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Left atrial appendage closure device implantation in patients with prior intracranial hemorrhage

Published:December 02, 2018DOI:https://doi.org/10.1016/j.hrthm.2018.11.022

      Background

      The Watchman device (Boston Scientific), used for left atrial appendage closure (LAAC), was approved for stroke prevention in patients with atrial fibrillation (AF) and an appropriate rationale to avoid long-term oral anticoagulation. Patients with AF and prior intracranial hemorrhage (ICH) were excluded from clinical trials because of perceived risks of perioperative anticoagulation.

      Objective

      The purpose of this study was to study the efficacy and safety of LAAC using Watchman in patients with AF and prior ICH.

      Methods

      In a multidisciplinary AF/stroke prevention clinic, 38 consecutive patients with AF and prior ICH underwent Watchman implantation. Patients were enrolled in a prospectively maintained data registry.

      Results

      Patients’ mean CHA2DS2-VASc score was 5.0 ± 1.3 and HAS-BLED score 4.2 ± 1.0. Prior ICH events were intraparenchymal (60%), subdural (24%), or subarachnoid bleeds (16%). The median event-to-implantation time was 637 days (minimum 60). Watchman was implanted in all patients with no procedural complications. All patients completed 45 days of anticoagulation with warfarin (55%), apixaban (37%), or dabigatran (8%). Transesophageal echocardiograms at 45 days showed no peridevice leak, and 1 patient had a small filamentous echodensity on device that resolved with anticoagulation. While undergoing anticoagulation, none of the patients developed recurrent ICH. Minor bleeding occurred in 1 patient (trauma-related lower extremity hematoma at 19 days postimplantation). At 13.4 months (quartiles 8–19) of follow-up, there were no strokes, ICH, or deaths.

      Conclusion

      AF patients with prior ICH tolerated short-term anticoagulation for the purpose of Watchman implantation. LAAC with attendant short-term anticoagulation seems to be both safe and effective in this patient population.

      Keywords

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      Linked Article

      • Left atrial appendage closure device implantation in patients with atrial fibrillation and prior intracranial hemorrhage: “No man left behind”
        Heart RhythmVol. 16Issue 5
        • Preview
          Several left atrial appendage (LAA) closure devices have been developed for patients with atrial fibrillation (AF) seeking an alternative to long-term oral anticoagulation (OAC). PROTECT AF (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation) was the first multicenter randomized controlled trial (RCT) comparing LAA closure device vs OAC with warfarin. Primary safety events were statistically more frequent in the device group (7.4% vs 4.4%). At mean follow-up of 3.8 years, LAA closure device showed superiority for the primary efficacy endpoint (ie, composite of stroke, cardiovascular death, and systemic embolism), with a 34% relative risk reduction in total mortality.
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