Outcomes of Transcatheter Aortic Valve Implantation Comparing Medtronic’s Evolut PRO and Evolut R: A Systematic Review and Meta-Analysis of Observational Studies

Mirosław Gozdek, Łukasz Kuźma, Emil Julian Dąbrowski, Michał Janiak, Martyna Pietrzak, Karolina Skonieczna, Mikołaj Woźnica, Lidia Wydeheft, Maged Makhoul, Matteo Matteucci, Radosław Litwinowicz, Adam Kowalówka, Wojciech Wańha, Michał Pasierski, Daniele Ronco, Giulio Massimi, Federica Jiritano, Dario Fina, Gennaro Martucci, Giuseppe Maria Raffa, Piotr Suwalski, Roberto Lorusso, Paolo Meani and Mariusz Kowalewski ()
Additional contact information
Mirosław Gozdek: Department of Cardiology, Hospital of the Ministry of Interior, 72-122 Bydgoszcz, Poland
Łukasz Kuźma: Department of Invasive Cardiology, Medical University of Bialystok, 15-540 Bialystok, Poland
Emil Julian Dąbrowski: Department of Invasive Cardiology, Medical University of Bialystok, 15-540 Bialystok, Poland
Michał Janiak: Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland
Martyna Pietrzak: Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland
Karolina Skonieczna: Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland
Mikołaj Woźnica: Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland
Lidia Wydeheft: Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland
Maged Makhoul: Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland
Matteo Matteucci: Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland
Radosław Litwinowicz: Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland
Adam Kowalówka: Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland
Wojciech Wańha: Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland
Michał Pasierski: Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland
Daniele Ronco: Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland
Giulio Massimi: Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland
Federica Jiritano: Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland
Dario Fina: Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland
Gennaro Martucci: Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland
Giuseppe Maria Raffa: Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland
Piotr Suwalski: Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland
Roberto Lorusso: Cardiothoracic Surgery Department, Heart and Vascular Centre, Maastricht University Medical Centre (MUMC), The Cardiovascular Research Institute Maastricht (CARIM), 6229 ER Maastricht, The Netherlands
Paolo Meani: Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland
Mariusz Kowalewski: Thoracic Research Centre, Collegium Medicum Nicolaus Copernicus University, Innovative Medical Forum, 85-094 Bydgoszcz, Poland

IJERPH, 2023, vol. 20, issue 4, 1-12

Abstract: 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’s 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 < 0.001), sex ( p < 0.001) and STS–PROM 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; I 2 = 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; I 2 = 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.

Keywords: TAVI; transcatheter intervention; aortic stenosis; heart failure; permanent pacemaker; paravalvular leak; Evolut PRO; Evolut R; meta-analysis (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2023
References: View references in EconPapers View complete reference list from CitEc
Citations:

Downloads: (external link)
https://www.mdpi.com/1660-4601/20/4/3439/pdf (application/pdf)
https://www.mdpi.com/1660-4601/20/4/3439/ (text/html)

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:gam:jijerp:v:20:y:2023:i:4:p:3439-:d:1069752

Access Statistics for this article

IJERPH is currently edited by Ms. Jenna Liu

More articles in IJERPH from MDPI
Bibliographic data for series maintained by MDPI Indexing Manager ().