Left atrial appendage closure device implantation in patients at very high risk for stroke

Heart Rhythm. 2020 Jan;17(1):27-32. doi: 10.1016/j.hrthm.2019.07.011. Epub 2019 Jul 12.

Abstract

Background: Little is known about the role of left atrial appendage closure using the Watchman device (Boston Scientific) in patients who are at very high risk for stroke.

Objective: The purpose of this study was to assess the role of Watchman in patients with CHA2DS2-VASc ≥5.

Methods: All patients undergoing procedures for Watchman implant at our institution were enrolled in a prospective registry. All 104 consecutive recipients with CHA2DS2-VASc ≥5 were included.

Results: Median patient age was 78.5 ± 6.4 years, 56% were male, mean CHA2DS2-VASc was 5.7 ± 0.9, and mean HASBLED was 4.0 ± 1.0. Indications for implantation were significant prior bleeding (73%), unacceptable bleeding risk (21%), and unacceptable stroke and bleeding risk (6%). Watchman implantation was successful in all patients. All but 2 patients completed 45 days of postprocedural anticoagulation; 56% used warfarin and 44% used a novel oral anticoagulant. Transesophageal echocardiogram at 45 days revealed no significant peridevice leak. One patient was found to have a small mobile, filamentous echodensity attached on the medial aspect of the Watchman device. This resolved with longer anticoagulation with dabigatran and did not result in adverse outcome. At 1-year follow up, ischemic stroke had occurred in 3 patients (2.8%) at 96, 119, and 276 days after the procedure.

Conclusion: In a population of patients with mean CHA2DS2-VASc of 5.7, Watchman implantation seemed to be safe and efficacious, with a residual annual ischemic stroke risk of 2.8%. In an atrial fibrillation population with a similar CHA2DS2-VASc score, the estimated annual risk of stroke is ≈12% off anticoagulation and >4% on warfarin.

Keywords: Anticoagulation; Atrial fibrillation; Left atrial appendage closure; Stroke; Watchman device.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Atrial Appendage / diagnostic imaging
  • Atrial Appendage / surgery*
  • Atrial Fibrillation / complications*
  • Atrial Fibrillation / physiopathology
  • Atrial Fibrillation / surgery
  • Cardiac Catheterization / methods*
  • Cardiac Surgical Procedures / methods*
  • Echocardiography, Transesophageal
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Prospective Studies
  • Prosthesis Implantation / methods*
  • Risk Factors
  • Stroke / etiology
  • Stroke / prevention & control*
  • Time Factors
  • Treatment Outcome