Concomitant Valvular Procedures During LVAD Implantation and Outcomes: An Analysis of the MOMENTUM 3 Trial Portfolio

Purpose: Correction of valvular pathology is often undertaken in patients undergoing LVAD implantation but impact on outcomes is uncertain. We compared clinical outcomes with HeartMate 3 (HM3) LVAD implantation in those with concurrent valve procedures (VP) to those with an isolated LVAD implant within the MOMENTUM3 trial portfolio, including the Pivotal Trial (n=515, NCT02224755) and Continued Access Protocol/ CAP (n=1685, NCT02892955). Methods: The study included 2200 HM3 implanted patients. Among 820 concurrent procedures (including VP, CABG, RVAD, LAA closure), 466 (21.8%) were VPs (HM3+VP), including 81 aortic, 61 mitral, 163 tricuspid, and 85 patients with multiple VPs. Short and Long-term outcomes including peri-operative complications and healthcare resource use, major adverse events and survival were analyzed. Results: Patients undergoing HM3+VP were older (63[54-70] vs. 62[52-68] yrs), with a sicker INTERMACS profile (1-2:41% vs.31%) and higher central venous pressure (11[8-16] vs. 9[6-14] mmHg) compared to HM3 alone (all p\u3c0.05). The cardiopulmonary bypass time (124[97-158] vs.76[59-96] mins); ICU (8.5 [5-16] vs. 7 [5-13]) and hospital length of stay (20 [15-30] vs. 18 [14-24] days) were longer in HM3+VP (all p\u3c0.0001). A significantly 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 for 0-30 days post-implant (all p\u3c0.01), but 30-day survival was similar between groups (96.7% vs. 96.1%). There was no difference in 2-year survival in HM3+VP vs HM3 alone patients (HR[95%CI]:0.93 [0.71-1.21];p=0.60). Analysis of individual VPs showed no significant differences in survival compared to HM3 alone (Figure). Conclusion: Concurrent VPs are commonly performed during LVAD implantation, are associated with increased morbidity during the index hospitalization, but short and long-term survival are not impacted adversely when compared with those that undergo an isolated LVAD procedure