Nicolas A Geis1, Miriam Puls2, Edith Lubos3, Christine S Zuern4, Jennifer Franke5, Robert Schueler6, Ralph S von Bardeleben7, Peter Boekstegers8, Taoufik Ouarrak9, Ralf Zahn10, Hüseyin Ince11, Jochen Senges9, Hugo A Katus1, Raffi Bekeredjian1. 1. Department of Internal Medicine III, University of Heidelberg, Heidelberg, Germany. 2. Department of Cardiology and Pneumology, University of Göttingen, Göttingen, Germany. 3. Heart Centre Eppendorf, University of Hamburg, Hamburg, Germany. 4. Clinic of Cardiology and Cardiovascular Medicine, University of Tübingen, Tübingen, Germany. 5. Cardiovascular Centre St. Katharinen Frankfurt, Frankfurt, Germany. 6. Heart Centre, University of Bonn, Bonn, Germany. 7. Medical Clinic II, University of Mainz, Mainz, Germany. 8. Helios Heart Centre, Siegburg, Germany. 9. Stiftung Institut für Herzinfarktforschung, Ludwigshafen, Germany. 10. Heart Centre Ludwigshafen, Ludwigshafen am Rhein, Germany. 11. Department of Cardiology, Vivantes Klinikum im Friedrichshain and Vivantes Klinikum Am Urban, Berlin, Germany, and Rostock University Medical Centre, Rostock, Germany.
Abstract
AIMS: The aim of the present study was to assess the safety and efficacy of percutaneous mitral valve repair using the MitraClip™ device in patients with severely reduced systolic left ventricular (LV) function. METHODS AND RESULTS: Among 777 MitraClip™ implantations included in the German mitral valve registry, we identified 256 patients suffering from severely reduced LV function [ejection fraction (EF) <30%] in whom successful percutaneous mitral valve repair was performed. Procedural safety, efficacy, and 1-year outcome was compared with 241 patients with preserved LV function (EF >50%) and 280 patients presenting with an EF 30-50% prior to MitraClip™ therapy. High procedural success rates, low periprocedural complication rates, and low residual mitral regurgitation grades at discharge were achieved throughout all groups. In-hospital mortality was low and comparable in all groups. After 1 year, mortality rates were 24.2% (EF <30%), 17.3% (EF 30-50%), and 18.9% (EF >50%). Major adverse cardiac or cardiovascular event rates were 29.7% (EF <30%), 24.4% (EF 30-50%), and 23.5% (EF >50%). Procedural failure was the main predictor for mortality in EF <30% patients (hazard ratio 10.38; 95% CI 3.71-29.02). Improved clinical symptoms were observed in the majority of patients in all groups. Thus, 69.5% of EF <30% patients improved by one or more New York Heart Association functional class. Compared with patients with preserved LV function, this is a significantly larger proportion (EF >50%: 56.8%; P < 0.05). Moreover, quality of life, being very poor at baseline, improved distinctively in severe heart failure patients. CONCLUSION: In patients with severely reduced systolic LV function undergoing MitraClip™ therapy, procedural safety, efficacy, and clinical improvement after 1 year are comparable to patients with preserved LV function.
AIMS: The aim of the present study was to assess the safety and efficacy of percutaneous mitral valve repair using the MitraClip™ device in patients with severely reduced systolic left ventricular (LV) function. METHODS AND RESULTS: Among 777 MitraClip™ implantations included in the German mitral valve registry, we identified 256 patients suffering from severely reduced LV function [ejection fraction (EF) <30%] in whom successful percutaneous mitral valve repair was performed. Procedural safety, efficacy, and 1-year outcome was compared with 241 patients with preserved LV function (EF >50%) and 280 patients presenting with an EF 30-50% prior to MitraClip™ therapy. High procedural success rates, low periprocedural complication rates, and low residual mitral regurgitation grades at discharge were achieved throughout all groups. In-hospital mortality was low and comparable in all groups. After 1 year, mortality rates were 24.2% (EF <30%), 17.3% (EF 30-50%), and 18.9% (EF >50%). Major adverse cardiac or cardiovascular event rates were 29.7% (EF <30%), 24.4% (EF 30-50%), and 23.5% (EF >50%). Procedural failure was the main predictor for mortality in EF <30% patients (hazard ratio 10.38; 95% CI 3.71-29.02). Improved clinical symptoms were observed in the majority of patients in all groups. Thus, 69.5% of EF <30% patients improved by one or more New York Heart Association functional class. Compared with patients with preserved LV function, this is a significantly larger proportion (EF >50%: 56.8%; P < 0.05). Moreover, quality of life, being very poor at baseline, improved distinctively in severe heart failurepatients. CONCLUSION: In patients with severely reduced systolic LV function undergoing MitraClip™ therapy, procedural safety, efficacy, and clinical improvement after 1 year are comparable to patients with preserved LV function.
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