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Introduction: Cryoballoon ablation (CBA) aiming at pulmonary vein isolation (PVI) became a standardized atrial fibrillation (AF) ablation procedure. Life-threatening complications like cardiac tamponade exist. Intracardiac echocardiography (ICE) usage is associated with superior safety in radiofrequency ablation. It is unclear if ICE has an impact on safety of CBA., Methods: The FREEZE Cohort (NCT01360008) subanalysis included patients undergoing "PVI only" CBA. Patients with intraprocedural transesophageal echocardiography were excluded. Group A comprises conventional, group B ICE-guided CBA. Periprocedural results were compared., Results: From 2011 to 2016, a total of 4189 patients were enrolled, and 1906 (45.5%) were included in this subanalysis, split up in two groups (A: 1066 [55.9%], B: 840 [44.1%]). Group A was younger (60.6 ± 10.8 vs. 62.4 ± 10.5 years, p < .001), with smaller left atria (41 vs. 43 mm, p < .001), and less persistent AF (23.1 vs. 38.1%, p < .001). Procedure, left atrial, and fluoroscopy times were shorter in group A as compared to group B. Dose area product was significantly higher in group A (2911 vs. 2072 cGyxcm 2 , p < .001). In-hospital major adverse cerebrovascular and cardiac event rates including two deaths in group A were not different between groups (0.5% vs. 0.1%, p = .18). The rate of total procedural (10.4% vs. 5.1%, p < .001) and major complications (3.2% vs. 1.3%, p < .001) was significantly higher in group A. Cardiac tamponade occurred significantly more frequently in group A (8 [0.8%] vs. 1 [0.1%], p = .046). Independent predictors for major complications were female sex (odds ratio [OR] 2.03, p = .03) and non-ICE usage (OR 2.38, p = .02). No differences were observed for persistent phrenic nerve palsy, nor for groin complications., Conclusion: CBA was significantly safer and required less radiation if ICE was used, although the procedures were more complex. The risk of groin complications was not increased with ICE usage. Non-ICE usage was the only modifiable independent predictor of major complications., (© 2023 Wiley Periodicals LLC.)

Aims: Cryoballoon (CB)-based pulmonary vein isolation (PVI) is an effective treatment for atrial fibrillation (AF). The most frequent complication during CB-based PVI is right-sided phrenic nerve injury (PNI) which is leading to premature abortion of the freeze cycle. Here, we analysed reconnection rates after CB-based PVI and PNI in a large-scale population during repeat procedures., Methods and Results: In the YETI registry, a total of 17 356 patients underwent CB-based PVI in 33 centres, and 731 (4.2%) patients experienced PNI. A total of 111/731 (15.2%) patients received a repeat procedure for treatment of recurrent AF. In 94/111 (84.7%) patients data on repeat procedures were available. A total of 89/94 (94.7%) index pulmonary veins (PVs) have been isolated during the initial PVI. During repeat procedures, 22 (24.7%) of initially isolated index PVs showed reconnection. The use of a double stop technique did non influence the PV reconnection rate (P = 0.464). The time to PNI was 140.5 ± 45.1 s in patients with persistent PVI and 133.5 ± 53.8 s in patients with reconnection (P = 0.559). No differences were noted between the two populations in terms of CB temperature at the time of PNI (P = 0.362). The only parameter associated with isolation durability was CB temperature after 30 s of freezing. The PV reconnection did not influence the time to AF recurrence., Conclusion: In patients with cryoballon application abortion due to PNI, a high rate of persistent PVI rate was found at repeat procedures. Our data may help to identify the optimal dosing protocol in CB-based PVI procedures., Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT03645577?term=YETI&cntry=DE&draw=2&rank=1 ClinicalTrials.gov Identifier: NCT03645577., Competing Interests: Conflict of interest: C.H.H. received travel grants and research grants from Medtronic, Boston Scientific, Biosense Webster and Cardiofocus and is a proctor and lecturer of Medtronic, Boston Scientific, Cardiofocus and Biosense Webster. K.H.K. received travel grants and research grants from Biosense Webster, Stereotaxis, Prorhythm, Medtronic, Edwards, Cryocath, and is a consultant to St. Jude Medical, Biosense Webster, Prorhythm, and Stereotaxis. He received speaker's honoraria from Medtronic. R.R.T. received travel grants from St. Jude Medical, Biosense Webster, Daiichi Sankyo, SentreHeart and Speaker’s Bureau Honoraria from Biosense Webster, Biotronik, Boston scientific, Pfizer, Topera, Bristol-Myers Squibb, Bayer, Sanofi Aventis, and research grants by Cardiofocus, Boston Scientific and Lifetech. K.A. is a proctor and lecturer for Medtronic, Biosense Webster, and Abbott. A.M. received speaker's honoraria and travel grants from Medtronic, Biosense Webster and Cardiofocus. F.S. received honoraria for lectures from Medtronic, Philips EPD Solutions, and Bristol-Myers-Squibb, outside the submitted work; and educational support from Pfizer. S.C. received travel grants and speaker’s honoraria from Medtronic, Biosense Webster and Abbott, and is a proctor of Medtronic. E.J.P. received consultant fees from Medtronic, Biotronik, Abbott, Boston Scientific. E.W. is a consultant to Medtronic. All other authors have no relevant disclosures., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Pulmonary vein isolation (PVI) is recommended to treat paroxysmal and persistent atrial fibrillation (AF). This analysis aimed to assess the hospital efficiency of single-shot cryoballoon ablation (CBA) and point-by-point radiofrequency ablation (RFA)., Methods: The discrete event simulation used PVI procedure times from the FREEZE Cohort study to establish the electrophysiology (EP) lab occupancy time. 1000 EP lab days were simulated according to an illustrative German hospital, including 3 PVI cases per day using CBA at one site and RFA at the other., Results: The analysis included 1560 CBA patients and 1344 RFA patients from the FREEZE Cohort. Some baseline patients' characteristics were different between groups (age, AF type, and some concomitant diseases), without being statistically associated to ablation procedure time. Mean procedure time was 122.2 ± 39.4 min for CBA and 160.3 ± 53.5 min for RFA (p < 0.0001). RFA was associated with a more than five-fold increase of cumulative overtime compared to CBA over the simulated period (1285 h with RFA and 253 h with CBA). 70.7% of RFA lab days included overtime versus 25.7% for CBA. CBA was associated with more days with an additional hour at the end of the EP lab shift compared to RFA (47.8% vs 11.5% days with one hour left, respectively)., Conclusion: CBA is faster and more predictable than point-by-point RFA, and enables improvements in EP lab efficiency, including: fewer cumulative overtime hours, more days where overtime is avoided and more days with remaining time for the staff or for any EP lab usage. Clinical trial registration NCT01360008 (first registration 25/05/2011)., (© 2023. The Author(s).)

Background: Cryoballoon-based pulmonary vein isolation (PVI) has emerged as an effective treatment for atrial fibrillation. The most frequent complication during cryoballoon-based PVI is phrenic nerve injury (PNI). However, data on PNI are scarce., Methods: The YETI registry is a retrospective, multicenter, and multinational registry evaluating the incidence, characteristics, prognostic factors for PNI recovery and follow-up data of patients with PNI during cryoballoon-based PVI. Experienced electrophysiological centers were invited to participate. All patients with PNI during CB2 or third (CB3) and fourth-generation cryoballoon (CB4)-based PVI were eligible., Results: A total of 17 356 patients underwent cryoballoon-based PVI in 33 centers from 10 countries. A total of 731 (4.2%) patients experienced PNI. The mean time to PNI was 127.7±50.4 seconds, and the mean temperature at the time of PNI was -49±8°C. At the end of the procedure, PNI recovered in 394/731 patients (53.9%). Recovery of PNI at 12 months of follow-up was found in 97.0% of patients (682/703, with 28 patients lost to follow-up). A total of 16/703 (2.3%) reported symptomatic PNI. Only 0.06% of the overall population showed symptomatic and permanent PNI. Prognostic factors improving PNI recovery are immediate stop at PNI by double-stop technique and utilization of a bonus-freeze protocol. Age, cryoballoon temperature at PNI, and compound motor action potential amplitude loss >30% were identified as factors decreasing PNI recovery. Based on these parameters, a score was calculated. The YETI score has a numerical value that will directly represent the probability of a specific patient of recovering from PNI within 12 months., Conclusions: The incidence of PNI during cryoballoon-based PVI was 4.2%. Overall 97% of PNI recovered within 12 months. Symptomatic and permanent PNI is exceedingly rare in patients after cryoballoon-based PVI. The YETI score estimates the prognosis after iatrogenic cryoballoon-derived PNI. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03645577. Graphic Abstract: A graphic abstract is available for this article.

Although cryoballoon ablation of atrial fibrillation (AF) traditionally has been guided by pulmonary vein (PV) occlusion, there is evidence and growing interest in performing segmental, nonocclusive cryoballoon ablation to target not only large/common PVs but extra-PV structures such as the left atrial (LA) roof and posterior wall in conjunction with PV isolation. A number of studies have demonstrated improved clinical efficacy associated with nonocclusive cryoballoon ablation of the LA roof and posterior wall in addition to PV isolation, particularly in patients with persistent AF. Not only can the cryoballoon be used for targeting extra-PV structures through segmental, nonocclusive ablation, but the large size and durability of cryolesions coupled with the enhanced stability afforded through cryoadhesion render the cryoballoon an effective tool for such an approach. This article reviews the rationale and practical approach to segmental, nonocclusive cryoballoon ablation of large/common PV antra and the LA roof and posterior wall., (Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

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.)

Introduction: Stroke is one of the most feared complications during catheter ablation of atrial fibrillation (AF). While symptomatic thromboembolic events are rare, magnetic resonance imaging (MRI) may identify asymptomatic (ie, silent) cerebral lesions (SCLs) following pulmonary vein isolation (PVI) procedures., Methods and Results: The REDUCE-TE Pilot was a prospective multicenter, single-arm observational study investigating the incidence of SCL in patients with symptomatic paroxysmal AF undergoing PVI with a novel gold-tip, externally irrigated ablation catheter. After ablation, cerebral diffusion-weighted MRI and a postablation follow-up were performed at 1 to 3 days after the ablation procedure. A neurocognitive test was done before and after ablation. The primary study endpoint was the occurrence of one or more new SCLs. Secondary study endpoints included neurocognitive status, procedural success rate, and periprocedural complications including symptomatic thromboembolic events. A total of 104 patients were enrolled (69% male, mean age: 61.5 ± 9.7 years, mean CHA 2 DS 2 -VASc score: 1.7 ± 1.2). Postprocedural MRI examination was performed in 97 patients, and in nine of them (9.3%; 95% CI: 4.3-16.9%) a total of 11 SCLs were detected. Univariate analyses did not reveal any significant predictor for new SCLs. Nonsignificant trends were observed for low activated clotting time during ablation and for international normalized ratio value outside the range of 2 to 3 at ablation. There was no evidence of significant deterioration of neurocognitive function after PVI. In four patients, a pericardial tamponade was noted but all patients fully recovered during follow-up., Conclusions: Ablation of AF using a novel gold-tip, externally irrigated ablation catheter, resulted in SCLs in approximately one out of 10 patients without a measurable effect on neurocognitive function., (© 2019 The Authors. Journal of Cardiovascular Electrophysiology Published by Wiley Periodicals, Inc.)

Introduction: We analyzed the procedural experience and clinical outcome after pulmonary vein isolation (PVI) in patients with persistent atrial fibrillation (AF) gained over 5 years using the second-generation cryoballoon (CB-Adv)., Methods and Results: For this retrospective study, we enrolled 281 patients undergoing PVI at our institution between 2012 and 2016. The analyzed period was divided into 5 calendar years. Follow-up data, including Holter electrocardiography recordings, were collected during outpatient clinic visits. The impact of several variables on outcome was evaluated by means of univariate and multivariate analyses and Cox proportional hazards regression models. The median procedure and fluoroscopy times over the years were 90 (72 of 114) and 15 (11 of 21) minutes, respectively. A continuous decline in complication rates and fluoroscopy and procedure times was observed in each subsequent year. During mid-term follow-up (33 [25 of 48] months), 178 (63.3%) patients were AF, atrial flutter, or atrial tachycardia free. Multivariate analysis revealed left atrial area (hazard ratio [HR] = 1.05; P < 0.001), female sex (HR = 2.53; P < 0.001), and common ostium (HR = 1.93; P < 0.001) as significant predictors of outcome. The overall 1-year success rate was 76.2%. A gradual decrease in the 1-year success rate (from 90.5% in 2012 to 67.9% in 2016) was mainly related to a steady increase of left atrial area in the entire cohort with successive years of the study., Conclusions: PVI using CB-Adv in patients with persistent AF is accompanied by a learning curve and facilitates a satisfactory outcome, followed by the proper selection of patients., (© 2018 Wiley Periodicals, Inc.)

Aims: Predictors of atrial arrhythmia recurrence have not been described in a long-term follow-up study of patients undergoing pulmonary vein isolation (PVI) using the cryoballoon technique. We aimed to evaluate the efficacy of a second-generation cryoballoon and identify pre-procedural predictors of 3-year outcome after PVI., Methods and Results: For this observational cohort study, we enrolled 440 patients ablated at our institution with a second-generation cryoballoon. The endpoint was the first documented recurrence (>30 s) of atrial fibrillation (AF), atrial flutter, or atrial tachycardia after a 3-month blanking period. The impact of several pre-existing variables on clinical outcome was evaluated by univariate and multivariate analyses using the Cox proportional hazards regression model. The PLAAF (persistent AF, left atrial area, abnormal PV anatomy, AF history, female gender) score was defined to predict outcome. After a median follow-up of 36 months (interquartile range 25/75-27/42), the endpoint was achieved in 95 of 440 (21.6%) patients. Cox regression analysis showed that persistent AF, left atrial (LA) area, abnormal PV anatomy, AF history, and female gender independently predicted recurrence. The calculated optimal cut-offs for LA area and AF history were 21 cm2 and 3 years, respectively. Patients with a PLAAF score of 0 showed the best outcome, with an arrhythmia-free survival of 86.7%., Conclusion: PVI using the cryoballoon technique shows acceptable long-term results depending on predictors described by the new PLAAF score, which may facilitate patient selection for PVI.

Introduction: The aim of this observational study was to compare the postprocedural incidence of bleeding and thromboembolic complications associated with novel oral anticoagulants (NOACs) with that of interrupted and continuous phenprocoumon after pulmonary vein isolation (PVI) using a purse-string suture (PSS) closure of the puncture site., Methods and Results: Consecutive patients who had undergone PVI via cryoballoon ablation were divided into the following groups: (1) interrupted phenprocoumon with heparin bridging (n=101), (2) continuous phenprocoumon targeting an internationally normalized ratio>2 (n=70), and (3) NOACs without bridging that were restarted 2-4h after the procedure (n=185). Protamine was not administered after venous closure with PSS at the end of the procedure. The total complication rate was significantly lower in group 3 than in groups 1 and 2 (1.62% vs. 6.93% vs. 7.14%, p=0.04). The hospital costs were lower and the hospital stay length was significantly shorter (4484±3742 vs. 6082±4044 Euro vs. 4908±2925, p=0.03; 1.94±1.67 vs. 2.70±1.80 vs. 2.19±1.30days, p<0.01). No thromboembolic event occurred. Vascular complications were the most common complications noted (80%). The occurrence of any complication led to a significantly longer hospital stay (5 vs. 2days, p<0.01) and higher costs (10,052±6241 Euro vs. 4747±3447, p<0.01). The vascular complication rate after PSS was independent of intraprocedural heparin dosage and activated clotting time., Conclusions: NOACs have a lower complication rate and appear to be safer in this setting than phenprocoumon. The hospital costs and hospital stay length after PVI was significantly reduced in patients treated with NOACs compared with phenprocoumon., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Introduction: This observational study was designed to analyze the safety and feasibility of percutaneous skin closure using a purse-string suture and compare it with the use of a compression bandage after pulmonary vein isolation., Methods and Results: A total of 407 patients undergoing pulmonary vein isolation (217 with radiofrequency and 190 with cryoballoon ablation) were treated with either purse-string sutures or compression bandages. The purse-string suture was applied after ablation before withdrawal of the sheaths. Patients were on bed rest for 6 hours prior to suture removal, which was accomplished 18-24 h after ablation. The compression bandage was applied after sheath withdrawal and was removed after 12 hours of bed rest. We analyzed the occurrence of any vascular or thromboembolic complication as well as hospital costs and hospital stay length after ablation. The incidence of vascular complications after compression bandage was higher than after purse-string suture in the cryoballoon and radiofrequency group (P < 0.05, respectively). The hospital costs were lower and hospital stay was shorter in both radiofrequency (4.921 ± 3.145 vs. 5.802 ± 4.006 Euro; 2.34 ± 1.32 vs. 2.98 ± 1.57 days, P < 0.05) and cryoballoon groups (4.705 ± 3.091 vs. 5.661 ± 3.563 Euro; 2.14 ± 1.37 vs. 2.61 ± 1.55 days, P < 0.05) in patients treated with a purse-string suture., Conclusions: Percutaneous skin closure with a purse-string suture has the clinical impact to reduce vascular complications, hospital costs, and hospital stay length after pulmonary vein isolation., (© 2017 Wiley Periodicals, Inc.)

Aims: There is no objective, early indicator of occlusion quality, and efficacy of cryoballoon pulmonary vein isolation. As previous experience suggests that the initial cooling rate correlates with these parameters, we investigated the slope of the initial temperature drop as an objective measure., Methods and Results: A systematic evaluation of 523 cryoapplications in 105 patients using a serial ROC-AUC analysis was performed. We found the slope of a linear regression of the temperature-time function to be a good predictor (PPV 0.9, specificity 0.72, sensitivity 0.71, and ROC-AUC 0.75) of acute isolation. It also correlated with nadir temperatures (P< 0.001, adjusted R2= 0.43), predicted very low nadir temperatures, and varied according to visual occlusion grades (ANOVA P< 0.001)., Conclusions: About 25 s after freeze initiation, the temperature-time slope predicts important key characteristics of a cryoablation, such as nadir temperature. The slope is the only reported predictor to actually precede acute isolation and thus to support decisions about pull-down manoeuvres or aborting a cryoablation early on. It is also predictive of very low nadir temperatures and phrenic nerve palsy and thus may add to patient safety., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.)

Aims: Although the generation of linear lesions by ablation improves success rates in patients with persistent atrial fibrillation (AF), the procedure has been considered unsuitable for cryoablation balloon catheter technologies. We developed a technique for linear ablations, using second-generation cryoballoon technology., Methods and Results: This was a single-arm, prospective study in 76 patients with persistent AF treated consecutively at our centre. Cryoablation was performed using a 28 mm second-generation cryoballoon. The first cryoenergy application was performed in close proximity to the position during isolation of the left superior pulmonary vein (PV). Sequential overlapping freezes were applied along the left atrial (LA) roof by slight clockwise rotation of the sheath in combination with slight retraction of the sheath and incremental advancement of the cryoballoon, until reaching the original position for right superior PV isolation. The acute endpoint was the creation of a roofline, defined as complete conduction block across the LA roof >120 ms and ascending activation across the posterior LA wall. Acute success in roofline generation was achieved in 88% of patients, applying on average five (median 4-6) freezes with nadir temperature of -40°C (-36 to -44°C). In five patients, conduction block could not be achieved. No phrenic nerve injuries occurred during roofline generation., Conclusion: Generation of linear roofline lesions is possible with the second-generation cryoballoon. The technique can be used in combination with PV isolation to treat persistent AF with good acute success rates, short procedure times, and acceptable safety concerns. If validated by further studies, the method would be an appealing alternative to radiofrequency ablation techniques., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.)

Aims: First-line ablation prior to antiarrhythmic drug (AAD) therapy is an option for symptomatic paroxysmal atrial fibrillation (PAF); however, the optimal ablation technique, radiofrequency (RF), or cryoballoon (CB) has to be determined., Methods and Results: The FREEZE Cohort Study compares RF and CB ablation. Treatment-naïve patients were documented in the FREEZEplus Registry. Periprocedural data and outcome were analysed. From 2011 to 2014, a total of 373/4184 (8.9%) patients with PAF naïve to AAD were identified. Pulmonary vein isolation (PVI) was performed with RF (n = 180) or CB (n = 193). In the RF group, patients were older (65 vs. 61 years, P < 0.01) compared with the CB group. The procedure time was significantly shorter and radiation exposure higher in the CB group. Major adverse events occurred in 1.6% (CB) and 3.7% (RF) of patients (P = 0.22). AF/atrial tachycardia (AT) recurrence until discharge was 4.5% (RF) and 8.5% (CB, P = 0.2). Follow-up (FU) ≥12 months was available in 99 (RF) and 107 (CB) patients. After 1.4 years of FU, freedom from AF/atrial tachycardia (AT) was 61% (RF) and 71% (CB, P = 0.11). In the RF group, more patients underwent cardioversion, and a trend for more repeat ablations was observed. Persistent phrenic nerve palsy was observed in one patient treated by CB., Conclusion: First-line ablation for PAF is safe and effective with either RF or CB. The procedure was faster with the CB, but the radiation exposure was higher. Although there was a trend for more recurrences and complications in the RF group, a more favourable risk profile in patients undergoing CB ablation might have biased the results., Clinicaltrialsgov Identifier: NCT01360008., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.)

Aims: Cryoballoon (CB) ablation has proven very effective in achieving pulmonary vein isolation (PVI). The Achieve catheter (AC) is a novel inner lumen catheter designed to be used in conjunction with the CB, which serves the double purpose of a guidewire and a mapping catheter. We aimed to evaluate the feasibility of CB ablation in conjunction with the novel AC, in terms of PVI and safety in a series of patients affected by drug resistant paroxysmal atrial fibrillation (AF)., Methods and Results: Seventy patients (49 male) affected by paroxysmal AF were assigned to CB PVI using the AC as a mapping catheter. Patients underwent loop-Holter monitoring 1, 3 and 6 months after ablation. Isolation occurred in 98% of PVs with the CB-AC association without having switching to a regular guidewire. Pulmonary vein isolation could be documented by real-time (RT) recordings in 47% (132) of veins. Time to isolation was significantly longer in PVs exhibiting early left atrium-PV reconnection if compared with veins with sustained isolation (117 ± 25 s vs. 59 ± 25 s; P< 0,005). No serious complications occurred; four transient phrenic nerve palsies occurred all resolving completely before the end of the procedure., Conclusion: Cryoballoon ablation in conjunction with the novel AC is feasible, safe, and most importantly affords PVI in nearly all veins without having to switch to a regular guidewire. However, RT recordings could be documented in only 47% of pulmonary veins.

Introduction and Objectives: Several biomarkers have been used for evaluation and quantification of myocardial injury after effective ablation. We studied possible different thermal stability and usability of the proteins released by cardiac cells injured by different energy sources., Methods: Firstly, we tested in vitro thermal stability of creatinine kinase (CK), myocardial bound creatinine kinase (CKMB), cardiac troponins I (cTnI) and cardiac troponins T (cTnT) in collected blood samples from 15 patients (pts) with confirmed ST-segment elevated myocardial infarction (STEMI). Secondly, the biomarkers were collected and analyzed in 82 pts treated with radiofrequency ablation (RFA) and in 79 pts treated with cryo-balloon ablation (CBA)., Results: In vitro experiment showed that all biomarkers were stable in low temperature of -30(o)C. Troponins were stable in the high temperatures analyzed. A substantial drop in CK and CKMB levels were measured at 50°C and 40° C, respectively. In vivo study showed that the increase in CKMB levels was highly significant in CBA pts only. Pathological CKMB values were observed in 24% of RFA pts and 98% of CBA pts. Pathological cTnI values were observed in all pts and the rise in cTnI levels was highly significant in both groups after ablation., Conclusions: Both in vitro and in vivo results show that CKMB cannot be used for quantitative determination of myocardial injury produced by radiofrequency energy. Only cardiac troponins reflect myocardial injury, regardless of energy source, and may be considered in future studies for comparison of biomarkers effects of cryo versus radiofrequency ablation., (Copyright © 2010 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.)

Aims: Cerebral embolism is a possible serious complication during catheter ablation of atrial fibrillation (AF). The purpose of this prospective pilot study was to analyse the incidence and possible impact of cryo ablation on cerebral lesions and possible differences to radiofrequency (RF) ablation during pulmonary vein isolation (PVI)., Methods and Results: Pulmonary vein isolation was performed in 89 patients, either with the cryoballoon technique (n = 45) or with RF ablation (n = 44). Phenprocoumon was stopped 3 days before intervention and replaced by subcutaneous low-molecular-weight heparin. During the catheter procedure, an infusion of unfractionated heparin was maintained to achieve an activated clotting time (ACT) of > 300 s. Cerebral magnetic resonance imaging scans were performed 1 day before and after PVI, and at 3-month follow-up. Chronic lesions were observed in 11 patients (12.3%) before PVI without statistically significant difference between the two groups. None of the patients had neurological symptoms during or following the procedure. Seven patients (7.9%) developed acute lesions 1 day after PVI, without statistically significant difference between the group treated by cryoenergy (8.9%) and RF ablation (6.8%). Patients with acute lesions were significantly older compared with those without acute cerebral lesions. No additional cerebral lesions during follow-up were observed., Conclusion: A considerable portion of patients with AF but without any neurological symptoms had chronic cerebral lesions before PVI. Additional acute lesions could be added after the procedure. Both ablation techniques showed additional cerebral acute lesions with no neurological symptoms after PVI.

Aims: The data on anti-arrhythmic effect of renin-angiotensin-aldesteron system blockers (RASB) in patients with atrial fibrillation (AF) are controversially discussed. The goal of this analysis was to identify cohort of patients with AF and hypertension, who may have benefit from RASB therapy after pulmonary vein isolation (PVI)., Methods: A total of 284 patients with AF and hypertension (paroxysmal AF [PAF]= 218, male = 185, age = 61 years, left ventricular ejection fraction = 60%, coronary artery disease = 42) considered for PVI were included. The patients with PAF were stratified according to time spent in AF (AF burden) within 3 months prior to admission ( 500 hours). Further patients were divided into two groups: (1) low-burden AF; (2) high-burden AF (PAF and persistent AF). In 195 patients, RASB therapy was administered. A 7-day continuous Holter electrocardiogram was performed after discharge, every 3 months thereafter and by symptoms., Results: Preventive effect of RASB was revealed in whole group (112 out of 195 [57%] vs 36 out of 89 [40%]; P = 0.025) and was more pronounced in patients with low-burden AF (79 out of 112 [71%] receiving RASB vs 27 out of 55 [49%] being on other drugs; P = 0.013). However, efficiency of RASB failed in patients with high-burden AF (33 out of 83 on RASB [40%] vs nine out of 34 on other drugs [27%]; P = 0.328)., Conclusions: Our data suggest that RASB appears to protect against AF recurrences after PVI in patients with low-burden paroxysmal AF. These results should be tested in a prospective study., (©2010, The Authors. Journal compilation ©2010 Wiley Periodicals, Inc.)

Background: Delayed interatrial conduction, manifested on the electrocardiogram as a P wave >or=110 ms (interatrial block, IAB), is highly prevalent and associated with atrial fibrillation (AF). It is correlated with P-terminal force (Ptf; product of the duration and amplitude of the negative terminal phase of the P wave in lead V1). Our purpose was to describe the modifications of the P-wave duration and Ptf after pulmonary vein antrum isolation (PVAI) in patients with paroxysmal AF., Methods: PVAI was performed in 45 patients with paroxysmal AF, either with the cryoballoon technique (n = 15) or radiofrequency ablation (n = 30). Electrocardiograms were recorded before PVAI, 3 and 6 months after ablation., Results: From the sample (median age 60 [53; 66] years; female 40%), median P-wave duration was 122 [114; 134] ms before PVAI and 116 [106; 124] ms at 3-month follow-up (P < 0.001). IAB was observed in 42 patients (93.3%) before ablation and in 31 patients (68.9%) at 3-month follow-up. Median Ptf was 0.047 [0.020; 0.068] before ablation and 0.013 [0.004; 0.025] at 3-month follow-up (P < 0.001). Twenty-six patients (57.8%) had a Ptf > 0.04 mV x ms before ablation and only one (2.2%) at 3-month follow-up. P-wave duration and Ptf were not significantly modified between 3- and 6-month follow-up., Conclusion: The terminal part of the P wave is modified after PVAI, perhaps due to the loss of pulmonary vein antrum signals. P-wave duration and Ptf must be carefully interpreted after such a procedure. The prognostic value of these modifications should be evaluated.

Introduction: Severe pulmonary vein stenosis (PVS) after catheter ablation of atrial fibrillation (AF) is a well-recognized complication with a further reported incidence of 1.3%. The preferred therapy for symptomatic PVS is pulmonary vein (PV) angioplasty, but this treatment modality is followed by restenosis in 44-70%. Whether there is additional long-term benefit from PVS stenting is uncertain. The aim of this study was the evaluation of the long-term success after PV stenting of severe stenosis., Methods and Results: Ten patients (pts) with 13 PVS were prospectively evaluated. PV stenting was performed with Palmaz Genesis stents. Magnetic resonance imaging (MRI), lung perfusion scans, and CT-scans were performed before, directly after, and every 12 months thereafter. Primary endpoint of the study was the occurrence of restenosis after PV stenting. After a median follow-up of 47.7 (IQRs 25/75 47.2-48.5) months, the primary endpoint was achieved in 3 out of 13 PVs (23% of the treated PVs). We observed two in-stent restenosis 2 and 4 years after PV stenting. These pts experienced onset of dyspnea some weeks before. After an additional balloon angioplasty, the in-stent restenosis was resolved. In one asymptomatic patient, we observed an occlusion of the PV stent 13 months poststenting. Normalization of lung perfusion was noted 4 years after PV stenting versus directly poststenting in all pts without in-stent restenosis (n = 7)., Conclusion: PVS stenting with stent sizes >or=10 mm seems to be an adequate therapy modality for treatment of severe acquired PVS. Late in-stent restenosis after PVS stenting can occur. The normalization of the initially disturbed lung perfusion scan is possible and remains stable, even 4 years after PVS stenting.

Objectives: The purpose of this study was to investigate the efficacy safety of the novel cryoballoon device (Arctic Front, Cryocath, Quebec, Canada)., Background: Antral pulmonary vein (PV) ablation with radiofrequency energy is widely used as a strategy for catheter ablation of paroxysmal atrial fibrillation (PAF). A novel double lumen cryoballoon catheter was designed for circumferential pulmonary vein isolation (PVI) with the cryoablation technique., Methods: We consecutively enrolled 346 patients with symptomatic, drug refractory paroxysmal (n = 293) or persistent (n = 53) atrial fibrillation (AF). In all patients, PVI of all targeted PVs was the therapeutic aim. The primary end points of this nonrandomized study were: 1) acute isolation rate of targeted PV; and 2) first electrocardiogram-documented recurrence of AF. The secondary end point was occurrence of PV stenosis or atrio-esophageal fistula., Results: The 1,360 of 1,403 PVs (97%) were targeted with balloons or balloons in combination with the use of Freezor Max (Cryocath). We found that ablation with the cryoballoon resulted in maintenance of sinus rhythm in 74% of patients with PAF and 42% of patients with persistent AF. No PV narrowing occurred. The most frequent complication was right phrenic nerve palsy observed during cryoballoon ablation at the right superior PV., Conclusions: Pulmonary vein isolation with a new cryoballoon technique is feasible. Sinus rhythm can be maintained in the majority of patients with PAF by circumferential PVI using a cryoballoon ablation system. Cryoablation was less effective in patients with persistent AF than in patients with PAF.

Aims: The purpose of this study was to determine the occurrence of asymptomatic episodes of atrial fibrillation (AF) and wrong AF perception after pulmonary vein isolation (PVI). We evaluated the success of ablation by using the following measurements: (i) clinical symptoms and duration of symptoms noticed by patients and (ii) synchronous event recording (ER)., Methods and Results: Eighty patients with paroxysmal AF underwent PVI and were provided repeatedly with a portable ER upon discharge and every 3 months for a year. The ER automatically detects arrhythmias by a detection algorithm and can also be manually triggered by the patient. In 46/80 patients (57.5%), episodes of AF were documented. Asymptomatic AF was detected in 21.3%. In 9/80 patients (11.3%), who reported clinical AF recurrence, no AF could be shown by ER. We compared patients' perception to have suffered AF episodes with the ERs and found a sensitivity of 75% and a specificity of 92%., Conclusion: Reliance on perception of AF by patients after PVI results in an underestimation of recurrence of the arrhythmia. We observed a maximal occurrence of silent AF or wrong perception of AF in 26/80 (32.6%) patients.

Background: The definition of symptomatic improvement after pulmonary vein isolation (PVI) is controversial. We assessed primarily the usefulness and predictive accuracy (PA) of AF (atrial fibrillation) burden (AFB) within the first 3 months after the procedure as an early predictor for curative success as well as reduction of symptoms., Methods: We studied 100 pts (62 men, mean age: 54 +/- 9 years, LVEF: 57 +/- 9%, paroxysmal AF, 85, persistent AF, 15) who underwent PVI. RF ablation was used in 63 patients. The combination of cryoablation and RF (Hybrid therapy) was used in the remaining 37 patients, in 19 patients of whom additionally linear lesions were performed. All patients were followed up 3 months after PVI (the blanking period) and every 3 months thereafter. The significance of early recurrence of AF (ERAF) was separately analyzed for RF and for hybrid therapy arm. Quality of life (QoL) was assessed using the physical composite summary score (PCS) and mental composite summary score (MCS). AFB was dichotomized at: 0, 0.5, 1, 6, 12, and 24 hours., Results: ANOVA revealed significant differences between PCS at baseline and after PVI in patients without recurrence and with those with postablation AFB <12 hours. There was no difference between PCS in patients with AFB > or =12 hours within a 3 months interval and PCS at baseline. ERAF occurred in 35% of patients (16 patients, AFB > or =12 hours). Symptomatic ERAF occurred in 29 patients (17 patients AFB > or =12 hours). After the blanking period, documented AF recurrence was found in 50 patients (17 patients, AFB > or =12 hour). Symptomatic late recurrence was found in 47 patients (31 patients with AFB > or =12 hours). Absence of ERAF was revealed to be predictive for long-term success and symptomatic ERAF was found to be predictive for symptomatic AF recurrence (P <0.0001)., Conclusion: AF recurrence with AFB > or =12 hours within 3 months is associated with a missed improvement of QoL. Symptomatic ERAF predicts recurrence independently of therapy.

Introduction: Pulmonary vein stenosis (PVS) is a potential complication of pulmonary vein isolation (PVI) using radiofrequency energy. The aim of our study was the evaluation of the severity and long-term outcome of primary angioplasty and angioplasty with pulmonary vein stenting for PVS., Methods and Results: Twelve patients with 15 PVS (greater than 70% stenosis) were prospectively evaluated. Primary dilation of the stenosis was performed because of clinical symptoms (10 patients) and/or the lung perfusion scans showed a significant perfusion defect (11 patients). Magnetic resonance imaging and lung perfusion scans performed before, directly after, during 3-month, and 6-month follow-up. In the stenting group additional multislice CT-scans directly after, during 6-month, and 12-month follow-up were performed. Within 2 months after primary balloon angioplasty, the PV size parameters were significantly reduced (P < 0.001) with recurrence of PVS in 11 of 15 PVs (73%). Pulmonary vein stenting in 8 patients and 11 PVs resulted in no vein stenosis during 12-month follow-up. Normalization of lung perfusion was noted in 8 of 12 patients. We observed 2 patients with hemoptysis during PV dilation, as severe complications with potential life-threatening character., Conclusion: PVS stenting seems to be superior to balloon angioplasty and effective at least over a period of 12 months in treating acquired PVS after pulmonary vein isolation.

A decrease in ostial pulmonary vein (PV) diameter was observed in patients on the day after radiofrequency ablation of atrial fibrillation (AF). This study examined whether a relative reduction in PV diameter on day 1 (RRPVD1) after the procedure predicts the late development of severe PV stenosis (PVS). The study included 104 consecutive patients (mean age = 55 years, range 46-61, 34 women) with drug refractory AF. Pulmonary vein diameter was measured using MR angiography (MRA) on the day before and on day 1 after the ablation procedure. The MRA was repeated every 3 months after the procedure. Severe PVS was defined as a >70% diameter reduction from the initial ostial diameter. The cut-off of RRPVD1 was prespecified as 25% decrease in initial diameter. The data are presented as medians and interquartile range. A total of 357 PV were treated. The RRPVD1 was 0.0% (0.0-11.1%). Severe PVS was found in 18 PV during a follow-up of 12 months (range 6-13). The log-rank analysis confirmed a strong association between a RRPVD1 >/=25% and the development of PVS (hazard ratio: 7.1; 95% confidence interval 3.8-13.5, P < 0.0001). By multivariate Cox regression model, after adjustment of procedure variables, RRPVD1 was the strongest predictor of development of severe PVS. RRPVD1 >/=25% was a strong independent predictor of development of severe PVS.

Background and Aims: Noninvasive mapping allows the identification of patient-specific atrial rotational activity (RA) that might play a key role in the perpetuation of persistent atrial fibrillation (PsAF). So far, the impact of pulmonary vein isolation by cryoballoon (Cryo-PVI) on RA is unclear. Moreover, the long-term effect of periprocedural termination of AF during the ablation procedure is controversial. Methods: Noninvasive electrocardiographic mapping with a 252-electrode vest was performed in 42 patients with PsAF. After the first analysis, Cryo-PVI was performed. The RA was analyzed again and then targeted by radiofrequency catheter ablation. The primary clinical endpoint was periprocedural termination of AF. The secondary endpoint was freedom from any atrial arrhythmia >30 s during a 12-month follow-up. Results: In 33 patients (79%), right atrial RA was identified leading to biatrial ablation, and nine patients (21%) had left atrial RA only. Twelve patients (28.6%) converted from AF to sinus rhythm (SR) (Group A). Thirteen patients (30.9%) converted to atrial tachycardia (AT) (Group B). In 17 patients (40.5%), AF was not terminated by ablation (Group C). After a mean follow-up time of 13.8 months, 26 patients were free from AF and AT (61.9%). In terms of rhythm, control Group A (75%) and B (83.3%) showed higher success rates than Group C (33.3%) (p < 0.01). Cryo-PVI had no substantial impact on RA. Conclusions: The RA-based ablation approach showed acceptable success rates. Periprocedural termination of AF had a positive predictive impact on the outcome. No difference was observed between conversion to SR or to AT. Cryo-PVI had no impact on RA. [ABSTRACT FROM AUTHOR]

Pulmonary vein stenosis (PVS) after radiofrequency energy‐mediated percutaneous pulmonary vein isolation as a treatment option for atrial fibrillation is a serious complication and the prevalence in historical reports varies between 0% and 42%. Symptoms of PVS are nonspecific and can include general symptoms such as dyspnea, cough, recurrent pneumonia, and chest pain. Pathophysiologically it increases the postcapillary pressure in the pulmonary circuit and may result in pulmonary hypertension (PH). Misdiagnosis and delayed treatment are common. We here report a case of a 59‐year‐old female with a history of pulmonary vein ablation followed by progressive dyspnea (New York Heart Association IV), right heart failure, CPR, and the need for extracorporeal membrane oxygenation (ECMO). Further treatment strategy includes pulmonary vein dilatation and stenting of both the left superior pulmonary vein and left inferior pulmonary vein, as well as balloon dilatation of RIPV under temporary ECMO support. Symptomatic, severe PVS is a rare complication after catheter ablation of atrial fibrillation. PVS can result in life‐ threatening complications such as PH with acute right heart failure. Early diagnosis is crucial but challenging. Mechanical cardiopulmonary support by veno‐arterial ECMO for bridging to angioplasty could be a lifesaving option. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Aims: First-line ablation prior to antiarrhythmic drug (AAD) therapy is an option for symptomatic paroxysmal atrial fibrillation (PAF); however, the optimal ablation technique, radiofrequency (RF), or cryoballoon (CB) has to be determined.Methods and Results: The FREEZE Cohort Study compares RF and CB ablation. Treatment-naïve patients were documented in the FREEZEplus Registry. Periprocedural data and outcome were analysed. From 2011 to 2014, a total of 373/4184 (8.9%) patients with PAF naïve to AAD were identified. Pulmonary vein isolation (PVI) was performed with RF (n = 180) or CB (n = 193). In the RF group, patients were older (65 vs. 61 years, P < 0.01) compared with the CB group. The procedure time was significantly shorter and radiation exposure higher in the CB group. Major adverse events occurred in 1.6% (CB) and 3.7% (RF) of patients (P = 0.22). AF/atrial tachycardia (AT) recurrence until discharge was 4.5% (RF) and 8.5% (CB, P = 0.2). Follow-up (FU) ≥12 months was available in 99 (RF) and 107 (CB) patients. After 1.4 years of FU, freedom from AF/atrial tachycardia (AT) was 61% (RF) and 71% (CB, P = 0.11). In the RF group, more patients underwent cardioversion, and a trend for more repeat ablations was observed. Persistent phrenic nerve palsy was observed in one patient treated by CB.Conclusion: First-line ablation for PAF is safe and effective with either RF or CB. The procedure was faster with the CB, but the radiation exposure was higher. Although there was a trend for more recurrences and complications in the RF group, a more favourable risk profile in patients undergoing CB ablation might have biased the results.Clinicaltrialsgov Identifier: NCT01360008. [ABSTRACT FROM AUTHOR]

Aims In this observational study, we examine the significance of the left atrial (LA) surface area and compare the clinical usage of the Arctic Front Advance (CBA) versus Arctic Front (CB) cryoballoon with the intent to investigate the impact of each in terms of long-term freedom from atrial fibrillation (AF) for patients with nonvalvular AF. Methods Pulmonary vein isolation (PVI) was performed while using a cryoballoon ablation catheter in conjunction with an intraluminal circular diagnostic mapping catheter, Achieve. The consecutive patients ablated with CBA were matched with patients previously ablated with CB, using propensity score matching. The primary endpoint of this observational single-center retrospective study was the first observation of electrocardiogram-documented recurrence of atrial arrhythmias lasting >30 seconds. Results The patient demographic data were similar in the CBA- and CB-group (N = 188 patients each group). In all patients in the CBA-group and in 95% of the patients in the CB group, acute procedural PVI of all veins was achieved with the single usage of a 28-mm cryoballoon. The one-year freedom from atrial arrhythmias was significantly better in the CBA- versus the CB-group of patients, 90% versus 64%, respectively. During 15-month clinical follow-up in CBA group, patients with LA area above 23 cm2 were more likely to experience recurrence of AF (23%) than patients with LA area below 23 cm2 (7%). Conclusions Comparing one-year outcomes, the CBA is superior to the CB with regards to maintenance of normal sinus rhythm. When using the CBA catheter, an enlarged LA is associated with a higher recurrence of arrhythmia. [ABSTRACT FROM AUTHOR]

There are no data concerning clinical outcome and left atrial (LA) function after LA roof ablation using a second-generation cryoballoon (CB) for treatment of persistent atrial fibrillation (AF). Here, we report the first follow-up results after pulmonary vein isolation (PVI) plus LA roof ablation with the CB technique in patients with symptomatic persistent AF. We enrolled 107 consecutive patients who underwent CB ablation at our institution with the aim of PVI and bidirectional conduction block across the LA roof. Clinical success was defined as freedom from >30-s recurrence of AF, atrial flutter, or atrial tachycardia after a 3-month blanking period. Follow-up data were collected during outpatient clinic visits. LA volume, LA emptying fraction, and LA expansion index (parameters of LA function) were evaluated by echocardiography before and 3 months after ablation. PVI was achieved in all patients, and bidirectional conduction block was verified in 91.6%. Median follow-up duration was 31 (interquartile range 11/44) months. PVI plus LA roof ablation was sufficient to restore and maintain sinus rhythm in 72.9% (n = 78) of patients. The overall complication rate was 1.8%. LA volumes decreased significantly after ablation (P < 0.05), whereas total LA emptying fraction (P = 0.25) and LA expansion index (P = 0.32) were preserved within the 3-month follow-up. LA roof ablation combined with PVI using the CB technique is a safe and effective adjuvant treatment with a promising midterm outcome and preserved LA function 3 months after ablation. • Left atrial roof ablation using second-generation cryoballoon was safe and effective. • Pulmonary vein isolation plus roof line ablation showed a promising outcome. • Left atrial function was not impaired during short-term follow-up. [ABSTRACT FROM AUTHOR]

Introduction Antiarrhythmic drug (AAD) therapy of patients with atrial fibrillation (AF) has limitations. We investigated the 2-year outcome and pre-procedural predictors of recurrence for first-line catheter ablation using the second-generation cryoballoon (CB-Adv) in a large cohort of patients with symptomatic AF. Methods and results For this prospective observational study, we enrolled 457 patients with symptomatic AF (278 paroxysmal, 179 persistent) who had no history of AAD use and who underwent pulmonary vein isolation (PVI) with the CB-Adv at our institution. Follow-up data, including Holter-ECGs, were collected during outpatient clinic visits. The impact of several variables on outcome was evaluated in univariate and multivariate analyses and Cox proportional hazards regression models. Median follow-up duration was 28 (interquartile range 15/42) months. PVI was sufficient in restoring and maintaining sinus rhythm in 79.2% ( n = 362) of patients. The median procedure and fluoroscopy times were 90 (72/120) and 16 (12/21) min, respectively. Phrenic nerve injury occurred in 16 (3.5%) patients, persisting until hospital discharge in 6 (1.3%) patients; phrenic nerve function recovered in all patients during follow-up. Seven patients developed groin hematomas (1.5%). Cox regression analysis showed that left atrial area > 21 cm 2 independently predicted recurrence. Conclusion This is the first demonstration that PVI with CB-Adv is safe and effective as a first-line treatment of symptomatic AF. Sinus rhythm persisted in 79.2% of patients even 2 years after ablation. The success rate was lower in patients with enlarged left atria. [ABSTRACT FROM AUTHOR]