Thevathasan Tharusan, Berlinghof Sophie, Elschenbroich Daniel, Wiedenhofer Julia M, Degbeon Sêhnou, Holzhauser Luise, Barbieri Fabian, Kasner Mario, Brand Anna, Dreger Henryk, Desch Steffen, Landmesser Ulf, Reinthaler Markus, Skurk Carsten
Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité (DHZC), Campus Benjamin Franklin, Hindenburgdamm 30, 12203 Berlin, Germany.
Institute of Medical Informatics, Charité - Universitätsmedizin Berlin, Campus Mitte, Charitéplatz 1, 10117 Berlin, Germany.
Int J Cardiol Heart Vasc. 2025 May 10;59:101696. doi: 10.1016/j.ijcha.2025.101696. eCollection 2025 Aug.
Transcatheter edge-to-edge repair (TEER) for mitral regurgitation has rapidly progressed. The MitraClip® system underwent stepwise improvements between 2016 and 2019 (second to fourth generation). However, real-world data on -procedural outcomes remain limited. We analyzed -procedural healthcare resource utilization and safety of TEER with the MitraClip® system in the U.S. between 2016 and 2019.
Primary outcomes (healthcare resource utilization) included hospital length of stay (LOS), adverse discharge to a short-term hospital or skilled nursing facility and hospital costs. Secondary outcomes (safety) were in-hospital mortality and post-procedural complications.
A total of 5,212 adults underwent mitral TEER. Mean age was 77.7 (±10.1) years; 3,645 patients (69.9 %) were over 75 years. Median Charlson Comorbidity Index was 3 [IQR 1-4], number of cardiovascular risk factors 3 [2-4], CHADS-VASc score 4 [3-5] and simplified HAS-BLED score 2 [2-3]. Most procedures were performed at large hospitals (76.0 %) and regional hubs on both U.S. coasts. Between 2016 and 2019, LOS decreased by 21 % (95 % CI 0.79-0.85), adverse discharges by 41 % (95 % CI 0.45-0.78) and hospital costs by 8 % (95 % CI 0.88-0.95). TEER showed favorable safety: vascular complications, ischemic strokes, cardiac arrests and tamponades each <1 %; mortality 1.6 %, bleeding 3.3 % and cardiogenic shock 4.5 %. The composite safety outcome declined by 27 % (95 % CI 0.59-0.91). All adverse outcomes increased linearly with increasing comorbidity burden (P for trend < 0.001).
Mitral TEER has become safer and more efficient due to technological advances, operator experience and centralized care. Caution is advised in highly comorbid patients.
经导管二尖瓣缘对缘修复术(TEER)进展迅速。MitraClip®系统在2016年至2019年期间(第二代至第四代)逐步改进。然而,关于手术结果的真实世界数据仍然有限。我们分析了2016年至2019年期间美国使用MitraClip®系统进行TEER的手术医疗资源利用情况和安全性。
主要结果(医疗资源利用)包括住院时间(LOS)、转至短期医院或专业护理机构的不良出院情况以及住院费用。次要结果(安全性)为住院死亡率和术后并发症。
共有5212名成年人接受了二尖瓣TEER。平均年龄为77.7(±10.1)岁;3645例患者(69.9%)年龄超过75岁。Charlson合并症指数中位数为3[四分位间距1 - 4],心血管危险因素数量为3[2 - 4],CHADS - VASc评分4[3 - 5],简化的HAS - BLED评分2[2 - 3]。大多数手术在大型医院(76.0%)以及美国东西海岸的区域中心进行。2016年至2019年期间,住院时间减少了21%(95%置信区间0.79 - 0.85),不良出院情况减少了41%(95%置信区间0.45 - 0.78),住院费用减少了8%(95%置信区间0.88 - 0.95)。TEER显示出良好的安全性:血管并发症、缺血性卒中、心脏骤停和心包填塞均<1%;死亡率1.6%,出血3.3%,心源性休克4.5%。综合安全结果下降了27%(95%置信区间0.59 - 0.91)。所有不良结果均随合并症负担的增加呈线性增加(趋势P<0.001)。
由于技术进步、术者经验和集中护理,二尖瓣TEER已变得更安全、更高效。对于合并症严重的患者建议谨慎操作。