A Philadelphia cardiologist has written a newspaper column questioning the efficacy and cost of Boston Scientific’s Watchman device for stroke prevention.
The Watchman left atrial appendage closure device is designed to prevent blood clots that form in the heart’s left atrial appendage from reaching the brain. Boston Scientific (NYSE:BSX) markets it as an alternative to blood-thinning drugs such as warfarin.
Dr. David Becker of Chestnut Hill Temple Cardiology in Flourtown, Pa., part of the Temple University Heart & Vascular Institute, acknowledges the efficacy of blood thinners such as Eliquis, Xarelto and Pradaxa, but considers them expensive. Warfarin (marketed as Coumadin) is less expensive but necessitates frequent blood tests for monitoring.
In his Philadelphia Inquirer column, Becker describes his experience recommending a Watchman device for a 72-year-old patient with atrial fibrillation and a history of stroke. The man was not a candidate for blood thinners.
“The device is FDA-approved and research suggests it is effective in reducing stroke in people who cannot take blood thinners,” Becker wrote. “The downside: expense, potential complications, and spiraling use as the device begins to be implanted for questionable indications. There have already been well more than 50,000 placed worldwide.”
Becker cites a handful of studies that shed less-than-favorable light on the Watchman. A 2018 study published in Heart Rhythm Society journal, questions the routine clinical use of Watchman. Another 2018 study, published in the American Heart Association journal Circulation, reports on the formation of blood clots on the Watchman itself in the months after implantation. Finally, he cites a 2016 University of Alabama-Birmingham analysis that found the Watchman ranked last in terms of safety compared with five different blood-thinning drugs.
Becker also refers to a 2016 study that found the Watchman more cost-effective than certain blood thinners. (The Centers for Medicare and Medicaid Services (CMS) approved coverage of the device that same year.) Boston Scientific recently released the results of a cost-effectiveness analysis that reached a similar conclusion when comparing the Watchman with blood thinners over the long term. Dr. Vivek Reddy, a professor of medicine and cardiology at Mount Sinai Hospital in New York City and a paid consultant to Boston Scientific, Abbott and Biosense Webster, was principal investigator on both studies.
“Boston Scientific stands behind the robust body of clinical evidence and real-world outcomes supporting the Watchman left atrial appendage closure (LAAC) device,” the company said in an email statement to MassDevice. “As the most studied LAAC device, Watchman is proven as a safe, efficacious alternative to long-term warfarin therapy for patients with non-valvular atrial fibrillation seeking another treatment option to reduce their risk of stroke.
“The Watchman device, which has been implanted in more than 90,000 patients globally, continues to demonstrate a reduced risk of stroke and has shown reduced bleeding post-procedure and mortality when compared to warfarin in long-term, post-market studies,” the company concluded.
Becker also wrote that Boston Scientific charges a hospital an upfront fee to set up a program to implant the Watchman, and offers a discount to hospitals that reach higher implantation rates. The company said it does not comment on product pricing or specifics of customer contracts.
Becker’s patient ultimately declined the Watchman.
“Other than isolated cases like this, I would not recommend it for my patients,” the cardiologist wrote. “Most people with atrial fibrillation will unfortunately continue to need powerful blood thinners to reduce their risk of stroke.”