Columbia University Irving Medical Center, New York, New York, USA.
Columbia University Irving Medical Center, New York, New York, USA; Cardiovascular Research Foundation, New York, New York, USA.
JACC Cardiovasc Interv. 2022 Mar 14;15(5):471-480. doi: 10.1016/j.jcin.2022.01.016.
The TRISCEND study (Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy after Replacement of Tricuspid Valve with Transcatheter Device) is evaluating the safety and performance of transfemoral transcatheter tricuspid valve replacement in patients with clinically significant tricuspid regurgitation (TR) and elevated surgical risk.
Transcatheter valve replacement could lead to a paradigm shift in treating TR and improving patient quality of life.
In the prospective, single-arm, multicenter TRISCEND study, patients with symptomatic moderate or greater TR, despite medical therapy, underwent percutaneous transcatheter tricuspid valve replacement with the EVOQUE system. A composite rate of major adverse events, echocardiographic parameters, and clinical, functional, and quality-of-life measures were assessed at 30 days.
Fifty-six patients (mean age of 79.3 years, 76.8% female, 91.1% TR severe or greater, 91.1% atrial fibrillation, and 87.5% New York Heart Association functional class III or IV) were treated. At 30 days, TR was reduced to mild or less in 98%. The composite major adverse events rate was 26.8% at 30 days caused by 1 cardiovascular death in a patient with a failed procedure, 2 reinterventions after device embolization, 1 major access site or vascular complication, and 15 severe bleeds, of which none were life-threatening or fatal. No myocardial infarction, stroke, renal failure, major cardiac structural complications, or device-related pulmonary embolism were observed. New York Heart Association significantly improved to functional class I or II (78.8%; P < 0.001), 6-minute walk distance improved 49.8 m (P < 0.001), and Kansas City Cardiomyopathy Questionnaire score improved 19 points (P < 0.001).
Early experience with the transfemoral EVOQUE system in patients with clinically significant TR demonstrated technical feasibility, acceptable safety, TR reduction, and symptomatic improvement at 30 days. The TRISCEND II randomized trial (NCT04482062) is underway.
TRISCEND 研究（爱德华兹 EVOQUE 三尖瓣置换：经导管装置置换三尖瓣后安全性和临床疗效的调查）正在评估经股静脉经导管三尖瓣置换术在临床上有显著三尖瓣反流（TR）和手术风险升高的患者中的安全性和性能。
经导管瓣膜置换术可能会导致治疗 TR 和改善患者生活质量的范式转变。
在这项前瞻性、单臂、多中心的 TRISCEND 研究中，经皮经导管三尖瓣置换术采用 EVOQUE 系统治疗有症状的中重度或以上 TR 且经药物治疗仍有症状的患者。在 30 天时评估主要不良事件、超声心动图参数以及临床、功能和生活质量指标的复合发生率。
56 例患者（平均年龄 79.3 岁，76.8%为女性，91.1%为严重或以上 TR，91.1%为心房颤动，87.5%为纽约心脏协会功能分级 III 或 IV）接受了治疗。在 30 天时，98%的患者 TR 减轻至轻度或以下。30 天时的复合主要不良事件发生率为 26.8%，由 1 例手术失败患者的心血管死亡、2 例器械栓塞后的再介入、1 例主要入路或血管并发症和 15 例严重出血引起，其中无致命或致命性出血。未观察到心肌梗死、中风、肾功能衰竭、严重心脏结构并发症或器械相关肺栓塞。纽约心脏协会功能显著改善至 I 级或 II 级（78.8%；P<0.001），6 分钟步行距离增加 49.8m（P<0.001），堪萨斯城心肌病问卷评分增加 19 分（P<0.001）。
在临床上有显著 TR 的患者中经股静脉 EVOQUE 系统的早期经验表明该技术具有可行性、可接受的安全性、TR 减轻和 30 天时的症状改善。正在进行 TRISCEND II 随机试验（NCT04482062）。
