 3.4 years) 74 ± 3% 68 ± 4% Mid trial (N=281) Early trial (N=133) ± 3% 58 ± 4% Mechanically Assisted Circulation: Contemporary Devices Axial Flow Pump Centrifugal Flow Pump Continuous Flow Pumps Flow Characteristics: continuous Valves: no Operating Mode: fixed speed Mechanically Assisted Circulation: Contemporary Devices and Outcomes Percent Survival Bridge to Transplant Months Ann Thorac Surg 2011;92: MN WALK V Bridge to Transplant V Circulation 2012;125: NYHA CLASS Destination Therapy P(log-rank) = P(adjusted for BSA) = Average Support Duration Time (Months) Circ Heart Failure 2012;5:241-8 KCCQ J Am Coll Cardiol 2010; 55: Ongoing trials using MCS in non-inotrope dependent, ambulatory heart failure REVVE-T ROADMAP Sponsor NH, Thoratec Thoratec Design Randomized Non-randomized N Follow-up Duration (mo) Current VAD indication No Yes 1 0 Endpoint Survival free from disabling stroke and increased 6MWD 75 m at 24 months Survival with increased 6MWD 75 m at 12 months LVEF NYHA Class b-v 6 min Walk 350 meters <300 meters

7 nnovations in Mechanical Circulatory Support Focus on enhanced durability, biocompatibility, energy efficiency and less invasive implant techniques New Devices Totally mplantable VADS for Partial Support Circulite Synergy Surgical or percutaneous implant Partial cardiac assist Flow 2-3 l/min Modeling suggests reduction of LVEDP 7-10 mm Hg 8-12 hours of untethered support Eur J Cardiothorac Surg 2011;39:693-8 Proximal Aortic Counterpulsation Curr Heart Fail Report 2010;7:27-34

8 Total Artificial Heart Bridge to Transplant vs Medical Therapy New Engl J Med 2004;351: Strategies for BiVentricular Support 30-day survival 82% Circulation 2011; 124 (suppl1):s179-s186 Myocardial Functional Recovery on a Pulsatile Device: The Harefield Experience Adjunctive Clenbuterol Adjunctive Cell Therapy Allogeneic Stem Cells N Engl J Med 2006;355:

9 16 patients with ischemic cmy, LVEF < million autologous cardiac stem cells administered C Lancet 2011; 378: Tissue Re-Engineering Taylor DA Texas Heart nst J :148-9

90 80 80 Prefers comfort care Prefer DNR Pain Confusion Dyspnea 70 % Patients 60 40 % Patients 60 50 40 30 20 20 10 0 6 Mo- 3 Mo 3 Mo- 1 Mo 1 Mo- 3 Days 3 Days-Death 0 6 Mo-3 Mo 3 Mo-1 Mo 1 Mo-3 Days

10 Prefers comfort care Prefer DNR Pain Confusion Dyspnea 70 % Patients % Patients Mo- 3 Mo 3 Mo- 1 Mo 1 Mo- 3 Days 3 Days-Death 0 6 Mo-3 Mo 3 Mo-1 Mo 1 Mo-3 Days J Am Geriatr Soc 48:S101 Summary and Conclusions Advanced heart failure is associated with high residual morbidity and mortality despite contemporary medical and electrical therapies Acute cardiogenic shock requires a more innovative and evidencebased approach Transplant remain the gold standard (MCS takes bronze) New devices will be smaller, energy efficient and will be implanted with less invasive techniques The totally implantable systems may significantly reduce morbidty and improve quality of life Clinical trials for biventricular support are needed Stem cells remain the holy grail of heart failure therapy t is imperative that we understand how to utilize palliative care and hospice in heart failure

Mechanical Circulatory Support in the Management of Heart Failure

Mechanical Circulatory Support in the Management of Heart Failure Feras Bader, MD, MS, FACC Associate Professor of Medicine Director, Heart Failure and Transplant Cleveland Clinic Abu Dhabi Chairman, Heart