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经导管缘对缘修复或置换术治疗三尖瓣反流的真实世界患者入选标准和可行性。

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

机构信息

Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic Foundation, Cleveland, Ohio.

Department of Thoracic and Cardiovascular Surgery, Heart, Vascular, and Thoracic Institute, Cleveland Clinic Foundation, Cleveland, Ohio.

出版信息

J Card Fail. 2024 Oct;30(10):1265-1272. doi: 10.1016/j.cardfail.2024.07.014.

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.

摘要

新型经导管三尖瓣反流(TR)治疗方法似乎很有前途,但它们在所有三尖瓣反流患者人群中的适用性尚不清楚。我们旨在评估新兴经导管三尖瓣治疗方法在有症状性大于或等于中度 TR 的更广泛人群中的可行性。2019 年 1 月至 2021 年 12 月期间,共有 178 例有症状性大于或等于中度 TR 的患者被转诊到我们中心,并将其分为 4 组:研究组(符合 Triluminate、Clasp TR 和 TRISCEND 试验入组条件的患者)、非适应证夹闭术、手术和药物治疗。研究组中共有 10.7%的患者被认为有资格接受研究性治疗,分别有 20.2%和 19.7%的患者接受了非适应证夹闭术和手术治疗,49.4%的患者接受了药物治疗。与其他组相比,研究组不太可能同时存在≥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(P<0.05)。与药物治疗组相比,研究组在 1 年时 TR 严重程度仍显著降低(P<0.001)。然而,结果与非适应证夹闭术相当(P=0.60),逊于手术治疗(P=0.04)。探索性分析未显示各组之间全因死亡率(P=0.40)和心力衰竭住院率(P=0.94)的差异有统计学意义。目前,TR 患者接受新兴经导管治疗的实际资格仍然有限,这突显了需要继续进行创新努力,为更广泛的 TR 患者提供设备治疗。

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