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Background: Cardiac resynchronisation therapy (CRT) can be necessary in patients with chronic heart failure, who have already been provided with transvenous cardiac implantable electrical devices. Upgrade procedures revealed controversial results, while long-term outcomes regarding underlying Ischaemic- (ICM) or Non-Ischaemic heart disease (NICM) have yet to be described., Methods: The Mannheim Cardiac Resynchronisation Therapy Registry (MARACANA) was designed as a retrospective observational single-centre registry, including all CRT implantations from 2013-2021 ( n  = 459). CRT upgrades ( n  = 136) were retrospectively grouped to either ICM ( n  = 84) or NICM ( n  = 52) and compared for New York Heart Association classification (NYHA), paced QRS-width, left ventricular ejection fraction (LVEF), tricuspid annular plane systolic excursion (TAPSE) and other heart failure modification aspects in the long-term (59.3 ± 5 months)., Results: Baseline-characteristics including paced QRS-width, upgrade indications or NYHA-classification were comparable for both groups (group comparison p >.05). The CRT upgrade improved NYHA (ICM: 2.98 ± 0.4 to 2.29 ± 0.7, NICM: 2.94 ± 0.5 to 2.08 ± 0.5) and the LVEF (ICM: 27.2 ± 6.6 to 38.25 ± 8.8, NICM: 30.2 ± 9.4 to 38.7 ± 13.8%) after five years, irrespective of underlying heart disease (each group p  < .05, group comparison p >.05). Only ICM revealed significant improvements in TAPSE (15.9 ± 4.1 to 18.9 ± 4.1 mm) and narrowing of the paced QRS-width (185.4 ± 29 to 147.2 ± 16.3 ms) after five years (each p  < .05)., Conclusions: Upgrade to CRT might improve heart failure symptoms and left-ventricular systolic function in the long-term, irrespective of underlying ischaemic or non-ischaemic heart disease.

We hypothesized that myocardial septal scarring, assessed by cardiac magnetic resonance (CMR) using late gadolinium enhancement (LGE), at the site of cardiac contractility modulation (CCM) lead placement may predict treatment response. Eligible heart failure (HF) patients underwent LGE CMR imaging before CCM device implantation. The response to CCM therapy at follow-up was determined by a change in NYHA class and echocardiographic left ventricular ejection fraction (LVEF) assessment. Patients were classified as responders, if they showed an improvement in either NYHA class or improvement of LVEF by ≥ 5%. 58 patients were included. 67% of patients were classified as responders according to improved NYHA; 55% according to LVEF improvement. 74% of patients were responders if either NYHA class or LVEF improvement was observed. 90% of responders (according to NYHA class) showed septal LGE < 25% at septal position of the leads, while 44% of non-responders showed septal LGE > 25% (p < 0.01). In patients treated with CCM, an improvement of NYHA class was observed when leads were placed at myocardial segments with a CMR- LGE burden less than 25%., (© 2022. The Author(s).)

Background: Cardiac contractility modulation (CCM) is an FDA-approved device therapy for patients with refractory systolic heart failure and normal QRS width. Randomized trials demonstrated benefits of CCM primarily for patients with severe heart failure (> NYHA class II)., Purpose: To better understand individualized indication in clinical practice, we compared the effect of CCM in patients with baseline NYHA class II vs. NYHA class III or ambulatory IV over the 5-year period in our large clinical registry (MAINTAINED Observational Study)., Methods: Changes in NYHA class, left ventricular ejection fraction (LVEF), tricuspid annular plane systolic excursion (TAPSE), NT-proBNP level, and KDIGO chronic kidney disease stage were compared as functional parameters. In addition, mortality within 3 years was compared with the prediction of the Meta-Analysis Global Group in Chronic heart failure risk score., Results: A total of 172 patients were included in the analyses (10% with NYHA class II). Only patients with NYHA class III/IV showed a significant improvement in NYHA class over 5 years of CCM (II: 0.1 ± 0.6; p = 0.96 vs. III/IV: - 0.6 ± 0.6; p < 0.0001). In both groups, LVEF improved significantly (II: 4.7 ± 8.3; p = 0.0072 vs. III/IV: 7.0 ± 10.7%; p < 0.0001), while TAPSE improved significantly only in NYHA class III/IV patients (II: 2.2 ± 1.6; p = 0.20 vs. III/IV: 1.8 ± 5.2 mm; p = 0.0397). LVEF improvement was comparable in both groups over 5 years of CCM (p = 0.83). NYHA class II patients had significantly lower NT-proBNP levels at baseline (858 [175/6887] vs. 2632 [17/28830] ng/L; p = 0.0044), which was offset under therapy (399 [323/1497] vs. 901 [13/18155] ng/L; p = 0.61). Actual 3-year mortality was 17 and 26% vs. a predicted mortality of 31 and 42%, respectively (p = 0.0038 for NYHA class III/IV patients)., Conclusions: NYHA class III/IV patients experienced more direct and extensive functional improvements with CCM and a survival benefit compared with the predicted risk. However, our data suggest that NYHA class II patients may also benefit from the sustained positive effects of LVEF improvement., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)

Background: Cardiac contractility modulation (CCM), being reserved for patients with symptomatic chronic heart failure (HF) and narrow QRS complex under guideline directed medical therapy, can recover initially reduced left ventricular ejection fraction (LVEF); however, the influence of pre-implantation LVEF on long-term outcomes is not fully understood. This study aimed to compare the effects of lower and higher preimplantation LVEF on long-term outcomes in CCM-therapy., Methods: One-hundred seventy-two patients from our single-centre registry were retrospectively included (2002-2019). Follow-up data were collected up to 5 years after implantation. Patients were divided into Group 1 (baseline LVEF≤ 30%) and Group 2 (≥ 31%). Both groups were compared based on differences in survival, echocardiographic- and clinical parameters including LVEF, tricuspid annular plane systolic excursion (TAPSE), NYHA class or Minnesota living with heart failure questionnaire-score (MLWHFQ)., Results: 11% of the patients did have a LVEF ≥31%. Mean LVEF ± SD for both groups were 21.98 ± 5.4 versus 35.2 ± 3.7%, respectively. MLWHFQ (47 ± 21.2 vs. 42±21.4) and mean peak oxygen consumption (VO2, 13.6 ± 4.1 vs. 12.7 ± 2.8 ml/kg/min) were comparable between both groups. LVEF-grouping did not influence survival. Lower baseline LVEF resulted in significantly better recovery of echocardiographic parameters such as LVEF and TAPSE. Irrespective from baseline LVEF, both groups showed nearly comparable improvements for clinical parameters like NYHA-class and MLWHFQ., Conclusion: Long-term biventricular systolic recovery potential in CCM-therapy might be better for preimplantation LVEF values ≤30%, whereas clinical parameters such as NYHA-class can improve irrespective from baseline LVEF., (© 2022 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals LLC.)

Background: Cardiac contractility modulation (CCM) is an FDA-approved device-based therapy for patients with systolic heart failure and normal QRS width who are symptomatic despite optimal drug therapy. The purpose of this study was to compare the long-term therapeutic effects of CCM therapy in patients with ischemic (ICM) versus non-ischemic cardiomyopathy (NICM)., Methods: Changes in NYHA class, KDIGO CKD stage, left ventricular ejection fraction (LVEF), tricuspid annular plane systolic excursion (TAPSE), and NT-proBNP levels were compared as functional parameters. Moreover, observed mortality rates at 1 and 3 years were compared to those predicted by the MAGGIC heart failure risk score, and observed mortality rates were compared between groups for the entire follow-up period., Results: One hundred and seventy-four consecutive patients with chronic heart failure and CCM device implantation between 2002 and 2019 were included in this retrospective analysis. LVEF was significantly higher in NICM patients after 3 years of CCM therapy (35 ± 9 vs. 30 ± 9%; p = 0.0211), and after 5 years, also TAPSE of NICM patients was significantly higher (21 ± 5 vs. 18 ± 5%; p = 0.0437). There were no differences in other effectiveness parameters. Over the entire follow-up period, 35% of all patients died (p = 0.81); only in ICM patients, mortality was lower than predicted at 3 years (35 vs. 43%, p = 0.0395)., Conclusions: Regarding improvement of biventricular systolic function, patients with NICM appear to benefit particularly from CCM therapy., (Copyright © 2021 Elsevier B.V. All rights reserved.)

The worldwide prevalence of heart failure is 1-2% with a portion of >10% in patients older than 70 years. In addition to treatment of causal determined factors and lifestyle modification, basic treatment consists of guideline-directed medical therapy with angiotensin-converting enzyme inhibitors (ACE), β‑blockers (BB), mineralocorticoid receptor antagonists (MRA), diuretics, digitalis (class IIb recommendation), angiotensin receptor blockers (ARB), Iƒ-channel blockers plus recently recommended in the guidelines angiotensin receptor neprilysin inhibitor (ARNI) to substitute the ACE inhibitor (class I b). Cardiac contractility modulation (CCM) is a device-based electrical therapy for the treatment of refractory heart failure symptoms. CCM signals are relatively high intensity, nonexcitatory signals applied during the absolute refractory period that have been shown to enhance the strength of left ventricular (LV) contraction and improve exercise tolerance and quality of life. The mechanisms of action appear to involve effects on myocardial gene expression and normalization of myocardial key-proteins. So far, more than 3500 CCM devices have been implanted worldwide. For patients with symptomatic heart failure and narrow QRS complex, CCM is together with baroreceptor activation the only additive electrical therapy which had been approved in Germany. Actually, for the first time, CCM has been referenced in the current Heart Failure Guidelines. Prognostic data with regard to mortality are currently being evaluated in case series; some of which have since been published. Approval by the US Food and Drug Administration (FDA) is expected within the next months.

Background: Cardiac 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., Hypothesis: CCM and S-ICD can be combined to work efficaciously and safely., Methods: We 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., Results: Mean 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., Conclusions: CCM 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., (© 2018 The Authors. Clinical Cardiology published by Wiley Periodicals, Inc.)

Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) is an implantable device for antiarrhythmic therapy with no intravascular leads., Objective: The purpose of this study was to describe the technical feasibility of combining the S-ICD with other cardiac implantable electronic devices (CIEDs), including pacemakers with transvenous or epicardial electrodes. We also provide the first experience of combining an S-ICD with catheter-based therapies, including cardiac contractility modulation (CCM) and vagus nerve stimulation., Methods: Between July 2011 and November 2014, 6 patients received a CCM device and S-ICD, 3 patients with a single-chamber pacemaker using either transvenous or epicardial pacing electrodes received and S-ICD, and 1 patient with an implanted S-ICD received vagus nerve stimulation. In all patients, intraoperative S-ICD testing, crosstalk tests, and postoperative ergometric testing were performed., Results: In all 10 patients, device implantations were successfully performed without complications. S-ICD therapy was shown to be technically feasible with concomitant CIED. Mean follow-up was nearly 17 months. S-ICD testing and crosstalk testing before and during exercise enabled device programming across a broad range of test conditions and was associated with no subsequent evidence of adverse device interaction. None of the devices required permanent inactivation or removal, and no patient received an inappropriate shock., Conclusion: In suitable patients, combining an S-ICD with CCM or pacemaker may provide an acceptable means to reduce the number of transvascular leads. S-ICD appeared safe with CCM over an intermediate follow-up period. Additional prospective randomized controlled trials examining S-ICD in conjunction with CIEDs are warranted., (Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Aims: Cardiac contractility modulation (CCM) is an electrical therapy for heart failure (HF) with reduced ejection fraction. Sinus rhythm is deemed necessary for effective treatment because the current CCM signal delivery algorithm requires sequential sensing of a p wave, followed by depolarizations at each ventricular lead. In case of atrial fibrillation (AF) CCM is inhibited. This study demonstrates the feasibility of CCM therapy in patients with permanent AF by circumventing the requirement for sensing of a natural p wave., Methods and Results: Five CCM patients with AF received a pacemaker or implantable cardioverter/defibrillator (ICD) upgrade to cardiac resynchronization therapy (CRT) with low atrial sensitivity, which resulted in compulsory atrial stimulation followed by biventricular pacing. The CCM system recognized the atrial stimuli as p waves, which led to CCM signal delivery. Three patients developed permanent AF after a mean follow-up of 40 months of CCM therapy. Two patients had permanent AF at the time of CCM device implantation. All pacemaker or ICD devices were successfully upgraded to CRT. Cardiac resynchronization therapy stimulation rates of ≥96% and CCM stimulation rates between 60% and 95% were achieved. Clinical condition of the patients improved (mean NYHA class -0.7, left ventricular ejection fraction +2%, Minnesota living with HF questionnaire -15.6 points)., Conclusion: CCM signal delivery is feasible in HF patients with permanent AF by sequential atrial-ventricular pacing, so that the atrial pacing spike is interpreted as a p wave by the CCM signal delivery algorithm. This experimental approach can be considered in individual cases. A new CCM algorithm, which does not require an atrial electrode, is desirable., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.)