The relation of device related thrombosis (DRT) and major bleeding after left atrial appendage closure (LAAC) to laboratory thrombosis and hemostasis markers has not been studied. We performed a prospective case control study to identify clinical characteristics and laboratory markers in patients who developed DRT and major bleeding following WATCHMAN LAAC. Thromboelastography, platelet aggregation (PA), urinary 11-dehydrothromboxane B2 (UTX), fibrinogen, d-dimer, thrombin time and von Willebrand factor activity were determined at baseline, immediately following, and at 45 and 180 days post-LAAC (n = 32) and outcomes were followed for 1 year. Baseline characteristics and thrombogenic profiles of patients with and without DRT and/or BARC bleeding were compared. Mean age was 76 ± 8 years and CHADS2 VASc score was 4.4 ± 1.4. There were 3 DRTs (2 within 6 months, and 1 at 12 months), 4 Type 3A BARC bleeds, and 2 non-cardiac deaths. Patients with DRT had higher baseline thrombin-induced platelet–fibrin clot strength (68.0 ± 1.8 vs. 62.7 ± 4.7 mm, p = 0.06); FCS (35.6 ± 6.0 vs. 24.4 ± 6.6 mm, p = 0.009); and d-dimer (1712 ± 2330 vs. 283 ± 213 ng/mL, p = 0.001). At baseline, 5 patients had all 3 factors associated with high thrombotic risk and 2 experienced a DRT within 6 months. Patients with Type 3A BARC bleeding had lower baseline collagen-induced and 45-day ADP-induced PA (p < 0.01 for both). DRT following LAAC was associated with a baseline prothrombogenic profile whereas bleeding was associated with low platelet reactivity. These preliminary findings warrant further validation and have future implications on patient selection and adjunctive antithrombotic therapy following LAAC.
Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT03040622.
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Major bleeding using the Academic Research Consortium
Device related thrombosis
Fibrin clot strength
High platelet reactivity
International normalized ratio
Left atrial appendage closure
Novel oral anticoagulant
Thrombin induced platelet–fibrin clot strength
Thrombin receptor-activating peptide
Urinary 11-dehydrothromboxane B2
Upper limits normal
Von Willebrand factor
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We wish to acknowledge Andrea Fitzgerald BSN-RN, MA for her contributions to this study
This study was funded by Boston Scientific Corporation (300 Boston Scientific Way Marlborough, MA).
Conflict of interest
Dr. Gurbel receives honoraria for lectures, consultations, including service on speakers’ bureaus from Bayer, Merck, Janssen, Medicure, and World Medical; receiving grants from the National Institutes of Health, Janssen, Merck, Bayer, Haemonetics, Instrumentation Labs, and Amgen. Dr. Gurbel is holding stock or stock options in Merck, Medtronic, and Pfizer; and holding patents in the area of personalized antiplatelet therapy and interventional cardiology. Dr. Sherwood receives honoraria from Medtronic. Dr. Navarese reports honoraria and payment for lectures from Astra Zeneca, Daiichi Sankyo/Lilly, Sanofi-Regeneron and Amgen; and receipt of grants from Amgen. Dr. Batchelor reports honoraria from Boston Scientific Corporation. Other authors report no disclosures.
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Sherwood, M., Bliden, K.P., Ilkhanoff, L. et al. Detailed thrombogenicity phenotyping and 1 year outcomes in patients undergoing WATCHMAN implantation: (TARGET-WATCHMAN) a case–control study. J Thromb Thrombolysis (2020). https://doi.org/10.1007/s11239-020-02205-5
- Thrombotic risk
- Platelet aggregation
- Antithrombotic therapy