Patent Foramen Ovale and Migraine Headaches
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.
Comments
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.