Incidence and standardised definitions of mitral valve leaflet adverse events after transcatheter mitral valve repair: The EXPAND study

Federico M. Asch, Stephen H. Little, G. Burkhard Mackensen, Paul A. Grayburn, Paul Sorajja, Michael Rinaldi, Francesco Maisano, Saibal Kar

Research output: Contribution to journalArticlepeer-review

Abstract

Background: An independent panel of experts reviewed all investigator-reported cases of mitral valve leaflet adverse events (LAE) after MitraClip NTR/XTR in the EXPAND study. Aims: We aimed to report the findings of the expert panel and standardise definitions for LAE. Methods: Standard definitions for different types of LAE were formulated and events adjudicated after detailed review by the expert panel. Results: Enrolling centres reported LAE in 35 cases, 11 leaflet injuries (9 tears, 2 perforations) 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 (n=7) or at 30 days of follow-up (n=7) and were resolved (≤2+ residual MR) with additional clips in 75% of cases. Conclusions: Mitral valve repair with MitraClip NTR/XTR is safe. The rate of LAE is lower than previously reported using older-generation devices. The proposed definitions and findings will help to differentiate leaflet injury from inadequate leaflet insertion and SLDA and provide guidance for consistent diagnosis of LAE post MitraClip implantation.

Original languageEnglish (US)
Pages (from-to)E932-E941
JournalEuroIntervention
Volume17
Issue number11
DOIs
StatePublished - Dec 2021

Keywords

  • Miscellaneous
  • Mitral regurgitation
  • Mitral valve repair
  • Transoesophageal echocardiogram

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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