Abstract
Introduction
Although the landmark MOMENTUM 3 trial was associated with excellent short-term left
ventricular assist device (LVAD) outcomes, many end-stage heart failure patients would
not have met the trial eligibility criteria. Moreover, the outcomes of trial ineligible
patients are poorly characterized. Therefore, we undertook this study to compare MOMENTUM
3 eligible and ineligible patients.
Methods
We conducted a retrospective review of all primary LVAD implants from 2017 to 2022.
Primary stratification was according to MOMENTUM 3 inclusion and exclusion criteria.
Primary outcome was survival. Secondary outcomes included complications and length
of stay. Multivariable Cox proportional hazards regression models were constructed
to further characterize outcomes.
Results
From 2017 to 2022, 96 patients underwent primary LVAD implantation. Thirty-seven (38.54%)
patients were trial eligible while 59 (61.46%) were ineligible. When stratified by
trial eligibility, patients who were trial eligible had higher 1-year (80.15% versus 94.52%, P = 0.04) and 2-year survival (70.17% versus 94.52%, P = 0.02). Multivariable analysis showed that trial eligibility was protective of mortality
at both 1 y (HR: 0.19 [0.04-0.99], P = 0.049) and 2 y (HR: 0.17 [0.03-0.81], P = 0.03). Although the groups had similar rates of bleeding, stroke, and right ventricular
failure, trial ineligibility was associated with a longer periprocedural length of
stay.
Conclusions
In conclusion, the majority of contemporary LVAD patients would not have been eligible
for the MOMENTUM 3 trial. Ineligible patients have decreased but acceptable short-term
survival. Our findings suggest that a simply reductionist approach to short-term mortality
may improve outcomes but fail to capture the majority of patients who could benefit
from therapy.
Keywords
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Article info
Publication history
Published online: March 01, 2023
Accepted:
January 28,
2023
Received in revised form:
January 1,
2023
Received:
September 20,
2022
Identification
Copyright
© 2023 Elsevier Inc. All rights reserved.
