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Surgical Deactivation of Headache Trigger Sites

Number 7.01.135

Effective Date October 14, 2013

Revision Date(s) 10/14/13

Replaces N/A

Policy

Surgical deactivation of trigger sites is considered investigational for the treatment of migraine and non-migraine headache.

Related Policies

2.01.29

Biofeedback as a Treatment for Headache

5.01.512

Botulinum Toxin

7.01.125

Occipital Nerve Stimulation

Policy Guidelines

International Headache Society (IHS) Classification II criteria: (2)

Migraine without aura:

Description:

Recurrent headache disorder manifesting in attacks lasting 4-72 hours. Typical characteristics of the headache are unilateral location, pulsating quality, moderate or severe intensity, aggravation by routine physical activity and association with nausea and/or photophobia and phonophobia.

Diagnostic criteria:

  1. At least 5 attacks fulfilling criteria B-D
  2. Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
  3. Headache has at least two of the following characteristics:
  1. Unilateral location
  2. Pulsating quality
  3. Moderate or severe pain intensity
  4. Aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs)
  1. During headache at least one of the following:
  1. Nausea and/or vomiting
  2. Photophobia and phonophobia
  1. Not attributed to another disorder

Migraine with Aura

Description:

Recurrent disorder manifesting in attacks of reversible focal neurological symptoms that usually develop gradually over 5-20 minutes and last for less than 60 minutes. Headache with the features of migraine without aura usually follows the aura symptoms. Less commonly, headache lacks migrainous features or is completely absent.

Diagnostic criteria:

  1. At least 2 attacks fulfilling criterion B
  2. Migraine aura fulfilling criteria B and C for one of the subforms 1.2.1-1.2.6
  3. Not attributed to another disorder
  4. Not attributed to another disorder

Coding

There is no specific CPT code for this procedure but it might be reported using one of the following:

15824 Rhytidectomy; forehead

15826 ; glabellar frown lines

30130 Excision inferior turbinate, partial or complete, any method

30140 Submucous resection inferior turbinate, partial or complete, any method

30520 Septoplasty or submucous resection, with or without cartilage scoring, contouring or replacement with graft

64716 Neuroplasty and/or transposition; cranial nerve (specify)

67900 Repair of brow ptosis (supraciliary, mid-forehead or coronal approach)

Description

Surgical deactivation of trigger sites is a proposed treatment of migraine headaches. The procedure involves identifying a patient’s predominant migraine trigger site and transecting the branches of the trigeminal nerve supplying that area of head and neck. The treatment is based on the theory that migraine headaches arise due to inflammation of trigeminal nerve branches in the head and neck caused by irritation of the surrounding structures. The technique could potentially be used to treat other types of headache.

Background

Migraine is a common headache disorder with a prevalence in the United States of approximately 18% in women and 6% in men. (1) According to the International Headache Society, migraine headache is a recurrent disorder with attacks lasting 4-72 hours. Typical features of migraine headaches include unilateral location, pulsating quality, moderate or severe intensity and associated symptoms such as nausea, photophobia, and/or phonophobia. (2)

A variety of medications are used to treat acute migraine episodes. These include medications that are taken at the outset of an attack to abort the attack (triptans, ergotamines), and medications to treat the pain and other symptoms of migraines once they are established (non-steroidal anti-inflammatory drugs (NSAIDS), narcotic analgesics, antiemetics). Prophylactic medication therapy may be appropriate for individuals with migraines that occur more than 2 days per week. In addition to medication, behavioral treatments such as relaxation and cognitive therapy are used in the management of migraine headache. Moreover, botulinum toxin A injections are a Food and Drug Administration (FDA)-approved treatment for chronic migraine (migraines occurring on at least 15 days per month for at least 3 months).

Surgical deactivation of trigger sites is Another proposed treatment of migraine headaches. The procedure was developed by plastic surgeon Bahman Guyuron, MD, following observations that some patients who had cosmetic forehead lifts often reported improvement or elimination of migraine symptoms post-surgery. (3, 4) The procedure is based on the theory that migraine headaches arise due to inflammation of trigeminal nerve branches in the head and neck caused by irritation of the surrounding musculature, bony foramen, and perhaps fascia bands. Accordingly, surgical treatment of migraines involves removing the relevant nerve sections, muscles, fascia and/or vessels. The treatment is also based on the theory that there are specific migraine trigger sites and that these can be located in individual patients. In studies conducted by Dr. Guyuron’s research group, clinical evaluation and diagnostic injections of botulinum toxin have been used to locate trigger sites. The specific surgical procedure varies according to the individual’s migraine trigger site. The surgical procedures are performed under general anesthesia in an ambulatory care setting and take an average of 1 hour.

Surgical procedures have been developed at 4 trigger sites; frontal, temporal, rhinogenic, and occipital. Frontal headaches are believed to be activated by irritation of the supratrochlear and suborbital nerves by glabellar muscles or vessels. The surgical procedure involves removal of the glabellar muscles encasing these nerves. Fat from the upper eyelid is used to fill the defect in the muscles and shield the nerve. Temporal headaches may be activated by inflammation of the zygomatico-temporal branch of the trigeminal nerve by the temporalis muscles or vessels adjacent to the nerve. To treat migraines located at this trigger site, a segment (approximately 2.5 cm) of the zygomatico-temporal branch of the trigeminal nerve is removed endoscopically. Paranasal headaches may involve intranasal abnormalities, e.g., deviated septum, which may irritate the end branches of the trigeminal nerve. Surgical treatment includes septoplasty and turbinectomy. Finally, occipital headaches may be triggered by irritation of the occipital nerve by the semispinalis capitis muscle or the occipital artery. Surgery consists of removal of a segment of the semispinalis capitis muscle medial to the greater occipital nerve approximately 1 cm wide and 2.5 cm long, followed by insertion of a subcutaneous flap between the nerve and the muscle to avoid nerve impingement.

It has been proposed that other types of headaches, e.g., tension headaches, may also be triggered by irritation of the trigeminal nerve. Although this mechanism of action is less well-established for headaches other than migraine, it is possible that surgical treatment of trigger sites may also be beneficial for some non-migraine headaches.

Regulatory Status

Not applicable.

Scope

Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply.

Benefit Application

N/A

Rationale

Literature Review

The policy was created with a search of the MEDLINE database through June 2012. The policy was updated with a search of the literature from June 2012 through July 1, 2013.

Migraine Headache

Randomized controlled trials

Outcomes in headache studies e.g. pain intensity and duration, are subjective and thus blinded, sham-controlled randomized controlled trials (RCTs) are the ideal study design. To date, 2 RCTs, both from the same research group, have been published evaluating surgical deactivation of migraine headache trigger sites. A description of these RCTs is as follows:

An initial RCT evaluating surgical deactivation of migraine trigger sites was published by Guyuron and colleagues in 2005; this study was not blinded and did not include a sham control. (5) Individuals diagnosed with migraine headache according to International Classification of Headache Disorders II (ICHD-II) criteria were eligible to participate. A total of 100 patients were assigned to the treatment group and 25 to the control group in a 4:1 allocation. They received up to 3 injections of botulinum toxin A (Botox), one at each of their most common trigger sites, to identify a predominant site of headache trigger and potential response to treatment. Individuals were considered candidates for surgery if they had at least a 50% reduction in symptoms for 4 weeks after a Botox injection. Patients in the control group received saline injections instead of Botox and were not eligible for surgery; for the remainder of the treatment period they received usual care. For patients in the intervention group, surgery varied by trigger site. In patients with predominantly frontal trigger migraine headache, the glabellar muscle group was removed to relieve compression of the supraorbital and supratrochlear nerves. Patients with temporal migraine headache underwent removal of 3 cm of the zygomatico-temporal branch of the trigeminal nerve. Patients with both temporal and frontal migraine headaches underwent both procedures. Patients with occipital migraine headache underwent removal of a portion of the semispinalis capitis muscles surrounding the occipital nerve, and a subcutaneous flap was used to shield the nerve from the muscle. Finally, patients with migraine headaches triggered from the septum and turbinates underwent septoplasty and inferior and/or middle turbinectomies.

Among patients assigned to the treatment group, 91 responded to Botox injection and underwent surgery and 89 of 100 (89%) completed the 12-month follow-up. Nineteen of 25 (76%) patients in the control group were evaluated at 12 months. A total of 17 of 125 (14%) randomized patients were excluded from the analysis. In a per protocol analysis at 12 months, 82 of 89 (92%) patients in the treatment group and 3 of 19 (16%) in the control group experienced significant improvement, defined as at least a 50% reduction in baseline migraine frequency, intensity, or duration. The difference between groups was statistically significant, p<0.001. Thirty-one (35%) of patients in the treatment group and none in the control group reported complete elimination of migraines. Most adverse events following surgery were minor and transient. The most commonly reported events were temporary nasal dryness (n=12) and rhinorrhea (n=11). Seven patients experienced intense scalp itching that lasted a mean of 6 months.

Five-year outcomes for individuals in the treatment group were reported by Guyuron and colleagues in 2011. (6) Follow-up data were available for 79 patients (87% of those who underwent surgery and 79% of those randomized to this group). Outcomes were reported for 69 patients. The other 10 had received additional migraine headache surgery and were excluded from the analysis. At 5 years, 20 of 69 (29%) reported complete elimination of migraine headache, 41 (59%) reported a significant decrease in symptoms, and 8 (12%) reported no significant change. All measured variables improved significantly at 5 years compared to baseline. For example, mean headache frequency per month decreased from 10.9 to 4.0 (p<0.0001). Long-term data were not reported for patients assigned to the control group.

Limitations of the 2005 RCT include lack of blinding, lack of a sham-control, and randomization prior to determining eligibility for surgery. In addition, findings were not reported separately by surgical procedure. In terms of long-term follow-up, 5-year data were reported only for the treatment group; long-term outcomes compared to the control group are not available.

In 2009, Guyuron and colleagues published a double-blind, sham-controlled trial evaluating surgical deactivation of migraine trigger sites in 76 patients. (3) Eligibility criteria included a diagnosis of migraine headache according to ICHD-II criteria. (2) In addition, participants were required to have headaches triggered from a single or predominant site, as determined by a headache diary and physical examination. Individuals were then given an injection of botulinum toxin A (Botox) at the prominent site from which migraine pain started. Patients who had a positive response to Botox (i.e., at least a 50% decrease in headache symptoms) and in whom headaches recurred after the effect of the Botox disappeared were eligible for randomization. The methodology differed from that of the 2005 RCT, described above, which randomized patients prior to receiving diagnostic Botox injections. In addition, it is worth noting that in 2012, Liu and colleagues (Dr. Guyuron was a co-author of this study) published an analysis further investigating the method of botulinum toxin injections to select patients for deactivation surgery and found that outcomes were similar in migraine surgery patients who did and did not undergo diagnostic Botox injections. (4) The Liu et al. analysis raises questions about the need for the complex patient selection process used in the published RCTs.

In the 2009 RCT, participants were stratified by the predominant site from which headaches were triggered; frontal (F), temporal (T), or occipital (O) and were then randomized on a 2:1 basis to receive active or sham surgery. A total of 317 individuals were screened for inclusion, 130 received Botox injections and, based on their response to Botox, 76 were considered eligible to participate and underwent randomization. In each of the 3 active treatment groups, surgery consisted of exposure and removal of nerves and/or muscles. For patients in the sham group, surgery was limited to exposing the nerves and/or muscles; the integrity of the structures was left intact. The procedures differed according to the predominant headache trigger site and were similar to procedures used in the Guyuron et al. 2005 trial. Briefly, patients in the F active surgery group underwent removal of the glabellar muscles encasing the supraorbital and supratrochlear nerves. Patients in the T active surgery group underwent removal of a segment of the zygomaticotemporal branch of the trigeminal nerve. In the O surgery group, a segment of the semispinalis capitis muscle medial to the greater occipital nerve was removed.

Patients kept headache diaries and were seen at 3, 6, 9, and 12 months after surgery. Seventy-five of 76 patients (49 in the active treatment group and 26 in the sham group) completed the 1-year follow-up. There were 29 patients in the F group (19 active treatment, 10 sham), 28 in the T group (19 active treatment, 9 sham), and 18 in the O group (11 active treatment, 7 sham). Patients remained blinded to their group assignment through 12 months, at which time individuals in the sham surgery group were offered the operation. Key results are displayed in the table below. Note that for the frequency, intensity, and duration variables, there were no statistically significant differences by trigger site, so overall results are displayed. Results for the same outcomes from the Guyuron et al. 2005 RCT are also summarized below.

Baseline data and 12-month change from baseline data

Outcome variable

Guyuron et al. 2009

Guyuron et al. 2005

Active surgery (n=49)

Sham surgery (n=26)

P value (between- group)

Active surgery (n=89)

Usual

care

(n=19)

P value (between- group)

Complete elimination of headaches

28/49 (57.1%)

1/26 (3.8%)

<0.001

31/89 (35%)

0/19 (0%)

<0.001

Significant improvement*

41/49 (84%)

15/26 (58%)

0.005

82/89 (92%)

3/19 (16%)

<0.001

Headache frequency (mean, per month)

Baseline

12 months

9.9 (SD: 6.0)

7.4 (SD: 5.8)

9.5 (SD: 4.4)

3.5 (SD: 5.4)

0.005

10.9 (SD: 0.8)

3.8 (SD: 0.4)

9.9 (SD: 1.7)

10.2 (SD: 1.7)

<0.001

Headache intensity

(mean, 1-10 VAS)

Baseline

12 months

6.2 (SD: 1.7)

3.0 (SD: 3.5)

5.5 (SD: 1.4)

1.3 (SD: 2.9)

0.03

8.6 (SD: 0.13)

4.0 (SD: 0.3)

8.8 (0.24)

7.0 (0.3)

<0.001

Headache duration [mean days (2009), mean hours (2005)] Baseline

12 months

0.5 (SD: 0.6)

0.3 (SD: 0.5)

1.7 (SD: 5.6)

0.9 (SD: 4.5)

0.43

1.4 (SD: 0.14)

0.4 (SD: 0.05)

1.3 (SD: 0.25)

1.0 (SD: 0.2)

0.007

SD= standard deviation; VAS=visual analogue scale

*Significant improvement was defined as at least a 50% reduction in migraine frequency, intensity, or duration compared to baseline.

In the 2009 study, in addition to the between-group differences, there was statistically significant improvement in headache frequency, intensity, and duration from baseline to 12 months within the active surgery group and significant improvement in headache frequency and intensity within the sham surgery group. The improvement in outcomes within the sham group were greater than those seen after usual care in the 2005 RCT, suggesting that there may be a substantial placebo effect associated with the surgery to deactivate trigger sites.

No adverse events were reported in the sham surgery group. All patients in the active treatment group reported some degree of paresthesia immediately after the operation. One patient experienced numbness 12 months after the operation. The most common adverse event in the active treatment group was temporal hollowing in 10 of 19 (53%) patients in the T (temporal) group.

Advantages of the 2009 study included a sham control group and blinded comparison of outcomes in the 2 groups through 12 months after surgery. Limitations of the study include small numbers of patients in each sub-group and a lack of reporting of patients’ use of other migraine treatments e.g., Botox, medications, etc. during the 12-month follow-up period. In addition, patient selection involved a long multi-component selection process, which might not be practical on a widespread basis.

Case Series

Other research groups have published retrospective case series evaluating some type of surgical deactivation of trigger sites for individuals with migraine headache, but no controlled studies. Dirnberger and Becker in Austria reported on 60 patients with migraine headache diagnoses meeting International Headache Society criteria. (7) Patients all underwent resection of the corrugator supercilii muscle by the same surgeon who used the technique recommended by Guyuron. At 6 months, 35 of 60 (58%) reported at least a 50% reduction in headache days and at least a 50% reduction in headache medication use. Twenty patients (33.3%) reported no reduction in headache days at 6 months. Poggi and colleagues reported on 18 patients who had undergone surgical decompression of various nerves by a single surgeon. (8) Mean follow-up was 16 months (range, 6 to 41 months). The mean number of headaches per month decreased from 11.9 (standard deviation [SD]: 9.3) pre-operatively to 3.7 (SD: 4.4) post-operatively. Three patients (17%) reported complete relief of migraines. Behin and colleagues published outcomes in 21 patients who underwent endoscopic sinus surgery and septoplasty for refractory migraine headache and completed a 2-year follow-up questionnaire. (9) Mean reported headache frequency was 17.7 (SD: 11.2) per month prior to surgery and 7.7 (SD: 7.6) at follow-up. Mean headache severity (10-point scale) decreased from 7.8 (SD: 1.5) to 3.6 (SD: 3.7).

In 2012 and 2013, the research group headed by Guyuron published several retrospective case series that included patients who underwent surgical deactivation of migraine headache trigger sites. (10-12) The case series evaluated various aspects of the intervention, such as whether removal of the third occipital nerve improves outcomes (11) and whether outcomes are better with endoscopic versus transpalpebral decompression (12).

Non-Migraine Headache

No studies were identified that evaluated surgical deactivation of trigger sites as a treatment of non-migraine headache.

Summary

The evidence on the effectiveness of surgical deactivation of trigger sites to treat migraine headache consists of one double-blind sham-controlled RCT and an earlier non-blinded RCT without sham control by the same research group, which is also the research group that developed the procedure. In the 2 published RCTs, patients were selected for randomization based on clinical evaluation and their response to injections of botulinum toxin A. A 2012 analysis questions the necessity of using diagnostic botulinum toxin injections for patient selection; however, the efficacy of surgical deactivation of trigger sites following patient selection by clinical evaluation alone has not been evaluated in RCTs. Both trials reported statistically significantly better outcomes at 12 months in patients who received active surgery for migraine headache. In addition, several case series, but no controlled studies, have been published by other research groups.

This evidence is suggestive of a benefit from surgical deactivation, but is not sufficient to form definite conclusions. There is a need for additional sham-controlled studies by other research groups to confirm the results of the single published trial using sham surgery. In addition, there is a need for further refinement of patient selection criteria and evaluation of any altered selection process e.g., without the use of diagnostic Botox injections in controlled studies. Thus, surgical deactivation of trigger sites to treat migraine headache is considered investigational.

No published studies have evaluated surgical deactivation of trigger sites as a treatment of non-migraine headache, and therefore, this is considered investigational.

Practice Guidelines and Position Statements

No relevant national guidelines or position statements were identified. The American Academy of Neurology (AAN) evidence-based headache guidelines do not address surgical deactivation of trigger points.

Medicare National Coverage

No national coverage determination.

References

  1. Bigal ME, Lipton RB. The epidemiology, burden, and comorbidities of migraine. Neurol Clin 2009; 27(2):321-34.
  2. 2nd Edition of the International Headache Classification (ICHD-2)2nd Edition of the International Headache Classification (ICHD-2). Available online at: http://ihs-classification.org/en/. Last accessed September 6, 2013.
  3. Guyuron B, Reed D, Kriegler JS et al. A placebo-controlled surgical trial of the treatment of migraine headaches. Plast Reconstr Surg 2009; 124(2):461-8.
  4. Liu MT, Armijo BS, Guyuron B. A comparison of outcome of surgical treatment of migraine headaches using a constellation of symptoms versus botulinum toxin type A to identify the trigger sites. Plast Reconstr Surg 2012; 129(2):413-9.
  5. Guyuron B, Kriegler JS, Davis J et al. Comprehensive surgical treatment of migraine headaches. Plast Reconstr Surg 2005; 115(1):1-9.
  6. Guyuron B, Kriegler JS, Davis J et al. Five-year outcome of surgical treatment of migraine headaches. Plast Reconstr Surg 2011; 127(2):603-8.
  7. Dirnberger F, Becker K. Surgical treatment of migraine headaches by corrugator muscle resection. Plast Reconstr Surg 2004; 114(3):652-7; discussion 58-9.
  8. Poggi JT, Grizzell BE, Helmer SD. Confirmation of surgical decompression to relieve migraine headaches. Plast Reconstr Surg 2008; 122(1):115-22; discussion 23-4.
  9. Behin F, Behin B, Bigal ME et al. Surgical treatment of patients with refractory migraine headaches and intranasal contact points. Cephalalgia 2005; 25(6):439-43.
  10. Chmielewski L, Liu MT, Guyuron B. The role of occipital artery resection in the surgical treatment of occipital migraine headaches. Plast Reconstr Surg 2013; 131(3):351e-6e.
  11. Lee M, Lineberry K, Reed D et al. The role of the third occipital nerve in surgical treatment of occipital migraine headaches. J Plast Reconstr Aesthet Surg 2013.
  12. Liu MT, Chim H, Guyuron B. Outcome comparison of endoscopic and transpalpebral decompression for treatment of frontal migraine headaches. Plast Reconstr Surg 2012; 129(5):1113-9.
  13. Blue Cross and Blue Shield Association. Surgical Deactivation of Headache Trigger Sites. Medical Policy Reference Manual. Policy 7.01.135, 2013.

Coding

Codes

Number

Description

CPT

15824

Rhytidectomy; forehead

 

15826

glabellar frown lines

 

30130

Excision inferior turbinate, partial or complete, any method

 

30140

Submucous resection inferior turbinate, partial or complete, any method

 

30520

Septoplasty or submucous resection, with or without cartilage scoring, contouring or replacement with graft

 

64716

Neuroplasty and/or transposition; cranial nerve (specify)

 

67900

Repair of brow ptosis (supraciliary, mid-forehead or coronal approach)

ICD-9-CM Diagnosis

   

ICD-10-CM
(effective 10/01/14)

G43.001 - G43.919

Migraine code range

ICD-10-PCS
(effective 10/01/14)

008K0ZZ, 008K3ZZ,
008K4ZZ

Surgical, central nervous system, division, trigeminal nerve, code by approach

 

00BK0ZZ, 00BK3ZZ,
00BK4ZZ

Surgical, central nervous system, excision, trigeminal nerve, code by approach

 

00NK0ZZ, 00NK3ZZ,
00NK4ZZ

Surgical, central nervous system, release, trigeminal nerve, code by approach

 

09BL0ZZ, 09BL3ZZ,
09BL4ZZ, 09BL7ZZ,
09BL8ZZ

Surgical, ear, nose, sinus, excision, nasal turbinate, code by approach

 

09BM0ZZ, 09BM3ZZ,
09BM4ZZ

Surgical, ear, nose, sinus, excision, nasal septum, code by approach

 

09TL0ZZ, 09TL4ZZ,
09TL7ZZ, 09TL8ZZ

Surgical, ear, nose, sinus, resection, nasal turbinate, code by approach

 

0HQ1XZZ

Surgical, skin, repair, face, external

 

0W020ZZ, 0W023ZZ,
0W024ZZ

Surgical, anatomical region, alteration, face, code by approach

Appendix

N/A

History

Date

Reason

10/15/12

New Policy. Policy created with literature search through June 2012. Policy states “Surgical deactivation of trigger sites is considered investigational for the treatment of migraine headache”.

10/14/13

Replace policy. Policy updated with literature search through July 1, 2013. References 10-12 added. Non-migraine headache added to policy statement.


Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
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