Late follow-up for a randomized trial of surgical treatment of tricuspid valve regurgitation in patients undergoing left ventricular assist device implantation.

Abstract

Background: We previously reported that concurrent tricuspid valve surgery (TVS) was not associated with a lower incidence of early right heart failure (RHF) in patients undergoing durable left ventricular assist device (LVAD) implantation. This follow-up analysis aimed to further define the clinical impact of concurrent TVS after 2 months of follow-up.

Methods: Patients with moderate or severe tricuspid regurgitation (TR) on preoperative echocardiography (n = 71) were randomized to LVAD implantation either alone (no TVS group; n = 34) or with concurrent TVS (TVS group; n = 37). Randomization was stratified by preoperative right ventricular dysfunction. The patients were followed for at least 12 months after surgery. The incidence of RHF was determined by an adjudication committee using Interagency Registry for Mechanically Assisted Circulatory Support criteria. Functional studies and repeat echocardiography were performed at 12 months.

Results: Demographics were similar in the 2 study arms. At 12 months, the rate of moderate or severe RHF was 50.0% in the no TVS arm versus 51.4% in the TVS arm. No patients developed RHF between 6 and 12 months following the procedure. Death from RHF was 5.4% in the TVS arm versus 8.8% in the no TVS arm. At 12 months, there was no significant difference in TR severity between the 2 arms, owing to improvement in TR severity in the no TVS arm. Cardiopulmonary exercise testing at 12+ months revealed no significant between-group difference in peak oxygen consumption.

Conclusions: In patients with significant preimplantation TR, the severity of TR improved over time in the no TVS arm with LVAD implantation alone. By 12 months, there was no significant difference in TR severity between the 2 arms. This may account for the lack of difference in late clinical or functional parameters.