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.
- transcatheter valve interventions
- mitral regurgitation
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Contributors All authors had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Design and conduct of the studies: Abbott Vascular. Collection, management, analysis and clinical events adjudication: The Harvard Clinical Research Institute. Interpretation of data: SKar, TF, AQ, AT, SKapadia, WP, DSL, RK, RWS, TB, HCH, JBH, JML, MR, DG, LM and PW. Preparation, review or approval of the manuscript: SKar, TF, AQ, AT, SKapadia, WP, DSL, RK, RWS, TB, HCH, JBH, JML, MR, DG and LM.
Funding The EVEREST II High Risk Study was funded by Abbott Vascular.
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.
Ethics approval The EVEREST II High Risk Study was reviewed and approved by the Institutional Review Board at each participating site.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The EVEREST II High Risk Study 5-year data have been posted on www.clinicaltrials.gov (Trial registration number NCT01940120).
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