The supposed association between PFOs and migraines has led several companies to begin developing catheter-based devices for closing PFOs, and to begin funding clinical trials aimed at demonstrating that closing PFOs reduces or cures migraines. On March 3, the journal Circulation published the results of a the first such randomized clinical trial, the MIST trial. The study was entirely negative. Closing PFOs in patients with severe migraines did not affect the headaches in any way.
The MIST trial has proven to be controversial for several reasons. One of the principle investigators quit the study over a disagreement on how the data was being analyzed, and is now speaking out against the trial. The sponsor of the trial, a company called NMT Medical, says this investigator had been dropped from the trial (and had not quit) for protocol violations. And to top it off, results that originally had been presented as being partially positive at a major medical conference in 2006 (by none other than the physician formerly known as a principle investigator), finally showed up this month, in print, as being entirely negative.
Other randomized trials are underway to try to show that closing PFOs will cure migraines, but these studies were designed in response to the supposed positive MIST results (since these results were, again, somewhat positive in 2006). Whether these ongoing studies are actually testing a reasonable hypothesis now appears to be doubtful.
DrRich Comments:
I have previously expressed doubts about the likelihood that PFOs are related to migraine headaches. It seemed to me at the time that the supposed link between the two was extremely tenuous, and was based as much on wishful thinking as on plausible theory. (I suspected then that some cardiologists had simply found a really neat new therapy - PFO closure - that was in desperate need of an indication, and that migraines had fortuitously and unexpectedly turned up as a suitable candidate.) So you might think that now I would be crowing, "I told you so."
That I'm not crowing is less a function of my humility than it is simple puzzlement over what the heck is really going on. It seems to me that it is nearly impossible to figure out whether this trial was negative principally because PFOs have nothing to do with migraines (as I suspect), or because of incredibly inept handling of the data (as the ex-principle investigator alleges).
Whatever the reason, anyone with migraines whose doctor wants them to have off-label PFO closure should keep two things in mind: 1) The best information that we have to date is that PFO closure does no good. 2) In the MIST trial, PFO closure was not as benign a procedure as the investigators and the sponsor had hoped. Five of the 65 patients having PFO closure experienced significant complications, three of which could potentially be lethal (though none died). That's a pretty high risk for a procedure that has no measurable benefit.
As a migraine sufferer (and a cardiologist) myself, this is one potential therapy I'm crossing off my list at least for the time being.
Sources:
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; 117:1397-1404.
My doctor talked me into getting screened for a PFO for my Migraine with Aura. Turned out I didnt have it and Insurance paid 100% of the test so I was only out my time.
What I have found to be great is Caffiene avoidance. I started this after reading:
http://www.caffeineandmigraine.com/
Went from 12 – 14 Migrains / year to less then 3 last year, to 0 in the last 7 months with total caffiene avoidance!
Take a look and try it. You have nothing but Migraines to lose!
I said that caffiene could be the cause at first too.
I suffered from migraines with aura at least once a month since puberty and even before that! I suffered a stroke in 2004 which went without a known cause ’till t a year later I was found to have PFO by a specialist. That being the only probably reason for my stroke and not wanting another..I had a procedure implanting an amplatzer occulder a few months later.I was up and around the next day. I have had zero migraines since that day! I believe it worked for me.
I took part in the Mist Trial in th U.K.
I was one of the people to have the “Sham” procedure – which I was convinced of all along by the way, even though I didn’t have one Migraine during those six months of waiting to find out – so afterwards I opted to have the Starflex fitted, believing that closing the hole would be best because of the risk of a stroke, & obviously hoping that it would help prevent Migraines. The Migraines started up again, maybe not quite as often as before but still significant.I think the Asprin & the other blood thinning drug taken during the first six months was what stopped the Migraines initially. As I continued with the extended follow up I couldn’t try taking Asprin to see if that helped. My last appointment was a few days ago though so I’m going to check with my GP to see if it’s ok to try a low dose each day (I have Kidney Disease so have to check). My worry is I’ve had a ’stitch-like’ pain in the left side of my chest for about 15 months now, and wonder if it’s anything to do with the Starflex. Obviously I mentioned it to the Neorosurgeon who’s been monitering me, and he said it may be something to do with it, but I am a little concerned after reading here that a few people had problems! I only had the follow up “Echo” test recently, after much pestering – everything had closed up ok. but it was April 2006 I had the Starflex fitted & it was supposed to be checked six months later, not two years! The Neurosurgeon & nurse monitering my diaries & questionnaires etc. were brilliant, but the Professor who I originally saw & who did the procedure, well, I’m not impressed at all if he couldn’t even be bothered to follow it up. If I hadn’t kept asking for it to be checked I think I would still be waiting. How can I find out if this pain is normal, & if anyone else who had it done is experiencing a similar thing? Help!
I just had to post and thank you for this thoughtful, informative examination of the issue.
I’m a migraineur who blogs about my experiences and migraine-related news, and I have shared this link with many people since I first found it because I think the information is so valuable.
Please BE VERY CAREFUL and do not believe everything written about this perceived cure for migraine by a PFO closure. Although we had gone to see a consultant about fainting and palps, not migraine, it was established my daughter aged 17 had an ASD (larger than a PFO) which was closed with an Amplatzer device in Sept 08. She was on clopidigrel and asprin for 6 month post op. and has had 30+ migraines since. At 6 month check-up she has been told that it is completely sealed, and from the potential “Stroke” point of view, it’s fantastic news, but, it has considerably exacerbated her migraine with aura. She has been on beta-blockers, varying doses to try and manage the migraine, but that is not working. We are now visiting the Migrine Trust, London to see what her triggers are, and how best to manage the attacks. I believe that working with the causes and symptoms is her only way forwards, but I am extremely thankful that the ASD was found. Good luck, we wish you all the best.
I had a PFO closure by stitch in May 2008 for a large atrial shunt (without valsava)which closed the shunt completely even with valsava. My headaches are gone and I now have stamina, no shortness of breath and I can walk for miles all day whereas before I was limited to a hundred yards or so. It was a life saver for me. My guess is my previously enlarged aorta wil be gone in a year. It worked for me and all my family and friends have noticed the improvements. Thank you Royal Brompton Hospital and Dr Mullen.
no shortness of breath and I can walk for miles all day whereas before I was limited to a hundred yards or so. It was a life saver for me. My guess is my previously enlarged aorta wil be gone in a year.
At the age of 27, I began having migraines with auras two to three times a year. Twenty years later, in 1997, I had an ablation procedure for PSVT, and in the process the catheter went across the atrial wall through a PFO, perhaps stretching it. From that point on, I began having auras and migraines with auras 4-6 times per month. I tried everything, from eliminating all caffeine, wine, cheese, cured foods, etc. for months at a time, and nothing made a bit of difference. When I developed a seizure disorder, a new cardiologist agreed to do a bubble test to see if the PFO was significant. It was, with l to r and r to l shunting. I went on Coumadin for 18 months, but it was problematic. In 2005, I had a percutaneous closure of the PFO with a Cardioseal Occluder device. Since that day, I have had NO auras. Not one. I have 1-2 mild migraines per year which respond well to Frova. I am VERY happy with the results of the PFO closure. I also love not taking Coumadin. Clearly, everyone’s situation is unique, and what is causing one person’s migraines may not be what is causing someone else’s. I recommend, though, that those who have migraines with auras have a cardiac ultrasound with agitated saline. If you have a significant PFO or ASD, you should talk to your doctor about aspirin therapy to reduce the chance of stroke.
My thirteen year old daughter had a very large ASD reoair in Mar., 2007. The cardiologist who is following up says that the repair is complete, and there is no longer abnormal “shunting” from one side of her heart to the other. However, she has developed migraine. The first was 4 mos post op that lasted about 3 mos., and the second migraine began in Feb., and has not supsided. Some research shows a correlation between post op migraine and an allergy to the nickel in the closure device. (She had the Amplayzer Occluder seated.) We are having her tested for nickel allergies using the TRUE patch test. We must wait three days to have the patch removed by an allergist to see if she might be sensative to the nickel in the device. From what I can tell, an inflamatory immune response may be the cause of the headaches. Some success in aleviating the pain has been achived by taking Plavex and steroids for a short period of time. We’ll wait and see.
Follow-up from my previous comments. My daughter has been seen by The City of London Migraine Clinic and has been weaned off the beta-blockers because they were not working. Migraines are now down to approx 1 per week, sometimes with paralysis, but not always. In order to get through A2’s my daughter has taken 300mgs of aspirin daily and this seemed to stop the migraines. SHe is not taking anything now and they are back up to 1 per week. We are thinking about trying to establish an optimum dose of daily aspirin to keep the migraines away! I’ll update you later…
I have been having aura migraines since I was 19. At 42 I had an eye stroke and was diagnosed with a PFO. I am now on coumadin (7 years) and my migraines are rare. Coumadin is a pain because you have to get your blood checked once a month but I believe it will prevent me from having another stroke. Blood clotting must have been causing my headaches. Coumadin is my cure to no more migraines.
I’ve have been keeping abreast of the latest research on PFO’s and migraine, but haven’t done anything beyond getting an echo done (which was inconclusive). I’m 38 now and have had migraines since I was a teenager. The triptan drugs like imitrex are effective most (80%) of the time for me, but getting a migraine can still disrupt my normal activities and cause a lot of discomfort. I found that strenuous physical exertion and/or going to a high altitude (> 5000′) often triggers my migraines. Through some trial and error, I also found that wearing sports tights (particularly the ones with more compression) seems to help reduce the incidence and severity of my migraines during outdoor activities.
I had the pfo closure 2 years ago for migraines. There wasn’t hardly any information on the procedure and I had only a very small hole – 2mm but was really desperate as I was getting them 3 times a month and the cardiologist said it would either cure it, make it less or just the same. Unfortunately, after the procedure, I got them everytime I did anything that involved moving about. The cardiologist at the time put me on ‘plavix’ and it stop the migraines. After 2 years I am still on ‘plavix’ as when I go off it I get migraines. The cardiologist doesn’t want to know, and as far as he is concerned I am cured. I have visited so many doctors to get answers but most aren’t up to date with this procedure and some didn’t believe it was done for a ‘migraine’. I have just decided to keep with the ‘plavix’ but have to be on a private script (very expensive) as migraines are not on the list. My recent doctor says that the plavix and that it stops the migraines is a just a coindence. Where I live there is no info on at all on this. I feel I have made a huge mistake as I had no idea I would have this problem.
I agree. I had a PFO closure and it did nothing itself. BUT i did start taking Plavix. and it has saved my life. I went from multiple complex migraines a week to none. Literally, none. I have had ONE in the last year and it was because i was dehydrated and had forgotten to take my medicine. I seriously recommend looking into it. There is a doctor in London who has done a lot of research on it. here is a link to an article about it.
http://www.independent.co.uk/life-style/health-and-families/health-news/drug-promises-end-to-migraine-misery-766812.html
It doesn’t work for everyone. But it did for me. Best of luck!
I suffered from migraines daily for nearly 2 months before I had a stroke at 35 years old. Previously I had 2 TIA’s which cardiology workup was never done. It was found that I had a 10mm PFO (aka ASD) with shunting and an atrial aneurysm right below the defect. I opted to have the septal occluder placed via cardiac cath. After the first couple weeks I still had migraines with the addition of an aura, which my surgeon (director at Mass General) warned me might happen. Then the headaches got worse and after my 6 month follow up I had another echo done (TEE) and found the aneurysm was now a hole. A 25mm hole. No wonder things got worse! I opted for placement of a 2nd device, this one was the cribiform. About 2 weeks after the 2nd placement my migraines went away, the aura went away. I can walk, run and exercise without getting short of breath. Truly has changed my life!! For me, I am a believer that PFO def has a correlation with migraine headaches.
I had suffered with migraines with auras since puberty which were put down to variuos causes: allergies to foods, hormonal changes, contraceptive pills etcs. I also had a number of miscarriages, was anaemic, loved exercise but became tired very quickly, had chest pains put down to cramp in the ribs. In 2003 I had a stroke. No cause was found. I did not drink, smoke and was physical fit. In fact I had a personal trainer at the time and told him the exercise too tiring but he said not. I had every test going. 5 years later during a check up technology had advanced and a hole in my heart was discovered. I had the PFO closure on 25 February 2009 and since that date to this – 2 May 2010 – I have had not 1 migraine or even 1 headache. So you cannot tell me that the migraines were nothing to do the hole in the heart. I am so grateful for the PFO as it chnaged my life.
My husband has 12+ migraines per month. Through a study, he found out he has a PFO. He was in the placebo group, thus didn’t get the closure. We are convinced that closing the PFO will greating improve his quality of life. However, we cannot find a doctor/hospital that is willing to close it unless he has a stoke. Has anyone out there had this done without having some other heart problem?? Please help. We are desperate.
I have had migraines with an aura ever since I was 17 years old. I am now 40. I have had shortness of breath upon certain types of exertion and found out thru numerous testing that I had a PFO, I also only had these migraines about every 3 to 5 months…So they did surgery on me on Aug. 17 of 2010 it is now a month later and I have had 4 migraines in a 3 week time period…. He said something about me having a reaction to the closure device cause it was made of nickel… Do I want something in my body that I am allergic to? Especially on my heart? I am worried now.. cause I cannot function or have a normal job when these migraines come out of nowhere and at anytiime…… I have to have some one pick me up and go home cause it is very hard to see. I hope this goes away… but if it doesn’t do they take it out? I just don’t understand… he said my headaches would go away… but that is not the main reason I got this closure.. it was because I could not hardly do anything physical. Anyways.. thanks for letting me vent!!
I always suffered hormonal headaches from puberty to my mid thirties. At 35 I suffered a stroke, due to the fact that I had no obvious reason to have such a thing at such a young age, my consultant was adamant that it was due to a PFO. An intial heart scan showed my heart to be fine, but my consultant was determined that something wasn’t right, so insisted that I had the bubble test. A bit like what you do with a puncture on a cycle tyre. There it was a 2.5cm hole which was repaired by a fairly straight forward procedure. Yes I’ve had the odd headache since, but certainly not a migraine!
I see a lot of negative comments in regards to the MIST Trials. The article seemed to focus on personal disagreements/mistakes of the MIST trials. What about the others, such as PREMIUM trials? These are not being plauged by ‘personal’ issues. Why would there be multiple companies putting so much money into researching this if it was only for cardiologists curiosity?
I had the PFO closed when i was 8 years old, i had severe migraines after the surgery they got worse then completly stopped after i had quit taking the medcine i had to take afterwards.
For MELISSA, re: your desperate situation on 10/17/10. I had a three quarter inch,congenital ASD (atrial septal defect) that caused me several tias before being discovered and occluded. My brother, then, began to have tias and an ASD was found in him and also “plugged”. We have had no further tias. Coincidence or trend? My sister then began to wonder if she, too, had this condition, and she didn’t want to wait around for her tias to begin. Based on both her siblings’ histories, and with some determined effort, we were able to get her the definitive TEE exam–revealing an ASD!! We were able to test our mother and guess what! If you have family history, you CAN get the surgery without the required symptoms. We don’t have migrains, but you get the point!
I suffered from migraine my entire life but as I reached my 40’s they became more frequent. At the age of 48 I had a large PFO repaired. I went 10 months without a migraine and now I am having 2-3 a week. I am desperate for help. I am unable to work and usually ending up having to get a shot because the pain is so intense.
I’ve suffered from migraines all my life. At 25 I underwent heart surgery (unrelated). They stimulated my PFO and subsequently, I had an attack that lasted for three whole days with all the side-effects you can imagine. I suppose that stimulating the PFO (area) is a trigger for me.