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Edge-to-Edge Transcatheter Mitral Valve Repair Using PASCAL vs. MitraClip: A Systematic Review and Meta-Analysis

Background: Transcatheter edge-to-edge repair (TEER) of the mitral valve (MV) can be performed using the PASCAL or MitraClip devices. Few studies offer a head-to-head outcome comparison of these two devices. Material and Methods: PubMed, EMBASE, Cochrane Library, Clinicaltrials.gov and WHO’s Interna...

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Autores principales: Hosseini, Kaveh, Soleimani, Hamidreza, Nasrollahizadeh, Amir, Jenab, Yaser, Karlas, Angelos, Avgerinos, Dimitrios V., Briasoulis, Alexandros, Kuno, Toshiki, Doulamis, Ilias, Kampaktsis, Polydoros N.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
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Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10219028/
https://www.ncbi.nlm.nih.gov/pubmed/37240685
http://dx.doi.org/10.3390/jcm12103579
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author Hosseini, Kaveh
Soleimani, Hamidreza
Nasrollahizadeh, Amir
Jenab, Yaser
Karlas, Angelos
Avgerinos, Dimitrios V.
Briasoulis, Alexandros
Kuno, Toshiki
Doulamis, Ilias
Kampaktsis, Polydoros N.
author_facet Hosseini, Kaveh
Soleimani, Hamidreza
Nasrollahizadeh, Amir
Jenab, Yaser
Karlas, Angelos
Avgerinos, Dimitrios V.
Briasoulis, Alexandros
Kuno, Toshiki
Doulamis, Ilias
Kampaktsis, Polydoros N.
author_sort Hosseini, Kaveh
collection PubMed
description Background: Transcatheter edge-to-edge repair (TEER) of the mitral valve (MV) can be performed using the PASCAL or MitraClip devices. Few studies offer a head-to-head outcome comparison of these two devices. Material and Methods: PubMed, EMBASE, Cochrane Library, Clinicaltrials.gov and WHO’s International Clinical Trials Registry Platform, from 1 January 2000 until 1 March 2023, were searched. Study protocol details were registered in the International Prospective Register of Systematic Reviews (PROSPERO ID: CRD42023405400). Randomized Controlled Trials and observational studies reporting head-to-head clinical comparison of PASCAL and MitraClip devices were eligible for selection. Patients with severe functional or degenerative mitral regurgitation (MR) who had undergone TEER of the MV with either PASCAL or MitraClip devices were included in the meta-analysis. Data from six studies (five observational and one randomized clinical trial) were extracted and analyzed. The main outcomes were a reduction in MR to 2+ or less, improvement of New York Heart Association (NYHA) and 30-day all-cause mortality. Peri-procedural mortality, success rate and adverse events were also compared. Results: Data from 785 and 796 patients that underwent TEER using PASCAL and MitraClip, respectively, were analyzed. Thirty-day all-cause mortality (Risk ratio [RR] = 1.51, 95% CI 0.79–2.89), MR reduction to maximum 2+ (RR = 1.00, 95% CI 0.98–1.02) and NYHA improvement (RR = 0.98, 95% CI 0.84–1.15) were similar in both device groups. Both devices had high and similar success rates (96.9% and 96.7% for the PASCAL and MitraClip group, respectively, p value = 0.91). MR reduction to 1+ or less at discharge was similar in both device groups (RR = 1.06, 95% CI 0.95–1.19). Composite peri-procedural and in-hospital mortality was 0.64% and 1.66% in the PASCAL and MitraClip groups, respectively (p value = 0.094). Rates of peri-procedural cerebrovascular accidents were 0.26% in PASCAL and 1.01% in MitraClip (p value = 0.108). Conclusions: Both PASCAL and MitraClip devices have high success and low complication rates for TEER of the MV. PASCAL was not inferior to MitraClip in reducing the MR level at discharge.
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spelling pubmed-102190282023-05-27 Edge-to-Edge Transcatheter Mitral Valve Repair Using PASCAL vs. MitraClip: A Systematic Review and Meta-Analysis Hosseini, Kaveh Soleimani, Hamidreza Nasrollahizadeh, Amir Jenab, Yaser Karlas, Angelos Avgerinos, Dimitrios V. Briasoulis, Alexandros Kuno, Toshiki Doulamis, Ilias Kampaktsis, Polydoros N. J Clin Med Systematic Review Background: Transcatheter edge-to-edge repair (TEER) of the mitral valve (MV) can be performed using the PASCAL or MitraClip devices. Few studies offer a head-to-head outcome comparison of these two devices. Material and Methods: PubMed, EMBASE, Cochrane Library, Clinicaltrials.gov and WHO’s International Clinical Trials Registry Platform, from 1 January 2000 until 1 March 2023, were searched. Study protocol details were registered in the International Prospective Register of Systematic Reviews (PROSPERO ID: CRD42023405400). Randomized Controlled Trials and observational studies reporting head-to-head clinical comparison of PASCAL and MitraClip devices were eligible for selection. Patients with severe functional or degenerative mitral regurgitation (MR) who had undergone TEER of the MV with either PASCAL or MitraClip devices were included in the meta-analysis. Data from six studies (five observational and one randomized clinical trial) were extracted and analyzed. The main outcomes were a reduction in MR to 2+ or less, improvement of New York Heart Association (NYHA) and 30-day all-cause mortality. Peri-procedural mortality, success rate and adverse events were also compared. Results: Data from 785 and 796 patients that underwent TEER using PASCAL and MitraClip, respectively, were analyzed. Thirty-day all-cause mortality (Risk ratio [RR] = 1.51, 95% CI 0.79–2.89), MR reduction to maximum 2+ (RR = 1.00, 95% CI 0.98–1.02) and NYHA improvement (RR = 0.98, 95% CI 0.84–1.15) were similar in both device groups. Both devices had high and similar success rates (96.9% and 96.7% for the PASCAL and MitraClip group, respectively, p value = 0.91). MR reduction to 1+ or less at discharge was similar in both device groups (RR = 1.06, 95% CI 0.95–1.19). Composite peri-procedural and in-hospital mortality was 0.64% and 1.66% in the PASCAL and MitraClip groups, respectively (p value = 0.094). Rates of peri-procedural cerebrovascular accidents were 0.26% in PASCAL and 1.01% in MitraClip (p value = 0.108). Conclusions: Both PASCAL and MitraClip devices have high success and low complication rates for TEER of the MV. PASCAL was not inferior to MitraClip in reducing the MR level at discharge. MDPI 2023-05-20 /pmc/articles/PMC10219028/ /pubmed/37240685 http://dx.doi.org/10.3390/jcm12103579 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/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 (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Systematic Review
Hosseini, Kaveh
Soleimani, Hamidreza
Nasrollahizadeh, Amir
Jenab, Yaser
Karlas, Angelos
Avgerinos, Dimitrios V.
Briasoulis, Alexandros
Kuno, Toshiki
Doulamis, Ilias
Kampaktsis, Polydoros N.
Edge-to-Edge Transcatheter Mitral Valve Repair Using PASCAL vs. MitraClip: A Systematic Review and Meta-Analysis
title Edge-to-Edge Transcatheter Mitral Valve Repair Using PASCAL vs. MitraClip: A Systematic Review and Meta-Analysis
title_full Edge-to-Edge Transcatheter Mitral Valve Repair Using PASCAL vs. MitraClip: A Systematic Review and Meta-Analysis
title_fullStr Edge-to-Edge Transcatheter Mitral Valve Repair Using PASCAL vs. MitraClip: A Systematic Review and Meta-Analysis
title_full_unstemmed Edge-to-Edge Transcatheter Mitral Valve Repair Using PASCAL vs. MitraClip: A Systematic Review and Meta-Analysis
title_short Edge-to-Edge Transcatheter Mitral Valve Repair Using PASCAL vs. MitraClip: A Systematic Review and Meta-Analysis
title_sort edge-to-edge transcatheter mitral valve repair using pascal vs. mitraclip: a systematic review and meta-analysis
topic Systematic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10219028/
https://www.ncbi.nlm.nih.gov/pubmed/37240685
http://dx.doi.org/10.3390/jcm12103579
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