Meta-analysis of MitraClip and PASCAL for transcatheter mitral edge-to-edge repair

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Abstract

Background

Despite the promising results of both MitraClip and PASCAL systems for the treatment of mitral regurgitation (MR), there is limited data on the comparison of both systems regarding their safety and efficacy. We aim to compare both systems for MR.

Materials and methods

Five databases were searched until October 2024. Original studies were only included and critically appraised using an adapted version of the Newcastle–Ottawa scale for observational cohort studies and the Cochrane risk of bias tool for randomized controlled trials. The risk ratio (RR) and mean difference (MD) with their corresponding 95% confidence interval (95% CI).

Results

From the database search, we identified 197 studies, of which eight studies comprising 1,612 patients who underwent transcatheter edge-to-edge repair with either MitraClip or PASCAL were included in this meta-analysis. The statistical analysis revealed no significant difference between the two devices in achieving a two-grade reduction in MR severity (RR = 0.95; 95% CI: [0.86, 1.04]; p = 0.28), one-grade reduction (RR = 1.17; 95% CI: [0.92, 1.49]; p = 0.19), or in cases with no improvement (RR = 1.23; 95% CI: [0.79, 1.90]; p = 0.36). Additionally, there were no significant differences between PASCAL and MitraClip regarding procedure time, procedural success, reinterventions, or all-cause mortality. However, PASCAL trended towards better residual MR reduction, although this was accompanied by moderate heterogeneity. Both devices demonstrated comparable safety profiles and were effective in reducing MR and improving cardiac function.

Conclusion

MitraClip and PASCAL devices showed comparable safety profiles and procedural success rates. However, the analysis did not reveal a statistically significant difference between the two devices in reducing the severity of MR.

Supplementary Information

The online version contains supplementary material available at 10.1186/s13019-024-03218-4.

Related collections

Most cited references 30

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The PRISMA 2020 statement: an updated guideline for reporting systematic reviews

Matthew J L Page, Joanne E McKenzie, Patrick Bossuyt … (2028)

The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update to the guideline. The PRISMA 2020 statement replaces the 2009 statement and includes new reporting guidance that reflects advances in methods to identify, select, appraise, and synthesise studies. The structure and presentation of the items have been modified to facilitate implementation. In this article, we present the PRISMA 2020 27-item checklist, an expanded checklist that details reporting recommendations for each item, the PRISMA 2020 abstract checklist, and the revised flow diagrams for original and updated reviews.

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Transcatheter Mitral-Valve Repair in Patients with Heart Failure

Gregg Stone, JoAnn Lindenfeld, William T. Abraham … (2018)

Among patients with heart failure who have mitral regurgitation due to left ventricular dysfunction, the prognosis is poor. Transcatheter mitral-valve repair may improve their clinical outcomes.

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Development of AMSTAR: a measurement tool to assess the methodological quality of systematic reviews

Beverley Shea, Jeremy M. Grimshaw, George A Wells … (2007)

Background Our objective was to develop an instrument to assess the methodological quality of systematic reviews, building upon previous tools, empirical evidence and expert consensus. Methods A 37-item assessment tool was formed by combining 1) the enhanced Overview Quality Assessment Questionnaire (OQAQ), 2) a checklist created by Sacks, and 3) three additional items recently judged to be of methodological importance. This tool was applied to 99 paper-based and 52 electronic systematic reviews. Exploratory factor analysis was used to identify underlying components. The results were considered by methodological experts using a nominal group technique aimed at item reduction and design of an assessment tool with face and content validity. Results The factor analysis identified 11 components. From each component, one item was selected by the nominal group. The resulting instrument was judged to have face and content validity. Conclusion A measurement tool for the 'assessment of multiple systematic reviews' (AMSTAR) was developed. The tool consists of 11 items and has good face and content validity for measuring the methodological quality of systematic reviews. Additional studies are needed with a focus on the reproducibility and construct validity of AMSTAR, before strong recommendations can be made on its use.

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Author and article information

Contributors

Mahmoud Balata: mahmoud.m.balata@fau.de

Journal

Journal ID (nlm-ta): J Cardiothorac Surg

Journal ID (iso-abbrev): J Cardiothorac Surg

Title: Journal of Cardiothoracic Surgery

Publisher: BioMed Central (London )

ISSN (Electronic): 1749-8090

Publication date (Electronic): 3 January 2025

Publication date PMC-release: 3 January 2025

Publication date Collection: 2025

Volume: 20

Electronic Location Identifier: 3

Affiliations

[1 ]Friedrich-Alexander-Universität Erlangen-Nürnberg, ( https://ror.org/00f7hpc57) Nürnberg, Germany

[2 ]Faculty of Medicine, ( https://ror.org/05y06tg49) October 6 University, Giza Egypt

[3 ]Faculty of Medicine, Al-Azhar University, ( https://ror.org/05fnp1145) Cairo, Egypt

[4 ]Department of Immunology, Theodor Bilharz Research institute, ( https://ror.org/04d4dr544) Giza, Egypt

[5 ]Department of Internal Medicine II, Städtisches Klinikum Solingen, ( https://ror.org/01s3w8y48) Solingen, Germany

Article

Publisher ID: 3218

DOI: 10.1186/s13019-024-03218-4

PMC ID: 11697868

PubMed ID: 39754135

SO-VID: ca5660b0-e71d-4665-8e2e-6239d7b7461b

License:

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

History

Date received : 24 August 2024

Date accepted : 24 December 2024

Funding

Funded by: Rheinische Friedrich-Wilhelms-Universität Bonn (1040)

Open Access :

Open Access funding enabled and organized by Projekt DEAL.

Custom metadata

ScienceOpen disciplines: Surgery

Keywords: mitraclip, pascal,mitral regurgitation,transcatheter edge-to-edge repair,review,and meta-analysis

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