Update in Advanced Therapies for Heart Failure
3/30/2015 Update in Advanced Therapies for Heart Failure Brent C. Lampert, DO 15th Annual Cardiovascular Symposium April 9, 2015 1 Disclosures No conflicts of interest No financial relationships 2 1 3/30/2015 Objectives Review factors that help identify high risk heart failure patients Review the CardioMEMS implantable PA hemodynamic monitoring system Review the patient selection process and current outcomes for cardiac transplantation 3 Heart Failure Affects ~ 6 million people in the U.S. Expected to increase > 25% by 2030 60,000 deaths per year directly attributed to HF Half of patients die w/in 5 yrs of diagnosis Costs $34.4 billion annually in the U.S. Hospital Discharges for HF by sex Go, et al. Circulation 2013. Heidenriech, et al. Circulation 2011 4 2 3/30/2015 Heart Failure Treatment 5 Identifying Patients for Advanced Therapies A balance: Risks of multi-system organ failure from progressive heart failure (> 50% death in 1 year) versus Risks of surgical intervention and chronic management of MCS/Tx 3 3/30/2015 Identifying Patients for Advanced Therapies Indications for Cardiac Transplant High-risk HF patients / Stage D disease Isolated cardiac disease for which no other therapies exist Refractory VT Refractory angina Certain restrictive cardiomyopathies 7 Identifying High Risk HF Patients Criteria for referral of pts < 80 y.o. to HF Specialist: SBP < 90 Creatinine ≥ 1.6 Hemoglobin ≤ 12 No RAS antagonist No β-blocker Presence of 1,2, or 3-5 factors = 79%, 60%, or 39% 1-year survival Thorvaldsen, et al. JACC 2014. 8 4 3/30/2015 Treatment Options CardioMEMS Intravenous Inotropes Ultrafiltration Cardiac Transplantation Mechanical Circulatory Support Palliative Care 9 CardioMEMS Implantable hemodynamic monitoring CHAMPION Trial 390 NYHA III pts (23% HFpEF) 37% ↓ in HF hospitalizations over average of 15 mos HFpEF 0.16 vs 0.33 (p<0.0001) HFrEF 0.36 vs 0.47 (p=0.007) Low (1.4%) rate of device related complications 10 5 3/30/2015 CardioMEMS 11 CardioMEMS – Patient List 12 6 3/30/2015 CardioMEMS – Physician Website Trend Data • Physician notification • Home transmission • Secure, encrypted web-based access 13 Cardiac Transplantation 1967: Christian Barnard performs first heart transplant in 54 y.o. man Æ pt dies 18 days later d/t pneumonia 1968: Shumway performs first heart transplant in U.S. 1968:102 transplants at 52 centers Æ 28% alive at 12 weeks 1981: Cyclosporine immunosuppression introduced 14 7 3/30/2015 Post Transplant Survival Lund, JHLT 2014 15 The Problem Supply 8 3/30/2015 The Problem Lund, JHLT 2014 17 Transplant Patient Selection Donor organs are a limited resource With critical organ shortage, risk stratification & patient selection is vital Challenges: Optimal timing Determine patients with best chance for long term survival and improvement in quality of life 18 9 3/30/2015 Transplant Patient Selection Mancini, et al. Circulation 1991. 19 Transplant Patient Selection ISHLT Recommendations for Heart Transplant Evaluation 20 10 3/30/2015 Contraindications Conditions with high peri-operative risk Conditions that would limit graft function Conditions that increase risk of rejection Conditions that increase risk of complications Other life-limiting conditions 21 Conditions with high perioperative risk Bleeding disorders/clotting disorders Anatomic considerations Multiple repeat surgeries Allergies/sensitivities to perioperative medications e.g. HIT Significant renal disease Cerebral vascular disease 22 11 3/30/2015 Conditions that would limit graft function Pulmonary hypertension RV dysfunction is a major cause of acute graft failure Systemic diseases that can affect new heart e.g. amyloidosis Conditions increasing risk of allograft vasculopathy Ongoing smoking/tobacco use Exposure to second hand smoke 23 Conditions that increase risk of rejection Sensitization High PRA levels Strategies involving cross-matching can mitigate risk Intolerance to immunosuppression Significant renal disease Uncontrolled diabetes Myelodysplastic disorders/low cell counts Ability to comply with complex medical regimen Pyschosocial disorders Illicit drug use Insurance/cost factors 24 12 3/30/2015 Conditions with increased complications Obesity (BMI >35) Chronic debilitation Amputations/non-ambulatory conditions Uncontrolled diabetes Significant pulmonary disease High infectious risk profiles (e.g. HIV) Noncompliance or lack of social support Substance abuse 25 Other life-limiting/quality-limiting conditions Active or recent (<5 yrs) malignancy Solid organ or malignant hematological disease Required age & risk-appropriate cancer screening Age >70 years Not absolute contraindication Dementia/significant neurological deficits Significant renal disease (dialysis risk) Dual-organ transplant can be considered Peripheral artery disease Uncontrolled diabetes Risk of progression on posttransplant meds 26 13 3/30/2015 Heart Transplant - Age 27 Heart Transplant – Patient Selection Following objective evaluation, each case is discussed in multi-disciplinary meeting: HF Cardiology Cardiac Surgery Transplant coordinators Social Work Pulmonology Infectious Disease Good candidates with a chance to have their lives improved by transplant are placed on the waiting list 28 14 3/30/2015 Heart Transplant % of adult wait-listed patients (2010) receiving a heart transplant within 1 year 29 Heart Transplant - Donor Rates Deceased donor heart donation rates (per 1,000 deaths), by state 30 15 3/30/2015 Our Team Robert Higgins Garrie Haas Ayesha Hasan Veronica Franco Sandi Parsons Ramesh Emani Susan Montgomery Ragavendra Baliga Erin Bumgardner Sakima Smith Emily Jarvis Ray Hershberger Jodi Knisley Kristin Kuntz Laura Newman Amy Pope-Harman Peter Lee Stan Martin Ahmet Kilic Nicole Theodoropoulos Bryan Whitson Pam Burcham Juan Crestanello Erik Abel 31 Thank You 32 16
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