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Background: Device-related thrombus (DRT) following left atrial appendage occlusion (LAAO) can lead to adverse clinical outcomes. DRT rates and outcomes from randomized trials are limited., Objectives: This analysis investigated the incidence, predictors, and clinical outcomes of DRT following LAAO in the Amulet IDE (AMPLATZER Amulet LAA Occluder Trial) trial., Methods: Successful implants occurred in 903 patients with an Amulet occluder (dual occlusive mechanism device) and 885 patients with a Watchman device (single occlusive mechanism device). These patients were then followed through 18 months and DRT was assessed by transesophageal echocardiography., Results: The overall incidence of DRT was 3.9% (n = 70) with 3.4% (n = 30) in dual occlusive mechanism device patients and 4.8% (n = 40) in single occlusive mechanism device patients. Most DRTs (n = 19 of 31) were identified early (≤45 days) on the dual occlusive mechanism device, whereas most of the DRTs (n = 31 of 42) were identified late (>45 days) on the single occlusive mechanism device. Strong predictors of DRT included atrial fibrillation at time of procedure (HR: 2.44; 95% CI: 1.42-4.22; P < 0.01), female sex (HR: 1.65; 95% CI: 1.01-2.71; P = 0.04), and older age (HR: 1.04; 95% CI: 1.01-1.08; P = 0.02). There were no stroke events following DRT in the dual occlusive mechanism device group and 3 stroke events following DRT in the single occlusive mechanism device group. Patients with DRT were at a greater risk for cardiovascular mortality compared with non-DRT patients (8.7% vs 3.9%; HR: 2.33; 95% CI: 1.01-5.39; P = 0.04)., Conclusions: Incidence of DRT following LAAO was low. Early DRTs are seen with the dual occlusive mechanism device and late DRTs are seen with the single occlusive mechanism device. Increased cardiovascular mortality risk in patients with DRT should be further investigated. (AMPLATZER Amulet LAA Occluder Trial; NCT02879448)., Competing Interests: Funding Support and Author Disclosures Abbott funded the Amulet IDE trial. No funding was provided for this analysis. Dr Schmidt has received speaker honoraria and consulting fees from Abbott, Boston Scientific, Biosense Webster, and Medtronic. Dr Nielsen-Kudsk has received institutional research grants from Abbott and Boston Scientific. Dr Ellis has received institutional research grants from Boehringer Ingelheim, Medtronic, Boston Scientific. Consulting/Advisory- Medtronic, Abbott Medical, Boston Scientific, and Atricure. Dr Thaler has received consulting fees from Abbott and Occlutech; and institutional research grants for clinical trials from Abbott and the National Institutes of Health. Dr Sabir has received institutional research grants for clinical trials from Abbott and Boston Scientific; and speaker honoraria or consulting fees from Abbott and Boston Scientific. Dr Gambhir has received consulting fees from Abbott, Biosense Webster, and Boston Scientific; and speaker honoraria from Boston Scientific. Dr Landmesser has served as an advisor to and received fees from Abbott, Biotronik, Rewa, and Bayer. Dr Shah has no disclosures. Dr Gray has served as a consultant for or has received grant support from Boston Scientific, Cook Medical, Medtronic, Surmodics, and Philips. Dr Swarup has received consulting fees from Biosense Webster, Boston Scientific, and Abbott. Dr Lim’s institution has received research grant funding on his behalf from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; and has also received consulting fees from Venus Medtech and W.L. Gore. Dr Koulogiannis has received speaker honoraria from Abbott and consulting fees from Edwards Lifesciences. Dr Anderson and Mr Gage are employees of Abbott. Dr Lakkireddy has received research and educational grants to his institution from Abbott, Atricure, Alta Thera, Medtronic, Biosense Webster, Biotronik, and Boston Scientific; and speaker honoraria from Abbott, Medtronic, Biotronik, and Boston Scientific., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to assess temporal changes and clinical implications of peridevice leak (PDL) after left atrial appendage closure., Background: Endocardial left atrial appendage closure devices are alternatives to long-term oral anticoagulation (OAC) for patients with atrial fibrillation. PDL >5 mm may prohibit discontinuation of OAC., Methods: Patients included in the study had: 1) successful Watchman device implantation without immediate PDL; 2) new PDL identified at 45 to 90 days using transesophageal echocardiography; 3) eligibility for OAC; and 4) 1 follow-up transesophageal echocardiographic study for PDL surveillance. Relevant clinical and imaging data were collected by chart review. The combined primary outcome included failure to stop OAC after 45 to 90 days, transient ischemic attack or stroke, device-related thrombi, and need for PDL closure., Results: Relevant data were reviewed for 1,039 successful Watchman device implantations. One hundred eight patients (10.5%) met the inclusion criteria. The average PDL at 45 to 90 days was 3.2 ± 1.6 mm. On the basis of a median PDL of 3 mm, patients were separated into ≤3 mm (n = 73) and >3 mm (n = 35) groups. In the ≤3 mm group, PDL regressed significantly (2.2 ± 0.8 mm vs 1.6 ± 1.4 mm; P = 0.002) after 275 ± 125 days. In the >3 mm group, there was no significant change in PDL (4.9 ± 1.4 mm vs 4.0 ± 3.0 mm; P = 0.12) after 208 ± 137 days. The primary outcome occurred more frequently (69% vs 34%; P = 0.002) in the >3 mm group. The incidence of transient ischemic attack or stroke in patients with PDL was significantly higher compared with patients without PDL, irrespective of PDL size., Conclusions: New PDL detected by transesophageal echocardiography at 45 to 90 days occurred in a significant percentage of patients and was associated with worse clinical outcomes. PDL ≤3 mm tended to regress over time., Competing Interests: Funding Support and Author Disclosures Dr Ellis has received research grants (to Vanderbilt University) from Boehringer-Ingelheim, Medtronic, and Boston Scientific; is a consultant or adviser to Medtronic, Abbott Medical, Boston Scientific, and Atricure. All other authors reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to report the incidence of device-related thrombosis (DRT) and thromboembolic (TE) events when an alternative to clopidogrel is prescribed in loss-of-function (LOF) allele carriers of the cytochrome P450 2C19 (CYP2C19) gene., Background: LOF polymorphisms of the CYP2C19 gene are associated with reduced hepatic bioactivation of clopidogrel., Methods: A total of 1,002 Watchman patients were included. Six hundred forty-five patients underwent CYP2C19 genetic testing; among patients with clopidogrel resistance, clopidogrel was replaced by either prasugrel (pilot cohort) or half dose direct oral anticoagulant ([DOAC]/Group 1), both in combination with aspirin. We compared the incidence of DRT/TE events among genotyped patients and a control group which received standard dual antiplatelet therapy (DAPT) (Group 2; n = 357). All reported events occurred during a timeframe between 45- and 180-day follow-up transesophageal echocardiograms, when the 2 different antithrombotic strategies (genotype-guided vs standard DAPT) were adopted., Results: In the pilot cohort (n = 244), bleeding events occurred in 10.2% of patients who received aspirin plus prasugrel, leading to early discontinuation of the prasugrel-based protocol. DOAC Group 1 patients (n = 401), 25.7% were reduced metabolizers, and clopidogrel was replaced by half dose direct oral anticoagulant. DRT was documented in 1 (0.2%) patient of Group 1 and 7 (1.96%) patients of Group 2 (log-rank P = 0.021). The composite endpoint of DRT/TE events was significantly lower among patients receiving a genotype-guided antithrombotic strategy (0.75% vs 3.10%; log-rank P = 0.017)., Conclusions: In Watchman patients, a genotype-based antithrombotic strategy with aspirin plus half dose DOAC in reduced clopidogrel metabolizers was superior to standard DAPT with respect to DRT/TE events., Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021. Published by Elsevier Inc.)

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%, I 2  = 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, CHA 2 DS 2 -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 (32 studies; n = 7,689) was 13.2% (37 of 280) in patients with DRT and 3.8% (285 of 7,399) in those without DRT (OR: 5.27, 95% confidence interval [CI]: 3.66 to 7.59; p < 0.001, I 2  = 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, I 2  = 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., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study investigated characteristics and clinical impact of device-related thrombus formation after Watchman device implantation in atrial fibrillation (AF) patients., Background: Left atrial appendage occlusion using the Watchman device is an effective alternative to anticoagulation for stroke prevention in AF patients. However, device-related thrombus formation remains an important concern after Watchman implantation., Methods: From 2006 to 2014, 119 consecutive AF patients underwent Watchman implantation. Transesophageal echocardiographic (TEE) follow-up was scheduled at 45 days, at 6 months, and at 12 months after the procedure. The incidence, characteristics, and clinical course of device-related thrombus formation detected by TEE were assessed., Results: Follow-up TEE identified thrombus formation on the Watchman device in 4 patients (3.4%). The prevalence of chronic AF was 100% in patients with thrombus, which was higher than that for patients without thrombus (40.0%). Deployed device size was numerically larger in patients with thrombus (29.3 ± 3.8 mm vs. 25.7 ± 3.2 mm, respectively). All patients with thrombus discontinued any of the anticoagulant/antiplatelet therapy which was required under the study protocol. After restarting or continuing warfarin and aspirin therapy, complete resolution of the thrombus was achieved in all patients at subsequent follow-up TEE. Warfarin therapy was discontinued within 6 months for all cases, and there was no thrombus recurrence. The mean follow-up duration was 1,456 ± 546 days, with no death, stroke, or systemic embolization events in patients with thrombus., Conclusions: AF burden, device size, and anticoagulant/antiplatelet regimens can be associated with device-related thrombus after Watchman device implantation. Short-term warfarin therapy was effective, and the clinical outcomes were favorable., (Copyright © 2017 American College of Cardiology Foundation. All rights reserved.)