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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

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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pone-0111178-g003: 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).

Mentions: At the time of follow up, significant improvement of NYHA class was seen in both groups from 3.1±0.6 to 2.2±0.5 (p<0.0001) in patients without diabetes and 3.2±0.6 to 2.2±0.5 (p<0.0001) in patients with diabetes. Quality of life measured by the MLHF Questionnaire was improved with a score reduction from 43±15 to 36±14 (p<0.0001) in non-diabetic patients and 45±12 to 36±11 (p<0.001) in patients with diabetes (Figure 2). 6-MWT (296±121.6 m to 300±130.8 m; p = 0.743), left ventricular ejection fraction (45±16% to 44±13%; p = 0.660), and left ventricular end-diastolic diameter (59±11 mm to 60±12 mm; p = 0.163) did not change in patients without diabetes. In patients with diabetes 6-MWT (275±90 m to 308±11 m; p = 0.057), ejection fraction (37±13% to 35±13%; p = 0.455) and left ventricular end-diastolic diameter (61±14 mm to 63±11 mm; p = 0.243) were also unaffected. MR reduction ≥1 grade was observed in 65.8% (n = 25) of patients without diabetes and in all patients with diabetes (Figure 3).


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)

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).
© Copyright Policy
Related In: Results  -  Collection

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

pone-0111178-g003: 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).
Mentions: At the time of follow up, significant improvement of NYHA class was seen in both groups from 3.1±0.6 to 2.2±0.5 (p<0.0001) in patients without diabetes and 3.2±0.6 to 2.2±0.5 (p<0.0001) in patients with diabetes. Quality of life measured by the MLHF Questionnaire was improved with a score reduction from 43±15 to 36±14 (p<0.0001) in non-diabetic patients and 45±12 to 36±11 (p<0.001) in patients with diabetes (Figure 2). 6-MWT (296±121.6 m to 300±130.8 m; p = 0.743), left ventricular ejection fraction (45±16% to 44±13%; p = 0.660), and left ventricular end-diastolic diameter (59±11 mm to 60±12 mm; p = 0.163) did not change in patients without diabetes. In patients with diabetes 6-MWT (275±90 m to 308±11 m; p = 0.057), ejection fraction (37±13% to 35±13%; p = 0.455) and left ventricular end-diastolic diameter (61±14 mm to 63±11 mm; p = 0.243) were also unaffected. MR reduction ≥1 grade was observed in 65.8% (n = 25) of patients without diabetes and in all patients with diabetes (Figure 3).

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