Cardiac contractility modulation improves long‐term survival and hospitalizations in heart failure with reduced ejection fraction

Abstract

Aims Cardiac contractility modulation (CCM) improves symptoms and exercise tolerance and reduces heart failure (HF) hospitalizations over 6‐month follow‐up in patients with New York Heart Association (NYHA) class III or IV symptoms, QRS < 130 ms and 25% ≤ left ventricular ejection fraction (LVEF) ≤ 45% (FIX‐HF‐5C study). The current prospective registry study (CCM‐REG) aimed to assess the longer‐term impact of CCM on hospitalizations and mortality in real‐world experience in this same population. Methods and results A total of 140 patients with 25% ≤ LVEF ≤ 45% receiving CCM therapy (CCM‐REG25‐45) for clinical indications were included. Cardiovascular and HF hospitalizations, Minnesota Living with Heart Failure Questionnaire (MLHFQ) and NYHA class were assessed over 2 years. Mortality was tracked through 3 years and compared with predictions by the Seattle Heart Failure Model (SHFM). A separate analysis was performed on patients with 35% ≤ LVEF ≤ 45% (CCM‐REG35‐45) and 25% ≤ LVEF < 35% (CCM‐REG25‐34). Hospitalizations decreased by 75% (from 1.2/patient‐year the year before, to 0.35/patient‐year during the 2 years following CCM, P < 0.0001) in CCM‐REG25‐45 and by a similar amount in CCM‐REG35‐45 (P < 0.0001) and CCM‐REG25‐34. MLHFQ and NYHA class improved in all three cohorts, with progressive improvements over time (P < 0.002). Three‐year survival in CCM‐REG25‐45 (82.8%) and CCM‐REG24‐34 (79.4%) were similar to those predicted by SHFM (76.7%, P = 0.16; 78.0%, P = 0.81, respectively) and was better than predicted in CCM‐REG35‐45 (88.0% vs. 74.7%, P = 0.046). Conclusion In real‐world experience, CCM produces results similar to those of previous studies in subjects with 25% ≤ LVEF ≤ 45% and QRS < 130 ms; cardiovascular and HF hospitalizations are reduced and MLHFQ and NYHA class are improved. Overall mortality was comparable to that predicted by the SHFM but was lower than predicted in patients with 35% ≤ LVEF ≤ 45%.

Cost‐effectiveness of a cardiac contractility modulation device in heart failure with normal QRS duration

“…In addition to these three RCTs, a number of single and multicentre registry studies contribute additional evidence of the safety and efficacy of CCM as a treatment for HF in patients with a broad range of ejection fractions . In accordance with these findings, the current European Society of Cardiology guidelines for the treatment of patients with HF recommend that the Optimizer System may be considered in selected patients with HFrEF.…”

Optimizer Smart in the Treatment of moderate-to-severe Chronic Heart Failure

“…The largest study to address long term outcomes is the CCM-REG 25-45 . CCM-REG 25-45 is a multicenter prospective observational registry designed to address long-term (3-year) mortality of patients who received CCM as part of routine clinical indication in Europe compared with the predicted mortality assessed by the SHFM [41]. 140 were enrolled in the overall cohort (CCM-REG 25-45 ), among them: 83 patients were in the CCM-REG 25-34 subgroup and 57 patients were in the CCM-REG 34-45 subgroup.…”

September 2019 at a glance: focus on devices

“…Three‐year mortality was comparable to that predicted by the Seattle Heart Failure Model in the overall population and among patients with LVEF between 25% and 34%. Interestingly, it was lower than predicted in patients with LVEF between 35% and 45% …”

“…Cardiac contractility modulation (CCM) improved symptoms and exercise tolerance and reduced HF hospitalizations in patients with chronic HF and a LVEF between 25% and 45% . Anker et al . reported the long‐term results of a prospective multi‐centre registry including 140 patients with chronic HF receiving CCM.…”