Randomized trial of tricuspid flexible band versus rigid ring in patients with moderate tricuspid regurgitation or greater: results of the JPH2019 trial.

Abstract

To compare the efficacy and clinical outcomes of flexible band versus rigid ring annuloplasty for the correction of moderate tricuspid regurgitation (TR) or greater. In this single-center randomized trial, adult patients with moderate or greater TR were assigned to receive either a flexible band or a rigid ring. The primary outcome was recurrent TR during follow-up. Secondary outcomes included death, permanent pacemaker implantation, and other adverse events. In total, 400 patients were randomized with a 1:1 ratio, and 321 were included in the final analysis (flexible band, n = 156; rigid ring, n = 165). Baseline characteristics were balanced between arms. At discharge, recurrent TR was significantly greater in the flexible band arm than the rigid ring arm (10.1% vs 3.8%, P = .03). However, the significance was no longer significant during follow-up (6.1%/patient-years vs 4.7%/ patient-years, P = .21). Multivariable analysis identified female sex (subdistribution hazard ratio [sHR], 2.16, 95% CI, 1.1-4.22, P = .025), preoperative severe TR (sHR, 2.09; 95% CI, 1.06-4.11, P = .033) and massive TR (sHR, 4.63; 95% CI, 1.29-16.61, P = .019), and preoperative permanent pacemaker implantation (sHR, 3.69; 95% CI, 1.35-10.09, P = .011) as independent risk factors for recurrent TR. Subgroup analyses based on these factors showed no significant between-arm difference in the primary outcome. secondary outcomes were also comparable between the arms during follow-up. Both annuloplasty devices provided acceptable TR correction with similar adverse event rates over a median 3-year follow-up.