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