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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.)

Aim: The aim of the study was to investigate the role of anatomical characteristics of the pulmonary veins (PVs) determining cooling kinetics during second-generation cryoballoon ablation (CbA)., Methods and Results: we enrolled all consecutive patients who underwent CbA for symptomatic atrial fibrillation in our center from January 2019 to March 2019. All patients had complete computed tomography scans of the heart before the ablation. Anatomical characteristics were tested for prediction of a nadir temperature (NT) ≤ -48°C. Significant differences were noted among PV max diameter (20.8 ± 2.8 vs 18.5 ± 2.5 mm; P < .001); PV minimum diameter (15.2 ± 3.0 vs 13.0 ± 3.1 mm; P < .001); PV area (268.1 ± 71.9 vs 206.2 ± 58.7 mm 2 ; P < .001); PV ovality (1.4 ± 0.3 vs 1.5 ± 0.3; P = .005); and PV trunk length (27.4 ± 7.4 vs 21.3 ± 6.5 mm; P < .001). A scoring system was created by assigning one point each ranging from 0 (best anatomical combination) to 5. In the group with a score of 0, 94.0% of the CbA could reach a NT ≤ -48°C whereas with a score of 5, only 29.0% (P < .001). Left superior pulmonary vein with short trunk length and acute angle of PV branch was significantly associated with warmer NT (11.8% satisfactory CbA; P = .003). Regarding right inferior pulmonary vein, trunk length (P = .004), maximum diameter (P = .044), and transverse angle (P = .008) were independently associated with good NT., Conclusion: Anatomical PV features are associated with cooling kinetics and an anatomical score could predict lower NT during second-generation CbA. Specific characteristics were identified for inferior PV. Although heart imaging is not mandatory prior CbA, it can be a useful tool to predict cooling kinetics., (© 2020 Wiley Periodicals, Inc.)

Background: Unrecognized incomplete pulmonary vein isolation (PVI), as opposed to post-PVI pulmonary vein reconnection, may be responsible for clinical recurrences of atrial fibrillation (AF). To date, no data are available on the use of high-resolution mapping (HRM) during cryoballoon (CB) ablation for AF as the index procedure. The aims of this study were: - to assess the value of using a HRM system during CB ablation procedures in terms of ability in acutely detecting incomplete CB lesions; - to compare the 8-pole circular mapping catheter (CMC, Achieve) and the 64-pole mini-basket catheter (Orion) with respect to pulmonary vein (PV) signals detection at baseline and after CB ablation; - to characterize the extension of the lesion produced by CB ablation by means of high-density voltage mapping., Methods: Consecutive patients with drug-resistant paroxysmal or early-persistent AF undergoing CB ablation as the index procedure, assisted by a HRM system, were retrospectively included in this study., Results: A total of 33 patients (25 males; mean age: 59 ± 18 years, 28 paroxysmal AF) were included. At baseline, CMC catheter revealed PV activity in 102 PVs (77%), while the Orion documented PV signals in all veins (100%). Failure of complete CB-PVI was more frequently revealed by atrial re-mapping with the Orion as compared to the Achieve catheter (24% vs 0%, p < 0.05). A repeat ablation was performed in 8 patients (24%). In 9% of cases, the Orion catheter detected far-field signals originating from the right atrium. Quantitative assessment of the created lesion revealed a significant reduction of the left atrial area having voltage >0.5 mV. A total of 29 patients (88%) remained free of symptomatic AF during a mean follow-up of 13.2 ± 3.7 months., Conclusion: Atrial re-mapping after CB ablation by means of a HRM system improves the detection of areas of incomplete ablation, characterizes the extension of the cryo-ablated tissue and can identify abolishment of potential non-PVI related sources of AF., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Data evaluating the impact of the periprocedural administration of novel oral anticoagulants (NOACs) on complications in the setting of pulmonary vein (PV) isolation using cryoballoon (CB) is limited. In the present study, our aim was to analyze procedural characteristics and incidence of complications in those patients who underwent CB ablation for atrial fibrillation and the impact of NOACs on adverse events compared with vitamin K antagonists (VKAs). Consecutive patients with drug resistant atrial fibrillation who underwent PV isolation by CB as index procedure were retrospectively included in our analysis. In group I, 290 of 454 patients (63.9%) received VKAs (warfarin: n = 222 and acenocoumarol: n = 68), and in group II, 164 of 454 patients (36.1%) were treated with NOACs (rivaroxaban: n = 71; dabigatran: n = 60; and apixaban: n = 33). Age was significantly higher in the group II (62.8 ± 9.7 vs 58.6 ± 11.3; p <0.001). During the study period, 454 consecutive patients (male 71%, age 60.1 ± 10.9 years) were enrolled. Major complications occurred in 9 patients (2.0%): peripheral vascular complications were observed in 6 patients (1.3% per procedure), persistent phrenic nerve palsy occurred in 2 (0.4%), and transient ischemic attacks in 1 (0.2%). In both groups, the incidence of major complications was similar (group I [VKAs]: 7 patients [2.4%] vs group II [NOACs]: 2 patients [1.2%]; p = 0.5). In conclusion, CB ablation is a safe procedure for PV isolation and is associated with low complication rates. The incidence of adverse events in PV isolation using the second-generation CB with the periprocedural administration of NOACs is not significantly different than VKA treatment., (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.

Introduction: Second-generation cryoballoon (CB-Adv) ablation is highly effective in achieving pulmonary vein isolation (PVI) with promising mid-term clinical outcome. However, the ideal freezing strategy is still under debate. The aim of this study was to assess the efficacy of a single 3-minute approach compared to the conventional 4-minute plus bonus application using CB-Adv., Methods and Results: One hundred and sixty patients (67% male; mean age 58.0 ± 13.3 years) underwent PVI using CB-Adv for paroxysmal atrial fibrillation (PAF). Among 160 patients, 80 received a single 3-minute approach (3-mns group), while the remaining 80 conventional 4-minute plus bonus-freeze (4-mns group). Mean procedure and fluoroscopy times were 90.6 ± 15.8 and 18.3 ± 6.9 in the 4-mns group, 75.2 ± 17.1 and 13.5 ± 8.7 in the 3-mns group (P < 0.001, respectively). First-freeze isolation rate was 91.6% in the 4- versus 90.6% in the 3-mns group (P = 0.78). Persistent phrenic nerve palsy (PNP) occurred in 6/80 (3.5%) in the 4-mns group and 4/80 in the 3-mns group (P = 0.75). The overall freedom from ATas 2 years after the procedure was 78.1% (125/160): 77.5% (62/80 patients) in the 3-mns and 78.8% (63/80 patients) in the 4-mns group (P = 0.82). In multivariate analysis, time to PVI and nadir temperature independently predicted ATa recurrences (P < 0.001)., Conclusions: CB-Adv ablation for PAF is highly effective, resulting in 78% 2-year freedom from arrhythmic recurrences. A "single 3-minute strategy" showed equal efficacy as compared to the conventional 4-minute plus bonus freeze approach at 2-year follow-up, providing shorter procedure and fluoroscopy time. Nadir temperature and time to PVI were predictors of arrhythmic recurrences. "Bonus-freeze" strategy might be unnecessary., (© 2016 Wiley Periodicals, Inc.)

Aim: The second-generation cryoballoon (CB-Adv) is effective in achieving pulmonary vein isolation (PVI) with encouraging results. In this study, we assessed the single-procedure outcome on a 1-year follow-up period in a large sample of patients having undergone PVI for drug-resistant atrial fibrillation (AF) using the CB-Adv., Methods and Results: A total of 393 patients (122 female, 31%; mean age 57.7 ± 12.9 years) with drug-refractory AF undergoing PVI using the novel CB-Adv were enrolled. Follow-up was based on outpatient clinic visits including Holter electrocardiograms. Recurrence of atrial tachyarrhythmias (ATas) was defined as a symptomatic or documented episode >30 s. A total of 1572 pulmonary veins (PVs) were identified and successfully isolated with 1.2 ± 0.3 mean freezes. Mean procedure and fluoroscopy times were 87.1 ± 38.2 and 14.9 ± 6.1 min, respectively. At a mean follow-up of 12 months, freedom from ATas after a single procedure was achieved in 85.8% of patients with paroxysmal atrial fibrillation and in 61.3% of patients with persistent AF (persAF). Similar success rates were observed between bonus freeze and single freeze strategies, 82.5 and 81.8%, respectively (P = 0.9). Multivariate analysis demonstrated that persAF (P = 0.04) and relapses during blanking period (BP) (P < 0.0001) were independent predictors of ATas recurrences., Conclusion: Freedom from any ATa can be achieved in 81.9% of patients after a single CB-Adv procedure in a large cohort of patients. A bonus freeze does not influence the clinical outcome, and reducing the duration of the cryoapplication to 3 min offers excellent results. Persistent AF and arrhythmia recurrence during the BP are strong predictors of AF recurrence., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.)

Background: The aim of this study was to assess the overall incidence of complications in a large sample of consecutive patients having undergone pulmonary vein (PV) isolation, evaluating also the rate of complications in radiofrequency (RF) and cryoballoon (CB) ablation technologies., Methods and Results: From January 2008 to December 2014, 1352 consecutive PV isolation procedures were performed in our center; a total amount of 1233 AF ablation procedures fulfilling inclusion criteria was finally taken into consideration for our analysis. A total of 642 procedures were performed using RF ablation technology and 591 using CB system. Serious adverse events occurred in 36 procedures (2.9%): specifically, vascular complications in 14 (1.1%); cardiac tamponade in 13 (1.0%); a thromboembolic event in 4 (0.3%); and atrial-esophageal fistula, PV intramural hematoma, retroperitoneal hematoma, pleural hematoma and persisting phrenic nerve palsy all occurred in 1 patient individually (0.1%). No deaths related to the procedure occurred. The complication rate did not significantly differ in the RF and CB groups (respectively, 3.6% vs 2.2%; p=0.1). Complication rates considerably decreased over the study period from 4.67% in 2008 to 1.55% in 2014. Interestingly, each 1-point increase in the CHA2DS2-VASc score was found to increase by 51% the likelihood of a serious adverse event., Conclusions: The incidence of serious adverse events following AF ablation procedures was 2.9%. Vascular complications were the most frequent complication followed by tamponade and thromboembolic events. The rate of complications considerably decreased over time. CHA2DS2-VASc score was found to be associated with higher risk of complications., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Aim: The second-generation cryoballoon (CB-Adv) is effective in achieving pulmonary vein isolation (PVI) with encouraging results. In this study, we assessed the single-procedure outcome on a 1-year follow-up period in a large sample of patients having undergone PVI for drug-resistant atrial fibrillation (AF) using the CB-Adv.Methods and Results: A total of 393 patients (122 female, 31%; mean age 57.7 ± 12.9 years) with drug-refractory AF undergoing PVI using the novel CB-Adv were enrolled. Follow-up was based on outpatient clinic visits including Holter electrocardiograms. Recurrence of atrial tachyarrhythmias (ATas) was defined as a symptomatic or documented episode >30 s. A total of 1572 pulmonary veins (PVs) were identified and successfully isolated with 1.2 ± 0.3 mean freezes. Mean procedure and fluoroscopy times were 87.1 ± 38.2 and 14.9 ± 6.1 min, respectively. At a mean follow-up of 12 months, freedom from ATas after a single procedure was achieved in 85.8% of patients with paroxysmal atrial fibrillation and in 61.3% of patients with persistent AF (persAF). Similar success rates were observed between bonus freeze and single freeze strategies, 82.5 and 81.8%, respectively (P = 0.9). Multivariate analysis demonstrated that persAF (P = 0.04) and relapses during blanking period (BP) (P < 0.0001) were independent predictors of ATas recurrences.Conclusion: Freedom from any ATa can be achieved in 81.9% of patients after a single CB-Adv procedure in a large cohort of patients. A bonus freeze does not influence the clinical outcome, and reducing the duration of the cryoapplication to 3 min offers excellent results. Persistent AF and arrhythmia recurrence during the BP are strong predictors of AF recurrence. [ABSTRACT FROM AUTHOR]

Background. The novel Polarx™ cryoablation system is currently being studied for atrial fibrillation (AF) ablation. To the best of our knowledge, no study comparing the novel cryoablation system with the standard Arctic Front™ cryoballoon is available in today's literature. This study aims to compare Polarx™ and Arctic Front™ cryoballoon in terms of safety and efficacy. Methods. From a total cohort of 202 patients who underwent pulmonary vein (PV) isolation for paroxysmal AF through cryoablation, a population of 30 patients who used Polarx™ were compared with 30 propensity-score matched patients who used Arctic Front™. Results. Pulmonary vein occlusion and electrical isolation were achieved in all (100%) veins with a mean number of 1.09 ± 0.3 occlusion per vein using Polarx™ and 1.19 ± 0.5 occlusion per vein using Arctic Front™ (p = 0.6). Shorter procedure and fluoroscopy time were observed with Polarx™ group (60.5 ± 14.23 vs 73.43 ± 13.26 mins, p = 0.001; 12.83 ± 6.03 vs 17.23 ± 7.17 mins, p = 0.01, respectively). Lower cumulative freeze duration per vein was also observed with Polarx™ (203.38 ± 72.03 vs 224.9 ± 79.35 mins, p = 0.02). There was no significant difference in isolation time between the two groups (34.47 ± 21.23 vs 34.18 ± 26.79 secs, p = 0.9). Conclusion. The novel Polarx™ cryoablation system showed similar efficacy in vein occlusion and isolation and safety profile when compared to Arctic Front™ cryoablation system. Procedure time, fluoroscopy time, and cumulative freeze duration were significantly lower with Polarx™ cryoablation system. [ABSTRACT FROM AUTHOR]