Background: LAAO using the Watchman device is a viable alternative to Warfarin for preventing stroke in AF patients. However, Warfarin post-implant is recommended until a TEE demonstrated LAA closure at 6 wks. We describe a consecutive extreme high risk population of patients with severe bleeding contraindications for warfarin, treated with watchman LAAO.
Methods: A Prospective registry of consecutive pts with non-valvular AF and a significant contraindication to Warfarin use according to the Israeli health basket indications. The Watchman device was implanted in standard fashion with 45 days Follow-up TEE.
Results: 16 patients are reported, mean age 74 ± 8 yrs. mean CHADS2 score was 2.8 ±1.2 (compared with 2.8 ± 1.2 in the ASAP registry and 2.2 ± 1.2 in PROTECT AF). The main Warfarin contraindications were GI bleeding requiring blood transfusions (69%), and intracranial hemorrhage (19%). Watchman implantation was successful in 94% (1 case with a very large LAA was subsequently occluded with an Amplazer device). No intra or periprocedural complications were noted. 61% of pts were discharged on aspirin Plavix, 27% on Plavix alone and 6% on new oral anticoagulants, for 1 month. At 9.1 ± 6.8 month of follow-up, there were no strokes/TIA (compared with an expected > 6% rate according to CHADS2 ). 1 instances of device-related thrombus by TEE was noted and resolved after limited heparin and warfarin therapy.
Conclusions:We describe a cohort of extremely high risk AF patients, in whom oral anticoagulation is contraindicated. Our patient population's clinical characteristics pose a significantly higher risk then in published trials and registries (including ASAP and PROTECT AF). Nevertheless, LAAO with the watchman device proved feasible, safe and effective even in such a consecutive group of extremely high risk patients
