Detailed thrombogenicity phenotyping and 1 year outcomes in patients undergoing WATCHMAN implantation: (TARGET-WATCHMAN) a case-control study.

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 .

The impact of cardiac resynchronization therapy on ventricular tachycardia/fibrillation: an analysis from the combined Contak-CD and InSync-ICD studies.

OBJECTIVES: To determine the potential influence of cardiac resynchronization therapy (CRT) on the frequency and types of ventricular arrhythmia (VA) in patients with an indication for the implantable cardioverter-defibrillator (ICD), we performed a retrospective electrogram (EGM) analysis of stored VA events from the two largest CRT-ICD trials. BACKGROUND: Previous reports suggest that CRT might promote polymorphic VT (PVT), while a beneficial effect of CRT on ventricular function might reduce the frequency of monomorphic VT (MVT). Theoretically, a balanced effect produces no change in overall VA. METHODS: We analyzed stored EGMs from patients in the Contak-CD and Insync-ICD studies receiving appropriate therapy for VA. EGM inspection distinguishes MVT and PVT using morphologic criteria rather than cycle length classification alone. RESULTS: Of 1,041 subjects entering the two trials, 880 were randomized CRT (N = 439) or control (N = 441). We were able to analyze 840 EGMs in 150 patients with VA, including 678 MVT episodes and 162 PVT episodes. These events were distributed among 68 patients with active CRT (390 MVT vs 111 PVT) and 82 patients assigned to control (288 MVT compared to 51 PVT). The apparent increase in PVT episodes in the CRT group is not significant and can be explained by a disproportionate number of episodes in a few patients. We were unable to identify clinical variables predictive of PVT during CRT. CONCLUSIONS: CRT is not associated with a measurable increase in the incidence of PVT, or in a reduction in MVT in the combined InSync-ICD and Contak-CD populations.