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Background: Management of atrial fibrillation (AF) in very severe obese patients is challenging. Cryoballoon ablation (CBA) represents an effective rhythm control strategy. However, data in this patient group were limited., Methods: Highly symptomatic AF patients with body mass index (BMI) ≥ 40 kg/m 2 who had failed antiarrhythmic drug therapy and electrocardioversion and failure to achieve targeted body-weight-reduction underwent CBA., Results: Data of 72 very severe obese AF patients (Group A) and 129 AF patients with normal BMI (Group B, BMI < 25 kg/m 2 ) were consecutively collected. Group A had significantly younger age (60.6 ± 10.4 vs. 69.2 ± 11.2 years), higher BMI (44.3 ± 4.3 vs. 22.5 ± 1.6 kg/m 2 ). Procedural pulmonary vein isolation (PVI) was successful in all patients (2 touch-up ablation in Group A). Compared to Group B, Group A had similar procedural (61.3 ± 22.6 vs. 57.5 ± 19 min), similar fluoroscopy time (10.1 ± 5.5 vs. 9.2 ± 4.8 min) but significantly higher radiation dose (2852 ± 2095 vs. 884 ± 732 µGym 2 ). We observed similar rates of real-time-isolation (78.6% vs. 78.5%), single-shot-isolation (86.5% vs. 88.8%), but significantly longer time-to-sustained-isolation (53.5 ± 33 vs. 43.2 ± 25 s). There was significantly higher rate of puncture-site-complication (6.9% vs. 1.6%) in Group A. One-year clinical success in paroxysmal AF was (Group A: 69.4% vs. Group B: 80.2%; p < .001), in persistent AF was (Group A: 58.1% vs. Group B: 62.8%; p = .889). In Re-Do procedures Group A had a numerically lower PVI durability (75.0% vs. 83.6%, p = .089)., Conclusion: For very severe obese AF patients, CBA appears feasible, leads to relatively good clinical outcome., (© 2024 The Authors. Journal of Cardiovascular Electrophysiology published by 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.)

The use of a blanking period (BP) after an atrial fibrillation (AF) ablation procedure is a common practice, but recent data questions the benign nature of early recurrences of atrial tachyarrhythmias (ERATs). A physician-based survey was carried out by the European Heart Rhythm Association (EHRA) to investigate the current definition and applicability of BP and ERAT management. An online questionnaire was sent to clinical and interventional electrophysiologists. A total of 436 respondents (88% interventional electrophysiologists) reported observing ERATs in 25% (interquartile range 15-35) of patients, less commonly in paroxysmal AF (PAF) compared with persistent AF (persAF). The median reported duration of BP used by respondents was 90 days, with 22% preferring a shorter BP duration for PAF patients compared with persAF. Half of the patients with ERATs are expected to also experience late recurrences (LR). Isolated episodes of ERATs are treated conservatively by 99% of the respondents, but repeat ablation during the BP is preferred by 20% of electrophysiologists for multiple ERATs and by 16% in patients with organized atrial tachyarrhythmias. In conclusion, ERATs are commonly observed after AF ablation, particularly in persAF patients, and are perceived as predictors of LR by half of the respondents. A general adherence to a 90-day BP duration was observed. During this time period, ERAT is mainly treated conservatively, but repeat ablation during the BP is occasionally offered to patients with multiple ERATs and those with organized atrial tachyarrhythmias., Competing Interests: Conflict of interest: S.B.: speaking and proctoring honoraria from Biosense & Webster, Boston Scientific, Medtronic. S.B.: no conflict of interest. R.P.: no conflict of interest. C.d.A.: no conflict of interest. E.M.: no conflict of interest. M.M.F.: speaker and proctoring honoraria from Abbott and Medtronic. A.A.: consulting fees and speaking honoraria: Boston Scientific Inc., Farapulse Inc., Galaxy Medical Inc., Biosense & Webster, contracted research: Boston Scientific Inc., Farapulse Inc., Galaxy Medical Inc., Biosense & Webster. J.M.G.: consultant honoraria from Medtronic, Boston Scientific, Johnson & Johnson and Abbott, speaker fees from Medtronic, Boston Scientific and Abbott, research grants from Johnson & Johnson, Medtronic, and Abbott. J.K.: no conflict of interest. K.I.: no conflict of interest. B.S.: speaking and proctoring honoraria from Abbot Medical, Biosense Webster, Boston Scientific, Cardiofocus, Medtronic; consulting for Abbot Medical and Boston Scientific. G.C.: no conflict of interest. K.R.J.C.: speaking and proctoring honoraria from Biosense & Webster, Boston Scientific, Medtronic. S.B.: consultant honoraria from Medtronic, Boston Scientific, Microport, and Zoll., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Ablation of atrial fibrillation (AF) is an established treatment option for symptomatic patients. The cornerstone of all ablation strategies is electrical isolation of the pulmonary veins (PVs). Ablation strategies going beyond PV isolation (PVI) might be considered in the setting of recurrent AF despite durably isolated PVs. The lack of persistent PVI, however, limits the opportunities to perceive the real impact of this endpoint on AF suppression and to fully understand the benefit of extended ablation strategies going beyond. To overcome this limitation, novel and innovative ablation systems have been developed to facilitate acute PVI and to increase its durability. These systems include balloon-based ablation devices incorporating different energy sources such as cryo energy, laser, or radiofrequency current, but also new energy sources such as pulsed field ablation as a non-thermal energy source. These technologies could advance catheter ablation of AF to an early stage of the disease and to the primary treatment tool. The current manuscript focuses on the past, the present, and the future value of PVI as the cornerstone for interventional treatment of AF and on how to achieve durable PVI during the first procedure and to further improve the clinical success rates of AF ablation. It also analyses extended ablation strategies going beyond PVI and their impact., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2022. For permissions, please email: journals.permissions@oup.com.)

To conduct a systematic review and meta-analysis to compare the effectiveness and safety of cryoballoon ablation of atrial fibrillation (AF) performed using a single freeze strategy in comparison to an empiric double ('bonus') freeze strategy. We systematically searched MEDLINE, EMBASE, and CENTRAL databases from inception to 12 July 2020, for prospective and retrospective studies of patients undergoing cryoballoon for paroxysmal or persistent AF comparing a single vs. bonus freeze strategy. The main outcome was atrial arrhythmia-free survival and eligible studies required at least 12 months of follow-up; the primary safety outcome was a composite of all complications. Study quality was assessed using the Cochrane risk of bias tool and the Newcastle-Ottawa Scale. Thirteen studies (3 randomized controlled trials and 10 observational studies) comprising 3163 patients were eligible for inclusion (64% males, 71.5% paroxysmal AF, mean CHA2DS2-VASc score 1.3 ± 0.9). There was no significant difference in pooled effectiveness between single freeze strategy compared to double freeze strategy [relative risk (RR) 1.03; 95% confidence interval (CI): 0.98-1.07; I2 = 0%]. Single freeze procedures were associated with a significantly lower adverse event rate (RR 0.72; 95% CI: 0.53-0.98; I2 = 0%) and shorter average procedure time (90 ± 27 min vs. 121 ± 36 min, P < 0.001). A trend for lower risk of persistent phrenic nerve palsy was observed (RR 0.61; 95% CI: 0.37-1.01; I2 = 0%). The quality of included studies was moderate/good, with no evidence of significant publication bias. Single freeze strategy for cryoballoon of AF is as effective as an empiric double ('bonus') freeze strategy while appearing safer and probably quicker (PROSPERO registration number CRD42020158696)., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)

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.

Aims: Cryoballoon (CB) pulmonary vein isolation (PVI) is an accepted ablation strategy for rhythm control in atrial fibrillation (AF). We describe efficacy and safety in a high volume centre with a long experience in the use of the second-generation CB (CB2)., Methods and Results: Consecutive paroxysmal AF (PAF) or persistent AF (persAF) patients undergoing CB2-PVI were enrolled. Procedural data, efficacy, and safety issues were systematically collected. The 28 mm CB2 was used in combination with an inner lumen spiral catheter, a luminal oesophageal temperature (LET) probe was used with a cut-off of 15°C, the phrenic nerve (PN) monitored during septal PVs ablation. Freeze duration was mainly set at 240 s with a bonus application in case of delayed time-to-isolation (TTI > 75 s). A total of 1017 CB2 procedures were analysed (58% male, 66 ± 12 years old, 70% with PAF). 3964 PVs were identified, 99.8% PVs isolated using solely the 28 mm CB. Mean procedure time was 69 ± 25 min, TTI during the first application was recorded in 77% of PVs after a mean of 48 ± 31 s. We recorded 0.2% cardiac tamponade, 4.8% PN injury (1.6% of PN palsy), and 19% of LET < 15°C. Among 725 patients with follow-up data, 84% with PAF and 75% with persAF were in stable SR at 1 year. Shorter freezing duration and longer TTI were procedural predictors for recurrence., Conclusion: Cryoballoon procedures are fast and associated with a benign safety profile. Shorter TTI and longer freeze durations are associated with sinus rhythm during follow-up., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)

Background: Pulmonary vein isolation (PVI) represents the cornerstone in atrial fibrillation ablation. Cryoballoon and laserballoon catheters have emerged as promising devices but lack randomized comparisons. Therefore, we sought to compare efficacy and safety comparing both balloons in patients with persistent and paroxysmal atrial fibrillation (AF)., Methods: Symptomatic AF patients (n=200) were prospectively randomized (1:1) to receive either cryoballoon or laserballoon PVI (cryoballoon: n=100: 50 paroxysmal atrial fibrillation + 50 persistent AF versus laserballoon: n=100: 50 paroxysmal atrial fibrillation + 50 persistent AF). All antiarrhythmic drugs were stopped after ablation. Follow-up included 3-day Holter-ECG recordings and office visits at 3, 6, and 12 months. Primary efficacy end point was defined as freedom from atrial tachyarrhythmia between 90 and 365 days after a single ablation. Secondary end points included procedural parameters and periprocedural complications., Results: Patient baseline parameters were not different between both groups. In all (n=200) complete PVI was obtained and the entire follow-up accomplished. Balloon only PVI was obtained in 98% (cryoballoon) versus 95% (laserballoon) requiring focal touch-up in 2 and 5 patients, respectively. Procedure but not fluoroscopy time was significantly shorter in the cryoballoon group (50.9±21.0 versus 96.0±20.4 minutes; P <0.0001 and 7.4±4.4 versus 8.4±3.2 minutes, P =0.083). Overall, the primary end point of no atrial tachyarrhythmia recurrence was met in 79% (cryoballoon: 80.0% versus laserballoon: 78.0%, P =ns). No death, atrio-esophageal fistula, tamponade, or vascular laceration requiring surgery occurred. In the cryoballoon group, 8 transient but no persistent phrenic nerve palsy were noted compared with 2 persistent phrenic nerve palsy and one transient ischemic attack in the laserballoon group., Conclusions: Both balloon technologies represent highly effective and safe tools for PVI resulting in similar favorable rhythm outcome after 12 months. Use of the cryoballoon is associated with significantly shorter procedure but not fluoroscopy time.

Aims: To evaluate the effectiveness and safety of cryoballoon ablation (CBA) compared with radiofrequency ablation (RFA) for symptomatic paroxysmal or drug-refractory persistent atrial fibrillation (AF)., Methods and Results: Prospective cluster cohort study in experienced CBA and RFA centres. Primary endpoint was 'atrial arrhythmia recurrence', secondary endpoints were as follows: procedural results, safety, and clinical course. A total of 4189 patients were included: CBA 2329 (55.6%) and RFA 1860 (44.4%). Cryoballoon ablation population was younger, with fewer comorbidities. Procedure time was longer in the RFA group (P = 0.01). Radiation exposure was 2487 (CBA) and 1792 cGycm2 (RFA) (P < 0.001). Follow-up duration was 441 (CBA) and 511 days (RFA) (P < 0.0001). Primary endpoint occurred in 30.7% (CBA) and 39.4% patients (RFA) [adjusted hazard ratio (adjHR) 0.85, 95% confidence interval (CI) 0.70-1.04; P = 0.12). In paroxysmal AF, CBA resulted in a lower risk of recurrence (adjHR 0.80, 95% CI 0.64-0.99; P = 0.047). In persistent AF, the primary outcome was not different between groups. Major adverse cardiovascular and cerebrovascular event rates were 1.0% (CBA) and 2.8% (RFA) (adjHR 0.53, 95% CI 0.26-1.10; P = 0.088). Re-ablations (adjHR 0.46, 95% CI 0.34-0.61; P < 0.0001) and adverse events during follow-up (adjHR 0.64, 95% CI 0.48-0.88; P = 0.005) were less common after CBA. Higher rehospitalization rates with RFA were caused by re-ablations., Conclusions: The primary endpoint did not differ between CBA and RFA. Cryoballoon ablation was completed rapidly; the radiation exposure was greater. Rehospitalization due to re-ablations and adverse events during follow-up were observed significantly less frequently after CBA than after RFA. Subgroup analysis suggested a lower risk of recurrence after CBA in paroxysmal AF., Trial Registration: ClinicalTrials.gov (NCT01360008), https://clinicaltrials.gov/ct2/show/NCT01360008., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: The left atrial appendage (LAA) has been identified as a potential source of atrial fibrillation (AF) and has been described as the "fifth" pulmonary vein (PV). We report our initial experience in LAA isolation (LAAI) using the cryoballoon (CB) and data on durability of CB-LAAI., Methods: Patients treated with a CB-LAAI were retrospectively identified. Six weeks after electrical LAAI, patients were scheduled for staged percutaneous LAA closure. During the second procedure, a subset of patients underwent invasive remapping of the LAA., Results: A total of 32 patients (21 males, 68 ± 10 years old) were treated with CB-LAAI. Acute LAAI was achieved in 29 of 32 (91%) patients: single-shot LAAI was observed in 18 of 32 (56%) patients. Acute procedural sustained LAAI was related with a significantly shorter time to LAAI (sustained LAAI: 84 ± 50 s vs nonsustained LAAI: 166 ± 76 s, P = 0.004). Mean procedure and fluoroscopy time were 61 ± 29 and 8 ± 6 min, respectively. One left-sided phrenic nerve palsy occurred. In 25 of 32 (78%) patients, a second procedure for percutaneous LAA closure device implantation was performed. In 22 patients, persistency of LAAI was tested: durable LAAI was documented in 16/22 patients (73%)., Conclusion: In the present report, CB LAA isolation followed by staged LAA closure appeared to be safe and feasible but more data are required. Time to LAAI played a role in predicting acute sustained LAAI rate. CB LAA ablation leads to 73% of durable LAA isolation., (© 2019 Wiley Periodicals, Inc.)

Background: The second-generation cryoballoon (CB2) has recently been introduced featuring improved surface cooling. Increased procedural efficacy of pulmonary vein isolation (PVI) when compared to the first-generation balloon (CB1) has been reported. The aim of the study was to investigate the clinical outcome of cryoballoon PVI after 1 year using the CB2 as compared to the CB1., Methods and Results: A total of 105 consecutive patients with paroxysmal atrial fibrillation (AF) were studied. Cryoballoon PVI (28 mm) was performed in 50 patients using the CB1, and in 55 patients using the CB2. Patients were scheduled for 72-hour Holter ECG recording at 3, 6, 9, and 12 months and every 6 months thereafter. The study endpoint was defined as recurrent AF or atrial tachycardia >30 seconds documented after a blanking period of 90 days after the procedure. Complete PVI was achieved in 49/50 (98%) and 55/55 (100%) patients in the CB1 and CB2 group, respectively. After a mean follow-up of 416 ± 75 days, 21 (CB1 group) and 10 (CB2 group) patients reached the study endpoint. Kaplan-Meier estimates of arrhythmia-free survival after a single procedure without AAD therapy after 1 year were 63.9% versus 83.6% (P = 0.008) in the CB1 and CB2 group, respectively. Persistent phrenic nerve palsy with delayed healing occurred in 2 (CB1 group) and 3 (CB2 group) patients., Conclusion: Clinical outcome of PVI using the CB2 was significantly improved when compared to the CB1., (© 2014 Wiley Periodicals, Inc.)