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经导管二尖瓣夹合术治疗继发性二尖瓣反流作为心脏移植桥接治疗:国际 MitraBridge 注册研究的 1 年结果。

MitraClip in secondary mitral regurgitation as a bridge to heart transplantation: 1-year outcomes from the International MitraBridge Registry.

机构信息

Cardio-Thoracic-Vascular Department, San Raffaele Scientific Institute, Milan, Italy.

Cardio-Thoracic-Vascular Department, San Raffaele Scientific Institute, Milan, Italy.

出版信息

J Heart Lung Transplant. 2020 Dec;39(12):1353-1362. doi: 10.1016/j.healun.2020.09.005. Epub 2020 Sep 17.

Abstract

BACKGROUND

Patients awaiting heart transplantation (HTx) often need bridging therapies to reduce worsening and progression of underlying disease. Limited data are available regarding the use of the MitraClip procedure in secondary mitral regurgitation for this clinical condition.

METHODS

We evaluated an international, multicenter (17 centers) registry including 119 patients (median age: 58 years) with moderate-to-severe or severe secondary mitral regurgitation and advanced heart failure (HF) (median left ventricular ejection fraction: 26%) treated with MitraClip as a bridge strategy according to 1 of the following criteria: (1) patients active on HTx list (in list group) (n = 31); (2) patients suitable for HTx but awaiting clinical decision (bridge to decision group) (n = 54); or (3) patients not yet suitable for HTx because of potentially reversible relative contraindications (bridge to candidacy group) (n = 34).

RESULTS

Procedural success was achieved in 87.5% of cases, and 30-day survival was 100%. At 1 year, Kaplan-Meier estimates of freedom from the composite primary end-point (death, urgent HTx or left ventricular assist device implantation, first rehospitalization for HF) was 64%. At the time of last available follow-up (median: 532 days), 15% of patients underwent elective transplant, 15.5% remained or could be included in the HTx waiting list, and 23.5% had no more indication to HTx because of clinical improvement.

CONCLUSIONS

MitraClip procedure as a bridge strategy to HTx in patients with advanced HF with significant mitral regurgitation was safe, and two thirds of patients remained free from adverse events at 1 year. These findings should be considered exploratory and hypothesis-generating to guide further study for percutaneous intervention in high-risk patients with advanced HF.

摘要

背景

等待心脏移植(HTx)的患者通常需要桥接治疗来减轻基础疾病的恶化和进展。对于这种临床情况,二尖瓣反流的 MitraClip 手术在继发性二尖瓣反流中的应用数据有限。

方法

我们评估了一项国际性、多中心(17 个中心)注册研究,共纳入 119 例中重度或重度继发性二尖瓣反流和晚期心力衰竭(HF)(中位左心室射血分数:26%)患者,这些患者采用 MitraClip 作为桥接策略进行治疗,符合以下标准之一:(1)HTx 名单上的活跃患者(名单组)(n=31);(2)适合 HTx 但等待临床决策的患者(桥接至决策组)(n=54);或(3)由于潜在可逆转的相对禁忌症不适合 HTx 的患者(桥接至候选组)(n=34)。

结果

87.5%的病例手术成功,30 天生存率为 100%。1 年时,复合主要终点(死亡、紧急 HTx 或左心室辅助装置植入、HF 首次再住院)的 Kaplan-Meier 估计无事件生存率为 64%。在最后一次可获得的随访时(中位:532 天),15%的患者接受了选择性移植,15.5%的患者仍保留或可纳入 HTx 等待名单,23.5%的患者因临床改善而不再需要 HTx。

结论

MitraClip 手术作为晚期 HF 伴严重二尖瓣反流患者 HTx 的桥接策略是安全的,67%的患者在 1 年内无不良事件发生。这些发现应被视为探索性的,并产生假设以指导进一步研究高危患者的经皮介入治疗。

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