EHMTI-0398. Long term safety of the ATI neurostimulation system for the treatment of cluster headache
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KeywordsPain Relief Cluster Headache Invasive Technique Similar Time Attack Frequency
At least two-thirds of cluster headache (CH) patients that received the ATI Neurostimulation System have achieved profound clinical improvements including acute headache pain relief and/or significant attack frequency reduction. The ATI Neurostimulator is inserted trans-orally using a minimally invasive technique.
This analysis aims to characterize the long term safety of the ATI Neurostimulation System in CH sufferers.
Patients from the Pathway CH-1 and Pathway R-1 studies were included in the analysis. All adverse events (AEs) including transient swelling and pain, were documented and assessed for relationship to procedure and/or the presence of the neurostimulator.
Ninety-eight (98) patients received the ATI Neurostimulator as of May 2014. Fifteen patients (15%) reported no AEs and 83 patients (85%) reported at least one related AE. In total, 341 AEs were reported (average 4.1 AEs/patient). Currently, 216 (63%) of all AEs have resolved; average time to resolution was 69 days (range 0-611). The majority of reported AEs (77.4%) occurred within 30 days of the insertion procedure (peri-op AEs). Of these AEs, 82% of patients experienced sensory disturbances. The large majority (72%) of these events had a mild to moderate impact on the patient's daily activities and were transient, with an average resolution of 110.3 days (range 20-313).
The majority of AEs were reported within 30 days of the Neurostimulator insertion procedure and the majority resolved within 3 months. These AEs are not different from standard sequelae reported for other trans-oral procedures and display a similar time course for healing.
Conflict of interest.
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.