LDS Hospital is part of heart trial

Cardiologists at LDS Hospital are part of an international clinical trial to see if implanting a device in the heart will reduce strokes associated with atrial fibrillation. The condition is the most common heart rhythm disorder and affects more than 2 million Americans, placing them at much higher risk of stroke.

"It's extraordinarily common," says Dr. Brian Whisenant, interventional cardiologist with the Utah Heart Clinic and the hospital's lead investigator for the study.

With atrial fibrillation, chaotic electrical activity in the upper chambers of the heart causes the muscle there to lose its ability to contract. Since the heart is not pumping well, blood can pool in the left atrial appendage, which can lead to blood clots.

Patients with atrial fibrillation have a six-fold risk of stroke compared with those who have normal heart rhythm. The stroke is caused when the clots break off and move to the brain. The American Heart Association estimates that 20 percent of all strokes are the result of the heart rhythm disorder. Because the clots that form tend to be larger, the stroke can be particularly debilitating. Currently, the treatment to prevent the blood stagnating involves the powerful blood-thinning medicine Coumadin (warfarin).

"It's a miserable drug to take," says Whisenant, who cites bleeding risks and the requirement for careful regulation, monitoring and adjustment. Many patients, he says, simply stop taking it.

LDS Hospital is one of 60 centers (and the only one in Utah) participating in the "PROTECT AF" clinical trial. Patients who have atrial fibrillation and could be on Coumadin are randomly assigned to receive the medication or have implanted a self-expanding cagelike device that fills the thumb-sized appendage, which in normal rhythm contracts with the rest of the heart muscle to let blood flow in and out. Once the device is inserted by catheter through the groin and into the appendage, cells start to form over it, closing the space so there's no place for blood to pool.

One patient will be randomized to receive standard Coumadin treatment for every two who receive the implant. It's not a blind study. Both patient and doctor will know who has the cage and who takes the medications, since there's no "sham procedure" to mask who gets what.

Implanting the device takes an hour or two and the patient is kept overnight for observation, Whisenant says. While the device may reduce the risk of clot formation, it doesn't treat the heart rhythm disorder itself.

The device is called the Watchman left atrial appendage system. It's implanted in the cath lab. Patients will be followed for a couple of years, says Whisenant.

To enroll in the study or to get more information, call the Utah Heart Clinic at 801-408-3900.

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