Title : A novel technology to treat and reverse moderate/servere heart failure to NYHA I-II using electrical microcurrent
Abstract:
Device-based therapy for heart failure is essentially based on two systems available on the market and has only limited long-term success. The basis of these systems is the delivery of different electrical pulses to the myocardium. Based on the knowledge that physiologically constant electrical potential differences and currents play a crucial role in all living biological systems, we developed the idea of applying a constant, extremely low continuous current via two electrodes to the patient's heart with the intention of improving cardiac function. The microcurrent is applied via two electrodes, one (coil electrode) placed transvenously in the right heart and a second (patch electrode) surgically placed extrapericardially over the free wall of the left ventricle. A microcurrent of the order of a few microamperes is applied between the two electrodes, supplied by a current generator (C-MIC system) located in a subclavian pocket (pacemaker-like).
In a pilot study, a significant (>10 percent) improvement in left ventricular ejection fraction (EF) was observed after 6 months of use. The improvement in cardiac function was maintained for two years after power was turned off, which was confirmed in a two-year follow-up study. This supports the intent of microcurrent therapy, which is to achieve a sustained improvement in cardiac function after a limited period of application. Recruitment of patients for an open, randomized pivotal trial for the C-MIC system with 69 patients has been completed. The last patient will complete the study at the end of November 2024. The initial results confirm the observations from the pilot study. The application of microcurrent at the cellular level (protein and gene level; transcriptional analysis) shows that microcurrent intervenes deeply in cell function, making the observed sustained effect of microcurrent at the functional level plausible.
In my talk I will discuss the specific results of the studies and report on the results of the molecular analyses.
