Cardiac contractility modulation in heart failure patients: Randomized comparison of signal delivery through one vs. two ventricular leads

Röger, Susanne; Said, Samir M.; Kloppe, Axel; Lawo, Thomas; Emig, Ulf; Rousso, Benny; Gutterman, David D.; Borggrefe, Martin; Kuschyk, Jürgen

doi:10.1016/j.jjcc.2016.06.015

Cited by 20 publications

(13 citation statements)

References 21 publications

(32 reference statements)

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…21 In a recent study, it was demonstrated that efficacy and safety of CCM were similar when the signal was delivered through either 1 or 2 ventricular leads. 22 These results support the potential future use of a single ventricular lead for delivery of CCM, further reducing device implantation-associated risk.…”

Section: Discussionsupporting

confidence: 60%

“…The new mode also allows the delivery of CCM therapy in patients with permanent atrial fibrillation, which was considered a contraindication for the prior‐generation Optimizer device . In a recent study, it was demonstrated that efficacy and safety of CCM were similar when the signal was delivered through either 1 or 2 ventricular leads . These results support the potential future use of a single ventricular lead for delivery of CCM, further reducing device implantation–associated risk.…”

Section: Discussionmentioning

confidence: 88%

See 1 more Smart Citation

Long‐term results of combined cardiac contractility modulation and subcutaneous defibrillator therapy in patients with heart failure and reduced ejection fraction

Röger

Rudic

Akın

et al. 2018

Clinical Cardiology

Self Cite

View full text Add to dashboard Cite

BackgroundCardiac contractility modulation (CCM) is an electrical‐device therapy for patients with heart failure with reduced ejection fraction (HFrEF). Patients with left ventricular ejection fraction (LVEF) ≤35% also have indication for an implantable cardioverter‐defibrillator (ICD), and in some cases subcutaneous ICD (S‐ICD) is selected.HypothesisCCM and S‐ICD can be combined to work efficaciously and safely.MethodsWe report on 20 patients with HFrEF and LVEF ≤35% who received CCM and S‐ICD. To exclude device interference, patients received intraoperative crosstalk testing, S‐ICD testing, and bicycle exercise testing while CCM was activated. Clinical and QOL measures before CCM activation and at last follow‐up were analyzed. S‐ICD performance was evaluated while both CCM and S‐ICD were active.ResultsMean follow‐up was 34.3 months. NYHA class improved from 2.9 ± 0.4 to 2.1 ± 0.7 (P < 0.0001), Minnesota Living With Heart Failure Questionnaire score improved from 50.2 ± 23.7 to 29.6 ± 22.8 points (P < 0.0001), and LVEF improved from 24.4% ± 8.1% to 30.9% ± 9.6% (P = 0.002). Mean follow‐up time with both devices active was 22 months. Three patients experienced a total of 6 episodes of sustained ventricular tachycardia, all successfully treated with first ICD shock. One case received an inappropriate shock unrelated to the concomitant CCM. One patient received an LVAD, so CCM and S‐ICD were discontinued.ConclusionsCCM and S‐ICD can be successfully combined in patients with HFrEF. S‐ICD and CCM remain efficacious when used together, with no interference affecting their function.

show abstract

Section: Discussionsupporting

confidence: 60%

Section: Discussionmentioning

confidence: 88%

Long‐term results of combined cardiac contractility modulation and subcutaneous defibrillator therapy in patients with heart failure and reduced ejection fraction

Röger

Rudic

Akın

et al. 2018

Clinical Cardiology

Self Cite

View full text Add to dashboard Cite

show abstract

“…Future changes can be anticipated in the refinement of this technology. A small randomized control trial of 48 patients found that the efficacy and safety of CCM was similar when the signal was delivered through a single ventricular lead rather than dual ventricular leads [49]. Thus, future models will likely consist of a single ventricular lead.…”

Section: Future Perspectivementioning

confidence: 99%

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

2019

View full text Add to dashboard Cite

Cardiac contractility modulation, also referred to as CCM™, by the Optimizer Smart device is an innovative intracardiac device-based therapy that has been recently US FDA-approved for the treatment of patients with chronic heart failure, left ventricular ejection fraction (LVEF) between 25 and 45%, QRS <130 ms who remain symptomatic despite optimal medical therapy. Clinical trials demonstrate that CCM therapy is safe and effective in reducing heart failure hospitalization and improving heart failure symptoms, quality of life and functional performance. This novel device-based therapeutic offers benefits to patients who do not otherwise qualify for cardiac resynchronization therapy. CCM expands the indication beyond the traditional LVEF cutoff of 35% to a newer group including patients who fall in midrange LVEF group, up to 45%.

show abstract

“…Параметрами, независимо связанными с наступлением вторичной ККТ в течение 2 лет у пациентов, получающих терапию МСС, стал NTproBNP. Интересно, что отключение одного из электродов не повлияло на смертность и госпитализации, что согласуется с данными исследования Röger S, et al (2017), где стимуляция только одним электродом по сравнению с двухэлектродной стимуляцией зоны межжелудочковой перегородки не оказывала существенного воздействия на ФК ХСН, пиковое потребление кислорода и смертность в течение 6 мес. МСС терапии [14].…”

Section: Discussionunclassified

Two-year follow-up of patients with heart failure with reduced ejection fraction receiving cardiac contractility modulation

et al. 2020

View full text Add to dashboard Cite

Aim. To assess the 2-year prognosis of patients with heart failure with reduced ejection fraction (HFrEF) receiving cardiac contractility modulation (CCM).Material and methods. This single-center observational study included 55 patients (46 men, mean age 53±11 years) with NYHA class II-III HFrEF receiving optimal medical therapy, with sinus rhythm, QRS <130 ms or QRS<150 ms with nonspecific intraventricular conduction delay. NYHA class II and III were established in 76% and 24% of patients, respectively. All patients were implanted with CCM devices between October 2016 and September 2017. Follow-up visits were carried out every 3 months during the 1st year and every 6 months during the 2nd year of observation. The primary composite endpoint was mortality and heart transplantation. Secondary composite endpoints included death, heart transplantation, paroxysmal ventricular tachycardia/ ventricular fibrillation, hospitalizations due decompensated HFResults. The one-year and two-year survival rate was 95% and 80%, respectively. Primary endpoint was observed in 20% of patients. NYHA class III and higher levels of N-terminal pro-brain natriuretic peptide (NTproBNP) were associated with unfavorable prognosis (p=0,014 and p=0,026, respectively). NTproBNP was an independent predictor of survival (p=0,018). CCM contributed to a significant decrease in hospitalizations due to decompensated HF (p<0,0001). The secondary endpoint was observed in 18 (33%) of patients during the 1st year. The predictor for the secondary composite endpoint was NTproBNP (p=0,047).Conclusion. CCM is associated with a significant decrease in hospitalization rate due to decompensated HF. The 2-year survival rate of patients with NYHA class II-III HF receiving CCM was 80%. The NTproBNP level was an independent predictor of survival in patients receiving CMM for 2 years. Further longer-term studies of the CCM efficacy are required.

show abstract

Cardiac contractility modulation in heart failure patients: Randomized comparison of signal delivery through one vs. two ventricular leads

Abstract: The efficacy and safety of CCM in this study were similar when the signal was delivered through either one or two ventricular leads. These results support the potential use of a single ventricular lead for delivery of CCM.

Cited by 20 publications

References 21 publications

Long‐term results of combined cardiac contractility modulation and subcutaneous defibrillator therapy in patients with heart failure and reduced ejection fraction

Long‐term results of combined cardiac contractility modulation and subcutaneous defibrillator therapy in patients with heart failure and reduced ejection fraction

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

Two-year follow-up of patients with heart failure with reduced ejection fraction receiving cardiac contractility modulation

Contact Info

Product

Resources

About