Hospitals across the U.S. are beginning to implant patients with the Watchman left atrial appendage closure device, which the FDA approved in March.
Last week, medical professionals at Charlton Memorial hospital in Fall River, Mass., performed their first four procedures with the Watchman device. Christopher Abadi, MD, FACC, who performs the transesophageal echocardiography, said all of the procedures were successful and patients were discharged after one night in the hospital.
Earlier this year, Abadi and his colleagues flew to Atlanta and received training instructions from Boston Scientific on how to use the Watchman device. Some procedures can be completed in less than an hour, although it could take longer with more difficult cases.
The Watchman device is approved to reduce the risk of stroke in patients with non-valvular atrial fibrillation who seek an alternative to warfarin or novel anticoagulants.
Patients who are implanted with the Watchman device are required to take warfarin for 45 days following the procedure. They then undergo transesophageal echocardiography to make sure there is no blood clot or issues around the device. If everything looks fine, patients can discontinue taking warfarin.
“The big advantage is if the procedure goes well, you have the ability of getting someone off blood thinners and reducing their risk of stroke,” Abati said.
In 2009, the FDA failed to approve the device after conclusion of the PROTECT AF (Prospective Randomized Evaluation of the Watchman LAA Closure Device In Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) trial. However, the device has been available internationally since 2009. As of March, more than 10,000 patients worldwide had been implanted with the device.
The approval in March was based on a clinical trial program that included more than 2,400 patients. The studies showed the device reduced the risk of stroke. A meta-analysis of the randomized studies found patients who received the device had reductions in hemorrhagic stroke, disabling stroke and cardiovascular death compared with the warfarin group. Patients who received warfarin had reductions in ischemic stroke, while the groups were similar in terms of all-cause stroke.