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Observational Study
. 2025 Oct;40(4):943-953.
doi: 10.1007/s12928-025-01155-0. Epub 2025 Jul 8.

Five-year outcomes after surgical versus transcatheter aortic valve replacement with new generation devices from the prospective OBSERVANT studies

Stefano Rosato  1 , Fausto Biancari  2 , Marco Barbanti  3 , Giuseppe Tarantini  4 , Marco Ranucci  5 , Giuliano Costa  3 , Timo Mäkikallio  6 , Gian Paolo Ussia  7 , Giovanni Baglio  8 , Mahin Tatari  9   10 , Gabriella Badoni  9 , Paola D'Errigo  9 ; OBSERVANT I. I. Research Group
Affiliations
Observational Study

Five-year outcomes after surgical versus transcatheter aortic valve replacement with new generation devices from the prospective OBSERVANT studies

Stefano Rosato et al. Cardiovasc Interv Ther. 2025 Oct.

Abstract

The efficacy and durability of transcatheter (TAVR) over surgical aortic valve replacement (SAVR) for severe aortic stenosis (AS) has been demonstrated in randomized studies, but these findings were not confirmed in several observational studies. This is an analysis of 5706 AS patients who underwent SAVR from 2010 and 2012, and 2989 AS patients who underwent TAVR from 2017 and 2018 from the prospective OBSERVANT I and II studies. TAVR procedures were performed with new-generation devices. Five-year all-cause mortality was the primary outcome of this analysis. Propensity score matching yielded 1008 pairs of TAVR and SAVR patients. The mean EuroSCORE II was comparable between the study cohorts (TAVR 4.7 ± 4.0% and SAVR 4.5 ± 5.7%, p = 0.419). At 5 years, TAVR was associated with higher mortality (44.4% vs. 33.2%, HR 1.36, 95%CI 1.18-1.57, Log-rank test p < 0.001), major adverse cardiac and cerebrovascular events (MACCEs) (49.3% vs. 37.9%, HR 1.32, 95%CI 1.15-1.51, Log-rank test p < 0.001), permanent pacemaker implantation (23.1% vs. 9.3%, HR 2.72, 95%CI 2.14-3.45, Log-rank test p < 0.001) and percutaneous coronary intervention rates (3.7% vs. 1.2%, HR 3.44, 95%CI 1.76-6.71, Log-rank test p < 0.001) compared to SAVR. Age ≤ 80 years, male gender, EuroSCORE II ≤ 4.0%, absence of coronary artery disease and absence of diabetes were associated with higher 5-year mortality after TAVR compared to SAVR. TAVR had a significantly higher 5-year mortality than SAVR both in patients with left ventricular ejection fraction ≤ 50% and > 50%. This observational study from prospective data showed that TAVR using new-generation devices was associated with increased rates of all-cause mortality compared to SAVR at 5 years. These findings should be viewed considering the non-randomized nature of this study and may be attributable to the characteristics of patients selected for TAVR, rather than the procedure itself.

Keywords: SAVR; TAVR; Transcatheter aortic valve implantation; Transcatheter aortic valve replacement.

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Conflict of interest statement

Declarations. Conflicts of interest: Prof. Barbanti is a consultant for Medtronic, Edwards Lifesciences and Boston Scientific. The other authors do not have any conflict of interest to disclose. Institutional review boad: The Ethical Committee of each participating centers granted permission to participate in the OBSERVANT I and II studies. Informed consent: Informed consent was obtained from all subjects involved in the study.

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