INTRODUCTION:Vascular closure devices, used for the percutaneous closure of the femoral venous access-sites following electrophysiology (EP) procedures, are known to require shorter time to hemostasis compared to manual compression. The new VASCADE MVP_XL (Haemonetics Corp., USA) was designed for procedures utilizing large procedural sheaths, with a resorbable patch with 58% higher collagen content than the earlier VASCADE-MVP system, for better efficacy. OBJECTIVE:We aimed to compare the safety and efficacy of VASCADE MVP-XL and VASCADE MVP in consecutive patients with atrial fibrillation (AF) undergoing procedures utilizing large sheaths (i.e. Farapulse pulsed-field ablation and left atrial appendage closure procedure). METHODS:Based on the device used to achieve access-site hemostasis, AF patients undergoing EP procedures were classified into group 1: MVP-XL (n = 151) and group 2: MVP (n = 423). The closure device was deployed under ultrasound guidance and included 2-4 min of gentle compression followed by approximately 2 h of bedrest. Fluoroscopy was used for proper positioning and accurate deployment of the collagen patch. All procedures were conducted under uninterrupted anticoagulation. The access-sites were examined immediately after the procedure, after the 2 h bed-rest and before discharge. RESULTS:Baseline characteristics were similar between the groups except the procedure type (Watchman) and rivaroxaban use. Time to final sheath pull, time to ambulation and time to discharge were similar between the groups. Access-site bleeding occurred in 13 patients (3.1%) in the MVP group versus none (0%) in the MVP-XL group (p = 0.029). Time to hemostasis was significantly shorter in the MVP-XL group. CONCLUSION:VASCADE MVP-XL has a better safety and efficacy profile compared to the VASCADE-MVP system, especially in procedures involving large sheaths.

Left atrial appendage occlusion is a treatment for patients with atrial fibrillation who have a high risk of bleeding and are unable to take oral anticoagulants. The Watchman device is an option and has been shown to be safe and effective in reducing embolic stroke risk. Rare but serious and potentially life-threatening complications, such as dislodgment, can occur. Though there is a designated apparatus available for delivery and implantation of these devices, there are no predefined instructions or required equipment available for extraction of dislodged device. This multicenter study aimed to describe the Watchman extraction procedure and to assess the success rates and potential complications associated with the procedure. In this observational study, we analyzed prospectively collected data from 9 patients that underwent percutaneous Watchman extraction with an endoscopic gasping tool (Raptor) at two high volume centers for Watchman implant in United States between 2019 and 2023. Procedural success was described as complete extraction of Watchman without procedural complication. The Watchman was removed due to dislodgement, a potential risk factor for device embolization. The maximum and the minimum size of the extracted Watchman were 24 and 31 respectively. Mean dwell time was 34±8 days. In all the first attempt of retrieval the watchman was done with only one transeptal access with one bioptome (Raptor) to stabilize the watchman and trying to pull inside a 16 mm sheath. In 7 case a second transeptal was required to use another bioptome to allow entry into the sheath. Thus, in these cases sheath bigger than 16 mm was required to extract the Watchman (Fig.1-2). The device was replaced with a bigger watchman in 6 cases, with an amulet in 1 case and in 2 cases, it was not replaced but oral anticoagulation therapy was continued. Procedural success was obtained in 8 (73%) patients. In one case, the use of a single bioptome during extraction led to the embolization of the Watchman device into the ascending aorta, causing a dissection and the patient's subsequent death within the initial week. Watchman extraction is a valuable option when complication, such as dislodgment, occur and should be done using two transeptal access with two bioptomes to improve safety and effectiveness.

Abstract Objective We compared the risk of bleeding and early device-related thrombosis (DRT) events associated with low dose of non-vitamin K antagonist oral anticoagulants (LD-NOAC) vs dual antiplatelet therapy (DAPT) in post-left atrial appendage closure (LAAC) cases. Methods Based on the post-LAAC thromboprophylaxis, consecutive patients were categorized into DAPT group: aspirin+ clopidogrel for 6 months followed by aspirin 81 mg/day (n=501) or LD-NOAC group: low-dose of the non-vitamin K antagonist OAC (LD-NOAC) (n=917). Transesophageal echocardiography (TEE) was performed at 45 days and 3, 6 and 12-month post-procedure to exclude DRT. DRT were considered ‘early’ if they were detected within six months post-procedure. Patients on DAPT were propensity-matched with those on LD-NOAC with a 1:1.5 ratio, to control for confounding due to imbalance of covariates between groups. Results Real-world patients: DRT were detected in 21 (1.48%) patients; 15 (2.99%) and 6 (0.65%) patients in the DAPT and LD-NOAC cohort respectively (p=0.0005) All DRTs in the DAPT-group were detected by 3 months whereas it was detected at 6-mo TEE in 3 of the 6 (50%) patients of the LD-NOAC group Higher number of bleeding events were reported in the DAPT group (81 (16.2%) vs 79 (8.6%), p=0.001). Propensity-matched population: The matched population included 501 in the DAPT group and 751 patients in the LD-NOAC group (1: 1.5). DRT were detected in 13 (2.6%) vs 5 (0.7%) patients from the DAPT and LD-NOAC group respectively (p=0.005). In the multivariable model, DAPT (OR:3.921, 95% CI: 1.399-11.081, p=0.006) was an independent predictor of DRT. Conclusion DRT was detected in significantly higher number of real-world as well as matched patients that remained on DAPT vs LD-NOAC. DAPT was associated with >3 times higher risk of early DRT compared to LD-NOAC in propensity-matched populations Future randomized trials are needed to validate the current study findings

Pulse Field Ablation (PFA) has been acknowledged as an effective and safe tool for ablation of Atrial Fibrillation (AF). It is known that during AF ablation, the arrhythmia may organize into atrial flutter. The left atrial posterior wall is identified as a critical source of non-Pulmonary Vein (PV) triggers that facilitate maintenance of atrial fibrillation. The purpose of this study is to investigate the phenomenon of atrial flutter organization from AF during the application of PFA. This prospective multicentric study encompasses 248 consecutive patients with persistent AF across American and European institutions, undergoing first time catheter ablation. All receive isolation of the Pulmonary Veins (PV) plus Posterior Wall (PW) isolation. The PW isolation procedure targeted the standard area between the PVs and extended to the area demarcated by the line connecting the inferior borders of the inferior PV-encircling lesions to the coronary sinus defined lower part of PW (Fig. 1). The study documented the specific locations where AF organized into atrial flutter with a stable cycle length during PFA. Organization of AF to atrial flutter during PFA was observed in 156 (62.9%) patients. Analysis of the organization of flutter revealed that in 86 (55.1%) of these cases, flutter began while ablating the lower part of the PW. Moreover, 17 (10.9%) initiated while ablating the PVs, and 53 (33.9%) during the ablation of the central part of posterior wall (Fig.1). Notably, flutter were described as perimitral in 73 (46.8%), as typical in 49 (31.4%), and as roof-dependent in 34 (21.8%) of cases (Fig.2). The findings underscore that during PFA for AF, there is a pronounced tendency for the arrhythmia to organize into atrial flutter, particularly during the ablation of the lower posterior wall. Notably ablation in the left atrium organized AF in typical atrial flutter at a considerable rate.Fig.1 Fig.2

Pulsed Field Ablation (PFA) represents a novel, energy approach for pulmonary vein isolation (PVI) in atrial fibrillation (AF) patients, differing from traditional thermal ablation such as radioquency ablation (RFA) for its tissue selectivity and impact of surrounding structure. The impact of these methods on the cardiac autonomic nervous system (ANS), particularly concerning the modulation of blood pressure (BP) and heart rate (HR), remains poorly explored. This study aimed to evaluate the effects of PFA compared to RFA on the ANS, specifically by assessing intraprocedural BP and HR variations. We analyzed consecutive patients from our prospective registry from January to June 2024, undergoing first-time paroxysmal AF ablation with either PFA or RFA. The effects on ANS were assessed by monitoring BP peaks throughout the entire procedure. Blood Pressure Peak: 2 consecutive non invasive measurements of systemic blood pressure with a five minute interval >130/80 mmHg and an increment of ≥30 mmHg from baseline blood pressure for ≥ 15 min. Severe Blood Pressure Peak: 2 consecutive non invasive measurements of systemic blood pressure with a two minute interval > 180/110 mmHg. During this peak all vasopressor were stable. Additionally, HR was evaluated at three time points: before the procedure (t1), prior to discharge (t2), and at the three-month follow-up (t3). We included 356 consecutive patients in our analysis. PFA and RFA was used in 209 (58.7%) and 147 (41.3%) of population respectively. Baseline and procedural caractheristics were similar between the 2 groups. PFA demonstrated a significantly higher incidence of BP peaks compared to RFA (18.2% vs. 2.7%, p<0.001), with 3 (1.4%) severe peaks observed only in PFA group during ablation in the right superior PV. Both ablation methods resulted in acute increases in HR before discharge [delta PFA (t1-t2) = 10.2±4.2 (p<0.001) and delta RFA (t1-t2) = 9.3±5.9 (p<0.001)]. However, the increase observed with RFA appeared to be more sustained, with HR remaining elevated at the three-month follow-up [delta PFA (t1-t3) = 1.3±1.5 (p=0.139) and delta RFA (t1-t3) = 6.2±4.2 (p<0.001)]. Fig.1 Our findings indicate that PFA results in acute autonomic changes, as evidenced by the variable BP trends observed during the procedure and the increase in heart rate before discharge. When compared to PFA, RFA seems to have a more lasting effect on ANS, as indicated by the sustained elevation in HR during follow-up.

Background Peridevice leak (PDL) is commonly observed after Watchman implantation for left atrial appendage occlusion (LAAO) in atrial fibrillation (AF). Because the LAA is actively contractile, it is fair to assume that some degree of device shifting could occur because of LAA contraction during the initial period of device implantation. Objectives This study examined PDL prevalence in Watchman patients with vs without electrical isolation of LAA that consequentially leads to loss of contractility of the appendage. Methods Consecutive patients with AF undergoing the Watchman procedure were included in the study and prospectively followed up. Based on prior LAA isolation (LAAI), patients were divided into Group 1 (prior LAAI) and Group 2 (no LAAI). In all patients in Group 1, electroanatomical mapping and transesophageal echocardiogram (TEE) were used to confirm LAAI and absence of contractility of the appendage before the Watchman implantation. Repeat TEE was scheduled at 45 to 60 days’ post-Watchman implantation to assess for PDL on color Doppler. The leaks were reassessed by computed tomography imaging at 6 months. If leaks were detected during the first follow-up TEE, another TEE/computed tomography imaging was performed at 12 months to exclude persistent leak. Results A total of 495 patients were included in Group 1 and 810 in Group 2. Baseline characteristics were comparable between groups. At the first follow-up TEE at 45 to 60 days, leaks of any size were noted in 90 (18.2%) patients in Group 1 and 199 (24.6%) patients in Group 2 (P = 0.007). The majority of the leaks in Group 2 were ≥3 mm in size (Group 1: 26 [28.9%] vs Group 2: 109 [54.8%]; P < 0.001). Prior LAAI was found to be an independent predictor (OR: 0.662; 95% CI: 0.488-0.900; P = 0.008) of lower risk of leaks. Conclusions In this large prospective series of real-world patients, prior LAAI was seen to be associated with a lower risk of PDL in patients with AF and a Watchman device in situ.

Background Left atrial appendage closure (LAAC) is an established therapeutic strategy to prevent ischemic stroke in selected patients with atrial fibrillation. However, residual peridevice leaks (PDLs) post-LAAC remain a critical concern. Objectives This study sought to assess the clinical impact of Watchman FLX device overcompression. Methods Data on consecutive patients undergoing a transesophageal echocardiography (TEE)-guided LAAC between 2020 and 2023 in 2 high-LAAC volume centers were collected and patients with a device compression higher (overcompression group) or lower (normal compression group) than 30% as evaluated by procedural TEE were compared in terms of procedural complications, composite of cardiovascular death, ischemic stroke, or systemic embolism, and PDL at TEE follow-up. Results This study included 61 overcompression and 175 normal compression patients. Baseline and procedural characteristics did not differ between the 2 groups. Both composite of procedural complications (1.6% vs 1.7%; P = 0.968) and of cardiovascular death, ischemic stroke, or systemic embolism during follow-up (9.8% vs 12%; P = 0.971) did not significantly differ between the 2 groups. At 2-month TEE follow-up, the rate of residual PDL was significantly lower in the overcompression group (8.2% vs 32.6%; P < 0.001). At the multivariate analysis, the device compression rate was the only variable independently associated to risk of PDL at TEE follow-up (adjusted OR: 0.935; 95% CI: 0.927-0.948; P = 0.003). Conclusions In this dual-center cohort of TEE-guided LAAC, the overcompression group was independently associated to a higher rate of LAA occlusion at TEE follow-up.

Catheter ablation of scar-related interatrial septal atrial tachycardias (IAS-ATs) is challenging and can be refractory to conventional unipolar radiofrequency catheter ablation (RFCA). This multicenter study investigated the safety and efficacy of bipolar radiofrequency catheter ablation (Bi-RFCA) in patients with IAS-AT refractory to conventional unipolar RFCA. Consecutive patients with scar-related IAS-AT refractory to conventional unipolar RFA across three electrophysiological centers were included in the study. Bi-RFCA with power up to 40 W and duration up to 60 s was performed with two ablation catheters across the IAS at sites identified with activation and entrainment mapping. Acute termination and noninducibility of the targeted IAS-AT was used as the intraprocedural ablation endpoint. Arrhythmia-free survival from any atrial arrhythmia (AT or atrial fibrillation) lasting > 30 s was used as a follow-up outcome measure. A total of 17 patients (12 males, age 62 ± 13) were included in the study. Acute elimination of arrhythmia with Bi-RFCA was achieved in all patients. Mean procedure time was 173 ± 69 min, mean bipolar RF time 209 ± 193 s, and mean power 39 ± 3 W. During 11 ± 3 months of follow-up, AT/AF recurrence was observed in 2 (12

Atrial fibrillation (AF) ablation with radiofrequency energy (RFA) can result in transient functional impairment of the upper gastro-intestinal (GI) system, likely due to the injury of the vagal nerve. We evaluated the severity and duration of GI motility-dysfunction following RFA vs pulsed-field (PFA) ablation in AF patients. Consecutive AF patients undergoing catheter ablation at our center between 2022 to 2024 were included in this study and divided into two groups based on the energy modalities used for the ablation procedure; group 1: RFA (n=1701) and group 2: PFA (n=1962). Patients were asked to report their GI symptoms at 24 hours, 1 week and 1 month after the procedure. Symptoms of GI dysmotility included nausea, heartburn, bloating, odynophagia, feeling excessively full after meals leading to intolerance for solid food. A multivariable regression analysis was conducted to identify independent predictors of GI motility symptoms. Baseline characteristics were comparable between groups (table). Symptoms of GI motility disorder were observed in 242 (14.2%) and 123 (6.3%) patients in group 1 and 2 respectively (p<0.001). In post-PFA cases, the symptoms included mild nausea (46, 64.8%) and bloating (27, 38%) that lasted for 5.7±2.6 hours and most likely were the side-effects of anesthesia. Only 8 of these 123 patients (6.5%) had GI symptoms persistent for ≥12 hours and they all had history of dyspepsia at baseline. None in the post-PFA group and 201 (83%) patients in the post-RFA population developed excessive stomach-fullness and inability to eat solid food (p<0.001). Overall, the duration of symptoms was significantly higher following RFA compared to the post-PFA population (21.8 ±6.1 days vs 4.3±3.1 hours, p <0.001). In the multivariable analysis, RFA was an independent predictor of GI dysmotility (OR = 1.322, 95% CI 1.011 – 1.722; p-value <0.001) whereas PFA was associated with lower risk (OR = 0.516, 95% CI 0.465 – 0.818; p-value <0.001). Prevalence and duration of GI motility-disorder were substantially lower following PFA compared to RFA. Additionally, none of the post-PFA patients developed intolerance to solid food and excessive fullness.Baseline table

Background The endothelial injury that can promote thrombus formation during radiofrequency ablation (RFA) of atrial fibrillation does not occur with pulsed field ablation (PFA). objective The purpose of this study was to evaluate different strategies for oral anticoagulation (OAC) management following PFA and RFA. Methods Consecutive patients undergoing PFA were propensity score matched with consecutive patients undergoing RFA during the same time period (1:1) and prospectively followed up for 15 months. Based on the duration of OAC therapy, patients were classified into PFA/RFA-group 1 (OAC for 1 month) and PFA/RFA-group 2 (OAC for ≥2 months). Results A total of 800 patients were included in this analysis: 400 from the PFA population (PFA-group 1: 196; PFA-group 2: 204) and 400 from the RFA population 400 (RFA-group 1: 182; RFA-group 2:218). At follow-up, none of the patients in PFA-group 1 (0%) and 2 patients (0.98%) in PFA-group 2 experienced stroke or transient ischemic attack (TIA). In the RFA cohort, 23 stroke/TIA were reported; 16 (8.8%) and 7 (3.2%) in group 1 and 2 respectively (p=0.017). Compared to the PFA population, total number of events were significantly higher in the overall RFA cohort (0.50% vs 5.8%, p <0.001) as well as in RFA-group 1 (0% vs 8.8%, p<0.001). Arrhythmia-recurrence at 15-month was detected in 73 (18.25%) and 108 (27.0%) (27.4%) patients in the PFA and RFA cohort respectively (p=0.003) Conclusion In this consecutive series, no stroke/TIA were reported in the PFA population after discontinuation of OAC at 1 month, whereas a significantly higher number of strokes were documented after OAC interruption at 1 month in the RFA group.

BACKGROUND:Catheter-tissue contact is critical in creating durable lesions during pulsed-field ablation (PFA) of atrial fibrillation (AF). OBJECTIVE:This study aimed to compare the reconnection rate of previously ablated targets using PFA with vs without intracardiac echocardiography (ICE) guidance for confirmation of tissue contact. METHODS:This multicenter prospective study included consecutive patients with paroxysmal and persistent AF undergoing their first procedure using the PFA system. Patients were classified as the ICE group if ICE was used for the assessment of catheter-tissue contact (n = 310) or the fluoro group if fluoroscopy-guided ablation was used (n = 286). All patients received isolation of pulmonary veins; left atrial posterior wall isolation was performed in most patients at the index procedure. Further ablations were performed only in the presence of spontaneous triggers or documentation that those triggers were responsible for arrhythmia either spontaneously or after isoproterenol challenge. RESULTS:Baseline characteristics were comparable between the groups. At the end of the follow-up, arrhythmia recurrence was noted in 39 (12.6%) and 64 patients (22.3%) in the ICE and fluoro groups, respectively (P = .002). All 39 patients in the ICE group and 54 patients (84%) in the fluoro group received repeat ablation. At the redo procedure, reconnection of previously ablated structures was detected in 4 of 39 (10.3%) and 32 of 54 patients (59.2%) in the ICE and fluoro groups, respectively (P < .001). "Fluoroscopy-guided" ablation was found to be an independent predictor of reconnection (odds ratio 8.548; 95% confidence interval 3.224-22.667; P < .001) and recurrence (odds ratio 1.221; 95% confidence interval 1.001-1.971; P = .021). CONCLUSION:ICE-guided PFA with confirmed catheter-tissue contact was associated with a better success rate and a significantly lower reconnection rate in patients with AF.