Author + information
- Received June 21, 2018
- Revision received August 27, 2018
- Accepted September 6, 2018
- Published online October 31, 2018.
- Mohamad Alkhouli, MD∗ (, )
- Tatiana Busu, MD,
- Kuldeep Shah, MD,
- Mohammed Osman, MD,
- Fahad Alqahtani, MD and
- Bryan Raybuck, MD
- ↵∗Address for correspondence:
Dr. Mohamad Alkhouli, Division of Cardiology, West Virginia University School of Medicine, 1 Medical Center Drive, Morgantown, West Virginia 26505-8059.
Objectives This study sought to assess the incidence and clinical impact of device related thrombus (DRT) following precautions left atrial appendage occlusion (LAAO).
Background Device-related thrombus is a known complication of LAAO. However, data on the incidence of DRT and its impact on outcomes are limited.
Methods The authors performed a meta-analysis of randomized and observational studies to calculate the pooled incidence of DRT and the pooled odds ratio (OR) of ischemic events in patients with DRT and those without DRT.
Results In the 66 included studies; the incidence of DRT was 351/10, 153 (3.8%, range 0 to 17%, I2 = 56.8). The diagnosis was made in <90, 90 to 365, and >365 days in 42%, 57%, and 1% of patients, respectively. There was no difference in DRT rates between the AMPLATZER (AMPLATZER, AGA Medical Corporation, Golden Valley, Minnesota) and WATCHMAN (WATCHMAN, Boston Scientific Corporation, Marlborough, Massachusetts) devices (3.6% vs. 3.1%, p = 0.24). In a meta-regression, age, gender, heart failure, diabetes, CHA2DS2–VASc score, previous stroke, and post-LAAO antithrombotic regimen did not explain the heterogeneity in the incidence of DRT. The pooled incidence of ischemic events in studies that compared outcomes of patients with and without DRT (n = 32 studies; 7,689 patients) was 13.2% (37/280) in patients with DRT and 3.8% (285/7,399) in those without DRT (OR 5.27, 95% confidence interval [CI] 3.66 to 7.59, p < 0.001, I2 = 0). In a sensitivity analysis including randomized trials and prospective multicenter registries, the incidence of DRT was 3.7%, and DRT remained associated with higher rates of ischemic events (13.5% vs. 4.4%, OR 4.15, 95% CI 2.77 to 6.22, p < 0.001, I2 = 0).
Conclusions DRT after LAAO is uncommon (3.8%) but is associated with a 4- to 5-fold increase in ischemic events. Further studies are needed to understand the underlying mechanisms and the optimal surveillance and management of DRT.
The authors have reported that they have no relationships relevant to this paper to disclose.
All authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page.
- Received June 21, 2018.
- Revision received August 27, 2018.
- Accepted September 6, 2018.
- 2018 American College of Cardiology Foundation
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