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

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.
Competing Interests: Competing interests: SK is a consultant for and has received honoraria/institutional research support from Abbott, Boston Scientific, WL Gore, Mitralign, Edwards. TF is a consultant for and has received honoraria/institutional research support from Abbott, Boston Scientific, Edwards and WL Gore. AQ has received research grant from Abbott. DSL is a consultant for and has received research grants from Abbott. RWS has received grant support from Abbott Vascular. HCH has received institutional research support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, St Jude Medical, Medtronic, Cardiokinetx, Gore and Mitraspan; is a consultant for Edwards Lifesciences and Siemens; and has equity ownership in Microinterventional Devices. LM’s institution has received research grants from Abbott Vascular, Boston Scientific, Cordis, Medtronic, Eli Lilly, Daiichi Sankyo, Bristol-Myers Squibb and Sanofi-Aventis. All other authors have reported they have no relationships relevant to the contents of this paper to disclose.
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