Premium
Safety and efficacy of MitraClip ™ therapy in patients with severely impaired left ventricular ejection fraction: results from the German transcatheter mitral valve interventions ( TRAMI ) registry
Author(s) -
Geis Nicolas A.,
Puls Miriam,
Lubos Edith,
Zuern Christine S.,
Franke Jennifer,
Schueler Robert,
von Bardeleben Ralph S.,
Boekstegers Peter,
Ouarrak Taoufik,
Zahn Ralf,
Ince Hüseyin,
Senges Jochen,
Katus Hugo A.,
Bekeredjian Raffi
Publication year - 2018
Publication title -
european journal of heart failure
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.149
H-Index - 133
eISSN - 1879-0844
pISSN - 1388-9842
DOI - 10.1002/ejhf.910
Subject(s) - mitraclip , medicine , ejection fraction , cardiology , heart failure , hazard ratio , mitral regurgitation , mitral valve repair , mitral valve , adverse effect , cardiac function curve , confidence interval
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.