A subgaleal electrode array for neurostimulation allows the recording of relevant information in closed loop applications.

BACKGROUND: Neurostimulation is an emerging treatment option for patients resistant to pharmacotherapy and ineligible for neurosurgical intervention. Compared to intracranial stimulation placement of electrodes in the subgaleal space offers a minimally invasive option for long-term seizure monitoring for responsive systems. NEW METHOD: It was investigated, whether electrode contacts of a device being developed as a stimulation system placed in the subgaleal space are suited for recording of EEG activity for seizure detection. EEG was recorded intraoperatively in four participants participating in a clinical trial during the insertion of the device. Quantitative parameters like electrode impedance, signal amplitude ranges and amplitude spectra were determined. Epileptiform patterns in the recordings were compared to patterns occurring in scalp EEG prior to device implantation. RESULTS: Electrode impedances, amplitude ranges for artefact free intervals and intervals containing artefacts were determined. Spectral analysis showed typical properties of EEG recordings with high amplitude content at low frequencies and a peak in the alpha band. No major noise except at power line frequency disturbed the recordings. In two patients, typical epileptiform patterns could be identified having similar characteristics as their respective scalp EEG recordings prior to device implantation. COMPARISON WITH EXISTING METHODS: New and less invasive electrode system compared to existing solutions for responsive neurostimulation. CONCLUSIONS: The subgaleal electrode system allows for high quality EEG recordings even in an hostile unfavorable environment like an operation theatre. For the design of a signal acquisition unit of a responsive system using subgaleal electrodes, specifications could be obtained.

Efficacy and safety of pimecrolimus-eluting stents in porcine coronary arteries.

OBJECTIVE: We aimed to evaluate an effective dosage and safety profile of pimecrolimus as an anti-inflammatory drug for drug-eluting stents. METHODS: In the dose finding study, coronary arteries of 20 domestic swine were randomly implanted with bare metal stents (ProKinetic and Guidant Vision), the ProKinetic stent with polylactic acid (PLLA), and pimecrolimus-eluting stents (32, 75, and 120 microg) over a period of 4 weeks. In addition, pimecrolimus (75 microg) and ProKinetic stents were randomly implanted into six swine over 3 months. In the safety study, the ProKinetic stent, the ProKinetic stent with PLLA, mid- (45 microg) and high-dose pimecrolimus (120 microg), and overlapping mid-dose stents were implanted over a period of 4 weeks. Mid-dose, ProKinetic stent, and ProKinetic stent with PLLA were implanted over a period of 3 months. RESULTS: The dose finding study revealed excellent luminal patency with low percent occlusion (approximately 29% vs. approximately 41%), injury (0.53-0.59 vs. 1.25), and inflammation (0.78-0.97 vs. 1.08) for the pimecrolimus group compared with the vision group. The safety study arm showed similar angiographic results for all tested groups, with a significantly larger minimal lumen diameter for pimecrolimus stents compared to PLLA stents. Except for the high-dose group and overlapping area of the overlapping group, promising morphometric results were found for pimecrolimus compared to bare metal stents. CONCLUSIONS: Present data suggest that pimecrolimus-eluting stents are safe and have a similar healing profile to bare metal stents. They may suppress inflammation, leading to a reduced intimal response and a milder inflammatory reaction in a porcine model.