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

Autor: D. Scott Lim, John M. Lasala, Ted Feldman, Richard W. Smalling, Howard C Hermann, James B. Hermiller, Saibal Kar, Patrick L. Whitlow, Atif Qasim, Samir R. Kapadia, Donald D. Glower, Mark Reisman, Alfredo Trento, Robert Kipperman, Laura Mauri, Wesley R. Pedersen, Tanvir Bajwa
Rok vydání: 2017
Předmět:
Zdroj: Heart (British Cardiac Society). 105(21)
ISSN: 1468-201X
0194-0120
Popis: ObjectivesThis 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).MethodsPatients 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.ResultsAt 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; pConclusionsThe 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 numberNCT01940120.
Databáze: OpenAIRE