Prepared by: Dr. Muhammet Ali Ekiz

Title of the Study: Five-Year Outcomes from the Evolut Low Risk Bicuspid TAVI study

Published in Congress: EuroPCR 2025

Link:https://media.pcronline.com/diapo.pdf

Introduction: Transcatheter aortic valve implantation (TAVI) has emerged in recent years as an effective treatment for severe aortic stenosis, including in patients with low surgical risk. However, patients with bicuspid aortic valve (BAV) morphology have generally been excluded from previous randomized controlled trials. This has created a significant knowledge gap regarding the long-term safety and efficacy of TAVI in this specific patient population. The Evolut Low Risk Bicuspid study aims to evaluate the five-year clinical and hemodynamic outcomes of TAVI in low-risk BAV patients.

Objective: To evaluate the five-year clinical and hemodynamic outcomes after TAVI in patients with BAV anatomy and low surgical risk.

Methods: The Evolut Low Risk Bicuspid TAVI Study is a prospective, single-arm study conducted at 25 centers in the United States between December 2018 and October 2019. A total of 150 patients were included. Participants were evaluated to have a surgical mortality risk of <3%. The primary safety endpoint was defined as all-cause mortality or disabling stroke within 30 days. The primary efficacy endpoint was procedural success. All patients were treated with Evolut R or Evolut PRO valves.

Results: The total five-year mortality or disabling stroke rate was 11.6%, all-cause mortality was 10.3%, cardiovascular mortality was 7.5%, stroke rate was 6.8% (disabling stroke 2.1%), valve-related rehospitalization was 14.0%, need for permanent pacemaker was 21.8%, moderate or greater paravalvular regurgitation (PVR) was 0%, revascularization/reintervention was 3.7%, valve thrombosis was 3.5% (clinical 1.3%, subclinical 2.2%), and endocarditis was 3.3%. Hemodynamic parameters (effective orifice area and mean gradient) remained stable throughout the 5 years. Quality of life scores measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) increased significantly; 85% of patients were alive and in “good” condition at the end of 5 years.

Discussion: This study is one of the most comprehensive to reveal the long-term safety and efficacy profile of TAVI in low-risk BAV patients. TAVI stands out as a successful alternative in this patient group with a low mortality and disabling stroke rate of 11.6%. Furthermore, the absence of structural complications such as paravalvular regurgitation indicates that TAVI can be successfully applied despite anatomical challenges. The requirement for a permanent pacemaker was 21.8%, consistent with findings in previous studies; although this rate suggests involvement of the conduction system post-procedure, its negative impact on overall clinical outcomes is limited. In terms of valve performance, EOA and mean gradient values remained stable over 5 years, which is a positive finding in terms of bioprosthetic valve durability. Significant increases in quality of life as measured by KCCQ support patients' functional improvement. Study limitations include the lack of randomization, the influence of the multidisciplinary heart team's decision in patient selection (selection bias), and the fact that it was conducted only in experienced centers. Nevertheless, the 5-year follow-up results strongly support TAVI as a reliable alternative to surgery in BAV patients.

Conclusion: Evolut TAVI has provided a safe and effective treatment option over 5 years in patients with bicuspid aortic stenosis and low surgical risk, with high success rates, low complication rates, and sustained hemodynamic performance. Therefore, TAVI should be considered as part of the decision-making process instead of surgery in eligible patients.