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

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

doi:10.1371/journal.pone.0111178

Katharina Hellhammer, Silke van Hall + Show 7 more

Open Access

https://doi.org/10.1371/journal.pone.0111178

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Abstract

BackgroundPatients 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 ResultsWe 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.ConclusionsMitral valve repair with the MitraClip system is safe and effective in patients with type II diabetes mellitus.Trial RegistrationMitraClip Registry NCT02033811

Highlights

Mitral valve regurgitation (MR) is the second common valvular heart disease and severely affects morbidity and mortality [1,2,3,4,5]
Many of the high-risk patients present with diabetes mellitus, which is known to worsen outcome in patients referred to percutaneous coronary intervention (PCI) [8,9,10,11,12], cardiac surgery [13,14,15] or transcatheter aortic valve replacement (TAVI) [16,17]
We sought to assess whether percutaneous mitral valve repair with the MitraClip system is safe and effective in patients with diabetes mellitus

Summary

Introduction

Mitral valve regurgitation (MR) is the second common valvular heart disease and severely affects morbidity and mortality [1,2,3,4,5]. Percutaneous mitral valve repair (PMVR) with the MitraClip system, has emerged to an effective therapeutic alternative for patients who can not undergo surgery due to high surgical risk [7]. Many of the high-risk patients present with diabetes mellitus, which is known to worsen outcome in patients referred to percutaneous coronary intervention (PCI) [8,9,10,11,12], cardiac surgery [13,14,15] or transcatheter aortic valve replacement (TAVI) [16,17]. 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 sought to assess whether percutaneous mitral valve repair with the MitraClip system is safe and effective in patients with diabetes mellitus

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Conclusion