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

PLoS One. 2014 Nov 6;9(11):e111178. doi: 10.1371/journal.pone.0111178. eCollection 2014.

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.

Publication types

  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Cardiac Surgical Procedures / adverse effects*
  • Diabetes Mellitus, Type 2 / complications*
  • Diabetes Mellitus, Type 2 / drug therapy
  • Female
  • Humans
  • Hypoglycemic Agents / therapeutic use
  • Male
  • Middle Aged
  • Mitral Valve / surgery*
  • Mitral Valve Insufficiency / complications
  • Mitral Valve Insufficiency / surgery*
  • Postoperative Complications / etiology*
  • Treatment Outcome

Substances

  • Hypoglycemic Agents

Associated data

  • ClinicalTrials.gov/NCT02033811

Grants and funding

TR is a Heisenbergprofessor funded by the German Research Foundation (DFG RA969/7-2). This study was supported in part with a restricted grant from the federal state government of North Rhine-Westphalia and the European Union (EFRE-Program "Med in.NRW", support code 005-GW01-235A). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.