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Background: Hybrid-convergent radiofrequency (RF) ablation targeting pulmonary veins (PVs) and left atrial posterior wall (LAPW) has shown better arrhythmic outcomes than an endocardial-only RF strategy, despite higher rates of complications. Comparisons with extensive pulsed field ablation (PFA) are currently lacking., Objectives: This study aimed to compare the efficacy and safety of the hybrid-convergent RF vs PFA of PVs and LAPW in long-standing persistent atrial fibrillation (LSPAF)., Methods: Ninety-three consecutive LSPAF patients, treated with 2-step hybrid-convergent RF ablation (hybrid group, n = 49) or with PFA of PVs and LAPW (PFA group, n = 44) were enrolled. Primary efficacy endpoint was defined as any atrial tachyarrhythmias (ATA) recurrence after the 3-month blanking period, over a follow-up time of 12 months. Periprocedural adverse events and late complications during follow-up were deemed primary safety outcomes., Results: The hybrid and PFA groups had similar baseline characteristics; mean age was hybrid 63.8 ± 10.6 years vs PFA 66.0 ± 7.4 years; P = 0.105. PV and LAPW ablation were acutely successful in all patients. Step 1 hybrid-epicardial procedures were longer than PFA (166 [Q1-Q3: 140-205] minutes vs 107.5 [Q1-Q3: 82.5-12] minutes; P < 0.01). At 12-month follow-up, there was no difference in ATA recurrences between groups (hybrid 36.7% vs PFA 40.9%; P = 0.680; log-rank at survival analysis P = 0.539). After adjusting for confounders, a larger left atrial volume and recurrences during the blanking-period were predictors of ATA recurrences after ablation, regardless of procedural technique employed. PFA showed a better safety profile with a lower rate of major periprocedural complications compared with hybrid ablation (12% vs 0%; P = 0.028)., Conclusions: Hybrid-convergent and PFA share comparable arrhythmic outcomes in LSPAF, but hybrid-convergent ablation carries higher periprocedural risks., Competing Interests: Funding Support and Author Disclosures Dr Tondo serves a member of scientific advisory boards for Medtronic Inc and Boston Scientific; and receives lecture/proctoring fees from Abbott Medical, AtriCure, Boston Scientific, and Medtronic Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Introduction: Limited data exist on pulsed-field ablation (PFA) in patients with persistent atrial fibrillation (PeAF) undergoing left atrial posterior wall isolation (LAPWI)., Methods: The Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice (ATHENA) prospective registry included consecutive patients referred for PeAF catheter ablation at 9 Italian centers, treated with the FARAPULSE TM -PFA system. The primary efficacy and safety study endpoints were the acute LAPWI rate, freedom from arrhythmic recurrences and the incidence of major periprocedural complications. Patients undergoing pulmonary vein isolation (PVI) alone, PWI + LAPWI and redo procedures were compared., Results: Among 249 patients, 21.7% had long-standing PeAF, 79.5% were male; mean age was 63 ± 9 years. LAPWI was performed in 57.6% of cases, with 15.3% being redo procedures. Median skin-to-skin times (PVI-only 68 [60-90] vs. PVI + LAPWI 70 [59-88] mins) did not differ between groups. 45.8% LAPWI cases were approached with a 3D-mapping system, and 37.3% with intracardiac echocardiography. LAPWI was achieved in all patients by means of PFA alone, in 88.8% cases at first pass. LAPWI was validated either by an Ultrahigh-density mapping system or by recording electrical activity + pacing maneuvers. No major complications occurred, while 2.4% minor complications were detected. During a median follow-up of 273 [191-379] days, 41 patients (16.5%) experienced an arrhythmic recurrence after the 90-day blanking period, with a mean time to recurrence of 223 ± 100 days and no differences among ablation strategies., Conclusion: LAPWI with PFA demonstrates feasibility, rapidity, and safety in real-world practice, offering a viable alternative for PeAF patients. LAPWI is achievable even with a fluoroscopy-only method and does not significantly extend overall procedural times., (© 2024 The Authors. Journal of Cardiovascular Electrophysiology published by Wiley Periodicals LLC.)

Pulmonary vein isolation and left atrial posterior wall ablation using the Farapulse system, followed by left atrial appendage occlusion, have been achieved as single combined procedure to treat long-standing persistent atrial fibrillation in a patient at high hemorrhagic risk., (© 2023 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals LLC.)

Introduction: Recently, a new cryoballoon (CB) technology (POLARx; Boston Scientific) has come onto the market. Preliminary data have shown that its acute safety and efficacy are similar to those of the first-generation CB. The aim of this study was to assess the medium-term outcome of pulmonary vein isolation (PVI) with the POLARxTM CB in a large multicenter registry., Methods: We prospectively collected data on 125 consecutive patients with paroxysmal atrial fibrillation (AF) who underwent PVI by means of a novel CB system. Two cases of transient phrenic nerve palsy occurred, with full recovery in the 48h post procedure; no major procedure-related adverse events were reported. During the 90-day blanking period, 4 (3.2%) patients experienced an early recurrence. After the blanking period, over a mean follow-up of 411 ± 62 days, 19 patients (15.2%) suffered an AF/atrial tachycardia (AT) recurrence. The 1-year freedom from AF/AT recurrence was 86.4% (n = 17): 10 (8%) patients had an AF recurrence, 6 (4.8%) had an AT occurrence and 1 (0.8%) suffered both events. Patients with AF/AT recurrences had both a shorter deflation time and total deflation time. Moreover, CB ablations with measured TTI < 90 s and TTI < 60 s were more frequent in patients without AF/AT recurrence (88.5% and 77.4%, respectively) than in those who experienced at least one AF/AT recurrence (67.5% and 55.0%, p = .001 and p = .005, respectively)., Conclusion: The novel POLARx cryo-balloon system is safe and effective for PV isolation, displaying a 1-year freedom from atrial arrhythmia recurrence of 86.4%, which is in line to that reported with AFA-Pro CB or RF ablation., Clinical Trial Registration: Catheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice (CHARISMA). URL: http://clinicaltrials.gov/ Identifier: NCT03793998. Registration date: January 4, 2019., (© 2023 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals LLC.)

Aims: Pulmonary vein isolation (PVI) either by balloon devices or radiofrequency forms the cornerstone of invasive atrial fibrillation (AF) treatment. Although equally effective cryoballoon (CB)-based PVI offers shorter procedure duration and a better safety profile. Beside the worldwide established Arctic Front Advance system, a novel CB device, POLARx, was recently introduced. This CB incorporates unique features, which may translate into improved efficacy and safety. However, multicentre assessment of periprocedural efficacy and safety is lacking up to date., Methods and Results: A total of 317 patients with paroxysmal or persistent AF were included and underwent POLARx CB-based PVI in 6 centres from Germany and Italy. Acute efficacy and safety were assessed in this prospective multicenter observational study. In 317 patients [mean age: 64 ± 12 years, 209 of 317 (66%) paroxysmal AF], a total of 1256 pulmonary veins (PVs) were identified and 1252 (99,7%) PVs were successfully isolated utilizing mainly the short tip POLARx CB (82%). The mean minimal CB temperature was -57.9 ± 7°C. Real-time PVI was registered in 72% of PVs. The rate of serious adverse events was 6.0% which was significantly reduced after a learning curve of 25 cases (9.3% vs. 3.0%, P = 0.018). The rate of recurrence-free survival after mean follow-up of 226 ± 115 days including a 90-day blanking period was 86.1%., Conclusion: In this large multicentre assessment, the novel POLARx CB shows a promising efficacy and safety profile after a short learning curve., Competing Interests: Conflict of interest: C.-H.H. received travel grants and research grants by Boston Scientific, Biosense Webster and Cardiofocus and Speaker’s Honoraria from Boston Scientific, Biosense Webster, Bayer and Cardiofocus. He is a consultant of Medtronic, Boston Scientific, Biosense Webster and Cardiofocus. R.R.T. is a consultant of Boston Scientific, Biotronik and Biosense Webster and received Speaker’s Honoraria from Biosense Webster, Medtronic, Boston Scientific and Abbot Medical. K.-H.K. reports grants and personal fees from Abbott Vascular, Medtronic, Biosense Webster outside submitted work. A.M. received speaker's honoraria and travel grants from Medtronic, Biosense Webster and Cardiofocus. A.P. received speaker’s honoraria and consulting fees from Medtronic, Biosense Webster, Daiichi-Sankyo, Bayer and is invited fellow of the Boston Scientific EP training programme. T.D. received speaker’s honoraria and consulting fees from Medtronic, Biosense Webster, Boerhringer-Ingelheim, Bayer, Daiichi-Sankyo. C.T. received Speaker’s and Proctor’s fees from Boston Scientific, Medtronic, Abbott and Biosense Webster. He serves in the Advisory Board of Medtronic, Boston Scientific. All remaining authors have declared no conflicts of interest., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Purpose: A new cryoballoon (CB) technology (POLARx™; Boston Scientific) for pulmonary vein (PV) isolation in patients with atrial fibrillation (AF) has recently been introduced. The aim of this study was to evaluate procedural and biophysical parameters resulting in acute PV isolation when using this new CB., Methods: We assessed the first 69 consecutive patients indicated for AF ablation who underwent PV isolation by means of a novel CB system. Procedural metrics were prospectively recorded., Results: A total of 274 PVs were targeted in 69 patients. PV isolation was achieved in all patients by means of cryoablation alone. The median time to isolation (TTI) was 44 [31-68] s (median temperature at TTI =  - 49 [- 53 to - 41] °C). The median duration of CB ablation was 180 [180 to 240] s. The median nadir temperature was - 56.0 [- 61 to - 52] °C, and the median thaw time to 0 °C was 18 [15-21] s. The median grade of PV occlusion was 4 [3 to 4]. On the basis of ROC analysis, we defined the following cut-off values for acute PV isolation: - 56 °C for nadir temperature (sensitivity = 73.3%, specificity = 64.6%, AUC = 0.716; positive predictive value = 88.1%), 30 s for TTT (60.2%, 53.3%, 0.578; 79.7%), thaw time > 17 s (65.3%, 70.0%, 0.709; 86.9%), and grade of PV occlusion = 4 (79.4%, 66.7%, 0.738; 88.5%). No major procedure-related adverse events were observed at 30-day post-procedure., Conclusions: The new POLARx™ CB appears to be effective and safe. A nadir temperature of - 56 °C, a thaw time to 0 °C ≥ 17 s, and complete PV occlusion were the best predictors of acute PV isolation., Clinical Trial Registration: Catheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice (CHARISMA). URL: http://clinicaltrials.gov/Identifier : NCT03793998. Registration date: January 4, 2019., (© 2021. Springer Science+Business Media, LLC, part of Springer Nature.)

Introduction: Catheter ablation is superior to drugs regarding atrial fibrillation (AF) recurrence, symptoms improvement, and mortality reduction in heart failure. POLARx™ is a novel cryoballoon, with technical improvements seeking to improve outcomes. So far, its clinical evidence is restricted to a case report., Methods: To compare the POLARx™ cryoballoon procedural safety and efficacy to the already established Arctic Front Advance PRO™ (AFAP) in a single-center cohort study, consecutive patients undergoing AF cryoablation with the POLARx™ were enrolled. Data were prospectively gathered. POLARx™ patients were compared with a historical cohort of patients submitted to AF cryoablation with the AFAP., Results: Seventy patients were analyzed, 20 in POLARx™, and 50 in the AFAP group. They all underwent first-time pulmonary vein isolation, 77% were male, 94% had paroxysmal AF, median age was 62.5 years, median CHA 2 DS 2 -VASc 1, left-atrium size 34 ml/m², and 65% were receiving anticoagulation. The primary end-point, all pulmonary veins isolation, was 100% in both groups. The complication rate was similar (0% POLARx™ vs. 5.7% AFAP, p = .39). The median total procedural time was longer in the POLARx™ group (90 min vs. 60 min, p < .001), but the overall time-to-isolation (TTI; 44.8 s vs. 39 s, p = .253) and ablation time (15 min vs. 13.7 min, p = .122) was similar between POLARx™ and AFAP groups, respectively. Despite equal TTI, the POLARx™ had a lower minimal temperature reached (-57°C vs -47°C, p < .001)., Conclusion: The novel POLARx™ cryoballoon had similar efficacy and safety compared with the AFAP. It was also associated with longer procedural times, similar TTI, and lower minimum temperature reached., (© 2021 Wiley Periodicals LLC.)

Cryoballoon ablation is a recognized and widespread method for pulmonary vein isolation. For many years the impossibility of using it to create additional lines was considered a drawback of this approach. However, recently, the technique was adapted to allow the creation of rooflines, and potentially also inferior lines. In this article, we present the first reported case of a patient submitted to pulmonary vein isolation plus posterior wall isolation using the novel Boston POLAR X™ cryoballoon exclusively. To confirm the quality of the lesions, the patient underwent pre and postablation high-density mapping., (© 2020 Wiley Periodicals LLC.)

Cryoballoon ablation was developed as a new treatment for pulmonary vein (PV) isolation and has demonstrated high procedural success and comforting long-term clinical outcome. However, some improvements are necessary for real-time visualization of PV signals that appeared important to increase the efficacy and reduce ineffective cryoapplications. We report, for the first time, a cryoablation procedure using the fourth-generation cryoballoon, describing betterment in vein signal recording and acute procedural success., (© 2018 Wiley Periodicals, Inc.)

Background: Pulmonary vein isolation (PVI) is a cornerstone ablation strategy in the management of patients with atrial fibrillation (AF). Consensus guidelines and statements recommend PVI during the index catheter ablation procedure in patients with paroxysmal and persistent AF., Objective: The objective of this analysis was to evaluate patients with persistent and long-standing persistent AF who were treated with the cryoballoon ablation catheter by PVI technique., Methods: Consecutive patients with drug-refractory symptomatic persistent and long-standing persistent AF who underwent cryoballoon catheter ablation by a PVI-only procedure were prospectively included in this single-arm multicenter evaluation. Data on procedural characteristics, safety, and long-term freedom from AF recurrence were analyzed., Results: Four hundred eighty-six subjects (mean age 60.8 ± 9.3 years; 389 (80%) men; 434 (89.3%) with persistent AF; 52 (10.7%) with long-standing persistent AF; left atrial diameter 44.6 ± 6.2 mm) underwent cryoballoon ablation in 35 Italian centers. The mean procedure time (skin-to-skin) was 109.9 ± 52.9 minutes, and the mean fluoroscopy time was 29.6 ± 14.5 minutes. Periprocedural complications were observed in 21 subjects (4.3%), and the acute PVI success rate was 97.6% across all patients. Using a 90-day blanking period, the single procedure Kaplan-Meier estimates of AF event-free survival were 63.9% at 12 months and 51.5% at 18 months., Conclusion: In this multicenter evaluation of cryoballoon ablation, the PVI procedure was safe, effective, and efficient with regard to the treatment of patients with persistent and long-standing persistent AF. The reasonable mid-term success rates agree with current clinical studies that establish PVI as a cornerstone index ablation strategy., (Copyright © 2017 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: The outcome of radiofrequency catheter ablation (RFCA) of atrial fibrillation (AF) has improved thanks to left atrium (LA) anatomy reconstruction by cardiac computed tomography (CCT). A new model-based iterative reconstruction algorithm (MBIR) provides image noise reduction achieving effective radiation dose (ED) close to chest X-ray exposure. Aim of this study was comparing RFCA procedural characteristics, AF recurrence and radiation exposure between patients in whom RFCA was guided by CCT image integration with MBIR versus a CCT standard protocol., Methods: Three-hundred consecutive patients with drug-refractory AF were studied with CCT using MBIR (Group 1; N:150) or CCT with standard protocol (Group 2; N:150) for LA evaluation and treated by image integration-supported RFCA. Image noise, signal to noise ratio (SNR), contrast to noise ratio (CNR), RFCA procedural characteristics, rate of AF recurrence and radiation exposure were compared., Results: Group 1 showed higher SNR (25.9±7.1 vs. 16.2±4.8, p<0.001) and CNR (23.3±7.1 vs. 12.2±4.2, p<0.001) and lower image noise (22.3±5.2 vs. 32.6±8.1 HU, p<0.001), fluoroscopy time (21±12 vs. 29±15min, p<0.01) and procedural duration (135±89 vs. 172±55, p<0.001). Group 1 showed a 94% reduction of ED as compared to Group 2 (CCT-ED related: 0.41±0.04 vs. 6.17±4.11mSv, p<0.001; cumulative CCT+RFCA-ED related: 21.9±17.9 vs. 36.0±24.1mSv, p<0.001) with similar rate of AF recurrence (25% vs. 29%, p=0.437)., Conclusions: CCT with MBIR allows accurate reconstruction of LA anatomy in AF patients undergoing RFCA with a sub-millisievert ED and comparable success rate of RFCA as compared to a standard CCT scan protocol., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Aims: Pulmonary veins (PVs) isolation is the cornerstone of atrial fibrillation (AF) ablation and can be achieved either by conventional radiofrequency ablation or by cryoenergy. Left atrial appendage (LAA) closure has been proposed as alternative treatment to vitamin K antagonists (VKA). We aimed to evaluate the feasibility of combining cryoballoon (CB) ablation and LAA occlusion in patients with AF and a high thromboembolic risk or contraindication to antithrombotic therapy., Methods and Results: Thirty-five patients (28 males, 74 ± 2 years) underwent CB ablation. Left atrial appendage occlusion was carried out by using two occluder devices (Amplatz Cardiac Plug, ACP, St. Jude Medical, MN, USA, in 25 patients; Watchman, Boston Scientific, MA, USA, in 10 patients). Thirty patients (86%) had previous stroke/TIA episodes, 6 patients (17%) had major bleeding while on VKA therapy, and 7 patients (20%) had inherited bleeding disorders. Over the follow-up (24 ± 12 months), atrial arrhythmias recurred in 10 (28%) patients. Thirty patients (86%) had complete sealing; 5 patients (14%) showed a residual flow (<5 mm) at first transoesophageal echocardiography (TEE) check, while at 1-year TEE residual flow was detected in 3 patients. In 13 patients (37%), VKA therapy was immediately discontinued. Six patients (17%) received novel oral anticoagulants treatment and then discontinued 3 months thereafter. No device-related complications or clinical thromboembolic events occurred., Conclusion: Combined CB ablation and LAA closure using different devices appears to be feasible in patients with non-valvular AF associated with high risk of stroke or contraindication to antithrombotic treatment., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.)

Background: It is unclear whether isolation of the left atrial posterior wall (LAPW) offers additional benefits over pulmonary vein antrum isolation (PVAI) alone in patients with persistent atrial fibrillation (AF)., Objective: We sought to determine the impact of PVAI and LAPW isolation (PVAI+LAPW) versus PVAI alone on the outcome of ablation of persistent AF., Methods: During the first procedure, PVAI was performed in 20 patients (group 1), whereas in 32 patients (group 2), PVAI was extended to the left atrial (LA) septum and coronary sinus (CS), and isolation of the LAPW was targeted (ePVAI+LAPW). Isolation of the superior vena cava was achieved in both groups. All patients, regardless of arrhythmia recurrence, underwent a second procedure 3 months after the first procedure. In patients with reconnection of pulmonary veins or LAPW, reisolation was performed, and a third procedure was performed 3 months later to verify isolation. Patients entered follow-up only after PVAI (group 1) or PVAI+LAPW (group 2) isolation was proven., Results: At the 1-, 2-, and 3-year follow-up examinations, the rates of freedom from atrial tachyarrhythmia without use of an antiarrhythmic drug were 20%, 15%, and 10% in group 1 and 65%, 50%, and 40% in group 2, respectively (log-rank P < .001). The median recurrence-free survival time was 8.5 months (interquartile range 6.5-11.0) in group 1 and 28.0 months (interquartile range 8.5-32.0) in group 2., Conclusion: Proven isolation of the LAPW provides additional benefits over PVAI alone in the treatment of persistent AF and improves procedural outcome at follow-up. However, the ablation strategy of ePVAI+LAPW is still associated with a significant high incidence of very late recurrence of atrial tachyarrhythmia., Clinical Trial Registration: "Outcome of Atrial Fibrillation Ablation After Permanent Pulmonary Vein Antrum Isolation With or Without Proven Left Atrial Posterior Wall Isolation" (LIBERATION). ClinicalTrials.gov Identifier: NCT01660100., (Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Previous studies reported the usefulness of an irrigated circular radiofrequency ablation catheter (nMARQ(TM), Biosense Webster) for pulmonary vein isolation (PVI). We evaluated the role of intracardiac echocardiography (ICE) to optimize the manipulation of nMARQ(TM) catheter., Methods: Thirty-seven patients (pts), (mean age 55 ± 12 years; 28 males) were enrolled to perform PVI. All pts underwent PVI with the nMARQ(TM) catheter. In 20 pts (group 1), we utilized ICE to guide nMARQ(TM) catheter positioning at the PV ostia; in the other 17 pts (group 2), nMARQ(TM) catheter was positioned at the PV ostia guided by fluoroscopy and TissueConnect(TM) technology., Results: Radiofrequency (RF) applications were significantly lower in group 1 compared to group 2 [left PVs: 6 (range 3 to 12) in group 1 and 12 (range 5 to 16) in group 2 (p < 0.001); right PVs: 7 (range 4 to 14) in group 1 and 10 (range 5 to 16) in group 2 (p = 0.04)]; similarly regarding the time of RF delivery [left PVs: 318 ± 194 s in group 1 vs. 542 ± 104 s in group 2 (p < 0.001); right PVs: 410 ± 270 s in group 1 vs. 550 ± 156 s in group 2 (p = 0.05)]. Fluoroscopy time (23 ± 9 min vs. 28 ± 5 min; p = 0.05), procedural time (83 ± 23 min vs. 160 ± 42 min; p < 0.001), and radiation dose (109 ± 20 Gy/cm(2) vs. 127 ± 29 Gy/cm(2); p = 0.04) were significantly lower in group 1 compared to group 2., Conclusion: ICE might be a useful tool to guide nMARQ(TM) catheter position in the left atrium during atrial fibrillation (AF) ablation procedures.

Introduction: Aim of this study was to compare efficacy and safety of the new ThermoCool Surround Flow® catheter (SFc) versus the ThermoCool® (TCc) in achieving persistent circumferential electrical isolation of the pulmonary veins (PVs) in patients with paroxysmal atrial fibrillation (AF)., Methods and Results: This multicenter, randomized, controlled study enrolled patients suffering from paroxysmal AF. Randomization was run in a one-to-one fashion between radiofrequency ablation by TCc or SFc. Aim of PVs ablation was documentation of electrical isolation with exit/entrance block recorded on a circular catheter. Among the 106 enrolled patients, 52 (49.0%) were randomized to TCc and 54 (51.0%) to SFc. Total volume of infused saline solution during the procedure was lower in the SFc than in TCc group (752.7 ± 268.6 mL vs 1,165.9 ± 436.2 mL, P < 0.0001). Number of identified and isolated PVs was similar in the 2 groups. Number of PVs remaining isolated 30 minutes after ablation was higher in the SFc than in TCc group (95.2% vs 90.5%, P < 0.03), mainly driven by acute ablation result in the left PVs (96.1% vs 89.7%, P < 0.04). Complications were seldom and observed only in the TCc group (0% vs 3.84%, P < 0.03). At 6-month follow-up SFc patients reported a trend toward less AF recurrences compared to those in the TCc group (22.9% vs 27.0%, P = 0.69)., Conclusion: PV isolation by SFc lowered the rate of left PV early reconnections and reduced the volume of infused saline solution while maintaining the safety profile of AF ablation., (© 2012 Wiley Periodicals, Inc.)