Results from the prospective, multi-centre EWOLUTION registry presented at AHA conference

Topline data confirming peri-procedural safety of left atrial appendage (LAA) occlusion with the WATCHMAN™ Left Atrial Appendage (LAA) Closure device was presented in an oral session during the American Heart Association (AHA) Scientific Sessions.

This is the first study to collect real-world WATCHMAN LAA Closure Device experience outside of selected populations in randomized trials.

Results from the prospective, multi-centre EWOLUTION registry include:

  • The lowest peri-procedural risk of any WATCHMAN trial, even in multi-morbid patients with high stroke and bleeding risk. There was only a 2.8 percent procedure-related serious adverse event (SAE) rate at seven days post implant.
  • The highest risk patient population ever studied in a WATCHMAN trial. Baseline data showed higher CHADS2 (2.8 ± 1.3), CHA2DS2-VASc (4.5 ± 1.6) and HAS-BLED (2.3 ± 1.2) scores compared to prior WATCHMAN trials.

                - 61.8 percent of patients were deemed to be                 contraindicated for oral anticoagulation.

  • Patients will continue be followed for two years to obtain data on long-term patient outcomes, including bleeding and incidence of stroke and transient ischemic attack.
Boersma L., Peri-procedural Safety of Left Atrial Appendage Occlusion with the WATCHMAN Device. Preliminary Data From the EWOLUTION Registry – Presented at AHA 2015