The Journal of thoracic and cardiovascular surgery · 2026
Randomized trial of tricuspid flexible band versus rigid ring in patients with moderate tricuspid regurgitation or greater: results of the JPH2019 trial.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Xu Xiufan, Gu Jiaxi, Liu Hong, Du Junjie, Gu Weidong, Ni Buqing, Shao Yongfeng
Аннотация
OBJECTIVE: To compare the efficacy and clinical outcomes of flexible band versus rigid ring annuloplasty for the correction of moderate tricuspid regurgitation (TR) or greater.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: Both annuloplasty devices provided acceptable TR correction with similar adverse event rates over a median 3-year follow-up.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: Both annuloplasty devices provided acceptable TR correction with similar adverse event rates over a median 3-year follow-up.