Long Term Safety of the ATI Neurostimulation System for the Treatment of Cluster Headache (P3.041)

OBJECTIVE: This analysis aims to characterize the long term safety of the ATI Neurostimulation System in CH sufferers and to understand the severity of adverse events (AEs) associated with treatment. BACKGROUND: SPG Stimulation is a novel therapy that applies electrical stimulation to the sphenopalantine ganglion (SPG) to relieve pain associated with Cluster Headache. The ATI Neurostimulator is inserted trans-orally using a minimally invasive technique. At least two-thirds of patients using the ATI Neurostimulation System have achieved profound clinical improvements including acute headache pain relief and/or significant attack frequency reduction. DESIGN/METHODS: Patients from both Pathway CH-1 and Pathway R-1 studies were included in the analysis. All adverse events (AEs) were documented and followed throughout enrollment. AEs were also assessed for relationship to procedure and/or the presence of the neurostimulator. RESULTS: Ninety-eight (98) patients received the ATI Neurostimulator as of May 2014. Fifteen patients (15[percnt]) reported no AEs and 83 patients (85[percnt]) reported at least one related AE. In total, 341 AEs were reported (average 4.1 AEs/patient). Currently, 216 (63[percnt]) of all AEs have resolved; average time to resolution was 69 days (range 0-611). The majority of reported AEs (77.4[percnt]) occurred within 30 days of the insertion procedure (peri-op AEs). Of these AEs, 82[percnt] of patients experienced sensory disturbances. The large majority (72[percnt]) of these events had mild to moderate impact on the patient’s daily activities and were transient, with an average resolution of 110.3 days (range 20-313). CONCLUSIONS: The majority of AEs were reported within 30 days of Neurostimulator insertion and the majority resolved within 3 months. These AEs are similar to standard sequelae reported for other trans-oral procedures and display a similar time course for healing. The majority of ongoing AEs are mild (63[percnt]) and do not have any effect on patients’ daily activities. Study Supported by: Autonomic Technologies, Inc. Disclosure: Dr. Caparso has nothing to disclose. Dr. Hillerup has nothing to disclose. Dr. Rostgaard has nothing to disclose. Dr. Assaf has nothing to disclose. Dr. Jurgens has nothing to disclose. Dr. Barloese has nothing to disclose. Dr. Lainez has nothing to disclose. Dr. Bigazzi has nothing to disclose. Dr. Goodman has received personal compensation for activities with Autonomic Technologies as an employee. Dr. Jensen has nothing to disclose. Dr. May has received personal compensation for activities with Autonomic Technologies as a consultant.