Atrial fibrillation is a cardiovascular disorder that affects 2.2 million people in the United States. It occurs when the heart’s two small upper chambers (the atria) quiver instead of beating effectively because of an electrical short-circuit, and 15 percent of these patients are susceptible to having a stroke, the third leading cause of death for adults in the United States and Europe, and the leading cause of adult disability in the nation, according to experts.
But new technology that is a part of a clinical study led by a Harvard-trained Santa Monica cardiologist and electrophysiologist may bring those afflicted with this condition the hope of living a normal life.
Dr. Shephal Doshi, director of the Pacific Heart Institute in Santa Monica, is a principal investigator in a two-year-old clinical study on atrial fibrillation. He and other researchers are hoping that a new device called the Watchman can not only reduce the need for prescription blood thinners, but eliminate or greatly lessen the potential for strokes.
“This device may prove to have a larger impact on the treatment of patients with atrial fibrillation, more than any other therapy over the last few decades,” asserts Doshi, who practices at St. John’s Hospital in Santa Monica.
The Watchman is designed to permanently keep blood clots that form in the left atrial appendage from entering the bloodstream, creating the potential to cause a stroke.
The procedure involves the insertion, using a cable, of a small parachute-like device into the left atrial appendage of the heart. The device is placed without surgery and, once there, the device is designed to reduce the potential for blood clots to leave the left atrial appendage and travel to the brain.
“It’s like filling a pothole, so blood doesn’t stay in there and turn into blood clots,” the doctor explained.
After insertion, a protective membrane grows over the device, and after two weeks the patient will return for analysis and further examination to ensure that there are no side effects.
“We put a tube through a vein in the leg, and we inject dye into it so that we can see the shape of the appendage, so that we can take measurements of how big it is,” Doshi explained. “That way, we can decide what size the device should be.”
After the Watchman is deployed, the cable is unscrewed, and the device is freed.
“For the 48 days, it acts like a filter, so no blood clots can pass, only red blood cells for oxygen, and the membrane eventually seals the appendage completely,” says Doshi.
“Atrial fibrillation can significantly raise the possibility of stroke, and any device or procedure that is given scientific review would be welcome,” said Reames Freedman, director of the Southern California Stroke Association.
The rate of stroke for patients with this cardiovascular condition who have no access to medical care is approximately five to seven percent a year, which is considered very high among medical professionals. It increases exponentially, which means that in two years it could be ten to 14 percent, and three years 15 to 21 percent. This, say medical researchers, is crucial because, in patients that have atrial fibrillation and have suffered stokes, over 90 percent of them had blood clots in the appendage.
“It makes sense from that information that we address the problem directly in fixing the blood clots in that pouch,” said Doshi. “The purpose of the study is that we believe, if you fix the issue with the appendage, then patients should not need to take some kind of significant blood thinner like warfarin.”
Warfarin, the generic name for the blood-thinning drug Couma-din and others, interacts with what a person eats, and it is therefore hard to maintain stable blood levels in patients.
“Sometimes your blood gets too thick, and it doesn’t work, and sometimes it gets too thin, and you bleed,” said Doshi.
Coumadin has been shown to reduce the risk of strke by 70 percent in clinical trials. To date, says Doshi, it has been the best option for those with atrial fibrillation.
“Now we’re saying, let’s see what we can do — with current technology and an understanding of what’s going on, we’re trying to make it better for patients,” said the doctor. “Even if it is only as effective as Coumadin, at least patients at high risk don’t have to take this medicine every day or come in every week sometimes to get their levels checked.
“We’re hoping that this will be even better than Coumadin,” Doshi continued. “But even if it is just the equivalent of Couma- din, it’s a win-win situation for everybody, including the patient.”
One of Doshi’s patients in the study is Art Linkletter, the radio and television host. Linkletter, who gained prominence for hosting television programs like House Party and Kids Say The Darndest Things, underwent the procedure at St. John’s two months ago, with Doshi as his physician.
“I had been taking blood thinners and had several blood tests over a period of years,” said the former television host. “I was concerned because with atrial fibrillation, strokes can ensue.”
After a recent visit to his doctor, Linkletter’s was informed that there was a clinic study being conducted by Doshi and other investigators. “[My doctor] asked me, ‘How would you like to do away with [the heart medication]?'” Linkletter said.
Prior to qualifying for the study, Linkletter was required to undergo an ultrasound to make sure that he did not have a blood clot, and then submit to a random selection from the Federal Food and Drug Adminstration (FDA).
The procedure takes approximately 30 to 45 minutes, and is considered a “non-surgical, interventional” procedure, according to Doshi.
Along with Linkletter, there are currently about 500 patients participating in the clinical trial. Two thirds of the patients undergo the procedure with the Watchman and one-third take Coumadin.
“We’ve had an exciting interest in this device, primarily because of people like Art Linkletter, who have been great spokes- men for it,” Doshi said. “The problem for us is, this is not necessarily something that you advertise, although you do want to raise awareness in people who could benefit from [the Watchman].”
Many cardiologists are unaware of the current study, Doshi says, “because it’s so cutting edge. And it’s our job as electrophysiologists and to educate them, and that takes time.”
Doshi says he is “like an electrician for your heart.”
Linkletter, 95, recently went in for a checkup and reports that he “has never felt better.”
Primarily a disease of advanced aging, atrial fibrillation can affect ten percent of the population over 80 years of age.
“That’s why this study has such a huge impact,” Doshi stressed. “If we can do this one procedure that allows them to stop taking blood thinners, it can improve not only their quality of life, but it can also be cost effective, because there can be less strokes and less doctors visits.”
Because the study is still ongoing, Doshi was reluctant to discuss any findings in detail.
“But so far, we’re very encouraged with the way that things are going, and we hope that we can continue to enroll patients at the rate that we are.”
To find out how to qualify for the study, contact Lissa Dela Cruz of the Pacific Heart Institute, (310) 829-7678, ext 57, or Ldelacruz@pacificheart.com.