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Research Studies

Simplicity- HTN Trial:

Revolutionary clinical trial to treat high blood pressure using a small catheter to ablate the nerves in the renal arteries (renal artery denervation) call Gemma Miralles, RN, BSN, CCRN, CCRC, CCRP LEAD CLINICAL RESEARCH COORDINATOR, HEART & VASCULAR CENTER 1100 West Stewart Drive, Orange, CA 92868 T: 714-744-8776 F: 714-744-8798 gemma.miralles@stjoe.org or Dr. Santora for information.

WATCHMAN OFFER

We are currently offering the WATCHMAN left atrial occlusion device on an investigational basis. The primary investigation, which is titled Protect AF Clinical Trial, will be closing on June 30, 2008. It looks like Dr. Tucker is going to be the No. 1 implanter worldwide with about 70 patients enrolled in the clinical trial, exceeding all other sites, including the Mayo Clinic and Harvard and Cleveland Clinic. So, once again, we are very proud to be the most experienced center in the world with this exciting new technology. Going forward as of July 1, patients will still be able to get the WATCHMAN device through a registry, and there will no longer be a randomized clinical trial. That is, all patients interested in the device can simply get the device implanted if they qualify. For more information, contact Dr. Tucker at the Orange County Heart Institute.

Cardiology Research at OCHI

Thursday, September 21, 2006

A step against strokes
Local doctor is part of a national study on a heart device that could upgrade care for millions with atrial fibrillation.

By BLYTHE BERNHARD
The Orange County Register

A new treatment is available for the more than 2 million Americans who have atrial fibrillation, a disorder that keeps the heart from pumping effectively. When blood doesn't completely pump out of the heart, clots can form. Strokes can result if a clot travels to an artery in the brain. The disorder is thought to cause about 15 percent of strokes. Atrial fibrillation is commonly treated with blood-thinning drugs, surgery or pacemakers. Now, an implantable device called the Watchman has been designed to keep clots from traveling to the brain. The device is available through a clinical trial hosted by Western Medical Center in Santa Ana and 40 other hospitals nationwide. Western Medical cardiologist and principal investigator Dr. Kelly Tucker talks about why he thinks the Watchman is a promising alternative to current therapies.

Q: How does the Watchman work?

A:
This device is a cork, if you will or purse of the left. New knowledge has shown us that the blood clots form in a small appendageatrium. It's designed to stick into this appendage and stay there and occlude it. It acts as a barrier so clots cannot form.

Q: What are the results?

A:
The device was studied in a pilot trial, beginning in 2001. Of 66 patients, 97% got the device. There were no complications of the procedure. All have come off (blood-thinning drug) Coumadin. There have been no strokes in that group. That's very promising. Based on the trial the FDA approved a larger trial at 40 centers internationally. We're very experienced with the device and we like it. We've done 15 patients. The patients seem to do very well with this strategy and they can stop their Coumadin. The Coumadin is designed to cause your blood to be thin and prevent a blood clot. If you overly thin the blood, the patients can have life-threatening bleeding.

Q: How much does it cost?

A:
Probably in the future the actual device will cost a couple of thousand dollars. The federal government has agreed to pay for this. You can bill for this through Medicare. If Medicare covers it, any other insurance will pay as well. Compared to lifelong therapy with this pill, it's extraordinarily inexpensive. Device therapy is almost a perfect therapy. Once you get the device implanted that's the end of it. There's no pill to take, nothing to remember. This particular device never needs to be replaced.

Q: Who is this device for?

A:
This is appropriate for patients with atrial fibrillation who are on Coumadin. The FDA is going to require about 600 patients to get the device (before the agency either approves or denies the device for general use). We're about a third of the way there. It should be on the market in two to three years. We've really enjoyed the device. We've found it to be technically easy to implant. In follow-ups it appears to be doing the job.

Q: What is the procedure like?

A:
It's an outpatient procedure. There are no stitches or incisions. It's all catheter-based. Patients are up and around immediately and can go home within 23 hours. In the pilot trial, average time for the procedure was 50 minutes. In our hands we're doing them in less than 30 minutes.

Q: What about anesthesia?

A:
We do a general anesthetic. We have to put the patients to sleep because we have to image their heart in a special way and we don't want them moving. It's no different than, say, having your appendix out, but there are no stitches or incisions.

Q: Aren't similar devices already out there?

A:
It's not as though this is a revolutionary, brand-new idea. We've built on other technologies. We're using them for this specific medical problem. It's very similar to other implantable filters that have been used for many, many years.

Q: How does the clinical trial process work?

A:
The FDA of course has to oversee the whole thing. There's a fair amount of regulatory scrutiny involved. The company (Atritech of Plymouth, Minn.) does help support us with a full-time guy; all he does is coordinate the study. There's an enormous amount of paperwork to do a study of this type. They try to help us meet our costs on this sort of thing.

Q: Is there a financial incentive for you to co-host this study?

A:
There's a process for us getting paid. These days it's one of the areas of concern for any health care provider. I'm happy to save a life, but my employees want to be paid and I have to pay overhead. Whenever we try to collect for any patient it's a real ordeal. With a study it's a little easier for us in some ways. But we don't support a practice by doing a study of this type. This is almost philanthropic.

Q: Why do you participate in clinical studies?

A:
We really are trying to reach out to the community and help people. Coumadin is OK, but this is much, much better. And I know this in my heart. This is the future of medicine. I have a pretty strong heritage of being at the leading edge. When this new technology comes up, if I think it's something that's going to last and help the patients, we get involved with it. I wouldn't even stay in medicine if I couldn't get involved in studies like this. This type of leading-edge medicine is the only thing I'm interested in. To be honest, I don't want to see 800 HMO patients a month. I want to bring in new technologies and change the world.

Monday, November 27, 2006; 11:24 PM

Doctors Test Implants to Block Strokes

By LAURAN NEERGAARD
The Associated Press

WASHINGTON -- At least 120,000 Americans a year suffer strokes because of a common irregular heartbeat -- one that's on the rise, hard to treat and can shoot deadly blood clots straight to the brain. Now doctors are experimenting with a new way to prevent those brain attacks: a tiny device that seals off a little section of the jiggling heart where the clots form.

If it works -- and a major study is under way -- the Watchman device might provide long-needed protection for thousands of people with atrial fibrillation, whose main hope now is a problematic blood-thinning drug that too many can't tolerate.

"I don't think I'm biased, but it could potentially revolutionize a-fib, which is a ton of people," says Dr. Steven Almany, vice chief of cardiology at William Beaumont Hospital in Royal Oak, Mich. He has implanted the Watchman into more than a dozen patients so far.

About 2.8 million Americans have atrial fibrillation, the most common type of irregular heartbeat. It is most common among the elderly, and cases are increasing as the population grays.

A-fib occurs when the heart's top chambers, called the atria, get out of sync with the bottom chambers' pumping. The atria speed up, sometimes so fast that they quiver like a bag of worms. Blood pools inside a pocket of the heart, allowing clots to form.

About 20 percent of the nation's strokes are blamed on the condition, and they tend to be particularly severe. About a third of the victims die, and another third are significantly disabled, Almany says.

The blood thinner warfarin, also called Coumadin, lowers the stroke risk dramatically. But it is very difficult to use -- it can't be taken together with dozens of other medicines, and requires dietary restrictions and regular blood testing. In addition, side effects include serious, even life-threatening, bleeding.

By some estimates, almost half the people who should take the drug can't or won't, and "there are lots of people out there on Coumadin who want off," says Dr. William Gray, a cardiologist studying the Watchman at New York's Columbia University Medical Center. "This provides the opportunity, hopefully, to get them off the drug."

In atrial fibrillation, 90 percent of stroke-causing blood clots collect inside a jalapeno pepper-shaped flap of tissue that hangs off the edge of the left atrium. Some call it the heart's belly button, a leftover from fetal development that the body no longer needs.

The Watchman physically seals off that flap, depriving clots of their staging area. The question is whether that really will stop strokes. To find out, doctors are recruiting hundreds of patients around the country to get either the experimental device or the usual Coumadin.

How does the Watchman work?

Doctors thread the mesh-covered metal brace through a leg vein up to the heart, and wedge it into the opening of the troublesome flap. Tiny hooks hold it in place until heart tissue grows over it to form a permanent seal. Forty-five days after implantation, Watchman recipients have a tube put down their throats for a special heart scan to tell if the flap really is closed off. If so, they quit Coumadin.Of the roughly 250 patients enrolled so far, 97 percent of Watchman recipients have quit the drug, Almany says. They still must be tracked for at least two years, to see how many have a stroke.

"I was a little apprehensive at first," Grace Holland of Shelby Township, Mich., says of the experiment.

Holland, 76, didn't mention her heartbeat's "flutter" to doctors for years; she had no idea it could cause a stroke. Finally diagnosed, she took Coumadin for about two years before suddenly suffering internal bleeding that almost killed her, her arms and legs streaked with black as an ambulance sped her to the hospital.

The close call persuaded Holland to try the Watchman, and a year later she's off Coumadin and feeling good. "It's such a relief."

An American Stroke Association spokesman cautioned that it's far too early to know if an implant will prove a better gamble than Coumadin, a proven stroke fighter. "I wouldn't want to raise hopes before the data is in," said Dr. Larry Goldstein, director of Duke University's stroke center.

Nor is the Watchman risk-free. The flap it blocks is very thin, posing a puncture risk as doctors hook the device in place.

"You put a hole in there, you've got a problem," says Almany, who had that happen to one patient -- and had to do emergency surgery to stop massive bleeding and save the man.

Columbia's Gray notes that a similar experimental device, called the PLAATO, did seem to cut stroke risk by two-thirds in a small study several years ago; it hasn't yet moved into large-scale testing.

If the Watchman ultimately works, Almany predicts the procedure could cost $12,000 or so, less than treating a stroke or a bad Coumadin side effect.

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