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

Hellhammer K, Zeus T, Balzer J, van Hall S, Rammos C, Wagstaff R, Kelm M, Rassaf T - PLoS ONE (2014)

Bottom Line: Ninteen patients were under oral medication or insulin therapy for type II diabetes mellitus.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.MitraClip Registry NCT02033811.

View Article: PubMed Central - PubMed

Affiliation: University Hospital Düsseldorf, Medical Faculty, Dept. of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine, Düsseldorf, Germany.

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.

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Related in: MedlinePlus

CONSORT flow chart.
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pone-0111178-g001: CONSORT flow chart.

Mentions: A total of 58 Patients with symptomatic severe or moderate-to-severe MR evaluated by trans-thoracic and trans-esophageal echocardiography who underwent PMVR with the MitraClip System at the Heart Center Duesseldorf were included in the study (Figure 1). All patients were discussed in the institutional heart team and declined for surgical treatment due to high operative risk. Patients were included into our registry after informed written consent was obtained. The registry is registered at clinical trials (NCT02033811). In a sub-analysis of this registry, patients were grouped according to the presence of type II diabetes mellitus (oral medication or on insulin therapy). The objective of the study was to evaluate the safety and efficacy of the MitraClip procedure in patients with diabetes mellitus with a follow-up after 3 months. Study procedures were in accordance with the Declaration of Helsinki and the institutional Ethics Committee of the Heinrich-Heine University approved the study protocol.


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

Hellhammer K, Zeus T, Balzer J, van Hall S, Rammos C, Wagstaff R, Kelm M, Rassaf T - PLoS ONE (2014)

CONSORT flow chart.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4222883&req=5

pone-0111178-g001: CONSORT flow chart.
Mentions: A total of 58 Patients with symptomatic severe or moderate-to-severe MR evaluated by trans-thoracic and trans-esophageal echocardiography who underwent PMVR with the MitraClip System at the Heart Center Duesseldorf were included in the study (Figure 1). All patients were discussed in the institutional heart team and declined for surgical treatment due to high operative risk. Patients were included into our registry after informed written consent was obtained. The registry is registered at clinical trials (NCT02033811). In a sub-analysis of this registry, patients were grouped according to the presence of type II diabetes mellitus (oral medication or on insulin therapy). The objective of the study was to evaluate the safety and efficacy of the MitraClip procedure in patients with diabetes mellitus with a follow-up after 3 months. Study procedures were in accordance with the Declaration of Helsinki and the institutional Ethics Committee of the Heinrich-Heine University approved the study protocol.

Bottom Line: Ninteen patients were under oral medication or insulin therapy for type II diabetes mellitus.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.MitraClip Registry NCT02033811.

View Article: PubMed Central - PubMed

Affiliation: University Hospital Düsseldorf, Medical Faculty, Dept. of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine, Düsseldorf, Germany.

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.

Show MeSH
Related in: MedlinePlus