Five-year outcomes of transcatheter reduction of significant mitral regurgitation in high-surgical-risk patients

Saibal Kar, Ted Feldman, Atif Qasim, Alfredo Trento, Samir Kapadia, Wesley Pedersen, D. Scott Lim, Robert Kipperman, Richard W. Smalling, Tanvir Bajwa, Howard C. Hermann, James B. Hermiller, John M. Lasala, Mark Reisman, Donald Glower, Laura Mauri, Patrick Whitlow

Research output: Contribution to journalArticlepeer-review

45 Scopus citations

Abstract

Objectives This study evaluates the 5-year clinical outcomes of transcatheter mitral valve (MV) repair with the MitraClip device in patients at high risk for MV surgery treated in the Endovascular Valve Edge-to-Edge Repair (EVEREST) II High Risk Study (HRS). Methods Patients with mitral regurgitation (MR) 3+ or 4+ and predicted surgical mortality risk ≥12% or surgeon assessment based on prespecified high-risk factors were enrolled. Patients prospectively consented to 5 years of follow-up. Results At 5 years, clinical follow-up was achieved in 90% of 78 enrolled patients. The rate of postprocedural adverse events declined from 30 days to 1 year follow-up and was stable thereafter through 5 years. Two patients (2.6%) developed mitral stenosis (MS). Two patients underwent MV surgery, including one due to MS. A total of 42 deaths were reported through 5 years. Effectiveness measures at 5 years showed reductions in MR severity to ≤2+ in 75% of patients (p=0.0107), left ventricular (LV) end-diastolic volume (-38.2 mL; 95% CI-55.0 to-21.4; p<0.0001) and LV end-systolic volume (-14.6 mL; 95% CI-27.7 to-1.5; p=0.0303) compared with baseline. The New York Heart Association (NYHA) functional class improved from baseline to 5 years (p<0.005), and septal-lateral annular dimensions remained stable with no indication of mitral annular dilation through 5 years. Conclusions The EVEREST II HRS demonstrated long-term safety and efficacy of MitraClip in high-surgical-risk patients through 5 years. The observed mortality was most likely a consequence of the advanced age and comorbidity profile of the enrolled patients, while improvements in NYHA class in surviving patients were durable through long-term follow-up. Trial registration number NCT01940120.

Original languageEnglish
Pages (from-to)1622-1628
Number of pages7
JournalHeart
Volume105
Issue number21
DOIs
StatePublished - Nov 1 2019

Keywords

  • mitral regurgitation
  • transcatheter valve interventions

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