Cardiac contractility modulation in left ventricular systolic dysfunction: one-year experience in a pilot study and design of a prospective registry.

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Cardiac contractility modulation (CCM) is a treatment option for patients suffering symptomatic chronic heart failure (CHF) with reduced left ventricular ejection fraction (LVEF) who are not eligible for cardiac resynchronization. Data on mid-term follow-up are limited to small observational studies. The aim of this study was to assess the impact of CCM on quality of life, symptoms, exercise tolerance and left ventricular function in patients with CHF and moderate-to-severe left ventricular systolic dysfunction. Patients suffering CHF with LVEF <45% and NYHA class >II despite optimal medical therapy, underwent CCM implantation. Enrolled patients underwent baseline and 3, 6 and 12-months evaluation with ECG, echocardiogram, clinical assessment, 6-minute walking test and Minnesota Living with Heart Failure Questionnaire (MLWHFQ). Ten patients underwent CCM implantation. All patients were actively treated with the optimal pharmacological therapy as tolerated and had at least one hospitalization for worsening heart failure during the previous year. After a mean follow-up of 15 months, 9 patients were alive, while one patient died for worsening heart failure precipitated by pneumonia. Among the remaining 9 patients, LVEF improved non-significantly from 29.4±8% to 32.2±10% (P=0.092), 6-minute walking test distance improved from 179±73 m to 304±99 m (P<0.001), NYHA class reduced from 3.0±0.4 to 1.6±0.5 (P=0.003) and MLWHFQ score improved from 59.6±49 to 34.2±32 (P=0.037). Only 2 patients have been hospitalized during the 12 months. Overall, a net clinical benefit was detected in 6 out of 9 patients. CCM could be effective in improving quality of life, symptoms and exercise tolerance, and reduces hospitalizations in patients with symptomatic CHF on top of optimal medical and electrical therapy. A prospective registry has been designed to identify the subsets of patients gaining more benefit, and to assess the long-term effect of CCM on those clinical endpoints.