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Background: Intracardiac echocardiography (ICE) is increasingly employed in atrial fibrillation (AF) ablation procedures, with the potential to enhance procedural efficacy. Nevertheless, there is currently a lack of evidence assessing the impact of ICE on the efficiency, effectiveness, and safety outcomes in the context of novel pulsed-field ablation (PFA) for AF., Purpose: We aimed to assess whether the use of ICE could improve procedural parameters in a large population undergoing AF ablation with FARAPULSE™ catheter., Methods: Consecutive patients who had undergone PFA of AF from nine Italian centers were included. In procedures where the ICE catheter was employed for guidance (ICE-guided group), it was used to maneuver the PFA catheter within the left atrium to achieve optimal contact with atrial structures., Results: We analyzed 556 patients: 357 (66%) with paroxysmal AF, 499 (89.7%) de novo PVI. ICE-guided procedures (n = 138) were propensity matched with patients with a standard approach (n = 138), and their outcomes were compared. During ICE-guided procedures, no improvement in procedural metrics was recorded (ICE vs Standard, 23 ± 6 min vs 18.5 ± 9 min for time to PVI, p < 0.0001; 38.8 ± 7 vs 32.5 ± 5 number of PFA deliveries to achieve PVI, p < 0.0001; 68.8 ± 19 min vs 71.8 ± 29 min for primary operator time, p = 0.5301; 16.1 ± 8 min vs 18.2 ± 10 min for fluoroscopy time, p = 0.5476) except for support time (76.8 ± 26 min vs 91.4 ± 37 min, p = 0.0046). No major procedure-related adverse events were reported., Conclusion: Our findings confirmed that PFA could be consistently performed in a rapid, safe, and efficacious manner. The use of ICE to guide PFA was not associated with an improvement in procedural metrics., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Pulsed field ablation (PFA) is an emerging technology for the treatment of atrial fibrillation (AF), for which pre-clinical and early-stage clinical data are suggestive of some degree of preferentiality to myocardial tissue ablation without damage to adjacent structures. Here in the MANIFEST-17K study we assessed the safety of PFA by studying the post-approval use of this treatment modality. Of the 116 centers performing post-approval PFA with a pentaspline catheter, data were received from 106 centers (91.4% participation) regarding 17,642 patients undergoing PFA (mean age 64, 34.7% female, 57.8% paroxysmal AF and 35.2% persistent AF). No esophageal complications, pulmonary vein stenosis or persistent phrenic palsy was reported (transient palsy was reported in 0.06% of patients; 11 of 17,642). Major complications, reported for ~1% of patients (173 of 17,642), were pericardial tamponade (0.36%; 63 of 17,642) and vascular events (0.30%; 53 of 17,642). Stroke was rare (0.12%; 22 of 17,642) and death was even rarer (0.03%; 5 of 17,642). Unexpected complications of PFA were coronary arterial spasm in 0.14% of patients (25 of 17,642) and hemolysis-related acute renal failure necessitating hemodialysis in 0.03% of patients (5 of 17,642). Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation. PFA has the potential to be transformative for the management of patients with AF., (© 2024. The Author(s).)

Background: Pulsed field ablation (PFA) is selective for the myocardium. However, vagal responses and reversible effects on ganglionated plexi (GP) are observed during pulmonary vein isolation (PVI). Anterior-right GP ablation has been proven to effectively prevent vagal responses during radiofrequency-based PVI., Objective: The purpose of this study was to test the hypothesis that PFA-induced transient anterior-right GP modulation when targeting the right superior pulmonary vein (RSPV) before any other pulmonary veins (PVs) may effectively prevent intraprocedural vagal responses., Methods: Eighty consecutive paroxysmal atrial fibrillation patients undergoing PVI with PFA were prospectively included. In the first 40 patients, PVI was performed first targeting the left superior pulmonary vein (LSPV-first group). In the last 40 patients, RSPV was targeted first, followed by left PVs and right inferior PV (RSPV-first group). Heart rate (HR) and extracardiac vagal stimulation (ECVS) were evaluated at baseline, during PVI, and postablation to assess GP modulation., Results: Vagal responses occurred in 31 patients (78%) in the LSPV-first group and 5 (13%) in the RSPV-first group (P <.001). Temporary pacing was needed in 14 patients (35%) in the LSPV-first group and 3 (8%) in the RSPV-first group (P = .003). RSPV isolation was associated with similar acute HR increase in the 2 groups (13 ± 11 bpm vs 15 ± 12 bpm; P = .3). No significant residual changes in HR or ECVS response were documented in both groups at the end of the procedure compared to baseline (all P >.05)., Conclusion: PVI with PFA frequently induced vagal responses when initiated from the LSPV. Nevertheless, an RSPV-first approach promoted transient HR increase and reduced vagal response occurrence., Competing Interests: Disclosures Dr Sarkozy is a consultant for Biosense Webster, Medtronic, Biotronik, and MicroPort. Dr de Asmundis received research grants on behalf of the center from Biotronik, Medtronic, Abbott, LivaNova, Boston Scientific, AtriCure, Philips, and Acutus; and compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, LivaNova, Boston Scientific, AtriCure, Acutus Medical, and Daiichi Sankyo. Dr Chierchia received compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, Boston Scientific, and Acutus Medical. All other authors have no conflicts of interest to disclose., (Copyright © 2024 Heart Rhythm Society. 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.)

Introduction: Cryoablation therapy for pulmonary vein isolation (PVI) to treat paroxysmal atrial fibrillation (PAF) is well established. A novel 28 mm cryoballoon system designed to operate under low pressure to safely reach a lower nadir temperature and maintain constant balloon size during cooling has not been prospectively studied in a large patient population for safety and efficacy. The FROZEN AF (NCT04133168) trial was an international multicenter, open-label, prospective, single-arm study on the safety and performance of a novel cryoballoon system for treatment of PAF., Methods and Results: The study enrolled patients at 44 sites in 10 countries across North America, Europe, and Asia. Subjects were indicated for PVI treatment of PAF and had failed or were intolerant of one or more antiarrhythmic drugs. Procedural outcomes were defined based on the 2017 HRS consensus statement. Follow-up was performed at 7 days, 3, 6, and 12 months. Data are reported as mean ± SD or median (IQR). PVI was performed with a 28 mm cryoballoon in 325 drug refractory PAF patients. Complete PVI was achieved in 95.7% of patients. In cryoablation lesions longer than 60 s, 60.1% of PV isolations required only a single cryoballoon application. Procedure related complications included: phrenic nerve palsy [temporary 4 (1.2%), persistent 0 (0.0%)], cardiac tamponade/perforation 2 (0.6%), and air embolism 1 (0.3%). Freedom from documented atrial arrhythmia recurrence at 12 months was 79.9% (AF 82.7%, AFL 96.5%, AT 98.1%), antiarrhythmic drugs (AAD) were continued or re-initiated in 26.8% of patients after the 3-month blanking period. Additionally, an extension arm enrolled 50 pts for treatment with 28/31 mm variable size cryoballoon. A single temporary PNP occurred in this group, which resolved before discharge. Freedom from documented recurrence at 12 months in these pts was 82.0%., Conclusions: This novel cryoballoon may facilitate PVI to treat PAF, providing more options to address the variety of anatomies present in patients with PAF. This cryoballoon system proved to be safe and effective for treatment of patients with drug refractory or drug intolerant PAF., (© 2024 Wiley Periodicals LLC.)

Background: The aims of this analysis were: to evaluate the impact of timing of ablation on the rate of atrial arrhythmias recurrence, verify if the timing of ablation impact differently in patients with paroxysmal and persistent AF., Methods: Three thousand two hundred and five patients (60.5 ± 10 years, female 28.4%%, 78.8%% paroxysmal AF) were included in the analysis. All patients underwent only cryoballoon (CB) pulmonary vein (PV) isolation during the index procedure., Results: The mean procedure time was 102.8 ± 50 min, with a mean fluoroscopy time of 26.3 ± 49 min. Acute PV isolation was achieved in 11760/11793 (99.7%) PVs. A total of 91 (2.8%) patients experienced a procedure-related complication. During the observation period 913/3205 (28.5%) patients had at least one atrial arrhythmias episode: 28% of patients with paroxysmal AF vs 33% of patients with persistent AF. In multivariate analysis, persistent AF together with time from symptomatic AF diagnosis to ablation, female sex, and ablation time showed to be significant predictors for AF recurrence. In particular, months from first symptomatic AF episode > 18 months was a significant predictor of AF recurrence (HR = 1.23, 95% CI = 1.03-1.46, p = 0.020). In patients with paroxysmal AF, the multivariate analysis confirmed that months from first symptomatic AF episode > 18 month was an independent predictor of AF recurrence together with age > 62 years and female sex. In patients with persistent AF, the time from persistent AF showed to be significant predictor for AF recurrence., Conclusions: In this multicenter analysis, time from first symptomatic AF episode > 18 months was a significant predictor of AF recurrence after CB PV isolation., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Pulmonary vein isolation by cryoablation (PVI-C) is a standard therapy for the treatment of patients with symptomatic atrial fibrillation (AF). AF symptoms are highly subjective; however, they are important outcomes for the patient. The aim is to describe the use and impact of a web-based App to collect AF-related symptoms in a population of patients who underwent PVI-C in seven Italian centers., Methods: A patient App to collect AF-related symptoms and general health status was proposed to all patients who underwent an index PVI-C. Patients were divided into two groups according to the utilization of the App or the non-usage., Results: Out of 865 patients, 353 (41%) subjects composed the App group, and 512 (59%) composed the No-App group. Baseline characteristics were comparable between the two cohorts except for age, sex, type of AF, and body mass index. During a mean follow-up of 7.9±13.8 months, AF recurrence was found in 57/865 (7%) subjects with an annual rate of 7.36% (95% CI:5.67-9.55%) in the No-App versus 10.99% (95% CI:9.67-12.48%) in the App group, p=0.007. In total, 14,458 diaries were sent by the 353 subjects in the App group and 77.1% reported a good health status and no symptoms. In only 518 diaries (3.6%), the patients reported a bad health status, and bad health status was an independent parameter of AF recurrence during follow-up., Conclusions: The use of a web App to record AF-related symptoms was feasible and effective. Additionally, a bad health status reporting in the App was associated with AF recurrence during follow-up., (© 2023. The Author(s).)

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.)

Background: In terms of safety and efficacy, cryoballoon ablation (CB-A) has become a valid option for achieving pulmonary vein isolation (PVI) in patients affected by symptomatic atrial fibrillation. However, CB-A data in octogenarians are still scarce and limited to single-centre experiences. The present multicentre study aimed to compare the outcomes and complications of index CB-A in patients older than 80 years with a cohort of younger patients., Methods and Results: We retrospectively enrolled 97 consecutive patients aged ≥80 years who underwent PVI using the second-generation CB-A. This group was compared with a younger cohort of patients using a 1:1 propensity score matching. After the matching, 70 patients from the elderly group were analysed and compared with 70 younger patients (control group). The mean age was 81.4 ± 1.9 years among octogenarians and 65.2 ± 10.2 years in the younger cohort. The global success rate after a median follow-up of 23 [18-32.5] months was 60.0% in the elderly group and 71.4% in the control group (P = 0.17). Phrenic nerve palsy was the most common complication occurring in a total of 11 patients (7.9%): in 6 (8.6%) patients in the elderly group and in 5 patients (7.1%) in the younger group (P = 0.51). Only two (1.4%) major complications occurred: one (1.4%) femoral artery pseudoaneurysm in the control group, which resolved with a tight groin bandage, and one (1.4%) case of urosepsis in the elderly group. Arrhythmia recurrence during the blanking period and the need for electrical cardioversion to restore sinus rhythm after PVI were found to be the only independent predictors of late arrhythmia relapses., Conclusions: The present study showed that CB-A PVI is as feasible, safe and effective among appropriately selected octogenarians as it is in younger patients., (Copyright © 2023 Italian Federation of Cardiology - I.F.C. All rights reserved.)

Background: Atrial fibrillation (AF) is an uncommon arrhythmia in young adults without structural heart disease, and cryoballoon pulmonary vein isolation (CB-PVI) is an important therapeutic strategy for rhythm control in patients with drug-refractory AF. The aim of this analysis was to evaluate efficacy and safety of CB-PVI in a large cohort of young patients in comparison with middle-aged adults in a real-world setting., Methods: From 2012 to 2020, a total of 3033 patients with AF underwent CB-PVI and were followed prospectively in the framework of the 1STOP Clinical Service project, involving 34 Italian centers. Out of 3033 total 1STOP project subjects, a subgroup of 1318 patients were defined which included a YOUNG group (age ≤ 45 years; n = 368) and a MIDDLE-AGED group (age 60-65 years; n = 950)., Results: The acute success rate of PVI did not differ between the two cohorts (99.9 ± 1.3% vs. 99.8 ± 3.2%, p = 0.415). There was no difference in procedural characteristics, and periprocedural complication rates were similar among the two cohort (1.9% vs. 2.3%, p = 0.646). The 12-month freedom from AF recurrence was 88.9% (95% confidence interval [CI]: 84.7-92.0) in the YOUNG cohort and 85.6% (95% CI: 82.9-88.0) in the MIDDLE-AGED group. At 36-month follow-up, freedom from AF recurrence was 72.4% (65.5%-78.2%) and 71.8% (67.7%-75.6%), respectively with no significant difference among groups (p = 0.550)., Conclusion: CB-PVI had similar efficacy and safety in YOUNG and MIDDLE-AGED patients. Younger age did not affect acute procedural results, complication rate, or AF recurrence after a single procedure., (© 2022 The Authors. Clinical Cardiology published by Wiley Periodicals, LLC.)

Background: Cryoballoon technology (CB-A) has become a cornerstone of atrial fibrillation (AF) ablation in terms of safety and efficacy. Data regarding CB-A in octogenarians are still scarce and limited to single center experiences. The present study sought to analyze the performances of index CB-A in patients older than 80 years-old referring to 3 high-volume European centers., Methods and Results: We retrospectively enrolled 95 patients with a median age of 81 [80, 83] years. 62 (65.3%) patients presented with paroxysmal AF and 33 (33.7%) with persistent AF. Mean procedure and fluoroscopy times were 73.8 ± 25.2 and 15.3 ± 7.5 min, respectively. At 12 months and 24 months of follow-up, the overall freedom from AF was 81.1% and 66.6%, respectively. When divided for AF type, freedom from AF was higher in patients with paroxysmal AF (p = 0.007). Cryoballoon ablation was able to significantly improve AF-related symptoms as proven by the significant decrease in EHRA score during the follow-up (p < 0.0001). Phrenic nerve palsy occurred in 8 (8.5%) patients and always resolved during the procedure without affecting procedural outcome. Two major complications occurred (2.1%); one patient experienced pneumonia, successfully treated with antibiotics and non-invasive mechanical ventilation, the latter one experienced acute kidney failure secondary to urosepsis successfully treated by renal replacement therapy., Conclusions: The present study showed that CB-A is a feasible and effective procedure among octogenarians with a low complication rate. Contemporarily, CB-A can help to alleviate arrhythmia-related symptoms also among this group of subjects., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Purpose: Radiofrequency (RF) catheter ablation is widely accepted as a first-line therapy for cavotricuspid isthmus (CTI)-dependent atrial flutter (AFL). The novel DiamondTemp (DT) catheter with temperature feedback during RF ablation has been released recently on the market. The purpose of this study was to evaluate the impact of DiamondTemp (DT) technology on ablation efficiency during AFL., Methods: In this single-center study, 30 consecutive patients with typical AFL indicated to ablation of CTI were included. The first 15 patients underwent CTI ablation using 8-mm tip catheter, and the following 15 patients underwent temperature-controlled RF ablation using DT catheter. The endpoints were number and mean total duration of RF applications, mean temperature reached in the setting of CTI, procedural times, and fluoroscopy times., Results: There were no significant differences between the two groups concerning baseline characteristics. Mean duration of the each application (71.5 s ± 30.6 vs 12.4 s ± 13.2, p value < 0.001), mean total duration of RF applications (517,73 s ± 377,96 vs 112,8 s ± 43,58; p value < 0.001), procedural times (51.6 min ± 24.2 vs 38.6 ± 8.2; p = 0.03), and fluoroscopy times (16.2 min ± 10.2 vs 8 min ± 4.24; p = 0.005) were longer in the 8-mm ablation catheter group. Mean temperature measurements (51.9 °C ± 3.59 vs 56.7 °C ± 3.34, p value < 0.003) were as well lower in the 8-mm ablation catheter group., Conclusions: Catheter ablation of CTI-dependent AFL by means of DT resulted in a significant reduction of total and single application RF delivery time, procedure, and fluoroscopy times., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

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.)

Background: It has been observed that the fourth-generation cryoballoon (CB4) ablation catheter increased the rate of acute real-time recordings of pulmonary vein isolation (PVI) during the ablation for the treatment of atrial fibrillation (AF). The aim of this analysis was to compare the long-term outcome results between patients treated with the CB4 and second-generation cryoballoon (CB2)., Methods: In total, 492 patients suffering from AF, underwent PVI ablation with either the CB2 or CB4 catheter within this examination of the 1STOP real-world Italian project and were included in the analysis. Specifically, 246 consecutive patients treated by CB4 were compared to 246 propensity-matched control patients who underwent PVI using CB2., Results: When comparing the patient cohorts treated with CB2 versus CB4, acute success rate (99.6 ± 4.7% vs. 99.7 ± 3.6%, p = .949) and peri-procedural complications (3.7% vs.1.2%, p = .080) were similar in both groups, respectively. However, procedure time (100 vs.75 min, p < .001) and fluoroscopy duration (21 vs.17 min, p < .001) were all significantly lower in the CB4 treated patient cohort. At the 12-month follow-up, the freedom from AF recurrence after a 90-day blanking period was significant higher in the CB4 as compared with the CB2 group (93.3% vs.81.3%, p < .001)., Conclusions: In summary, usage of the CB4 ablation catheter increased the rate of acute PVI recording capability and resulted in a higher rate of long-term PVI success, as demonstrated by the reduced rate of AF recurrence in comparison to the CB2 cohort at the 12-month follow-up period., (© 2022 Wiley Periodicals LLC.)

Background: Left atrial posterior wall isolation (LAPWI) is often performed in addition to pulmonary vein isolation (PVI) in the setting of persistent atrial fibrillation (AF) ablation. The aim of this study was to evaluate the feasibility and safety of a new cryoballoon ablation system in achieving PVI + LAPWI isolation., Methods: The study was a prospective, non-randomized, single center study. Forty consecutive patients, undergoing PVI + LAPWI with the novel POLARx™, were compared to 40 consecutive patients who underwent the same procedure with the established Arctic Front Advance PRO™., Results: Acute isolation was achieved in all PVs in both groups and left posterior wall isolation (LAPWI) was achieved in 38 patients (95%) in the POLARx group and in 36 patients (90%) in Arctic Front group. Procedural outcomes were similar between both groups, except for lower temperatures during cryoenergy in the POLARx group, for both pulmonary vein isolation (PVI) and LAPWI., Conclusion: LAPWI + PVI with the novel POLARx™ Cryoballoon is feasible and safe; the results are comparable with the Arctic Front Advance PRO™ system., (© 2022 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals LLC.)

Introduction: Catheter ablation has been demonstrated to be a safe and an effective treatment for drug resistant atrial fibrillation (AF); electrical isolation of pulmonary veins (PVI) is the main strategy in paroxysmal AF, since pulmonary vein triggers have a pivotal role in its pathogenesis; non-paroxysmal AF is a complex arrhythmia that results from the interplay of a substrate, namely AF-induced electrical and structural atrial remodeling, and a trigger that can be often found outside pulmonary veins, namely non-pulmonary veins triggers., Areas Covered: The aim of this review is to provide a state-of-the-art overview of non-pulmonary veins triggers with special focus on cryoballoon (CB) catheter ablation., Expert Opinion: Besides PVI, CB catheter ablation of non-pulmonary veins triggers is a novel and promising strategy for non-paroxysmal AF.

Background: Cryoballoon ablation (CBA) as a first-line rhythm control strategy is superior to antiarrhythmic drugs (AADs) for preventing atrial fibrillation (AF) recurrence; the impact of first-line CBA on quality of life (QoL) and symptoms has not been well characterized., Methods: Patients aged 18 to 75 with symptomatic paroxysmal AF naïve to rhythm control therapy were randomized (1:1) to CBA (Arctic Front Advance, Medtronic) or AAD (Class I or III). Symptoms and QoL were assessed at baseline, 1, 3, 6, 9, and 12 months using the EHRA classification and Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and SF-36v2 questionnaires. Symptomatic palpitations were evaluated via patient diary., Results: Overall, 107 patients were randomized to CBA and 111 to AAD; crossovers occurred in 9%. Larger improvements in the AFEQT summary, subscale and treatment satisfaction scores were observed at 12 months with CBA vs AAD (all P <0.05). At 12 months, the mean adjusted difference in the AFEQT summary score was 9.9 points higher in the CBA group (95% CI: 5.5 -14.2, P <0.001). Clinically important improvements in the SF-36 physical and mental component scores were observed at 12 months in both groups, with no significant between group differences at this timepoint. In the CBA vs AAD group, larger improvements in EHRA class were observed at 6, 9 and 12 months (P <0.05) and the incidence rate of symptomatic palpitations was lower (4.6 vs 15.2 days/year post-blanking; IRR: 0.30, P <0.001)., Conclusions: In patients with symptomatic AF, first-line CBA was superior to AAD for improving AF-specific QoL and symptoms., Trial Registration: ClinicalTrials.gov number: NCT01803438., (Copyright © 2021. Published by Elsevier Inc.)

Background: Much debate is still going on about the best ablation strategy-via endocardial or epicardial approach-in patients with atrial fibrillation (AF), and evidence gaps exist in current guidelines in this area. More specifically, there are no clear long-term outcome data after failed surgical AF ablation., Methods: Since June 2008, 549 surgical AF ablation procedures through a right minithoracotomy were performed at our institution. From 2008 to 2011, a unipolar radiofrequency device was used (151 patients), whereas from 2011 to 2020 a bipolar radiofrequency device was used (398 patients). Patients were scheduled for surgery on the basis of the following criteria: recurrent episodes of paroxysmal or persistent lone AF refractory to maximally tolerated antiarrhythmic drug dosing and at least one failed cardioversion attempt. Besides the recommended follow-up by the local cardiologist, starting from 2021, surviving patients were asked to undergo assessment of left ventricular function and to complete a questionnaire addressing quality of life and predisposing factors for recurrent AF., Results: At a mean follow-up of 77 months, the rate of AF recurrence was 20.7% (n = 114). On multivariate analysis, impaired left ventricular ejection fraction (58 patients, 51%, p = 0.002), worsening of European Heart Rhythm Association (EHRA) symptom class (37 patients, 32%, p = 0.003) and cognitive decline or depression (23 patients, 20%, p = 0.023) during follow-up were found to be significantly associated with AF recurrence., Conclusions: Surgical AF ablation through a right minithoracotomy is safe, but a better outcome could be achieved using a hybrid approach. Patients after initial failed surgical AF ablation show worsening of cardiac function, clinical status and quality of life at follow-up compared to patients with successful AF ablation., (© 2021. The Author(s).)

Purpose: The purpose of the study was to evaluate the impact of left atrial posterior wall isolation (LAPWI) in addition to pulmonary vein isolation (PVI) vs PVI alone, performed using CB-A, in patients with PAF on a midterm follow-up of 12 months., Methods: Eighty consecutive patients indicated to index cryoballoon ablation (CB-A) for the treatment of drug resistant PAF were included. The first 50 (62.5%) underwent PVI only, and the following 30 patients (37.5%) underwent LAPWI + PVI., Results: Acute isolation was achieved in all PVs in both groups. The LAPW was successfully isolated in 29 out of 30 (97%) patients; in the remaining patient, adjunct radiofrequency ablation was required. The total procedure time and the mean fluoroscopy time were significantly shorter in patients who underwent PV isolation only (p < 0.001). The freedom from atrial fibrillation (AF) at 12 months was not significantly different between the 2 groups (LAPW + PVI = 90% vs PVI = 88%) (log-rank p = 0.816)., Conclusion: LAPW ablation in addition to PVI by the means of CB-A does not seem to reduce the risk of AF recurrence if compared with the standard PVI on a midterm follow-up of 12 months., (© 2020. Springer Science+Business Media, LLC, part of Springer Nature.)

Aims: Treatment guidelines for patients with atrial fibrillation (AF) suggest that patients should be managed with an antiarrhythmic drug (AAD) before undergoing catheter ablation (CA). This study evaluated whether pulmonary vein isolation employing cryoballoon CA is superior to AAD therapy for the prevention of atrial arrhythmia (AA) recurrence in rhythm control naive patients with paroxysmal AF (PAF)., Methods and Results: A total of 218 treatment naive patients with symptomatic PAF were randomized (1 : 1) to cryoballoon CA (Arctic Front Advance, Medtronic) or AAD (Class I or III) and followed for 12 months. The primary endpoint was ≥1 episode of recurrent AA (AF, atrial flutter, or atrial tachycardia) >30 s after a prespecified 90-day blanking period. Secondary endpoints included the rate of serious adverse events (SAEs) and recurrence of symptomatic palpitations (evaluated via patient diaries). Freedom from AA was achieved in 82.2% of subjects in the cryoballoon arm and 67.6% of subjects in the AAD arm (HR = 0.48, P = 0.01). There were no group differences in the time-to-first (HR = 0.76, P = 0.28) or overall incidence [incidence rate ratio (IRR)=0.79, P = 0.28] of SAEs. The incidence rate of symptomatic palpitations was lower in the cryoballoon (7.61 days/year) compared with the AAD arm (18.96 days/year; IRR = 0.40, P < 0.001)., Conclusions: Cryoballoon CA was superior to AAD therapy, significantly reducing AA recurrence in treatment naive patients with PAF. Additionally, cryoballoon CA was associated with lower symptom recurrence and a similar rate of SAEs compared with AAD therapy., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Purpose: A strategy based on the attainment of the specific parameter of - 40 °C within the first 60 s during cryoenergy applications in the setting of cryoballoon ablation (CB-A) without the use of an inner lumen mapping catheter (ILMC) (Achieve; Medtronic, USA) for the visualization of real-time recordings (RTR) has been previously described. The latter has proven to be very effective in guaranteeing freedom from atrial arrhythmias in patients affected by paroxysmal atrial fibrillation (PAF) at 1-year follow-up. The purpose of this retrospective observational study was to evaluate the clinical outcomes of this strategy in a multicenter experience on a long-term follow-up of 3 years., Methods: A total of 192 patients having undergone CB ablation for paroxysmal AF (PAF) starting from September 2015 to November 2016 that underwent a temperature-guided approach were included., Results: Mean procedural time was 68.77 ± 18.88. The mean number of freezes in the LSPV was 1.2 ± 0.4, 1.2 ± 0.4 in the LIPV, 1.1 ± 0.4 in the RSPV, and 1.2 ± 0.4 in the RIPV. Considering a blanking period of 3 months, freedom from AF off-AAD was achieved in 77.6% (149/192) at mean 34.5 ± 5.5 months and median 35.1 months (IQR, 32.3-37.0 months) follow-up after 1 procedure., Conclusions: A temperature-guided approach affords freedom from AF at a 3-year follow-up period in a large majority of patients affected by PAF having undergone a single CB-A procedure.

Background: The second-generation cryoballoon ablation (CB-A) has been proven to be safe and effective for pulmonary vein (PV) isolation. Little is known regarding the long-term outcome following CB-A ablation for paroxysmal atrial fibrillation (AF). The aim of the study was to evaluate the freedom from atrial arrhythmias during a 5-year follow-up period among consecutive patients having undergone PV isolation with the CB-A for paroxysmal AF METHODS AND RESULTS: A total of 208 consecutive patients having undergone index PV isolation using CB-A (138 males, 66%; mean age 59.0 ± 12.6 years) were included in our retrospective analysis. Follow-up was based on outpatient clinic visits including Holter electrocardiograms. Recurrence of atrial tachyarrhythmias was defined as a symptomatic or documented episode of > 30 s. At a median follow-up of 62 months, freedom from atrial arrhythmias after a single procedure was achieved in 57.2% of patients. Multivariate analysis demonstrated that obesity, left atrial diameter, and duration of symptoms before AF ablation were independent predictors of ATas recurrences. Major complications occurred in 2.4% of patients., Conclusions: The present study found a 5-year single-procedure success rate of 57.2% following CB-A ablation procedure. Obesity, higher LA dimensions, and longer duration of symptoms before ablation independently predicted the outcome.

Purpose: The purpose of this study was to evaluate the feasibility and safety of superior vena cava (SVC) isolation in addition to standard pulmonary vein isolation (PVI) using the second-generation cryoballoon (CB) in patients with paroxysmal atrial fibrillation., Methods: Thirty-seven consecutive patients that underwent CB ablation for paroxysmal atrial fibrillation (PAF) were prospectively enrolled in our study. After PVI the SVC was mapped for potentials. If the SVC exhibited electrical activity, isolation was achieved performing a single 180-s balloon application., Results: Regarding SVC isolation, 180-s freeze in the SVC could be completed in 32 (86.4%) patients, and 5 patients had at least 120 s of freezing application (13.5%). Real-time recording during SVC isolation was observed in 30 (81.0%) patients. The mean time to isolation was 36.9 ± 28.7 s and the temperature at isolation was - 33 (- 15 to - 40) °C. No cases developed persistent phrenic nerve palsy (PNP) or any other complication., Conclusions: Superior vena cava isolation proved to be safe and feasible with the second generation cryoballoon in a prospective series of patients affected by PAF.

Purpose: There is still sparse information regarding phrenic nerve palsy (PNP) during the cryoablation of both right-sided pulmonary vein (PV) and its anatomical predictors., Methods: Consecutive patients who had undergone pulmonary vein isolation (PVI) using CB-A and suffered PNP during both right-sided PVs were retrospectively included in our study. Two other groups were then selected among patients who experienced PNP during RIPV application only (group 2) and RSPV application only (group 3)., Results: The incidence of PNI during both right-sided PVs cryoapplications was 2.1%, (32 of 1542 patients). There were no significant clinical differences between the 3 groups. Time from basal temperature to -40 °C significantly differed among the groups for both RIPV (p = 0.0026) and RSPV applications (p = 0.0382). Patients with PNP occurring during RSPV applications had significantly larger RSPV cross-sectional area compared to patients without PNP (p = 0.0116), while in patients with PNP during RIPV application, the angle of RIPV ostium on the transverse plane was significantly smaller compared to patients without PNP (p = 0.0035). The carina width was significantly smaller in patients with PNP occurring during both right-sided PVs cryoapplications compared to patients in which PNP occurred only during one right-sided PV application (p < 0.0001); a cutoff value of 8.5 mm had a sensitivity of 87.3% and a specificity of 75.0%., Conclusion: PNP in both right-sided PVs applications is a complication that occurred in 2.1% of cases during CB-A. Pre-procedural evaluation of right PVs anatomy might be useful in evaluating the risk of PNP.

Aims: The aims of this study were to determine the rate and the predictors of early recurrences of atrial fibrillation (ERAF) after cryoballoon (CB) ablation and to evaluate whether ERAF correlate with the long-term outcome., Methods and Results: Three thousand, six hundred, and eighty-one consecutive patients (59.9 ± 10.5 years, female 26.5%, and 74.3% paroxysmal AF) were included in the analysis. Atrial fibrillation recurrence, lasting at least 30 s, was collected during and after the 3-month blanking period. Three-hundred and sixteen patients (8.6%) (Group A) had ERAF during the blanking period, and 3365 patients (Group B) had no ERAF. Persistent AF and number of tested anti-arrhythmic drugs ≥2 resulted as significant predictors of ERAF. After a mean follow-up of 16.8 ± 16.4 months, 923/3681 (25%) patients had at least one AF recurrence. The observed freedom from AF recurrence, at 24-month follow-up from procedure, was 25.7% and 64.8% in Groups A and B, respectively (P < 0.001). ERAF, persistent AF, and number of tested anti-arrhythmic drugs ≥2 resulted as significant predictors of AF. In a propensity score matching, the logistic model showed that ERAF 1 month after ablation are the best predictor of long-term AF recurrence (P = 0.042)., Conclusion: In patients undergoing CB ablation for AF, ERAF are rare and are a strong predictor of AF recurrence in the follow-up, above all when occur >30 days after the ablation., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)

Purpose: The purpose of this study was to analyze the efficacy and complication rates of a one-stage left unilateral thoracoscopic hybrid procedure in a series of patients with persistent and long-standing persistent atrial fibrillation (AF) in a 2-year follow-up., Methods: Fifty-one consecutive patients (34 males, 65.7 ± 8 years) having undergone hybrid isolation of pulmonary veins (PVs) and posterior wall of left atrium (LA) by means of left unilateral hybrid thoracoscopic ablation for symptomatic persistent (n = 22, 43%) and long-standing persistent atrial fibrillation (AF) (n = 29, 57%) were analyzed., Results: At a mean follow-up of 24.9 ± 11.8 months (median 24), the success rate without antiarrhythmic therapy was achieved in 68.6% of patients. Procedure-related major complications were observed in 2 patients (4%) including diaphragmatic perforation and late pericardial tamponade requiring mini left-sided thoracotomy and pericardial drainage, respectively. The success rate did not significantly differ between persistent and long-standing persistent AF (respectively, 68.2 and 69%; P = 0.89). Patients with AF relapse during the blanking period were 3.8 times more likely to have AF recurrence after 3 months from the ablation procedure., Conclusion: The hybrid one-stage left unilateral thoracoscopic procedure exhibits encouraging results in the setting of both persistent and long-standing persistent AF after a 2-year follow-up, at a low rate of adverse events.

Aims: The main cause of atrial fibrillation recurrence after catheter ablation is pulmonary vein reconnection. The purpose of this retrospective study was to analyse the electophysiological findings in patients undergoing repeat procedures after an index cryoballoon ablation (CB-A) and presenting with permanency of pulmonary vein isolation (PVI) in all veins. In addition, we sought to compare the latter with a similar group of patients with reconnected veins at the redo procedure., Methods: A total of 132 patients (81 men, 60.7 ± 12.4 years) who underwent CB-A for paroxysmal atrial fibrillation (PAF) were enrolled. Indication for the redo procedure was symptomatic PAF in 83 (63%), persistent atrial fibrillation (PerAF) in 32 (24%) or persistent regular atrial tachycardia (RAT) in 17 (13%) patients., Results: Seventy-five (57%) patients presented a pulmonary vein reconnection (pulmonary vein group) during the redo procedure, whereas 57 (43%) had no pulmonary vein reconnection (non-pulmonary vein group). The non-pulmonary vein group exhibited significantly more non-pulmonary vein foci and atrial flutters than the pulmonary vein group after induction protocol (51 vs. 24%, P = 0.002 and 67 vs. 36%, P = 0.003, respectively). Twenty-two (29.3%) patients of the pulmonary vein group and 20 (35%) patients of the non-pulmonary vein group had atrial fibrillation/RAT recurrence after a mean follow-up of 12.5 ± 8 months. The survival analysis demonstrated no statistical significance in recurrence between both groups (log rank P = 0.358)., Conclusion: Atrial fibrillation/RAT recurrence in patients after CB-A with durable PVI is significantly associated with non-pulmonary vein foci and atrial flutters. No statistically different success rate regarding atrial fibrillation/RAT freedom was detected between the pulmonary vein and non-pulmonary vein groups after redoing RF-CA.

Background: The impact of pulmonary vein isolation (PVI) performed with cryoballoon (CB) on the intrinsic cardiac autonomic nervous system (ICANS) remains unclear., Objective: The purpose of this study was to evaluate the predictors and the clinical meaning of cardiac neuromodulation achieved by CB-ablation as assessed by sinus heart rate (HR) response after the procedure., Methods: Patients who underwent CB-ablation for drug-resistant atrial fibrillation (AF) from January 2014 to October 2018 were included. Twelve‑leads rest ECG was taken both before and after the procedure. After discharge, patients were scheduled for follow-up visits at 1, 3, 6, and 12 months and 24 h Holter recordings were obtained at each follow-up visit. All documented AF episodes of >30 s were considered as recurrence., Results: Four-hundred seventy-two patients (62.3% male, age 56.7 ± 13.6 years, 97.2% paroxysmal AF) were included. Mean HR before the procedure was 60.17 ± 10.4 bpm, while the morning after the procedure mean HR was 75.48 ± 12.0 bpm. Age at enrollment (R = -0.26; p < 0.001), baseline HR before the CB-A (R = -0.32; p < 0.001), nadir temperature in each right pulmonary vein (R = -0.11, p = 0.022; R = -0.16; p = 0.001) were significantly associated with the ∆HR. At 2-year follow-up, freedom from recurrences was 83.1% for the patients with HR increase ≥15 bpm after CB-A and 66.3% in patients with HR increase ˂15 bpm (p = 0.021)., Conclusion: Sinus HR increase is a frequent phenomenon after CB-A, that can be predicted by both clinical and procedural factors and that correlates with better outcome after cryo-PVI., Competing Interests: Declaration of competing interest Prof. de Asmundis, Prof Brugada, and Prof Chierchia have received consulting fees and speaker honoraria from Medtronic. G.B.C. and C.d.A. have received compensation for teach-ing and proctoring purposes from AF solutions Medtronic., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Introduction: Four generations of the cryoballoon (CB) catheter were retrospectively evaluated in a real-world examination of patients with atrial fibrillation (AF)., Methods and Results: Four hundred eighty patients (27% female and 60 ± 10 years) suffering from AF, underwent pulmonary vein (PV) ablation with one-of-four generations of the CB catheter. The total cohort was divided into four groups of patients: 120 with first-generation (CB-1); 120 with second-generation (CB-2); 120 with third-generation (CB-3); and 120 with fourth-generation (CB-4). Equal group sizes were achieved by examining the last 120 patients treated in each cohort, attempting to minimize the effect of a learning curve between the generations of CB catheter. Baseline clinical and patient characteristics were similar between the four cohorts, excepting age and the number of tested antiarrhythmic drugs. Procedure, fluoroscopy, and left atrial dwell times were significantly lower in the CB-4 cohort compared to previous generations of the CB catheters, while the acute procedural success rate was comparable across all catheter groups (>99%). Total acute procedural complications were low (2.5%), and acute complications were comparable within the CB-2, CB-3, and CB-4 groups (0.8% reported in each cohort). The rate of time-to-isolation (TTI) visualization increased with later generations of the CB catheters., Conclusions: The novel CB-4 achieved significantly faster procedural ablation times in comparison to the previous generations, while still maintaining a low rate of acute complications. Also, the rate of TTI visualization was observed to be higher with the CB-4 catheter. Further long-term evaluation is necessary, including an assessment of AF recurrence and PV reconnection(s)., (© 2019 Wiley Periodicals, Inc.)

Background: The creation of a posterior box isolation of the left atrium (LAPWI) in addition to pulmonary vein isolation (PVI) with the second-generation cryoballoon (CB-A) seems to offer promising clinical outcome in patients affected by persistent atrial fibrillation (PersAF)., Aim: This work aims to study the clinical outcome of an ablation strategy based on the creation of a LAPWI during repeat procedures for recurrent AF after an index CB-A procedure for PersAF., Methods and Results: A total of 33 patients having undergone a repeat procedure consisting in redo PVI plus LAPWI for recurrent PersAF with the CB-A after an index PVI ablation were retrospective included in our study. Electrical reconnection could be documented in 18 veins (13%). The LAPW was successfully isolated solely by CB-A ablation in 30 out of 33 (91%) patients; in the remaining 3 patients, isolation of the LAPW was completed by focal tip-irrigated RF ablation. The mean number of CB-A applications required for the superior portion of the LAPW and the inferior portion of the LAPW creation were 5.4 ± 0.9 and 4 ± 0.6, respectively. After a mean follow-up of 11.8 ± 3 months, 28 patients (85%) did not experience recurrence of any atrial arrhythmias during follow-up, without the need of further ablation or class I or III AADs., Conclusion: Left posterior wall isolation with the CB-A is feasible and safe during repeat ablation procedures for recurrent PersAF. In our study, the 12-month freedom from any arrhythmia was 85% following this ablation strategy.

Background: Pulmonary vein isolation (PVI) is an accepted strategy for paroxysmal atrial fibrillation (PAF) and persistent AF (PerAF) ablation. Limited data are available on outcomes of cryoballoon (CB) PVI in patients with structural heart disease (SHD). The purpose is to assess the clinical efficacy of a single CB-PVI procedure in patients with PAF or PerAF who also have SHD., Methods: From April 2012, 460 AF patients with concomitant SHD underwent CB-PVI and were followed prospectively in the framework of the 1STOP ClinicalService ® project. Data on procedural outcomes and long-term freedom from AF recurrence were evaluated. Out of 460 subjects, 282 patients (61%) had PAF and 178 (39%) PerAF., Results: SHD patients were predominantly male (80.9%), old (62.8±8.9 years), with preserved functional capacity (New York Heart Association class >1: 39.4%), high cardioembolic risk (CHA 2 DS 2 VASc score ≥2: 69.3%), and conserved left ventricular ejection fraction (56.5±8% LVEF). Both subjects with PAF and PerAF had similar baseline clinical characteristics except for left atrial diameter (43.8±7 vs. 45.7±7mm) and area (22.9±5.2 vs. 25.1±4.4cm 2 ), respectively. Procedure time and fluoroscopic time as well as the rate of procedural complications were not different between subjects with PAF and PerAF. After a mean follow-up of 12 months, antiarrhythmic drug therapy had dropped from 71.7% before ablation to 33.6% post-ablation (p<0.001) and the freedom from symptomatic AF recurrence was 78% for PAF and 77% for PerAF (p=0.793). Furthermore, atrial arrhythmia recurrence rate was not related to SHD., Conclusions: In a large multicenter, real-world cohort, CB-PVI was used to treat patients with PAF and PerAF who also had SHD. The arrhythmia recurrence after a single procedure was not related to either the degree of cardiac structural remodeling or the type of AF, and the rate of AF recurrence was lower than previously reported in patients with SHD in other cohort series using focal radiofrequency catheter ablation., Clinical Trial Registration: clinicaltrials.gov (NCT01007474)., (Copyright © 2019 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.)

Background: Abnormal delayed electrograms (EGMs) from the anterior wall of the right ventricular outflow tract (RVOT) epicardium have become the ablation target in Brugada syndrome (BrS)., Objective: The aim of this study was to analyze the safety, feasibility, and efficacy of a novel hybrid thoracoscopic approach to perform epicardial RVOT radiofrequency ablation in BrS., Methods: Thirty-six patients with BrS (26 men (72.2%); mean age 36.6±15.8 years; range 3-63 years) who underwent hybrid thoracoscopic epicardial ablation of RVOT from January 2016 to April 2018 were included in this study. Two expert electrophysiologists analyzed the EGMs during ajmaline challenge and guided the surgeon to perform ablation. Ajmaline challenge was repeated after 1 month to assess the absence of the BrS electrocardiographic pattern. Patients were followed by remote monitoring and outpatient visits every 6 months., Results: The elimination of all abnormal EGMs was achieved in 94.4% of patients. After a mean follow-up of 16 ± 8 months (range 6-30 months), freedom from ventricular arrhythmias was obtained in 7 (77.8%) patients in secondary prevention 9/36 (25%) and in 24 (100%) patients in primary prevention 24/36 (75%). Major complications were observed in 1 patient (2.8%), who experienced late cardiac tamponade., Conclusion: Hybrid thoracoscopic epicardial RVOT ablation in BrS is a safe and feasible approach, allowing direct visualization of ablation during radiofrequency delivery. Because of ventricular arrhythmia recurrences, implantable cardioverter-defibrillator implantation is still mandatory in patients treated in secondary prevention and with high risk., (Copyright © 2018 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Purpose: Cryoballoon (CB) technology in the context of anatomical pulmonary vein (PV) variants might hypothetically hamper successful PV isolation (PVI). Our aim was to assess the impact of a right middle PV (RMPV) in the setting of second-generation cryoballoon (CB advance-CB-A), on procedural parameters and on mid-term follow-up., Methods: Consecutive patients with AF presenting RMPV (RMPV+) at the pre-procedural computed tomography who underwent PVI by CB-A were enrolled. Comparison with propensity score-matched patients without RMPV (RMPV-) was performed. Acute procedural parameters and clinical follow-up were assessed., Results: A total of 240 patients (80 RMPV+) were included in the analysis. Twelve of 80 (15%) RMPV+ patients underwent a direct cryo-application in this variant and accomplished the isolation without phrenic nerve palsy, whereas in 25 of 80 (31%) RMPV+ patients, the RMPVs were not targeted directly nor indirectly (by co-occlusion during application at a major PV). At a median follow-up of 17.3 [interquartile range 11.3-26.5] months, there was no significant difference in AF-free survival between RMPV+ and RMPV- patients (78.8 vs 78.1%, P = 1.00), and the recurrence of atrial arrhythmias among patients with versus without an intentional or indirect cryo-application to the RMPV was not different (22 vs 20%, P = 1.00)., Conclusions: Mid-term outcome after CB-A ablation did not differ between RMPV+ and RMPV- patients. Within RMPV+ patients, outcome was similar between those with versus without a cryo-application (either direct or indirect) to the additional vein.

Background: Pulmonary vein isolation (PVI) by means of cryoballoon is increasingly being used for the treatment of atrial fibrillation (AF). This study assessed whether the left atrial volume index (LAVI) predicts AF recurrence following PVI by means of 2nd-generation cryoballoon (Cryoballoon Advance; CB-A) when comparing persistent AF (PeAF) and paroxysmal AF (PAF)., Methods and results: Patients with drug-resistant AF and undergoing preprocedural computed tomography (CT) and PVI with CB-A were included. LAV was estimated from 3D CT images. A total of 417 patients with AF were included (95 PeAF, 322 PAF patients). After a mean of 22.1±9.4 months follow-up, 45/95 (47%) PeAF patients and 254/322 (79%) PAF patients had no recurrence. LAVI was an independent predictor for AF recurrence in PeAF patients (hazard ratio 1.042 per 1 mL/m 2 ; 95% confidence interval 1.006-1.080, P=0.02), but not in PAF patients. In PeAF patients with LAVI ≤61 mL/m 2 , the freedom from recurrence was 78.5% vs. 22.2% in those with LAVI >61 mL/m 2 (hazard ratio 5.771, 95% confidence interval 2.434-13.682, P<0.001), and the mid-term success rate was comparable with PAF patients., Conclusions: LAVI predicted AF recurrence after PVI using CB-A in PeAF patients but not in PAF patients. If LAVI was ≤61 mL/m 2 , the mid-term efficacy among PeAF patients was equivalent to that for PAF patients.

Background: Real-time visualization of the electrical activity of the pulmonary veins (PV) is not always possible in the setting of atrial fibrillation (AF) cryoballoon ablation. We investigated the relation between the effective documentation of time to PV isolation and the clinical outcome in a cohort of patients with paroxysmal AF who underwent cryoballoon ablation., Methods: One thousand forty two consecutive patients were enrolled. An inner lumen mapping catheter was typically used to visualize real-time electrical activity inside the PVs., Results: Time to PV isolation was documented in all targeted PVs in 391 patients (Group 1), in 651 patients it was not possible to record PV potentials and assess time to PV isolation in at least one PV (Group 2). In Group 1 a longer procedure duration and ablation time were observed, while a longer fluoroscopy time was observed in Group 2. After a mean follow-up of 14 ± 11 months, 209/1042 (20%) patients had an atrial arrhythmia recurrence (20.2% in Group 1, 19.9% in Group 2, p = 0.25). Complications occurred in 54/1042 (5.2%) patients without any difference among the two study groups., Conclusion: In our retrospective analysis, in about two thirds of patients undergoing cryoballoon ablation it was not possible to acutely assess time to PV isolation in all PVs. However, one-year freedom from clinically symptomatic atrial tachyarrhythmia was similar to that of patients in which time to PV isolation was documented in all targeted veins., Clinical Trial Registration: clinicaltrials.gov (NCT01007474)., (Copyright © 2018. Published by Elsevier B.V.)

Background: The aim of this research was to evaluate whether the procedural data, the incidence of complications, and the long-term freedom from atrial fibrillation (AF) recurrences are influenced by center experience in a paroxysmal AF (PAF) population performing a first-time pulmonary vein isolation (PVI) by cryoballoon ablation (CBA)., Methods: A total of 860 patients underwent PVI by CBA. Center experience groups were predefined according to the quartiles of the distribution regarding the amount of performed procedures: 3.1%, 10.6%, 22.7% and 63.6% of patients were respectively followed in each group from 1st (less experienced) to 4th (more experienced) quartile of experience., Results: In the entire population, median procedure and fluoroscopy time were 105 and 25 min, respectively. The median procedure time significantly decreased from 130 to 90 min (P < 0.001) as the center's experience increased. In 47 (5.5%) patients, a peri-procedural complication occurred. As the experience of centers increased, the acute intraprocedural PVI success rate increased (from 94.3% to 98.9%, P = 0.007), whereas there was a tendency towards a decreased incidence of peri-procedure complications (from 7.4% to 4.6%, P = 0.998). The mean 1-year freedom from AF recurrence probability was 78.3%, and the 18-month mean was 68.9% with no difference among the groups with different levels of experience., Conclusion: CBA is a safe and effective treatment for patients with PAF. Peri-procedural complications and procedural times were low in all the analyzed sub-groups, showing a decreasing trend in function of center expertise. The long-term freedom from AF recurrence was not influenced by the level of experience. (clinicaltrials.gov: NCT01007474)., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Aims: Leadless pacemaker (LDP) allows implantation using a femoral approach. This access could be utilized for conventional atrioventricular nodal ablation (AVNA). It could facilitate unifying the two procedural components. Data regarding its feasibility and long-term outcomes remain lacking. We aim to evaluate the feasibility and long-term outcomes of sequential LDP and AVNA., Methods: Prospective, observational multicenter study including consecutive patients with indication for single-chamber pacemaker placement. In those with additional indication for AVNA, ablation was performed immediately after the LPD through the same sheath., Results: A total of 137 patients were included. Mean age was 77.9 ± 10.5 years; 74 (54%) were men. Immediately following LDP implantation, 27 patients (19.7%) underwent concurrent AVNA. There were six (5.5%) complications in patients referred for LDP procedures and three (11%) in those who underwent a combined approach. None of these complications were solely attributable to the added AVNA component. No mechanical dislodgement, electrical damage to any device, or electromagnetic interference ever took place. During a mean follow-up period of 123 ± 48 days, three patients (3.6%) died of noncardiovascular causes. The remaining population stayed alive without significant arrhythmias. There were no relevant differences with regard to sensing and pacing thresholds between patients in the two groups., Conclusions: AVNA can safely be performed immediately following LDP. A combined approach obviates the need for additional vascular access and optimizes feasibility and comfort for patients and healthcare providers. It offers an acceptable safety and efficacy profile, both acutely and upon intermediate-term follow-up., (© 2018 Wiley Periodicals, Inc.)

Purpose: The purpose of the present study was to assess the long-term success rate of a single 3-min freeze per vein ablation strategy in the setting of pulmonary vein isolation (PVI) by means of second-generation cryoballoon (CB-A; Arctic Front Advance, Medtronic, Minneapolis, MN, USA) in a large cohort of patients., Methods: Three hundred and one patients with drug resistant atrial fibrillation (AF) having undergone PVI by means of CB-A using a single 3-min freeze per vein ablation strategy were included in the analysis., Results: Paroxysmal AF (PAF) was documented in 70.8% of the patients, while 29.2% presented with persistent AF (PersAF). The mean number of CB applications was 1.09 ± 0.3 in the left superior pulmonary vein (LSPV), 1.04 ± 0.2 in the left inferior pulmonary vein (LIPV), 1.12 ± 0.3 in the right superior pulmonary vein (RSPV), and 1.12 ± 0.3 in the right inferior pulmonary vein (RIPV). All PVs were successfully isolated with a 28-mm CB-A only. After a mean follow-up of 38.1 ± 7.5 months, 207 (68.8%) patients were free of atrial tachyarrhythmia (ATa) recurrences following a single procedure. Specifically, 72.8% of patients presenting with PAF and 59.1% of individuals with PersAF did not experience a recurrence., Conclusions: A single 3-min freeze per vein strategy is effective in treating AF on a long term follow-up of 38 months. Specifically, it can afford freedom from ATa recurrences in 72.8% of patients affected by PAF and 59.1% of patients initially presenting with PersAF after a single CB-A procedure.

Aims: The predictive value of induction studies after catheter ablation for atrial fibrillation (AF) is still debatable. To date, these studies have not been implemented in patients after cryoballoon (CB) ablation. Our aim was to analyse the clinical value of AF induction in patients treated by second generation CB for paroxysmal AF., Methods and Results: Seventy patients underwent at first an isoproterenol challenge after pulmonary vein (PV) isolation to assess AF induction and early PV reconnections (EPVR). Patients without EPVR were evaluated for premature atrial contraction (PAC) induction; atrial ectopy was considered frequent (PAC+) if >1/10 cycles or >6/min. After restitution of baseline heart rate, rapid atrial pacing (RAP) was performed on all patients. AF induction by isoproterenol occurred only in 3/70 (4%) patients of whom 2/3 (66%) patients with an EPVR of a triggering vein. In the 62 patients without EPVR, PAC+ occurred in 17 patients (27%). RAP could induce AF in 23/70 (33%) patients. At a mean follow-up of 13.5 months, there were 11/70 (16%) AF recurrences. There was no significant difference in the AF recurrence rate between RAP inducible vs. non-inducible patients (log-rank P = 0.33). A 41% recurrence rate (7/17 patients) was seen in the PAC+ group with significantly different AF-free survival for PAC+ vs. PAC- patients (log rank P < 0.0001). PAC+ was the only independent determinant to predict AF recurrence after multivariate analysis., Conclusion: PAC occurrence in response to isoproterenol could predict AF recurrence after PV isolation by CB, while RAP showed no prognostic implication.

Purpose: Acute pericarditis is a minor complication following atrial fibrillation (AF) ablation procedures. The aim of the study was to evaluate the incidence and clinical aspects of pericarditis following cryoballoon (CB) ablation of AF investigating a possible association with procedural characteristics and a possible relationship with post-ablation recurrences., Methods: Four hundred fifty consecutive patients (male 73%, age 59.9 ± 11.2 years) with drug-resistant paroxysmal AF who underwent CB ablation as index procedure were enrolled. Exclusion criteria were any contraindication for the procedure including the presence of intracavitary thrombus and uncontrolled heart failure and contraindications to general anesthesia., Results: Acute pericarditis following CB ablation occurred in 18 patients (4%) of our study population. Pericardial effusion occurred in 14 patients (78%) and was mild/moderate. The total number of cryoapplications and the total freeze duration were significantly higher in patients with pericarditis compared with those without (respectively, p = 0.0006 and p = 0.01). Specifically, the number of applications and freeze duration in right inferior pulmonary vein were found significantly higher in patients with pericarditis (p = 0.007). The recurrence rate did not significantly differ between the two study groups (respectively, 16.7 vs 18.1%; p = 0.9)., Conclusions: The incidence of acute pericarditis following CB ablation in our study population accounted for 4% and was associated with both total freezing time and number of cryoapplications. The clinical course was favorable in all these patients and the occurrence of acute pericarditis did not affect the outcome during the follow-up period.

Aims: The therapeutical management of atrial fibrillation (AF) in the setting of Brugada syndrome (BS) might be challenging as many antiarrhythmic drugs (AADs) with sodium channel blocking properties might lead to to the development of ventricular arrhythmias. This study sought to evaluate the clinical outcome in a consecutive series of patients with BS having undergone pulmonary vein (PV) isolation by means of radiofrequency (RF) or cryoballoon (CB) ablation and the efficacy of catheter ablation for preventing inappropriate interventions delivered by implantable cardioverter defibrillators (ICD) on a 3-year follow up., Methods and Results: Twenty-three consecutive patients with BS (13 males; mean age was 47 ± 18 years) having undergone PV isolation for drug-resistant paroxysmal AF were enrolled. Eleven patients (48%) had an ICD implanted of whom four had inappropriate shocks secondary to rapid AF. Over a mean follow-up period of 35.0 ± 25.4 months (median 36 months) the freedom from AF recurrence after the index PV isolation procedure was 74% without AADs. Patients with inappropriate ICD interventions for AF did not present futher ICD shocks after AF ablation. No major complications occurred., Conclusion: Catheter ablation is a valid therapeutic choice for patients with BS and paroxysmal AF considering the high success rates, the limitations of the AADs and the safety of the procedure, and it should be taken into consideration especially in those patients presenting inappropriate ICD shocks due to rapid AF., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.)

Background: Second generation cryoballoon (CB-A) ablation is highly effective in achieving pulmonary vein (PV) isolation and freedom from atrial fibrillation (AF). However, the ideal freezing strategy is still under debate. Our objective was to investigate the efficacy and outcome between different freezing strategies used with the CB-A in a multicenter, matched population., Methods: From a total cohort of 1018 patients having undergone CB-A ablation for drug-refractory AF, 673 patients with follow-up ≥6months were included and stratified according to the applied freezing strategy: bonus freeze (BF) versus single freeze (SF). Final population of 256 BF patients was compared with 256 propensity-score matched SF patients., Results: BF strategy consisted of 3 different protocols: 3cycles of 180s; 2cycles of 240s; and cycles of 240s followed by 180s in 99/256 (39%); 42/256 (16%); and 115/256 (45%) patients, respectively. SF approach included cycles of 240s in 23/256 (9%), and 180s in 233/256 (91%) patients. Electrical isolation could be achieved in all PVs by both protocols, with shorter procedure and fluoroscopy times in the SF group (mean 106 vs 65min, and 18 vs 14min, respectively, P<0.001). Phrenic nerve palsy persisted after discharge in a total of 11 patients (2.1%): 4 (1.6%) in the BF group vs 7 (2.7%) in the SF group, P=0.5. AF-free survival was similar between the 2 groups during follow-up (mean 18±10months) (log rank, P=0.6)., Conclusions: CB-A ablation showed equal efficacy and outcome between SF and BF strategy., (Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.)

Aims: Pulmonary vein isolation (PVI) has been demonstrated more effective in young patients, in which the substrate for atrial fibrillation (AF) is probably more confined to pulmonary vein potentials. The present study sought to focus on the midterm outcomes in patients under 40 years having undergone PVI with the Cryoballoon Advance because of drug resistant AF., Methods and Results: Between June 2012 and December 2015, 57 patients having undergone Cryoballoon ablation (CB-A) below 40 years of age for AF in our centre were retrospectively analysed and considered for our analysis. All patients underwent this procedure with the 28 mm Cryoballon Advance. All 227 veins were successfully isolated without the need for additional focal tip ablation. Median follow-up was 18 ±10 months. The freedom from AF after a blanking period of 3 months was 88% in our cohort of patients younger than 40 years old. The most frequent periprocedural complication was related to the groin puncture and occurred in 2 patients. After a single procedure, the only univariate predictor of clinical recurrence was the diagnosis of hypertrophic cardiomyopathy., Conclusion: Young patients affected by AF can be effectively and safely treated with CB-A that grants freedom from AF in 88% of the patients at 18 months follow-up following a 3-month blanking period. All veins could be isolated with the large 28 mm Cryoballoon Advance only., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.)

Aims: In this double centre, retrospective study, we aimed to analyse the 1-year efficacy and safety of cryoballoon ablation (CB-A) in patients older than 75 years compared with those younger than 75-years old., Methods and Results: Fifty-three consecutive patients aged 75 years or older with drug-resistant paroxysmal AF (PAF) who underwent pulmonary vein isolation (PVI) by the means of second generation CB-A, were compared with 106 patients aged <75 years. The mean age in the study group (>75 years) was 78.19 ± 2.7 years and 58.97 ± 8.5 in the control group. At 1-year follow-up the global success rate was 83.6% and did not significantly differ between older (10/53) and younger patients (16/106) (81.1 vs. 84.9%, P = 0.54). Transient phrenic nerve palsy was the most common complication which occurred in eight patients in the younger group and in three in the older group (7.5 vs. 5.7%, respectively, P = 0.66)., Conclusions: The results of our study showed that CB-A for the treatment of PAF is a feasible and safe procedure in elderly patients, with similar success and complications rates when compared with a younger population., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.)

Purpose: Recent data suggests that high burden of premature atrial complexes after pulmonary vein isolation predicts recurrences of atrial arrhythmias. The present study sought to assess the role of premature atrial complexes burden in predicting atrial arrhythmias recurrences in patients with atrial fibrillation (AF) who have undergone second-generation cryoballoon ablation (CB-Adv)., Methods: Consecutive patients with drug-resistant paroxysmal atrial fibrillation who underwent pulmonary vein isolation using CB-Adv technology as the index procedure were retrospectively included. Twenty-four-hour Holter recordings were performed for every patient. Based on previously published data, a burden of more than 76 premature atrial complexes per day was considered as being high., Results: One hundred and seven patients were included in the analysis. The recurrence rate among the group of patients with more than 76 premature atrial complexes per day was significantly higher compared with the group with a lower burden of premature atrial complexes (47.5 vs 11.9%, respectively; p < 0.001). In the multivariate analysis, the documentation of more than 76 premature atrial complexes per day registered at 1 month and at the end of the blanking period, predicted late recurrence of atrial arrhythmias., Conclusions: Frequent premature atrial complexes in the early stages after CB-Adv ablation strongly predict late recurrences of atrial arrhythmias.

Background: A left common pulmonary vein (LCPV) accounts for the most frequent PV variation. Use of the cryoballoon (CB) for isolating these veins is still debatable. To date, no data are available regarding the feasibility, acute PV isolation, and clinical outcome of the second-generation CB (CB-A) in this setting., Objective: The purpose of this study was to investigate the performance of the CB-A in patients with LCPVs., Methods: In a total cohort of 433 patients having undergone CB-A ablation for drug-refractory atrial fibrillation together with preprocedural computed tomographic scanning, 146 patients presented an LCPV. Measurement of ostial area and trunk distance was performed, together with analysis of procedural and fluoroscopic data in order to determine the ablation strategy. The latter 146 LCPV+ patients were compared for outcome with a cohort of 146 propensity-score matched LCPV- patients., Results: Electrical isolation could be achieved in all left-sided veins. A long left common trunk (>15 mm) was found in 25% (37/146) of the LCPV+ patients. LCPVs treated with a single-shot freeze strategy presented a longer trunk (22 ± 5 mm vs 9 ± 4 mm, P <.001) and smaller ostial area (305 ± 109 mm 2 vs 400 ± 108 mm 2 , P <.001) compared to LCPV patients in whom a segmental (superior and inferior) freeze was delivered. Survival free from atrial fibrillation was similar between LCPV+ and LCPV- patients during mean follow-up of 19 ± 10 months (log rank P = .33)., Conclusion: CB-A ablation in LCPV+ patients is effective and showed no difference in clinical outcome compared to LCPV- patients., (Copyright © 2017 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Purpose: Pulmonary vein isolation is now widely accepted for the treatment of symptomatic atrial fibrillation refractory to antiarrhythmic drugs. However, multiple procedures are often required to significantly reduce atrial fibrillation (AF) recurrence. In the present study, we analyzed the acute results and the midterm clinical outcome of a second-generation cryoballoon ablation (CB-A) performed during repeat procedures for recurrence of AF after an initial procedure performed with conventional radiofrequency (RF)., Methods: Consecutive patients with paroxysmal and persistent AF who underwent pulmonary vein isolation by CB-A from June 2012 in our hospital as a redo procedure after a previous pulmonary vein isolation with RF were retrospectively included in this analysis., Results: Forty-seven patients having undergone CB-A as a redo procedure were considered for our analysis. Pulmonary vein potentials were documented in 83 pulmonary veins (PV) that were all successfully re-isolated using the CB-A. Transient phrenic nerve palsy was the only complication occurring in our study cohort. After a mean follow-up of 15 ± 8 months, 76.6% of patients were free from recurrence of atrial fibrillation. If taking into consideration a 3-month blanking period, 83% of patients were free from recurrence. The success rate in patients affected by paroxysmal AF was 87% at final follow-up following the blanking period., Conclusions: The second-generation CB is effective in treating recurrence of AF after a previous ablation performed with conventional RF. Considering a 3-month blanking period, 83% of the patients were free from any atrial tachycardia recurrence during a 15-month follow-up. This approach proved particularly successful in patients affected by paroxysmal AF.

Catheter ablation is considered the first-line treatment for drug-refractory atrial fibrillation (AF). Minimally invasive epicardial pulmonary veins isolation may provide durable freedom from recurrent arrhythmia. However, evidence come from small studies. Aim of this study is to assess early- and mid-term performance of surgical bipolar ablation of AF through right minithoracotomy in a large cohort of patients. From September 2012 till September 2015, 126 consecutive patients with drug-refractory isolated AF, equally suitable for both surgical or catheter ablation, underwent bipolar minimally invasive surgical isolation of the pulmonary veins through right 3- to 4-cm minithoracotomy at our institution, and they were followed up for a median of 23.5 months (interquartile range = 20). There was a relatively low rate of postoperative complication with no perioperative death. One patient died at follow-up. The shape of the time-varying probability of AF was calculated, with 3 peaks approximately 6, 12, and 24 months after procedures. Three patients were lost at last follow-up; thus, it was 97.6% completed. Overall freedom from recurrent arrhythmia was 78.8%. However, freedom from antiarrhythmic drugs was very low because of gap in medication management. Quantitative but not qualitative measure of health outcome significantly improved at follow-up (P < 0.001). Bipolar radiofrequency ablation via right minithoracotomy was a safe procedure with acceptable early outcomes; however, mid-term results should be interpreted in a context of a very low freedom from antiarrhythmic drugs., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: The second-generation cryoballoon (cryoballoon Advance; CB-A) offers excellent outcomes on the mid-term follow-up. To the best of our knowledge, little is known regarding the long-term outcome after CB-A ablation for paroxysmal atrial fibrillation (AF)., Objective: The aim of the study was to evaluate the freedom from recurrence of AF during a 3-year follow-up period, among consecutive patients having undergone pulmonary vein isolation (PVI) with the CB-A for paroxysmal AF (PAF)., Methods: Consecutive patients with drug-resistant PAF who underwent PVI using CB-A as an index procedure formed the study group. Patients were evaluated with holter ECG recordings at 1, 3, 6 and 12 months and subsequent follow-up was biannual or based on the clinical status and at the physician discretion., Results: Seventy-six consecutive patients were enrolled. Of these patients, 6 were excluded because of lack of long-term follow-up. A total of 70 patients [44 male (63%); mean age 57.9 ± 14.5 years] with a mean follow-up of 38.0 ± 7.4 months were finally included. In total, 278 PVs were depicted on the pre-procedural CT scan. All PVs (100%) could be isolated with the CB-A only. The freedom from AF without antiarrhythmic drug (AADs) after a single procedure was 71.5% of patients at a mean 38.0 ± 7.4 months follow-up. If including repeat procedures, 80% of the patients were free from AF recurrence after 1.11 ± 0.32 procedures without AADs., Conclusion: The second-generation cryoballoon offers long-term freedom from PAF in 71.5% of treated patients with a single procedure without AADs on a 3-year follow-up period.