Department of Cardiology, Heart Valve Center, University Medical Center Mainz, Mainz, Germany.
Cardiology Department, NewYork-Presbyterian/Columbia University Medical Center, New York, New York, USA.
JACC Cardiovasc Interv. 2021 Jun 14;14(11):1231-1240. doi: 10.1016/j.jcin.2021.03.033.
The aim of this study was to assess 30-day outcomes of transcatheter edge-to-edge repair with the MitraClip XTR for significant tricuspid regurgitation (TR), relative to baseline coaptation gap sizes (CGS).
Transcatheter edge-to-edge repair using the MitraClip NT for patients with significant TR is safe and efficacious; the utility of the MitraClip XTR is unknown.
Patients with significant, symptomatic TR treated at a single site between April 2018 and December 2019, with consent and with complete data, were included (n = 50). Baseline and 30-day echocardiograms were assessed by an echocardiography core laboratory. Patients were divided into 3 subgroups on the basis of site-assessed CGS: subgroup I (< 7 mm), subgroup II (7 to 10 mm), and subgroup III (>10 mm).
Technical success of the MitraClip XTR implantation was 100% (88% in the septal-anterior position) using a median of 2 clips (interquartile range: 1 to 2). At 30 days, single-leaflet detachment was noted in 3 patients (6%), with no instances of device embolization. TR was reduced by 1 grade in subgroup I and by 2 grades in subgroups II and III. New York Heart Association functional class was reduced by 1 class in all 3 subgroups. The 6-min walk distance increased in subgroup I (+115 m; p = 0.014) and subgroup II (+31.5 m; p = 0.028) but not subgroup III (+50 m; p = 0.999). A CGS of ≤8.4 mm was predictive of a reduction to moderate or less TR.
MitraClip XTR implantation is a safe, effective treatment for a wider range of CGS in patients with symptomatic, significant TR than prior device iterations. All patients showed improvement in New York Heart Association functional class, and those with CGS <10 mm also experienced improved functional capacity.
本研究旨在评估经导管缘对缘修复术（TEER）应用 MitraClip XTR 治疗重度三尖瓣反流（TR）的 30 天结局，并与基线对合间隙（CGS）大小进行比较。
经导管缘对缘修复术应用 MitraClip NT 治疗重度 TR 患者是安全有效的，而 MitraClip XTR 的应用尚不清楚。
2018 年 4 月至 2019 年 12 月期间，在一家医疗机构中，对同意并提供完整数据的重度、有症状 TR 患者进行了单组病例研究（n=50）。由心脏超声核心实验室对基线和 30 天的超声心动图进行评估。根据心超评估的 CGS 将患者分为 3 个亚组：亚组 I（<7mm）、亚组 II（7~10mm）和亚组 III（>10mm）。
MitraClip XTR 的植入技术成功率为 100%（前间隔瓣 88%），中位数使用 2 个夹子（四分位间距：1~2）。在 30 天时，3 例患者（6%）出现单叶瓣游离，无器械栓塞发生。在亚组 I，TR 减少 1 个级别，在亚组 II 和 III，TR 减少 2 个级别。在所有 3 个亚组中，纽约心脏协会心功能分级均降低 1 级。在亚组 I（+115m；p=0.014）和亚组 II（+31.5m；p=0.028），6 分钟步行距离增加，但在亚组 III 中无增加（+50m；p=0.999）。CGS≤8.4mm 可预测 TR 减少至中度或以下。
与前代器械相比，MitraClip XTR 植入术在治疗有症状的重度 TR 患者时，对更广泛的 CGS 范围更为安全、有效。所有患者的纽约心脏协会心功能分级均得到改善，CGS<10mm 的患者的功能能力也得到改善。
