Safety and efficacy of percutaneous mitral valve repair using the MitraClip® system in patients with diabetes mellitus

Katharina Hellhammer, Tobias Zeus, Jan Balzer, Silke van Hall, Christos Rammos, Rabea Wagstaff, Malte Kelm, Tienush Rassaf, Katharina Hellhammer, Tobias Zeus, Jan Balzer, Silke van Hall, Christos Rammos, Rabea Wagstaff, Malte Kelm, Tienush Rassaf

Abstract

Background: Patients with diabetes mellitus show a negative outcome in percutaneous coronary intervention, aortic valve replacement and cardiac surgery. The impact of diabetes on patients undergoing treatment of severe mitral regurgitation (MR) using the MitraClip system is not known. We therefore sought to assess whether percutaneous mitral valve repair with the MitraClip system is safe and effective in patients with diabetes mellitus.

Methods and results: We included 58 patients with severe and moderate-to-severe MR in an open-label observational single-center study. Ninteen patients were under oral medication or insulin therapy for type II diabetes mellitus. MitraClip devices were successfully implanted in all patients with diabetes and in 97.4% (n = 38) of patients without diabetes (p = 0.672). Periprocedural major cardiac adverse and cerebrovascular events (MACCE) occurred in 5.1% (n = 2) of patients without diabetes whereas patients with diabetes did not show any MACCE (p = 0.448). 30-day mortality was 1.7% (n = 1) with no case of death in the diabetes group. Short-term follow up of three months showed a significant improvement of NYHA class and quality of life evaluated by the Minnesota Living with Heart Failure Questionnaire in both groups, with no changes in the 6-minute walk test.

Conclusions: Mitral valve repair with the MitraClip system is safe and effective in patients with type II diabetes mellitus.

Trial registration: MitraClip Registry NCT02033811.

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Figure 1. CONSORT flow chart.
Figure 1. CONSORT flow chart.
Figure 2. Changes in functional parameters after…
Figure 2. Changes in functional parameters after short-term follow up (3 months).
A NYHA class before and 3 months after MitraClip. B 6-MWT before and 3 months after MitraClip. C Results of MLHF Q before and 3 months after MitraClip. NYHA = New York Heart Association; 6-MWT = 6-minute walk test; MLHF Q = Minnesota Living With Heart Failure Questionnaire. ns =  non significant (p≥0.05). *** denotes p<0.0001, ** denotes p<0.001.
Figure 3. Changes in cardiac parameters after…
Figure 3. Changes in cardiac parameters after short-term follow up (3 month) in patients undergoing MitraClip.
A Ejection fraction before and 3 months after MitraClip. B Left ventricular end-diastolic diameter before and 3 months after MitraClip. C Grade of reduction of mitral regurgitation 3 months after MitraClip. EF = ejection fraction; LVEDD = left ventricular end-diastolic diameter. ns =  non significant (p≥0.05).

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