Aims Oesophageal fistula represents a rare but dreadful complication of atrial fibrillation catheter ablation. Data on its incidence, management and outcome are sparse. Methods and results This international multicenter registry investigates the characteristics of oesophageal fistulae after treatment of atrial fibrillation by catheter ablation. A total of 553,729 catheter ablation procedures (radiofrequency: 62.9%, cryoballoon: 36.2%, other modalities: 0.9%) were performed at 214 centers in 35 countries. In 78 centers 138 patients (0.025%, radiofrequency: 0.038%, cryoballoon: 0.0015% (p<0.0001)) were diagnosed with an oesophageal fistula. Periprocedural data were available for 118 patients (85.5%). Following catheter ablation, the median time to symptoms and the median time to diagnosis were 18 (7.75, 25; range: 0-60) days and 21 (15, 29.5; range: 2-63) days, respectively. The median time from symptom onset to oesophageal fistula diagnosis was 3 (1, 9; range: 0-42) days. The most common initial symptom was fever (59.3%). The diagnosis was established by chest computed tomography in 80.2% of patients. Oesophageal surgery was performed in 47.4% and direct endoscopic treatment in 19.8%, and conservative treatment in 32.8% of patients. The overall mortality was 65.8%. Mortality following surgical (51.9%) or endoscopic treatment (56.5%) was significantly lower as compared to conservative management (89.5%) (odds ratio 7.463 (2.414, 23.072) p<0.001). Conclusions Oesophageal fistula after catheter ablation of atrial fibrillation is rare and occurs mostly with the use of radiofrequency energy rather than cryoenergy. Mortality without surgical or endoscopic intervention is exceedingly high.
Background Left atrial appendage closure (LAAC) has emerged as an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). OAC treatment has been proven feasible in mild‐to‐moderate chronic kidney disease (CKD). In contrast, the optimal antithrombotic management of AF patients with end‐stage renal disease (ESRD) is unknown and LAAC has not been proven in these patients in prospective randomized clinical trials. Objectives The objective of this study is to evaluate safety and efficacy of LAAC in patients with ESRD. Methods Patients undergoing LAAC were collected in a German multicenter real‐world observational registry. A composite endpoint consisting of the occurrence of ischemic stroke/transient ischemic attack, systemic embolism, and/or major clinical bleeding was assessed. Patients with ESRD were compared with propensity score‐matched patients without severe CKD. ESRD was defined as a glomerular filtration rate < 15 ml/min/1.73 m2 or chronic hemodialysis treatment. Results A total of 604 patients were analyzed, including 57 with ESRD and 57 propensity‐matched patients. Overall, 596 endocardial and 8 epicardial LAAC procedures were performed. Frequency of major complications was 7.0% (42/604 patients) in the overall cohort, 8.8% (5/57 patients) in patients with ESRD, and 10.5% (6/57 patients) in matched controls (p = 0.75). The estimated event‐free survival of the combined endpoint after 500 days was 90.7 ± 4.5% in patients with ESRD and 90.2 ± 5.5% in matched controls (p = 0.33). Conclusions LAAC had comparable procedural safety and clinical efficacy in patients with ESRD and patients without severe CKD.
Objectives To compare the Watchman™ versus Amulet™ left atrial appendage closure (LAAC) devices in a consecutive, industry-independent registry. Background Data reporting a head-to-head comparison between Amulet and Watchman devices are scarce. Methods Patients who underwent LAAC using Watchman or Amulet devices from January 2014 to December 2019 at the University Heart Center Lübeck, Lübeck, Germany were included in the present analysis. Primary endpoints included periprocedural complications (in-hospital death, pericardial tamponade, device embolization, stroke, major bleeding and vascular access complications), and complications during 2-year-follow-up (ischemic stroke, hemorrhagic stroke, thromboembolism, device thrombus, bleeding and death). Results After matching the patients for age (± 5 years), gender, CHA2DS2Vasc score (± 1) and HASBLED score (± 1), each of the Watchman and the Amulet groups included 113 patients. Patients in the Amulet group had significantly more periprocedural complications (2.7% vs 10.6%, p = 0.029; respectively) and more major bleeding complications (0% vs 5.3%, p = 0.029; respectively). During 2-year follow-up, the rate of events was comparable between the Watchman and Amulet groups (18.3% versus 20.8%, p = 0.729; respectively). Conclusion Amulet LAAC device was associated with increased periprocedural complications as compared to Watchman LAAC device. On 2-year follow-up, both devices showed comparable efficacy and safety.
Patient: Male, 76-year-old Final Diagnosis: Left atrial appendage thrombus despite optimal anticoagulation Symptoms: Palpitations Medication: — Clinical Procedure: Cryoballoon-based ablation • percutaneous left atrial appendage closure • transesophageal echocardiogram Specialty: Cardiology Objective: Unusual clinical course Background: Despite use of optimal oral anticoagulation regimens, left atrial appendage (LAA) thrombus may develop and persist in patients with atrial fibrillation (AF). The therapeutic options in this population are limited. Percutaneous LAA closure (LAAC) is performed to reduce thrombus formation and the risk of thromboembolism. However, this approach is prohibited in patients with LAA thrombus. We report the case of a 76-year-old man with AF and persistent LAA thrombus who underwent percutaneous LAAC with the LAmbre device protected by the SENTINEL Cerebral Protection System (CPS). Case Report: A 76-year-old man with history of persistent AF treated with pulmonary veins and LAA isolation developed LAA thrombus resistant to different anticoagulation therapies, including apixaban and Phenprocoumon, with a target international normalized ratio (INR) of 3–3,5. Repeated follow-up transesophageal echocardiography showed a persistent LAA thrombus despite optimal INR values. Thus, we performed a percutaneous LAAC using a double-umbrella-designed appendage occluder and a CPS to minimize the risk of intraprocedural cerebral embolization. The procedure was guided by transesophageal echocardiography and fluoroscopy. No signs of systemic thromboembolism were noted, and the CPS filters showed no evidence of thrombotic material. Conclusions: This report shows that the use of a CPS during percutaneous LAAC may reduce the risk of procedural cerebral embolization and could be used as an alternative therapy for patients with contraindication or lack of effectiveness of oral anticoagulation.
Funding Acknowledgements Type of funding sources: None. Background Endoscopic laser balloon systems (ELBS) are a new tool for pulmonary vein isolation (PVI). The third generation ELBS underwent significant structural improvements compared to its predecessors. These include a novel feature (RAPID mode), potentially allowing an automized and high-speed circumferential energy delivery for PVI. However, there is a lack of data on its use. Objective We analyzed the safety, efficiency, and efficacy of the third-generation ELBS in a cohort of patients who underwent ablation of atrial fibrillation in a German and an Italian centre. Methods We prospectively enrolled all consecutive patients who underwent PVI using the third-generation ELBS between June 2019 and November 2022. All the procedures were performed by four operators. For each pulmonary vein (PV), we always attempted to obtain a complete circumferential lesion using only the RAPID mode. When this was not feasible, the operator treated the remaining gaps with point-by-point laser delivery. Results We included 163 patients in our study (mean age 61.9 ± 11.4, persistent atrial fibrillation 30.6%, female patients 30.6%). The operators identified and successfully isolated 655 pulmonary veins. There was an anatomical variation of the PVs in 41 (25.1%) patients, of whom 19 had either a left or a right common trunk, and 23 had a supernumerary right PV. 424 PVs (64%) were isolated for at least 80% of their circumference using the RAPID mode, 389 (59.4%) were treated using it for a minimum of 90% of their circumference, and finally, 289 (44%) were isolated using only RAPID. The operators could perform the procedure using only the RAPID mode in 35 (21.5%) patients. We observed a mean total procedural and fluoroscopic times of 95.7 ± 44.5 min and 13.9 ± 8.4, respectively. 5 (3%) periprocedural complications occurred. There were three episodes of transient phrenic nerve palsy (the most extended episode resolved two months after discharge). One episode of pericardial tamponade occurred, with a subsequent need for pericardiocentesis. Finally, there was one periprocedural transient ischaemic attack (TIA). During energy delivery, eight pinhole balloon ruptures occurred. Eighty-five patients were followed up for at least six months (mean follow-up 12.2 ± 4.4 months). Among these, 26 (30.5%) presented a recurrence after the blanking period. Among baseline features, persistent AF was not a predictor of recurrence. Conclusion This is one of the largest cohorts of patients treated with third-generation ELBS. In our two-centre experience, the system proved efficient, safe, and effective and the RAPID mode showed good applicability.
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