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Safety and Efficacy of Percutaneous Mitral Valve Repair Using the MitraClip(®) System in Patients with Diabetes Mellitus

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 s...

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Autores principales: Hellhammer, Katharina, Zeus, Tobias, Balzer, Jan, van Hall, Silke, Rammos, Christos, Wagstaff, Rabea, Kelm, Malte, Rassaf, Tienush
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4222883/
https://www.ncbi.nlm.nih.gov/pubmed/25375257
http://dx.doi.org/10.1371/journal.pone.0111178
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author Hellhammer, Katharina
Zeus, Tobias
Balzer, Jan
van Hall, Silke
Rammos, Christos
Wagstaff, Rabea
Kelm, Malte
Rassaf, Tienush
author_facet Hellhammer, Katharina
Zeus, Tobias
Balzer, Jan
van Hall, Silke
Rammos, Christos
Wagstaff, Rabea
Kelm, Malte
Rassaf, Tienush
author_sort Hellhammer, Katharina
collection PubMed
description 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
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spelling pubmed-42228832014-11-13 Safety and Efficacy of Percutaneous Mitral Valve Repair Using the MitraClip(®) System in Patients with Diabetes Mellitus Hellhammer, Katharina Zeus, Tobias Balzer, Jan van Hall, Silke Rammos, Christos Wagstaff, Rabea Kelm, Malte Rassaf, Tienush PLoS One Research Article 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 Public Library of Science 2014-11-06 /pmc/articles/PMC4222883/ /pubmed/25375257 http://dx.doi.org/10.1371/journal.pone.0111178 Text en © 2014 Hellhammer et al http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.
spellingShingle Research Article
Hellhammer, Katharina
Zeus, Tobias
Balzer, Jan
van Hall, Silke
Rammos, Christos
Wagstaff, Rabea
Kelm, Malte
Rassaf, Tienush
Safety and Efficacy of Percutaneous Mitral Valve Repair Using the MitraClip(®) System in Patients with Diabetes Mellitus
title Safety and Efficacy of Percutaneous Mitral Valve Repair Using the MitraClip(®) System in Patients with Diabetes Mellitus
title_full Safety and Efficacy of Percutaneous Mitral Valve Repair Using the MitraClip(®) System in Patients with Diabetes Mellitus
title_fullStr Safety and Efficacy of Percutaneous Mitral Valve Repair Using the MitraClip(®) System in Patients with Diabetes Mellitus
title_full_unstemmed Safety and Efficacy of Percutaneous Mitral Valve Repair Using the MitraClip(®) System in Patients with Diabetes Mellitus
title_short Safety and Efficacy of Percutaneous Mitral Valve Repair Using the MitraClip(®) System in Patients with Diabetes Mellitus
title_sort safety and efficacy of percutaneous mitral valve repair using the mitraclip(®) system in patients with diabetes mellitus
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4222883/
https://www.ncbi.nlm.nih.gov/pubmed/25375257
http://dx.doi.org/10.1371/journal.pone.0111178
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