Migraines associated with PFO heart defect: Wikis

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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 and cause significant loss of workdays and billions of dollars in productivity. It is well documented that migraine headaches cause significant disability, and reduce of quality of life that is as dire, if not worse than, debilitating chronic diseases. 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 removal of muscles or nerves in areas known as "trigger sites", and those involving the correction of a congenital heart defect.

Contents

Invasive procedures

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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).[2][3][4] The fourth trigger point, however, has been identified in the nose of patients who have significant nasal septum deviation with enlargement of the turbinates.[3] 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.[3][5][6] 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. Currently this treatment has institutional approval for adults, and trials for the pediatric population are ongoing.

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.[3]

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.[7]

It is estimated that 20-25% of the general population in the United States has a PFO.[8][9] Medical research studies have shown that migraineurs are twice as likely as the general population to have a PFO,[7][8] that over 50% of sufferers of migraine with aura have a PFO,[7] 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,[7] and that patients with migraine with aura are much more likely to have a large opening than the general PFO population.[7][9][10]

Anatomy

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.[9]

Toxic circulation

Early speculation regarding this link centered around 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.[9][11] 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.[9][12]

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.[7][9] 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.[13]

Genetic linkage

One study has found a genetic linkage between migraines and PFOs.[10] 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.[14] As well, ANP levels are elevated in patients with a PFO.[14] All together, this suggests a possible correlation between ANP concentration and migraine with aura.[14]

Procedures

It has been shown that migraine frequency and severity is reduced if the hole is patched surgically.[15] 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".[16] 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.[17][18] As well, at least one patient with infrequent migraines who underwent the surgery ended up with daily migraines for at least 6 months,[14] and others have reported short-term increases in migraine frequency and quality following the surgery.[19][20][21]

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.[22] 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.

CardioSEAL

Another closure system is in use right now called CardioSEAL.[23] 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.[24]

Amplatzer ASD

Another device for PFO Closure is called the Amplatzer ASD septal occlude device.[23] Two wire mesh discs filled with polyester fabric are folded into a catheter and inserted into a vein in the leg to advance to the heart. In the same process as the CardioSEAL device, the device is pushed out from the catheter and the discs of the device sit on each side of the hole. The tissue grows over the device over time.[25]

Premium trial

University of Washington Medical Center tests the effectiveness of PFO closure in eliminating migraines in a clinical trial called the Premium Trial.[26] 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. “The device looks like a double umbrella that is opened up to cover each side of the hole to close it. Heart tissue grows over the implant over time. In some cases, the implant is absorbed and replaced with the patient's heart tissue”.

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”.[27] 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 procedure involves two-thirds of the patients who will have their PFO closed, while the other third will have 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 will be asked to maintain an electronic journal of their migraines for one year. The apparent relation between an opening of the PFO valve and migraines will further receive validation through this study.

Other invasive approaches

Surgical ligation of scalp vessels has shown some promise in the treatment of migraine headaches. Ligation of temporal vessels was first described by Abu al-Qasim al-Zahrawi (936 - 1013 AD), a Moorish physician.[28][29] 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.[29] Thus far, this technique has not been popularized. A recent study however, showed that selected patients with chronic migraine experienced a significant reduction in pain levels and significant improvement in their quality of life following the surgery.[29][30][31]

Spinal cord stimulators are a medical stimulator 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.[32]

Non-invasive procedures

Botulinum neurotoxin A (BoNT-A, popularly known as Botox) injections have been reported by various headache specialists as a potential treatment for migraines.[33][34][35][36][37][38][39][40]

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'.[38] 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,[39][40] others observed no significant benefits.[41][42] The AAN has thus reported that they can not yet draw any conclusions on the effectiveness of BoNT-A injections in chronic daily headaches.[38] 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.[38][40]

In the same report, the AAN concluded that the injections were "probably ineffective" in treating episodic migraines. Other studies have reached the same conclusion.[36][37]

Studies examining the effectiveness of BoTN-A injections that were not included in the AAN report have yielded positive results.[33][34][35][36][37] 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.[34][39]

Footnotes

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  2. ^ Mosser, W.; Guyuron, B.; Janis, E.; Rohrich, J. (Feb 2004). "The Anatomy of the Greater Occipital Nerve: Implications for the Etiology of Migraine Headaches". Plastic and Reconstructive Surgery 113 (2): 693. doi:10.1097/01.PRS.0000101502.22727.5D. ISSN 0032-1052. PMID 14758238.   edit
  3. ^ a b c d Guyuron, B; Kriegler, Js; Davis, J; Amini, Sb (Jan 2005). "Comprehensive surgical treatment of migraine headaches". Plastic and reconstructive surgery 115 (1): 1–9. ISSN 0032-1052. PMID 15622223.   edit
  4. ^ Poggi, T.; Grizzell, E.; Helmer, D. (Jul 2008). "Confirmation of Surgical Decompression to Relieve Migraine Headaches". Plastic and Reconstructive Surgery 122 (1): 115. doi:10.1097/PRS.0b013e31817742da. ISSN 0032-1052. PMID 18594393.   edit
  5. ^ Guyuron, B; Tucker, T; Davis, J (Jun 2002). "Surgical treatment of migraine headaches". Plastic and reconstructive surgery 109 (7): 2183–9. doi:10.1097/00006534-200206000-00001. ISSN 0032-1052. PMID 12045534.   edit
  6. ^ Totonchi, A; Pashmini, N; Guyuron, B (Jan 2005). "The zygomaticotemporal branch of the trigeminal nerve: an anatomical study". Plastic and reconstructive surgery 115 (1): 273–7. ISSN 0032-1052. PMID 15622263.   edit
  7. ^ a b c d e f Schwedt, T. J. (2009). "The Migraine Association with Cardiac Anomalies, Cardiovascular Disease, and Stroke". Neurologic Clinics 27 (2): 513–523. doi:10.1016/j.ncl.2008.11.006. PMID 19289229.   edit
  8. ^ a b Waters, Jen (31 Jul 2007). "Easing Migraines.; Drugs, surgery help some; heart defect role studied". Washington Times (Washington, D.C.): pp. B01.  
  9. ^ a b c d e f Post, M. C.; Luermans, J.; Plokker, H.; Budts, W. (Jan 2007). "Patent foramen ovale and migraine". Catheterization and Cardiovascular Interventions 69 (1): 9–9. doi:10.1002/ccd.20931. ISSN 1522-1946. PMID 17143907.   edit
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  14. ^ a b c d Yankovsky, A. E.; Kuritzky, A. (2003). "Transformation into Daily Migraine with Aura Following Transcutaneous Atrial Septal Defect Closure". Headache the Journal of Head and Face Pain 43: 496–498. doi:10.1046/j.1526-4610.2003.03096.x.   edit
  15. ^ Schwerzmann, M; Wiher, S; Nedeltchev, K; Mattle, Hp; Wahl, A; Seiler, C; Meier, B; Windecker, S (Apr 2004). "Percutaneous closure of patent foramen ovale reduces the frequency of migraine attacks". Neurology 62 (8): 1399–401. ISSN 0028-3878. PMID 15111681.   edit
  16. ^ "Against the Migraine". Science News 167 (8): 119–120. 19 February 2005. doi:10.2307/4016110. ISSN 00368423.   edit
  17. ^ Schürks, M.; Diener, C. (Jan 2009). "Closure of patent foramen ovale in the prevention of migraine: not enough evidence in favor". Nature Clinical Practice Neurology 5 (1): 22. doi:10.1038/ncpneuro0971. ISSN 1745-834X. PMID 19048002.   edit
  18. ^ Sarens, T.; Herroelen, L.; Van Deyk, K.; Budts, W. (Jan 2009). "Patent foramen ovale closure and migraine: Are we following the wrong pathway?". Journal of Neurology 256 (1): 143. doi:10.1007/s00415-009-0126-9. ISSN 0340-5354. PMID 19172218.   edit
  19. ^ Bhindi, R.; Ormerod, O. (Apr 2008). "Rebound increase in migraines following PFO closure". Catheterization and Cardiovascular Interventions 71 (5): 719. doi:10.1002/ccd.21394. ISSN 1522-1946. PMID 18360874.   edit
  20. ^ Wilmshurst, T.; Nightingale, S.; Walsh, P.; Morrison, L. (Sep 2005). "Clopidogrel reduces migraine with aura after transcatheter closure of persistent foramen ovale and atrial septal defects". Heart 91 (9): 1173. doi:10.1136/hrt.2004.047746. ISSN 1355-6037. PMID 16103551.   edit
  21. ^ Sharifi, M.; Dehghani, M.; Mehdipour, M.; Al-Bustami, O.; Emrani, F.; Burks, J. (Jun 2005). "Intense Migraines Secondary to Percutaneous Closure of Atrial Septal Defects". Journal of Interventional Cardiology 18 (3): 181. doi:10.1111/j.1540-8183.2005.04068.x. ISSN 0896-4327. PMID 15966922.   edit
  22. ^ Collins, Lois M. (October 3, 2007). "Utah company's new stent may help repair heart defects". Deseret News (Salt Lake City, Utah, USA): pp. E1.  
  23. ^ a b "Patent Foramen Ovale". Cleveland Clinic. Cleveland Clinic. August 2009. http://www.clevelandclinic.org/heartcenter/pub/guide/disease/congenital/pfo.htm.  
  24. ^ "CardioSEAL® Technology/Approach". NMT Medical, Inc.. http://www.nmtmedical.com/technology.aspx?id=90.  
  25. ^ "AMPLATZER® Septal Occluder for Atrial Septal Defect Closure". AGA Medical Corporation. Plymouth, Minnesota, USA. 2008. http://international.amplatzer.com/InternationalProducts/ASDDevices/tabid/505/Default.aspx.  
  26. ^ Black, Cherie (October 22, 2007). "Researchers Look to Herat for Migraine". Seattle Post-Intelligencer (Seattle, Washington, USA): pp. A1.  
  27. ^ Yalonsky Stat, Terry (October 28, 2007). "Clinical Trial in the Works; Probing a heart-migraine tie". Chicago Tribune: pp. 8.  
  28. ^ Al-Zahrawi, Abu al-Qasim (c. 1000). Al-Tasrif.  
  29. ^ a b c Shevel, Elliot (September 19, 2007). "The Role of the External Carotid Vasculature in Migraine". in Clarke, Laura B. Migraine Disorders Research Trends. New York, New York, USA: Nova Science Publishers. pp. 165–183. ISBN 9781600215537.   Preview the chapter at Google Book Search
  30. ^ Shevel, E. (2007). "Vascular surgery for chronic migraine". Therapy 4: 451–422. doi:10.2217/14750708.4.4.451.   edit
  31. ^ Fan, Z.; Fan, Z.; Wang, H. (Aug 2006). "New Surgical Approach for Migraine". Otology & Neurotology 27 (5): 713. doi:10.1097/01.mao.0000226304.66822.6d. ISSN 1531-7129. PMID 16868520.   edit
  32. ^ Matharu, S.; Bartsch, T.; Ward, N.; Frackowiak, S.; Weiner, R.; Goadsby, J. (Jan 2004). "Central neuromodulation in chronic migraine patients with suboccipital stimulators: a PET study" (Free full text). Brain 127 (Pt 1): 220. doi:10.1093/brain/awh022. ISSN 0006-8950. PMID 14607792. http://brain.oxfordjournals.org/cgi/pmidlookup?view=long&pmid=14607792.   edit
  33. ^ a b Schulte-Mattler, Wj; Wieser, T; Zierz, S (May 1999). "Treatment of tension-type headache with botulinum toxin: a pilot study" (Free full text). European journal of medical research 4 (5): 183–6. ISSN 0949-2321. PMID 10336407. http://www.nlm.nih.gov/medlineplus/botox.html.   edit
  34. ^ a b c Samton, J.; Mauskop, A. (Mar 2006). "Treatment of headaches with botulinum toxin". Expert Review of Neurotherapeutics 6 (3): 313. doi:10.1586/14737175.6.3.313. ISSN 1473-7175. PMID 16533136.   edit
  35. ^ a b Blumenfeld, Am; Binder, W; Silberstein, Sd; Blitzer, A (Sep 2003). "Procedures for administering botulinum toxin type a for migraine and tension-type headache". Headache 43 (8): 884–91. doi:10.1046/j.1526-4610.2003.03167.x. ISSN 0017-8748. PMID 12940810.   edit
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  38. ^ a b c d Naumann, M.; So, Y.; Argoff, E.; Childers, K.; Dykstra, D.; Gronseth, S.; Jabbari, B.; Kaufmann, C. et al. (May 2008). "Assessment: Botulinum neurotoxin in the treatment of autonomic disorders and pain (an evidence-based review): Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology". Neurology 70 (19): 1707. doi:10.1212/01.wnl.0000311390.87642.d8. ISSN 0028-3878. PMID 18458231.   edit
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  42. ^ doi:10.4065/​80.9.1126
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References


PFO, or patent foramen ovale, is a heart valve in humans that usually closes off at or shortly after birth. The valve’s function is to let the circulating blood bypass the lungs, which the body doesn't rely on until a newborn starts breathing air.[1] Tissue flaps in the heart usually fuse and close the hole, but complete closure never occurs in about 20 percent of the U.S. population. [2] According to Dr. Thompson, division chief of pediatric cardiology at Inova Fairfax Hospital in Merrifield, "Approximately twice as many people with migraine headaches have PFO compared to the general population."[3]

Contents

Relation to migraines

Problems occur when the valve is not completely fused and allows unfiltered blood returning to the heart from other parts of the body to bypass the lungs. Normally, the blood picks up oxygen to circulate directly to organs, including the brain [4] Without the needed oxygen, the proper amount of oxygen does not reach the brain. Cardiologist Dr. Pranav Loyalka, of the Texas Heart Institute, explained it as a “trap door” that “opens when the person strains, such as during a cough or sneeze.” [5] Air bubbles and dissolved chemicals can also slip through the one-way shunt rather than ride to the lungs, where they'd be exhaled or broken down. [5] Wilmhurst, a cardiologist at the Royal Shrewsbury Hospital in England, speculated that the PFO permits a substance that would be filtered in the lungs to get to the brain." [1] He and some other researchers suspect the peptide serotonin, which is neurologically active and doesn't usually circulate in blood heading from the heart to the brain. [6]

A major effect of the opening is that occasionally blood clots escape through the valve and can trigger strokes. [6] According to the research of Lois Collins, a writer for the Deseret News, half a million cryptogenic strokes worldwide every year are directly attributed to PFOs. [7] Because of the association of strokes and PFO, many stroke patients commonly undergo a procedure to test for an opening of the PFO. Stroke patients who are found to have the opening often undergo surgery to close the PFO valve and prevent the possibility of future strokes. Patients have related a disappearance of their migraines to their surgery.

PFO closure has not only been used for stroke patients. A cardiologist of Royal Shrewsbury Hospital in England found that scuba divers with PFOs were unusually susceptible to decompression sickness, a disorder that can occur when bubbles of nitrogen form in the blood and don't get expelled by the lungs. After closing the heart defects of professional divers, several also reported the disappearance of their migraines.[6] Roman Szatajzel, a neurologist at the University Hospitals of Geneva, performed a PFO valve surgery on a stroke patient. As a result of the surgery, the patient reported a disappearance of her migraines.[1] Even though the migraines disappeared after surgery, not all migraines are associated with an opening in the PFO valve. As related by the Journal of Head & Face Pain, “the relationship between migraine and patent foramen ovale may be stronger in patients suffering from migraine with aura compared to patients with common migraine.[8] Because of the many causes of migraines, studies are now beginning to take place to determine the relation between migraines and an opening of the PFO valve.

Studies

The article “Against the Migraine” relates two instances where relief has been found for migraines from PFO closure:

In the February 2005 issue of Journal of the American College of Cardiology, Reisman, Jesurum, and their Seattle colleagues describe the results of 162 PFO closures in people with a history of stroke or related vascular blockages.[9] Migraines had affected 57 of the patients before the operations. In more than half the patients who had been troubled with migraines, the headaches disappeared after the operation. Another 14 percent of patients reported a reduction by at least half in migraine frequency.

At a meeting of the American Heart Association in New Orleans last November, Sherman G. Sorensen of the Utah Heart Clinic in Salt Lake City and his colleagues reported on 121 stroke patients who'd had a PFO closed. Of the 69 people who'd had migraine headaches before the procedure, 30 had no headaches afterward and 27 reported partial relief from migraine symptoms. [1] Findings continue to provide evidence that many migraines are associated with the opening of the PFO valve. Even with the many causes for headaches, at least half of patients who undergo the PFO closure procedure have fewer migraines. PFO closure continues to provide evidence of migraine relief.

However, the study design in most of these observational studies reporting on headache cessation or relief of migraine symptoms is questionable. Most of them report on retrospective analyses of headache symptoms prone to recall bias. So far, no placebo-controlled randomized controlled trial has indisputably confirmed that PFO closure might result in migraine cessation or in a decrease of headache symptoms.

Treatment

The most common treatment for headaches is medication, but for many people, medications do not help migraines subside or cease and cause unwanted side effects. Mark Reisman, cardiologist of Seattle's Swedish Medical Center explained an advantage to non medication migraine relief. He said, “In contrast to drugs, PFO closure appears highly effective against migraines and usually has no side effects”.[6] Because PFO closure continues to prove successful, new devices are being produced to make the heart surgery process easier and less severe.

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.[10] 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.[6]

CardioSEAL

Another closure system is in use right now called CardioSEAL.[11] 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. Figure 2 below shows the catheter and its relation to the size of a penny. [12] You can see the double umbrellas that open up on either side of the vein.

Amplatzer ASD

Another device for PFO Closure is called the Amplatzer ASD septal occlude device.[11] Two wire mesh discs filled with polyester fabric are folded into a catheter and inserted into a vein in the leg to advance to the heart. In the same process as the CardioSEAL device, the device is pushed out from the catheter and the discs of the device sit on each side of the hole. The tissue grows over the device over time. Figure 3 below shows the Amplatzer ASD device.[13]

Premium trial

University of Washington Medical Center tests the effectiveness of PFO closure in eliminating migraines in a clinical trial called the Premium Trial. [14] 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. “The device looks like a double umbrella that is opened up to cover each side of the hole to close it. Heart tissue grows over the implant over time. In some cases, the implant is absorbed and replaced with the patient's heart tissue”.[6]

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”.[15] 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 procedure involves two-thirds of the patients who will have their PFO closed, while the other third will have 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 will be asked to maintain an electronic journal of their migraines for one year.[6] The apparent relation between an opening of the PFO valve and migraines will further receive validation through this study.

Conclusion

The relation between migraines and the closure of the PFO valve is still undergoing a lot of research. Studies so far appear to show that there is a relation, but that migraines are not always associated with the heart defect. Specific types of migraines may caused by an opening of the PFO valve, but research is still being done to find out the specific relation of certain causes to PFO. Many devices are being studied to improve the PFO Closure process and for now, it looks like many people will find relief from migraines through closure of the PFO.

References

  1. 1.0 1.1 1.2 1.3 Harder, Ben. “Against the Migraine.” Science News Feb. 19, 2005: 119-120. SIRS Researcher. SIRS. Brigham Young University, Provo, UT. 9 Nov. 2007 <http://www.ebsco.com/>.
  2. The Seattle Post-Intelligencer. "Migraines: Where the heart is :Studies aim to learn whether repairing common defect halts terrible headaches. " The Grand Rapids Press” [Grand Rapids, Mich.] 28 Oct. 2007: A 20. ProQuest Newsstand. ProQuest. Brigham Young University, Provo, UT. 9 Nov. 2007 <http://www.proquest.com/>.
  3. Waters, Jen. The Washington Times. "Easing Migraines.; Drugs, surgery help some; heart defect role studied." Washington Times [Washington, D.C.] 31 Jul 2007: B01. ProQuest Newsstand. ProQuest. Brigham Young University, Provo, UT. 9 Nov. 2007 <http://www.proquest.com/>.
  4. Grant, Alexis. "Migraines may not start in your head / Closing up tiny heart defect shows promise for some headache sufferers:[4 STAR , 0 Edition]." Houston Chronicle [Houston, Tex.] 14 Oct. 2007, 1. ProQuest Newsstand. ProQuest. Brigham Young University, Provo, UT. 9 Nov. 2007 <http://www.proquest.com/>.
  5. 5.0 5.1 Ibid
  6. 6.0 6.1 6.2 6.3 6.4 6.5 6.6 Ibid.
  7. Collins, Lois M. Deseret Morning News. "Utah company's new stent may help repair heart defects." Deseret News [Salt Lake City, Utah] 3 Oct. 2007: E 1. ProQuest Newsstand. ProQuest. Brigham Young University, Provo, UT. 9 Nov. 2007 <http://www.proquest.com/>
  8. Domitrz, Izabela; Mieszkowski, Jerzy; Kamińska, Anna. “Relationship Between Migraine and Patent Foramen Ovale: A Study of 121 Patients with Migraine.” Headache: The Journal of Head & Face Pain. Oct 2007: 1311-1318. EBSCOhost. EBSCO. Brigham Young University, Provo, UT. 10 Dec. 2007 <http://www.ebsco.com/>.
  9. Reisman M, Christofferson RD, Jesurum J, et al. (2005). "Migraine headache relief after transcatheter closure of patent foramen ovale". J. Am. Coll. Cardiol. 45 (4): 493–5. doi:10.1016/j.jacc.2004.10.055. PMID 15708692. http://linkinghub.elsevier.com/retrieve/pii/S0735-1097(04)02245-4. 
  10. Collins, Lois M. Deseret Morning News. "Utah company's new stent may help repair heart defects." Deseret News [Salt Lake City, Utah] 3 Oct. 2007: E 1. ProQuest Newsstand. ProQuest. Brigham Young University, Provo, UT. 9 Nov. 2007 <http://www.proquest.com/>.
  11. 11.0 11.1 http://www.clevelandclinic.org/heartcenter/pub/guide/disease/congenital/pfo.htm.
  12. Welcome to NMT Medical.com
  13. AGA Medical Corporation > Home
  14. Black, Cherie. "Researchers Look to Heart for Migraine. "Seattle Post - Intelligencer [Seattle,Wash.] 22 Oct. 2007: A 1. ProQuest Newsstand. ProQuest. Brigham Young University,Provo, UT. 9 Nov. 2007 <http://www.proquest.com/>.
  15. Yablonsky Stat, Terry. "Clincal Trial in the Works; Probing a heart-migraine tie :[Chicagoland Final Edition]." Chicago Tribune [Chicago, Ill.] 28 Oct. 2007: 8. Chicago Tribune. ProQuest. Brigham Young University, Provo, UT. 28 Nov. 2007 <http://www.proquest.com/>.

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