1-Year Outcomes With Fourth-Generation Mitral Valve Transcatheter Edge-to-Edge Repair From the EXPAND G4 Study.

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Citation: Jacc: Cardiovascular Interventions. 16(21):2600-2610, 2023 Nov 13.PMID: 37877913Institution: MedStar Health Research InstituteForm of publication: Journal ArticleMedline article type(s): Journal Article | Multicenter StudySubject headings: *Cardiomyopathies | *Heart Failure | *Heart Valve Prosthesis Implantation | *Mitral Valve Insufficiency | Humans | Mitral Valve Insufficiency/dg [Diagnostic Imaging] | Mitral Valve Insufficiency/su [Surgery] | Mitral Valve/dg [Diagnostic Imaging] | Mitral Valve/su [Surgery] | Prospective Studies | Quality of Life | Treatment OutcomeYear: 2023ISSN:
  • 1936-8798
Name of journal: JACC. Cardiovascular interventionsAbstract: BACKGROUND: The fourth-generation mitral transcatheter edge-to-edge repair (M-TEER) device introduced an improved clip deployment sequence, independent leaflet grasping, and 2 wider clip sizes to tailor the treatment of patients with mitral regurgitation (MR) for a broad range of anatomies. The 30-day safety and effectiveness of the fourth-generation M-TEER device were previously demonstrated.CONCLUSIONS: M-TEER with the fourth-generation M-TEER device was safe and effective at 1 year, with durable reductions in MR severity to <=1+ in more than 90% of patients and concomitant improvements in functional status and quality of life. Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.METHODS: EXPAND G4 is an ongoing prospective, multicenter, international, single-arm study that enrolled subjects with primary and secondary MR. One-year outcomes included MR severity (echocardiographic core laboratory assessed), heart failure hospitalization, all-cause mortality, functional capacity (NYHA functional class), and quality of life (Kansas City Cardiomyopathy Questionnaire).OBJECTIVES: The aim of this study was to evaluate 1-year outcomes in a contemporary, real-world cohort of subjects treated with the MitraClip G4 system.RESULTS: A total of 1,164 subjects underwent M-TEER from 2020 to 2022. At 1 year, there was a durable reduction in MR to mild or less in 92.6% and to none or trace in 44.2% (P < 0.0001 vs baseline). Few subjects had major adverse events through 1 year (<2% for myocardial infarction, surgical reintervention, or single-leaflet device attachment). The 1-year Kaplan-Meier estimates for all-cause mortality and heart failure hospitalization were 12.3% and 16.9%. Significant improvements in functional capacity (NYHA functional class I or II in 82%; P < 0.0001 vs baseline) and quality of life (18.5-point Kansas City Cardiomyopathy Questionnaire overall summary score improvement; P < 0.0001) were observed.All authors: von Bardeleben RS, Mahoney P, Morse MA, Price MJ, Denti P, Maisano F, Rogers JH, Rinaldi M, De Marco F, Rollefson W, Chehab B, Williams M, Leurent G, Asch FM, Rodriguez EFiscal year: FY2024Digital Object Identifier: Date added to catalog: 2024-01-16
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Journal Article MedStar Authors Catalog Article 37877913 Available 37877913

BACKGROUND: The fourth-generation mitral transcatheter edge-to-edge repair (M-TEER) device introduced an improved clip deployment sequence, independent leaflet grasping, and 2 wider clip sizes to tailor the treatment of patients with mitral regurgitation (MR) for a broad range of anatomies. The 30-day safety and effectiveness of the fourth-generation M-TEER device were previously demonstrated.

CONCLUSIONS: M-TEER with the fourth-generation M-TEER device was safe and effective at 1 year, with durable reductions in MR severity to <=1+ in more than 90% of patients and concomitant improvements in functional status and quality of life. Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.

METHODS: EXPAND G4 is an ongoing prospective, multicenter, international, single-arm study that enrolled subjects with primary and secondary MR. One-year outcomes included MR severity (echocardiographic core laboratory assessed), heart failure hospitalization, all-cause mortality, functional capacity (NYHA functional class), and quality of life (Kansas City Cardiomyopathy Questionnaire).

OBJECTIVES: The aim of this study was to evaluate 1-year outcomes in a contemporary, real-world cohort of subjects treated with the MitraClip G4 system.

RESULTS: A total of 1,164 subjects underwent M-TEER from 2020 to 2022. At 1 year, there was a durable reduction in MR to mild or less in 92.6% and to none or trace in 44.2% (P < 0.0001 vs baseline). Few subjects had major adverse events through 1 year (<2% for myocardial infarction, surgical reintervention, or single-leaflet device attachment). The 1-year Kaplan-Meier estimates for all-cause mortality and heart failure hospitalization were 12.3% and 16.9%. Significant improvements in functional capacity (NYHA functional class I or II in 82%; P < 0.0001 vs baseline) and quality of life (18.5-point Kansas City Cardiomyopathy Questionnaire overall summary score improvement; P < 0.0001) were observed.

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