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Real-World Outcomes of Fourth-Generation Mitral Transcatheter Repair: 30-Day Results From EXPAND G4.

MedStar author(s):

Citation: Jacc: Cardiovascular Interventions. 16(12):1463-1473, 2023 06 26.PMID: 37380228Institution: MedStar Health Research InstituteForm of publication: Journal ArticleMedline article type(s): Journal Article | Multicenter Study | Research Support, Non-U.S. Gov'tSubject headings: *Cardiomyopathies | *Mitral Valve Insufficiency | Echocardiography | Humans | Mitral Valve Insufficiency/dg [Diagnostic Imaging] | Mitral Valve Insufficiency/su [Surgery] | Prospective Studies | Quality of Life | Treatment Outcome | Year: 2023 Local holdings: Available online through MWHC library: 2008 - presentISSN:

1936-8798

Name of journal: JACC. Cardiovascular interventionsAbstract: BACKGROUND: The fourth-generation MitraClip G4 System builds on the previous NTR/XTR system with additional wider clip sizes (NTW and XTW), an independent grasping feature, and an improved clip deployment sequence.CONCLUSIONS: This study demonstrates for the first time the effectiveness and safety of MitraClip G4 System at 30 days in a cohort of >1,000 patients with MR in a contemporary, real-world setting. Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.METHODS: EXPAND G4 is a prospective, multicenter, international, single-arm, postapproval study that enrolled patients with primary (degenerative) mitral regurgitation (MR) and secondary (functional) MR at 60 centers. Follow-up of the full cohort has been conducted through 30 days. Echocardiograms were analyzed by an echocardiography core laboratory. Study outcomes included MR severity, functional capacity measured by NYHA functional class, quality of life measured using the Kansas City Cardiomyopathy Questionnaire, major adverse event rates, and all-cause mortality.OBJECTIVES: The primary objective of this study was to assess the safety and performance of the MitraClip G4 System within a contemporary real-world setting.RESULTS: In EXPAND G4, 1,141 subjects with primary MR and secondary MR were treated from March 2021 to February 2022. Implantation and acute procedural success rates were 98.0% and 96.2%, respectively, with a mean of 1.4 +/- 0.6 clips implanted per subject. MR was significantly reduced at 30 days compared with baseline (98% achieved MR <= 2+, and 91% achieved MR <= 1+; P < 0.0001). Functional capacity and quality of life were substantially improved, with 83% of patients achieving NYHA functional class I or II. Likewise, an 18-point improvement was observed in Kansas City Cardiomyopathy Questionnaire summary scores compared with baseline. The composite major adverse event rate was 2.7%, and the all-cause death rate was 1.3% at 30 days.All authors: Asch FM, Chehab B, De Marco F, Denti P, Mahoney P, Maisano F, Price MJ, Rinaldi M, Rodriguez E, Rogers JH, Rollefson WA, von Bardeleben RS, Williams MRFiscal year: FY2023 Digital Object Identifier:

https://dx.doi.org/10.1016/j.jcin.2023.05.013

Date added to catalog: 2023-07-27

Holdings ( 1 )
Title notes ( 7 )

Holdings
Item type	Current library	Collection	Call number	Status	Date due	Barcode
Journal Article	MedStar Authors Catalog	Article	37380228	Available		37380228

Available online through MWHC library: 2008 - present

BACKGROUND: The fourth-generation MitraClip G4 System builds on the previous NTR/XTR system with additional wider clip sizes (NTW and XTW), an independent grasping feature, and an improved clip deployment sequence.

CONCLUSIONS: This study demonstrates for the first time the effectiveness and safety of MitraClip G4 System at 30 days in a cohort of >1,000 patients with MR in a contemporary, real-world setting. Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.

METHODS: EXPAND G4 is a prospective, multicenter, international, single-arm, postapproval study that enrolled patients with primary (degenerative) mitral regurgitation (MR) and secondary (functional) MR at 60 centers. Follow-up of the full cohort has been conducted through 30 days. Echocardiograms were analyzed by an echocardiography core laboratory. Study outcomes included MR severity, functional capacity measured by NYHA functional class, quality of life measured using the Kansas City Cardiomyopathy Questionnaire, major adverse event rates, and all-cause mortality.

OBJECTIVES: The primary objective of this study was to assess the safety and performance of the MitraClip G4 System within a contemporary real-world setting.

RESULTS: In EXPAND G4, 1,141 subjects with primary MR and secondary MR were treated from March 2021 to February 2022. Implantation and acute procedural success rates were 98.0% and 96.2%, respectively, with a mean of 1.4 +/- 0.6 clips implanted per subject. MR was significantly reduced at 30 days compared with baseline (98% achieved MR <= 2+, and 91% achieved MR <= 1+; P < 0.0001). Functional capacity and quality of life were substantially improved, with 83% of patients achieving NYHA functional class I or II. Likewise, an 18-point improvement was observed in Kansas City Cardiomyopathy Questionnaire summary scores compared with baseline. The composite major adverse event rate was 2.7%, and the all-cause death rate was 1.3% at 30 days.

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