Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.
Department of Cardiothoracic Surgery, Transplantation and Vascular Surgery, Medical University of Hanover, Hanover, Germany.
Eur J Cardiothorac Surg. 2017 Aug 1;52(2):281-287. doi: 10.1093/ejcts/ezx103.
Rapid deployment aortic valve replacement (AVR) has been developed to facilitate minimally invasive approaches for cardiac surgery and shorten procedural times. TRITON is a prospectively designed study to assess safety and efficacy of rapid deployment AVR with Edwards INTUITY valve system. This report presents the 5-year outcomes of the TRITON trial.
A total of 295 patients with aortic valve stenosis were enrolled in the TRITON trial and 287 patients received the study valve. Procedural, early (≤30 days) and late (>30 days) outcomes were collected. Valve haemodynamic performance was evaluated at specified time points by an independent Echocardiography Core Laboratory and clinical events adjudicated by an independent Clinical Events Committee.
Mean age was 75.3 ± 6.7 years. A total of 158 patients underwent isolated AVR and 129 patients underwent AVR with concomitant procedures. The 5-year survival rates were 85.7 ± 3.4% and 75.2 ± 4.9% for isolated AVR and concomitant AVR, respectively. Overall, freedom from valve-related death at 5 years was 98.2 ± 0.8%. At 5 years, the valve effective orifice area was 1.6 ± 0.3 cm 2 , mean gradient was 10.5 ± 5.4 mmHg and peak gradient was 18.9 ± 9.3 mmHg.
The 5-year outcomes of the TRITON trial demonstrate acceptable long-term safety and excellent haemodynamic performance of rapid deployment AVR with the Edwards INTUITY valve system.
CLINICALTRIALS.GOV: NCT01445171.
快速部署主动脉瓣置换术（AVR）的发展旨在促进心脏手术的微创方法，并缩短手术时间。TRITON 是一项前瞻性设计的研究，旨在评估爱德华兹 INTUITY 瓣膜系统快速部署 AVR 的安全性和疗效。本报告介绍了 TRITON 试验的 5 年结果。
共有 295 例主动脉瓣狭窄患者入组 TRITON 试验，287 例患者接受了研究瓣膜。收集了手术过程、早期（≤30 天）和晚期（>30 天）的结果。在指定时间点，由独立的超声心动图核心实验室评估瓣膜血流动力学性能，并由独立的临床事件委员会裁定临床事件。
平均年龄为 75.3±6.7 岁。共有 158 例患者接受了单纯 AVR，129 例患者接受了同期 AVR 手术。单纯 AVR 和同期 AVR 的 5 年生存率分别为 85.7±3.4%和 75.2±4.9%。总体而言，5 年瓣膜相关死亡率为 98.2±0.8%。5 年时，瓣膜有效开口面积为 1.6±0.3cm 2 ，平均梯度为 10.5±5.4mmHg，峰值梯度为 18.9±9.3mmHg。
TRITON 试验的 5 年结果表明，爱德华兹 INTUITY 瓣膜系统的快速部署 AVR 具有可接受的长期安全性和出色的血流动力学性能。
临床试验.gov：NCT01445171。
