Comparison of Sutureless Bioprosthetic Valve With Surgical or TAVR for Severe Aortic Stenosis

Ho Jin Kim; Do-Yoon Kang; Hanbit Park; Jung-Min Ahn; Joon Bum Kim; Seon-Ok Kim; You Jung Ok; Seung Hun Lee; Won Kyung Pyo; Euihong Ko; Seung-Ah Lee; Dae-Hee Kim; Seung-Jung Park; Duk-Woo Park; Suk Jung Choo

doi:10.1016/j.jacasi.2021.08.007

Comparison of Sutureless Bioprosthetic Valve With Surgical or TAVR for Severe Aortic Stenosis

JACC Asia. 2021 Oct 26;1(3):317-329. doi: 10.1016/j.jacasi.2021.08.007. eCollection 2021 Dec.

Authors

Affiliations

¹ Department of Thoracic and Cardiovascular Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
² Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
³ Division of Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.

Abstract

Background: Clinical advantages of sutureless rapid-deployment (RD) aortic valve replacement (AVR) for severe aortic valve stenosis (AS) have not been elucidated compared with surgical (SAVR) or transcatheter (TAVR) aortic valve replacement.

Objectives: This study sought to investigate comparative effectiveness and safety of RD-AVR compared with SAVR and TAVR in a prospective cohort of patients with severe AS.

Methods: The primary outcome was a composite of death, stroke, or rehospitalization at 12 months. Propensity score matching was used to assemble a cohort of patients with similar baseline characteristics.

Results: Among 1,020 eligible patients, 107 (10.5%) underwent RD-AVR, 437 (42.8%) underwent SAVR, and 476 (46.7%) underwent TAVR. In the matched cohorts of RD-AVR and SAVR (n = 107), the incidence of primary composite outcome at 12 months was similar between the 2 groups (8.0% vs 10.8%, respectively; hazard ratio [HR]: 0.74; 95% confidence interval [CI]: 0.30-1.84; P = 0.52). In the matched cohorts of RD and TAVR (n = 58), the incidence of primary composite outcome at 12 months did not statistically differ between the 2 groups (9.4% vs 16.2%, respectively; HR: 0.53; 95% CI: 0.18-1.57; P = 0.25).

Conclusions: In this propensity-matched cohort of patients who underwent AVR for severe AS, we did not detect significant differences in the rates of the primary composite of death, stroke, or rehospitalization at 12 months when comparing RD-AVR with SAVR and TAVR. Because the study was underpowered, the results should be considered as hypothesis generating highlighting the need for further research. (ASAN Medical Center Aortic Valve Replacement Registry [ASAN-AVR]; NCT03298178).

Keywords: AS, aortic valve stenosis; ASAN-AVR, ASAN Medical Center Aortic Valve Replacement; AVR, aortic valve replacement; GARY, German Aortic Valve Registry; RCT, randomized clinical trial; RD, rapid deployment; SAVR, surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement; heart valves; mortality; surgery; transcatheter aortic valve replacement.

Associated data

ClinicalTrials.gov/NCT03298178