Cardio‐microcurrent device for chronic heart failure: first‐in‐human clinical study

Abstract

Aims Most devices for treating ambulatory Class II and III heart failure are linked to electrical pulses. However, a steady electric potential gradient is also necessary for appropriate myocardial performance and may be disturbed by structural heart diseases. We investigated whether chronic application of electrical microcurrent to the heart is feasible and safe and improves cardiac performance. The results of this study should provide guidance for the design of a two-arm, randomized, controlled Phase II trial. Methods and results This single-arm, non-randomized pilot study involved 10 patients (9 men; mean age, 62 ± 12 years) at two sites with 6 month follow-up. All patients had New York Heart Association (NYHA) Class III heart failure and non-ischaemic dilated cardiomyopathy, with left ventricular ejection fraction (LVEF) <35%. A device was surgically placed to deliver a constant microcurrent to the heart. The following tests were performed at baseline, at hospital discharge, and at six time points during follow-up: determination of LVEF and left ventricular end-diastolic/end-systolic diameter by echocardiography; the 6 min walk test; and assessment of NYHA classification and quality of life (36-Item Short-Form Health Survey questionnaire). Microcurrent application was feasible and safe; no device-related or treatment-related adverse events occurred. During follow-up, rapid and significant signal of efficacy (P < 0.005) was present with improvements in LVEF, left ventricular end-diastolic diameter, left ventricular end-systolic diameter, and distance walked. For eight patients, NYHA classification improved from Class III to Class I (for seven, as early as 14 days post-operatively); for one, to Class II; and for one, to Class II/III. 36-Item Short-Form Health Survey questionnaire scores also improved highly significantly. Conclusions Chronic application of microcurrent to the heart is feasible and safe and leads to a rapid and lasting improvement in heart function and a near normalization of heart size within days. The NYHA classification and quality of life improve just as rapidly.

Microcurrent-Mediated Modulation of Myofibroblasts for Cardiac Repair and Regeneration

“…Furthermore, it is important to note that devices for electrical stimulation of organs with a weak constant electrical current are in clinical testing and have shown promising results [ 14 , 15 ]. There is, however, a dire need to understand the underlying mechanisms of how cells behave upon electrical stimulation.…”

“…In vivo studies on rat hearts have shown that electric stimuli regulate the expression of ECM components and their inhibitors, accompanied by a significant decrease in pro-inflammatory cytokines [ 12 , 13 ]. Furthermore, recent studies with a Cardio-microcurrent device concluded that weak constant electrical current application to the heart is not only feasible and safe but also shows promising results in heart function and size [ 14 , 15 ]. Considering these promising outcomes observed with rat cardiomyocytes and preliminary clinical applications, this study specifically aimed to unveil the mechanism by which myofibroblasts respond to electrical stimulation to promote cardiac functional recovery.…”

First-in-man Implantation of a Cardiac Microcurrent Device for Chronic Systolic Heart Failure

“…The C-MIC device is currently under investigation for clinical use within the first pilot study including 10 patients with nonischemic dilated cardiomyopathy. 9…”

Myocardial Edema Revisited in a New Paradigm of Cardiac Electrical Microcurrent Application in Heart Failure

“…A recently reported longitudinal study identified an increased left ventricular ejection fraction with a reduction in end-systolic and end-diastolic left ventricular size along with an increase in 6-min walk, NYHA functional class, and quality of life. 1 There is a rapid functional improvement that can be demonstrated after only a few hours of microcurrent application (Fig. 1).…”

“…A recently reported longitudinal study identified an increased left ventricular ejection fraction with a reduction in end-systolic and end-diastolic left ventricular size along with an increase in 6-min walk, NYHA functional class, and quality of life. 1 …”