Local patients to be part of trial for Coumadin alternative
A Cottonwood cardiology office is taking part in research that will involve an alternative to a popular blood thinner.
Dr. Nintin Patel and Cardiac Care is participating in trial for the Watchman device, a parachute-like medical device implanted in an appendage of the heart to prevent the escape of blood clots and resulting stroke that may occur.
Atrial fibrillation is a condition that affects 10-percent of Americans over age 65. Millions of people have this condition.
The American Heart Association describes atrial fibrillation as the condition in which the heart's two small upper chambers (the atria) quiver instead of beating effectively. Blood isn't pumped completely out of them, so it may pool and clot. The association estimates that 15 percent of all strokes occur in patients with atrial fibrillation.
The medication Coumadin is often used to thin the blood and prevent clotting. But the blood thinner has its own side affects. It may cause bruising, nosebleeds and occasionally gastro-intestinal bleeds. Many people cannot use Coumadin at all.
Dr. Drory S. Tendler is an electrophysiologist with the Arizona Arrhythmia Consultants. The doctors' group is overseeing a clinical trial in Arizona to prove the effectiveness of a medical device alternative to Coumadin and was chosen as the only implant site in the state. Tendler says, "we are concerned about these patients because atrial fibrillation has a stroke rate of approximately seven percent a year. If 5 percent of those patients with AF cannot use Coumadin, then about a half million people are unprotected with a stroke rate of seven percent each year."
He points out that 98 percent of all clots are formed in the left atrial appendage, an extension of the atrium of the heart that looks like a little ear. The Watchman device can be implanted in the opening of the appendage to prevent a clot from escaping into the blood stream and causing a stroke. The device does not affect the functioning of the heart.
Candidates for the clinical trial are being recruited from the Verde Valley area because it has a high retirement population with a large number of patients who suffer atrial fibrillation, many of whom may have a contra-indication to the use of Coumadin and are ideal subjects for the trial.
Because it is a randomized study, two-thirds of the patients will be implanted with the Watchman device and one-third will be treated with Coumadin, Tendler says.
A patient may be disqualified if a screening finds an existing clot in the atrial appendage. "We wouldn't want to do anything to dislodge that clot."
The complication with the implant, according to Tendler, "could include a perforation of the left atrial appendage. This is seen at a very low rate."
The Watchman device is placed at the opening of the atrial appending and implanted through a flexible tube (catheter) inserted through a vein in the upper leg. The procedure is performed in Scottsdale though the screening.
"Patients who participate in the study will be reviewed regularly for up to five years and are kept informed of new developments and adverse and positive outcomes."
About 50 patients have been screened through Patel's practice so far and 175 people remain to be screened. "I hope that people in the local area will take part in this treatment," Tendler says. "If they qualify and want to participate, we will add them to the list."
About 1,500 patients from across the country are expected to be part of the trial.
Patel says Cardiac Care is working to develop a research facility to provide state of the art care for patients in Northern Arizona. This is one of the first studies conducted here.