Incidence and Standardized Definitions of Mitral Valve Leaflet Adverse Events After Transcatheter Mitral Valve Repair: the EXPAND Study.

MedStar author(s):
Citation: Eurointervention. 2021 May 25PMID: 34031024Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: IN PROCESS -- NOT YET INDEXEDYear: 2021ISSN:
  • 1774-024X
Name of journal: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of CardiologyAbstract: AIMS: We aimed to report the findings of the expert panel and standardize definitions for LAE.BACKGROUND: An independent panel of experts reviewed all investigator-reported cases of mitral valve leaflet adverse events (LAE) after MitraClipTM NTR/XTR in the EXPAND Study.CONCLUSIONS: Mitral valve repair with MitraClipTM NTR/XTR is safe. The rate of LAE is lower than previously reported using older generation devices. The proposed definitions and findings will help differentiate leaflet injury from inadequate leaflet insertion and SLDA, and provide guidance to consistently diagnose LAE post MitraClipTM.METHODS: Standard definitions for different types of LAE were formulated and events adjudicated after detailed review by the expert panel.RESULTS: Enrolling centers reported LAE in 35 cases, 11 leaflet injuries (9 tear, 2 perforation) and 24 single leaflet device attachment (SLDA). The panel confirmed LAE in 20 cases (2.0% incidence), 18 patients had SLDA and 4 had leaflet injury (2 cases had both SLDA and injury). Leaflet injury occurred during device implant and resulted in surgical valve replacement or death. SLDA-alone events were identified during implant (n=2), pre-discharge (7) or at 30 days of follow-up (7) and were resolved ( 2+ residual MR) with additional clips in 75% of cases.All authors: Asch FM, Grayburn PA, Kar S, Little SH, Mackensen GB, Maisano F, Rinaldi MJ, Sorajja PFiscal year: FY2021Digital Object Identifier: Date added to catalog: 2021-06-28
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Journal Article MedStar Authors Catalog Article 34031024 Available 34031024

AIMS: We aimed to report the findings of the expert panel and standardize definitions for LAE.

BACKGROUND: An independent panel of experts reviewed all investigator-reported cases of mitral valve leaflet adverse events (LAE) after MitraClipTM NTR/XTR in the EXPAND Study.

CONCLUSIONS: Mitral valve repair with MitraClipTM NTR/XTR is safe. The rate of LAE is lower than previously reported using older generation devices. The proposed definitions and findings will help differentiate leaflet injury from inadequate leaflet insertion and SLDA, and provide guidance to consistently diagnose LAE post MitraClipTM.

METHODS: Standard definitions for different types of LAE were formulated and events adjudicated after detailed review by the expert panel.

RESULTS: Enrolling centers reported LAE in 35 cases, 11 leaflet injuries (9 tear, 2 perforation) and 24 single leaflet device attachment (SLDA). The panel confirmed LAE in 20 cases (2.0% incidence), 18 patients had SLDA and 4 had leaflet injury (2 cases had both SLDA and injury). Leaflet injury occurred during device implant and resulted in surgical valve replacement or death. SLDA-alone events were identified during implant (n=2), pre-discharge (7) or at 30 days of follow-up (7) and were resolved ( 2+ residual MR) with additional clips in 75% of cases.

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