Herzzentrum Göttingen, Universitätsmedizin Göttingen, Göttingen, Germany.
Klinik für Kardiologie und Angiologie, Helios Klinikum Siegburg, Siegburg, Germany.
Catheter Cardiovasc Interv. 2020 Sep 1;96(3):E360-E368. doi: 10.1002/ccd.28613. Epub 2019 Dec 2.
To compare baseline characteristics and outcomes in patients treated with either 1 or 2 MitraClips in the German TRAMI (Transcatheter Mitral Valve Interventions) registry.
The MitraClip community seems to silently assume that results should intrinsically be better after implantation of more than one clip, although data is still sparse.
In 2010-2013, 803 patients were enrolled prospectively into TRAMI (461 one-clip and 312 two-clip procedures). Follow-up was performed centrally at 30 days and 1 year.
Baseline characteristics of TRAMI-patients with two clips differed significantly from single-clip patients regarding constitutional (more men, taller body height) and heart failure-related factors (larger left ventricular dimensions, reduced left ventricular ejection fraction, more severe heart failure). Also, a significant increase in two-clip procedures over time was present. After propensity score matching for differing baseline characteristics, residual moderate mitral regurgitation (MR) occurred more frequently after implantation of two clips, whereas residual severe MR could more frequently be observed after one-clip procedures. However, no or mild residual MR at discharge was present in 71.6% after single-clip and in 70.1% after two-clips implantation (p = .81). After 1 year, no significant differences regarding mortality or New York Heart Association status could be detected in the propensity matched cohorts. However, TRAMI-patients treated with two clips had a significantly higher incidence of cerebral-vascular events (p = .02).
TRAMI data cannot support the theory that implantation of more than one clip is associated with better clinical outcomes. The finding of more cerebral-vascular events after two-clip procedures might be hypothesis-generating.
比较德国 TRAMI（经导管二尖瓣介入治疗）注册研究中接受 1 个或 2 个 MitraClip 治疗的患者的基线特征和结局。
MitraClip 社区似乎默认认为，尽管数据仍然很少，但植入一个以上的夹子后，结果应该内在地更好。
2010-2013 年，前瞻性纳入 803 例患者进入 TRAMI（461 例单夹和 312 例双夹手术）。中心随访 30 天和 1 年。
与单夹患者相比，双夹患者的 TRAMI 患者的基线特征在体质（更多男性，更高的身高）和心力衰竭相关因素（更大的左心室尺寸，降低的左心室射血分数，更严重的心力衰竭）方面存在显著差异。此外，双夹手术的比例随着时间的推移显著增加。在对不同基线特征进行倾向评分匹配后，植入两个夹子后残留中度二尖瓣反流（MR）更为常见，而植入一个夹子后更常观察到严重的 MR。然而，单夹组出院时无或轻度残余 MR 发生率为 71.6%，双夹组为 70.1%（p=.81）。在倾向匹配队列中，1 年后在死亡率或纽约心脏协会（NYHA）状态方面没有发现显著差异。然而，接受双夹治疗的 TRAMI 患者发生脑血管事件的发生率显著升高（p=.02）。
TRAMI 数据不能支持植入一个以上夹子与更好的临床结局相关的理论。双夹手术后发生更多脑血管事件的发现可能是产生假说的。
