Abstract
Background: AF patients at the highest risk for embolic stroke also experience the greatest risk of hemorrhagic complications of anticoagulant use. The PROTECT AF trial revealed that LAA closure using the Watchman device was non-inferior to Warfarin for preventing stroke in AF pts with CHADS 2 ≥ 1. However, these pts were treated with Warfarin post-implant until a TEE demonstrated LAA closure at 6 wks. Due to the pressing need for strategies that can prevent stroke in pts with contraindications to Warfarin, we performed a prospective study of Watchman implantation in Warfarin-contraindicated pts. Methods: Prospective registry of pts with non-valvular AF, a CHADS 2 score ≥1, and a contraindication to Warfarin use. The Watchman device was implanted in standard fashion. Post-implant, patients were discharged on 6 mo of clopidogrel and life-long aspirin. Follow-up TEE was performed at 3/12 months. Results: At 4 centers, 150 pts were enrolled. The mean age was 72.5 ± 7.4 yrs. The prevalence of stroke risk factors was: CHF in 29%, HTN in 95%, Age ≥ 75 in 43%, DM in 32%, and stroke/TIA in 41%. The mean CHADS 2 score was 2.8 ± 1.2. The reason for Warfarin contraindication was: hemorrhagic tendencies (26%), blood dyscrasias (7%), bleeding tendencies (67%), unsupervised pts with senility/high fall risk (4%), and other (5%). Watchman implantation was successful in 95% (142/150). At 14.2 ± 8.7 mo of follow-up, there were 4 strokes (3 ischemic) and 6 instances of device-related thrombus by TEE. The observed rate of ischemic stroke 1.7% represents 77% fewer events from that expected in pts with a similar CHADS2 score treated with aspirin alone (7.3%; Figure). Data from additional follow-up (to a total of >250 pt-yrs) will be available. Conclusion: Watchman implantation without a Warfarin transition is safe and effective in AF pts with contraindications to even short-term oral anticoagulation
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