Can plugging a hole in the heart end headache agony?
A year and a half ago, Nancy Buie's cardiologist carefully threaded a patch of mesh through a vein and into her heart, using it to block a small tunnel between the organ's two upper chambers. The opening shouldn't have been there--it was a defect--and it had caused the 57-year-old Eugene, Ore., woman's stroke. When the procedure was over, Buie looked at her physician and asked, "No more strokes?" No, he said: No more.
Within a few months, Buie realized the heart repair had banished something else. Her agonizing migraines had stopped their monthly, miserable appearances. "I haven't had a migraine since September 2003," she says.
New therapy. Several recent studies suggest that Buie's experience is no fluke. Exactly what links a hole in the heart to migraines, devastating headaches that plague some 28 million Americans, "is still an enigma. But it looks like there's a definite relationship," says neurologist Stephen Landy of the Wesley Headache Clinic in Memphis. More than one quarter of the people who struggle with migraines have the heart defect. If fixing it works, this could be a new treatment for millions of sufferers. And companies that make these mesh plugs would benefit to the tune of billions of dollars.
That is still a large "if," cautions neurologist David Dodick of the Mayo Clinic in Scottsdale, Ariz. Migraines may have many triggers, and the mere presence of a heart defect in some sufferers does not make it one of them. As far as treating it goes, the repair may only appear effective because people's memories of past headache pain are not reliable. But the connection is interesting enough that many neurologists and cardiologists are anxiously awaiting the results of a new trial, now underway in England, that is testing the heart intervention head to head against a mock procedure to eliminate any confusion. "If the trial in England is positive, it's going to be huge," says cardiologist Mark Reisman of Seattle's Swedish Medical Center.
The defect under scrutiny, called patent foramen ovale or PFO, arises when two overlapping curtains of heart tissue never fully join, allowing some blood to go directly from the heart's intake side to its outflow side, bypassing the normal route through the lungs. Doctors regard PFOs as generally harmless, although in a small number of people who have strokes for no other apparent cause, they suspect a clot passing through a PFO may be to blame.
It was stroke victims who first alerted Reisman to the migraine connection, after he started treating some of them by closing their PFOs. On follow-up visits, patients mentioned that their migraines had gone. Intrigued, Reisman and his colleagues did a systematic survey of 162 stroke patients with PFOs. More than a third of them had had migraines. Of those, more than half--Buie among them--were completely cured after PFO closure. Others experienced headaches less frequently than before.
Reisman's team published their observations in February in the Journal of the American College of Cardiology, alongside similar data from a separate investigation of 89 patients by University of California-Los Angeles researchers. A third medical team, from LDS Hospital in Salt Lake City, has found the same connection in an additional 200 patients. And in Europe, researchers have published five studies pointing to the same phenomenon. (The procedure seemed most effective for sufferers who had migraines with auras--visual flashes that go along with attacks in some people.)
Why? Researchers suspect that some substance that migraine sufferers are sensitive to--perhaps a hormone or minute particles of debris--is taking the PFO detour around the lungs and going directly to the brain, where it disturbs blood vessels and triggers a migraine. Normally the lungs filter such things out.
The evidence has mounted to a point where one device manufacturer, Boston-based NMT Medical, started the trial in England this January in which some migraine patients will get PFO closure but other volunteers, unknowingly, will get a fake treatment. The results should indicate whether the operation actually does stop migraines or--if the sham treatment group also improves--if the procedure is simply producing an illusory effect. It will be next year before results are known. Another company, AGA Medical Corp. of Minneapolis, has requested permission from the Food and Drug Administration to undertake a similar study in the United States.
Desperate patients. If the treatment clears the scientific bar, insurance companies might cover it for migraine. So it's not surprising that mesh manufacturers are pursuing it. "It would be a huge market," says cardiologist Sotirios Tsimikas of the University of California-San Diego. "But we have to be careful not to oversell this until we have better data."
Demand for the procedure is already racing ahead of the evidence. When NMT sought fewer than 200 volunteers for its British trial, thousands of interested--and desperate--people overwhelmed its website and jammed phone lines with inquiries. One of them was Jacquelyn Compton, 56, a Williamsburg, Mass., resident, who suffers migraines on as many as 23 days per month. Compton doesn't even know if she has a PFO, and if she gets into a trial also won't know whether she gets the mesh plug or a sham procedure.
None of that deters her. She plans to get tested for the defect--usually a small probe is pushed down the throat to image heart structure with ultrasound--as soon as possible. "If I have the PFO," she says, "I'll get the repair by hook or by crook. It's just too alluring to think of being free of this."
Med for the head
Heart repair isn't the only migraine help available. Medicines can stop a growing migraine or even prevent one from starting.
Easing attacks. Triptans are often the drugs of choice for severe migraines. These medications can alleviate or even stop oncoming headaches, but they need to be taken early, while symptoms are still mild.
Prevention. Topamax was developed to help seizures. Taken daily, it can stop migraines before they begin. Drugs called beta blockers do this too, and Topamax may not work any better, but it can have an appealing side effect--weight loss. (And an unappealing one--forgetfulness.)
This story appears in the April 11, 2005 print edition of U.S. News & World Report.