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Transcatheter Aortic Valve Replacement with Self-Expandable ACURATE neo as Compared to Balloon-Expandable SAPIEN 3 in Patients with Severe Aortic Stenosis: Meta-Analysis of Randomized and Propensity-Matched Studies

Frequent occurrence of paravalvular leak (PVL) after transcatheter aortic valve replacement (TAVR) was the main concern with earlier-generation devices. Current meta-analysis compared outcomes of TAVR with next-generation devices: ACURATE neo and SAPIEN 3. In random-effects meta-analysis, the pooled...

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Autores principales: Gozdek, Mirosław, Zieliński, Kamil, Pasierski, Michał, Matteucci, Matteo, Fina, Dario, Jiritano, Federica, Meani, Paolo, Raffa, Giuseppe Maria, Malvindi, Pietro Giorgio, Pilato, Michele, Paparella, Domenico, Słomka, Artur, Kubica, Jacek, Jagielak, Dariusz, Lorusso, Roberto, Suwalski, Piotr, Kowalewski, Mariusz
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7074302/
https://www.ncbi.nlm.nih.gov/pubmed/32024168
http://dx.doi.org/10.3390/jcm9020397
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author Gozdek, Mirosław
Zieliński, Kamil
Pasierski, Michał
Matteucci, Matteo
Fina, Dario
Jiritano, Federica
Meani, Paolo
Raffa, Giuseppe Maria
Malvindi, Pietro Giorgio
Pilato, Michele
Paparella, Domenico
Słomka, Artur
Kubica, Jacek
Jagielak, Dariusz
Lorusso, Roberto
Suwalski, Piotr
Kowalewski, Mariusz
author_facet Gozdek, Mirosław
Zieliński, Kamil
Pasierski, Michał
Matteucci, Matteo
Fina, Dario
Jiritano, Federica
Meani, Paolo
Raffa, Giuseppe Maria
Malvindi, Pietro Giorgio
Pilato, Michele
Paparella, Domenico
Słomka, Artur
Kubica, Jacek
Jagielak, Dariusz
Lorusso, Roberto
Suwalski, Piotr
Kowalewski, Mariusz
author_sort Gozdek, Mirosław
collection PubMed
description Frequent occurrence of paravalvular leak (PVL) after transcatheter aortic valve replacement (TAVR) was the main concern with earlier-generation devices. Current meta-analysis compared outcomes of TAVR with next-generation devices: ACURATE neo and SAPIEN 3. In random-effects meta-analysis, the pooled incidence rates of procedural, clinical and functional outcomes according to VARC-2 definitions were assessed. One randomized controlled trial and five observational studies including 2818 patients (ACURATE neo n = 1256 vs. SAPIEN 3 n = 1562) met inclusion criteria. ACURATE neo was associated with a 3.7-fold increase of moderate-to-severe PVL (RR (risk ratio): 3.70 (2.04–6.70); P < 0.0001), which was indirectly related to higher observed 30-day mortality with ACURATE valve (RR: 1.77 (1.03–3.04); P = 0.04). Major vascular complications, acute kidney injury, periprocedural myocardial infarction, stroke and serious bleeding events were similar between devices. ACURATE neo demonstrated lower transvalvular pressure gradients both at discharge (P < 0.00001) and at 30 days (P < 0.00001), along with lower risk of patient–prosthesis mismatch (RR: 0.29 (0.10–0.87); P = 0.03) and pacemaker implantation (RR: 0.64 (0.50–0.81); P = 0.0002), but no differences were observed regarding composite endpoints early safety and device success. In conclusion, ACURATE neo, as compared with SAPIEN 3, was associated with higher rates of moderate-to-severe PVL, which were indirectly linked with increased observed 30-day all-cause mortality.
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spelling pubmed-70743022020-03-19 Transcatheter Aortic Valve Replacement with Self-Expandable ACURATE neo as Compared to Balloon-Expandable SAPIEN 3 in Patients with Severe Aortic Stenosis: Meta-Analysis of Randomized and Propensity-Matched Studies Gozdek, Mirosław Zieliński, Kamil Pasierski, Michał Matteucci, Matteo Fina, Dario Jiritano, Federica Meani, Paolo Raffa, Giuseppe Maria Malvindi, Pietro Giorgio Pilato, Michele Paparella, Domenico Słomka, Artur Kubica, Jacek Jagielak, Dariusz Lorusso, Roberto Suwalski, Piotr Kowalewski, Mariusz J Clin Med Article Frequent occurrence of paravalvular leak (PVL) after transcatheter aortic valve replacement (TAVR) was the main concern with earlier-generation devices. Current meta-analysis compared outcomes of TAVR with next-generation devices: ACURATE neo and SAPIEN 3. In random-effects meta-analysis, the pooled incidence rates of procedural, clinical and functional outcomes according to VARC-2 definitions were assessed. One randomized controlled trial and five observational studies including 2818 patients (ACURATE neo n = 1256 vs. SAPIEN 3 n = 1562) met inclusion criteria. ACURATE neo was associated with a 3.7-fold increase of moderate-to-severe PVL (RR (risk ratio): 3.70 (2.04–6.70); P < 0.0001), which was indirectly related to higher observed 30-day mortality with ACURATE valve (RR: 1.77 (1.03–3.04); P = 0.04). Major vascular complications, acute kidney injury, periprocedural myocardial infarction, stroke and serious bleeding events were similar between devices. ACURATE neo demonstrated lower transvalvular pressure gradients both at discharge (P < 0.00001) and at 30 days (P < 0.00001), along with lower risk of patient–prosthesis mismatch (RR: 0.29 (0.10–0.87); P = 0.03) and pacemaker implantation (RR: 0.64 (0.50–0.81); P = 0.0002), but no differences were observed regarding composite endpoints early safety and device success. In conclusion, ACURATE neo, as compared with SAPIEN 3, was associated with higher rates of moderate-to-severe PVL, which were indirectly linked with increased observed 30-day all-cause mortality. MDPI 2020-02-01 /pmc/articles/PMC7074302/ /pubmed/32024168 http://dx.doi.org/10.3390/jcm9020397 Text en © 2020 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 (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Gozdek, Mirosław
Zieliński, Kamil
Pasierski, Michał
Matteucci, Matteo
Fina, Dario
Jiritano, Federica
Meani, Paolo
Raffa, Giuseppe Maria
Malvindi, Pietro Giorgio
Pilato, Michele
Paparella, Domenico
Słomka, Artur
Kubica, Jacek
Jagielak, Dariusz
Lorusso, Roberto
Suwalski, Piotr
Kowalewski, Mariusz
Transcatheter Aortic Valve Replacement with Self-Expandable ACURATE neo as Compared to Balloon-Expandable SAPIEN 3 in Patients with Severe Aortic Stenosis: Meta-Analysis of Randomized and Propensity-Matched Studies
title Transcatheter Aortic Valve Replacement with Self-Expandable ACURATE neo as Compared to Balloon-Expandable SAPIEN 3 in Patients with Severe Aortic Stenosis: Meta-Analysis of Randomized and Propensity-Matched Studies
title_full Transcatheter Aortic Valve Replacement with Self-Expandable ACURATE neo as Compared to Balloon-Expandable SAPIEN 3 in Patients with Severe Aortic Stenosis: Meta-Analysis of Randomized and Propensity-Matched Studies
title_fullStr Transcatheter Aortic Valve Replacement with Self-Expandable ACURATE neo as Compared to Balloon-Expandable SAPIEN 3 in Patients with Severe Aortic Stenosis: Meta-Analysis of Randomized and Propensity-Matched Studies
title_full_unstemmed Transcatheter Aortic Valve Replacement with Self-Expandable ACURATE neo as Compared to Balloon-Expandable SAPIEN 3 in Patients with Severe Aortic Stenosis: Meta-Analysis of Randomized and Propensity-Matched Studies
title_short Transcatheter Aortic Valve Replacement with Self-Expandable ACURATE neo as Compared to Balloon-Expandable SAPIEN 3 in Patients with Severe Aortic Stenosis: Meta-Analysis of Randomized and Propensity-Matched Studies
title_sort transcatheter aortic valve replacement with self-expandable acurate neo as compared to balloon-expandable sapien 3 in patients with severe aortic stenosis: meta-analysis of randomized and propensity-matched studies
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7074302/
https://www.ncbi.nlm.nih.gov/pubmed/32024168
http://dx.doi.org/10.3390/jcm9020397
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