Endocardial Left Atrial Appendage Device Implantation During Hybrid Atrial Fibrillation Ablation (WINNING): First Results.
Mindy Vroomen1, Bart Maesen1, Mark La Meir2, Jos Maessen1, Harry Crijns1, Laurent Pison1.
1Maastricht University Medical Center, Maastricht, Netherlands, 2UZ Brussel, Brussel, Belgium.
OBJECTIVE: The WATCHMAN™ Left Atrial Closure Device (Boston Scientific) reduces the risk of stroke by closing off the LAA. We studied the safety and feasibility of implantation in a hybrid AF ablation setting (combination of epicardial surgical and endocardial catheter ablation).
METHODS: In this prospective, single center, non-randomized trial, 10 consecutive patients with drug-refractory AF, qualifying for a hybrid AF ablation procedure with necessity of LAA exclusion (CHA2DS2-VASc ≥ 1), are included. For the implantation and peri-procedural care, the standard protocol is followed. The primary safety endpoint comprises major complications (e.g. stroke, device embolization and device related complications). The primary feasibility endpoint is successful implantation. Secondary endpoints are procedure time, radiation exposure, (serious) adverse device events and (serious) adverse events. The follow-up period is 6 months.
RESULTS: At the beginning of October 2016 the first 8 procedures were performed. In all patients the device could be delivered successfully (Fig 1). The total procedure time (ablation and implantation) was prolonged by a mean of 33 minutes, radiation exposure time by 6 minutes and 28 mGy. One adverse event occurred 3 days post-procedural (blood transfusion due to bleeding). After 6 weeks a transesophageal echocardiogram was performed, which showed a good position of the device without significant peridevice flow. Oral anticoagulation was discontinued and Clopidogrel was started. It is expected to have all procedures performed in 2016.
CONCLUSIONS: The WINNING Trial (NCT02471131) investigates the safety and feasibility of the Watchman Device in a hybrid AF ablation setting, with encouraging preliminary results. Keywords: atrial fibrillation, hybrid ablation, watchman implantation.
Back to 2017 Posters