Alternate PFO Treatment

diverklondike

While I am not a fan of cross posting... I saw this on another forum and felt it would be of high value to everyone on Rebreather World.

Dive Safe

Mark

http://www.canada.com/nationalpost/n...53c9f025e0&k=0

'Futuristic' patch prompts heart to heal its defects

By Tom Blackwell
National Post

Thursday, August 23, 2007

A Toronto-area stroke patient has become the first person in North America to be implanted with a "futuristic" new patch that prompts the heart to naturally heal a common defect, then dissolves harmlessly into the body.

The device, made largely from pig intestine, fixes a hole in the heart that causes ailments such as strokes and migraines in otherwise healthy patients, some only in their teens. Unlike previous methods for treating the same problem, no permanent implants are left behind in the heart, where they can trigger clotting or inflammation and impede future surgery.

It is a novel approach that may have broader applications for heart-disease treatment down the road, and could help migraine sufferers in the short term, said Dr. Eric Horlick, the Toronto General Hospital cardiologist who pioneered the technique on this continent.

Derwyn Miller, a 59-year-old retired high school teacher from Aurora, Ont., became the first North American to undergo the procedure last month.

Another three of Dr. Horlick's patients have had the treatment since then.

"It's really the way of the future ... a new way of thinking," he said. "If you put something in and it goes away, the heart heals itself - that whole emphasis on getting the body to repair itself, healing the heart with the body's own tissues - is likely the safest way to do it."

The BioStar device targets defects known as patent foramen ovales, or PFOs, a type of hole in the wall separating the upper right and left sides of the heart. As many as 30% of adults have one, in most cases with no adverse consequences.

But in a small number of people, blood can travel from the right to the left chamber, pushing any clot that might be in the right side out of the heart to the brain, causing a stroke, or into a coronary artery, causing a heart attack. The problems can strike at a young age. "I see many 18- and 22-year-olds who are perfectly normal, and show up in emergency with paralysis of half their body."

The defect has also been implicated in an unknown percentage of migraine cases, sleep apnea and altitude sickness.

Until now, the defect has been repaired with permanent implants that essentially bridge the gap in the heart. They can take weeks or months to close the hole completely, and sometimes lead to side effects such as increased clotting, Dr. Horlick said.

They also hamper surgeons from operating on the left side of the heart if problems develop there later, he said.

The new device, made largely from the collagen layer of pig intestine, is inserted in the groin and fed through a vein to the left side of the heart, where it is pushed through the hole and opened like an umbrella.

The mesh is pulled tight over one side of the opening, and a similar umbrella opens on the other side, immediately closing the hole.

In an action that Dr. Horlick compared with using a Steri-strip to treat a deep cut, the heart naturally heals and tissue grows over the implant. Within a month, the hole is fixed and the "bioabsorbable" patch has almost completely dissolved.

A European study published in the journal Circulation last year, which saw the BioStar implanted successfully in most of 58 subjects, concluded the device is effective and safe.

Mr. Miller said he woke up one weekend morning in 2001 suddenly unable to do up his shirt or read. His foot dragged behind him.

Despite having no obvious risk factors and being only 53, Mr. Miller had suffered a stroke. Prescribed aspirin to thin his blood, his health seemed back to normal for the next few years, until, again with no warning, he woke up last November to find the vision in his left eye faltering, a terrifying prospect given he was already blind in the other eye.

A blood clot was causing the vision troubles, and a series of tests eventually identified the culprit as a PFO hole in his heart.

A BioStar device was implanted on July 13, fixing the defect, and ensuring that sudden exertion would not trigger a disastrous reaction in his heart.

"It's a huge relief to know that I can do something as simple as lift a suitcase out of a car without having to worry about there being a clot that could result in loss of vision," he said.

tblackwell@nationalpost.com

tibby

Maybe I should've waited to get my PFO closed (4 months ago)! I sure would could have done without a piece of wire mesh in my heart.
Thanks for the link.
Tibby

gtzavelas

wao!
very very interesting
can one of the docs of the forum trace the:
" European study published in the journal Circulation last year, which saw the BioStar implanted successfully in most of 58 subjects" ?

wedivebc

Very interesting. Thanks for the post.

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Cheers,

Dave....

Man is the only animal burdened with the knowledge he will eventually die

bendomatic

here.

Attached Images

1962.pdf (275.7 KB, 25 views)

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why deal with idiots on the net when you have to spend all day dealing with them at work.

bendomatic

while i am still in the middle of reading this, its nice to see that there inclusion policy included people who had had DCI and have a significant PFO.

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dteubner

Thanks Rachel - saved me finding it.

I guess I would make a couple of points. This is a phase 1 study - and represents the first use in humans. Results of phase 1 studies are often a fair bit better than what is subsequently seen in larger studies.

To really know which technique is better for closure then a comparison of the new device with existing technologies would have to be done - and proper phase 2 and 3 are not that common with devices like this.

If you are a diver with a PFO and a history of DCI and you want your PFO closed then you are (should be) interested in the rate of success and the rate of complications. A phase 1 study does not really give you this information.

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Dave T

Hanlon's Razor - Never attribute to malice that which can be adequately explained by stupidity.

MrClive

very very intresting, thanks for sharing.

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clive

debersole

As a cardiologist who percutaneously closes PFOs on a regular basis, I found the study interesting when it was published in Circulation. However, as mentioned above it is a "first in man" pilot study. If I had a PFO and needed it closed I would go with one of the currently approved devices that has a long track record of safety and efficacy. The bioabsorbable product is interesting, but needs a lot more investigation.

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tibby

Thanks to the Docs for your inputs. It is encouraging to read words like good track of safety and efficacy for the current devices. It is not a fun experience.
Tibby