Concomitant Tricuspid Valve Surgery During HeartMate 3 LVAD Implantation and Long-Term Outcomes: Insights From the ELEVATE Registry.

OBJECTIVES

To assess whether tricuspid valve surgery (TVS) during HeartMate 3 (HM3) left ventricular assist device (LVAD) implantation affects long-term survival and outcomes.

METHODS

The ELEVATE registry enrolled 540 HM3 patients across 26 centres; 463 undergoing primary LVAD implantation and at least mild tricuspid regurgitation (TR) formed this analysis. Concomitant TVS was performed in 70 (15.1%) patients. Five-year outcomes (survival, functional capacity, end-organ function, adverse events) were compared with those with similar severity of TR not receiving TVS in both overall population (with TVS n = 70 vs without TVS n = 264) and matched groups (each group n = 67, primary analysis cohort).

RESULTS

In the matched cohort, baseline demographics of patients with or without TVS showed no differences in age (57.9 ± 10.8 vs 57.3 ± 10.0; P = .728), sex (male, 92.5% vs 94.0%; P = 1.000), preoperative short-term mechanical circulatory support rate (6.0% vs 9.0% P = .744), New York Heart Association (NYHA) class and quality of life (QoL) score, and end-organ function. Preoperatively, patients with TVS had shorter 6-minute walk distances (6MWD; 58.0 ± 109.0 m vs 105.3 ± 154.0 m; P = .081). At 5 years, patients with TVS showed no differences in survival (69.0% vs 59.3%, P = .67), 6MWD (311.1 ± 129.5 m vs 295.6 ± 137.7 m, P = .758), QoL score, or end-organ function while presented a lower risk of right heart failure (EPPY 0.038 vs 0.092, P = .03).

CONCLUSIONS

In the ELEVATE registry, concomitant TVS during HM3 implantation was not associated with differences in 5-year survival; however, it may have a positive effect on functional capacity and right heart function.

CLINICAL REGISTRATION NUMBER: NCT02497950.