Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan, ROC.
Department of Exercise and Health Science, National Taipei University of Nursing and Healthy Science, Taipei, Taiwan, ROC.
J Chin Med Assoc. 2024 Nov 1;87(11):993-1001. doi: 10.1097/JCMA.0000000000001155. Epub 2024 Aug 20.
The present study aimed to investigate whether proper sizing can improve the procedural and clinical outcomes of transcatheter aortic valve replacement (TAVR) with new-generation self-expanding valves (SEVs) and balloon-expandable valves (BEVs) for treating bicuspid aortic stenosis (BAS).
We retrospectively evaluated consecutive patients who underwent TAVR with Sapien 3 valves (Edwards Lifesciences, Irvine, CA) or Evolut R/PRO valves (Medtronic, Minneapolis, MN) for severe BAS from 2017 to 2022. The primary endpoints were device success rate and major adverse cardiac and cerebral events (MACCEs), including mortality, nonfatal myocardial infarction or disabling stroke, transcatheter heart valve failure, or clinically relevant valve thrombosis during follow-up. Our team used a complementary approach of supraannular sizing in addition to the conventional annular sizing method (Wei's method) to guide the TAVR procedures.
We recruited a total of 75 consecutive patients, of whom 43 (57%) were treated with BEVs from October 2017 to June 2021, and 32 (43%) were treated with SEVs from July 2021 to December 2022. Device success was similar between the BEV and SEV groups (93% vs 94%; p > 0.99), and no cases of annular rupture occurred in either group. Similar rates of moderate-to-severe paravalvular leak were observed in the BEV and SEV groups (5% vs 6%, p > 0.99). At a median follow-up of 464 days, the MACCE rates were comparable between the two groups. In multivariate analysis, the presence of previous percutaneous coronary interventions (hazard ratio: 5.43; p = 0.039) and New York Heart Association functional class III/IV heart failure at 30 days of follow-up after TAVR (hazard ratio: 9.90; p = 0.037) were independently associated with long-term MACCEs.
Our results demonstrated comparable efficacy and safety for BAS patients undergoing TAVR using either BEVs or SEVs when using Wei's sizing method.
本研究旨在探讨对于治疗二叶式主动脉瓣狭窄（BAS），新一代自膨式瓣膜（SEV）和球囊扩张式瓣膜（BEV）行经导管主动脉瓣置换术（TAVR）时，合适的瓣膜尺寸选择是否能改善手术过程和临床结果。
我们回顾性评估了 2017 年至 2022 年期间因严重 BAS 行 TAVR 的连续患者，所用瓣膜分别为 Sapien 3 瓣膜（爱德华生命科学公司，加利福尼亚州欧文市）或 Evolut R/PRO 瓣膜（美敦力公司，明尼苏达州明尼阿波利斯市）。主要终点为器械成功率和主要心脑血管不良事件（MACCE），包括死亡率、非致死性心肌梗死或致残性卒中、经导管心脏瓣膜衰竭或随访期间临床相关的瓣膜血栓形成。我们的团队使用了一种补充方法，即在常规瓣环尺寸测量（Wei 法）的基础上，采用瓣上尺寸测量，以指导 TAVR 手术。
我们共招募了 75 名连续患者，其中 43 名（57%）患者于 2017 年 10 月至 2021 年 6 月期间接受了 BEV 治疗，32 名（43%）患者于 2021 年 7 月至 2022 年 12 月期间接受了 SEV 治疗。BEV 和 SEV 组的器械成功率相似（93% vs 94%；p>0.99），两组均未发生瓣环破裂。BEV 和 SEV 组的中度至重度瓣周漏发生率相似（5% vs 6%；p>0.99）。在中位随访 464 天内，两组的 MACCE 发生率相当。多变量分析显示，既往经皮冠状动脉介入治疗（风险比：5.43；p=0.039）和 TAVR 后 30 天纽约心脏协会心功能 III/IV 级（风险比：9.90；p=0.037）与长期 MACCE 独立相关。
当使用 Wei 法进行瓣膜尺寸选择时，对于接受 TAVR 的 BAS 患者，使用 BEV 或 SEV 的疗效和安全性相当。
