Abstract
Cluster headache (CH) is a debilitating, severe form of headache. A novel non-systemic
therapy has been developed that produces therapeutic electrical stimulation to the
sphenopalatine ganglion (SPG). A transoral surgical technique for inserting the Pulsante
SPG Microstimulator into the pterygopalatine fossa (PPF) is presented herein. Technical
aspects include detailed descriptions of the preoperative planning using computed
tomography or cone beam computed tomography scans for presurgical digital microstimulator
insertion into the patient-specific anatomy and intraoperative verification of microstimulator
placement. Surgical aspects include techniques to insert the microstimulator into
the proper midface location atraumatically. During the Pathway CH-1 and Pathway R-1
studies, 99 CH patients received an SPG microstimulator. Ninety-six had a microstimulator
placed within the PPF during their initial procedure. Perioperative surgical sequelae
included sensory disturbances, pain, and swelling. Follow-up procedures included placement
of a second microstimulator on the opposite side (n = 2), adjustment of the microstimulator lead location (n = 13), re-placement after initial unsuccessful placement (n = 1), and removal (n = 5). This SPG microstimulator insertion procedure has sequelae comparable to other
oral cavity procedures including tooth extractions, sinus surgery, and dental implant
placement. Twenty-five of 29 subjects (86%) completing a self-assessment questionnaire
indicated that the surgical effects were tolerable and 90% would make the same decision
again.
Key words
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Article info
Publication history
Published online: November 07, 2015
Accepted:
September 28,
2015
Identification
Copyright
© 2015 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.