To assess the safety and efficacy of LAA closure in patients with nonvalvular atrial fibrillation (AF) ineligible for warfarin therapy.
A prospective study that evaluated LAA closure with the Watchman device (Boston Scientific, Natick, MA; group A) in fifteen patients with nonvalvular AF and CHADS2 (congestive heart failure, hypertension, age ⩾75 years, diabetes mellitus, and prior stroke or transient ischemic attack) score ⩾1, who were considered ineligible for warfarin therapy. The primary efficacy endpoint was the combined events of ischemic/hemorrhagic stroke, systemic embolism and cardiovascular/unexplained death during a period of six months follow-up.
Successful closure of the LAA using the Watchman device was achieved in 15 patients (100%). The mean age was found to be 67.9 ± 9 years with 40% of them being males. No device or procedure related adverse events were detected. The mean CHADS2 score was 2.4 ± 0.8, while the mean CHA2DS2-VASC score was 4.4 ± 1.0. After a mean period of 8 ± 2 months of follow-up, no device dislodgement or device-related thrombi were documented. The all-cause stroke (ischemic and hemorrhagic) and systemic embolism were 0%. The device and procedure related mortality was found to be 0%. Only one patient died after 8 months of device implantation from pneumonia.
LAA closure with the Watchman device can be safely performed, and may be a reasonable alternative to consider for patients at high risk for stroke but with contraindications to systemic oral anticoagulation or with high risk of bleeding.