Rebecca Cogswell, MD
Associate Professor of Medicine
Medical Director, Mechanical Circulatory Support
University of Minnesota
Bridge to Transplant LVAD – Updates in the New Allocation System
OUTLINE• LVAD history • 2018 HT allocation system change • Changes in practice, outcomes • What the community is feeling (survey results) • Summary
LARGE GAP
• 25,000 candidates appropriate for advanced therapies • 3,000 cardiac transplants/year
KEY ADVERSE STROKE EVENT
5
KAPLAN MEIER CURVES- STATS LESSON
LVAD HISTORY
References: 1. Lund LF, Khush KK, Cherikh WS, et al. The Registry of the International Society for Heart and Lung Transplantation: Thirty-fourth Adult Heart Transplantation Report—2017; Focus theme: allograft ischemic time. J Heart Lung Transplant. 2017;36:1037-1046. 2. Mehra MR, Uriel N, Naka Y, et al. A Fully Magnetically Levitated Ventricular Assist Device-Final Report. N Engl J Med. 2019. 3. Rogers JG, Pagani FD, Tatooles AJ, et al. Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure. N Engl J Med. 2017;376:451-60. 4. Slaughter MS, Rogers JG, Milano CA, et al. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med. 2009;361:2241-2251. 5. Rose EA, Gelijns AC, Moskowitz AJ, et al. Long-term use of a left ventricular assist device for end-stage heart failure. N Engl J Med. 2001 Nov 15;345(20):1435-43.
Based on published data from multicenter experience and separate studies, which may involve different patient populations and other variables. Not a head to head comparison. Data presented for informational purposes only.
*82% 2-year survival for adult heart transplants patients between 2009 and 20151
BTT LVAD USE- WAS INCREASING
NEW ALLOCATION SYSTEM – Oct 2018
UNOS/OPTN Report
WAIT TIMES ARE DOWN
UNOS/OPTN Report
TEMPORARY MCS USE IS UP
LV
Esposito, F1000 Research May 2017
RV
ECMO TO ADVANCED THERAPIES TRENDS
DeFilippis, JACC HF Dec 2020
THE DEVICE STORY
UNOS/OPTN Report
54%
WAITLIST STATUS – AT TRANSPLANT
POST TRANSPLANT MORTALITY
17
One-year patient survival in the pre era was 91.1%
compared to 91.59% in the post era
ONE YEAR SURVIVAL- “ASSUME ALIVE APPROACH”
UNOS/OPTN Report
THE LVAD STORY
Mullen, JACC HF
NEW SYSTEM- SUMMARY• Shorter wait times, further stratification •Waitlist mortality similar • Post transplant survival similar • High use of exceptions, temporary support • Highest waitlist mortality among highest tiers
AS WE WENT ALONG, WE NOTICED…
• Constant influx of status 1,2 ahead of the others • High use of top statuses- high status needed to get to transplant • LVADs not making it through
Survey says…
N = 117
Who
I believe the allocation system for heart transplant instituted in 2018 (new system) requires modification.
My team is utilizing more temporary support than before the allocation system change to achieve a higher allocation status.
If there was a more reliable pathway for LVAD patients to receive a transplant, I would be more willing to place an LVAD as a bridge therapy.
I am concerned about the pattern of change in physician behavior and practices to achieve transplant under the new allocation system.
LVAD FOCUS ****• Reach 2 years on LVADà status 3 • LVAD complication à status 2 • LVADs- elective status 2 timeOTHER • IABP out of status 2 • Limit highest tier to LVAD exceptions
only (ARVC, restrictive) • Regulate exceptions
How would you modify the current allocation system?
Allocation Score• Model LVAD time • Points for race • Points for sensitization • Points for Blood group O• Points for acuity, not for device
• The advanced HF community (this sample)- feels change is needed• Allocation system- did what it was supposed to do – no one thought this
was final version • Devices have complications • Risk of waiting on temp MCS vs. LVAD forever
• Not enough hearts to go around – ethics • Advanced HF patients, different physiologies, trajectories hard to capture • I believe in our community- analyze frequently, open dialog, ask tough
questions
SUMMARY
THANK YOU
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