Medical Policy Surgical Treatment of Migraine Headache

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1 Medical Policy Surgical Treatment of Migraine Headache Effective Date: January, 2011; Revised [7/13; 7/15] Subject: Surgical Treatment of Migraine Headache Overview: Several surgical treatments are being explored to provide migraine headache relief. One of the procedures involves surgically removing muscle tissue. Another procedure identifies and corrects intranasal contact points between opposing mucosal surfaces. There is also interest in the closure of a patent foramen ovale to provide migraine relief. Policy and Coverage Criteria: Harvard Pilgrim does NOT cover surgical treatment of migraine headache. It is considered investigational/experimental and unproven. Exclusions: N/A Supporting Information: 1. Technology Assessment: Surgical treatments for migraine headaches have been developed as a potential means to obtain long-term or permanent headache prevention. This approach was investigated initially as an unanticipated benefit of cosmetic surgery. It has been postulated that activation of peripheral sensory nerves, including the trigeminal nerve causes release of peptides, (e.g., substance P, calcitonin gene-related peptide, neurokinins), resulting in vasodilatation and migraine headache. Also, that trigger points can be identified, particularly in the region of the forehead, at which peripheral nerve activation occurs. Botox has been used in some migraine patients. Injection of various craniofacial muscles can provide temporary relief in certain patients. Researchers have proposed using Botox injection as a screening test for peripheral nerve irritation caused by muscle compression as a cause of migraine. Those who respond to the Botox injections may benefit from surgical decompression of craniofacial peripheral nerves. Further, intranasal contact points between mucosal surfaces of the nasal septum and turbinates are suggested to act as triggers releasing pain mediators that are also present in the trigeminovascular system contributing to migraine headaches. Closure of patent foramen ovale (PFO) has also been explored as surgical treatment to improve or eliminate migraine. The pathophysiological mechanism is speculated to be passage of microemboli and vasoactive chemicals through the PFO, thereby evading pulmonary filtration and triggering migraine symptoms. 2. Literature Review: Evidence to support the surgical treatment of migraine continues to evolve. A number of surgical treatment approaches have been proposed with some reported success. However, stronger studies with adequate follow-up are needed to confirm results and better establish appropriate patient selection. Ducic et al (2014) conducted a retrospective chart review and supplemental survey of 71 patients who had undergone greater occipital nerve (GON) excision after failing occipital nerve decompression. The migraine headache index (MHI) was used to measure headache severity and the migraine disability assessment to assess disability. A reduction in MHI of greater than 50% at final follow-up (average 33 months) was considered a success. The success rate of surgery was 70.4%; 41% of patients showed a 90% or greater decrease in MHI. There was a significant improvement in MHI scores (146 to 49) resulting in an average reduction of 63%.There was a significant decrease in migraine disability assessment scores (49%). The authors concluded that excision of

2 the GON is a valid option for pain relief in patients with occipital headaches refractory to both medical treatment and surgical decompression. Liu et al. (2012) published results of a retrospective study comparing results of patients who underwent transpalpebral versus endoscopic approach to decompression of the supraorbital and supratrochlear nerves for treatment of frontal migraine. Charts for 253 patients were reviewed. 62 underwent transpalpebral nerve decompression and 191 underwent endoscopic decompression. The authors found the endoscopic approach had a significantly higher success rate than the transpalpebral nerve decompression. The elimination of migraine was significantly higher in the endoscopic nerve decompression group. A 2012 study (Chepla et al.) examined the outcomes of additional decompression methods by comparing results of patients who underwent glabellar myectomy alone and patients who also underwent supraorbital foraminotomy. Outcomes measures included migraine frequency, severity, and duration. The myectomy group statistically matched the myectomy with foramintomy group for age, number of surgical sites, and preoperative headache characteristics. Results found significantly lower scores for the group with myectomy with foraminotomy. Chepla et al. concluded the supraorbital foramen is a potential site of surbraorbital nerve compression that can trigger frontal migraine. If present, the authors recommend foraminotmy to ensure complete release of supraorbital nerve to optimize outcomes. Guyuron et al. (2000) retrospectively contacted 314 patients who had undergone corrugator supercilii resection for forehead rejuvenation. 39 patients met International Headache Society standards for migraine headaches. 31 of the 39 noted elimination or improvement in migraines immediately after the procedure. The benefits lasted for a mean follow-up period of 47 months. When further analyzed, 15 (38%) reported complete disappearance of migraines over a mean follow-up of 46.5 months, 16 (41%) reported improvement over a mean follow-up of 47 months. These, and additional results, led the researchers to conclude there is a strong correlation between the removal of the corrugators supercilii muscle and the elimination or significant improvement of migraine headaches. Based on the study by Guyuron et al., Dirnberger and Becker (2004) operated on 60 migraine patients between June 2001 and June Patients were divided into three groups based on the severity of their migraines: group A was comprised of patients with up to 4 days of migraine per month; group B included patients with 5 to 14 days of migraine per month; and group C was composed of patients with more than 15 days of headache per month or evidence of drug abuse and drug-related headaches. The effectiveness of the operation was evaluated using the following factors: percentage reduction of headache days; percentage reduction of drugs; percentage reduction of side effects, severity of headaches, and response to drugs; and patient grade of personal satisfaction. Out of 60 patients, 17 reported a total relief from migraine, 24 reported an essential improvement, and 19 reported minimal or no change. Patients with a rather mild form of migraine headache had a much better chance (almost 90 percent in group A and 75 percent in group B) to experience an improvement or total elimination of migraine than those patients (n = 27) from group C with severe migraine and drug-induced headaches. Contrary to the reports by Guyuron, 11 patients who had a very favorable response immediately and in the first weeks after the operation experienced a gradual return of their headaches to preoperative intensity after about 4 postoperative weeks. After 3 months, the results in all patients could be declared permanent. All side effects, such as paraesthesia in the frontal region, disappeared in all patients within 3 to 9 months. Guyuron et al. (2011) published 5 year follow up data on patients randomized to either surgical deactivation of migraine headache trigger sites or control group. 89 of 100 patients in the treatment group underwent surgery. 79 were followed for 5 years. 10 patients underwent deactivation of additional trigger sites during the follow-up period and were not included in the data analysis. 61 (88%) of 69 patients experienced a positive response to the surgery after 5 years. 20 (29%) reported complete elimination of migraine headache. 41 (59%) noticed a significant decrease, and 8 (12%) experienced no significant change. When compared with the baseline values, all measured variables at 60 months improved significantly. Based on the 5 year data, the researchers concluded there is strong evidence that surgical manipulation of one or more migraine trigger sites can successfully eliminate or reduce the frequency, duration, and intensity of migraine headache. Another study by Guyuron et al. (2009) investigated surgical treatment of migraine. The researchers conducted a single-center blinded randomized controlled trial on 76 patients with headache trigger sites identified by positive response to Botox injection. At 12 months, results found 15 of the 26 in the sham group and 41 of 49 in the surgery group experienced at least 50% reduction in migraine headache. (p<.05). 28 of the 49 patients in the treatment group reported complete elimination of migraine, compared with 1 out of 26 in the sham group. The surgery group demonstrated significant improvement in all validated migraine headache measurements at 1 year.

3 The improvements were not dependent on the trigger site. Guyuron et al. concluded the study confirmed that surgical deactivation of peripheral migraine headache trigger sites is an effective alternative treatment for those who suffer from frequent moderate to sever migraine headaches difficult to manage with standard treatments. Behin et al. (2005a) performed a retrospective chart review on patients who underwent septoplasty and sinus surgery for headache. 23 patients were identified who opted for surgery. Only 12 met criteria of having a contact point between the septum and medial wall of the ethmoid sinus or septum and superior turbinate (demonstrated via sinus CT). The surgical intervention aimed to relieve contact points. Results were obtained from a pain questionnaire given pre and post-op. The average follow-up time for the group was months. One of the patients did not meet criteria for migraine headache. 10 patients had no headaches postoperatively. One had significant relief in symptoms. Another patient had significant decrease in duration, frequency, and severity. Behin et al. felt the results showed that contact point headaches can be caused by contact between the septum and medial ethmoid wall and/or superior turbinate. The mechanism of this pain is referred pain involving the trigeminal nerve. The use of sinus CT scans can help diagnose this entity, and surgical management can be used to alleviate the headaches. Behin et al. (2005b) published another retrospective study of 21 patients who had undergone endoscopic surgery and septoplasty for pain due to contact of opposing mucosal surfaces. Specifically, 9 (43%) patients were free of migraines and 7 (33%) had at least 50% improvement in headache scores. In 2003 Welge-Luessen et al. published results of a 10-year longitudinal study of endonasal surgery for contact point headache. The study included 20 patients with a mean 18-year history of refractory cluster or migraine headaches who were selected for surgery. All had endoscopically visible endonasal contact as well as a positive preoperative cocaine test result. Changes in pain severity and frequency and duration of headache attacks were statistically rated using a MANOVA. Follow-up averaged 112 months. Almost 10 years after surgery, six patients remained completely free of pain, seven had significant symptom improvement, and seven received no benefit from surgery (65% improvement). Two patients had been free of all symptoms for 7 and 8 years, respectively, before complaints returned. The researchers felt the data suggested some paints with refractory headaches and endonasal contact benefit from surgery. They acknowledged surgery should only be considered after all other treatments have failed and preoperative patient selection remains crucial and warrants further investigation. Researchers have also investigated the surgical closure of patent foramen ovale (PFO). A higher prevalence of PFO has been noted in migraine sufferers compared to the general population. Some studies have shown the PFO closure resulted in migraine cessation or improvement. Dowson et al. (2008) discussed results of randomized, double-blind, sham-controlled trial of PFO closure for migraine. The treatment group underwent transcatheter PFO closure with the STARFlex implant. Primary efficacy end point was cessation of migraine 61 to 180 days after the procedure. In total, 163 of 432 patients (38%) had right-to-left shunts consistent with a moderate or large PFO. One hundred forty-seven patients were randomized. No significant difference was observed in the primary end point of migraine headache cessation between implant and sham groups (3 of 74 versus 3 of 73, respectively; p=0.51). Secondary end points also were not achieved. On exploratory analysis, excluding 2 outliers, the implant group demonstrated a greater reduction in total migraine headache days (p=0.027). As expected, the implant arm experienced more procedural serious adverse events. All events were transient. Dowson et al. determined the trial confirmed the high prevalence of right-to-left shunts in patients with migraine with aura. While no significant effect was found for primary or secondary end points, further investigation is warranted. Rigatelli et al. (2010) reported on results of a study evaluating the effectiveness of PFO transcatheter closure in migraine patients with anatomical and functional characteristics predisposing to paradoxical embolism without previous cerebral ischemia. Based on basal shunt and shower/curtain shunt pattern on transcranial Doppler and echocardiography, presence of interatrial septal aneurysm and Eustachian valve, 3 to 4 class MIDAS score, coagulation abnormalities, and medication-refractory migraine with or without aura, 40 patients underwent the PFO closure. After a mean follow up of 29.2 months (+/ months), PFO closure was complete in 95% of patients. All reported improved migraine symptomatology. Auras were eliminated in 100% of patients at final follow up. These results led the researchers to conclude primary transcatheter PFO closure resulted in a significant reduction in migraine in patients satisfying the inclusion criteria. Trabattoni et al. (2011) published results of a single-center, observational, prospective study evaluating the impact of PFO closure on migraine attacks over time. Between May 2000 and September 2009, 305 consecutive patients (mean age, 43 ± 12 years; 54.5% women) with a prior embolic cerebrovascular event underwent PFO closure with the Amplatzer PFO

4 occluder for recurrence prevention. All patients had right-to-left shunts; the shunts were associated with migraine symptoms in 77 (25%), either alone (n = 64, 83%) or with aura (n = 13, 17%). Septal aneurysm was present in 15 (19.5%) migraine patients, and 43 (56%) had a previous transient brain ischemic attack. All migraine patients had a CT or MRI, indicating a previous brain ischemic lesion. All 305 patients underwent transthoracic echocardiography with clinical follow-up at 24 hr, at 3, 6, and 12 months, and then yearly. There was a significant reduction in the number and intensity of migraine attackes in 46 of the 77 pants at 3-months followup. At 12 motnhs, migraine had ceased in 23 of the 77 and 20 had a reduction in the migraine recurrence rate and disabling symptoms. There was overall improvement in migraine in 89% of the treated patients. Trabattoni et al. concluded PFO closure may provide beneficail mid-term and long-term results with significant reduction in the intensity and frequency of migraine symptoms. A review of evidence, specifically the MIST trial, by Koppen et al. (2009) found there may be an epidemiological association between PFO and migraine with aura, but he casual relationship remains uncertain. The authors cautioned, the initial positive reports about the MIST study were premature, as ultimately the MIST trial did not show any significant difference between PFO closure and sham closure on migraine. Given these results, earlier retrospective, uncontrolled studies on PFO closure for migraine prophylaxis should be interpreted with great caution. At present PFO closure is not an option for migraine prophylaxis. More randomised studies may be useful, although the side effects of PFO closure might not outweigh the benefits. Nagpal et al. (2013) published results of long-term outcomes following percutaneous patent foramen ovale closure. Mean follow up time was years. 60 migraine patients completed the follow up. Migraine frequency and severity both declined. Codes: Not medically necessary ICD-10 codes: Codes Rhytidectomy; forehead Rhytidectomy; glabellar frown lines Excision inferior turbinate, partial or complete, any method Submucous resection inferior turbinate, partial or complete, any method Septoplasty or submucous resection, with or without cartilage scoring, contouring or replacement with graft Ethmoidectomy; intranasal, anterior Ethmoidectomy; intranasal, total Ethmoidectomy, extranasal, total Nasal/sinus endoscopy, surgical; with ethmoidectomy, partial (anterior) Nasal/sinus endoscopy, surgical; with ethmoidectomy, total (anterior and posterior) Transection or avulsion of; supraorbital nerve Transection or avulsion of; infraorbital nerve Repair of brow ptosis (supraciliary, mid-forehead or coronal approach) Percutaneous transcatheter closure of congenital interatrial communication (ie, Fontan fenestration, atrial septal defect) with implant References: 1. Hayes, Inc. Medical Technology Directory. Surgery for treatment of Migraine Headache. Lansdale, PA: Hayes, Inc. March 19, Guyuron, B., Kriegler, JS., Davis, J., Amini, SB. Five-year outcome of surgical treatment of migraine headaches. Plas Reconstr Surg. 2011; 127(2): Guyuron, B., Reed, D., Kriegler, JS., Davis, J., Pashmini, N., Amini, S. A placebo-controlled surgical trial of the treatment of migraine headaches. Plas Reconstr Surg. 2009; 124(2): Guyuron, B., Varghai, A., Michelow, BH., Thomas, T. Davis, J. Corrugator supercilii muscle resection and migraine headaches. Plast Reconstr Surg. 2000; 106(2): Dirnberger, F., Becker, K. Surgical treatment of migraine headaches by corrugator muscle resection. Plast Reconstr Surg. 2004; 114(3):

5 6. Behin, F., Behin, B., Behin, D., Baredes, S. Surgical management of contact point headaches. Headache. 2005; 45(3)L: Behin, F., Behin, B., Bigal, ME., Lipton, RB. Surgical treatment of patients with refractory migraine headaches and intranasal contact points. Cephalalgia. 2005; 25(6): Welge-Luessen, A., Hauser, R., Schimid, N., Kappos, L., Probst, R. Endonasal surgery for contact point headaches: a 10-year longitudinal study. Laryngoscope. 2003; 113(12): Kung, TA., Guyuron, B., Cederna, PS. Migraine Surgery: A plastic surgery solution for refractory migraine headache. Plas Reconstr Surg. 2011; 127(1): Dowson, A., Mullen, MJ., Peatfield, R., et al. Migraine intervention with STARFlex Technology(MIST) Trial: A prospective, multicenter, double-blind, sham-controlled trial to evaluate the effectiveness of patent foramen ovale closure with STARFlex septal repair implant to resolve refractory migraine headache. Circulation. 2008; 117; Rigatelli, G., Dell-Avvocata, F., Ronco, F., et al. Primary transcatheter patent foramen ovale closure is effecive in improving migraine in patients with high-risk aantomic and functional characteristics for paradoxical embolism. JACC Cardiovasc Interv. 2010; : Trabattoni, D., Fabbiocchi, F., Montorsi, P., et al. Sustained long-term benefit of patent foramen ovale closure on migraine. Catheter Cardiovasc Interv. 2011; 77(4): Koppen, H., Terwindt, GM., Haan, J., et al. No indication for patent foramien ovale closure in migraine. Neth Jeart J. 2009; 17(9): Liu, MT., Chim, H., Guyuron, B. Outcome comparison of endoscopic and traspalpebral decompression for the treatment of frontal migraine headaches. Plast Reconstr Surg. 2012; 129(5): Chepla, KJ., Oh, E., Guyuron, B. Clinical outcomes following supraorbital foraminotomy for treatment of frontal migraine headache. Plast Reconstr Surg. 2012; 129(4): 656e-62e. 16. Lee, M., Lineberry, K., Reed, D., Guyuron, B. The role of the third occipital nerve in surgical treatment of occipital migraine headaches. J Plast Reconstr Aestet Surg Jun 1 [epub ahead of print]. 17. Nagpal, SV., Lerakis, S., Flueckiger, PB., Halista, M., et al. Long-term outcomes after percutaneous patent foramen ovale closure. Am J Med Sci Jan 16 [epub ahead of print]. 18. Kung, TA., Pannucci, CJ., Chamberlian, JL., Cederna, PS. Migraine surgery practice patterns and attitudes. Plast Reconstr Surg. 2012; 129(3): Faber, C., Garcia, RM., Davis, J., Guyuron, B. A socioeconomic analysis of surgical treatment of migraine headaches. Plast Reconstr Surg. 2012; 129(3): Ducic, I., Felder, JM 3 rd., Khan, N., Youn, S. Greater occipital nerve excision for occipital neuralgia refractory to nerve decompression. Ann Plast Surg. 2014; 72(2): Summary of Changes Date Change 4/17 Removed Benchmarks and ICD 9 references