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022 _a1774-024X
024 _a10.4244/EIJ-D-21-00012 [doi]
024 _aEIJ-D-21-00012 [pii]
040 _aOvid MEDLINE(R)
099 _a34031024
245 _aIncidence and Standardized Definitions of Mitral Valve Leaflet Adverse Events After Transcatheter Mitral Valve Repair: the EXPAND Study.
251 _aEurointervention. 2021 May 25
252 _aEuroIntervention. 2021 May 25
253 _aEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
260 _c2021
260 _fFY2021
260 _p2021 May 25
265 _saheadofprint
266 _d2021-06-28
520 _aAIMS: We aimed to report the findings of the expert panel and standardize definitions for LAE.
520 _aBACKGROUND: 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.
520 _aCONCLUSIONS: 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.
520 _aMETHODS: Standard definitions for different types of LAE were formulated and events adjudicated after detailed review by the expert panel.
520 _aRESULTS: 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.
546 _aEnglish
650 _aIN PROCESS -- NOT YET INDEXED
651 _aMedStar Heart & Vascular Institute
657 _aJournal Article
700 _aAsch, Federico M
790 _aAsch FM, Grayburn PA, Kar S, Little SH, Mackensen GB, Maisano F, Rinaldi MJ, Sorajja P
856 _uhttps://dx.doi.org/10.4244/EIJ-D-21-00012
_zhttps://dx.doi.org/10.4244/EIJ-D-21-00012
942 _cART
_dArticle
999 _c6431
_d6431