Division of Cardiovascular Diseases, Vanderbilt University Medical Center, Nashville, TN (K.G., A.S., C.M.B.).
Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles, CA (R.M.).
Circulation. 2024 Nov 5;150(19):1493-1504. doi: 10.1161/CIRCULATIONAHA.124.068847. Epub 2024 Aug 5.
Previous transcatheter valve therapy registry analyses of transcatheter mitral valve in valve (MViV) replacement of degenerated bioprosthesis reported early experience in the United States. Given recent increases in transseptal MViV volumes and introduction of the SAPIEN 3 Ultra valve, it is important to determine contemporary outcomes for patients undergoing transseptal SAPIEN 3/SAPIEN 3 Ultra MViV replacement.
The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy Registry was used to extract data for all patients undergoing transseptal SAPIEN 3/SAPIEN 3 Ultra MViV from 2015 to September 2022. Primary efficacy outcome was 1-year all-cause mortality. Secondary end points included 30-day mortality, functional class, quality of life, and mitral valve performance. Primary safety outcomes were device success and in-hospital complications.
A total of 4243 patients with a mean±SD STS score of 9.2±7.7 underwent transseptal MViV at 455 sites. The rate of Mitral Valve Academic Research Consortium technical (96.6%) success was high, and procedural complications were low. All-cause in-hospital, 30-day, and 1-year mortality rates were 3.2%, 4.3%, and 13.4%, respectively. Significant improvements in New York Heart Association class (New York Heart Association I/II, 18% to 87%) and quality of life (Kansas City Cardiomyopathy Questionnaire score, 38 to 78) were noted at 1 year (<0.0001 for both) after MViV. Upon stratifying by STS scores, it was observed that the low-risk group (STS<4) had a significantly lower in-hospital mortality rate of 0.4%, whereas the intermediate-risk group (STS, 4-8) had an in-hospital mortality rate of 1.9%. From 2015 to 2022, the number of transseptal MViV cases/year increased significantly, whereas procedure times, length of stay, and intensive care unit hours shortened significantly. At the same time, there was a significant trend toward reduced in-hospital (=0.0005), 30-day (=0.004), and 1-year mortality rates (=0.01).
This multicenter, prospective study reports excellent procedural outcomes, acceptable 1-year mortality rates, and a significant improvement in quality of life for patients undergoing transseptal MViV in the contemporary era. Patients in the low-risk and intermediate-risk STS score categories had significantly better outcomes compared with those in the high-risk category. MViV is a reasonable therapy for the majority of patients with degenerated bioprosthetic mitral valves, who are anatomical candidates.
先前经导管二尖瓣置换术（MViV）治疗退行性生物瓣的经导管瓣膜治疗登记分析报告了美国的早期经验。鉴于经中隔 MViV 量的最近增加和 SAPIEN 3 Ultra 瓣膜的引入，重要的是要确定接受经中隔 SAPIEN 3/SAPIEN 3 Ultra MViV 置换的患者的当代结局。
使用胸外科医生协会（STS）/美国心脏病学会经导管瓣膜治疗登记处，从 2015 年至 2022 年 9 月提取所有接受经中隔 SAPIEN 3/SAPIEN 3 Ultra MViV 的患者的数据。主要疗效终点为 1 年全因死亡率。次要终点包括 30 天死亡率、功能分级、生活质量和二尖瓣功能。主要安全性结局为器械成功率和院内并发症。
共有 4243 名平均 STS 评分±标准差为 9.2±7.7 的患者在 455 个部位接受了经中隔 MViV。二尖瓣学术研究联盟技术（96.6%）成功率高，手术并发症发生率低。全因院内、30 天和 1 年死亡率分别为 3.2%、4.3%和 13.4%。MViV 后 1 年，纽约心脏协会（NYHA）心功能分级（NYHA I/II，18%至 87%）和生活质量（堪萨斯城心肌病问卷评分，38 至 78）显著改善（均<0.0001）。分层分析 STS 评分显示，低危组（STS<4）院内死亡率显著较低（0.4%），而中危组（STS，4-8）院内死亡率为 1.9%。从 2015 年到 2022 年，经中隔 MViV 例数/年显著增加，而手术时间、住院时间和重症监护病房时间显著缩短。同时，院内死亡率（=0.0005）、30 天死亡率（=0.004）和 1 年死亡率（=0.01）呈显著下降趋势。
这项多中心前瞻性研究报告了退行性生物瓣二尖瓣经中隔 MViV 治疗的极好的手术结局、可接受的 1 年死亡率和患者生活质量的显著改善。低危和中危 STS 评分组的患者与高危组相比，结局显著更好。对于大多数解剖学适合的退行性生物瓣二尖瓣患者，MViV 是一种合理的治疗方法。
