Sutureless versus transcatheter valves in patients with aortic stenosis at intermediate risk: A multi-institutional European study

Abstract

Background: Recent randomized controlled trials showed comparable short-term outcomes of transcatheter aortic valve implantation versus surgical aortic valve replacement in intermediate and low-risk patients. However, independent studies comparing transcatheter aortic valve implantation results versus surgical aortic valve replacement at 5 years showed worsening outcomes in patients treated with transcatheter aortic valve implantation. The aim of this study was to analyze mid- to long-term outcomes of patients with isolated aortic stenosis and an intermediate-risk profile who underwent aortic valve replacement using a sutureless valve versus transcatheter aortic valve implantation.

Methods: This retrospective multi-institutional European study investigated 2,123 consecutive patients with isolated aortic stenosis at intermediate risk profile treated with sutureless aortic valve replacement (824 patients) or transcatheter aortic valve implantation (1,299 patients) from 2013 to 2020. After 1:1 propensity score matching, 2 balanced groups of 517 patients were obtained. Primary endpoints were as follows: 30 days, late all-cause, and cardiac-related mortality. Secondary endpoints included major adverse cardiocerebrovascular events (all-cause death, stroke/transient ischemic attack, endocarditis, reoperation, permanent pacemaker implantation, and paravalvular leak grade ≥2).

Results: Median follow-up was 4.3 years (interquartile range 1.1-7.4 years). Primary endpoints were as follows-30-day mortality sutureless aortic valve replacement: 2.13% versus transcatheter aortic valve implantation: 4.64% (P = .026), all-cause mortality sutureless aortic valve replacement: 36.7% ± 7.8% vs transcatheter aortic valve implantation: 41.8% ± 8.2% (P = .023), and cardiac-related mortality sutureless aortic valve replacement: 10.2% ± 2.8% vs transcatheter aortic valve implantation: 19.2% ± 3.5%;(P = .00043) at follow-up. Secondary endpoints were as follows-major adverse cardiocerebrovascular events in the sutureless aortic valve replacement group: 47.2% ± 9.0% versus transcatheter aortic valve implantation: 57.3% ± 7.5% (P < .001). In particular, the incidence of permanent pacemaker implantation (sutureless aortic valve replacement: 6.38% versus transcatheter aortic valve implantation: 11.8% [P = .002]) and paravalvular leak ≥2 (sutureless aortic valve replacement: 0.97% versus transcatheter aortic valve implantation: 4.84% [P = .001]) was significantly higher in transcatheter aortic valve implantation group. At Multivariable Cox regression analysis, paravalvular leak ≥2 (hazard ratio: 1.63%; 95% confidence interval: 1.06-2.53, P = .042) and permanent pacemaker implantation (hazard ratio: 1.49%; 95% confidence interval: 1.02-2.20, P = .039) were identified as predictors of mortality.

Conclusion: Sutureless aortic valve replacement showed a significantly lower incidence of all-cause mortality, cardiac-related death, permanent pacemaker implantation, and paravalvular leak than transcatheter aortic valve implantation. Moreover, permanent pacemaker implantation and paravalvular leak negatively affected survival in patients treated for isolated aortic stenosis.