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Objectives This study evaluated the long-term efficacy of a standard antithrombotic strategy versus half-dose direct oral anticoagulation (DOAC) after Watchman implantation. Background No consensus currently exists on the selection of the most effective antithrombotic strategy to prevent device-related thrombosis (DRT) in patients undergoing endocardial left atrial appendage closure. Methods After successful left atrial appendage closure, consecutive patients were prescribed a standard antithrombotic strategy (SAT) or long-term half-dose DOAC (hdDOAC). The primary composite endpoint was DRT and thromboembolic (TE) and bleeding events. Results Overall, 555 patients (mean age 75 ± 8 years, 63% male; median CHA2DS2-VASc [congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65-74 years, sex category] score 4 [interquartile range (IQR): 3-6]; median HAS-BLED [hypertension, abnormal renal or liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol] score 3 [IQR: 2-4]) were included. Patients were categorized into 2 groups (SAT: n = 357 vs hdDOAC: n = 198). Baseline clinical characteristics were similar between groups. The median follow-up duration was 13 months (IQR: 12-15 months). DRT occurred in 12 (2.1%) patients, all in the SAT group (3.4% vs 0.0%; log-rank P = 0.009). The risk of nonprocedural major bleeding was significantly more favorable in the hdDOAC group (0.5% vs. 3.9%; log-rank P = 0.018). The rate of the primary composite endpoint of DRT and TE and major bleeding events was 9.5% in SAT patients and 1.0% in hdDOAC patients (HR: 9.8; 95% CI: 2.3-40.7; P = 0.002). Conclusions After successful Watchman implantation, long-term half-dose DOAC significantly reduced the risk of the composite endpoint of DRT and TE and major bleeding events compared with a standard, antiplatelet-based, antithrombotic therapy.

BACKGROUND Intracardiac electrogram data remain one of the primary diagnostic inputs guiding complex ablation procedures. However, the technology to collect, process, and display intracardiac signals has known shortcomings and has not advanced in several decades. OBJECTIVE The purpose of this study was to evaluate a new signal processing platform, the PURE EP™ system (PURE), in a multi-center, prospective study. METHODS Intracardiac signal data of clinical interest were collected from 51 patients undergoing ablation procedures with PURE, the signal recording system, and the 3D mapping system at the same time stamps. The samples were randomized and subjected to blinded, controlled evaluation by three independent electrophysiologists to determine the overall quality and clinical utility of PURE signals when compared to conventional sources. Each reviewer assessed the same (92) signal sample sets and responded to (235) questions using a 10-point rating scale. If two or more reviewers rated the PURE signal higher than the control, it was deemed superior. RESULTS A total of 93% of question responses showed consensus amongst the blinded reviewers. Based on the ratings for each pair of signals, a cumulative total of 164 PURE signals out of 218 (75.2%) were statistically rated as Superior for this data set (p

Introduction Watchman FLX has been recently approved for left atrial appendage occlusion (LAAO) in the US. Intracardiac echocardiography (ICE) - which is already commonly used to guide trans-septal access - can serve as an alternative to TEE, simplifying the procedure and reducing associated costs. Herein, we report our experience with ICE-guided LAAO with Watchman FLX. Methods and results This cohort study included the first 190 consecutive patients who underwent LAAO with Watchman FLX in our center. LAAO was successful in all patients without significant peri-procedural, device-related complications in either group. Compared to TEE, we observed a significant reduction in procedural times when using ICE. In addition, there was a potentially clinically relevant reduction in fluoroscopy dose, mainly secondary to fewer cine acquisition runs. At follow-up, no cases of device embolism were noted, whereas the rate of device-related thrombosis and peri-device leaks were comparable between groups. Conclusion ICE-guided LAAO with Watchman FLX is safe and feasible, with a significant reduction in procedural time and potential reduction in fluoroscopy dose when compared to TEE.

Background The creation of effective and permanent lesions is a crucial factor in determining the success rate of atrial fibrillation (AF) ablation. By increasing the efficacy of radiofrequency (RF) energy-mediated lesion formation, half-normal saline (HNS) as an irrigant for open-irrigated ablation catheters has the potential to reduce procedural times and improve acute and long-term outcomes. Methods This is a double-blind randomized clinical trial of 99 patients undergoing first-time RF catheter ablation for AF. Patients enrolled were randomly assigned in a 1:1 fashion to perform ablation using HNS or normal saline (NS) as an irrigant for the ablation catheter. Results The use of HNS is associated with shorter RF times (26 vs. 33 min; p = .02) with comparable procedure times (104 vs. 104 min). The rate of acute pulmonary vein reconnections (16% vs. 18%) was comparable, with a median of 1 vein reconnection in the HNS arm versus 2 in the NS arm. There was no difference in procedure-related complications, including the incidence of postprocedural hyponatremia when using HNS. Over the 1-year follow-up, there is no significant difference between the HNS and NS with respect to the recurrence of any atrial arrhythmia (off antiarrhythmic drugs [AAD]: 47% vs. 52%; hazard ratio [HR]: 1.17, 95% confidence interval [CI]: 0.66-2.06; off/on AAD: 66% vs. 66%, HR: 1.06, 95% CI: 0.53-2.12), with a potential benefit of using HNS when considering the paroxysmal AF cohort (on/off AAD 73% vs. 62%, HR: 0.72, 95% CI: 0.19-2.70). Conclusions In a mixed cohort of patients undergoing first-time AF ablation, irrigation of open-irrigated RF ablation catheters with HNS is associated with shorter RF times, with a comparably low rate of procedure-related complications. In the long term, there is no significant difference with respect to the recurrence of any atrial arrhythmia. Larger studies with a more homogeneous population are necessary to determine whether HNS improves clinical outcomes.

BACKGROUND We evaluated the efficacy of a new method in identifying peri-device leak (PDL) using morphology of the thrombus formed inside the left atrial appendage (LAA) as seen on follow-up transesophageal echo (TEE). METHOD A total of 291 consecutive patients undergoing Watchman procedure were included in this analysis. TEE was performed at 45 days postprocedure. Based on the presence of the thrombus inside the LAA behind the device, patients were grouped as (1) white (W) group: LAA completely filled with thrombus (n = 101), 2) nonwhite (NW) group: LAA completely black or mixed (part black and part white; n = 190). Follow-up TEE was repeated at 6 and 12 months. RESULTS Baseline characteristics were comparable between groups except the device size, number of patients with chicken-wing morphology, and prevalence of left atrial "smoke" that were significantly higher in the NW group. Detection of black appearance was comparable between the pre-coil closure image and the NW population (26/36 [72.2%] vs 99/154 [64.3%], p = .37). After adjusting for clinically relevant covariates, NW appearance of the LAA was associated with the presence of significant leak (odds ratio: 47.96, 95% confidence interval: 2.91-790.2, p

Rhythm control of persistent atrial fibrillation (AF) patients represents a challenge for the modern interventional cardiac electrophysiologist; as a matter of fact, there is still divergence regarding the best ablative approach to adopt in this population. Different investigational endpoints, variability of techniques and tools, significant technological evolution, and the lack of universally accepted pathophysiological models engendered a considerable heterogeneity in terms of techniques and outcomes, so much that the treatment of persistent subtypes of AF commonly still relies mainly on pulmonary vein (PV) isolation. The purpose of the present review is to report the current experimental and clinical evidence supporting the importance of mapping and ablating non-PV triggers and describe our institutional approach for the ablation of nonparoxysmal AF.

Herein, we describe the use of an Amplatzer PFO Occluder to treat incomplete LAA closure due to a malpositioned AtriClip.

COVID-19 mainly affects the respiratory system but has been correlated with cardiovascular manifestations such as myocarditis, heart failure, acute coronary syndromes, and arrhythmias. Cardiac arrhythmias are the second most frequent complication affecting about 30% of patients. Several mechanisms may lead to an increased risk of cardiac arrhythmias during COVID-19 infection, ranging from direct myocardial damage to extracardiac involvement. The aim of this review is to describe the role of COVID-19 in the pathogenesis of cardiac arrhythmias and provide a comprehensive guidance for their monitoring and management.

Introduction This study reports the procedural findings and ablation outcome in AF patients referred after ≥2 failed PV isolation (PVI). Methods Three hundred and five consecutive AF patients referred after ≥2 PVI were included in the analysis. High-dose isoproterenol challenge was used to identify PV reconnection and non-PV triggers; the latter were ablated based on the operator's discretion during the index procedure. At the repeat procedure, non-PV triggers were ablated in all. Empirical isolation of LA appendage (LAA) and coronary sinus (CS) was performed if the PVs were silent and no non-PV triggers were detected. Results PV reconnection was detected in 226 and non-PV triggers were identified or empirically isolated in 285 patients during the index procedure. At follow-up, 182 (60%) patients were recurrence-free off-AAD; the success rate with and without non-PV ablation was 81% vs. 8% (P

The aim of this study was to evaluate the incidence and clinical implications of leaks (acute incomplete occlusion, early and late reopenings) following LAA ligation with the LARIAT device.Percutaneous LAA ligation with the LARIAT device may represent an alternative for stroke prevention in high-risk patients with atrial fibrillation with contraindications to oral anticoagulation.This was a retrospective, multicenter study of 98 consecutive patients undergoing successful LAA ligation with the LARIAT device. Leaks were defined as the presence of flow as evaluated by transesophageal echocardiography (TEE). TEE was performed during the procedure, at 6 and 12 months, and after thromboembolic events.Leaks were detected in 5 (5%), 14 (15%), and 19 (20%) patients at the 3 time points. During follow-up, 5 patients developed neurological events (4 strokes and 1 transient ischemic attack). Two occurred early (1 fatal stroke and 1 stroke with multiple recurrences in the following months), and TEE was not repeated after the events. The remaining 3 occurred late (after 6 months) and were associated with small leaks (5 mm). In 2 of 3 cases, such a small leak was missed by the standard evaluation on 2-dimensional TEE, being evident only with the aid of 3-dimensional imaging.Incomplete occlusion of the LAA after LARIAT ligation is relatively common and may be associated with thromboembolic events. Proper long-term surveillance with careful TEE should be considered to detect leaks, which can be managed with either resumption of oral anticoagulation or percutaneous transcatheter closure.

Remote Navigation of Circular Mapping Catheters Introduction Circular mapping catheters (CMC) are an essential tool in most atrial fibrillation ablation procedures. The Vdrive™ with V-Loop™ system enables a physician to remotely manipulate a CMC during electrophysiology studies. Our aim was to compare the clinical performance of the system to conventional CMC navigation according to efficiency and safety endpoints. Methods and Results A total of 120 patients scheduled to undergo a CMC study followed by pulmonary vein isolation (PVI) were included. Treatment allocation was randomized 2:1, remote navigation:manual navigation. The primary effectiveness endpoint was assessed based on both successful navigation to the targeted pulmonary vein (PV) and successful recording of PV electrograms. All PVs were treated independently within and between patients. The primary safety endpoint was assessed based on the occurrence of major adverse events (MAEs) through seven days after the study procedure. Primary effectiveness endpoints were achieved in 295/302 PVs in the Vdrive arm (97.7%) and 167/167 PVs in the manual arm (100%). Effectiveness analysis indicates Vdrive non-inferiority (pnon-inferiority = 0.0405; δ = –0.05) per the Cochran–Mantel–Haenszel test adjusted for PV correlation. Five MAEs related to the ablation procedure occurred (three in the Vdrive arm—3.9%; two in the manual arm—2.33%). No device-related MAEs were observed; safety analysis indicates Vdrive non-inferiority (pnon-inferiority = 0.0441; δ = 0.07) per the normal Z test. Conclusion Remote navigation of a CMC is equivalent to manual in PVI in terms of safety and effectiveness. This allows for single-operator procedures in conjunction with a magnetically guided ablation catheter.

A Focus on Catheter Ablation of Ventricular Arrhythmias VT ablation is based on percutaneous catheter insertion under fluoroscopic guidance to selectively destroy (i.e., ablate) myocardial tissue regions responsible for the initiation or propagation of ventricular arrhythmias. Although the last decade has witnessed a rapid evolution of ablation equipment and techniques, the control over catheter movement during manual ablation has remained largely unchanged. Moreover, the procedures are long, and require ergonomically unfavorable positions, which can lead to operator fatigue. In an attempt to overcome these constraints, several technical advancements, including remote magnetic navigation (RMN), have been developed. RMN utilizes a magnetic field to remotely manipulate specially designed soft-tip ablation catheters anywhere in the x, y, or z plane inside the patient's chest. RMN also facilitates titration of the contact force between the catheter and the myocardial tissue, which may reduce the risk of complications while ensuring adequate lesion formation. There are several non-randomized studies showing that RMN has similar efficacy to manual ablation, while complication rates and total radiation exposure appears to be lower. Although these data are promising, larger randomized studies are needed to prove that RMN is superior to manual ablation of VT.

Hybrid versus Endocardial Ablation for LSPAFIntroduction Ablation of longstanding persistent atrial fibrillation (LSPAF) is the most challenging procedure in the treatment of AF, either by surgical or by percutaneous approach. Objective We investigated the difference in success and complication rates between combined surgical epicardial and endocardial catheter ablation procedure and our standard endocardial ablation procedure. Methods and Results Twenty-four consecutive patients (group 1) with LSPAF and enlarged left atrium (>4.5 cm) underwent a combined procedure, consisting of surgical, closed-chest, epicardial, radiofrequency ablation (nContact, NC, USA) via pericardial access, and concomitant endocardial ablation (hybrid procedure). Procedural complications and long-term outcomes were compared to those of 35 consecutive patients who refused the hybrid procedure and underwent standard endocardial only ablation (group 2). Baseline characteristics were comparable. In group 1, 1 patient (4.2%) developed post-procedural cardio-embolic stroke and 3 (12.5%) died (1 atrio-esophageal fistula, 1 fatal stroke, 1 of unknown cause in early follow-up), while no strokes or deaths occurred in group 2. Overall complication rates were higher for group 1 (P = 0.036). At 24-month follow-up, 4 (19%) patients in group 1 and 19 (54.3%) in group 2 were arrhythmia-free after a single procedure, on or off antiarrhythmic drugs (P

Management of Tamponade Following AF Ablation With FXaIIntroduction Because of the absence of a dedicated reversal agent, the outcome of pericardial effusion (PE) following procedures performed with uninterrupted apixaban or rivaroxaban is unknown. We report the characteristics of PEs presenting with tamponade in patients undergoing AF ablation with uninterrupted factor Xa inhibition (FXaI) to understand their management and prognosis. Methods and Results We performed a multicenter cross-sectional survey in 10 centers across the United States. Patient data were obtained by chart review. In all patients the procedure was performed with uninterrupted FXaI. A total of 16 PEs requiring intervention were reported from 5 centers. Two patients were on apixaban 5 mg BD, the remaining on rivaroxaban 20 mg OD. Eleven PEs occurred in the periprocedural setting, and 5 PEs occurred from 1 to 28 days after the procedure. Pericardiocentesis and drainage were performed in all cases. Protamine and 4-factor prothrombin complex concentrate (4F-PCC) were given in all periprocedural cases. Two patients required surgery: in one case coagulation of the pericardial blood prevented effective drainage, and in the other bleeding was secondary to a steam pop-induced atrial tear. None of the postprocedural cases required FXaI reversal and the dose of rivaroxaban was temporarily reduced. No fatal outcomes or thromboembolic events were reported. Conclusion Pericardiocentesis and drainage with FXaI reversal proved effective in the management of acute PEs with tamponade occurring periprocedurally in patients undergoing AF ablation with uninterrupted FXaI. Early postprocedural effusions can be treated with pericardiocentesis without the need of a reversal agent.

Benefits of PVI in Patients with Atrial Flutter Background This study examined incidence of AF following cavotricuspid isthmus (CTI) ablation alone or CTI plus prophylactic pulmonary vein isolation (PVI) in patients presenting with isolated atrial flutter (AFL) with no history of AF. Methods and Results We enrolled 216 patients with isolated typical atrial flutter and randomized them to CTI alone (group 1, n = 108, 61.2 ± 9.7 year, 75% male) or CTI+PVI ablation (group 2, n = 108, 62.4 ± 9.3 year, 73% male). Insertible loop recorder (ILR) was implanted in 21 and 19 patients from groups 1 and 2, respectively. Remaining patients were monitored with event recorders, ECG, 7-day Holter. Follow-up period was for 18 ± 6 months. Compared to group 1, group 2 had significantly longer procedural duration (75.9 ± 33 min vs. 161 ± 48 min [P < 0.001]) and fluoroscopy time (15.9 ± 12.3 min vs. 56.4+21 min [P < 0.001]). At the end of follow-up, 65 (60.2%) in group 1 and 77 (71.3%) in group 2 were arrhythmia free off-AAD (log-rank P = 0.044). A subgroup analysis was performed with 55 year age cut-off. In the

Background— We examined the influence of catheter ablation and periprocedural anticoagulation regimen on trajectory of migraine in atrial fibrillation patients with or without migraine history. Methods and Results— Forty patients with (group 1: 64±8 years; men 78%) and 85 (group 2: 61±10 years; men 73%) without migraine history undergoing atrial fibrillation-ablation were enrolled. Migraine status and quality of life were evaluated using standardized questionnaires. Diffusion magnetic resonance imaging of brain was performed for all at pre and 24 hours post procedure. Catheter ablation was performed with (88, 70%) or without (37, 30%) continuous warfarin treatment. Fifty-four patients (11 and 43 from groups 1 and 2, respectively) had subtherapeutic international normalized ratio on procedure day. At 17±5 months follow-up, from group 1, 25 (63%) reported no migraine, 10 (25%) had P P Conclusions— In most patients, migraine symptoms improved substantially after catheter ablation. Interestingly, the only cases of new migraine and aggravation of pre-existent headache had subtherapeutic international normalized ratio during the procedure and new cerebral infarcts.

Long-Term Outcome of AF Ablation in MMV PatientsIntroduction It is unclear whether extended pulmonary vein antrum isolation (PVAI) plus nonpulmonary vein (non-PV) trigger elimination prevents more arrhythmia recurrence than PVAI alone in patients with mechanical mitral valve (MMV) undergoing AF ablation. This study compared the efficacy and long-term outcome of 2 ablation strategies—PVAI alone versus extended PVAI plus non-PV trigger elimination—for the treatment of AF in patients with MMV. Methods and Results One hundred and nine consecutive AF patients with MMV were divided into 2 groups: standard PVAI was performed in group 1 (N = 45); in group 2 (N = 64) PVAI was extended to the LA posterior wall, LA septum, and CS; and all non-PV triggers were eliminated. Patients were followed up for 3 years. At the 12th month, 7 (15.6%) patients in group 1, and 39 (60.9%) patients in group 2 were arrhythmia free (log-rank P < 0.001). Four patients (8.9%; 3 cases of AT and 1 case of AF) from group 1, and 12 patients (18.8%; 9 cases of AT, and 3 cases of AFL) from group 2 experienced very late recurrence. At 36 ± 7 months follow-up, the cumulative recurrence after a single procedure was 42/45 (93.3%) in group 1, and 37/64 (57.8%) in group 2 (log-rank P < 0.001). Conclusion Compared with the standard PVAI alone, a strategy including extended PVAI and non-PV trigger elimination is associated with a higher 12-month and long-term arrhythmia-free survival in patients with MMV undergoing AF ablation. Very late recurrence may occur years after the initial procedure with focal AT as the most common type of recurrent arrhythmia.