University of Oulu

Rosato, S.; Biancari, F.; D’Errigo, P.; Barbanti, M.; Tarantini, G.; Bedogni, F.; Ranucci, M.; Costa, G.; Juvonen, T.; Ussia, G.P.; Marcellusi, A.; Baglio, G.; Cicala, S.D.; Badoni, G.; Seccareccia, F.; Tamburino, C.; on behalf of the OBSERVANT II Research Group. One-Year Outcomes after Surgical versus Transcatheter Aortic Valve Replacement with Newer Generation Devices. J. Clin. Med. 2021, 10, 3703.

One-year outcomes after surgical versus transcatheter aortic valve replacement with newer generation devices

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Author: Rosato, Stefano1; Biancari, Fausto2; D’Errigo, Paola1;
Organizations: 1National Centre for Global Health, Istituto Superiore di Sanità, 00161 Rome, Italy
2Clinica Montevergine, GVM Care and Research, 83013 Mercogliano, Italy
3Division of Cardiology, A.O.U. Policlinico “G. Rodolico—San Marco”, University of Catania, 95124 Catania, Italy
4Division of Cardiology, Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, 35122 Padova, Italy
5Department of Clinical and Interventional Cardiology, IRCCS Policlinico San Donato, San Donato Milanese, 20097 Milan, Italy
6Department of Cardiothoracic and Vascular Anesthesia and ICU, IRCCS Policlinico San Donato, San Donato Milanese, 20097 Milan, Italy
7Heart and Lung Center, Helsinki University Hospital, University of Helsinki, 00029 Helsinki, Finland
8Research Unit of Surgery, Anesthesiology and Critical Care, University of Oulu, 90570 Oulu, Finland
9Department of Interventional Cardiology, Campus Bio-Medico University of Rome, 00128 Rome, Italy
10Economic Evaluation and HTA (EEHTA), CEIS Faculty of Economics, University of Rome “Tor Vergata”, 00133 Rome, Italy
11Italian National Agency for Regional Healthcare Services, 00187 Rome, Italy
Format: article
Version: published version
Access: open
Online Access: PDF Full Text (PDF, 1.2 MB)
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Language: English
Published: Multidisciplinary Digital Publishing Institute, 2021
Publish Date: 2021-11-04


The superiority of transcatheter (TAVR) over surgical aortic valve replacement (SAVR) for severe aortic stenosis (AS) has not been fully demonstrated in a real-world setting. This prospective study included 5706 AS patients who underwent SAVR from 2010 to 2012 and 2989 AS patients who underwent TAVR from 2017 to 2018 from the prospective multicenter observational studies OBSERVANT I and II. Early adverse events as well as all-cause mortality, major adverse cardiac and cerebrovascular events (MACCEs), and hospital readmission due to heart failure at 1-year were investigated. Among 1008 propensity score matched pairs, TAVR was associated with significantly lower 30-day mortality (1.8 vs. 3.5%, p = 0.020), stroke (0.8 vs. 2.3%, p = 0.005), and acute kidney injury (0.6 vs. 8.2%, p < 0.001) compared to SAVR. Moderate-to-severe paravalvular regurgitation (5.9 vs. 2.0%, p < 0.001) and permanent pacemaker implantation (13.8 vs. 3.3%, p < 0.001) were more frequent after TAVR. At 1-year, TAVR was associated with lower risk of all-cause mortality (7.9 vs. 11.5%, p = 0.006), MACCE (12.0 vs. 15.8%, p = 0.011), readmission due to heart failure (10.8 vs. 15.9%, p < 0.001), and stroke (3.2 vs. 5.1%, p = 0.033) compared to SAVR. TAVR reduced 1-year mortality in the subgroups of patients aged 80 years or older (HR 0.49, 95% CI 0.33–0.71), in females (HR 0.57, 0.38–0.85), and among patients with EuroSCORE II ≥ 4.0% (HR 0.48, 95% CI 0.32–0.71). In a real-world setting, TAVR using new-generation devices was associated with lower rates of adverse events up to 1-year follow-up compared to SAVR.

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Series: Journal of clinical medicine
ISSN: 2077-0383
ISSN-E: 2077-0383
ISSN-L: 2077-0383
Volume: 10
Issue: 16
Article number: 3703
DOI: 10.3390/jcm10163703
Type of Publication: A1 Journal article – refereed
Field of Science: 3126 Surgery, anesthesiology, intensive care, radiology
Funding: The OBSERVANT I Study was supported by a grant (Fasc. 1M30) from the Italian Ministry of Health and Istituto Superiore di Sanità; the OBSERVANT II Study was supported by the Italian Ministry of Health under “Ricerca Finalizzata 2016” (code PE-2016-02364619).
Copyright information: © 2021 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (