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

Abstract

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.

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  • Authors+Show Affiliations

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    Medizinische Klinik B, Klinikum Ludwigshafen, Ludwigshafen, Germany.

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    Herzzentrum Göttingen, Universistätsmedizin Göttingen, Göttingen, Germany.

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    Herzzentrum, Universitätsklinikum Köln, Köln, Germany.

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    Universitäres Herzzentrum Eppendorf, Hamburg, Germany.

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    Innere Medizin III, Universitätsklinikum Heidelberg, Heidelberg, Germany.

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    CardioVascular Center Frankfurt CVC, Frankfurt, Germany and Anglia Ruskin University, Chelmsford, UK.

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    Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH, Hamburg, Germany.

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    Kardiologie, Asklepios Klinik St. Georg, Hamburg, Germany.

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    Klinik für Innere Medizin I, St.-Johannes-Hospital Dortmund, Dortmund, Germany.

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    Klinik für Kardiologie und Angiologie, Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH, Freiburg, Germany.

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    Medizinische Klinik II, Universitätsklinikum Bonn, Bonn, Germany.

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    Klinik für Kardiologie und Angiologie, Helios Klinikum Siegburg, Siegburg, Germany.

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    Institut für Herzinfarktforschung, Ludwigshafen, Germany.

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    Institut für Herzinfarktforschung, Ludwigshafen, Germany.

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    Medizinische Klinik B, Klinikum Ludwigshafen, Ludwigshafen, Germany.

    Source

    Pub Type(s)

    Journal Article

    Language

    eng

    PubMed ID

    31233278

    Citation

    Werner, Nicolas, et al. "Gender-related Differences in Patients Undergoing Transcatheter Mitral Valve Interventions in Clinical Practice: 1-year Results From the German TRAMI Registry." Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions, 2019.
    Werner N, Puls M, Baldus S, et al. Gender-related differences in patients undergoing transcatheter mitral valve interventions in clinical practice: 1-year results from the German TRAMI registry. Catheter Cardiovasc Interv. 2019.
    Werner, N., Puls, M., Baldus, S., Lubos, E., Bekeredjian, R., Sievert, H., ... Zahn, R. (2019). Gender-related differences in patients undergoing transcatheter mitral valve interventions in clinical practice: 1-year results from the German TRAMI registry. Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions, doi:10.1002/ccd.28372.
    Werner N, et al. Gender-related Differences in Patients Undergoing Transcatheter Mitral Valve Interventions in Clinical Practice: 1-year Results From the German TRAMI Registry. Catheter Cardiovasc Interv. 2019 Jun 24; PubMed PMID: 31233278.
    * Article titles in AMA citation format should be in sentence-case
    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 - ,, Y1 - 2019/06/24/ PY - 2018/03/11/received PY - 2019/05/04/revised PY - 2019/06/11/accepted PY - 2019/6/25/entrez KW - heart failure (HF) KW - mitral valve disease (MVD) KW - mitral valve disease percutaneous intervention (MVPI) JF - Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions JO - Catheter Cardiovasc Interv 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. SN - 1522-726X UR - https://www.unboundmedicine.com/medline/citation/31233278/Gender-related_differences_in_patients_undergoing_transcatheter_mitral_valve_interventions_in_clinical_practice:_1-year_results_from_the_German_TRAMI_registry L2 - https://doi.org/10.1002/ccd.28372 DB - PRIME DP - Unbound Medicine ER -