Detailed thrombogenicity phenotyping and 1 year outcomes in patients undergoing WATCHMAN implantation: (TARGET-WATCHMAN)
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Detailed thrombogenicity phenotyping and 1 year outcomes in patients undergoing WATCHMAN implantation: (TARGET‑WATCHMAN) a case–control study Matthew Sherwood1 · Kevin P. Bliden2 · Leonard Ilkhanoff1 · Ganesh Venkataraman3 · Adam Strickberger1 · Sharam Yazdani1 · Robert McSwain1 · Haroon Rashid1 · Eliano P. Navarese4 · Tracy Plummer1 · Wayne Batchelor1 · Rahul Chaudhary2,5 · Udaya S. Tantry2 · Paul A. Gurbel2
© Springer Science+Business Media, LLC, part of Springer Nature 2020
Abstract 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 B 2 (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 18 years of age meeting criteria for WATCHMAN device implantation (documented paroxysmal, persistent or permanent non-valvular AF with a CHA2DS2-VASc score ≥ 3 with appropriate rationale to seek a non-pharmacologic alternative to anticoagulation). Exclusion criteria were—contraindications to the use of warfarin, aspirin, or clopidogrel; presence of intracardiac thrombus; atrial septal defect repair or closure device present; left atrial appendage anatomy unsuitable to accommodate the device, and any other contraindications for LAAC procedures and comorbid conditions being present. Baseline demographics and procedural data for the WATCHMAN implant, and TEE data, and concomitant medical therapy. Laboratory assessments were collected at baseline, immediately post procedure, at 45 days, and 6 months post implantation. TEE was performed pre-procedure to exclude presence of LAA thrombus, at time of procedure, 45 days and 1-year post-implant. Clinical outcomes were determined for 1-year post procedure (Fig. 1). The study was performed in accordance with standard ethical principles and approved by the local IRB; written consent was obtained from all patients.
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