Background: The benefit of left atrial appendage closure (LAAC) in patients refusing oral anticoagulation (OAC) despite medical recommendations is unknown. We aim to assess the efficacy and the safety of LAAC in patients refusing OAC. Methods: Data on consecutive patients with atrial fibrillation undergoing percutaneous LAAC between 2009 and 2022 in 4 European centers were collected and patients undergoing LAAC due to refusal of OAC (refusal group) were compared with patients receiving LAAC for more established indications (control group). The primary end point of the study was the composite of cardiovascular death, stroke, or systemic embolism. The secondary end points included technical success and procedural complications. Events during follow‐up were compared with those predicted by CHA2DS2VASC and hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile International Normalized Ratio, elderly, drugs/alcohol concomitantly (HASBLED) score risks. Results: Of the 2649 patients submitted to LAAC, 119 were performed due to OAC refusal (4.5%). Two‐hundred‐thirty‐eight (8.9%) control patients were identified. Refusal as compared with the control group included younger and lower‐risk patients. At 3 years, the primary end point was significantly lower (4.2% versus 17.2%; adjusted hazard ratio: 0.37; 95% CI: 0.14–0.99; P =0.048) in the refusal in respect to the control group. Technical success and procedural complications were similar between groups. In the refusal group, the annual rate of thromboembolic events and major bleedings were 2.3% and 1.9%, respectively, corresponding to 62% and 47% risk reductions as compared with the rates expected by risk scores. Conclusions: In this multicenter cohort of consecutive patients with atrial fibrillation submitted to LAAC, OAC refusal appeared as an infrequent indication. In this subgroup, LAAC was confirmed to be feasible and safe. The ischemic outcomes rates at 3 years are promising. Further studies are needed to better understand the potential effects of preferring LAAC over OAC.
Objective: To determine the incidence of recurrent ischemic stroke following percutaneous left atrial appendage closure in patients with previous thromboembolic events despite oral anticoagulation. Methods: We conducted a systematic review and meta-analysis of studies of any design reporting ischemic stroke recurrence after left atrial appendage closure in patients with prior ischemic stroke despite oral anticoagulation therapy. The literature search was conducted in MEDLINE, Embase, and the Cochrane Library for studies published between 1 January 2010 and 31 December 2025. Data on study design, population characteristics, indexed intervention, and outcomes were extracted from each included report. The primary outcome was ischemic stroke occurring after left atrial appendage closure, as defined by each individual study. A pooled incidence rate was estimated using a random-effects model to account for anticipated between-study heterogeneity. The study is registered in Open Science Framework. The Risk of Bias in Non-randomized Studies of Interventions assessment tool was used to assess the risk of bias. Results: Overall, eight studies of a total of 1091 patients met the eligibility criteria. Patients were elderly (mean age range 71.8 to 78.1 years), 33% to 53% were women, and thromboembolic risk was consistently high (mean CHA2DS2-VASc scores ≥ 5.0). The risk of bias across the included studies was either moderate or serious. Antithrombotic therapy after left atrial appendage closure varied considerably across the included studies. In one study, all patients were discharged on dual antiplatelet therapy, whereas in five studies >70% received oral anticoagulation alone or in combination with antiplatelet therapy at discharge. In six studies, antithrombotic therapy at follow-up was reported, with the proportion of patients on oral anticoagulation alone or in combination with antiplatelet therapy at follow-up ranging from 8.1% to 100% in individual studies. Follow-up duration ranged from 1.0 to 3.1 years. At a mean follow-up of 17.7 months the pooled incidence of the ischemic stroke recurrence rate following left atrial appendage closure was 3.1% per year (95% confidence interval 2.35–4.20%). Conclusions: Among elderly patients with prior ischemic stroke despite oral anticoagulation, the recurrence rate of ischemic stroke following left atrial appendage closure was 3.1% per year. Given the residual risk of stroke recurrence and the substantial heterogeneity in post-procedural antithrombotic management observed across studies, prospective randomized trials are urgently needed to define both the protective impact of left atrial appendage closure and the optimal antithrombotic strategy in this high-risk population.
Aortic root injury during transseptal puncture (TSP) is a rare but well-recognized complication. However, injury to the descending aorta has not previously been described in this context. A 57-year-old woman underwent left atrial appendage closure. During TSP using the VersaCross Connect radiofrequency-powered system and a 15-F steerable sheath, an unrecognized perforation of the descending aorta occurred. Despite repeated transthoracic echocardiograms showing no pericardial effusion and initial hemodynamic stability, she subsequently developed a mediastinal hematoma and bilateral pleural effusion. Management required an emergency percutaneous thoracic endovascular aortic repair, followed by surgical evacuation of the hematoma. Excessive tenting during radiofrequency-powered TSP, related to interatrial septum aneurysm, resulted in injury to the descending aorta with life-threatening consequences. Radiofrequency-powered systems for TSP have enhanced tissue penetration capability and should therefore be used with caution, particularly in the presence of an interatrial septum aneurysm and atypical echocardiographic windows.
Background—Percutaneous left atrial appendage (LAA) closure (LAAC) offers a valid alternative to oral anticoagulation in patients with atrial fibrillation (AF) at high risk of bleeding. However, its impact on AF burden and device function in patients with cardiac implantable electronic devices (CIEDs) remains largely unexplored. Methods—From our prospective LAAC registry (clinicaltrial.gov—NCT04628078), which includes all consecutive LAAC procedures performed at our institution, we identified patients with a CIED and retrospectively analyzed procedural and follow-up data. The primary endpoint was defined as a composite of death, TIA/stroke, systemic or pulmonary embolism and major bleeding (BARC 3-5) within 7 days of the procedure. The secondary endpoint was CIED lead dislodgement. Additionally, AF burden was compared before and after LAAC. Results—Of the 586 LAAC procedures performed between August 2015 and January 2023, 36 patients (6%) had a CIED. The median CHA2DS2-VASC and HAS-BLED scores were 4.0 and 3.0, respectively. The primary endpoint occurred in one (3%) patient, and no patient experienced CIED lead dislodgement. AF burden data before and after LAAC were available in 20 patients. The mean AF burden increased from 6% to 31% following LAAC (p = 0.064). Conclusions—A CIED was present in 6% of LAAC procedures, and LAAC appears feasible and safe in this patient population. Larger, prospective studies are warranted to further evaluate the impact of LAAC on AF burden.