EWOLUTION Registry Confirms Safety of Boston Scientific's Watchman LAA Closure Device

May 19, 2016—Earlier this week, Boston Scientific Corporation announced 3-month results from the EWOLUTION registry. Prof. Martin. W. Bergmann, MD, presented the data from the prospective multicenter registry at the EuroPCR 2016 conference held May 17–20 in Paris, France. Prof. Bergmann is Head of Interventional Cardiology at Cardiologicum Hamburg in Hamburg, Germany.

The registry found that left atrial appendage (LAA) closure with the company’s Watchman device has a high success rate in complete LAA closure with low periprocedural risk, independent of the implanting physicians’ experience. The 3-month outcomes, which include data on more than 1,000 patients across Europe, focus on postprocedural drug regimen, impact of center experience, and peridevice leakage. 

According to Boston Scientific, the data demonstrated that the implantation procedure was successful in 98.5% of cases. Additionally, independent of center experience, 99% of implanted devices presented no or minimal (≤ 5 mm) peridevice leakage at the first follow-up, as assessed by periprocedural transesophageal echocardiogram. Device or procedure-related serious adverse events (SAE) rates at 92 days were similar if patients were treated with warfarin or dual-antiplatelet therapy (DAPT; 2.6% vs 4.8%, respectively). The rates for bleeding SAE were also similar if warfarin or DAPT was used after implantation (4.8% vs 3.6%, respectively).

After Watchman implantation, 6% of patients received no anticoagulation, 27% received oral anticoagulation (16% warfarin and 11% novel oral anticoagulants), 60% received DAPT, and 7% of patients were on single-antiplatelet therapy. Stroke (0.4%) and bleeding (4.1%) rates were low overall and did not vary by postimplantation medications. According to Boston Scientific, the findings confirm the safety of the device, and DAPT after device implantation also appears to be safe.