« My Jaw’s Contribution to Migraine & Chronic Daily Headache Triggers | Main | Looking Beyond Illness: Adding Up the Smallest Joys »
Closing Hole in Heart to Treat Migraine: PFO Closure Study Findings Not Promising
By Kerrie | March 7, 2008
Studies linking migraine with a hole in one’s heart have been big news in recent years. Preliminary studies showed promise. Results from a large trial, MIST-I (Migraine Intervention With STARFlex Technology), are finally available — and they aren’t good. Researchers concluded that “no significant effect was found for primary or secondary end points.”
Background
The hole, called a patent foramen ovale (or, more commonly, PFO), is an opening between the upper chambers of one’s heart. Some migraineurs who had PFOs closed for another reason reported that their migraine attacks stopped or were much less frequent after the surgery.
The hole is present in fetuses to allow blood to pass from one side to the other. In most people, the gap closes at or after birth. For an estimated 25% of the US population, it doesn’t close completely and the PFO forms. This remaining tunnel functions as a valve. Normally the valve is shut, but sometimes remains open, sending blood that’s supposed to go to the lungs off to the brain and other parts of the body.
MIST Study Findings
My head is too bad to give a good summary, so here’s what cardiologist and blogger Dr. Wes had to say:
This week’s Circulation (on-line version) released the much anticipated MIST trial (Migraine Intervention With STARFlex Technology) results which randomized 147 patients with a moderate to large PFOs between implantation of a STARFlex PFO closure device and a sham (or placebo) procedure.
The study’s primary efficacy end point was migraine headache cessation during the analysis phase. It was derived from diary data.
Secondary efficacy comparisons were incidence of migraine during the healing phase; change in the severity of migraine attacks based on MIDAS (over a 3-month retrospective period) and headache impact test (HIT-6) (over a 1-month retrospective period) scores; change in the frequency of migraine attacks other than elimination of attacks; change in the characteristics of migraine (with or without aura and change thereof); change in the severity, frequency, and character of migraine relative to effective closure rate or presence of residual leak; and change in quality of life based on the SF-36 questionnaire (over a 1-month retrospective period).
Dr. Wes notes that Peter Wilmshurst, one of the original main lead researchers is not included in the manuscript. At a conference last year, Wilmshurst claimed study data were not managed correctly.
Many PFO closure studies, like PREMIUM and ESCAPE are still happening. As is MIST-III, a longer-term trial with the same device as MIST-I. I’m not ready to dismiss PFO closure for migraine. This trial was a pretty big deal, but other study results are necessary. I guarantee I’m not letting anyone near my heart unless there’s strong evidence for doing so.
[via Kevin, MD]
Graphic from Cleveland Clinic’s PFO page.
Topics: Biology, News, Treatment |
March 7th, 2008 at 7:45 pm
That is disappointing news. Thanks for sharing. I was interested in how the heart could possibly be causing a headache. I guess we have to wait until future studies are conducted.
March 8th, 2008 at 8:29 pm
Thanks so much for posting this information. My neurologist just suggested that I undergo “the bubble test” to check for the hole. But I didn’t understand why I would have a hole in my heart in the first place! And why no other symptoms besides migraines?
Thanks again!
March 10th, 2008 at 7:04 am
Well that is not good news. I have a PFO and was enrolled in the ESCAPE trial, but I backed out at the last minute. I was hoping this would be a huge breakthrough and cure me forever! Oh well…
March 10th, 2008 at 6:04 pm
Last year I paid the $410 (not covered by insurance) to see if I had the PFO in my heart. I didn’t. It was good to rule one more thing out though.
May 27th, 2008 at 1:45 am
I had the PFO closure procedure done 11 1/2 months ago (June 2007). I have been migraine free since the procedure. Prior to the surgery I was suffering from one or more migraines per week, along with related TIA’s (trans ischemic attacks - aka mini-strokes). I continue to have severe hormone-related headaches once a month but the traditional migraines and TIA’s have completely stopped. For anyone suffering from severe, quality-of-life impacting migraines I strongly recommend you follow and research the PFO option. I had no side effects or difficulties as a result of the PFO closure and had a quick and easy out patient recovery period following the initial procedure.
May 29th, 2008 at 7:57 pm
I had a TEE performed yesterday that confirmed my PFO that was discovered 10 years ago when I started to have mini-stroke migraines. I was advised by the physician yesterday to have a closure performed. I am only 33 years old and pretty freaked out about this. All other websites that I have read on this procedure have been very promising and reading the above message from Zara makes me feel better about it.
June 16th, 2008 at 9:17 pm
I am 3 years post pfo closure with the Amplaxter clamshell. I have suffered from Migranines with aura, scintillating scotoma, brown outs and other migraine accompanyments including Hortons cephalgia and blurred and double vision for 47 years. I have had both tia’s and a cryptogenic and silent stroke. I have now been completely migraine free since the closure. The procedure was atrumatic, and without side effects. I am comploetely grateful that my neurologist made the correct diagnosis and that I qualified for the treatment. I have a strong family history, and my sister who did not qualify for either the procedure, nor for inclusion in the studies due to age, has had the procedure in South America. She is 1 month post op and has had two migrainous events. I’ll deep you posted. RRN
June 20th, 2008 at 8:45 pm
I am 1 yr post closure, and while the procedure has not rid me of all my migraines (I am still on the same pre-surgery preventative regimen and continue to get very predictable menstrual migraines), I have been able to track an approximately 50% reduction in my number of headache days per month. And, since I used to suffer 12-14 days per month, the surgery has brought welcome relief with no negative side effects. Who can say that about most prophylactic drug treatments?
July 15th, 2008 at 2:08 pm
I’m scheduled for the Escape trial at the end of this month and am just hanging on by my fingernails, hoping I get the PFO closure and that it helps. I find I always get severe migraines with any kind of exercise, so I’ve been pretty sedentary, and that’s causing an overall decline in health that is making me age very quickly. Despite the negative study results, what Robert, Zara, and Laura say encourage me. Please don’t stop the blog now! I’m really hoping for a breakthrough.
July 15th, 2008 at 3:09 pm
I am desperate for help with my migraines. My problems first started out as rare headaches until I had a syncope spell 10 years ago when I was 25. I have had several episodes of syncope along with heart palpatitations and chest pain over the past several years. Recently, my migraines have become unbearable and almost daily. I feel like none of the doctors I have seen care or feel like I truly have a problem. I was very interested in this study. I wonder if this may be my problem.
July 17th, 2008 at 12:51 pm
I participated in the ESCAPE trial and believe I was one of the lucky people to get a device. I went from 11-14 migraines a month to zero. Migraines were ruining my life and some of the side effects from prophylactics that I experienced were life threatening. I know one other person who had a PFO closed after a TIA and her migraines also disappeared. While admittedly the MIST trial had some complications, judgment shouldn’t be passed until ESCAPE and other notable trials publish their results. This technology greatly improves quality of life and migraine sufferers deserve the opportunity to access it before having a stroke or TIA.
July 20th, 2008 at 4:41 pm
I was diagnosed with Migraine headaches when I was a child. I am currently 66 years old. I thought that I had “out grown” the Migraines at about the age of 50.
In the last year and a half to two years, headaches, a little milder than most of the headaches I have had my lifetime, have returned. They last for weeks at a time and no medication seems to help.
In Oct 07 I had an Echo Cardiogram and was told that my Aortic Valve had to be replaced. A Catherization confirmed the necessity of the valve replacement and I was told that my arteries were fine and needed no attention. The Aortic Valve was replaced in Nov 07.
If I have a PFO would and/or should the surgeon have been able to see it during the surgery and told me about it after the surgery?
I have not discussed this with my doctor as I have just learned about PFO yesterday and my understanding is that a lot of family physicians are not aware of this condition, do not run tests for PFO or that PFO’s are associated with migraines.
I will check further but would appreciate any information I should ask my doctor.
Thanks!
*******
Hi Ron,
I’m not sure if your surgeon would have been able to see it. I would guess not, but don’t know for sure. I’d definitely ask your doctor about it. If you have no luck, you may want to talk to a headache specialist about it.
Best of luck,
Kerrie
July 28th, 2008 at 3:40 pm
Hi Ron-
I am being scheduled for an echo cardiogram myself specifically to check for a PFO (advised by my neurologist, who is truly amazing), so I’m guessing if they were checking the overall condition of your heart, they would have caught it.