TY - JOUR T1 - Five-year outcomes of transcatheter reduction of significant mitral regurgitation in high-surgical-risk patients JF - Heart JO - Heart SP - 1622 LP - 1628 DO - 10.1136/heartjnl-2017-312605 VL - 105 IS - 21 AU - Saibal Kar AU - Ted Feldman AU - Atif Qasim AU - Alfredo Trento AU - Samir Kapadia AU - Wesley Pedersen AU - D Scott Lim AU - Robert Kipperman AU - Richard W Smalling AU - Tanvir Bajwa AU - Howard C Hermann AU - James B Hermiller AU - John M Lasala AU - Mark Reisman AU - Donald Glower AU - Laura Mauri AU - Patrick Whitlow A2 - , Y1 - 2019/11/01 UR - http://heart.bmj.com/content/105/21/1622.abstract N2 - 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. ER -