Outcomes of Watchman device implantation in atrial fibrillation patients contraindicated for long-term anticoagulation: a single-center experience.

Key Findings▪Percutaneous left atrial appendage (LAA) occlusion has emerged as an alternative strategy to oral anticoagulants in selected patients with atrial fibrillation.▪The landmark trials comparing LAA occlusion to an oral anticoagulation strategy enrolled patients with no apparent contraindications to the use of warfarin.▪LAA occlusion has limited head-to-head comparison against the direct-acting oral anticoagulants.▪Observational data to date have generally shown specific adverse events after LAA occlusion in specific subgroups of patients (women, patients with kidney disease and heart failure, patients belonging to racial/ethnic subgroups and with advanced age), but further large-scale studies are necessary to elucidate reasons for increased adverse events associated with LAA occlusion in these subgroups of patients before recommending this modality as first-line therapy in all patient groups. ▪Percutaneous left atrial appendage (LAA) occlusion has emerged as an alternative strategy to oral anticoagulants in selected patients with atrial fibrillation.▪The landmark trials comparing LAA occlusion to an oral anticoagulation strategy enrolled patients with no apparent contraindications to the use of warfarin.▪LAA occlusion has limited head-to-head comparison against the direct-acting oral anticoagulants.▪Observational data to date have generally shown specific adverse events after LAA occlusion in specific subgroups of patients (women, patients with kidney disease and heart failure, patients belonging to racial/ethnic subgroups and with advanced age), but further large-scale studies are necessary to elucidate reasons for increased adverse events associated with LAA occlusion in these subgroups of patients before recommending this modality as first-line therapy in all patient groups.

DAPT Is Comparable to OAC Following LAAC With WATCHMAN FLX: A National Registry Analysis.

Meta-analysis of Stroke and Bleeding Risk in Patients with Various Atrial Fibrillation Patterns Receiving Oral Anticoagulants

Information about a real patient is presented in stages (boldface type) to an expert clinician (Dr Valentin Fuster), who responds to the information, sharing his reasoning with the reader (regular type). A discussion by the authors follows. A 61-year-old man presents with 2 weeks of exertional dyspnea. Pertinent medical history includes hypertension, nephrolithiasis, and internal hemorrhoids. He takes no medications and has no known drug allergies. His father died after a myocardial infarction at 57 years of age. He formerly smoked 1 pack of cigarettes daily for 15 years but ceased tobacco use 10 years before presentation. He ingests 2 glasses of alcohol weekly and denies illicit drug use. His caffeine intake is limited. He is an architect and is married, with healthy children. On physical examination, his temperature is 98.0°F, blood pressure is 130/85 mm Hg bilaterally, pulse is irregular at 130 beats per minute, and respiratory rate is 18 breaths per minute with an oxygen saturation of 97% while breathing room air. He is a slender white man in no distress. His jugular venous pressure is elevated at 14 cm H 2 O. There is no thyromegaly, and the carotid upstrokes are brisk, without bruits. Cardiovascular examination reveals a rapid and irregular heart rhythm with variation in the intensity of the first heart sound. The point of maximal impulse is not displaced. The remainder of the chest and abdominal examination is within normal limits. The extremities are warm and show mild pitting edema. Laboratory testing is significant for normal renal function and electrolytes, but a hemogram reveals a mild thrombocytopenia of 90 000 platelets/μL. ECG demonstrates atrial fibrillation (AF) with an average ventricular rate of 123 bpm ( Figure 1 ). Figure 1. The 12-lead ECG showing atrial fibrillation with a rapid ventricular rate. Dr Valentin Fuster : This is a …

In the last few years, percutaneous LAA occlusion (LAAO) has become a plausible alternative in atrial fibrillation (AF) patients with contraindications to anticoagulation therapy. Nevertheless, the optimal antiplatelet strategy following percutaneous LAAO remains to be defined. Studies comparing single antiplatelet therapy (SAPT) versus dual antiplatelet therapy (DAPT) following LAAO were systematically searched and screened. The outcomes of interest were ischemic stroke, device-related thrombus (DRT) and major bleeding. A random-effect meta-analysis was performed comparing outcomes in both groups. The moderator effect of baseline characteristics on outcomes was evaluated by univariate meta-regression analyses. Sixteen observational studies with 3255 patients treated with antiplatelet therapy (SAPT, n = 1033; DAPT, n = 2222) after LAAO were included. Mean age was 74.5 ± 8.3 years, mean CHA2DS2-VASc and HAS-BLED scores were 4.3 ± 1.5 and 3.2 ± 1.0, respectively. At a weighted mean follow-up of 12.7 months, the occurrence of stroke (RR 1.33; 95% CI 0.64-2.77; p =.44), DRT (RR 1.52; 95% CI 0.90-2.58; p =.12), and the composite of stroke and DRT (RR 1.26; 95% CI 0.67-2.37; p =.47) did not differ significantly between SAPT and DAPT groups. The rate of major bleedings was also not different between groups (RR 1.41; 95% CI 0.64-3.12; p =.39). Among AF patients at high bleeding risk undergoing percutaneous LAAO, a post-procedural minimalistic antiplatelet strategy with SAPT did not significantly differ from DAPT regimens regarding the rate of stroke, DRT and major bleeding.

902 Cluster Randomized Controlled Trial to Test the Effect of Computer-Generated Individualized Audit and Feedback to Patients and Physicians on Clinical Outcomes in Atrial Fibrillation Patients Participating in a Large Multi-Center Trial of Dabigatran

Incidence, Characteristics, and Clinical Course of Device-Related Thrombus AfterWatchman Left Atrial Appendage Occlusion Device Implantation in Atrial Fibrillation Patients.

BackgroundIn Spain, Vitamin K Antagonists (VKAs) remain the first-line therapy for stroke prevention in atrial fibrillation (AF) patients, as prescribing direct oral anticoagulants (DOACs) requires prior authorization to fulfill reimbursement criteria. Despite these reimbursement restrictions, a documented increase in DOAC use for stroke prevention in AF patients has been observed from 2013-2020. Real-world evidence is essential to gain further insights into the clinical outcomes and usage patterns of DOACs and VKAs in AF management.PurposeThe goal of this study is to evaluate the effectiveness and safety of DOACs vs. VKAs for stroke prevention in AF patients in routine clinical practice in Spain, including incidence rates of ischemic stroke (IS), systemic embolism (SE), major bleeding (MB), and all-cause mortality.MethodsThis retrospective observational cohort analysis used Spanish BIG-PAC data from 01/01/2017-31/12/2023, including adult nonvalvular AF patients initially prescribed a DOAC (edoxaban, apixaban, dabigatran, rivaroxaban) or a VKA (index date=first DOAC/VKA prescription). Patients with deep vein thrombosis, pulmonary embolism, mechanical heart valves within 12 months, or hip/knee replacements within 6 weeks before index were excluded. DOAC and VKA cohorts based on index treatment were identified. Effectiveness, safety, and all-cause mortality were compared between cohorts using inverse probability of treatment weighting (IPTW) to adjust for confounding, with hazard ratios (HR) and 95% confidence intervals (CI) calculated to assess outcomes. Sensitivity analyses censored data at 12 months.ResultsA total of 15,348 patients were included (DOACs, n=8,264; VKAs, n=7,084). After applying IPTW, patient characteristics were balanced across groups. DOACs showed significantly lower risk of MB compared to VKAs (HR [95% CI]: 0.47 [0.42-0.53]) and lower all-cause mortality (HR [95% CI]: 0.63 [0.58-0.68]). Similar results were seen for MB when censored at 12 months (Table 1). Additional analyses compared clinical outcomes between the 4 DOAC cohorts. Compared with edoxaban, dabigatran had a higher risk of IS/SE (HR [95% CI]: 2.12 [1.44–3.14]) and all-cause mortality (HR [95% CI]: 1.39 [1.02-1.89]) and apixaban had a higher risk of IS/SE (HR [95% CI]: 1.56 [1.12–2.18]). No significant differences in outcomes were observed between edoxaban and rivaroxaban, and MB risk did not differ significantly between edoxaban and any of the other DOACs.ConclusionsReal-world DOAC use for stroke prevention in Spanish AF patients demonstrated a better safety outcome and lower all-cause mortality with similar effectiveness relative to VKA. Safety profiles and survival rates were similar across DOACs. Patients on edoxaban had a lower risk of IS/SE compared to apixaban or dabigatran, suggesting a favorable benefit-risk profile for stroke prevention in AF.

Introduction: End-stage renal disease (ESRD) is associated with increased complications due to oral anticoagulation (OAC) use for stroke prevention in atrial fibrillation (AF). Left atrial appendage occlusion (LAAO) is indicated for patients who cannot tolerate or prefer not to use OAC but the outcomes of LAAO in ESRD has not been well studied. Methods: Using National Readmission Database January 2016-December 2017, we identified all adult AF patients who had LAAO performed in the months of January to November with no missing length of stay and/or mortality information. We excluded patients who had ablation, device implantation/revision, other form of LAAO and/or coronary artery bypass graft surgery performed during index hospitalization. 1:1 propensity score matching was performed for patients with and without ESRD based on variables shown in Table 1. The main outcome of interest was early mortality defined as mortality of index hospitalization or 30-day readmissions and index hospital complications. Results: A total of 13,790 procedures were included and of these 370 patients had history of ESRD. The baseline characteristics before and after matching are shown in table 1. After propensity score matching, ESRD group was associated with significantly higher early mortality, 30-day readmissions, systemic embolism and pericardial complications (Table 2). In the matched cohort, none of the patients had postprocedural cerebrovascular accident, transient ischemic attack, device thrombosis and device embolization. After propensity matching 2 (0.5%) developed acute kidney injury requiring hemodialysis. Conclusions: ESRD is associated with higher LOS, index hospital complications and early mortality from LAAO compared to patients without ESRD. Further studies comparing outcomes between OAC use and LAAO are warranted.

Percutaneous left atrial appendage (LAA) closure is a viable alternative to chronic oral anticoagulation for reducing thromboembolic risk in non-valvular atrial fibrillation (AF) patients. To date, no clinical data have been published on the novel nonpacifier LAA closure device evaluated herein.We therefore conducted a prospective, non-randomized, multi-center registry across 6 Chinese hospitals to provide the first clinical evidence of its safety and effectiveness among AF patients with an increased risk of stroke, using performance goals to assess 6-month effective LAA closure and 12-month ischemic stroke incidence. Among 187 enrolled patients (mean age 67.7 ± 7.5years; mean CHA2DS2-VASc 4.0 ± 1.6; mean HAS-BLED 2.5 ± 1.1), device implantation succeeded in 184 (98.4%), with 4 (2.1%) major peri-procedural complications. Effective LAA closure was achieved in all (100%) patients at 6months with a 1-sided 95% lower confidence interval (CI) of 98.0%. During the 12-month follow-up period, 1 of 176 patients (0.6%, 1-sided 95% upper CI 2.9%) experienced ischemic stroke, thus meeting both prespecified performance goals. The cumulative incidence of major clinical events was 11 of 176 patients (6.5%, 95% CI 2.9-10.1%). This novel LAA closure device is effective for stroke prevention in non-valvular AF, with high procedural success and low adverse events.

Atrial fibrillation (AF) is a prevalent cardiac arrhythmia associated with an increased risk of stroke due to disrupted heart function and potential clot formation. This review examines current management strategies for stroke prevention in AF, focusing on the efficacy, safety, and long-term outcomes of anticoagulation therapies. Anticoagulants, including novel oral anticoagulants (NOACs) and vitamin K antagonists, play a crucial role in reducing stroke risk by preventing clot formation in the heart. Recent studies highlight NOACs as superior alternatives to traditional therapies, offering improved safety profiles and enhanced patient adherence. Despite the risk of bleeding complications, judicious use of anticoagulants significantly improves clinical outcomes in AF patients. The review synthesizes evidence from clinical trials and meta-analyses to underscore the pivotal role of NOACs in transforming stroke prevention strategies in AF. Moreover, it discusses emerging interventions such as left atrial appendage occlusion and emphasizes the importance of personalized, patient-centered care in optimizing treatment decisions for AF patients at risk of stroke.

Vitamin K antagonist such as warfarin reduces the risk of stroke in atrial fibrillation (AF) patients. Since warfarin has a narrow therapeutic index, its administration needs to be regularly monitored to avoid any adverse clinical outcomes such as stroke and bleeding. The quality of anticoagulation control with warfarin therapy can be measured by using time in therapeutic range (TTR). This review focuses on the prevalence of AF, quality of anticoagulation control (TTR) and adverse clinical outcome in AF patients within different ethnic groups receiving warfarin therapy for stroke prevention. A literature search was conducted in Embase and PubMed using keywords of “prevalence,” “atrial fibrillation,” “stroke prevention,” “oral anticoagulants,” “warfarin,” “ethnicities,” “race” “time in therapeutic range,” “adverse clinical outcome,” “stroke, bleeding.” Articles published by 1st February 2020 were included. Forty-one studies were included in the final review consisting of AF prevalence (n = 14 studies), time in therapeutic range (n = 18 studies), adverse clinical outcome (n = 9 studies) within different ethnic groups. Findings indicate that higher prevalence of AF but better anticoagulation control among the Whites as compared to other ethnicities. Of note, non-whites had higher risk of strokes and bleeding outcomes while on warfarin therapy. Addressing disparities in prevention and healthcare resource allocation could potentially improve AF-related outcomes in minorities.

Background Little is known about the extent to which an active cancer diagnosis increases bleeding and thromboembolic risks in atrial fibrillation (AF) patients. Data on major bleeding rates per antithrombotic management strategy are lacking in AF patients with active cancer. Purpose To examine the incidence rates of major bleeding per antithrombotic treatment in AF patients with active cancer and to examine whether cancer type impacts major bleeding and thromboembolic risks. Methods We used Danish population-based health care databases to conduct this cohort study. We included all incident AF (including atrial flutter) patients aged ≥50 years between January 1st 1995 and December 31st 2016, out of whom we identified AF patients who subsequently developed cancer. We used International Classification of Diseases 10th Revision codes to identify data on cancer type and outcomes (i.e. major bleeding, arterial and venous thromboembolism). We used Anatomical Therapeutic Chemical codes to provide information on antithrombotic treatment (e.g. no anticoagulant treatment, platelet inhibitors, vitamin K antagonists, direct oral anticoagulants, or a combination of antithrombotic drugs) which was evaluated as a time-dependent variable. The follow-up started from the incident cancer diagnosis until the occurrence of an outcome, death or the end of the two year follow-up. Incidence rates per 100 patient-years and adjusted hazard ratios were computed. Results 22,996 AF patients with a subsequent incident cancer diagnosis were included in the study. These patients had higher major bleeding and thromboembolic risk compared to those without cancer, with adjusted HRs of 2.11 (1.99–2.23) and 1.36 (1.27–1.44), respectively (Figure 1). Highest bleeding risk was observed for intracranial and respiratory cancer, while haematological and respiratory cancer were associated with highest thromboembolic risk. Bleeding risk increased with increasing number of antithrombotic drugs and was higher in AF patients with active cancer compared to those without, across all exposure categories (Figure 2). Conclusions Patients with AF and active cancer are at increased risk of major bleeding and thromboembolisms than those without cancer. Treatment with dual or triple antithrombotic therapy in AF patients with active cancer showed very high bleeding rates. Funding Acknowledgement Type of funding sources: None.

Clinical Outcomes Associated With LeftAtrial Appendage Occlusion VersusDirect Oral Anticoagulation in Atrial Fibrillation.

Background: Percutaneous left atrial appendage occlusion (LAAO) has emerged as a stroke prevention strategy in patients with nonvalvular atrial fibrillation (NVAF), and these patients were required to receive antithrombotic therapy post-procedure. However, the optimal antithrombotic strategy after LAAO remains controversial. This study explored the safety and efficacy of different antithrombotic strategies after LAAO through a network comparison method. Methods: We systematically searched the MEDLINE, Embase, and Cochrane Library databases for studies that reported the interested efficacy and safety outcomes (stroke, device-related thrombus (DRT), and major bleeding) of different antithrombotic strategies [DAPT (dual antiplatelet therapy), DOACs (direct oral anticoagulants), and VKA (vitamin k antagonist)] in patients who had experienced LAAO. Pairwise comparisons and network meta-analysis were performed for the interested outcomes. Risk ratios (RRs) with their confidence intervals (CIs) were calculated using a random-effects model. The rank of the different strategies was calculated using the surface under the cumulative ranking curve (SUCRA). Results: Finally, 10 observational studies involving 1,674 patients were included. There was no significant difference in stroke, DRT, and major bleeding among the different antithrombotic strategies (DAPT, DOACs, and VKA). Furthermore, DAPT ranked the worst in terms of stroke (SUCRA: 19.8%), DRT (SUCRA: 3.6%), and major bleeding (SUCRA: 6.6%). VKA appeared to be superior to DOACs in terms of stroke (SUCRA: 74.9% vs. 55.3%) and DRT (SUCRA: 82.3% vs. 64.1%) while being slightly inferior to DOACs in terms of major bleeding (SUCRA: 71.0% vs. 72.4%). Conclusion: No significant difference was found among patients receiving DAPT, DOACs, and VKA in terms of stroke, DRT, and major bleeding events after LAAO. The SUCRA indicated that DAPT was ranked the worst among all antithrombotic strategies due to the higher risk of stroke, DRT, and major bleeding events, while VKAs were ranked the preferred antithrombotic strategy. However, DOACs are worthy of consideration due to their advantage of convenience.