{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T00:29:59Z","timestamp":1791419399262,"version":"4.3.3"},"reference-count":36,"publisher":"MDPI AG","issue":"4","license":[{"start":{"date-parts":[[2023,2,15]],"date-time":"2023-02-15T00:00:00Z","timestamp":1676419200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["IJERPH"],"abstract":"<jats:p>Background: Transcatheter aortic valve implantation (TAVI) has become a broadly acceptable alternative to AV surgery in patients with aortic stenosis (AS). New valve designs are becoming available to address the shortcomings of their predecessors and improve clinical outcomes. Methods: A systematic review and meta-analysis was carried out to compare Medtronic\u2019s Evolut PRO, a new valve, with the previous Evolut R design. Procedural, functional and clinical endpoints according to the VARC-2 criteria were assessed. Results: Eleven observational studies involving N = 12,363 patients were included. Evolut PRO patients differed regarding age (p &lt; 0.001), sex (p &lt; 0.001) and STS\u2013PROM estimated risk. There was no difference between the two devices in terms of TAVI-related early complications and clinical endpoints. A 35% reduction of the risk of moderate-to-severe paravalvular leak (PVL) favoring the Evolut PRO was observed (RR 0.66, 95%CI, [0.52, 0.86] p = 0.002; I2 = 0%). Similarly, Evolut PRO-treated patients demonstrated a reduction of over 35% in the risk of serious bleeding as compared with the Evolut R (RR 0.63, 95%CI, [0.41, 0.96]; p = 0.03; I2 = 39%), without differences in major vascular complications. Conclusions: The evidence shows good short-term outcomes of both the Evolut PRO and Evolut R prostheses, with no differences in clinical and procedural endpoints. The Evolut PRO was associated with a lower rate of moderate-to-severe PVL and major bleeding.<\/jats:p>","DOI":"10.3390\/ijerph20043439","type":"journal-article","created":{"date-parts":[[2023,2,16]],"date-time":"2023-02-16T02:04:03Z","timestamp":1676513043000},"page":"3439","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Outcomes of Transcatheter Aortic Valve Implantation Comparing Medtronic\u2019s Evolut PRO and Evolut R: A Systematic Review and Meta-Analysis of Observational Studies"],"prefix":"10.3390","volume":"20","author":[{"given":"Miros\u0142aw","family":"Gozdek","sequence":"first","affiliation":[{"name":"Department of Cardiology, Hospital of the Ministry of Interior, 72-122 Bydgoszcz, Poland"},{"name":"Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4156-5695","authenticated-orcid":false,"given":"\u0141ukasz","family":"Ku\u017ama","sequence":"additional","affiliation":[{"name":"Department of Invasive Cardiology, Medical University of Bialystok, 15-540 Bialystok, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7598-1913","authenticated-orcid":false,"given":"Emil Julian","family":"D\u0105browski","sequence":"additional","affiliation":[{"name":"Department of Invasive Cardiology, Medical University of Bialystok, 15-540 Bialystok, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Micha\u0142","family":"Janiak","sequence":"additional","affiliation":[{"name":"Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martyna","family":"Pietrzak","sequence":"additional","affiliation":[{"name":"Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karolina","family":"Skonieczna","sequence":"additional","affiliation":[{"name":"Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miko\u0142aj","family":"Wo\u017anica","sequence":"additional","affiliation":[{"name":"Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lidia","family":"Wydeheft","sequence":"additional","affiliation":[{"name":"Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4487-1153","authenticated-orcid":false,"given":"Maged","family":"Makhoul","sequence":"additional","affiliation":[{"name":"Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland"},{"name":"Department of Cardiac Surgery, Harefield Hospital, London UB9 6JH, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0694-2747","authenticated-orcid":false,"given":"Matteo","family":"Matteucci","sequence":"additional","affiliation":[{"name":"Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland"},{"name":"Cardiac Surgery Unit, ASST dei Sette Laghi, Department of Medicine and Surgery, University of Insubria, 21100 Varese, Italy"},{"name":"Cardiothoracic Surgery Department, Heart and Vascular Centre, Maastricht University Medical Centre (MUMC), The Cardiovascular Research Institute Maastricht (CARIM), 6229 ER Maastricht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rados\u0142aw","family":"Litwinowicz","sequence":"additional","affiliation":[{"name":"Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland"},{"name":"Department of Cardiac Surgery, Regional Specialist Hospital, 86-300 Grudzi\u0105dz, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8239-9099","authenticated-orcid":false,"given":"Adam","family":"Kowal\u00f3wka","sequence":"additional","affiliation":[{"name":"Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland"},{"name":"Department of Cardiac Surgery, Upper-Silesian Heart Center, 40-752 Katowice, Poland"},{"name":"Department of Cardiac Surgery, Faculty of Medical Sciences, Medical University of Silesia, 40-752 Katowice, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1220-9496","authenticated-orcid":false,"given":"Wojciech","family":"Wa\u0144ha","sequence":"additional","affiliation":[{"name":"Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland"},{"name":"Department of Cardiac Surgery, School of Medicine in Katowice, Medical University of Silesia, 40-752 Katowice, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Micha\u0142","family":"Pasierski","sequence":"additional","affiliation":[{"name":"Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland"},{"name":"Department of Cardiac Surgery and Transplantology, Central Clinical Hospital of the Ministry of Interior, Centre of Postgraduate Medical Education, 02-507 Warsaw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5250-1796","authenticated-orcid":false,"given":"Daniele","family":"Ronco","sequence":"additional","affiliation":[{"name":"Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland"},{"name":"Cardiothoracic Surgery Department, Heart and Vascular Centre, Maastricht University Medical Centre (MUMC), The Cardiovascular Research Institute Maastricht (CARIM), 6229 ER Maastricht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giulio","family":"Massimi","sequence":"additional","affiliation":[{"name":"Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland"},{"name":"Cardiothoracic Surgery Department, Heart and Vascular Centre, Maastricht University Medical Centre (MUMC), The Cardiovascular Research Institute Maastricht (CARIM), 6229 ER Maastricht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6889-5686","authenticated-orcid":false,"given":"Federica","family":"Jiritano","sequence":"additional","affiliation":[{"name":"Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland"},{"name":"Department of Experimental and Clinical Medicine, Magna Graecia University, 88100 Catanzaro, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dario","family":"Fina","sequence":"additional","affiliation":[{"name":"Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland"},{"name":"Department of Cardiothoracic, Vascular Anesthesia and Intensive Care Unit, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico, San Donato Milanese, 20097 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8443-2414","authenticated-orcid":false,"given":"Gennaro","family":"Martucci","sequence":"additional","affiliation":[{"name":"Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland"},{"name":"Department of Anesthesia and Intensive Care, Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (IRCCS-ISMETT), 90100 Palermo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe Maria","family":"Raffa","sequence":"additional","affiliation":[{"name":"Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland"},{"name":"Department for the Treatment and Study of Cardiothoracic Diseases and Cardiothoracic Transplantation, Istituto di Ricovero e Cura a Carattere Scientifico-Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (IRCCS-ISMETT), 90100 Palermo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Piotr","family":"Suwalski","sequence":"additional","affiliation":[{"name":"Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland"},{"name":"Department of Cardiac Surgery and Transplantology, Central Clinical Hospital of the Ministry of Interior, Centre of Postgraduate Medical Education, 02-507 Warsaw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberto","family":"Lorusso","sequence":"additional","affiliation":[{"name":"Cardiothoracic Surgery Department, Heart and Vascular Centre, Maastricht University Medical Centre (MUMC), The Cardiovascular Research Institute Maastricht (CARIM), 6229 ER Maastricht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo","family":"Meani","sequence":"additional","affiliation":[{"name":"Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland"},{"name":"Department of Cardiothoracic, Vascular Anesthesia and Intensive Care Unit, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico, San Donato Milanese, 20097 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5478-3245","authenticated-orcid":false,"given":"Mariusz","family":"Kowalewski","sequence":"additional","affiliation":[{"name":"Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland"},{"name":"Cardiothoracic Surgery Department, Heart and Vascular Centre, Maastricht University Medical Centre (MUMC), The Cardiovascular Research Institute Maastricht (CARIM), 6229 ER Maastricht, The Netherlands"},{"name":"Department of Cardiac Surgery and Transplantology, Central Clinical Hospital of the Ministry of Interior, Centre of Postgraduate Medical Education, 02-507 Warsaw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,2,15]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1597","DOI":"10.1056\/NEJMoa1008232","article-title":"Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery","volume":"363","author":"Leon","year":"2010","journal-title":"N. 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Devices"}],"container-title":["International Journal of Environmental Research and Public Health"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1660-4601\/20\/4\/3439\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T18:36:53Z","timestamp":1760121413000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1660-4601\/20\/4\/3439"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,2,15]]},"references-count":36,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2023,2]]}},"alternative-id":["ijerph20043439"],"URL":"https:\/\/doi.org\/10.3390\/ijerph20043439","relation":{},"ISSN":["1660-4601"],"issn-type":[{"value":"1660-4601","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,2,15]]}}}