Abstract
BACKGROUND: Correction of valvular disease is often undertaken during left ventricular assist device (LVAD) implantation with uncertain benefit. We analyzed clinical outcomes with HeartMate 3 (HM3; Abbott) LVAD implantation in those with various concurrent valve procedures (HM3+VP) with those with an isolated LVAD implant (HM3 alone).
METHODS: The study included 2200 patients with HM3 implanted within the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 (MOMENTUM 3) trial portfolio who underwent 820 concurrent procedures among which 466 (21.8%) were HM3+VP. VPs included 101 aortic, 61 mitral, 163 tricuspid; 85 patients had multiple VPs. Perioperative complications, major adverse events, and survival were analyzed.
RESULTS: Patients who underwent HM3+VP had higher-acuity Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profiles (1-2: 41% vs 31%) compared with no VPs (P < .05). The cardiopulmonary bypass time (124 vs 76 minutes; P < .0001) and hospital length of stay (20 vs 18 days; P < .0001) were longer in HM3+VP. A higher incidence of stroke (4.9% vs 2.4%), bleeding (33.9% vs 23.8%), and right heart failure (41.5% vs 29.6%) was noted in HM3+VP at 0 to 30 days (P < .01), with no difference in 30-day mortality (3.9% vs 3.3%) or 2-year survival (81.7% vs 80.8%). Analysis of individual VP showed no differences in survival compared to HM3 alone. No differences were noted among patients with either significant mitral (moderate or worse) or tricuspid (moderate or worse) regurgitation with or without corrective surgery.
CONCLUSIONS: Concurrent VPs, commonly performed during LVAD implantation, are associated with increased morbidity during the index hospitalization, with no effect on short- and long-term survival. There is sufficient equipoise to consider a randomized trial on the benefit of commonly performed VPs (such as mitral or tricuspid regurgitation correction), during LVAD implantation.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1684-1694.e18 |
| Journal | Journal of Thoracic and Cardiovascular Surgery |
| Volume | 166 |
| Issue number | 6 |
| DOIs | |
| State | Published - Dec 2023 |
Bibliographical note
Funding Information:Funded by Abbott (MOMENTUM 3 IDE Trial [NCT02224755] and MOMENTUM 3 CAP [NCT02892955]).
Funding Information:
R.J. is a consultant for Abbott and Medtronic, and received research grants from Abbott. M.K.K. is an advisory board member for Abiomed and Bayer. J.C.C. is a member for the clinical events committee for ARIES and data safety monitoring board for Repair MAR; both Abbott-sponsored studies. N.U. is on the medical advisory board for Livemetric, Revamp and Leviticus. He reports grants from Abbott, Abiomed, and Fire1. Y.N. reports personal fees from Abbott. C.S. reports personal fees from Abbott and Medtronic. D.H. is a consultant for Abbott. S.A.H. is a consultant for Abbott and Medtronic. J.A.C. is a consultant for Abbott, Medtronic, Bioventrix, Endotronix, and Procyrion, and has received research grant and speaker fees from Abbott. G.H. and S.I.S. are employees of Abbott. M.R.M. reports payments made to his institution from Abbott for consulting, consulting fees from Baim Institute for Clinical Research, Natera, Paragonix, Janssen, Mesoblast and Moderna, and is an advisory board member for NuPulseCV, Leviticus, and FineHeart.
Publisher Copyright:
© 2022 The American Association for Thoracic Surgery
Keywords
- HeartMate 3
- LVAD
- outcomes
- valve procedures
