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Thirty-Day Outcomes of Transcatheter Mitral Valve Replacement for Degenerated Mitral Bioprostheses (Valve-in-Valve), Failed Surgical Rings (Valve-in-Ring), and Native Valve With Severe Mitral Annular Calcification (Valve-in-Mitral Annular Calcification) in the United States
Circulation: Cardiovascular Interventions ( IF 6.1 ) Pub Date : 2020-03-06 , DOI: 10.1161/circinterventions.119.008425
Mayra Guerrero 1 , Sreekanth Vemulapalli 2 , Qun Xiang 2 , Dee Dee Wang 3 , Mackram Eleid 1 , Allison K. Cabalka 1 , Gurpreet Sandhu 1 , Michael Salinger 4 , Hyde Russell 5 , Adam Greenbaum 6 , Susheel Kodali 7 , Isaac George 8 , Danny Dvir 9 , Brian Whisenant 10 , Mark J. Russo 11 , Ashish Pershad 12 , Kenith Fang 13 , Megan Coylewright 14 , Pinak Shah 15 , Vasilis Babaliaros 6 , Jaffar M. Khan 16 , Carl Tommaso 17 , Jorge Saucedo , Saibal Kar 18 , Rajj Makkar 18 , Michael Mack 19 , David Holmes 1 , Martin Leon 7 , Vinayak Bapat 8 , Vinod H. Thourani 20 , Charanjit Rihal 1 , William O’Neill 3 , Ted Feldman 17
Affiliation  

Background:Transcatheter mitral valve replacement using aortic transcatheter heart valves has recently become an alternative for patients with degenerated mitral bioprostheses, failed surgical repairs with annuloplasty rings or severe mitral annular calcification who are poor surgical candidates. Outcomes of these procedures are collected in the Society of Thoracic Surgeons/American College of Cardiology/Transcatheter Valve Therapy Registry. A comprehensive analysis of mitral valve-in-valve (MViV), mitral valve-in-ring (MViR), and valve-in-mitral annular calcification (ViMAC) outcomes has not been performed. We sought to evaluate short-term outcomes of early experience with MViV, MViR, and ViMAC in the United States.Methods:Retrospective analysis of data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.Results:Nine hundred three high-risk patients (median Society of Thoracic Surgeons score 10%) underwent MViV (n=680), MViR (n=123), or ViMAC (n=100) between March 2013 and June 2017 at 172 hospitals. Median age was 75 years, 59.2% female. Technical and procedural success were higher in MViV. Left ventricular outflow tract obstruction occurred more frequently with ViMAC (ViMAC=10%, MViR=4.9%, MViV=0.7%; P<0.001). In-hospital mortality (MViV=6.3%, MViR=9%, ViMAC=18%; P=0.004) and 30-day mortality (MViV=8.1%, MViR=11.5%, ViMAC=21.8%; P=0.003) were higher in ViMAC. At 30-day follow-up, median mean mitral valve gradient was 7 mm Hg, most patients (96.7%) had mitral regurgitation grade ≤1 (+) and were in New York Heart Association class I to II (81.7%).Conclusions:MViV using aortic balloon-expandable transcatheter heart valves is associated with a low complication rate, a 30-day mortality lower than predicted by the Society of Thoracic Surgeons score, and superior short-term outcomes than MViR and ViMAC. At 30 days, patients in all groups experienced improvement of symptoms, and valve performance remained stable.Registration:URL: https://www.clinicaltrials.gov; Unique identifier: NCT02245763.

中文翻译:

经导管二尖瓣置换术治疗退化性二尖瓣生物瓣膜(瓣膜中瓣),手术环失败(环瓣)和天然瓣膜严重二尖瓣环钙化(二尖瓣瓣环钙化)的30天结果美国

背景:使用二尖瓣生物瓣膜置换术,二尖瓣生物瓣膜修复手术失败或二尖瓣环钙化严重,手术效果不佳的患者,近来使用主动脉导管心脏瓣膜置换术已成为一种选择。这些程序的结果收集在胸外科医师协会/美国心脏病学会/经导管瓣膜治疗注册中心。尚未对二尖瓣瓣膜(MViV),二尖瓣瓣膜(MViR)和二尖瓣膜环钙化(ViMAC)结果进行全面分析。我们试图评估在美国使用MViV,MViR和ViMAC的早期经验的短期结果。胸外科医师协会/美国心脏病学会经导管瓣膜治疗注册中心的数据进行回顾性分析。结果:933名高危患者(中位胸外科医师评分为10%)接受了MViV(n = 680),MViR(n = 123),或2013年3月至2017年6月在172家医院使用的ViMAC(n = 100)。中位年龄为75岁,女性为59.2%。MViV的技术和程序成功率更高。ViMAC较常发生左室流出道梗阻(ViMAC = 10%,MViR = 4.9%,MViV = 0.7%;P <0.001)。住院死亡率(MViV = 6.3%,MViR = 9%,ViMAC = 18%; P = 0.004)和30天死亡率(MViV = 8.1%,MViR = 11.5%,ViMAC = 21.8%; P= 0.003)在ViMAC中更高。在30天的随访中,二尖瓣平均中位梯度为7 mm Hg,大多数患者(96.7%)的二尖瓣反流级别≤1(+),并且属于纽约心脏协会I至II级(81.7%)。 :MViV使用主动脉球囊扩张式经导管心脏瓣膜与并发症发生率低,30天死亡率低于胸外科医生学会评分所预测的结果以及短期结果优于MViR和ViMAC的情况相关。在第30天时,所有组的患者症状均得到改善,瓣膜性能保持稳定。注册:URL:https://www.clinicaltrials.gov; 唯一标识符:NCT02245763。
更新日期:2020-03-06
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