The mean number of headache days each month likewise dropped by half (28 ± 4.1 to 14.6 ± 11.6; P < .001), and 71% of patients were able to reduce the number or amount of headache medications they took.

Overall, 91% of participants were satisfied with their treatment, with a mean satisfaction score of 7.35 ± 2.63 on a scale of 0 to 10; 83% said they would recommend PNS treatment to a friend or family member with chronic, intractable headaches.

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“I wanted to report on patients [in] our group because in a previous multicenter study headaches were reduced by only 30%, and there were frequent complications. But that study involved multiple centers with various levels of experience. I wanted to show that in our experience, PNS can offer long-term benefits,” Dr. Huh told Clinical Pain Advisor.

The previous multicenter study, published in 2012, was a prospective randomized study of more than 100 patients. Adverse events included infection and migration of wire leads (4% and 19%, respectively).1

“The 2012 study did not reach its headache intensity reduction goal of 50% and had high complication rates, which is a major reason that the FDA has not yet approved PNS,” Emad Estemalik, MD, told Clinical Pain Advisor. “This retrospective study lumps together migraine and cluster headache and is not controlled, but the results are impressive.” Dr. Estemalik, a headache specialist from the Cleveland Clinic Center for Neurological Restoration in Cleveland, OH, was not involved in the study.

In the current study of 46 patients, a total of 15 long-term complications were reported, including 2 lead migrations, 1 hardware failure, 3 cases of worsening headaches, and 6 cases of surgical wound infections. A total of 16 PNS devices were removed. Causes included decreased efficacy over time (n = 7), lead migration or malfunction that could not be adequately corrected (n = 4), infection (n = 3), and complete resolution of headaches (n = 2).

PNS Basics

Implanting a PNS device is an outpatient procedure, much like implanting a cardiac pacemaker. Once the device is in place, a remote control device can be used to program it.