A device that is permanently implanted in the opening of the left atrial appendage (LAA), may be more cost-effective than medication for patients with irregular heartbeat such as atrial fibrillation, new research has shown.

The Watchman, as the device is called, is delivered through a catheter, and once it is placed in the opening of the LAA, a thin layer of tissue grows over it, preventing blood clots from forming and stroke from occurring.

Researchers from Yale assessed the cost-effectiveness of the device when compared to blood thinning medication by developing a statistical model based on data from two research trials, PROTECT AF and PREVAIL.

“We used a Markov model to perform a decision analysis comparing three treatment strategies for the prevention of thromboembolism in patients with [atrial fibrillation],” Dr. James Freeman, assistant professor of cardiology at Yale and first author of the paper, told HCB News.

They used the model to estimate lifetime quality-adjusted survival, costs, and cost-effectiveness of LAA “closure” and compared it directly with warfarin, a blood thinner that treats and prevents blood clots, and indirectly with dabigatran, a different type of blood thinner.

When the researchers used data from PROTECT AF, they found that the cost-effectiveness ratio when compared to warfarin was $20,486 per quality-adjusted life year (which includes quality and quantity of life), and for dabigatran, it was $23,422.

“Using data from PREVAIL, LAA closure was dominated by warfarin and dabigatran, meaning that it was less effective and more costly,” said Freeman, and at a "willingness-to-pay threshold" of $50,000 per quality adjusted life year, LAA closure was cost effective 90 percent of the time under PROTECT AF and only nine percent of the time under PREVAIL.

“PROTECT AF enrolled more patients and has substantially longer follow-up time, allowing greater statistical certainty with the cost-effective results,” said Freeman.

He acknowledged that longer term trial results and “post-market surveillance” of any major adverse event would be needed to determine the value of Watchman when it is used in a clinical setting, but the current body of evidence appears promising.

Last year, Watchman received FDA approval, which came after a clinical program involving studies of 2,400 patients using Watchman. The results of the program showed that the device can be implanted safety, reduces the risk of stroke for certain patients, and can also replace warfarin therapy for most of the patients.

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