Jürgen Kuschyk1, Herbert Nägele2, Karl Heinz-Kuck3, Christian Butter4, Thomas Lawo5, Dietmar Wietholt6, Susanne Roeger1, David Gutterman7, Daniel Burkhoff8, Benny Rousso9, Martin Borggrefe1. 1. University Medical Centre, I. Medical Department, Mannheim, Germany. 2. Hospital Reinbek St. Adolf-Stift, Reinbek, Germany. 3. Asklepios Medical Center St. Georg, Hamburg, Germany. 4. Heart Center Brandenburg, Bernau, Germany. 5. University Hospital Bergmannsheil, Bochum, Germany. 6. Asklepios Klinik Wandsbek, Hamburg, Germany. 7. Medical College of Wisconsin, Milwaukee, WI, USA. Electronic address: dgutt@mcw.edu. 8. Columbia University, Cardiology, New York, USA. 9. Impulse Dynamics, Hod Hasharon, Israel.
Abstract
BACKGROUND: A significant proportion of patients receiving CRT are non-responders. We evaluated the efficacy of Cardiac Contractility Modulation in subjects with reduced LVEF who, despite cardiac resynchronization therapy (CRT), continued to experience clinically significant symptoms. METHODS: This was a multi-center, open label, treatment-only, feasibility study of 17 CRT non-responders who received CCM therapy. Changes in NYHA class, ejection fraction (EF), Minnesota Living with Heart Failure Questionnaire (MLWHFQ) score, and exercise tolerance (6 minute walk test; 6MWT and peak VO2) were analyzed over 6 months. Mortality and hospitalization rates were determined. RESULTS: Patients (82% male) were 69.4 ± 9.6 years of age with baseline EF = 22.8 ± 6.5%. Among primary endpoints, peak VO2 increased 1.1 ± 1.6 ml/kg/min (p = 0.03) and MLWHFQ improved (-16 ± 16 points; p < 0.01). Mean NYHA class improved (-0.33 ± 0.49; p = 0.02), 6MWT increased (52 ± 60 m; p < 0.01), while EF trended up (2.9 ± 5.8%; p = 0.08) at 6 months. During the 6-month follow-up period, there were 18 hospitalizations in 9 subjects and 2 patients died. CONCLUSIONS: Patients with heart failure and reduced ejection fraction who remain moderately to severely symptomatic despite use of CRT, may benefit from CCM therapy with improvement in quality of life and exercise tolerance. A larger prospective study in this population is warranted.
BACKGROUND: A significant proportion of patients receiving CRT are non-responders. We evaluated the efficacy of Cardiac Contractility Modulation in subjects with reduced LVEF who, despite cardiac resynchronization therapy (CRT), continued to experience clinically significant symptoms. METHODS: This was a multi-center, open label, treatment-only, feasibility study of 17 CRT non-responders who received CCM therapy. Changes in NYHA class, ejection fraction (EF), Minnesota Living with Heart Failure Questionnaire (MLWHFQ) score, and exercise tolerance (6 minute walk test; 6MWT and peak VO2) were analyzed over 6 months. Mortality and hospitalization rates were determined. RESULTS:Patients (82% male) were 69.4 ± 9.6 years of age with baseline EF = 22.8 ± 6.5%. Among primary endpoints, peak VO2 increased 1.1 ± 1.6 ml/kg/min (p = 0.03) and MLWHFQ improved (-16 ± 16 points; p < 0.01). Mean NYHA class improved (-0.33 ± 0.49; p = 0.02), 6MWT increased (52 ± 60 m; p < 0.01), while EF trended up (2.9 ± 5.8%; p = 0.08) at 6 months. During the 6-month follow-up period, there were 18 hospitalizations in 9 subjects and 2 patients died. CONCLUSIONS:Patients with heart failure and reduced ejection fraction who remain moderately to severely symptomatic despite use of CRT, may benefit from CCM therapy with improvement in quality of life and exercise tolerance. A larger prospective study in this population is warranted.
Authors: Klaus Witte; Gerd Hasenfuss; Axel Kloppe; Daniel Burkhoff; Michelle Green; Joe Moss; Alison Peel; Stuart Mealing; Isabelle Durand Zaleski; Martin R Cowie Journal: ESC Heart Fail Date: 2019-12
Authors: Francesco Giallauria; Gianluigi Cuomo; Alessandro Parlato; Nirav Y Raval; Jürgen Kuschyk; Andrew Js Stewart Coats Journal: ESC Heart Fail Date: 2020-07-23