Elsevier

International Journal of Cardiology

Volume 342, 1 November 2021, Pages 49-55
International Journal of Cardiology

Cardiac Contractility Modulation in Patients with Ischemic versus Non-ischemic Cardiomyopathy: Results from the MAINTAINED Observational Study

https://doi.org/10.1016/j.ijcard.2021.07.048Get rights and content

Highlights

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    Under CCM therapy, patients with NICM have more pronounced improvement in LVEF and TAPSE than patients with ICM in the long term.

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    Patients with more severely impaired LVEF of 20 to 25% also benefit from CCM therapy.

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    Safety events related to the device are rare with this therapy.

Abstract

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.

Section snippets

List of abbreviations

ARNIangiotensin receptor-neprilysin inhibitor
CCMcardiac contractility modulation
CKDchronic kidney disease
CRTcardiac resynchronization therapy
ICDimplantable cardioverter defibrillator
IPGimplanted pulse generator
(N)ICM(non-)ischemic cardiomyopathy
KDIGOKidney Disease Improving Global Outcomes
LVleft ventricular
LVEDDleft ventricular end-diastolic diameter
LVEFleft ventricular ejection fraction
MAGGICMeta-Analysis Global Group in Chronic [Heart Failure]
MAINTAINEDMAnnheim cardIac

The registry

MAINTAINED is a single-center, observational study that retrospectively enrolled all patients with CCM device implantation at our center since 2002. The study was carried out in accordance with the Declaration of Helsinki and with approval of the- Medical Ethics Committee II of the University of Heidelberg. These analyses included patients implanted until September 2019 so that there was complete follow-up for a minimum of 1 year. In addition to the implantation date, follow-up dates after 1, 3

Baseline characteristics

One hundred and seventy-four patients with completed CCM device implantation were included in this analyses (Fig. 1 and Table 1). One hundred and seven patients (61%) had ICM whereas 67 patients (39%) had NICM. Patients generally had advanced symptoms, with 77% having NYHA class III, 13% having NYHA class IV and 11% having NYHA class II (p = 0.45 between groups). The mean QRS width was 116 ± 25 ms (p = 0.83). Thirteen patients (7%) had previously received CRT and were considered CRT

Discussion

For the first time, results from the MAINTAINED observational study show that NICM patients can expect greater functional improvement in response to CCM therapy than ICM patients. After 5 years, NICM patients showed significantly better systolic LV and right ventricular (RV) function, although these parameters were similarly reduced at baseline in both groups.

At baseline, patients had significantly reduced LVEF which corresponded predominantly to NYHA class III symptoms. Previous work had

Limitations

Due to the retrospective and observational nature of this study, there is no randomized control group to assess functional and mortality benefits of CCM therapy compared to optimal medical therapy. Therefore, we used the MAGGIC heart failure risk score for assessment of a mortality benefit [8]. The sample size of this retrospective analysis was naturally not powered to achieve statistically significant differences between groups in the primary outcome measure. Unfortunately, our retrospective

Conclusions

In the long-term course of 5 years, NICM patients had significantly better systolic biventricular function under CCM therapy compared to ICM patients. Even patients with advanced heart failure und highest degree of reduced LVEF of 20–25% benefited from CCM therapy.

The following is the supplementary data related to this article.

. Repeated measures analysis of variance on LVEF and TAPSE.

Declaration of Competing Interest

CF received a travel allowance from Impulse Dynamics Germany GmbH (Stuttgart, Germany).

DB is a paid consultant to Impulse Dynamics (Marlton, NJ, USA).

BR received speaker fees from Impulse Dynamics Germany GmbH (Stuttgart, Germany).

JK works as a consultant for Impulse Dynamics (Marlton, NJ, USA) and received honoraria and lecture fees from this company.

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