Real-World Patient Eligibility and Feasibility of Transcatheter Edge-to-Edge Repair or Replacement Interventions for Tricuspid Regurgitation

IF 6.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Journal of Cardiac Failure Pub Date : 2024-10-01 DOI:10.1016/j.cardfail.2024.07.014

ABDELRAHMAN ABUSHOUK MD , HABIB LAYOUN MD , SERGE C. HARB MD , RHONDA MIYASAKA MD , CHONYANG ALBERT MD , RANDALL C. STARLING MD, MPH , GRANT W. REED MD, MSc , AMAR KRISHNASWAMY MD , JAMES J. YUN MD, PhD , SAMIR R. KAPADIA MD , RISHI PURI MD, PhD

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Abstract

Novel transcatheter therapies for tricuspid regurgitation (TR) appear promising, yet their applicability to an all-comer TR population remains unclear. We aimed to assess the feasibility of emerging transcatheter tricuspid therapies in a real-world population with greater than or equal to moderate symptomatic TR. A total of 178 patients were referred to our center between January 2019 and December 2021 for greater than or equal to moderate symptomatic TR and were classified into 4 groups: Investigative (patients eligible for enrollment in the Triluminate, Clasp TR, and TRISCEND trials), off-label clipping, surgery, and medical treatment. A total of 10.7% of the population were deemed eligible for investigative therapies, 20.2% and 19.7% of patients were offered off-label clipping and surgery, respectively, and 49.4% received medical treatment. Common reasons for investigative therapy–related ineligibility were unsuitable anatomy (large tricuspid annulus or wide leaflet coaptation gap) and the presence of significant comorbidities. Compared with the other groups, the investigative group was less likely to harbor concomitant ≥moderate mitral regurgitation, greater than or equal to moderate right ventricular dysfunction or severe pulmonary hypertension (P < .05). At 1 year, there remained a significant reduction in TR severity in the investigative group (P < .001) in comparison with the medical treatment group. However, the results were comparable to off-label clipping (P = .60) and inferior to surgery (P =.04). Exploratory analyses failed to show evidence of differences in the rates of all-cause mortality (P =.40) and heart failure hospitalizations (P = .94) between all groups. Current real-world eligibility of TR patients for emerging transcatheter therapies remains limited, underscoring the need for continued innovative efforts to offer device therapies to a broader TR cohort.

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三尖瓣反流的经导管边缘到边缘修复或置换干预的真实世界患者资格和可行性。

治疗三尖瓣反流（TR）的新型经导管疗法似乎很有前景，但它们是否适用于所有三尖瓣反流患者仍不清楚。我们的目的是评估新出现的三尖瓣经导管疗法在现实世界中大于或等于中度症状性三尖瓣反流人群中的可行性。在2019年1月至2021年12月期间，共有178名患者因大于或等于中度症状性TR转诊至本中心，并被分为4组：研究组（符合Triluminate、Clasp TR和TRISCEND试验入组条件的患者）、标签外剪切组、手术组和药物治疗组。共有 10.7% 的患者被认为有资格接受研究疗法，20.2% 和 19.7% 的患者分别接受了标示外剪切和手术治疗，49.4% 的患者接受了药物治疗。不符合研究疗法相关条件的常见原因是解剖结构不合适（三尖瓣环过大或瓣叶合流间隙过宽）以及存在严重的合并症。与其他组相比，研究组并发≥中度二尖瓣反流、大于或等于中度右心室功能障碍或严重肺动脉高压的可能性较小（P < .05）。1 年后，与药物治疗组相比，研究组的 TR 严重程度仍显著降低（P < .001）。不过，其结果与标签外剪切疗法相当（P = .60），但不如手术疗法（P = .04）。探索性分析未能显示各组之间全因死亡率（P = .40）和心衰住院率（P = .94）的差异。目前在现实世界中，TR 患者接受新兴经导管疗法的资格仍然有限，这说明需要继续创新，为更广泛的 TR 群体提供设备疗法。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Cardiac Failure 医学-心血管系统

CiteScore

7.80

自引率

8.30%

发文量

653

审稿时长

21 days

期刊介绍： Journal of Cardiac Failure publishes original, peer-reviewed communications of scientific excellence and review articles on clinical research, basic human studies, animal studies, and bench research with potential clinical applications to heart failure - pathogenesis, etiology, epidemiology, pathophysiological mechanisms, assessment, prevention, and treatment.