Migraine surgery

Migraine surgery

Migraine surgery is any surgical operation undertaken with the goal of reducing or preventing migraines. Innovative surgical techniques have been developed to help patients with migraine headaches. Migraines affect an estimated 10% of the worldwide population annually[citation needed] and cause significant loss of workdays and billions of dollars in productivity.[citation needed] It is well documented[by whom?] that migraine headaches cause significant disability, and reduce of quality of life that is as dire, if not worse than, debilitating chronic diseases.[citation needed] There have been major pharmacological advances for the treatment of migraine headaches, yet patients must still endure symptoms until the medications take effect. Furthermore, often they still experience a poor quality of life despite an aggressive regimen of pharmacotherapy.[1] For these reasons, surgical solutions to migraines are actively being researched, particularly those involving the surgical cauterization of the superficial blood vessels of the scalp (the terminal branches of the external carotid artery), the removal of muscles or nerves in areas known as "trigger sites", and those involving the correction of a congenital heart defect. Despite the lack of evidence supporting migraine surgery, there are over a dozen surgeons[2] actively performing the operations in the US.

Contents

Surgical procedures

Arterial surgery

The rationale for arterial surgery for the treatment of migraine is based upon the work done by Harold Wolff and his co-workers in the 1940s. Wolff first subjected the condition of migraine to rigorous scientific experimentation, and showed convincingly that in some migraine sufferers the pain originates in the distended terminal branches of the external carotid artery.[3][4][5][6][7][8] Wolff’s theory has since been confirmed many times.[9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31] There have been attempts to debunk Wolff's vascular theory,[32][33][34][35][36] and for years it has been out of favor. Recently however, there has been renewed interest in Wolff's vascular theory of migraine led by Elliot Shevel, a South African headache specialist, who has published a number of articles providing compelling evidence that Wolff was in fact correct.[31][37][38][39][40]

Minimally Invasive Arterial Surgery (MIAS)

There is compelling evidence to show that migraine pain often originates in the terminal branches of the external carotid artery.[41][42][43][44][45] In migraine sufferers with extracranial vascular pain, and in whom digital compression of the relevant artery reduces or abolishes the pain, surgical ligation or cauterization of the relevant vessel or vessels provides permanent relief from not only the pain of migraine, but also the associated symptoms such as the aura, light sensitivity (photophobia), sensitivity to sound (phonophobia), nausea, and vomiting.[46] MIAS is highly successful in migraine sufferers where a definite positive diagnosis has been made, by examining the patient while they are experiencing migraine pain. The terminal branches of the external carotid artery are systematically compressed against the underlying tissues to determine exactly which vessels are responsible for the pain. When the relevant vessels are compressed, the pain either diminishes significantly or disappears completely. In this way, a positive diagnosis is made.

Ligation of temporal vessels was first described by Abu al-Qasim al-Zahrawi (936 – 1013 AD), a Moorish physician.[47] Historically, it has been reported that Ambroise Paré (1510–1590 AD), father of modern medicine, ligated his own temporal vessels for relief of his migraines. Since then the efficacy of arterial ablation for migraine treatment by ligation, cryotherapy, or cauterization of the relevant vessels has been confirmed repeatedly.[48][49][50][51][52][53][54][55][56][57][58]

When is arterial surgery indicated?

This treatment modality is of particular value in: 1) patients who have not responded to conventional drug therapy, 2) patients who are unable to use drug therapy because they experience unacceptable side effects, or 3) patients who would prefer not to be on permanent medication. Included in this category are those with Chronic Daily Headache (headache on more than 15 days per month) and patients with what is known as "refractory headache" - headache that has not benefited from any other form of treatment. A recent study has shown that patients with chronic migraine experienced a significant reduction in pain levels and significant improvement in their quality of life following the surgery.[59] The most common vessels involved in the pain of migraine are the terminal branches of the external carotid artery, and in particular, the superficial temporal artery and its frontal branch, and the occipital artery. These vessels are subcutaneous and the small incisions required to access them mean that the surgery is minimally invasive and can be done in a day facility. As these vessels have no connection with the arterial supply to the brain, MIAS is exceedingly safe with no unpleasant side effects. The cosmetic effect is excellent as most of the incisions are within the hairline.

How do we diagnose who will benefit from arterial surgery?

There are a number of methods used to diagnose whether arterial surgery will be of benefit.

1) There are certain scalp arteries that most commonly cause the pain of migraine. These are compressed with the fingertip during an attack. If blocking the artery by pressure relieves the pain temporarily, and the pain returns when the finger pressure is removed, then arterial surgery is indicated.[60]

2) Some migraine sufferers get relief from tying a tight band round the head just above the eyes and ears. This closes off the arteries that are causing the pain. If a tight band provides relief, then the surgery is indicated.[61]

3) Certain medications provide relief from migraine pain by constricting or narrowing the scalp arteries. If these medications give relief, then the arterial surgery is indicated.[62] These medications include the:

a) Triptans, namely sumatriptan (Imitrex, Imigran, Cinie, Illument, Migriptan), zolmitriptan (Zomig), eletriptan (Relpax), rizatriptan (Maxalt), frovatriptan (Frova, Migard, Frovamig), naratriptan (Amerge, Naramig), avitriptan (BMS-180,048), and almotriptan (Axert, Almogran).

b) Ergots. Any medications that contain ergotamine or dihydroergotamine.

Trigger site release

It has been theorized that trigger sites (TSs) exist where sensory nerves are being stimulated by a surrounding muscle or specific contact points. Due to this nerve irritation, a cascade of events is initiated, leading to the inflammation of the meningeal layers surrounding the brain, and to migraine headaches.

Thus far, four trigger areas have been identified as surgical candidates. Three of these are in locations where the nerve passes through a muscle—where the greater occipital nerve pierces through the semispinalis capitis muscle, the zygomaticotemporal nerve through the temporalis muscle, and the supraorbital/supratrochlear nerves through the glabellar muscle group (the corrugator supercilii, depressor supercilii, and procerus muscles).[63][64][65] The fourth trigger point, however, has been identified in the nose of patients who have significant nasal septum deviation with enlargement of the turbinates.[64] The contact between these structures causes the irritation of the trigeminal nerve end branches and thus triggers migraine headaches. Several large series of studies have been conducted to evaluate the efficacy of surgical obliteration of trigger points. Almost all demonstrated more than 90% response, with at least 50% improvement to complete resolution of migraine pain symptoms.

This type of migraine surgery is not offered as a first line of treatment, but after extensive evaluation and failure of traditional medical treatments.[64][66][67] Trials are still ongoing to standardize the procedures of choice for definitive management of migraine headaches, but there have been successful guidelines for surgical therapy, which are being used by several migraine surgery specialists around the globe.[citation needed] Currently this treatment has institutional approval for adults, and trials for the pediatric population are ongoing.[citation needed]

Details of the procedure

Patients have to be screened preoperatively with a full neurological examination, and subsequent Botox injection and/or nasal endoscopy. A positive response to Botox has been a positive predictor of a successful outcome. Single or multiple TSs may be treated. Migraine headaches can start in one area depending on their corresponding trigger site and spread to the rest of the head. It is important to identify the initial trigger sites rather than address all the areas of pain, after the inflammation involves the entire trigeminal tree. Four different types of migraine have been defined based on their trigger point location, and are addressed individually. Sometimes the alleviation of one trigger site results in the unmasking a second site.

Forehead migraine headaches: In the glabellar area the supra-orbital and supra-trochlear nerves are skeletonized by resecting the corrugator and depressor supercilii muscle using an endoscopic approach similar that of used for cosmetic forehead lift.

Temporal migraine headaches: The temporal area, where the zygomaticotemporal branch of trigeminal nerve passes through the temporalis muscle, is addressed using a similar endoscopic approach but involves removing a segment of the nerve rather than transecting the muscle. This results in a slight sensory defect over temporal skin area, but cross-innervation from other sensory nerves helps to limit the damage.

Rhinogenic migraine headaches: The nasal trigger points where enlarged turbinates are in contact with the nasal septum are addressed with a septoplasty and a turbinectomy.

Occipital migraine headaches: The posterior neck area where the greater occipital nerve passes through the semispinalis capitis muscle is addressed with an open surgical approach with resection of a small segment of the semispinalis muscle and shielding the nerves with a subcutaneous adipose flap.[64]

Patent foramen ovale closure

Several clinical trials are currently under way in an effort to determine the existence of a causal linkage between migraines and the presence of a patent foramen ovale (PFO), a hole between the upper chambers (the atria) of the heart. There is significant evidence that a link exists between migraine with aura and the presence of a PFO.[68]

It is estimated that 20-25% of the general population in the United States has a PFO.[69][70] Medical research studies have shown that migraineurs are twice as likely as the general population to have a PFO,[68][69] that over 50% of sufferers of migraine with aura have a PFO,[68] that patients with a PFO are 5.1 times more likely to suffer from migraines and 3.2 times more likely to have migraines with aura than the general population,[68] and that patients with migraine with aura are much more likely to have a large opening than the general PFO population.[68][70][71]

Anatomy

Main articles: Atrial septal defect and Foramen ovale

The foramen ovale (literally oval hole) is present in all fetuses. Because a fetus' blood is oxygenated through the mother's placenta and not through breathing, the pulmonary system is unneeded. To make the fetal circulatory system more effective, the hole exists so that blood can travel from the right atrium to the left atrium without entering the pulmonary circulation. When the baby is born and begins breathing, the resistance in the lungs decreases dramatically, and blood begins to travel into the pulmonary system. This results in increased pressure in the left atrium, which then forces the flap down and effectively seals the hole. Once fully fused, the resulting structure is called the fossa ovalis (literally oval ditch). If the hole is not fully sealed, it is said to be patent (literally open).

Pathophysiological theories

In certain scenarios, such as when a person sneezes, the pressure in the left atrium decreases and the flap over the still-present foramen ovale opens temporarily. When this happens, blood is able to bypass the lungs and therefore the filtration process in the pulmonary system. There are at least 4 theories as to how this defect leads to migraines.[70]

Toxic circulation

Early speculation regarding this link centered on the idea that, because blood bypasses the detoxificaiton process in the lungs and reenters the circulatory system uncleaned, this "toxic blood" may contain various substances that then trigger migraines.[70][72] There is speculation that one of these substances is 5-HT, more commonly known as serotonin. Normally, 5-HT is filtered in the pulmonary circulation. However, if blood is bypassing that filtration process, 5-HT can re-enter systemic circulation and travel to and enter the brain. Numerous studies have related 5-HT to migraine pathogenesis, and the current pharmacological treatment of choice is a triptan drug, which binds to serotonin receptors in the brain and leads to the migraine being cured. This evidence lends support to the theory that 5-HT is one of the substances that triggers a migraine in a patient with a PFO.[70][73]

Micro-emboli

There is speculation that microemboli that develop in the venous system pass through the PFO and are able to reach the central nervous system.[68][70] The paradoxical embolism then reaches the cortex, triggering cortical spreading depression, a phenomenon that leads to migraines. There is also evidence that the number of gas bubbles in a paradoxical gas embolism is correlated with the severity of the headache.[74]

Genetic linkage

One study has found a genetic linkage between migraines and PFOs.[71] It was found that PFOs have an autosomal dominant pattern of inheritance, and that migraine with aura appears to be coinherited in some families.

Atrial natriuretic peptides

It has been shown that the changes in interarterial pressure that occur with a PFO cause an increase in atrial natriuretic peptide (ANP), and that the ANP concentration in migraineurs with aura is lower than the concentration in control subjects. A study has shown that when the cortical spreading depression phenomenon was induced in mice, ANP was expressed in the brain.[75] As well, ANP levels are elevated in patients with a PFO.[75] All together, this suggests a possible correlation between ANP concentration and migraine with aura.[75]

Procedures

It has been shown that migraine frequency and severity is reduced if the hole is patched surgically.[76] Mark Reisman, cardiologist at Seattle's Swedish Medical Center explained an advantage to non-pharmacological migraine relief. He said, "In contrast to drugs, PFO closure appears highly effective against migraines and usually has no side effects".[77] Because PFO closure continues to prove successful, new devices are being produced to make the surgery easier to perform and less invasive.

Recent studies, however, have emphasised caution in relating PFO closure surgeries to migraines, stating that the favourable studies have been poorly-designed retrospective studies and that insufficient evidence exists to justify the dangerous procedure.[78][79] As well, at least one patient with infrequent migraines who underwent the surgery ended up with daily migraines for at least 6 months,[75] and others have reported short-term increases in migraine frequency and intensity following the surgery.[80][81][82]

Coherex FlatStent Closure System

From Coherex Medical Inc. of Salt Lake City, a device called the Coherex FlatStent PFO Closure System is being tested as a new product for PFO closure. This device is first being studied by a European clinical study in Frankfurt, Germany. If this study proves to be a success, the device will begin to undergo FDA approval.[83] The Coherex Closure System is an alternative to the typical method of repairing a PFO by placing a disk on each side of the defect and clamping them together to form a solid wall. The typical method doesn't always work particularly well with PFOs because the lengths, widths and dimensions of the defect are always different. The Coherex device is small and looks delicate, although it's not. One of its unique features is that it's deployed inside the tunnel of the PFO, so it closes the defect from within Because of its construction, it adapts to a PFO's individual shape in terms of length and width, thus avoiding the typical problem with PFO closure. Besides pulling the opening closed, it has a sponge polymer that encourages tissue to grow into it and integrate it into the heart's structure.[citation needed]

CardioSEAL

Another closure system is in use right now called CardioSEAL.[84] This device looks like a small umbrella made out of Dacron fabric and folded into a special catheter. This catheter is inserted into a vein in the leg like the Coherex device. In order to close the PFO valve, each umbrella opens up and the device is pushed out of the catheter. The device is absorbed into the heart as the heart tissues grow over the implant in time.[85]

AMPLATZER PFO Occluder

Another device for PFO Closure is called the AMPLATZER PFO Occluder device.[84]

It consists of two wire mesh discs filled with polyester fabric. It is folded into a special delivery catheter, similar to the catheter used during a catheterization. The catheter is inserted into a vein in the leg, advanced into the heart and through the defect.

When the catheter is in proper position, the device is slowly pushed out of the catheter until the discs of the device sit on each side of the defect (like a sandwich). The two discs are linked together by a short connecting waist. The discs and the waist are filed with polyester fabric to increase the device’s closing ability.

Over time, heart tissue grows over the implant, and it becomes part of the heart. The tissue grows over the device over time.[86]

Premium trial

University of Washington Medical Center tests the effectiveness of PFO closure in eliminating migraines in a clinical trial called the Premium Trial.[87] All patients must meet certain criteria to qualify for the study including a diary that recounts the severity and frequency of migraines and undergoing tests to eliminate other medical reasons for migraines. A random selection process is then used to determine which patients have their PFO repaired and which ones do not. After a year, the patients will find out if they had the actual procedure and physicians will be able to determine if the process really worked.

The surgery is not performed by cutting open the chest and working on the heart. Instead, a catheter is pushed up to the hole in the heart after it is inserted in a vein in the leg. In order to keep the study blind, all patients are blindfolded and wear headphones while being mildly sedated. All patients receive a catheter in the leg, but not all catheters are pushed up to the heart.

ESCAPE migraine trial

One clinical trial being undertaken began in October 2007 called the ESCAPE Migraine trial to test the relation to PFO closure to migraine relief. Feldman, along with Dr. Susan Rubin, are co-principal investigators of the trial. “The clinical trial expects to enroll 500 patients in the U.S. who have not found relief from migraines with preventive medicine, have experienced unwanted side effects from drug therapy or have been advised by a doctor against medications due to another condition”.[88] This trial will use the closure system called the Premere PFO Closure System that uses the catheter system in the leg to go to the heart. This closure system was designed by St. Jude Medical but is only available for this clinical trial because it has not been approved by the Food and Drug Administration. The study is closed to new participants and has completed final data collection for its primary outcome. Results are expected to be released in fall of 2013.[89]

The procedure involves two-thirds of the patients who had their PFO closed, while the other third had a tube placed in their heart to measure the size of their PFO. The risk of migraine is related to the size of the PFO. Patients will not know until the end of the trial if they were assigned to receive PFO closure. Once the trial is complete, trial participants will meet with a cardiologist for a heart evaluation and a neurologist to evaluate and monitor their migraines after intervention. They were asked to maintain an electronic journal of their migraines for one year. The apparent relation between an opening of the PFO valve and migraines may receive further validation through this study.

Spinal cord stimulation

Spinal cord stimulators are medical stimulators implanted in the region of the spinal cord. They are sometimes used in cases of severe migraine headache on patients who tend to have multiple attacks per month.[90]

Non-surgical procedures

Botulinum neurotoxin A (BoNT-A, popularly known as Botox) injections have been reported by various headache specialists as a potential treatment for migraines.[91][92][93][94][95][96][97][98]

In 2008, a subcommittee of the American Academy of Neurology (AAN) assessed the effectiveness of botulinum toxin in numerous disorders, with one report focusing on autonomic disorders and pain, including 'chronic daily headache'—they noted that this group's headaches were "mainly transformed migraines", and 'chronic tension-type headaches' were not included—and 'episodic migraines'.[96] For chronic daily headaches, four studies were analyzed where the reduction in headache frequency when injected with BoNT-A was compared to a placebo-injected control group. While two of these studies showed favourable results,[97][98] others observed no significant benefits.[99][100] The AAN has thus reported that they can not yet draw any conclusions on the effectiveness of BoNT-A injections in chronic daily headaches.[96] It was noted that, in one study where subjects were stratified based on whether or not they were currently being treated with a prophylactic medication, patients who were not taking prophylactic medications concomittantly fared significantly better than those who were.[96][98]

In the same report, the AAN concluded that the injections were "probably ineffective" in treating episodic migraines. Other studies have reached the same conclusion.[94][95]

Studies examining the effectiveness of BoTN-A injections that were not included in the AAN report have yielded positive results.[91][92][93][94][95] It has been noted, however, that repeated injections are required to keep the headaches under control—the BoTN-A may have a cumulative effect—and they do not address the headaches which are triggered from the septum and turbinates.[92][97]

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