From LVAD to Transplant: State of the Art of Advanced Heart Failure Management
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Jeffrey Keenan, MD Duke University
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From LVAD to Transplant: State of the Art of Advanced Heart Failure Management
- 1. From LVAD to Transplant: State of the Art of Advanced Heart Failure Management Duke Heart Failure Symposium Durham, North Carolina May 4, 2024 Jeffrey E. Keenan, MD FACS Assistant Professor of Surgery Duke University Medical Center
- 3. • Heart Failure Cardiology • Other cardiology subspecialties – EP, structural heart, interventional • Cardiac Surgery • Transplant and VAD coordinators • Cardiothoracic Anesthesia & Intensive Care • Social Work • Transplant Infectious Disease • Transplant Psychology • Transplant Pharmacy • Inpatient and outpatient APPs The Advanced Heart Failure Multidisciplinary Team It takes a village!
- 4. VA-ECMO Heart Failure/Shock Refractory to GDMT and Inotropes Biventricular MCS Left Ventricular MCS Right Ventricular MCS Recovery Orthotopic Heart Transplant Durable MCS Bridge with Temporary Mechanical Circulatory Support Pathways to long-term survival Contemporary Management of Advance Heart Failure
- 5. Where we have come from: Rematch 2001 • Randomized comparison between Thoratec XVE and medical management in end-stage heart failure • Cohort • NYHA class IV despite 90 days of OMM, • LVEF <25%, • Peak VO2 <12, • Or Inotrope, IABP dependence
- 6. Where we have come from: Rematch 2001 • Significant survival benefit with XVE compared to OMM • One year survival: • 52% with XVE LVAD • 25% with medical therapy Ross et al, NEJM 2001
- 7. MOMENTUM 3 5-YEAR FOLLOW-UP The evolution of HeartMate™ LVADs Continuous flow (axial) Continuous flow (centrifugal) with Full MagLev™ Flow Technology Pulsatile flow HeartMate XVE™ LVAD* HeartMate II™ LVAD HeartMate 3™ LVAD 1. Abbott data on file. Based on clinical and device tracking data as of May 2, 2022 >27,000 patients implanted, with patients on therapy out to 10+ years1 >23,000 patients implanted, with patients on therapy out to 5+ years1 First LVAD FDA-approved for DT BTT 1998 | DT 2003 1998 2008 2017 BTT 2008 | DT 2010 ST (BTT) 2017 | LT (DT) 2018 *This product is no longer available for sale or use. MAT-2211854 v1.0 | Item approved for U.S. use only.
- 8. Main Outcomes of MOMENTUM 3 at 2 Years Composite of survival free of disabling stroke or reoperation to replace or remove a malfunctioning device Superiority of HeartMate 3 over HeartMate II LVAD was driven by significant reduction in Hemocompatibility Related Adverse Events (HRAEs), specifically: pump thrombosis, strokes, bleeding, including GI bleeding Mehra MR et al. A Fully Magnetically Levitated Left Ventricular Assist Device - Final Report. N Engl J Med. 2019;380:1618-1627 Figure S3. Actuarial Overall Survival (Per Protocol Population) 95% confidence intervals have not been adjusted for multiplicity and therefore inferences drawn from these intervals may not be reproducible. Overall Survival
- 9. JAMA. doi:10.1001/jama.2022.16197 Published online September 8, 2022. .
- 10. MOMENTUM 3 5-YEAR FOLLOW-UP Overall Survival Mehra, MR. 5-Year Survival with LVAD Therapy in MOMENTUM3. Presented at: European Society of Cardiology (ESC) Annual Meeting; August 28, 2022; Barcelona, Spain. HeartMate 3 LVAD is a proven life-extending therapy with median survival exceeding 5 years Modified Primary Endpoint • HeartMate 3™ LVAD 5-year survival 58.4% • Median survival exceeding 5 years
- 11. 63.5% survival at 5 years HM3 real world outcomes Source: F. Pagani, INTERMACS
- 12. Source: F. Pagani, INTERMACS 51.2% 5 yr survival HM3 real world outcomes
- 13. MOMENTUM 3 5-YEAR FOLLOW-UP Serious Adverse Events from 0-5 Years Mehra, MR. 5-Year Survival with LVAD Therapy in MOMENTUM3. Presented at: European Society of Cardiology (ESC) Annual Meeting; August 28, 2022; Barcelona, Spain. Significant reduction in serious adverse events was maintained for HeartMate 3 at 5 years
- 14. 0 100 200 300 400 500 600 700 800 Number Total Primary HM 3 LVAD’s Quarterly Trends August 23, 2017 and September 30, 2022 Quarterly Totals Total N= 11798 Source: Kormos, R. Intermacs Report for Abbott
- 15. What is solution to HM3 paradox? • Industry • Primary care • Cardiologists • EP cardiologists and Interventional Cardiologists • Cardiac Surgeons We can be the solution !!! • Estimated incidence of heart failure for adults in US : 6.5 million patients • 60, 000 ACC/AHA stage D heart failure • Heartmate 3 implant rates are flat
- 16. VA-ECMO Heart Failure/Shock Refractory to GDMT and Inotropes Biventricular MCS Left Ventricular MCS Right Ventricular MCS Recovery Orthotopic Heart Transplant Durable MCS Bridge with Temporary Mechanical Circulatory Support Pathways to long-term survival Contemporary Management of Advance Heart Failure
- 17. Survival after Heart Transplantation Median Survival after Heart Transplantation is now >12 years!
- 18. Survival after Heart Transplantation Conditional on 1-year Survival Median Survival after Heart Transplantation Conditional on 1-year Survival is now >14 years!
- 19. Peripheral MCS: the Left Side of the Equation Impella 5.5 • Catheter-based microaxial pump • Can be implanted peripherally through axillary artery side graft • Advanced into the left ventricle with inflow positioned in the LV cavity and the outflow positioned in the proximal aorta • Pump flows of >5 lpm • Compared with prior generation impella devices it is easier to position within the LV cavity, holds its position better, and rates or serious hemolysis are substantially reduced
- 20. Peripheral MCS: the Right Side of the Equation Dual lumen cannulas with extracorporeal circuit • Percutaneously inserted through right internal jugular or one of the subclavian veins • Device inflow situated in the right atrium and device outflow position in the pulmonary artery • Oxygenator can be included within circuit for gas exchange support
- 21. Contemporary Snapshot of Pre-transplant Support at a Single Center Pre-transplant support at Duke University Medical Center over one year from 4/1/2022 to 3/31/2023 • 139 Transplants total Pre-transplant Hemodynamic Support Number of Transplants Percentage of Transplants Inotropes or none 51 36.7 IABP 23 16.5 Durable LVAD 28 20.1 Impella 5.5 24 17.3 BiVAD 5 3.6 ECMO 8 5.8
- 22. Peripheral BiVAD Bridge to Transplant: One Patient’s Story • 25 YO M with prior OHT 2021 presented to outside institution in profound cardiogenic shock • Presumptive viral myocarditis • Cannulated for VA-ECMO + right axillary impella cp • Transferred to DUMC for consideration of OHT after ~2 weeks on VA-ECMO support and no improvement in allograft function • Following arrival at DUMC had clinical deterioration related to pneumonia requiring intubation and AKI requiring CRRT • Transitioned from ECMO to peripheral BiVAD support with left axillary Impella 5.5 and Protek Duo plus oxygenator
- 23. • Intensive medical management and rehabilitation while on peripheral BiVAD support • Tracheostomy and slow vent wean + removal of oxygenator from RVAD circuit • Renal replacement therapy • PT/OT/Mobilization • Once felt to be suitable from a medical and conditioning standpoint, he was activated for heart and kidney transplantation (status 2) • After 61 days of peripheral BiVAD support underwent successful heart and kidney transplantation Peripheral BiVAD Bridge to Transplant: One Patient’s Story
- 24. Evolving Technology for Cardiac Allograft Preservation LV vent PA drainage cannula Pacing wires Drain to pump From pump Root Vent Access ports for labs draws and med administration Transmedics Organ Care System • Transportable unit that places the donor heart in series with a pump and oxygenator with circulation of oxygenated normothermic donor blood • Minimal medicine and substrate additives • FDA approved for BD donors 2021 and DCD donors 2022
- 25. Conclusions • The current durable LVAD Heartmate 3 represents a marked improvement compared to prior durable LVAD devices, with improved long term-survival and complication profile • Improving technology in temporary mechanical support and cardiac allograft preservation has allowed heart transplantation to be extended to more end-stage heart failure patients • Heart transplantation continues provide the best outlook to end- stage heart failure patients, with excellent long-term survival and quality of life outcomes
Editor's Notes
- Note: remember that MOM3 was a trial – enrolling both bridge and DT patients, to reflect the real-world. Enrollment was approx. 60% DT MOM3 2-yr outcomes: primary composite endpoint Overall survival at 2 years
- Note: remember that MOM3 was a trial – enrolling both bridge and DT patients, to reflect the real-world. Enrollment was approx. 60% DT MOM3 2-yr outcomes: primary composite endpoint Overall survival at 2 years
- In the first ever report of 5-yr outcomes for an LVAD trial: Overall survival at 5 yrs: HM3 – 58.4%; a median survival for HM3 that easily exceeds 5 years.
- The improved survival for HM3 was shown to be due to a significant reduction in hemocompatibility-related mortality, resulting from reduced thrombosis, stroke, and bleeding events. Heart failure was the leading cause of death in HM3, followed by infection. The risk of death due to these causes were similar between treatment groups.