Treatment of patients with multiple organ dysfunction syndrome (MODS) with an electromagnetic field coupled to biorhythmically defined impulse configuration: the MicrocircMODS study.

BACKGROUND: To potentially improve impaired vasomotion of patients with multiple organ dysfunction syndrome (MODS), we tested whether an electromagnetic field of low flux density coupled with a biorhythmically defined impulse configuration (Physical Vascular Therapy BEMER®, PVT), in addition to standard care, is safe and feasible and might improve disturbed microcirculatory blood flow and thereby improve global haemodynamics. METHODS: In a prospective, monocentric, one-arm pilot study, 10 MODS patients (APACHE II score 20-35) were included. Patients were treated, in addition to standard care, for 4 days with PVT (3 treatment periods of 8 min each day; day 1: field intensity 10.5 µT; day 2:14 µT, day 3:17.5 µT; day 4:21.0 µT). Primary endpoint was the effect of PVT on sublingual microcirculatory perfusion, documented by microvascular flow index (MFI). Patient safety, adverse events, and outcomes were documented. RESULTS: An increase in MFI by approximately 25% paralleled 4-day PVT, with the increase starting immediately after the first PVT and lasting over the total 4-day treatment period. Concerning global haemodynamics (secondary endpoints), halving vasopressor use within 24 h, and haemodynamic stabilisation paralleled 4-day PVT with an increase in cardiac index, stroke volume index, and cardiac power index by 30%-50%. No adverse events (AEs) or serious adverse events (SAEs) were classified as causally related to the medical product (PVT) or study. Three patients died within 28 days and one patient between 28 and 180 days. CONCLUSION: PVT treatment was feasible and safe and could be performed without obstruction of standard patient care. An increase in microcirculatory blood flow, a rapid reduction in vasopressor use, and an improvement in global haemodynamics paralleled PVT treatment. Findings of this pilot study allowed forming a concept for a randomized trial for further proof.

Influence of inflammation and cardiac hypertrophy on mechanical properties of human pericardium.

Different devices for mechanical circulatory support (MCS) have been developed for the treatment of refractory cardiogenic shock. However, all of them are associated with direct blood contact, the need for anticoagulation and bleeding complications. To overcome these limitations the pericardial sac got into the focus as a promising implantation site for MCS. For this purpose, further knowledge about the mechanical properties of human pericardium is required. In this prospective, monocentric, experimental pilot study 56 samples of human pericardium were extracted postmortem from 13 critically ill patients. After preparation of test specimens uniaxial tensile tests were performed. The primary end points were load at fracture per sample width and strain at fracture. Acute inflammation was assessed by blood levels of C-reactive protein, white blood count and procalcitonin measured at several times during hospital stay. Inflammatory load was estimated by area under the inflammatory curves. Correlation and regression analysis were used to assess the relationship of primary end points to inflammation, comorbidities and postmortem time to preparation. Human pericardium showed a load at fracture per sample width of 1.95 [1.38-2.94] N/mm (median [inter quartile range]) and a strain at fracture of 89.29 [73.84-135.23] %. Markers of acute inflammation and cardiac hypertrophy did not correlate to load or strain at fracture. However, strain at fracture increased with higher body mass index and an increasing number of postmortem days. In contrast, higher patient age was associated with a lower strain at fracture. Inflammation and cardiac hypertrophy did not influence mechanical properties of human pericardium.