Nicolas Werner1, Miriam Puls2, Stephan Baldus3, Edith Lubos4, Raffi Bekeredjian5, Horst Sievert6, Joachim Schofer7, Karl-Heinz Kuck8, Helge Möllmann9, Christoph Hehrlein10, Georg Nickenig11, Peter Boekstegers12, Taoufik Ouarrak13, Jochen Senges13, Ralf Zahn1. 1. Medizinische Klinik B, Klinikum Ludwigshafen, Ludwigshafen, Germany. 2. Herzzentrum Göttingen, Universistätsmedizin Göttingen, Göttingen, Germany. 3. Herzzentrum, Universitätsklinikum Köln, Köln, Germany. 4. Universitäres Herzzentrum Eppendorf, Hamburg, Germany. 5. Innere Medizin III, Universitätsklinikum Heidelberg, Heidelberg, Germany. 6. CardioVascular Center Frankfurt CVC, Frankfurt, Germany and Anglia Ruskin University, Chelmsford, UK. 7. Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH, Hamburg, Germany. 8. Kardiologie, Asklepios Klinik St. Georg, Hamburg, Germany. 9. Klinik für Innere Medizin I, St.-Johannes-Hospital Dortmund, Dortmund, Germany. 10. Klinik für Kardiologie und Angiologie, Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH, Freiburg, Germany. 11. Medizinische Klinik II, Universitätsklinikum Bonn, Bonn, Germany. 12. Klinik für Kardiologie und Angiologie, Helios Klinikum Siegburg, Siegburg, Germany. 13. Institut für Herzinfarktforschung, Ludwigshafen, Germany.
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.
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.
Authors: Jacqueline T DesJardin; Joanna Chikwe; Rebecca T Hahn; Judy W Hung; Francesca N Delling Journal: Circ Res Date: 2022-02-17 Impact factor: 17.367
Authors: Michael G Paulus; Christine Meindl; Lukas Böhm; Magdalena Holzapfel; Michael Hamerle; Christian Schach; Lars S Maier; Kurt Debl; Bernhard Unsöld; Christoph Birner Journal: PLoS One Date: 2020-05-28 Impact factor: 3.240