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
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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. / 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.
In: EUR J HEART FAIL, Vol. 20, No. 3, 03.2018, p. 598-608.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - 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
AU - Geis, Nicolas A
AU - Puls, Miriam
AU - Lubos, Edith
AU - Zuern, Christine S
AU - Franke, Jennifer
AU - Schueler, Robert
AU - von Bardeleben, Ralph S
AU - Boekstegers, Peter
AU - Ouarrak, Taoufik
AU - Zahn, Ralf
AU - Ince, Hüseyin
AU - Senges, Jochen
AU - Katus, Hugo A
AU - Bekeredjian, Raffi
N1 - © 2017 The Authors. European Journal of Heart Failure © 2017 European Society of Cardiology.
PY - 2018/3
Y1 - 2018/3
N2 - 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.
AB - 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.
KW - Aged
KW - Aged, 80 and over
KW - Cardiac Catheterization/methods
KW - Echocardiography
KW - Female
KW - Follow-Up Studies
KW - Germany/epidemiology
KW - Heart Failure/complications
KW - Heart Valve Prosthesis Implantation/methods
KW - Hospital Mortality
KW - Humans
KW - Male
KW - Mitral Valve/diagnostic imaging
KW - Mitral Valve Insufficiency/complications
KW - Quality of Life
KW - Registries
KW - Retrospective Studies
KW - Stroke Volume/physiology
KW - Survival Rate/trends
KW - Time Factors
KW - Treatment Outcome
KW - Ventricular Function, Left
U2 - 10.1002/ejhf.910
DO - 10.1002/ejhf.910
M3 - SCORING: Journal article
C2 - 28834079
VL - 20
SP - 598
EP - 608
JO - EUR J HEART FAIL
JF - EUR J HEART FAIL
SN - 1388-9842
IS - 3
ER -
