Comparable efficacy and safety for bicuspid aortic valve stenosis patients undergoing transcatheter aortic valve replacement with balloon-expandable or self-expanding valves using Wei’s sizing method

Sep 29, 2026

Uploaded by Aria

Background: The study investigates whether proper sizing improves procedural and clinical outcomes of transcatheter aortic valve replacement (TAVR) in bicuspid aortic stenosis using new-generation self-expanding valves (SEVs) and balloon-expandable valves (BEVs). Methods: A retrospective cohort of consecutive severe BAS patients treated with Sapien 3 or Evolut R/PRO valves (2017–2022) evaluated device success and major adverse cardiac and cerebral events (MACCEs), guided by Wei’s sizing with complementary supraannular sizing. Results and conclusion: Similar device success and comparable MACCEs support comparable efficacy and safety when Wei’s method is used.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages9

Reading Time23 min

AccessFree to download

Abstract

Background

Methods

Results

Conclusion

1. Introduction

Challenges in BAS and valve selection

Sizing methods and rationale

2. Methods

2.1. Patient population

J Chin MedAssoc Original article Comparable efficacy and safety for bicuspid aortic valve stenosis patients undergoing transcatheter aortic valve replacement with balloon-expandable or self-expanding valves using Wei’s sizing method Yung-Tsai Leea,b, Wei-Hsian Yina,c,*, Tien-Ping Tsaoa,d, Kuo-Chen Leea, Huan-Chiu Lina,c, Chun-Ting Liua, Ming-Chon Hsiunga, Jeng Weia,d aHeart Center, Cheng Hsin General Hospital, Taipei, Taiwan, ROC; bDepartment of Exercise and Health Science, National Taipei University of Nursing and Healthy Science, Taipei, Taiwan, ROC; cFaculty of Medicine, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC; dFaculty of Medicine, National Defense Medical Center, Taipei, Taiwan, ROC Abstract Background: 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) . Methods: 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. Results: 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. Conclusion: Our results demonstrated comparable efficacy and safety for BAS patients undergoing TAVR using either BEVs or SEVs when using Wei’s sizing method. Keywords: Balloon-expandable valve; Bicuspid aortic stenosis; Procedural outcome; Self-expandable valve; Transcatheter aortic valve replacement; Valve sizing 1. INTRODUCTION The use of transcatheter aortic valve replacement (TAVR) for treating bicuspid aortic stenosis (BAS) remains a subject of ongoing debate due to the unique challenges posed by BAS *Address correspondence. Dr. Wei-Hsian Yin, Heart Center, Cheng Hsin General Hospital, 45, Cheng-Hsin Street, Taipei 112, Taiwan, ROC. E-mail address: [yinwh88@gmail.com](yinwh88@gmail.com) (W.-H. Yin). Conflicts of interest: Dr. Wei-Hsian Yin and Dr. Jeng Wei, editorial board members at the Journal of the Chinese Medical Association, had no role in the peer review process or decision to publish this article. The other authors declare that they have no conflicts of interest related to the subject matter or materials discussed in this article. Journal of Chinese Medical Association. (2024) 87: 993-1001. Received April 15, 2024; accepted August 4, 2024. doi: 10. 1097/JCMA.0000000000001155 Copyright © 2024, the Chinese Medical Association. This is an open access article under the CC BY-NC-ND license ([http://creativecommons.org/licenses/](http://creativecommons.org/licenses/)[ ](http

FAQs

What was the study’s primary goal regarding valve sizing?

To determine whether proper valve sizing improves procedural and clinical outcomes in TAVR for bicuspid aortic stenosis when using both self-expanding and balloon-expandable valves.

How were patients and outcomes evaluated in the study?

The study retrospectively assessed consecutive severe BAS patients undergoing TAVR with Sapien 3 or Evolut R/PRO valves from 2017 to 2022, using device success and MACCEs as primary endpoints.

Were efficacy and safety different between balloon-expandable and self-expanding valves?

Device success was similar (93% vs 94%), there were no annular rupture cases, and MACCE rates were comparable between groups at median follow-up of 464 days.

Sep 29, 2026

Uploaded by Aria