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Introduction and Objectives: The optimal antithrombotic therapy (AT) after left atrial appendage closure (LAAC) is debated. We assessed the impact of intensive vs nonintensive AT on the incidence of device-related thrombus (DRT) based on whether the device implantation was classified as optimal or suboptimal., Methods: This study included patients who underwent successful LAAC in 9 centers. Patients were classified according to the quality of device implantation: optimal (proximal implant without ≥ 3 mm peridevice leak) or suboptimal (distal implant and/or ≥ 3 mm peridevice leak). Postimplant AT was classified as either intensive (dual antiplatelet therapy, anticoagulants, or a combination of both) or nonintensive (no AT or a single antiplatelet therapy). The primary endpoint was the incidence of DRT between the 6th and 12th weeks postprocedure., Results: A total of 1225 patients underwent LAAC, with 757 (61.8%) achieving optimal device implantation and 468 (38.2%) classified as suboptimal. After a median follow-up of 20 months, the incidence of DRT in the optimal implant group was 2.6% with intensive AT and 3.7% with nonintensive AT (P =.38). In the suboptimal implant group, the incidence of DRT increased to 11.2% with intensive AT and 15.5% with nonintensive AT (P = .19). On multivariate analysis, suboptimal implantation (HR, 4.51; 95%CI, 2.70-7.54, P < .001) but not intensive AT (HR, 0,66; 95%CI, 0.40-1.07, P = .09) emerged as an independent predictor of DRT., Conclusions: The incidence of DRT after LAAC was higher in patients with suboptimal device implantation. In patients with optimal implantation, the incidence of DRT was low and similar between nonintensive and intensive AT strategies. Large, randomized trials are warranted to confirm these results., (Copyright © 2024 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Background: Oral anticoagulation is recommended after ablation for atrial fibrillation among patients at high risk for stroke. Left atrial appendage closure is a mechanical alternative to anticoagulation, but data regarding its use after atrial fibrillation ablation are lacking., Methods: We conducted an international randomized trial involving 1600 patients with atrial fibrillation who had an elevated score (≥2 in men and ≥3 in women) on the CHA 2 DS 2 -VASc scale (range, 0 to 9, with higher scores indicating a greater risk of stroke) and who underwent catheter ablation. Patients were randomly assigned in a 1:1 ratio to undergo left atrial appendage closure or receive oral anticoagulation. The primary safety end point, tested for superiority, was non-procedure-related major bleeding or clinically relevant nonmajor bleeding. The primary efficacy end point, tested for noninferiority, was a composite of death from any cause, stroke, or systemic embolism at 36 months. The secondary end point, tested for noninferiority, was major bleeding, including procedure-related bleeding, through 36 months., Results: A total of 803 patients were assigned to undergo left atrial appendage closure, and 797 to receive anticoagulant therapy. The mean (±SD) age of the patients was 69.6±7.7 years, 34.1% of the patients were women, and the mean CHA 2 DS 2 -VASc score was 3.5±1.3. At 36 months, a primary safety end-point event had occurred in 65 patients (8.5%) in the left atrial appendage closure group (device group) and in 137 patients (18.1%) in the anticoagulation group (P<0.001 for superiority); a primary efficacy end-point event had occurred in 41 patients (5.3%) and 44 patients (5.8%), respectively (P<0.001 for noninferiority); and a secondary end-point event had occurred in 3.9% and 5.0% (P<0.001 for noninferiority). Complications related to the appendage closure device or procedure occurred in 23 patients., Conclusions: Among patients who underwent catheter-based atrial fibrillation ablation, left atrial appendage closure was associated with a lower risk of non-procedure-related major or clinically relevant nonmajor bleeding than oral anticoagulation and was noninferior to oral anticoagulation with respect to a composite of death from any cause, stroke, or systemic embolism at 36 months. (Funded by Boston Scientific; OPTION ClinicalTrials.gov number, NCT03795298.)., (Copyright © 2024 Massachusetts Medical Society.)

Background: The Amulet IDE trial (AMPLATZER Amulet Left Atrial Appendage Occluder [LAAO] Investigational Device Exemption [IDE] Trial) evaluated the safety and effectiveness of the Amulet occluder (Abbott) in patients with nonvalvular atrial fibrillation. The Amulet IDE trial is the largest randomized LAAO trial, comparing the Amulet occluder with the Watchman 2.5 device (Boston Scientific)., Objectives: This analysis presents the 5-year results from the trial comparing the 2 devices head to head., Methods: Patients enrolled in the Amulet IDE trial were at a high risk of stroke or systemic embolism defined as a CHADS2 score ≥2 or CHA2DS2-VASc score ≥3. Oral anticoagulation (OAC) use and key clinical outcomes are presented through 5 years., Results: A total of 1,878 patients were randomized, with 1,833 undergoing a device implantation attempt (n = 917, Amulet occluder; and n = 916, Watchman device). A significantly higher percentage of patients were free of OAC in the Amulet occluder group at each follow-up visit, with 94.0% and 90.9% free of OAC at the last 5-year follow-up visit in the Amulet and Watchman device groups, respectively (P = 0.009). The 5-year clinical outcomes were similar between the Amulet and Watchman devices, including the composite of ischemic stroke or systemic embolism (7.4% vs 7.1%; P = 0.851), the composite of stroke, systemic embolism, or cardiovascular death (20.3% vs 20.7%; P = 0.666), major bleeding (20.1% vs 20.0%; P = 0.882), cardiovascular (CV) death (14.3% vs 15.4%; P = 0.429), and all-cause death (28.7% vs 31.1%; P = 0.217). Annualized ischemic stroke rates at 5 years were low and the same for Amulet (1.6%/y) and Watchman (1.6%/y) devices. Strokes in patients with the Amulet occluder were less severe (n = 38, nondisabling; n = 11, disabling; n = 11, fatal; n = 12, unknown) than strokes in patients with the Watchman device (n = 19, nondisabling; n = 22, disabling; n = 17, fatal; n = 10, unknown). Moreover, device factors (device-related thrombus or peridevice leak ≥3 mm) preceded stroke events and CV deaths more frequently in patients with the Watchman device (n = 63) compared with patients with the Amulet occluder (n = 31)., Conclusions: The 5-year outcomes from the largest randomized LAAO clinical trial demonstrated the long-term safety and effectiveness of the Amulet occluder and Watchman 2.5 devices. The dual-seal Amulet occluder reduces atrial fibrillation-related thromboembolic events while eliminating the need for long-term OAC. (AMPLATZER Amulet Left Atrial Appendage Occluder [LAAO] Investigational Device Exemption [IDE] Trial [Amulet IDE trial]; NCT02879448)., Competing Interests: Funding Support and Author Disclosures Abbott funded the Amulet IDE trial. No funding was provided for this analysis. Dr Lakkireddy has received institutional research and educational grants from Abbott, Atricure, Alta Thera, Medtronic, Biosense Webster, Biotronik, and Boston Scientific; and has received speaker honoraria from Abbott, Medtronic, Biotronik, and Boston Scientific. Dr Ellis has received institutional research grants from Boehringer Ingelheim, Medtronic, and Boston Scientific; and has served as a consultant or in an advisory capacity to Medtronic, Abbott Medical, Boston Scientific, and Atricure. Dr Thaler has received consulting fees from Abbott and Occlutech; and has received institutional research grants for clinical trials from Abbott and the National Institutes of Health. Dr Swarup has received consulting fees from Biosense Webster, Boston Scientific, and Abbott. Dr Gambhir has received consulting fees from Abbott, Biosense Webster, and Boston Scientific; and has received speaker honoraria from Boston Scientific. Dr Hermiller has served as a consultant to Abbott, Edwards, and Medtronic. Dr Nielsen-Kudsk has received institutional research grants from Abbott and Boston Scientific. Dr Worthley has served as a consultant and proctor to Edwards Lifesciences and Abbott; and has held shares in Three Peaks Medical. Dr Nair has received research grants and support from Medtronic, Boston Scientific, Abbott, Biosense Webster, and Adagio; has served on the advisory board of and as a consultant to Medtronic, Boston Scientific, Abbott, Biosense Webster, and Adagio; and has received honoraria from Medtronic, Boston Scientific, Abbott, Biosense Webster, and Adagio. Dr Schmidt has received speaker honoraria and consulting fees from Abbott, Boston Scientific, Biosense Webster, and Medtronic. Dr Horton has served as a consultant to Boston Scientific, Biosense Webster, St Jude/Abbott Medical, Biotronik, Baylis, and Medtronic. Dr Anderson is an employee of Abbott. Dr Gupta has received institutional research grants from Medtronic, Boston Scientific, Abbot, and CVRx. Dr Zhao is an employee of Abbott. Dr Alkhouli has served as a consultant to Boston Scientific and Abbott. Dr Windecker has received institutional research, travel, or educational grants from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, B Braun, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, Cardiovalve, Cleerly, Cordis Medical, CorFlow Therapeutics, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Farapulse, Fumedica, GE Medical Systems, Gebro Pharma, Guerbet, Idorsia, Inari Medical, InfraRedx, Janssen-Cilag, Johnson & Johnson, MedAlliance, Medicure, Medtronic, Merck Sharp & Dohme, Miracor Medical, Neucomed, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pharming Technologies, Pfizer, Philips, Polares, Regeneron, Sanofi-Aventis, Servier, Siemens Healthcare, Sinomed, SMT Sahajanand Medical Technologies, Terumo, Vifor, V-Wave, and Zoll Medical; has served as an advisory board member of and/or member of the steering or executive committee group for trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, and V-Wave, with payments to the institution but no personal payments; and has served as a member of the steering or executive committee group for several investigator-initiated trials that receive funding by industry without impact on his personal remuneration., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Current methods for quantifying perfusion from computed tomography pulmonary angiography (CTPA) often rely on semi-quantitative scoring systems and requires an experienced evaluator. Few studies report on absolute quantitative variables derived from the images, and the methods are varied with mixed results. Dual-energy CTPA (DE-CTPA) enables automatic quantification of lung and lobar perfusion with minimal user interaction by utilizing machine learning based software. We aimed to evaluate differences in DE-CTPA derived quantitative perfusion variables between patients with acute pulmonary embolism (PE) and chronic thromboembolic pulmonary hypertension (CTEPH). This retrospective, single-center, observational study included 162 adult patients diagnosed with PE ( n  = 81) or CTEPH ( n  = 81) and scanned using dual-energy CT between 2020 and 2023. Mann-Whitney U tests and permutational analysis of variance (PERMANOVA) were used for comparative analyses. We found whole lung perfusion blood volume to be lower ( p  < 0.001) in PE patients (median 3399 mL [2554, 4284]) than in CTEPH patients (median 4094 mL [3397, 4818]). The same was observed at single lung and lobar level. PERMANOVA encompassing all perfusion variables showed a difference between the two groups (F-statistic = 13.3, p  = 0.002). Utilizing logistic regression, right and left lower lobe perfusion blood volume showed some ability to differentiate between PE and CTEPH with area under the receiver operation characteristics curve values of 0.71 (95% CI: 0.56; 0.84) and 0.72 (95% CI: 0.56; 0.86). Pulmonary perfusion is lower in patients with PE than patients with CTEPH, highlighted by differences in DECT-derived perfusion blood volume. Quantitative perfusion variables might be useful to differentiate between the two diseases., Competing Interests: The authors declare no conflict of interest., (© 2024 The Author(s). Pulmonary Circulation published by John Wiley & Sons Ltd on behalf of Pulmonary Vascular Research Institute.)

Background: The exclusion/occlusion of the left atrial appendage (LAA) is a treatment option for atrial fibrillation (AF) patients who are at high risk of stroke and high risk of bleeding. As the role of the LAA is not well understood or explored, this study aims to assess its role on flow dynamics in the left atrium., Methods: Computational fluid dynamics (CFD) simulations were carried out for nine AF patients before and after LAA exclusion. The flow parameters investigated included the LA velocities, Time Averaged Wall Shear Stress (TAWSS), Oscillatory Shear Index (OSI), Relative Residence Time (RRT), and Pressure in the LA., Results: This study shows that, on average, a decrease in TAWSS (1.82 ± 1.85 Pa to 1.27 ± 0.96 Pa, p < 0.05) and a slight increase in OSI (0.16 ± 0.10 to 0.17 ± 0.10, p < 0.05), RRT (1.87 ± 1.84 Pa -1 to 2.11 ± 1.78 Pa -1 , p < 0.05), and pressure (-19.2 ± 6.8 mmHg to -15.3 ± 8.3 mmHg, p < 0.05) were observed in the LA after the exclusion of the LAA, with a decrease in low-magnitude velocities., Conclusion: The exclusion of the LAA seems to be associated with changes in LA flow dynamics. Further studies are needed to elucidate the clinical implications of these changes., (© 2024 Wiley Periodicals LLC.)

Background: Device-related thrombosis (DRT) occurs in up to 4% of patients undergoing left atrial appendage occlusion (LAAO) and is associated with substantial morbidity and mortality. However, its pathophysiology, predictors, and optimal management remain unclear., Objectives: This study aims to assess flow dynamic factors correlating to DRT., Methods: A multicenter registry of patients who underwent LAAO and had pre- and post-computed tomography imaging was used. Patient-specific 3-dimensional digital models of the left atrium were created, and finite element simulations were performed to implant an LAAO device into each model in a position that matched the clinical deployment. Computational fluid dynamic simulations were performed to quantify the following flow dynamic parameters: time averaged wall shear stress, oscillatory shear index, and endothelial cell activation potential., Results: A total of 38 patients (19 with DRT and 19 without DRT) were included. Left atrium volumes and mitral valve areas were larger in the DRT cohort compared with controls. Patients with DRT had a significantly lower time averaged wall shear stress (1.76 ± 1.24 Pa vs 2.90 ± 2.70 Pa), a higher oscillatory shear index (0.19 ± 0.11 vs 0.17 ± 0.11), and a higher endothelial cell activation potential (0.23 ± 0.58 Pa -1 vs 0.17 ± 0.30 Pa -1 ) than the controls ( P  < 0.001 for all). Thrombus locations identified from in-vivo images correlated well with the flow dynamic parameters tested., Conclusions: Flow dynamic parameters may be able to predict the risk of DRT after LAAO. Further investigation with a larger patient cohort and long-term follow-up is needed to assess the role of computational fluid dynamics in the risk stratification of patients considered for LAAO., Competing Interests: This research was partly supported by the American Heart Association (AHA) under award number 24CDA1269661. Dr De Backer has received consulting fees and institutional research grants from 10.13039/100000046Abbott and 10.13039/100008497Boston Scientific. Dr Nielsen-Kudsk has received institutional research grants from 10.13039/100000046Abbott, 10.13039/100008497Boston Scientific, and the 10.13039/501100009708Novo Nordic Foundation. Dr Bavo is an employee of FEops. Dr De Beule is a shareholder of FEops. Dr Vogl was partially supported by the 10.13039/100001502Blue Cross Blue Shield of Michigan Foundation, the DeVlieg Foundation, and the Health Research Institute fellowship at Michigan Tech. Dr Jia has received a scholarship from China Scholarship Council under the State Scholarship Fund of China. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2024 The Authors.)

Competing Interests: Funding Support and Author Disclosures Dr Nielsen-Kudsk has received institutional research grants from Abbott and Boston Scientific. Dr Andersen has received lecture fees from Abbott and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Background: Transcatheter patent foramen ovale (PFO) closure is the recommended treatment for patients age 18 to 60 years with cryptogenic stroke having a high probability of being PFO-related. Limited data exist on stroke recurrence after PFO closure outside clinical trials., Objectives: The purpose of this study was to examine stroke recurrence after PFO closure in routine clinical practice., Methods: We used nationwide population-based Danish registries to conduct a cohort study of all patients with PFO closure during 2008 to 2021 (n = 1,162) and a birth year and sex-matched comparison cohort from the general population (n = 11,620). We calculated absolute and relative risks of ischemic stroke within 4 years after PFO closure. We used weighted Cox regression to estimate adjusted HRs of the association between PFO closure vs the general population and ischemic stroke., Results: The absolute risks of ischemic stroke in patients with PFO closure and in the general population, respectively, were 1.4% (95% CI: 0.8%-2.3%) and 0.1% (95% CI: 0.0%-0.1%) at 1 year, 1.4% (95% CI: 0.8%-2.3%) and 0.2% (95% CI: 0.2%-0.4%) at 2 years, 2.2% (95% CI: 1.3%-3.5%) and 0.4% (95% CI: 0.2%-0.5%) at 3 years, and 2.5% (95% CI: 1.5%-4.0%) and 0.4% (95% CI: 0.3%-0.6%) at 4 years. Thus, the absolute 4-year risk of ischemic stroke was 2.1% (95% CI: 0.9%-3.3%) higher in patients with PFO closure than in the general population, corresponding to an adjusted HR of 6.3 (95% CI: 3.1-12.6)., Conclusions: The 4-year risk of ischemic stroke after routine PFO closure for cryptogenic stroke was comparable to that observed in clinical trials, but remained higher than in the general population., Competing Interests: Funding Support and Author Disclosures Dr Bonnesen was supported by research grants from the Danish Diabetes and Endocrine Academy, which is funded by the Novo Nordisk Foundation, under grant number NNF22SA0079901. Dr Schmidt was supported by the Novo Nordisk Foundation under grant number NNF19OC0054908. The funding sources had no role in the design, conduct, analysis, or reporting of the study. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Chronic thromboembolic pulmonary hypertension (CTEPH) is characterized by increased pulmonary vascular resistance (PVR) and pressure and right ventricular (RV) dysfunction. We aimed to evaluate the correlation of RV to pulmonary artery coupling, measured as the tricuspid annular plane systolic excursion/pulmonary arterial systolic pressure (TAPSE/PASP) ratio, and invasive hemodynamic measurements, and to assess the changes in this ratio following CTEPH treatment., Methods: We conducted a retrospective cohort study of CTEPH patients treated at Aarhus University Hospital with pulmonary angioplasty (BPA), pulmonary endarterectomy (PEA), and or medical therapy only. Patients underwent transthoracic echocardiography and right heart catheterization at baseline and follow-up. The primary endpoint was the association between TAPSE/PASP and PVR. Secondary endpoints included other hemodynamic and functional parameters., Results: The study included 139 patients. Mean TAPSE/PASP at baseline was 0.22 [0.16, 0.29] mm/mmHg. An exponential decay correlation was found between TAPSE/PASP and PVR (correlation coefficient - 0.67, p < 0.001). The TAPSE/PASP ratio improved from 0.23 [0.18; 0.29] to 0.33 [0.26; 0.46] mm/mmHg, p < 0.0001, following BPA, and from 0.20 [0.15;0.27] to 0.35 [0.21;0.41] mm/mmHg, p = 0.0007 following PEA, indicating enhanced RV to pulmonary artery coupling., Conclusion: In patients with CTEPH, the echocardiographic TAPSE/PASP ratio as a measure of RV-PA coupling correlates well with invasively measured pulmonary vascular resistance. The TAPSE/PASP ratio improved after BPA or PEA treatments suggesting a potential use for monitoring patient outcomes. Further prospective studies are warranted to establish the prognostic value of the TAPSE/PASP ratio and ability to guide treatment decisions., Competing Interests: Declaration of competing interest Dr. Mads J. Andersen reports serving as a consultant to Johnson & Johnson. The remaining authors report no conflicts of interest., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Importance: Patients with atrial fibrillation (AF) who have ischemic stroke despite taking oral anticoagulation therapy (OAT) have a very high risk of recurrence. Left atrial appendage occlusion (LAAO) is a mechanical stroke prevention strategy that may provide additional protection in patients with thromboembolic events under OAT., Objective: To compare percutaneous LAAO with continuing OAT alone regarding stroke prevention in patients with AF who had a thromboembolic event despite taking OAT., Design, Setting, and Participants: This cohort study was a propensity score-matched comparison of the STR-OAC LAAO cohort, an international collaboration of 21 sites combining patients from multiple prospective registries of patients who underwent LAAO between 2010 and 2022. STR-OAC LAAO cohort patients who had follow-up longer than 3 months were propensity score-matched to a previously published control cohort comprising patients from an established international collaboration of investigator-initiated prospective studies. This control cohort included patients with nonvalvular AF, recent ischemic stroke or transient ischemic attack, and follow-up longer than 3 months who were taking OAT before the index event. Analyses were adjusted for imbalances in gender, age, hypertension, diabetes, and CHA2 DS2-VASc score., Exposure: Left atrial appendage occlusion vs continuation of oral anticoagulation therapy alone (control group)., Main Outcomes and Measures: The primary outcome was time to first ischemic stroke., Results: Four hundred thirty-three patients from the STR-OAC LAAO cohort (mean [SD] age, 72 [9] years; 171 [39%] females and 262 [61%] males; mean [SD] CHA2 DS2-VASc score, 5.0 [1.6]) were matched to 433 of 1140 patients (38%) from the control group. During 2-year follow-up, 50 patients experienced ischemic stroke: an annualized event rate of 2.8% per patient-year in the STR-OAC LAAO group vs 8.9% per patient-year in the control group. Left atrial appendage occlusion was associated with a lower risk of ischemic stroke (hazard ratio, 0.33; 95% CI, 0.19-0.58; P < .001) compared with the control group. After LAAO, OAT was discontinued in 290 patients (67%), and the remaining 143 patients (33%) continued OAT after LAAO as an adjunctive therapy., Conclusions and Relevance: In patients with nonvalvular AF and a prior thromboembolic event despite taking OAT, LAAO was associated with a lower risk of ischemic stroke compared with continued OAT alone. Randomized clinical trial data are needed to confirm that LAAO may be a promising treatment option for this population with a very high risk of stroke.

Background: Patent foramen ovale (PFO) has been associated with ischemic stroke and transient ischemic attack (TIA). Guidelines recommend PFO closure for stroke prevention in selected patients, but the risk of recurrent stroke remains high compared to the background population. We aimed to evaluate the causes of recurrent stroke/TIA and post-interventional complications in patients after PFO closure., Methods: Patients from the Central Denmark Region who underwent PFO closure at Aarhus University Hospital between November 5, 2018, and May 12, 2023, following an ischemic stroke, TIA, amaurosis fugax, or retinal emboli were included. Data on patient demographics, risk factors, procedural details, post-interventional complications, and recurrent stroke/TIA were collected from electronic medical records., Results: PFO closure was performed in 310 patients (median age: 49 years). During a median follow-up of 2.6 years (interquartile range: 1.5-3.6, 814 total patient-years), recurrent stroke/TIA was observed in 8 patients (2.6%), or 0.98 recurrent strokes per 100 patient-years. Recurrent stroke/TIA was more frequent in patients with hypertension (50.0% vs. 16.9%, p = 0.039). Recurrent stroke/TIA was related to thrombophilia or hematologic conditions entailing hypercoagulability in 62.5% of patients. New-onset atrial fibrillation was observed in 9.4% of patients within 45 days after the procedure. None of these patients subsequently developed an ischemic event. Other adverse outcomes were uncommon., Conclusion: Rates of recurrent ischemic stroke/TIA after PFO closure were comparable to findings in previous trials. Pre-existing vascular risk factors (hypertension), and a hypercoagulable state were associated with recurrent ischemic stroke/TIA., Competing Interests: Declaration of conflicting interestThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article:CZS receives speaker fee from Pfizer. ELG has received speaker honoraria or consultancy fees from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, Novo Nordisk, Lundbeck Pharma, and Organon. He is an investigator in clinical studies sponsored by AstraZeneca, Idorsia, and Bayer and has received unrestricted research grants from Boehringer Ingelheim. JEN-K receives research grants from Novo Nordic Foundation, Abbott, and Boston Scientific. AA has received funding from the Karen Elise Jensen Foundation, speaker honoraria, or consultancy fees from ABBOTT, Gore Medical, Angiodynamics, EPS Vascular Jannsen, Inari Medical, and Magneto Thrombectomy Solutions. HS and JAH have no conflicts to disclose.

Acute pulmonary embolism (PE) is a potentially life-threatening condition that causes abrupt obstruction of the pulmonary arteries, leading to acute right heart failure. Novel diagnostic methods and catheter-directed therapies are being developed rapidly, and there is an obvious need for a realistic PE animal model that can be used for pathophysiological evaluation and preclinical testing. This protocol introduces a porcine model employing large autologous pulmonary emboli. Instrumentations are performed with minimally invasive techniques, creating a close-chest model that enables the investigation of various treatment options with high reproducibility. Three hours after drawing blood to create autologous emboli ex vivo, the induction of PE caused an immediate increase in the mean pulmonary arterial pressure (17 ± 3 mmHg to 33 ± 6 mmHg, p < 0.0001) and heart rate (50 ± 9 beats·min -1 to 63 ± 6 beats·min -1 , p < 0.0003) accompanied by a decreased cardiac output (5.0 ± 0.8 L/min to 4.5 ± 0.9 L/min, p < 0.037) compared to baseline. The CT pulmonary angiography revealed multiple emboli, and the pulmonary obstruction percentage was increased compared to baseline (0% [0-0] to 57.1% [38.8-63.3], p < 0.0001). In the acute phase, the phenotype is comparable to intermediate-risk PE. The model represents a realistic and well-characterized phenotype of intermediate-risk PE and creates an opportunity to test novel diagnostic methods, interventional and pharmaceutical treatments, and hands-on training for healthcare workers in interventional procedures.

Aims: To assess the reproducibility of interpreting hypoattenuated thickening (HAT) and peridevice leak (PDL) using cardiac computed tomography (CT) imaging following Watchman FLX left atrial appendage closure (LAAC)., Methods and Results: In this multicenter retrospective reproducibility study, 100 anonymized post-LAAC cardiac CT scans were evaluated within the same cardiac phase by an experienced and a novice rater blinded to prior evaluations. All scans were evaluated twice by each rater, assessing overall HAT and PDL categories as well as specific associated findings based on suggested algorithms for post-LAAC interpretation. Inter- and intra-rater agreement and reliability were evaluated using absolute agreement, Cohen's kappa and Kendall's tau for categorical variables, and mean difference, Bland-Altman plots, limits of agreement and intraclass correlation coefficients (ICC) for continuous variables.Within overall categories of both HAT and PDL, substantial agreement (kappa >0.61) and reliability (Kendall's tau-b  > 0.75) were observed. Specifically, identifying high-grade HAT (kappa >0.78) and distal patency (kappa >0.85) displayed the highest agreement within HAT and PDL interpretation. Meanwhile, measuring the height of the proximal screw hub cove represented the least reliable HAT assessment among both inter- and intra-rater comparisons (ICC<0.75), while suspected leak mechanism represented the least reproducible PDL measure., Conclusion: Despite only minimal training of one rater, overall high levels of inter- and intra-rater agreement and reliability were observed across the chosen algorithms for interpretation of HAT and PDL following Watchman FLX LAAC. Prognostic implications of the included variables are to be explored in future trials and registries., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Left atrial appendage occlusion (LAAO) is rapidly growing as valid stroke prevention therapy in atrial fibrillation. Cardiac imaging plays an instrumental role in preprocedural planning, procedural execution, and postprocedural follow-up. Recently, cardiac computed tomography (CCT) has made significant advancements, resulting in increasing use both preprocedurally and in outpatient follow-up. It provides a noninvasive, high-resolution alternative to the current standard, transesophageal echocardiography, and may display advantages in both the detection and characterization of device-specific complications, such as peridevice leak and device-related thrombosis. The implementation of CCT in the follow-up after LAAO has identified new findings such as hypoattenuated thickening on the atrial device surface and left atrial appendage contrast patency, which are not readily assessable on transesophageal echocardiography. Currently, there is a lack of standardization for acquisition and interpretation of images and consensus on definitions of essential findings on CCT in the postprocedural phase. This paper intends to provide a practical and standardized approach to both acquisition and interpretation of CCT after LAAO based on a comprehensive review of the literature and expert consensus among European and North American interventional and imaging specialists., Competing Interests: Funding Support and Author Disclosures Dr Korsholm has received speaker honorarium from Abbott and Boston Scientific. Dr Saw has received unrestricted research grant support from AstraZeneca, Abbott, Boston Scientific, and Servier; has received speaker honorarium from AstraZeneca, Abbott, Boston Scientific, and Sunovion; and is a consultant/proctor for Boston Scientific, AstraZeneca, and Abbott. Dr Wang has received research grant support from Boston Scientific; and is a consultant for Edwards Lifesciences, Boston Scientific, and Materialise. Dr Berti is a proctor for Abbott and Edwards Lifesciences. Dr Galea has received speaker honorarium from Boston Scientific. Dr De Backer is a consultant for Abbott. Dr Räber has received research grants to the institution from Abbott Vascular, Biotronik, Boston Scientific, Heartflow, Sanofi, Regeneron, Medis Medical Imaging Systems, and Bangerter-Rhyner Stiftung; and has received speaker or consultation fees from Abbott Vascular, Amgen, AstraZeneca, Canon, Novo Nordisk, Medtronic, Occlutech, and Sanofi outside the submitted work. Dr Alkhouli is on the Advisory Board for Abbott and Boston Scientific. Dr Nielsen-Kudsk is a consultant for Boston Scientific; and is a consultant/proctor for Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Device-related thrombosis (DRT) is a common finding after left atrial appendage closure (LAAC) and is associated with worse outcomes. As women are underrepresented in clinical studies, further understanding of sex differences in DRT patients is warranted., Methods and Results: This sub-analysis from the EUROC-DRT-registry compromises 176 patients with diagnosis of DRT after LAAC. Women, who accounted for 34.7% (61/176) of patients, were older (78.0 ± 6.7 vs. 74.9 ± 9.1 years, p = .06) with lower rates of comorbidities. While DRT was detected significantly later in women (173 ± 267 vs. 127 ± 192 days, p = .01), anticoagulation therapy was escalated similarly, mainly with initiation of novel oral anticoagulant (NOAC), vitamin K antagonist (VKA) or heparin. DRT resolution was achieved in 67.5% (27/40) of women and in 75.0% (54/72) of men (p = .40). In the remaining cases, an intensification/switch of anticoagulation was conducted in 50.% (9/18) of men and in 41.7% (5/12) of women. Final resolution was achieved in 72.5% (29/40) cases in women, and in 81.9% (59/72) cases in men (p = .24). Women were followed-up for a similar time as men (779 ± 520 vs. 908 ± 687 days, p = .51). Kaplan-Meier analysis revealed no difference in mortality rates in women (Hazard Ratio [HR]: 1.73, 95%-Confidence interval [95%-CI]: .68-4.37, p = .25) and no differences in stroke (HR: .83, 95%-CI: .30-2.32, p = .72) within 2 years after LAAC., Conclusion: Evaluation of risk factors and outcome revealed no differences between men and women, with DRT in women being diagnosed significantly later. Women should be monitored closely to assess for DRT formation/resolution. Treatment strategies appear to be equally effective., (© 2024 The Author(s). Echocardiography published by Wiley Periodicals LLC.)

Different rat strains are used in various animal models of pulmonary hypertension and right ventricular (RV) failure. No systematic assessment has been made to test differences in RV response to pressure overload between rat strains. We compared RV adaptation to pulmonary trunk banding (PTB) in Wistar (W), Sprague Dawley (SD), and Fischer344 (F) rats by hemodynamic profiling focusing on diastolic function. Age-matched male rat weanlings were randomized to sham surgery (W-sham, n = 5; SD-sham, n = 4; F-sham, n = 4) or PTB (W-PTB, n = 8; SD-PTB, n = 8; F-PTB, n = 8). RV function was evaluated after 5 weeks by echocardiography, cardiac MRI, and invasive pressure-volume measurements. PTB caused RV failure and increased RV systolic pressures four-fold in all three PTB groups compared with sham. W- and SD-PTB had a 2.4-fold increase in RV end-systolic volume index compared with sham, while F-PTB rats were less affected. Diastolic and right atrial impairment were evident by increased RV end-diastolic elastance, filling pressure, and E/e' in PTB rats compared with sham, again F-PTB the least affected. In conclusions, PTB caused RV failure with signs of diastolic dysfunction. Despite a similar increase in RV systolic pressure, F-PTB rats showed less RV dilatation and a more preserved diastolic function compared with W- and SD-PTB., (© 2024 The Author(s). Physiological Reports published by Wiley Periodicals LLC on behalf of The Physiological Society and the American Physiological Society.)

Background: Left atrial appendage (LAA) occluder embolization is an infrequent but serious complication., Objectives: We aim to describe timing, management and clinical outcomes of device embolization in a multi-center registry., Methods: Patient characteristics, imaging findings and procedure and follow-up data were collected retrospectively. Device embolizations were categorized according to 1) timing 2) management and 3) clinical outcomes., Results: Sixty-seven centers contributed data. Device embolization occurred in 108 patients. In 70.4 % of cases, it happened within the first 24 h of the procedure. The device was purposefully left in the LA and the aorta in two (1.9 %) patients, an initial percutaneous retrieval was attempted in 81 (75.0 %) and surgery without prior percutaneous retrieval attempt was performed in 23 (21.3 %) patients. Two patients died before a retrieval attempt could be made. In 28/81 (34.6 %) patients with an initial percutaneous retrieval attempt a second, additional attempt was performed, which was associated with a high mortality (death in patients with one attempt: 2.9 % vs. second attempt: 21.4 %, p < 0.001). The primary outcome (bailout surgery, cardiogenic shock, stroke, TIA, and/or death) occurred in 47 (43.5 %) patients. Other major complications related to device embolization occurred in 21 (19.4 %) patients., Conclusions: The majority of device embolizations after LAA closure occurs early. A percutaneous approach is often the preferred method for a first rescue attempt. Major adverse event rates, including death, are high particularly if the first retrieval attempt was unsuccessful., Condensed Abstract: This dedicated multicenter registry examined timing, management, and clinical outcome of device embolization. Early embolization (70.4 %) was most frequent. As a first rescue attempt, percutaneous retrieval was preferred in 75.0 %, followed by surgical removal (21.3 %). In patients with a second retrieval attempt a higher mortality (death first attempt: 2.9 % vs. death second attempt: 24.1 %, p < 0.001) was observed. Mortality (10.2 %) and the major complication rate after device embolization were high., Competing Interests: Declaration of competing interest A. Aminian is a consultant and proctor for Boston Scientific and Abbott. I. Akin received lecture and proctoring fees from Boston Scientific for the Watchman Okkluder. J. Lund discloses a clinical advisor (proctor) role in LAAC (Abbott) and lecture fees (Abbott, Boston scientific). E. Guerios serves as proctor for LAA closure for Abbott and Lifetech Scientific. N. Amabile has received proctoring and consulting fees from Abbott Vascular and Boston Scientific. C. Skurk has received proctor honoraria from Boston Scientific and speaker fees from Boston Scientific and Lifetech Scientific. J. Harvey is proctor for Abiomed, Boston Scientific and Medtronic and part of the Speaker's bureau for Abiomed, Boston Scientific and Medtronic. He also is part of the advisory board for Avail, Boston Scientific and Medtronic. H. Sievert has received study honoraria to institution, travel expenses and consulting fees from 4tech Cardio, Abbott, Ablative Solutions, Adona Medical, Akura Medical, Ancora Heart, Append Medical, Axon, Bavaria Medizin Technologie GmbH, Bioventrix, Boston Scientific, Cardiac Dimensions, Cardiac Success, Cardimed, Cardionovum, Celonova, Contego, Coramaze, Croivalve, CSL Behring LLC, CVRx, Dinova, Edwards, Endobar, Endologix, Endomatic, Esperion Therapeutics, Inc., Hangzhou Nuomao Medtech, Holistick Medical, Intershunt, Intervene, K2, Laminar, Lifetech, Magenta, Maquet Getinge Group, Metavention, Mitralix, Mokita, Neurotronic, NXT Biomedical, Occlutech, Recor, Renal Guard, Shifamed, Terumo, Trisol, Vascular Dynamics, Vectorious Medtech, Venus, Venock, Vivasure Medical, Vvital Biomed and Whiteswell. M. Kühne received personal fees from Bayer, Böhringer Ingelheim, Pfizer BMS, Daiichi Sankyo, Medtronic, Biotronik, Boston Scientific, Johnson & Johnson, and F. Hoffmann-La Roche Ltd., as well as grants from Bayer, Pfizer, Boston Scientific, BMS, Biotronik, and Daiichi Sankyo. S. Sabir is part of the Boston Scientific WATCHMAN advisory board. J. Kim has received proctoring fees from Abbott Vascular. M. Montorfano received consultant fees from Abbott, Boston Scientific, Kardia. M. Ancona received consultant fees from Abbott. Relevant research funding went to Vanderbilt University Medical Center from Boston Scientific, Boehringer-Ingelheim, Medtronic and Atricure, where C. Ellis is practicing. He also reseves a consultant and advisor fee from Abbott Medical, Atricure, Boston Scientific, Medtronic. L. Nombela-Franco is proctor for Abbott Vascular and has received lectures fees from Boston Scientific. A. Natale has received speaker honoraria from Boston Scientific, Biosense Webster, St. Jude Medical, Biotronik, and Medtronic. He also is a consultant for Biosense Webster, St. Jude Medical, and Janssen. All other authors declare that they have no competing interests., (Copyright © 2024. Published by Elsevier Inc.)

Background: Left atrial appendage occlusion (LAAO) provides mechanical cardioembolic protection for atrial fibrillation (AF) patients who cannot use oral anticoagulation therapy (OAT). Patients with a thrombotic event despite OAT are at high risk for recurrence and may also benefit from LAAO., Objectives: This study sought to investigate the efficacy of LAAO in AF patients with a thrombotic event on OAT compared to: 1) LAAO in AF patients with a contraindication for OAT; and 2) historical data., Methods: The international LAAO after stroke despite oral anticoagulation (STR-OAC LAAO) collaboration included patients who underwent LAAO because of thrombotic events on OAT. This cohort underwent propensity score matching and was compared to the EWOLUTION (Evaluating Real-Life Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology) registry, which represents patients who underwent LAAO because of OAT contraindications. The primary outcome was ischemic stroke. Event rates were compared between cohorts and with historical data without OAT, yielding relative risk reductions based on risk scores., Results: Analysis of 438 matched pairs revealed no significant difference in the ischemic stroke rate between the STR-OAC LAAO and EWOLUTION cohorts (2.5% vs 1.9%; HR: 1.37; 95% CI: 0.72-2.61). STR-OAC LAAO patients exhibited a higher thromboembolic risk (HR: 1.71; 95% CI: 1.04-2.83) but lower bleeding risk (HR: 0.39; 95% CI: 0.18-0.88) compared to EWOLUTION patients. The mortality rate was slightly higher in EWOLUTION (4.3% vs 6.9%; log-rank P = 0.028). Relative risk reductions for ischemic stroke were 70% and 78% in STR-OAC LAAO and EWOLUTION, respectively, compared to historical data without OAT., Conclusions: LAAO in patients with a thrombotic event on OAT demonstrated comparable stroke rates to the OAT contraindicated population in EWOLUTION. The thromboembolic event rate was higher and the bleeding rate lower, reflecting the intrinsically different risk profile of both populations. Until randomized trials are available, LAAO may be considered in patients with an ischemic event on OAT., Competing Interests: Funding Support and Author Disclosures Dr Maarse has received an educational grant from Boston Scientific. Dr Tondo serves on the advisory board of Boston Scientific; and has received lecture and tutoring fees from Boston Scientific and Abbott Medical. Dr Demkow has received proctoring fees from Boston Scientific and Abbott. Dr de Backer has received institutional research grants and consulting fees from Abbott and Boston Scientific. Dr Nielsen-Kudsk has received grants from Abbott and Boston Scientific. Dr Estevez-Loureiro is a proctor for Abbott Vascular, Boston Scientific, and Lifetech. Dr de Prado is a proctor for Boston Scientific. Dr Nombela-Franco is a proctor for Abbott Vascular, Edwards Lifesciences, and Boston Scientific. Dr Salinas is a proctor for Abbott Vascular. Dr Berti is a proctor for Edwards Lifesciences, Boston Scientific, and Abbott. Dr Millan has received consultant fees/honoraria from Abbott Laboratories and Boston Scientific. Dr Arzamendi has received consultant fees/honoraria from Abbott Laboratories and Boston Scientific. Dr Agarwal is a member of the Speaker Bureau and proctor for Medtronics, Abbott, Edwards Lifesciences, and Boston Scientific. Dr Spoon is a speaker for Medtronic, Abiomed, and Abbott. Dr El-Chami is a consultant for Medtronic and Boston Scientific. Dr Adamo has received speaker honoraria from Abbott Structural Heart. Dr van Dijk is a proctor for Boston Scientific. Dr Swaans is a proctor/lecturer for Abbott Vacular, Bioventrix Inc, Boston Scientific, Cardiac Dimensions, Edwards Lifesciences, GE Healthcare, and Philips Healthcare. Dr Vireca is an employee of Boston Scientific. Dr Bergmann has received speaker honoraria from Boston Scientific and Abbott; and has received research support from Boston Scientific and Abbott. Dr Boersma is a consultant for Boston Scientific; and is a proctor for Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Left atrial appendage occlusion (LAAO) is performed increasingly, but long-term follow-up imaging data are lacking., Aims: The aim of this study was to evaluate the safety and durability of the Amplatzer Amulet device >4 years after LAAO., Methods: This was a prospective observational cohort study including 52 patients implanted with the Amplatzer Amulet device at Aarhus University Hospital, Denmark. A >4-year follow-up cardiac computed tomography (CT) scan after LAAO was performed and compared with the results from the 2-month and 12-month scans. The primary outcome was left atrial appendage (LAA) sealing based on distal LAA contrast patency and peridevice leakage (PDL), stratified into complete occlusion (grade 0 [G0]) and grade 1-3 leakage (G1-3), respectively. Secondary outcomes were low- and high-grade hypoattenuated thickening (HAT), device-related thrombosis (DRT) and device durability., Results: The median (interquartile range [IQR]) follow-up time from LAAO to the latest CT scan was 5.8 years (4.5; 6.3). At 2-month (n=52), 12-month (n=27) and >4-year CT follow-ups (n=52), rates of both complete occlusion (33%, 37%, 35%) and G2 leaks (52%, 52%, 48%) remained stable. Rates of G1 leaks varied (14%, 4%, 6%) and G3 leaks rose (2%, 7%, 12%) from earliest to latest follow-up. The median left atrial (LA) volume increased from 127 mL (96; 176) to 144 mL (108; 182) and 147 mL (107; 193). No DRT was found. The structural device integrity was preserved., Conclusions: This study indicates a stable LAA sealing status throughout the follow-up period, emphasising the importance of the procedural result in avoiding PDL. Few patients displayed PDL progression, which might partly be related to LA remodelling with increasing volume. The long-term device durability appears excellent. Larger studies are warranted to confirm these findings.

Background: Amplatzer Amulet is a frequently used device for left atrial appendage occlusion (LAAO). The current sizing protocol is based on the maximum diameter of the left atrial appendage (LAA) landing zone. However, mean, perimeter-, or area-derived diameter might be more accurate measures for device sizing., Methods: Retrospective analysis of 150 consecutive patients undergoing LAAO is guided by pre-procedural cardiac CT. A total of 117 patients were included; 7 were excluded due to renal failure and 26 due to closure with the sandwich technique. The maximum, mean, area-, and perimeter-derived diameters of the landing zone were derived from pre-procedural cardiac CT scans, and their accuracy to predict the implanted device size was investigated. The predicted device size was determined based on the currently recommended sizing algorithm. Peri-device leak (PDL) was assessed (grade 1-3) along with the underlying mechanism., Results: Device-sizing accuracy was superior for mean, area-, and perimeter derived diameters compared with the maximal diameter, especially for eccentric landing zones. Mean difference between predicted and actually implanted device size was 0.08 mm (± 2.77), 0.30 mm (± 2.40), - 0.39 mm (± 2.43), and - 2.55 mm (± 2.57) across mean, area-derived, perimeter-derived, and maximal diameter, respectively. Grade 3 peri-device leak was seen in 8.5% of implants without a significant association to the eccentricity of the landing zone. The leading mechanism for PDL was device malalignment., Conclusion: Our results indicate mean, area-, and perimeter-derived diameters of the device landing zone to perform similar and superior in device-sizing accuracy compared with the maximum diameter., (© 2023. The Author(s).)

Background: Acute pulmonary embolism (PE) induces ventilation-perfusion mismatch and hypoxia and increases pulmonary pressure and right ventricular (RV) afterload, entailing potentially fatal RV failure within a short timeframe. Cardiopulmonary factors may respond differently to increased clot burden. We aimed to elucidate immediate cardiopulmonary responses during successive PE episodes in a porcine model., Methods: This was a randomized, controlled, blinded study of repeated measurements. Twelve pigs were randomly assigned to receive sham procedures or consecutive PEs every 15 min until doubling of mean pulmonary pressure. Cardiopulmonary assessments were conducted at 1, 2, 5, and 13 min after each PE using pressure-volume loops, invasive pressures, and arterial and mixed venous blood gas analyses. ANOVA and mixed-model statistical analyses were applied., Results: Pulmonary pressures increased after the initial PE administration (p < 0.0001), with a higher pulmonary pressure change compared to pressure change observed after the following PEs. Conversely, RV arterial elastance and pulmonary vascular resistance was not increased after the first PE, but after three PEs an increase was observed (p = 0.0103 and p = 0.0015, respectively). RV dilatation occurred following initial PEs, while RV ejection fraction declined after the third PE (p = 0.004). RV coupling exhibited a decreasing trend from the first PE (p = 0.095), despite increased mechanical work (p = 0.003). Ventilatory variables displayed more incremental changes with successive PEs., Conclusion: In an experimental model of consecutive PE, RV afterload elevation and dysfunction manifested after the third PE, in contrast to pulmonary pressure that increased after the first PE. Ventilatory variables exhibited a more direct association with clot burden., (© 2024. The Author(s).)

A significant proportion of patients who suffer from atrial fibrillation (AF) and are in need of thromboembolic protection are not treated with oral anticoagulation or discontinue this treatment shortly after its initiation. This undertreatment has not improved sufficiently despite the availability of direct oral anticoagulants which are associated with less major bleeding than vitamin K antagonists. Multiple reasons account for this, including bleeding events or ischaemic strokes whilst on anticoagulation, a serious risk of bleeding events, poor treatment compliance despite best educational attempts, or aversion to drug therapy. An alternative interventional therapy, which is not associated with long-term bleeding and is as effective as vitamin K anticoagulation, was introduced over 20 years ago. Because of significant improvements in procedural safety over the years, left atrial appendage closure, predominantly achieved using a catheter-based, device implantation approach, is increasingly favoured for the prevention of thromboembolic events in patients who cannot achieve effective anticoagulation. This management strategy is well known to the interventional cardiologist/electrophysiologist but is not more widely appreciated within cardiology or internal medicine. This article introduces the devices and briefly explains the implantation technique. The indications and device follow-up are more comprehensively described. Almost all physicians who care for adult patients will have many with AF. This practical guide, written within guideline/guidance boundaries, is aimed at those non-implanting physicians who may need to refer patients for consideration of this new therapy, which is becoming increasingly popular., Competing Interests: Conflict of interest: C.B.: none declared. R.B.: personal fees from Bayer, Bristol-Myers Squibb, LEO-Pharma, Pfizer, VIATRIS, and research support by the Bavarian State Ministry of Health; CPC University of Colorado; FADOI, Italy. S.Be.: proctor and speaker fees from Boston Scientific, Edwards, Abbott, fees go to the department. S.Bi.: none declared. L.V.A.B.: consultant for Medtronic, Boston Scientific, Adagio, and ACUTUS, fees go to the department. G.B.: speaker fees from Bayer, Boehringer Ingelheim, Boston Scientific, Daiichi-Sankyo, Janssen, and Sanofi. S.Bo.: Consultant for Medtronic, Boston Scientific, Microport, and Zoll. A.J.C.: personal fees from Abbott, Boston Scientific, Medtronic, Pfizer/BMS, Daiichi Sankyo, Bayer and Sanofi. T.D.P.: no personal disclosures to report. Consultancy activity for Boston Scientific, invoiced through institutional research fund. W.D.: consulting and speaker fees from Ai Mediq, Bayer, Boehringer Ingelheim, Medtronic, Boston Scientific, Vifor Pharma; travel support from Pharmacosmos; research support from EU (Horizon2020), German Ministry of Education and Research, German Center for Cardiovascular Research, Vifor Pharma. S.G.: consulting and speaker fees from Boston Scientific. M.G.: Advisory Board Member for Boston Scientific; proctor for Boston Scientific, Abbott; fees for lectures and travel grants: from Boston Scientific, Abbott, Occlutech, Pfizer. K.G.H.: speaker’s honoraria, consulting fees, lecture honoraria and/or study grants from Abbott, Amarin; Alexion, AstraZeneca, Bayer Healthcare, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Daiichi-Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, Portola, Premier Research, Sanofi, SUN Pharma, and W.L. Gore and Associates. J.E.N.-K.: consultant to Boston Scientific, Medtronic, Edwards Lifesciences, Picardia, Venus Medtech, speaker for Abbott. U.L.: research grant to institution from Abbott, Bayer, speaker or consulting honorary from Abbott, Boston Scientific, Bayer; Pfizer, Daiichi-Sankyo. G.Y.H.L.: consultant and speaker for BMS/Pfizer, Boehringer Ingelheim, Daiichi-Sankyo, Anthos. No fees are received personally. National Institute for Health and Care Research (NIHR) Senior Investigator and co-principal investigator of the AFFIRMO project on multi-morbidity in AF, funded from the European Union's Horizon 2020 research and innovation programme under grant agreement no. 899871. J.E.N.-K.: research grants from Abbott, Boston Scientific, Novo Nordic Foundation. J.E.N.-K.: research grants from Abbott, Boston Scientific, Novo Nordic Foundation. E.M.: research grants from Abbott, Biotronik, Boston Scientific, Medtronic, MicroPort, and Zoll. Consultant and speaker fees from Abbott, Abbott, Medtronic, and Zoll. J.E.N.-K.: research grants from Abbott, Boston Scientific, Novo Nordic Foundation. P.O.: speaking honoraria from Bayer, Abbott, Boston Scientific. T.P.: none declared. B.S.: consultant and speaker for Bostin Scientific, Abbott, Medtronic, Biosense Webster. M.S.: none declared. R.B.S. has received funding from the European Research Council (ERC) under the European Union's Horizon 2020 research and innovation programme under the grant agreement no. 648131, from the European Union's Horizon 2020 research and innovation programme under the grant agreement no. 847770 (AFFECT-EU) and German Center for Cardiovascular Research (DZHK e.V.) (81Z1710103 and 81Z0710114); German Ministry of Research and Education (BMBF 01ZX1408A) and ERACoSysMed3 (031L0239); Wolfgang Seefried project funding German Heart Foundation; lecture fees and advisory board fees from BMS/Pfizer and Novartis outside this work. C.T.: advisory board member of Boston Scientific; proctor for Boston Scientific and Abbott; fees for lectures and travel grants from Boston Scientific and Abbott. A portion of the fees goes to the institute. A.T.: consultant and proctor for Abbott, consultant for Boston Scientific and Pie Medical., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: The optimal antithrombotic therapy following left atrial appendage occlusion (LAAO) remains debated. Ideally, this therapy should effectively prevent device-related thrombosis (DRT) while minimising the associated bleeding risk., Aims: We aimed to evaluate the long-term safety and efficacy of a postprocedural single antiplatelet therapy (SAPT) strategy following Amplatzer LAAO in a large consecutive cohort., Methods: This retrospective, single-centre, observational study included all patients discharged on SAPT after LAAO with the Amplatzer Cardiac Plug (ACP) or Amplatzer Amulet between March 2010 and December 2021 at Aarhus University Hospital, Denmark. Baseline, procedural, and imaging data were obtained locally, while clinical outcomes and medication data were extracted from the Danish national health registries., Results: A total of 553 patients underwent Amplatzer LAAO during the specified time frame. Of these, 431 (77.9%) high bleeding risk patients were discharged on SAPT with either acetylsalicylic acid (n=403, 72.9%) or clopidogrel (n=28, 5.1%). At 6 months, 173 (41.7%) patients were not on any antithrombotic therapy. The mean CHA2DS2-VASc and HAS-BLED scores were 3.9±1.5 and 3.4±1.1, respectively. DRT was detected in 6 (1.5%) patients on 8-week follow-up imaging using cardiac computed tomography (n=386, 89.6%) or transoesophageal echocardiography (n=27, 6.3%). The 1-year ischaemic stroke rate was 2.2% (95% confidence interval [CI]: 1.1-4.2). One-year rates for major bleeding and cardiovascular death were 5.9% (95% CI: 4.0-8.9) and 2.9% (95% CI: 1.6-5.1), respectively., Conclusions: SAPT following Amplatzer LAAO displayed rates of DRT and stroke comparable to those reported with more intensive antithrombotic regimens. Meanwhile, we observed low rates of major bleeding.

Objectives: To investigate the contribution of mechanical obstruction and pulmonary vasoconstriction to pulmonary vascular resistance (PVR) in acute pulmonary embolism (PE) in pigs., Design: Controlled, animal study., Setting: Tertiary university hospital, animal research laboratory., Subjects: Female Danish slaughter pigs ( n = 12, ~60 kg)., Interventions: None., Measurements and Main Results: PE was induced by infusion of autologous blood clots in pigs. CT pulmonary angiograms were performed at baseline, after PE (first experimental day [PEd0]) and the following 2 days (second experimental day [PEd1] and third experimental day [PEd2]), and clot burden quantified by a modified Qanadli Obstruction Score. Hemodynamics were evaluated with left and right heart catheterization and systemic invasive pressures each day before, under, and after treatment with the pulmonary vasodilators sildenafil (0.1 mg/kg) and oxygen (Fio 2 40%). PE increased PVR (baseline vs. PEd0: 178 ± 54 vs. 526 ± 160 dynes; p < 0.0001) and obstruction score (baseline vs. PEd0: 0% vs. 45% ± 13%; p < 0.0001). PVR decreased toward baseline at day 1 (baseline vs. PEd1: 178 ± 54 vs. 219 ± 48; p = 0.16) and day 2 (baseline vs. PEd2: 178 ± 54 vs. 201 ± 50; p = 0.51). Obstruction score decreased only slightly at day 1 (PEd0 vs. PEd1: 45% ± 12% vs. 43% ± 14%; p = 0.04) and remained elevated throughout the study (PEd1 vs. PEd2: 43% ± 14% vs. 42% ± 17%; p = 0.74). Sildenafil and oxygen in combination decreased PVR at day 0 (-284 ± 154 dynes; p = 0.0064) but had no effects at day 1 (-8 ± 27 dynes; p = 0.4827) or day 2 (-18 ± 32 dynes; p = 0.0923)., Conclusions: Pulmonary vasoconstriction, and not mechanical obstruction, was the predominant cause of increased PVR in acute PE in pigs. PVR rapidly declined over the first 2 days after onset despite a persistent mechanical obstruction of the pulmonary circulation from emboli. The findings suggest that treatment with pulmonary vasodilators might only be effective in the acute phase of PE thereby limiting the window for such therapy., Competing Interests: Dr. Andersen is consultant of Magneto Thrombectomy Solutions and Inari Medical; he received teaching honorarium from AngioDynamics and Gore Medical; and he is a proctor for EP vascular and Abbott. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2024 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine.)

Left atrial appendage occlusion (LAAO) is an established alternative to oral anticoagulation for stroke prevention in atrial fibrillation. Antithrombotic therapy is used in the post-procedural period to prevent device-related thrombosis (DRT). The risk of DRT is considered highest in the first 45-90 days after device implantation, based on animal studies of the device healing process. Clinically applied antithrombotic regimens vary greatly across studies, continents, and centers. This article gives an overview of the evidence behind current antithrombotic regimens, ongoing randomized trials, and future post-procedural management.

Background: Right ventricular (RV) failure is the prime cause of death in patients with pulmonary arterial hypertension. Novel treatment strategies that protect the RV are needed. Empagliflozin, a sodium-glucose co-transporter-2 inhibitor, shows cardioprotective effects on the left ventricle in clinical and preclinical studies, but its direct effects on RV remain elusive. We investigated the effects of empagliflozin on RV dysfunction induced by pulmonary trunk banding (PTB)., Methods: Male Wistar rats (116 ± 10 g) were randomized to PTB or sham surgery. One week after surgery, PTB animals received empagliflozin mixed into the chow (300 mg empagliflozin/kg chow; PTB-empa, n  = 10) or standard chow (PTB-control, n  = 10). Sham rats (Sham, n  = 6) received standard chow. After five weeks, RV function was evaluated by echocardiography, cardiac MRI, and invasive pressure-volume measurements., Results: PTB caused RV failure evident by decreased cardiac output compared with sham. PTB-empa rats had a 49% increase in water intake compared with PTB-control yet no differences in hematocrit or blood glucose. Treatment with empagliflozin decreased RV end-systolic pressures without any changes in RV cardiac output or ventricular-arterial coupling (Ees/Ea). The decrease in RV end-systolic pressure was complemented by a slight reduction in RV cross sectional area as a sign of reduced hypertrophy. Load-independent measures of RV systolic and diastolic function were not affected in PTB-empa rats compared with PTB-control., Conclusion: Empagliflozin treatment reduced RV end-systolic pressure in RV failure induced by pressure overload. Further studies are needed to elucidate whether this simply relates to a diuretic effect and/or additional independent beneficial RV effects., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Axelsen, Nielsen-Kudsk, Schwab, Ringgaard, Nielsen-Kudsk, de Man, Andersen and Andersen.)

Background: Device-related thrombus (DRT) after left atrial appendage closure (LAAC) is associated with adverse outcomes, i.e. ischemic stroke or systemic embolism (SE). Data on predictors of stroke/SE in the context of DRT are limited., Aims: This study aimed to identify predisposing factors for stroke/SE in DRT patients. In addition, the temporal connection of stroke/SE to DRT diagnosis was analyzed., Methods: The EUROC-DRT registry included 176 patients, in whom DRT after LAAC were diagnosed. Patients with symptomatic DRT, defined as stroke/SE in the context of DRT diagnosis, were compared against patients with non-symptomatic DRT. Baseline characteristics, anti-thrombotic regimens, device position, and timing of stroke/SE were compared., Results: Stroke/SE occurred in 25/176 (14.2%) patients diagnosed with DRT (symptomatic DRT). Stroke/SE occurred after a median of 198 days (IQR 37-558) after LAAC. In 45.8% stroke/SE occurred within one month before/after DRT diagnosis (DRT-related stroke). Patients with symptomatic DRT had lower left ventricular ejection fractions (50.0 ± 9.1% vs. 54.2 ± 11.0%, p = 0.03) and higher rates of non-paroxysmal atrial fibrillation (84.0% vs. 64.9%, p = 0.06). Other baseline parameters and device positions were not different. Most ischemic events occurred among patients with single antiplatelet therapy (50%), however, stroke/SE was also observed under dual antiplatelet therapy (25%) or oral anticoagulation (20%)., Conclusion: Stroke/SE are documented in 14.2% and occur both in close temporal relation to the DRT finding and chronologically independently therefrom. Identification of risk factors remains cumbersome, putting all DRT patients at substantial risk for stroke/SE. Further studies are necessary to minimize the risk of DRT and ischemic events., (© 2023. The Author(s).)

Despite the unprecedented advances in the left atrial appendage occlusion field, device-related thrombus (DRT) remains an unresolved issue with the therapy. This paper aims to provide a state-of-the-art review of the literature on the incidence, clinical impact, predictors and management of DRT and propose a novel classification of DRT and hypoattenuated thickening., Competing Interests: Funding Support and Author Disclosures Dr Alkhouli is on the advisory boards of Boston Scientific, Abbott, and Philips. Dr Nielsen-Kudsk is on the advisory boards of Boston Scientific and Philips. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023. Published by Elsevier Inc.)

Background: Scarce data exist on the evolution of device-related thrombus (DRT) after left atrial appendage closure (LAAC)., Objectives: This study sought to assess the incidence, predictors, and clinical impact of persistent and recurrent DRT in LAAC recipients., Methods: Data were obtained from an international multicenter registry including 237 patients diagnosed with DRT after LAAC. Of these, 214 patients with a subsequent imaging examination after the initial diagnosis of DRT were included. Unfavorable evolution of DRT was defined as either persisting or recurrent DRT., Results: DRT resolved in 153 (71.5%) cases and persisted in 61 (28.5%) cases. Larger DRT size (OR per 1-mm increase: 1.08; 95% CI: 1.02-1.15; P = 0.009) and female (OR: 2.44; 95% CI: 1.12-5.26; P = 0.02) were independently associated with persistent DRT. After DRT resolution, 82 (53.6%) of 153 patients had repeated device imaging, with 14 (17.1%) cases diagnosed with recurrent DRT. Overall, 75 (35.0%) patients had unfavorable evolution of DRT, and the sole predictor was average thrombus size at initial diagnosis (OR per 1-mm increase: 1.09; 95% CI: 1.03-1.16; P = 0.003), with an optimal cutoff size of 7 mm (OR: 2.51; 95% CI: 1.39-4.52; P = 0.002). Unfavorable evolution of DRT was associated with a higher rate of thromboembolic events compared with resolved DRT (26.7% vs 15.1%; HR: 2.13; 95% CI: 1.15-3.94; P = 0.02)., Conclusions: About one-third of DRT events had an unfavorable evolution (either persisting or recurring), with a larger initial thrombus size (particularly >7 mm) portending an increased risk. Unfavorable evolution of DRT was associated with a 2-fold higher risk of thromboembolic events compared with resolved DRT., Competing Interests: Funding Support and Author Disclosures Dr Rodés-Cabau holds the Research Chair “Fondation Famille Jacques Larivière” for the Development of Structural Heart Disease Interventions (Laval University, Quebec City, Canada). He also has received institutional research grants from Boston Scientific. Dr Maarse has received an unrestricted grant from Boston Scientific. Dr Pérez de Prado has served as a proctor for Boston Scientific. Dr Gupta has served as a proctor for Abbott. Dr Sanchez has served as a speaker and proctor for Boston Scientific. Dr Wang has served as a consultant for Edwards Lifesciences, Boston Scientific, and Neochord; and received research grant support from Boston Scientific assigned to his employer, the Henry Ford Health System. Dr Demkow has served as a proctor for Abbott and Boston Scientific. Dr Alkhouli has served as a consultant for Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: Small, unrepaired atrial septal defects are considered a benign lesion with good prognosis. Recently, clinical and register-based studies discovered increased long-term mortality and morbidity. The nature of these findings is not fully understood. Therefore, MRI was performed to evaluate cardiac function at rest and during exercise., Methods: Adults with open or spontaneously closed atrial septal defects and healthy, matched controls underwent MRI for evaluation of cardiac chamber volume. Quantitative flow scans measured blood flow in the ascending aorta and the proximal pulmonary artery at rest and during increasing supine exercise., Results: In total, 15 open defects (39 ± 11 years) and 15 matched controls (38 ± 12 years) were included, along with 20 spontaneously closed (36 ± 13 years) and 20 controls (36 ± 11 years). Cardiac chamber volumes and flow measurements at rest were comparable between groups, as were heart rates and workloads during exercise. At maximal exercise, open defects reached 31% lower cardiac index and had 38% higher retrograde flow in the pulmonary artery than their controls, p < 0.01. Shunt ratio remained unchanged during exercise, 1.2 ± 0.2. Closed defects reached 18% lower cardiac index, p = 0.02, with comparable pulmonary retrograde flow. Maximal cardiac index was inversely correlated with increasing age for patients only., Conclusion: Adults with a small, open or spontaneously closed atrial septal defects exhibit markedly lower exercise capacity compared with healthy peers. Moreover, open defects exhibit higher retrograde flows with increasing exercise. Finally, increasing age is related to poorer results in patients but not healthy controls. Longitudinal studies are necessary in order to determine potential accelerated worsening of physical capacity along with age-related changes in patients.

Aims: Transcatheter closure of patent foramen ovale (PFO) is the recommended stroke prevention treatment in patients ≤60 years with cryptogenic ischemic stroke and PFO. Atrial fibrillation or flutter (AF) is a known potential procedure-related complication, but long-term risk of developing AF remains unknown. This paper studied the long-term risk of developing AF following PFO closure., Methods and Results: A Danish nationwide cohort study was conducted. During 2008-2020, this study identified a PFO closure cohort, a PFO diagnosis cohort without PFO closure, and a general population comparison cohort matched 10:1 to the PFO closure cohort on age and sex. The outcome was first-time AF diagnosis. Risk of AF and multivariable-adjusted hazard ratio (HR) of the association between PFO closure or PFO diagnosis and AF were calculated. A total of 817 patients with PFO closure, 1224 with PFO diagnosis, and 8170 matched individuals were identified. The 5 year risk of AF was 7.8% [95% confidence interval (CI): 5.5-10] in the PFO closure cohort, 3.1% (95% CI: 2.0-4.2) in the PFO diagnosis cohort, and 1.2% (95% CI: 0.8-1.6) in the matched cohort. The HR of AF comparing PFO closure with PFO diagnosis was 2.3 (95% CI: 1.3-4.0) within the first 3 months and 0.7 (95% CI: 0.3-1.7) thereafter. The HR of AF comparing PFO closure with the matched cohort was 51 (95% CI: 21-125) within the first 3 months and 2.5 (95% CI: 1.2-5.0) thereafter., Conclusion: Patent foramen ovale closure was not associated with any substantial increased long-term risk of developing AF beyond the well-known procedure-related short-term risk., Competing Interests: Conflict of interest The authors report no conflict of interest in this work., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Device-related thrombus (DRT) remains one of the main concerns after left atrial appendage occlusion (LAAO). Several risk factors have been proposed, but most cannot be modulated. A modifiable factor such as device implantation depth is a potential target to adjust the risk for DRT., Objectives: The aim of this study was to assess the impact of LAAO device implantation depth as a predisposing factor for DRT., Methods: The study included patients who underwent successful LAAO at 9 centers in Europe and Canada. Patients were classified into 2 groups: proximal device implantation (covered pulmonary ridge [PR] in the lobe and disc cohort or <5 mm from the PR in the single-lobe cohort) and distal device implantation (uncovered PR in the disc and lobe cohort and ≥5 mm in the single-lobe cohort)., Results: A total of 1,317 patients were included. Among these, proximal and distal device implantation was achieved in 732 (55%) and 585 (45%) patients, respectively. No differences in procedural outcomes were observed between the groups. At follow-up, patients with proximal implantation had a lower incidence of DRT (2.3%) than those with distal implantation (12.2%) (P < 0.001). Deeper device implantation and a larger uncovered left atrial appendage area were associated with a higher incidence of DRT (P < 0.001), regardless of device type. In multivariable analysis, distal implant (HR: 5.92; 95% CI: 3.39-10.36) and no or single antiplatelet therapy (HR: 1.62; 95% CI: 0.99-2.62) emerged as independent predictors of DRT., Conclusions: LAAO device implantation depth is an independent risk factor for DRT. Deeper device implantation and larger uncovered left atrial appendage areas were associated with a higher incidence of DRT., Competing Interests: Funding Support and Author Disclosures Dr De Backer has received institutional research grants and consulting fees from Abbott and Boston Scientific. Dr Sanchis is a proctor for Abbott Medical. Dr Garot has received speaker and advisory fees from Abbott, Biosensors, Boston Scientific, Edwards Lifesciences, GE Healthcare, and Terumo; and serves as medical director for and is a shareholder in the Cardiovascular European Research Center. Dr Aminian is a proctor and consultant for Abbott and Boston Scientific. Dr Rodés-Cabau has received an institutional research grant from Boston Scientific. Dr Freixa is a proctor for Abbott Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: In acute pulmonary embolism (PE), the right ventricle (RV) may dilate compromising left ventricular (LV) size, thereby increasing RV/LV ratio. End-diastolic RV/LV ratio is often used in PE risk stratification, though the cause of death is RV systolic failure. We aimed to confirm our pre-clinical observations of higher RV/LV ratio in systole compared to diastole in human patients with PE., Methods: We blinded and independently analyzed echocardiograms from 606 patients with PE, evaluated by a Pulmonary Embolism Response Team. We measured RV/LV ratios in end-systole and end-diastole and fractional area change (FAC). Our primary outcome was a composite of 7-day clinical deterioration, treatment escalation or death. Secondary outcomes were 7-day and 30-day all-cause mortality., Results: RV/LV ratio was higher in systole compared to diastole (median 1.010 [.812-1.256] vs. .975 [.843-1.149], p < .0001). RV/LV in systole and diastole were correlated (slope = 1.30 [95% CI 1.25-1.35], p < .0001 vs. slope = 1). RV/LV ratios in both systole and diastole were associated with the primary composite outcome but not with all-cause mortality., Conclusion: The RV/LV ratio is higher when measured in systole versus in diastole in patients with acute PE. The two approaches had similar associations with clinical outcomes, that is, it appears reasonable to measure RV/LV ratio in diastole., (© 2023 Wiley Periodicals LLC.)

Competing Interests: Disclosures Dr Andersen reports to serve as a consultant for Inari Medical, Inc, and Magneto Thrombectomy Solutions. He has received grants from Abbott Vascular, AngioDynamics, Inc, EPS Vascular, Janssens Pharmaceutical, and W.L. Gore & Associates, Inc. Dr Johnsen reports to serve as a consultant for Bristol Meyers Squibb and Pfizer. He has received grants from Novo Nordisk, Pfizer, and TrygFonden. Dr Nielsen-Kudsk has received grants from Abbott Laboratories and Boston Scientific Corporation. Dr Simonsen has received grants from Novo Nordisk Foundation and Health Research Foundation of Central Denmark Region. The other authors report no conflicts.

Background: The Amulet (Abbott) left atrial appendage occluder investigational device exemption trial is the largest randomized trial evaluating the safety and effectiveness of the Amulet left atrial appendage occluder compared with the Watchman 2.5 device (Boston Scientific) through 5 years., Objectives: This analysis evaluated the device effect on 3-year outcomes in the Amulet investigational device exemption trial., Methods: The medication regimen and key clinical outcomes were reported through 3 years including: 1) the composite of ischemic stroke or systemic embolism (SE); 2) the composite of all strokes, SE, or cardiovascular (CV) death; 3) major bleeding; and 4) all-cause death and CV death., Results: A total of 1,878 patients at 108 sites were randomized. A significantly higher percentage of patients were free of oral anticoagulation usage at 3 years with Amulet (96.2%) vs Watchman (92.5%) (P < 0.01). Clinical outcomes were comparable for the composite of ischemic stroke or SE (5.0% vs 4.6%; P = 0.69); the composite of all strokes, SE, or CV death (11.1% vs 12.7%; P = 0.31); major bleeding (16.1% vs 14.7%; P = 0.46); all-cause death (14.6% vs 17.9%; P = 0.08); and CV death (6.6% vs 8.5%; P = 0.14) for Amulet and Watchman, respectively. Through 3 years, device factors (device-related thrombus or peridevice leak ≥3 mm) preceded ischemic stroke events and CV deaths more frequently in Watchman compared with Amulet patients., Conclusions: The Amulet occluder demonstrated continued safety and effectiveness with over 96% free of oral anticoagulation usage through 3 years in a high-risk population compared to the Watchman device. (AMPLATZER Amulet LAA Occluder Trial [Amulet IDE]; NCT02879448)., Competing Interests: Funding Support and Author Disclosures Abbott funded the Amulet IDE Trial. No funding was provided for this analysis. Dr Lakkireddy has received research and educational grants to the institution from Abbott, AtriCure, Alta Thera, Medtronic, Biosense Webster, Biotronik, and Boston Scientific; and has received speaker honorarium from Abbott, Medtronic, Biotronik, and Boston Scientific. Dr Thaler has received consulting fees from Abbott and Occlutech; and has received institutional research grants for clinical trials from Abbott and the National Institutes of Health. Dr Ellis has received institutional research grants from Boehringer-Ingelheim Inc, Medtronic, and Boston Scientific; and has received consulting/advisory fees from, Abbott Medical Inc, Boston Scientific, and AtriCure Inc. Dr Swarup has received consulting fees from Biosense Webster, Boston Scientific, and Abbott. Dr Gambhir has received consulting fees from Abbott, Biosense Webster, and Boston Scientific, and speaker honorarium from Boston Scientific. Dr Hermiller serves as a consultant to Abbott, Edwards Lifesciences, and Medtronic. Dr Nielsen-Kudsk has received institutional research grants from Abbott and Boston Scientific. Dr Worthley has performed consultancy and proctoring for Edwards Lifesciences and Abbott; and is a shareholder for Three Peaks Medical. Dr Nair has received research grants and support from Medtronic, Boston Scientific, Abbott, Biosense Webster, and Adagio; is on the advisory board for Medtronic, Boston Scientific, Abbott, Biosense Webster, and Adagio; is a consultant for Medtronic, Boston Scientific, Abbott, Biosense Webster, and Adagio; and has received honoraria from Medtronic, Boston Scientific, Abbott, Biosense Webster, and Adagio. Dr Schmidt has received speaker honorarium and consulting fees from Abbott, Boston Scientific, Biosense Webster, and Medtronic. Dr Horton is a consultant for Boston Scientific, Biosense Webster, St. Jude/Abbott Medical, Biotronik, Baylis, and Medtronic. Dr Gupta has received institutional research grants from Medtronic, Boston Scientific, Abbott, and CVRx Inc. Dr Anderson is an employee of Abbott. Mr Gage is an employee of Abbott. Dr Alkhouli serves as a consultant to Boston Scientific and Abbott. Dr Windecker reports research, travel, or educational grants to the institution from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Corflow Therapeutics, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Janssen-Cilag, Johnson & Johnson, Medicure, Medtronic, Merck Sharp & Dohme, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pfizer, Polares, Regeneron, Sanofi, Servier, Sinomed, Terumo, Vifor, and V-Wave; serves as an advisory board member and/or member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, Janssen, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, V-Wave, and Xeltis with payments to the institution but no personal payments; and is a member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)