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

Erika Hutt; Oussama M Wazni; Walid I Saliba; Mohamed Kanj; Khaldoun G Tarakji; Jose Aguilera; Amr F Barakat; Peter Rasmussen; Ken Uchino; Andrew Russman; Shazam Hussain; Dolora Wisco; Samir Kapadia; Bruce D Lindsay; Ayman A Hussein

doi:10.1016/j.hrthm.2018.11.022

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

Heart Rhythm. 2019 May;16(5):663-668. doi: 10.1016/j.hrthm.2018.11.022. Epub 2018 Dec 3.

Authors

Affiliations

¹ Department of Medicine, Cleveland Clinic Foundation, Cleveland, Ohio.
² Section of Cardiac Pacing and Electrophysiology, Heart and Vascular Institute, Cleveland Clinic Foundation, Cleveland, Ohio.
³ Cardiovascular Medicine, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
⁴ Cerebrovascular Institute, Cleveland Clinic Foundation, Cleveland, Ohio.
⁵ Section of Cardiac Pacing and Electrophysiology, Heart and Vascular Institute, Cleveland Clinic Foundation, Cleveland, Ohio. Electronic address: [email protected].

PMID: 30521942
DOI: 10.1016/j.hrthm.2018.11.022

Abstract

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: Atrial fibrillation; Intracranial hemorrhage; Left atrial appendage closure; Stroke; Watchman device.

MeSH terms

Aged
Anticoagulants* / administration & dosage
Anticoagulants* / adverse effects
Atrial Appendage / surgery*
Atrial Fibrillation* / complications
Atrial Fibrillation* / drug therapy
Echocardiography, Transesophageal / methods
Female
Humans
Intracranial Hemorrhages* / diagnosis
Intracranial Hemorrhages* / prevention & control
Male
Outcome and Process Assessment, Health Care
Perioperative Period / methods
Prosthesis Implantation* / adverse effects
Prosthesis Implantation* / methods
Risk Adjustment / methods
Septal Occluder Device
Stroke* / diagnosis
Stroke* / etiology
Stroke* / prevention & control
Time Factors

Substances

Anticoagulants