Cardiology Plus (Jan 2016)

First clinical experience with new left atrial appendage closure device: WATCHMAN FLX® System

  • Xin Xue,
  • Erich Duenninger,
  • Manuela Muenzel,
  • Adam Fazakas,
  • Nina Schneider,
  • Jing Chang,
  • Jiangtao Yu

Journal volume & issue
Vol. 1, no. 3
pp. 9 – 12


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Background: Percutaneous left atrial appendage closure (LAAC) with WATCHMAN (WM) has been recognized as a new interventional routine, but the development of device is continuing. The WATCHMAN FLX® system (WMF) is a new equipment for LAAC which was used in patients since December 2015 until now; however, there is still lack of WMF clinical experience. We therefore evaluate selection of patient, safety, feasibility, and the early results of LAAC with WMF in a single hospital. Results: LAAC was performed using WMF in 16 nonvalvular atrial fibrillation (NVAF) patients mostly with long-term oral anticoagulant contraindication. Mean age at LAAC was 75 ± 5 years, and 70.6% were male. Hypertension, diabetes, and stroke before operation were present in 87.5%, 25%, and 18.8%, respectively. Mean CHADS2, CHA2DS-VASc, and HASBLED scores were 3.0 ± 1.1, 4.0 ± 1.5, and 3.0 ± 1.2, respectively. The success rate of device implantation was 100%, and there were no severe major procedural complications. Transesophageal echocardiography (TEE) was performed in the first 6 weeks and 6 months after LAAC; 100% of patients finished 6 weeks follow-up. No device-related death was recorded. No ischemic stroke/transient ischemic attack was observed. However, three cases experienced device dislocation. WMF devices were out of left appendage, two at descending aorta and one at ascending aorta. Fortunately, all the lost devices were found and successfully captured with Caesar Grasping Forceps System via arteria femoralis (18F sheath). Twelve patients have already accepted 6 months TEE, with one patient detected thrombosis on the WMF surface. Conclusions: LAAC with WM is a safe and effective therapy to prevent stroke in NVAF patients. The WMF is upgrading novel and updated version of the WATCHMAN device, but not the final device. It still needs accumulating clinical experience with WMF, product, and device dislocation should be also be closely monitored.