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Arash Alipour, Lisette I S Wintgens, Martin J Swaans, Jippe C Balt, Benno J W M Rensing, Lucas V A Boersma Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands Abstract: Atrial fibrillation (AF) remains an important clinical problem with severe complications such as stroke, which especially harms those with risk factors as calculated by the CHADS2 or CHA2DS2-VASc. Until now, no therapy has proven 100% effective against AF. Since the left atrial appendage (LAA) is the most prominent nonvalvular AF-related thromboembolic source and (novel) oral anticoagulant [(N)OAC] carries the hazard of bleeding, LAA occlusion may be an alternative, especially in patients who are ineligible for (N)OAC therapy. In this review, we discuss several LAA occlusion techniques with a focus on the Watchman device since this device is the most thoroughly studied device of all. Keywords: left atrial appendage, atrial fibrillation, ischemic stroke

Martin J Swaans, Lisette IS Wintgens, Arash Alipour, Benno JWM Rensing, Lucas VA Boersma Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands Abstract: Atrial fibrillation (AF) is the most common arrhythmia treated in the clinical practice. One of the major complications of AF is a thromboembolic cerebral ischemic event. Up to 20% of all strokes are caused by AF. Thromboembolic cerebral ischemic event in patients with AF occurs due to atrial thrombi, mainly from the left atrial appendage (LAA). Prevention of clot formation with antiplatelet agents and especially oral anticoagulants (­vitamin K antagonists or newer oral anticoagulants) has been shown to be effective in reducing the stroke risk in patients with AF but has several drawbacks with (major) bleedings as the most important disadvantage. Therefore, physical elimination of the LAA, which excludes the site of clot formation by surgical or percutaneous techniques, might be a good alternative. In this review, we discuss the safety, efficacy, and clinical utility of the Watchman™ LAA closure device. Keywords: stroke, left atrial appendage, prevention, atrial fibrillation

Purpose: The second-generation multi-electrode catheter, PVAC Gold, was designed to improve the safe delivery of phased radiofrequency energy using a "single shot" approach for pulmonary vein isolation (PVI), while retaining efficacy. This large registry presents long-term performance in a daily practice setting., Methods: A total of 1011 patients undergoing first time ablation for atrial fibrillation (AF) using PVAC Gold were included, 639 patients with PVI for paroxysmal AF (PAF PVI) and 372 patients with persistent or long-standing persistent AF, divided into 175 patients receiving PVI only (PersAF PVI) and 197 patients receiving PVI with additional substrate ablation (PersAF PVI +)., Results: At 24-month follow-up, single procedure freedom from atrial tachyarrhythmia (ATA) was 58% (368/639) in the PAF PVI group, 44% (77/175) in the PersAF PVI group, and 29% (57/197) in the PersAF PVI + group. Allowing one repeat procedure in 33% of patients, 76%, 65%, and 54% were free from ATA at 24 months, respectively. Pulmonary vein reconnection was observed in 98% of patients with recurrent arrhythmia after PVI., Conclusions: Although phased RF ablation with PVAC Gold is quick and safe, the efficacy outcomes are modest compared to current mainstream ablation strategies., (© 2022. The Author(s).)

Aims: Pulmonary vein isolation (PVI) for atrial fibrillation (AF) has become increasingly safe and effective with the evolution of single-tip ablation catheters aided by contact force sensing (ST-CF) and single-shot devices such as the second-generation pulmonary vein ablation catheter (PVAC) Gold multi-electrode array. The multicentre randomized GOLD FORCE trial was conducted to evaluate non-inferiority of safety and efficacy of PVAC Gold PVI compared to ST-CF ablation for paroxysmal AF., Methods and Results: The primary efficacy endpoint documented AF recurrence ≥30 s was assessed by time-to-first-event analysis after a 90-day blanking period using repeated 7-day Holters. Secondary endpoints include acute success and procedural characteristics. Safety endpoints included procedural complications, stroke/transient ischaemic attack (TIA), tamponade, bleeding, and access site complications. Two hundred and eight patients underwent randomization and PVI (103 assigned to PVAC Gold, 105 to ST-CF). Acute success rates were 95% and 97% for PVAC Gold and ST-CF, respectively. At 12 months, AF recurrence was observed in 46.6% of the PVAC Gold group and in 26.2% of the ST-CF group [absolute efficacy difference 20.4% (95% confidence interval, CI 7.5-33.2%), hazard ratio 2.05 (95% CI 1.28-3.29), P = 0.003]. PVAC Gold had significantly shorter procedure and ablation times. Complication rates were 5.7% and 4.9% for PVAC Gold and ST-CF, respectively (P = 0.782)., Conclusion: In this multicentre randomized clinical trial, ablation with ST-CF and PVAC Gold ablation catheters non-inferiority for efficacy was not met. AF recurrence was significantly more frequent in the PVAC Gold group compared to single-tip contact force group. Both groups had similarly low rates of adverse events. PVAC Gold ablation had significantly shorter procedure and ablation times., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)

Background: To which extent atrial remodeling occurs before atrial fibrillation (AF) is unknown., Objective: The PREventive left atrial appenDage resection for the predICtion of fuTure Atrial Fibrillation (PREDICT-AF) study investigated such subclinical remodeling, which may be used for risk stratification and AF prevention., Methods: Patients (N = 150) without a history of AF with a CHA 2 DS 2 -VASc score of ≥2 at an increased risk of developing AF were included. The left atrial appendage was excised and blood samples were collected during elective cardiothoracic surgery for biomarker discovery. Participants were followed for 2 years with Holter monitoring to determine any atrial tachyarrhythmia after a 50-day blanking period., Results: Eighteen patients (12%) developed incident AF, which was associated with increased tissue gene expression of collagen I (COL1A1), collagen III (COL3A1), and collagen VIII (COL8A2), tenascin-C (TNC), thrombospondin-2 (THBS2), and biglycan (BGN). Furthermore, the fibroblast activating endothelin-1 (EDN1) and sodium voltage-gated channel β subunit 2 (SCN2B) were associated with incident AF whereas the Kir2.1 channel (KCNJ2) tended to downregulate. The plasma levels of COL8A2 and TNC correlated with tissue expression and predicted incident AF. A gene panel including tissue KCNJ2, COL1A1, COL8A2, and EDN1 outperformed clinical prediction models in discriminating incident AF., Conclusion: The PREDICT-AF study demonstrates that atrial remodeling occurs long before incident AF and implies future potential for early patient identification and therapies to prevent AF (ClinicalTrials.gov identifier NCT03130985)., (Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Purpose: The second-generation multi-electrode catheter, pulmonary vein ablation catheter (PVAC) GOLD, was designed to improve the delivery of phased radiofrequency energy and reduce procedure times using a 'single-shot' approach for pulmonary vein isolation (PVI), while retaining efficacy and safety. This large registry presents acute success rates and safety outcomes in a daily practice setting., Methods: A total of 1017 patients undergoing first-time ablation for atrial fibrillation (AF) using PVAC GOLD were included, 644 patients with paroxysmal AF and 373 patients with non-paroxysmal AF, divided into 175 patients receiving PVI only and 198 patients receiving PVI with additional substrate modification., Results: High and comparable percentages of successful PVI could be achieved in all groups (98%, 95% and 99%; p = 0.108). The median total procedure time for all groups was 90 min [70-100]. As expected, the total procedure, ablation and fluoroscopy time were significantly longer in the PVI + substrate modification group compared with the PVI-only cases (all p < 0.001), but not between the PVI-only groups (p = 0.306, p = 0.088, p = 0.233, respectively). A total of 44 complications were observed in 43 patients (4.2%). Major complications were seen in 19 patients (1.87%) and non-major procedure-related complications were seen in 25 patients (2.46%). Complications leaving permanent sequelae were rare and occurred in only four patients (0.39%). Complications did not differ between groups (p = 0.199, p = 0.438, p = 0.240 and p = 0.465 respectively)., Conclusion: PVAC GOLD performs successful PVI, while reducing procedure times and retaining safety for paroxysmal, persistent and long-standing persistent AF. Safety was unaffected by additional substrate modification.

Introduction: Current guidelines recommend adequate anticoagulation for at least 3 weeks pre- and 4 weeks post-direct current cardioversion (DCCV) to reduce thrombo-embolic risk in patients with atrial fibrillation (AF) lasting greater than 48 h. No specific recommendations exist for DCCV in patients that have undergone left atrial appendage occlusion (LAAO), many of whom are ineligible for anticoagulation. This study aims to observe the efficacy and safety of DCCV post-LAAO in everyday clinical practice., Methods: This prospective multicenter registry included DCCVs in patients post-LAAO. Imaging strategy or anticoagulation treatment around DCCV were analyzed. Complications during 30-day follow-up were registered. DCCVs performed in accordance with current guidelines for the general AF population were compared to DCCVs performed deviating from these guidelines., Results: In 93 patients (age 65 ± 17 years, CHA 2 DS 2 -VASC 3.0 ± 1.3) 284 DCCVs were performed between 2010 and 2018, in 271 sinus rhythm was restored. A wide variety of imaging or anticoagulation strategies around DCCV was observed; in 128 episodes strategies deviated from current guidelines. No thrombo-embolic events were observed after any DCCV during 30-day follow-up. In 34 DCCVs trans-esophageal echocardiography (TOE) was performed before DCCV to exclude cardiac thrombi and/or (re-)verify adequate device positioning. In two patients without post-LAAO imaging before DCCV, a device rotation or embolization was observed during scheduled TOE after LAAO., Conclusion: DCCV in AF patients after LAAO is highly effective. No thrombo-embolic events were observed in any patient in this observational cohort, regardless of the periprocedural anticoagulation or imaging strategy. Confirmation of adequate device positioning at least once before DCCV seems recommendable., (© 2021 Wiley Periodicals LLC.)

Introduction: Atrial fibrillation (AF) is associated with an increased risk of stroke. Stroke prevention with oral anticoagulation (OAC) is recommended in AF patients at increased risk of stroke. The left atrial appendage (LAA) is the main source of thrombus formation in AF patients. The WATCHMAN percutaneous LAA closure (LAAC) device may serve as an alternative to OAC overcoming disadvantages including the risk of (major) bleeding., Areas Covered: This review will focus on LAAC with the Watchman device for stroke prevention in AF patients. Current status, available literature, clinical safety and efficacy will be summarized. Furthermore, the future perspectives of Watchman will be discussed., Expert Opinion: LAAC with Watchman appears a promising, safe, and effective alternative to OAC. Ongoing and future studies to consolidate the position of Watchman should focus on comparative safety and efficacy of different LAAC devices, patient selection, various post-procedural antithrombotic regimens, head-to-head comparisons with NOAC, better understanding of device-related thrombus, and the role of the LAA in the propagation of non-valvular AF. This research may attribute to a paradigm shift in which LAAC no longer serves as a 'last resort' treatment for AF patients ineligible for OAC but may serve as a second-line or even first-line treatment option for AF patients.

Aims: Oral anticoagulation (OAC) reduces the ischaemic stroke risk in patients with atrial fibrillation (AF), but in turn leads to an increased risk of adverse bleeding events. Alternatively, left atrial appendage closure (LAAC) using a mechanical device might overcome these bleeding complications. However, evidence regarding LAAC in patients at high bleeding risk is scarce. This study evaluates the clinical features of AF patients with previous bleeding that underwent LAAC., Methods: In this retrospective cohort study patients with previous major bleeding or a bleeding predisposition scheduled for transcatheter LAAC were included. The frequency and type of previous bleeding events and prevalence of bleeding and ischaemic stroke during follow-up were evaluated., Results: A total of 73 patients (58% male, age 72.1 ± 7.2 years; CHA 2 DS 2 -VASc 4.5 [3.0-5.0]; HAS-BLED 4.0 [3.0-4.0]; 46% paroxysmal AF) were included. Previous bleeding occurred from intracranial (n = 50, 69%), gastro-intestinal (n = 13, 18%) or multiple (n = 16, 22%) foci. After OAC discontinuation due to bleeding, 19% suffered subsequent stroke. LAAC was successful in 96% of patients. During a median of almost 3 years' follow-up recurrent major bleeding occurred in 4 patients (5.5%) despite OAC discontinuation in 93.2%. A total of 6 ischaemic strokes were observed, resulting in an annualised stroke rate of 2.9% compared to a calculated expected stroke rate of 6.7%., Conclusions: Percutaneous LAAC may provide an alternative strategy to long-term OAC therapy in AF patients with a high bleeding risk. During follow-up, both ischaemic stroke and recurrent bleeding rates were lower than expected based on the CHA 2 DS 2 -VASc and HAS-BLED scores respectively.

Aims: Left atrial appendage closure (LAAC) is increasingly used as an alternative to oral anticoagulation (OAC) for stroke prevention in atrial fibrillation (AF) patients. Feasibility and safety of left atrial (LA) catheter ablation (CA) in patients with previously implanted LAAC devices have not been well studied. We report on the feasibility, safety, and efficacy of LA CA in the presence of a previously implanted LAAC device., Methods and Results: In this prospective cohort study consecutive patients that underwent LA CA with a previously implanted Watchman device were included. Periprocedural characteristics and long-term clinical follow-up were evaluated. Twenty-three LA CA procedures were performed in 19/162 AF patients with previously implanted Watchman devices [47% male, age 63.9 ± 6.2 years, CHA2DS2-VASc 4.0 (3.0-5.0); HASBLED 3.0 (2.0-4.0); 63% paroxysmal]. Left atrial CA was performed with irrigated radiofrequency (RF; n = 20, 87%) or phased RF (n = 3, 13%) in a mean of 18 months after LAAC implantation (range 4-80 months). Targets of CA consisted of pulmonary vein isolation (n = 19, 83%), superior vena cava isolation (n = 13, 57%), and additional linear lesions (n = 8, 35%). Procedures were carried out under vitamin K antagonist (VKA; n = 6, 26%), non-VKA OAC (NOAC; n = 8, 35%), or single antiplatelet therapy alone (n = 9, 39%). Left atrial CA was successful without any signs of interference from the device. Procedure-related complications were not observed. During a mean follow-up of 28 months, 11 patients (58%) had AF recurrence., Conclusion: Left atrial CA after LAAC appears to be feasible, effective, and safe in this single centre cohort. Previously implanted Watchman device should not be a reason to relinquish CA in symptomatic AF patients, even in patients on single antiplatelet therapy alone., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2018. For permissions, please email: journals.permissions@oup.com.)