Clinical Paper
Oral Medicine
Technical and surgical aspects of the sphenopalatine ganglion (SPG) microstimulator insertion procedure

https://doi.org/10.1016/j.ijom.2015.09.023Get rights and content

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.

Section snippets

Materials and methods

Ninety-nine patients diagnosed with cluster headache (International Classification of Headache Disorders 2nd edition criteria (ICHD-2)) by a physician specializing in headache care (headache neurologist, pain specialist, and general neurologist), who presented for insertion of an SPG microstimulator through May 2014, were analyzed. These 99 patients included 32 Pathway CH-1 study patients who were part of a previously reported cohort,19 11 continued access Pathway CH-1 patients, and 56 patients

Results

Ninety-nine cluster headache patients who presented for insertion of an SPG microstimulator as a part of either the Pathway CH-1 study or the Pathway R-1 registry were analyzed. Baseline patient characteristics are provided in Table 1.

The average duration of the initial insertion procedure was 80 min (range 25–175 min). Ninety-six of the 99 patients had a microstimulator placed within the PPF during their initial procedure.

Follow-up procedures occurred for a variety of reasons, including

Discussion

The Pulsante Microstimulator insertion procedure is a novel procedure designed to place the stimulating electrodes near the SPG. The microstimulator is designed to fit the curvature of the maxilla and to allow placement of the integral lead proximate to the SPG. The remote powering avoids the need for a battery replacement procedure. To date, follow-up procedures have only been needed for cases of initial misplacement or removal; no late lead migrations or breakages have been observed.

The

Funding

The Pathway CH-1 and Pathway R-1 studies were supported by Autonomic Technologies, Inc.

Competing interests

Anthony Caparso is an employee of Autonomic Technologies, Inc. All other authors of this article have no conflicts of interest. There are no financial or personal relationships with other people or organizations that could inappropriately have influenced (biased) their actions.

Ethical approval

Ethical approval was given for the Pathway CH-1 and Pathway R-1 studies: Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen; De Videnskabsetiske Komiteer for Region Hovedstaden Regionsgarden (H-2-2010-092); Ethik-Kommission der Ärztekammer Hamburg (PVMP 3675); Comité d’Ethique CHR de la Citadelle (1112); Comité de Protection des Personnes Sud Mediterranée V (2010-A00896-33); Fundación de Investigación del Hospital Clínico Universitario de Valencia; Ethik-Kommission

Patient consent

Not required.

Acknowledgements

The authors would like to acknowledge the additional surgeons who have implanted the Pulsante Microstimulator System: Denys Fontaine, Thomas Hoffmann, Martin Kahn, Götz Lehnerdt, Lars Lemcke, Mariano Marqués Mateo, Sandrine Machiels, Oliver Müller, Heidi Olze, Kai Wermker, and Alain Wilmont. The authors would also like to acknowledge the neurologists who have participated in the Pathway CH-1 and Pathway R-1 studies. Finally, the authors would like to acknowledge Olivia Bigazzi, Amy Goodman, and

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