New data from the EWOLUTION registry, presented at EuroPCR 2016, confirms safety of the Boston Scientific left atrial appendage closure system (Watchman). The data are for more than 1,000 patients, from across Europe, who received the device and focus on post-procedural drug regimen, impact of centre experience and peri-device leakage. Dual antiplatelet therapy following the implantation also appears to be safe.
A press release reports that the three-month results from the EWOLUTION registry indicate that the Watchman device is associated with a high success rate in complete left atrial appendage closure with a low periprocedural risk. These findings were independent of implanting physicians’ experience, thus confirming the safety of the device. Highlights of the data, which were presented at EuroPCR 2016 by Martin W Bergmann (Cardiologicum Hamburg, Germany), include:
- The implant procedure was successful in 98.5% of cases
- Independent of centre experience, 99% of implanted devices presented no or minimal (≤5mm) peri-device leakage at the first follow-up, assessed by periprocedural transesophageal echocardiogram (TEE)
- Device or procedure related serious adverse events (SAE) rates at 92 days were similar if patients were treated with warfarin or DAPT (2.6% vs. 4.8%, respectively).
- Rates for bleeding SAE were also similar if warfarin or DAPT was used post-implantation (4.8% vs. 3.6%, respectively)
- Following WATCHMAN implantation, 6% of patients received no anticoagulation, 27% received oral anticoagulation (16% warfarin and 11% novel oral anticoagulants, NOACs), 60% received dual antiplatelet therapy (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 post-implantation medications.