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Aims: During atrial fibrillation ablation, oesophageal heating typically prompts reduction or termination of radiofrequency energy delivery. We previously demonstrated oesophageal temperature rises are associated with posterior left atrial pulmonary vein reconnection (PVR) during redo procedures. In this study, we assessed whether mechanical oesophageal deviation (MED) during an index procedure minimizes posterior wall PVRs during redo procedures., Methods and Results: Patients in whom we performed a first-ever procedure followed by a clinically driven redo procedure were divided based on both the use of MED for oesophageal protection and the ablation catheter employed (force or non-force sensing) in the first procedure. The PVR sites were compared between MED using a force-sensing catheter (MEDForce), or no MED with a non-force (ControlNoForce) or force (ControlForce) sensing catheter. Despite similar clinical characteristics, the MEDForce redo procedure rate (9.2%, 26/282 patients) was significantly less than the ControlNoForce (17.2%, 126/734 patients; P = 0.002) and ControlForce (17.5%, 20/114 patients; P = 0.024) groups. During the redo procedure, the posterior PVR rate with MEDForce (2%, 1/50 PV pairs) was significantly less than with either ControlNoForce (17.7%, 44/249 PV pairs; P = 0.004) or ControlForce (22.5%, 9/40 PV pairs; P = 0.003), or aggregate Controls (18.3%, 53/289 PV pairs; P = 0.006). However, the anterior PVR rate with MEDForce (8%, 4/50 PV pairs) was not significantly different than Controls (aggregate Controls-3.5%, 10/289 PV pairs, P = 0.136; ControlNoForce-2.4%, 6/249 PV pairs, P = 0.067; ControlForce-10%, 4/40 PV pairs, P = 1.0)., Conclusion: Oesophageal deviation improves the durability of the posterior wall ablation lesion set during AF ablation., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)

Objectives: The goal of this study was to determine the safety and feasibility of a novel esophageal balloon retractor (DV8) for MED during PVI., Background: The authors previously showed that mechanical esophageal deviation (MED) is feasible using an off-the-shelf metal stylet to allow uninterrupted ablation along the posterior left atrium during pulmonary vein isolation (PVI). Although it is an attractive strategy to avoid esophageal thermal injury, this technique was hampered by both the propensity for oropharyngeal trauma from the stiff stylet and the limited lateral esophageal displacement., Methods: In 200 consecutive patients undergoing atrial fibrillation ablation, the DV8 balloon retractor was used for MED; contrast was instilled into the esophagus to accurately delineate the trailing esophageal edge. Deviation was performed to maximize the distance from the trailing esophageal edge to the closest point of the ablation line (MED Effective ) and correlated to occurrences of luminal esophageal temperature elevation., Results: In patients undergoing MED during a first-ever PVI of 304 vein pairs, the MED Effective during right and left PVI were 21.2 ± 8.7 mm and 15.5 ± 6.8 mm, respectively. Deviation of at least 5 mm of MED Effective was achievable in 97.7%. Luminal esophageal temperature increases universally occurred (100%) at MED Effective  <5 mm, less often (28%) at MED Effective 5 to 20 mm, and rarely (1.9%) at MED Effective >20 mm. There were no esophageal complications, but 2 patients experienced oropharyngeal bleeding due to trauma related to device placement., Conclusions: MED with the balloon retractor safely moved the esophagus away from the site of energy delivery during atrial fibrillation ablation., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to determine the extent of lateral esophageal displacement required during mechanical esophageal deviation (MED) and to eliminate luminal esophageal temperature elevation (LET Elev ) during pulmonary vein (PV) isolation., Background: MED is a conceptually attractive strategy of minimizing esophageal injury while allowing uninterrupted energy delivery along the posterior left atrium during PV isolation., Methods: MED was performed using a malleable metal stylet within a plastic tube placed within the esophagus. Barium was instilled to characterize the trailing esophageal edge. For each MED attempt, the MED Effective , defined as the distance from the trailing esophageal edge-to-ablation line, was correlated to occurrences of LET Elev ., Results: In 114 consecutive patients/221 PV pairs undergoing MED (age 62.1 ± 11 years, 75% men, 62%/38% paroxysmal/persistent AF), esophageal stretching invariably occurred such that the esophageal edge trailed behind the plastic tube. MED Effective distances of 0 mm to 10 mm, 10 mm to 15 mm, 15 mm to 20 mm or >20 mm were achieved in 60 (27.1%), 64 (29%), 48 (21.7%), and 49 (22.2%) attempts, respectively. Overall, LET elevation >38°C occurred in 81 of 221 (36.7%) PV pairs. The incidence of LET Elev among the 4 groups was 73.3%, 35.9%, 25%, and 4.1%, respectively. MED Effective distances were 9.1 ± 6.5 mm and 18 ± 7.6 mm in patients with and without LET Elev , respectively (p < 0.0001). Three patients (2.6%) experienced clinically significant MED-related trauma, albeit only with a stiffer stylet., Conclusions: Mechanical esophageal deviation >20 mm from the PV ablation line prevents significant esophageal heating during PV isolation, but this level of displacement was difficult to safely achieve with this off-the-shelf mechanical stylet approach., (Copyright © 2017. Published by Elsevier Inc.)

Atrial fibrillation is the most common arrhythmia in the United States. With the ageing population, the incidence and prevalence of atrial fibrillation are on the rise. Catheter ablation of atrial fibrillation is a widely accepted treatment modality in patients with drug refractory symptomatic paroxysmal or persistent atrial fibrillation. The close proximity to the left atrium posterior wall makes the thermosensitive esophagus a potential site of injury during catheter ablation of AF leading to various gastrointestinal complications. The major gastrointestinal complications associated with catheter ablation include atrioesophageal fistula, gastroparesis, esophageal thermal lesions and esophageal ulcers. Multiple studies, case reports and series have described these complications with various catheter ablation techniques such as radiofrequency, cryoenergy and high frequency focused ultrasound energy ablation. This review addresses the gastrointestinal complications after AF ablation procedures and aims to provide the clinicians with an overview of clinical presentation, etiology, pathogenesis, prevention and management of these conditions., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background: Aim of our study was to assess the safety and efficacy on factor-Xa inhibitors (FXIs) in patients with non-valvular atrial fibrillation (NVAF) as compared to Vitamin K antagonist (VKA)., Methods: Phase II and III randomized controlled trials that reported clinical safety and efficacy of FXI in patients with NVAF were identified from MEDLINE, Embase, and Cochrane Central Register of Controlled Trials through December 10, 2015. The primary safety outcome of our study was composite of stroke and systemic embolic event. Secondary outcomes studied were individual endpoints of primary safety outcome, major bleeding, clinically relevant non-major bleed (CRNMB), and all-cause mortality., Results: We included 11 RCTs with a total of 59,164 participants, of which 34,231 patients received oral FXI and 24,933 patients were on VKA with a mean follow-up of 369days. There was a significant reduction in primary outcome with FXI compared to VKA, 1,112 (3.4%) versus 816 (3.6%) events, respectively (OR 0.82; 95% CI 0.68-0.99). Use of FXI significantly reduced major bleeding events compared to VKA, OR 0.74, 95% CI 0.58-0.96, test for heterogeneity (I(2)=74%). Incidence of CRNMB was not different between FXI and VKA groups, OR 0.84, 95% CI 0.68-1.04. There was a significant reduction in all-cause mortality in FXI group compared to VKA group, OR 0.88, 95% CI 0.83-0.94 with no significant heterogeneity., Conclusion: Use of FXI was associated with a significant reduction in major bleeding events and all-cause mortality without increased risk of stroke or SEE compared to VKA., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background: Patients who undergo catheter ablation for atrial fibrillation (AF) are at increased risk of developing thromboembolic and bleeding complications periprocedurally. Many patients are now on newer oral anticoagulants (NOACs), but data regarding their safety and efficacy during AF ablation are limited., Methods and Results: This article reviews the literature in PubMed from 1998 to 2014 and includes clinical trials and meta-analysis that analyzed the safety and efficacy of NOACs during AF catheter ablation. Dabigatran seems to be as effective and safe as warfarin, although most data are from single-center studies, with small samples and very low overall bleeding and thromboembolic complications. Periprocedural anticoagulation protocols also vary greatly between studies. Some recent meta-analysis has shown that warfarin could still be a safer and more effective alternative. There are fewer studies with rivaroxaban in AF ablation, and there have been no meta-analysis yet comparing rivaroxaban to warfarin or dabigatran. There seems to be no significant differences in safety or efficacy of rivaroxaban compared to warfarin. Interestingly, there are no available data for apixaban in AF ablation yet., Discussion: There are no consensus guidelines regarding the use of NOACs during AF ablation. Dabigatran and rivaroxaban seem as safe and effective as warfarin, although larger studies with standardized protocols are needed, as available studies may be underpowered to detect small differences in bleeding and thromboembolic rates., (© The Author(s) 2015.)

Objective: To investigate the severity of coronary artery disease by coronary angiography in age-matched and sex-matched patients with diabetes mellitus with atrial fibrillation versus sinus rhythm., Methods: The patients included 245 men and women, mean age of 70 years, with diabetes and atrial fibrillation and 245 age-matched and sex-matched patients with diabetes and sinus rhythm who underwent coronary angiography. Baseline characteristics and indications for coronary angiography were similar in both groups., Results: Greater than 50% narrowing of one, two, or three major coronary arteries were present in 229 of 245 patients (94%) with diabetes and atrial fibrillation and in 211 of 245 patients (86%) with diabetes and with sinus rhythm (P<0.01). Greater than 50% narrowing of three major coronary arteries were present in 150 of 245 patients (61%) with diabetes and atrial fibrillation and in 75 of 245 patients (31%) with diabetes and sinus rhythm (P<0.001)., Conclusion: Patients with diabetes and atrial fibrillation have a significantly higher prevalence of greater than 50% narrowing of one or more major coronary arteries and of three major coronary arteries than patients with diabetes and sinus rhythm.

Introduction: We aimed to study the procedural characteristics, efficacy and safety of cryoballoon ablation (CBA) versus radiofrequency ablation (RFA) for catheter ablation of paroxysmal atrial fibrillation (AF). Methods: A systematic literature search was performed using PubMed, EMBASE, Web of Science, and Cochrane Central Register of Controlled Trials to clinical trials comparing CBA and RFA for AF. Outcomes were evaluated for efficacy, procedure characteristics and safety. For each study, odd ratio (OR) and 95% confidence intervals (CIs) were calculated for endpoints for both approaches. Results: We analyzed a total of 9,957 participants (3,369 in the CBA and 6,588 in RFA group) enrolled in 16 clinical trials. No significant difference was observed between CBA and RFA with regards to freedom from atrial arrhythmia at 12-months, recurrent atrial arrhythmias or repeat catheter ablation. CBA group had a significantly higher transient phrenic nerve injury (OR 14.19, 95% CI: 6.92-29.10; p<0.001) and persistent phrenic nerve injury (OR 4.62, 95% CI: 1.97-10.81; p<0.001); and a significantly lower pericardial effusion/cardiac tamponade (OR 0.43, 95% CI: 0.26-0.72; p=0.001), and groin site complications (OR 0.60, 95% CI: 0.38-0.93; p=0.02). No significant difference was observed in overall complications, stroke/thromboembolic events, major bleeding, and minor bleeding. Conclusion: CBA was non-inferior to RFA for catheter ablation of paroxysmal AF. RF ablation was associated with a higher groin complications and pericardial effusion/cardiac tamponade, whereas CBA was associated with higher rates of transient and persistent phrenic nerve injury. [ABSTRACT FROM AUTHOR]