Based on an article that appeared in the October 2013 issue of Neurology Reviews, which covered the debate at the International Headache Congress in Boston in June 2013 between plastic surgeon Bahman Guyuron, MD, and neurologist Hans Christoph Diener, MD, PhD, regarding migraine trigger site deactivation surgery (MTSDS), I was asked to write an editorial on the subject. I have attended lectures given by Dr. Guyron and am very familiar with his work. I have also taken care of patients who have considered this procedure, as well as those who have proceeded with surgery against my recommendation.
MTSDS is a term that encompasses four procedures with poor supporting evidence for migraine prevention. The studies that have been performed to date contain many methodologic flaws that invalidate some of the conclusions drawn in the surgical literature. Some of these flaws include unclear patient selection, unmatched groups, and omission of headache medications used during the study period. Some studies inappropriately use the term “control group” even though there was no sham surgery performed. Some subjects received multiple procedures simultaneously, so single procedure efficacy cannot be determined.
The invalid end points of treatment success were a 50% reduction in any ONE of the following: migraine frequency, intensity, duration, or the migraine headache index (frequency × intensity × duration). The term migraine frequency is vague and may not account for multiday headaches, nonmigraine headaches, and postsurgical pain that may not be considered headache. Headache days per month is a more precise measure of frequency and has been the most consistently used unit of measurement in headache studies, including the pivotal PREEMT-2 trial, which demonstrated the efficacy of onabotulinumtoxinA (botox) for the treatment of chronic migraine. Intensity and duration are both variables that can be modified by introducing an effective abortive agent or even having the patient sleep to terminate an individual headache. The migraine headache index is a mathematical way to skew insignificant data into artificial significance.
In some studies, patients experienced “significant improvement” of their headaches but proceeded with additional surgery during follow-up periods. These patients were excluded from the final data analysis for unclear reasons. If one group with a suboptimal outcome was excluded, it would not be surprising if other patients with suboptimal outcomes were also excluded from the final analysis.
It is possible that some of the patients with positive outcomes had other primary headache disorders in addition to migraine that improved with MTSDS. For example, patients who responded to the intranasal trigger site procedure may have had contact point headache. Patients who responded to the frontal trigger site procedure may have had supraorbital neuralgia. Patients who responded to the occipital trigger site procedure may have had occipital neuralgia.
In addition to unclear efficacy, these procedures can be expensive, with an out of pocket cost as high as $15,000 per procedure. MTSDS can also have complications, which are likely downplayed in the surgical literature, including worsening pain, permanent numbness, and permanent itching. A case series will be published in the near future that details the extent of complications that can occur as a result of MTSDS.
The majority of patients in two of the larger studies had episodic migraine (<15 headache days per month), and some of these patients may not have had adequate medical management before being entered into these trials. This practice pattern is probably occurring outside of studies, as surgeries are likely being performed in patients who have not failed optimal medical management, including oral preventative medications, botox injections, and nerve blocks.
One of the longtime paradigms of surgery is to perform elective surgery based on a favorable risk to benefit ratio, and once best medical management has failed. This paradigm has clearly not been followed in clinical practice regarding MTSDS. The American Headache Society does not endorse the treatment of migraine with MTSDS. Any patients who wish to pursue MTSDS should have an evaluation by a headache specialist (one who is headache medicine fellowship trained or board certified in headache medicine) and should be advised of the risks these procedures can have in the absence of any convincing evidence of efficacy.
MTSDS may be useful in a subset of migraine patients, but the supporting data at this time are not convincing. MTSDS should not be recommended until further studies have demonstrated efficacy.
—Paul G. Mathew, MD,
Director of Continuing Medical Education, Brigham and Women’s Hospital, Department of Neurology, John R. Graham Headache Center, Harvard Medical School, Boston, and Director of Headache Medicine, Cambridge Health Alliance, Division of Neurology, Harvard Medical School, Cambridge, MA.