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Versiunea integrală: Minneapolis Star Tribune today 9/7/09
În acest moment vizualizezi o versiune simplificată a conţinutului. Vezi versiunea integrală cu formatarea adecvată.
Keeping the beat going
JANET MOORE, Star Tribune
For about 10 years, Tom Berner felt "a kind of shaking" in his chest between heartbeats.
The 49-year-old Grantsburg, Wis., guidance counselor and football coach figured he was just getting older. But when he went in for a medical procedure last December, a heart monitor told a different story.
He was suffering from atrial fibrillation, a serious but still somewhat obscure heart condition that affects some 3.3 million Americans. Though it sounds like the name of a Bruce Willis action film, "AFib'' has become the nation's most commonly diagnosed heart arrhythmia.
It has also become one of the most promising markets for medical device makers in over a decade. Now close to a $2 billion business, it has attracted many of the giants in medical technology, including Minnesota players such as St. Jude Medical Inc., Medtronic Inc. and Boston Scientific Corp., plus promising start-ups such as Atritech Inc.
AFib is characterized by the heart's upper chambers (or atria) quivering instead of beating effectively. Although the condition is not immediately life-threatening, the result is a dizzying variety of symptoms that leave sufferers feeling faint, breathless and lightheaded. Worse, because blood is not pumped out of the atria effectively, it may pool and clot, a dangerous situation that could lead to a stroke.
"Atrial fibrillation is totally unpredictable; it ruins lives," said Dr. William Katsiyiannis, an electrophysiologist at the Minneapolis Heart Institute. "Patients are fearful, because it can occur at any time. They could be sleeping. It's a real detriment to their quality of life."
In Berner's case, drugs failed to quell the quivers. The next therapy, an electrical shock to the heart, had only shortlived benefits.
Then his doctor suggested a "radiofrequency catheter ablation,'' a three-hour procedure where catheters inserted in the groin are snaked into the heart. The areas of erratic electrical activity are ablated, or burned, causing the heart to snap back into a regular rhythm.
Katsiyiannis, who performed Berner's procedure, cautions that not all ablations go as well, and that there is a small amount of risk associated with any surgical procedure.
When drugs fail
Berner's experience is fairly typical for AFib patients. Doctors usually prescribe drugs in an attempt to restore the heart rate to normal, plus a blood-thinner to prevent a stroke. The drugs work about half the time.
If drugs fail, more and more doctors are opting for the ablation procedure. Methods vary depending on the device; some involve burning the heart tissue, others involve freezing.
Last year, 78,000 ablations were performed, according to Morgan Stanley analyst David Lewis. But analysts say only 2 to 3 percent of patients who have atrial fibrillation diagnosed actually receive treatment. As a result, the market for ablation tools and mapping diagnostic equipment used in the procedure will exhibit "strong growth" from 2008 to 2013, at a compound annual rate of about 14 percent, according to Millennium Research, a Toronto research firm.
St. Jude moved early
"Everyone in med-tech has been saying the [AFib] market is two years away from picking up. They've been saying that for the past 15 years," said Venkat Rajan, medical device industry manager for Frost & Sullivan, a market research firm. "That's changed."
Little Canada-based St. Jude focused on the condition early on. The company formed a separate atrial fibrillation division in 2005, but its 1996 acquisition of Minnetonka-based catheter maker Daig Corp. for $428 million laid the groundwork for what is now a budding business. Several key acquisitions of AFib companies followed, plus the company invested $62 million into a sleek new headquarters building that includes an AFib technology center.
St. Jude is sponsoring a landmark clinical trial called Cabana, the largest to date in the field, enrolling 3,000 patients worldwide. Final results are not expected until 2014, although Lewis said interim results could be posted in 2011.
The efforts appear to have paid off. St. Jude's AFib division revenue grew 33 percent in 2008 to $546 million, and now comprises about 12.5 percent of the company's overall revenue.
But competitors, including drug giant Johnson & Johnson, Medtronic and Boston Scientific, have targeted the market as well.
In the past two years, Medtronic has paid more than $600 million for companies -- CryoCath and Ablation Frontiers -- developing devices to treat the condition. CryoCath uses balloon technology to freeze problem portions of the atria, while Ablation Frontiers is developing a technology aimed at simplifying ablation procedures. Neither has received Food and Drug Administration (FDA) approval, but they are available in Europe.
One of the most promising start-ups in Minnesota, Plymouth-based Atritech, developed a device to treat atrial fibrillation. Atritech's Watchman device, which prevents blood clots from entering the bloodstream and causing a stroke, is expected to receive FDA approval shortly.
Still obscure
One of the real challenges facing AFib treatment may be on the clinical level.
Katsiyiannis, of the Minneapolis Heart Institute, said there aren't enough specialists trained on the intricate ablation procedure. He estimates there are perhaps 200 centers nationwide equipped to perform the procedure, despite the population of patients suffering from the condition. (The cost of the procedure ranges from $9,000 to $16,000 and is reimbursed by Medicare and most private insurers.)
True Hills, a patient advocate, said many hospitals with the capability to perform ablations have long waiting lists. "If you're on a waiting list, your AFib may get worse while you're waiting," she said.
Lack of familiarity is a problem, too. "There's not a lot of awareness," she said. "When I was diagnosed I was like, 'What the heck is it?'''
She now operates a website (http://www.stopafib.org), writes a blog and gives talks about the condition.
Katsiyiannis said discussion with AFib patients is fairly intensive. "It's so easy to describe a heart attack to my patients; it takes 5 minutes," he said. "But AF? It could easily take an hour."
Another challenge, according to Frost & Sullivan's Rajan, is that a tough economy may prevent hospitals from investing in the capital equipment needed for some of the procedures.
But for patients like Berner, the ablation was worth it. His only complaint: "It didn't cure my snoring."
Janet Moore • 612-673-7752
un articol ce mi sa parut interesant
Da, e interesant articolul, mai ales ca incearca sa explice in termeni comuni pentru cei care nu sunt din domeniu cam care e situatia cu fibrilatia atriala.
Dar se vede ca articolul e scris de un reporter, se simte din limbaj big grin
Cat despre faptul ca cele doua companii cumparate recent de Medtronic, CryoCath si AblationFrontiers, nu au aprobarea FDA ... :cool: draga de ea, ar trebui sa se informeze mai bine.
CryoCath a obtinut aprobarea FDA pe 22 aprilie 2003, iar despre Ablation Frontiers nu stiu exact, dar stiu ca in februarie anul acesta au primit aprobarea FDA pentru a efectua un studiu clinic in State cu produsele lor.
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