Pulmonary Vein Isolation With or Without Left Atrial Appendage Ligation in Atrial Fibrillation: The aMAZE Randomized Clinical Trial.

Importance: Left atrial appendage elimination may improve catheter ablation outcomes for atrial fibrillation. Objective: To assess the safety and effectiveness of percutaneous left atrial appendage ligation adjunctive to catheter pulmonary vein isolation for nonparoxysmal atrial fibrillation. Design, Setting, and Participants: This multicenter, prospective, open-label, randomized clinical trial evaluated the safety and effectiveness of percutaneous left atrial appendage ligation adjunctive to planned pulmonary vein isolation for nonparoxysmal atrial fibrillation present for less than 3 years. Eligible patients were randomized in a 2:1 ratio to undergo left atrial appendage ligation and pulmonary vein isolation or pulmonary vein isolation alone. Use of a 2:1 randomization ratio was intended to provide more device experience and safety data. Patients were enrolled from October 2015 to December 2019 at 53 US sites, with the final follow-up visit on April 21, 2021. Interventions: Left atrial appendage ligation plus pulmonary vein isolation compared with pulmonary vein isolation alone. Main Outcomes and Measures: A bayesian adaptive analysis was used for primary end points. Primary effectiveness was freedom from documented atrial arrythmias of greater than 30 seconds duration 12 months after undergoing pulmonary vein isolation. Rhythm was assessed by Holter monitoring at 6 and 12 months after pulmonary vein isolation, symptomatic event monitoring, or any electrocardiographic tracing obtained through 12 months after pulmonary vein isolation. Primary safety was a composite of predefined serious adverse events compared with a prespecified 10% performance goal 30 days after the procedure. Left atrial appendage closure was evaluated through 12 months after pulmonary vein isolation. Results: Overall, 404 patients were randomized to undergo left atrial appendage ligation plus pulmonary vein isolation and 206 were randomized to undergo pulmonary vein isolation alone. Primary effectiveness was 64.3% with left atrial appendage ligation and pulmonary vein isolation and 59.9% with pulmonary vein isolation only (difference, 4.3% [bayesian 95% credible interval, -4.2% to 13.2%]; posterior superiority probability, 0.835), which did not meet the statistical criterion to establish superiority (0.977). Primary safety was met, with a 30-day serious adverse event rate of 3.4% (bayesian 95% credible interval, 2.0% to 5.0%; posterior probability, 1.0) which was less than the prespecified threshold of 10%. At 12 months after pulmonary vein isolation, complete left atrial appendage closure (0 mm residual communication) was observed in 84% of patients and less than or equal to 5 mm residual communication was observed in 99% of patients. Conclusions and Relevance: Percutaneous left atrial appendage ligation adjunctive to pulmonary vein isolation did not meet prespecified efficacy criteria for freedom from atrial arrhythmias at 12 months compared with pulmonary vein isolation alone for patients with nonparoxysmal atrial fibrillation, but met prespecified safety criteria and demonstrated high rates of closure at 12 months. Trial Registration: ClinicalTrials.gov Identifier: NCT02513797.

Conformal Left Atrial Appendage Seal Device for Left Atrial Appendage Closure: First Clinical Use.

OBJECTIVES: The authors report the first clinical experience with the Conformal Left Atrial Appendage Seal (CLAAS) device. BACKGROUND: The CLAAS device was designed to address the limitations of first-generation left atrial appendage closure (LAAC) devices by providing an implant that is minimally traumatic, can be deployed in a noncoaxial fashion, and does not require postprocedural oral anticoagulation. METHODS: Patients with atrial fibrillation at high stroke risk (CHA2DS2-VASc score ≥2) were recruited using standard selection criteria. The LAAC procedure was guided by transesophageal echocardiography with patients under general anesthesia. The CLAAS device is composed of a foam cup, with a Nitinol endoskeleton with an expanded polytetrafluoroethylene cover, delivered with a standard delivery system using a tether for full recapture. All patients received dual-antiplatelet therapy for 6 months, followed by aspirin alone. Transesophageal echocardiographic follow-up was scheduled for 45 days and 1 year. RESULTS: Twenty-two patients (63.7% with CHA2DS2-VASc scores ≥3, 76.2% with HAS-BLED scores ≥3) were enrolled. The device was successfully implanted in 18 patients and unsuccessfully in 4 patients. There were no serious procedural complications. On transesophageal echocardiography performed at 45 days, 1 significant leak (≥5 mm) was seen, which was due to a large posterior lobe not appreciated at the time of implantation, and 1 device-related thrombus was noted, which resolved on oral anticoagulation. There were no periprocedural strokes, major pericardial effusions, or systemic or device embolization. CONCLUSIONS: This first-in-human study demonstrates the clinical feasibility of the CLAAS device for LAAC.

Short and long-term outcomes of percutaneous left atrial appendage suture ligation: Results from a US multicenter evaluation.

BACKGROUND: Published studies of epicardial ligation of left atrial appendage (LAA) have reported discordant results. OBJECTIVE: The purpose of this study was to delineate the safety and efficacy of LAA closure with the LARIAT device. METHODS: This is a multicenter registry of 712 consecutive patients undergoing LAA ligation with LARIAT at 18 US hospitals. The primary end point was successful suture deployment, no leak by intraprocedural transesophageal echocardiography (TEE), and no major complication (death, stroke, cardiac perforation, and bleeding requiring transfusion) at discharge. A leak of 2-5 mm on follow-up TEE was the secondary end point. RESULTS: LARIAT was successfully deployed in 682 patients (95.5%). A complete closure was achieved in 669 patients (98%), while 13 patients (1.8%) had a trace leak (<2 mm). There was 1 death related to the procedure. Ten patients (1.44%) had cardiac perforation necessitating open heart surgery, while another 14 (2.01%) did not need surgery. The risk of cardiac perforation decreased significantly after the introduction of a micropuncture (MP) needle for pericardial access. Delayed complications (pericarditis requiring >2 weeks of treatment with nonsteroidal anti-inflammatory drugs/colchicine and pericardial and pleural effusion after discharge) occurred in 34 (4.78%) patients, and the risk decreased significantly with the periprocedural use of colchicine. Follow-up TEE (n = 480) showed a leak of 2-5 mm in 6.5% and a thrombus in 2.5%. One patient had a leak of >5 mm. CONCLUSION: LARIAT effectively closes the LAA and has acceptable procedural risks with the evolution of the use of the micropuncture needle for pericardial access and the use of colchicine for mitigating the postinflammatory response associated with LAA ligation and pericardial access.

Anatomical analysis of recurrent conduction after circumferential ablation.

INTRODUCTION: There is general agreement on the importance of electrical isolation of antral (including pulmonary vein) myocardium for effective atrial fibrillation (AF) ablation. However, isolation is often impermanent, and return of conduction (RoC) is associated with recrudescent AF. It is generally assumed that the mechanism of RoC is recovery of ablated myocardium, but this is based almost solely on experience after ablation at the venoatrial junctions. Our objective was to perform an anatomical analysis as a means to gain further insight into RoC risk factors and mechanism(s) after wide-area circumferential ablation. METHODS: Retrospective review of data from 512 consecutive patients who underwent wide-area circumferential antral ablation. After achieving left and right antral electrical isolation, each patient underwent a period of observation for RoC during this initial procedure. In addition, 76 of the 512 patients underwent a repeat procedure at an average of 10 months later, at which time they were again assayed for RoC. RESULTS: Left or right antral RoC was observed in 39 (8%) or 21 (4%) patients, respectively, during the initial procedure, and 26 (34%) or 16 (21%) patients, respectively, during the repeat procedure. Left antral RoC was more commonly observed among patients manifesting a long segment separating the circumferential lesion and the venoatrial junctions, and usually occurred in this segment, often at sites distant from ablated sites. Right antral RoC commonly occurred in the anterior and superior antral regions, also often at sites that were distant from ablated sites. CONCLUSIONS: In the left antrum, there was a correlation between electrophysiologic (RoC) and anatomic (long segment) properties. The observation in both antra that RoC often occurred in previously unablated areas suggested that, as an alternative to recovery of ablated myocardium, a second mechanism of RoC was plausible: conduction via unablated myocardium, which was not immediately manifest. These observations have compelled us to modify our circumferential lesion.

Amiodarone therapy for atrial rhythm control: insights gained from a single center experience.

INTRODUCTION: Amiodarone has been advocated as an effective "long-term" therapy for atrial rhythm control in patients with atrial fibrillation (AF). We sought to assess the sustainability of this therapeutic strategy. METHODS AND RESULTS: Retrospective analysis of a consecutive, single-center cohort (n = 168) with symptomatic AF who were treated with amiodarone and followed for 3 years. The incidence of amiodarone cessation was evaluated at 1, 2, and 3 years and attributed principally to drug inefficacy, intolerance, or toxicity. A gradual diminution in the number of patients on therapy was observed, such that by 3 years, only 45% remained. This was attributable to inefficacy (25%), intolerance (12%), or toxicity (18%). Pulmonary toxicity was surprisingly common, occurring in at least 7% of patients. CONCLUSIONS: These data challenge the notion of amiodarone as a reasonable "destination" therapy for AF.