Gender-related differences in patients undergoing transcatheter mitral valve interventions in clinical practice: 1-year results from the German TRAMI registry

TY - JOUR

T1 - Gender-related differences in patients undergoing transcatheter mitral valve interventions in clinical practice: 1-year results from the German TRAMI registry

AU - Werner, Nicolas

AU - Puls, Miriam

AU - Baldus, Stephan

AU - Lubos, Edith

AU - Bekeredjian, Raffi

AU - Sievert, Horst

AU - Schofer, Joachim

AU - Kuck, Karl-Heinz

AU - Möllmann, Helge

AU - Hehrlein, Christoph

AU - Nickenig, Georg

AU - Boekstegers, Peter

AU - Ouarrak, Taoufik

AU - Senges, Jochen

AU - Zahn, Ralf

AU - German Transcatheter Mitral Valve Intervention (TRAMI) investigators

N1 - © 2019 Wiley Periodicals, Inc.

PY - 2020/3/1

Y1 - 2020/3/1

N2 - OBJECTIVES: Information on gender-related differences in terms of baseline characteristics and clinical outcome of patients undergoing MitraClip® implantation in daily clinical practice have been studied in smaller populations previously. This study sought to additionally evaluate gender-related differences in a larger German real-world patient population.METHODS AND RESULTS: We analyzed data from the prospective and multicenter German TRAMI Registry. Between 08/2010 and 07/2013 327 women and 501 men underwent MitraClip® implantation for significant mitral valve regurgitation. Female patients were significantly older and showed higher rates of frailty compared to men. In contrast, men had significantly higher rates of comorbidities compared to women. The majority of patients underwent MitraClip® implantation for secondary mitral regurgitation, with no significant gender-related differences. MitraClip® treatment was equally effective in terms of procedural results and residual mitral regurgitation in women and men and complication rates were low. However, in this real-world analysis severe bleeding complications were significantly higher in women (p = .02) and re-intervention rates were significantly higher in men after MitraClip® treatment (p = .02). Women showed less improvement in functional NYHA class after MitraClip® treatment compared to men at 1-year follow-up (FU; p < .001). No significant differences between female and male patients were found in 1-year mortality and in re-hospitalization rates.CONCLUSION: In this analysis from a large prospective, multicenter real-world registry MitraClip® implantation is safe and effective for treatment of significant mitral regurgitation with equal postprocedural results and mortality rates during 1-year follow-up. Men and women showed a persisting and significant clinical benefit at 1-year FU after treatment. Complication and re-intervention rates were low. Additional studies are needed to further evaluate our findings on increased bleeding complications and decreased functional improvement in women at 1-year follow-up after MitraClip® therapy.

AB - OBJECTIVES: Information on gender-related differences in terms of baseline characteristics and clinical outcome of patients undergoing MitraClip® implantation in daily clinical practice have been studied in smaller populations previously. This study sought to additionally evaluate gender-related differences in a larger German real-world patient population.METHODS AND RESULTS: We analyzed data from the prospective and multicenter German TRAMI Registry. Between 08/2010 and 07/2013 327 women and 501 men underwent MitraClip® implantation for significant mitral valve regurgitation. Female patients were significantly older and showed higher rates of frailty compared to men. In contrast, men had significantly higher rates of comorbidities compared to women. The majority of patients underwent MitraClip® implantation for secondary mitral regurgitation, with no significant gender-related differences. MitraClip® treatment was equally effective in terms of procedural results and residual mitral regurgitation in women and men and complication rates were low. However, in this real-world analysis severe bleeding complications were significantly higher in women (p = .02) and re-intervention rates were significantly higher in men after MitraClip® treatment (p = .02). Women showed less improvement in functional NYHA class after MitraClip® treatment compared to men at 1-year follow-up (FU; p < .001). No significant differences between female and male patients were found in 1-year mortality and in re-hospitalization rates.CONCLUSION: In this analysis from a large prospective, multicenter real-world registry MitraClip® implantation is safe and effective for treatment of significant mitral regurgitation with equal postprocedural results and mortality rates during 1-year follow-up. Men and women showed a persisting and significant clinical benefit at 1-year FU after treatment. Complication and re-intervention rates were low. Additional studies are needed to further evaluate our findings on increased bleeding complications and decreased functional improvement in women at 1-year follow-up after MitraClip® therapy.

KW - Aged

KW - Aged, 80 and over

KW - Cardiac Catheterization/adverse effects

KW - Female

KW - Germany

KW - Health Status Disparities

KW - Healthcare Disparities/trends

KW - Heart Valve Prosthesis/trends

KW - Heart Valve Prosthesis Implantation/adverse effects

KW - Humans

KW - Male

KW - Mitral Valve/diagnostic imaging

KW - Mitral Valve Insufficiency/diagnostic imaging

KW - Mitral Valve Prolapse/diagnostic imaging

KW - Postoperative Complications/mortality

KW - Prospective Studies

KW - Registries

KW - Risk Assessment

KW - Risk Factors

KW - Sex Factors

KW - Time Factors

KW - Treatment Outcome

U2 - 10.1002/ccd.28372

DO - 10.1002/ccd.28372

M3 - SCORING: Journal article

C2 - 31233278

VL - 95

SP - 819

EP - 829

JO - CATHETER CARDIO INTE

JF - CATHETER CARDIO INTE

SN - 1522-1946

IS - 4

ER -