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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 cGyxcm2, 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. [ABSTRACT FROM AUTHOR]

Introduction: Pulmonary vein isolation (PVI) remains the cornerstone in the treatment of atrial fibrillation (AF). PVI using cryoballoon (CB) technology has emerged as a standard procedure in many centers. Recently, pulsed field ablation (PFA) has been introduced and used to achieve PVI. First data show high acute and favorable long‐term outcomes. So far, data comparing these new "single shot" devices are sparse. We sought to compare procedural and outcome data for first time PFA users versus CB in patients undergoing de novo PVI. Furthermore, potentially postprocedural discomfort and affection of autonomic ganglia were assessed. Methods and Results: A retrospective analysis and comparison of all de novo PVIs with PFA and CB was performed. Furthermore, PFA PVI learning curve was evaluated. During follow‐up, repeat outpatient visits and Holter electrocardiogram were performed to analyze arrhythmia‐free survival. Discomfort analysis was obtained by prescribed analgesic medication within first 48 h after PVI. Potential changes in heart rate (HR) between baseline and at 3‐month follow‐up were evaluated. A total of 108 patients (54 PFA and 54 CB; PFA; 33 (30%) female) with paroxysmal and persistent AF were analyzed. Type of AF was comparable (Patients suffering from PAF: PFA: 16 (30%), CB: 17 (31%), p = 1.0). In 107 (99%) patients, successful PVI was achieved. Transient phrenic palsy omitted complete PVI in one CB patient. A trend for a shorter overall procedure duration was observed in the PFA group (PFA: 64.5 ± 17.5 min; CB: 73.0 ± 24.8 min; p = 0.07). Excluding LA mapping time (first 14 cases), procedure time was significantly shorter using PFA (PFA: 58.0 ± 12.5 min, CB: 73.0 ± 24.8 min, p = 0.0001). Fluoroscopy time was significantly longer for PFA (PFA: 15.3 ± 4.7 min, CB: 12.3 ± 5.3 min; p = 0.001), but significantly less contrast medium was used (PFA: 12 ± 6 mL; CB: 51 ± 29 mL, p < 0.0001). Subgroup analysis of the PFA group revealed a significant shortening of procedure duration over time (first tertile: 72.7 ± 13.5 min, second tertile: 67.3 ± 21.7 min, third tertile: 53.4 ± 9.8 min, first vs. third tertile p < 0.0001). Two cardiac tamponades occurred in the PFA group (p = 0.495), of which one was most likely related to complex transseptal puncture. In the first 48 h after PVI, the number of prescribed analgesics due to postprocedural pain was equal between both groups (PFA: 7 (13%) patients, CB: 10 (19%) patients, p = 0.598). After a FU of 273 ± 129 days, 35 of 47 patients (74%) after PFA and 36 of 50 patients (72%) after CB PVI were free of any atrial arrhythmia (HR: 0.98, p = 0.88). Only in the PFA group, a significant increase in HR 3 months after PVI was observed (pre‐PVI: 61 ± 8 beats/min, post‐PVI: 65 ± 9 beats/min, p = 0.008). Conclusion: The new PFA technology is equally effective and safe as compared to CB for complete PVI with potentially shorter procedure time and significantly less contrast medium. However, AF recurrence rates after PFA PVI seem to be comparable to CB PVI. [ABSTRACT FROM AUTHOR]

Background: Several clinical trials have assessed predictors for atrial fibrillation recurrence following cryoballoon catheter ablation. With these predictors, a practical and new scoring system can be developed to evaluate atrial fibrillation recurrence. The present study aimed to analyze the predictive value of the age, creatinine, and ejection fractionleft atrium score for potential recurrence of atrial fibrillation following cryoballoon catheter ablation in patients with symptomatic paroxysmal or persistent atrial fibrillation. Methods: We retrospectively analyzed records of patients undergoing cryoballoon catheter ablation. atrial fibrillation recurrence was defined as an emerging atrial fibrillation episode around 12-month follow-up (with the exclusion of a 3-month blanking period). Univariate and multivariate analyses were performed to assess predictors of atrial fibrillation recurrence. In addition, receiver operating characteristic analysis was harnessed to evaluate the performance of the age, creatinine, and ejection fraction, left atrium score in determining the risk of atrial fibrillation recurrence. Results: The study population comprised 106 subjects (age 52 ± 13 years, 63.2% women) with paroxysmal (84.9%, n = 90) or persistent (15.1%, n = 16) atrial fibrillation. age, creatinine, and ejection fraction, left atrium score was significantly higher in subjects with atrial fibrillation recurrence in comparison to those with the maintenance of sinus rhythm. However, on multivariate logistic regression analysis, only the age, creatinine, and ejection fraction, left atrium score (OR = 12.93, 95% CI: 2.22-75.21, P = .004) served as an independent predictor of atrial fibrillation recurrence following cryoballoon catheter ablation. Conclusion: Age, creatinine, and ejection fraction, left atrium score had an independent association with the risk of atrial fibrillation recurrence in subjects with atrial fibrillation undergoing cryoballoon catheter ablation. Therefore, this score might potentially serve as a useful tool for risk stratification of patients with atrial fibrillation. [ABSTRACT FROM AUTHOR]

Background: Real‐world clinical data on the adverse events related to the use of cryoballoon catheter for pulmonary vein isolation remains limited. Objective: To report and describe the adverse events related to the use of Artic Front cryoballoon catheters (Arctic Front, Arctic Front Advance, and Arctic Front Advance Pro) reported in the Food and Drug Administration's (FDA) Manufacturers and User Defined Experience (MAUDE) database. Methods: We reviewed all the adverse events reported to the FDA MAUDE database over a 10.7‐year study period from January 01, 2011 to September 31, 2021. All events were independently reviewed by two physicians. Results: During the study period, a total of 320 procedural‐related adverse events reported in the MAUDE database were identified. The most common adverse event was transient or persistent phrenic nerve palsy (PNP), accounting for 48% of all events. This was followed by cardiac perforation (15%), pulmonary vein stenosis (8%), transient ischemic attack or stroke (6%), vascular injury (4%), transient or persistent ST‐elevation myocardial infarction (3%), hemoptysis (2%), pericarditis (2%), and esophageal ulcer or fistula (1%). There were six reported intra‐procedural death events as a result of cardiac perforation. Conclusion: The two most common procedural adverse events associated with cryoballoon ablation were PNP and cardiac perforation. All cases of procedural mortality were due to cardiac perforation. [ABSTRACT FROM AUTHOR]

Background: With advancements in technology and ablation techniques, catheter ablation for the treatment of atrial fibrillation (AF) has become safer with time. In the past, standard-of-care recommended overnight stay for outpatient procedures. As safety has improved and procedure times have shortened, some centers have allowed for same-day discharge. We report the results of a multi-center, randomized clinical trial investigating the safety of same-day discharge post-cryoballoon ablation. Methods: Patients with paroxysmal atrial fibrillation underwent pulmonary vein isolation (PVI) with the Medtronic Arctic Advance cryoballoon at 3 US centers. Six hours after the procedure, patients were randomized to either stay overnight or be discharged same day. Results: A total of 49 patients were enrolled. Two patients were withdrawn prior to randomization. One patient chose to withdraw after randomization. Of the 22 patients randomized to same-day discharge and the 23 patients randomized the overnight stay, no significant adverse outcomes were reported in either group. Occurrence of adverse events did not differ significantly between the two groups. Procedure time and fluoroscopy time did not significantly differ between groups. Conclusions: This is the first randomized trial examining the safety of same-day discharge post-cryoballoon ablation. Based on our results, same-day discharge following cryoballoon ablation for paroxysmal AF is a safe option following uncomplicated ablation for PVI. Operators should use their discretion in selecting patients for same-day discharge. [ABSTRACT FROM AUTHOR]

Background: An ablation index (AI)-guided pulmonary vein isolation (PVI) or 2nd generation cryoballoon (CB)-PVI has been shown to reduce the atrial fibrillation (AF) burden by 99% despite the absence of ablation of non-pulmonary vein (PV) triggers in patients with paroxysmal AF. The purpose of this study was to investigate the effects of PVI alone strategy using 2nd generation CB compared with AI-guided PVI with an additional induction test and subsequent AF trigger ablation. Methods and results: We investigated 223 patients with symptomatic paroxysmal AF who underwent an initial PVI between August 2018 and August 2020. The study patients were divided into 2 groups: CB-PVI without an induction test (CB-PVI alone group, n = 82) and AI-guided PVI with an induction test and subsequent additional ablation of non-PV triggers (AI-PVI plus group, n = 141). In the AI-PVI plus group, a total of 62 non-PV triggers were induced in 38 patients, and non-PV triggers in 22 patients were completely ablated. The procedure time and left atrium dwell time were significantly shorter in the CB-PVI alone group than AI-PVI plus group. There were no significant differences in the incidence of procedural complications between the 2 groups (P = 0.650). The AF free survival rate in the CB-PVI alone group and AI-PVI plus group was 80% vs. 80% at 24 months (P = 0.969). Conclusions: An PVI alone strategy using advanced generation CB did not differ in the clinical outcomes compared with an AI-guided PVI strategy with an induction test and subsequent ablation of non-PV triggers in the patients with paroxysmal AF. [ABSTRACT FROM AUTHOR]

Cryoballoon ablation (CBA) is an effective treatment for drug‐refractory atrial fibrillation (AF) patients. Whether CBA as a first‐line treatment is superior in the rhythm control of AF than antiarrhythmic drugs (AAD) remains unclear. CBA is superior to AAD as initial therapy for rhythm control of paroxysmal atrial fibrillation (PAF). A comprehensive database search was performed in PubMed, Embase, Cochrane, and Web of Science from inception to March 22, 2023. Treatment efficacy was pooled using risk ratio (RR) and standardized mean difference (SMD) with a 95% confidence interval (CI). This study was registered with Prospero (CRD42023401596). Five randomized‐controlled trials involving 923 patients and an observational study were included in this study. The CBA group had a significantly lower overall recurrence rate than the AAD group (CBA vs. AAD: RR = 0.59, 95% CI = 0.49–0.71, p <.05, I2 = 0). The incidence of persistent AF could be better controlled in the CBA group than in the AAD (CBA vs. AAD: RR = 0.17, 95% CI = 0.06–0.49, p <.05, I2 = 0). CBA could improve the quality of life (QoL) of patients better than AAD (CBA vs. AAD: SMD = 0.40, 95% CI = 0.14–0.67, p <.05, I2 = 68.5%). CBA can reduce hospitalization rate significantly than AAD at 36‐month follow‐up (CBA vs. AAD: RR = 0.29, 95% CI = 0.15‐0.58, p <.05, I2 = 0%). Compared to AAD, CBA as first‐line therapy could reduce the recurrence rate of atrial arrhythmia and incidence of persistent AF and improve QoL in PAF patients with lower incidences of hospitalization. [ABSTRACT FROM AUTHOR]

The relationship between epicardial adipose tissue (EAT) and atrial fibrillation (AF) has gained interest in recent years. The previous literature on the topic presents great heterogeneity, focusing especially on computed tomography imaging. The aim of the present study is to determine whether an increased volume of left atrial (LA) EAT evaluated at routine pre-procedural cardiac magnetic resonance imaging (MRI) relates to AF recurrences after catheter ablation. A total of 50 patients undergoing AF cryoballoon ablation and pre-procedural cardiac MRI allowing quantification of LA EAT were enrolled. In one patient, the segmentation of LA EAT could not be achieved. After a median follow-up of 16.0 months, AF recurrences occurred in 17 patients (34%). The absolute volume of EAT was not different in patients with and without AF recurrences (10.35 mL vs. 10.29 mL; p-value = 0.963), whereas the volume of EAT indexed on the LA volume (EATi) was lower, albeit non-statistically significant, in patients free from arrhythmias (12.77% vs. 14.06%; p-value = 0.467). The receiver operating characteristic curve testing the ability of LA EATi to predict AF recurrence after catheter ablation showed sub-optimal performance (AUC: 0.588). The finest identified cut-off of LA EATi was 10.65%, achieving a sensitivity of 0.5, a specificity of 0.82, a positive predictive value of 0.59 and a negative predictive value of 0.76. Patients with values of LA EATi lower than 10.65% showed greater survival, free from arrhythmias, than patients with values above this cut-off (84% vs. 48%; p-value = 0.04). In conclusion, EAT volume indexed on the LA volume evaluated at cardiac MRI emerges as a possible independent predictor of arrhythmia recurrence after AF cryoballoon ablation. Nevertheless, prospective studies are needed to confirm this finding and eventually sustain routine EAT evaluation in the management of patients undergoing AF catheter ablation.

Typical atrial flutter commonly occurs in patients with atrial fibrillation (AF). Limited information exists regarding the effects of concurrent atrial flutter on the long-term outcomes of rhythm control. This study investigated the association between concurrent typical atrial flutter and cavotricuspid isthmus (CTI) ablation and the recurrence of atrial arrhythmia. The data were obtained from a multicenter registry of cryoballoon ablation for AF (n = 2,689). Patients who were screened for typical atrial flutter were included in the analysis (n = 1,907). All the patients with typical atrial flutter underwent CTI ablation. The primary endpoint was the late recurrence of atrial arrhythmia, including AF, atrial flutter, and atrial tachycardia. Among the 1,907 patients, typical atrial flutter was detected in 493 patients (25.9%). Patients with concurrent atrial flutter had a lower incidence of persistent AF and a smaller size of the left atrium. Patients with atrial flutter had a significantly lower recurrence rate of atrial arrhythmia (19.7% vs. 29.9%, p

BackgroundThe comparative efficacy, saftey, and heart rate variability (HRV) parameters after pulmonary vein isolation using cryoballoon (Cryo-PVI), high-power short-duration (HPSD-PVI), and conventional radiofrequency ablation (conventional-PVI) for atrial fibrillation (AF) is unclear.Materials and methodsIn this propensity score-weighted, retrospective analysis of a single-center cohort, we analyzed 3,395 patients (26.2% female, 74.5% paroxysmal AF) who underwent AF catheter ablation without an empirical left atrial ablation. Procedural factors, recurrence rates, complication rates, and the post-procedural HRV parameters were compared across the Cryo-PVI (n = 625), HPSD-PVI (n = 748), and conventional-PVI (n = 2,022) groups.ResultsDespite the shortest procedural time in the Cryo-PVI group (74 min for Cryo-PVI vs. 104 min for HPSD-PVI vs. 153 min for conventional-PVI, p

Objective: To compare the efficacy of cryoballoon ablation (CBA) and radiofrequency catheter ablation (RFCA) in the treatment of paroxysmal atrial fibrillation (AF), and to explore the risk factors of recurrence 1 year after operation. Methods: 100 patients with paroxysmal AF who were admitted to our hospital from February 2019 to February 2021 were selected, and the patients were divided into group A (n=48, RFCA) and group B (n=52, CBA) according to the different operation schemes. The operation related indicators, the incidence of complications and the recurrence rate of 1 year after operation were compared in the two groups. All patients were divided into recurrence group and non-recurrence group according to whether or not they had a recurrence. Multivariate Logistic regression were used to analyze the risk factors of recurrence 1 year after operation. Results: The operation time, ablation time and X-ray exposure time in the group B were shorter than those in the group A (P＜0.05). The total incidence of complications in the group B was lower than that in the control group (P＜0.05). There was no significant difference in recurrence rate between the two groups (P＞0.05). Univariate analysis showed that the recurrence of paroxysmal AF patients 1 year after operation was related to B-type natriuretic peptide (BNP), age, white blood cell count (WBC), body mass index, creatinine (Cr), combined hypertension, high-sensitivity C-reactive protein (hs-CRP), diabetes,left atrial diameter (LAD), combined coronary heart disease, course of disease, uric acid, and the type of f wave in electrocardiogram (P＜0.05). Multivariate analysis showed that longer course of disease, higher uric acid, larger LAD, older age, higher hs-CRP, fine wave type of f wave in electrocardiogram, and higher BNP were risk factors for recurrence of paroxysmal AF patients 1 year after operation (P＜0.05). Conclusion: Both CBA and RFCA have a good effect in the treatment of paroxysmal AF. CBA has a good effect in improving the operation condition and safety of patients. The recurrence rate of patients with paroxysmal AF was high one year after operation, and the course of disease, uric acid, LAD, age, hs-CRP, BNP, and the type of f wave in electrocardiogram were all the influencing factors. [ABSTRACT FROM AUTHOR]

Background: Cryoballoon ablation (CBA) is an established approach for rhythm management of atrial fibrillation (AF). We sought to assess balloon temperature (BT) parameters as predictors of pulmonary vein (PV) reconnection within the index procedure and AF recurrence following CBA. Methods: BT was monitored in 119 AF patients undergoing CBA. PVs were assessed for reconnection during the procedure and patients were followed for arrhythmia recurrence. Results: PV reconnection was identified in 39 (8.3%) of 471 PVs. BT was significantly colder in the absence of PV reconnection (30 s: − 33.5 °C [− 36; − 30] vs − 29.5 °C [− 35; − 25.5], p = 0.001; 60 s: − 41 °C [− 44; − 37] vs − 36.5 °C [− 42; − 33.5], p < 0.001; nadir: − 47 °C [− 52; − 43] vs − 41.5 °C [− 47; − 38], p < 0.001). PV reconnection was associated with significantly longer time to reach − 15 °C and – 40 °C (14.5 s [11.5–18.5] vs 12 s [10–15.5], p = 0.023; and 75 s [40–95.5] vs 46 s [37–66.75], p = 0.005) and shorter rewarming time (5.75 s [4.75–8.5] vs 7 s [6–9], p = 0.012). ROC analysis of these procedural parameters had an AUC = 0.71 in predicting PV reconnection. AF recurrence occurred in 51 (42.8%) patients. Kaplan–Meier analysis showed better arrhythmia-free survival for patients in whom BT decreased below – 40 °C in all PVs and patients who had no early PV reconnections, compared to patients in whom BT below – 40 °C was not achieved in at least one PV (log rank = 6.3, p = 0.012) and patients who had PV reconnections (log rank = 4.1, p = 0.043). Conclusions: Slower BT decline, warmer BT nadir, and faster rewarming time predict early PV reconnection. Absence of early PV reconnections and BT dropping below – 40 °C in all PVs during CBA are associated with lower rates of AF recurrence. [ABSTRACT FROM AUTHOR]

Background: Studies have identified significant sex‐based differences and disparities in the clinical presentation and treatment of atrial fibrillation (AF). Studies have shown women are less likely to be referred for catheter ablation, are older at the time of ablation, and are more likely to have recurrence after ablation. However, in most studies investigating AF ablation outcomes, the female cohorts were relatively small. The impact of sex on the outcome and safety of ablation procedures is still unclear. Objective: To investigate sex‐based differences in outcomes and complications after AF catheter ablation, with a significant female cohort Method: In this retrospective study, patients undergoing AF ablation from January 1, 2014, to March 31, 2021, were included. We investigated clinical characteristics, duration and progression of AF, number of EP appointments from diagnosis to ablation, procedural data, and procedure complications. Results: Total of 1346 patients underwent first catheter ablation for AF during this period, including 896 (66.5%) male and 450 (33.4%) female patients. Female patients were older at the time of ablation (66.2 vs. 62.4 years; p <.001). Women had higher CHA2DS2‐VASc (congestive heart failure, hypertension, age, diabetes, stroke, vascular disease, sex category) scores (3 vs. 2; p <.001) than men, expectedly, as the female sex warrants an additional point. 25.3% female patients had PersAF at the time of diagnosis versus 35.3% male patients (p <.001). At the time of ablation, 31.8% female patients had PersAF as compared to 43.1% male patients (p <.001), indicating progression of PAF to PersAF in both sexes. Women tried more AADs than men before ablation (1.13 vs. 0.98; p =.002). Male and female patients had no statistically significant difference in (a) arrhythmia recurrence at 1‐year post ablation (27.7% vs. 30%; p =.38) or (b) procedural complication rate (1.8% vs. 3.1%; p =.56). Conclusion: Female patients were older and had higher CHA2DS2‐VASc scores compared to males at the time of AF ablation. Women tried more AADs than men before ablation. One‐year arrhythmia recurrence rates and procedural complications were similar in both sexes. No sex‐based differences were observed in safety and efficacy of ablation. [ABSTRACT FROM AUTHOR]

Introduction: Patients with persistent atrial fibrillation (AF) represent a challenging population for rhythm control therapies. Catheter ablation (CA) with pulmonary vein isolation (PVI) is an effective treatment option for the reduction of the arrhythmic burden. Data regarding the comparability between radiofrequency (RF) and cryoballoon ablation (CRYO) in persistent AF are limited. Methods: This is a prospective, randomized, single‐center study designed to compare the efficacy in terms of rhythm control between RF and CRYO in persistent AF. Eligible participants were randomized 2:1 in two arms: RF and CRYO. The primary endpoint of the study was arrhythmia relapse in the early postprocedural period (first 3 months) and in the middle term follow‐up (3 months to 12 months). Secondary endpoints included procedure duration, fluoroscopy time, and complications. Results: A total of 199 patients participated in the study (133 patients in the RF arm, 66 in the CRYO arm). No statistically significant difference occurred between the two groups regarding the primary endpoint (recurrences ≤3 months: 35.5% RF vs. 37.9% CRYO, p.755, recurrences >3 months: 26.3% RF vs. 27.3% CRYO, p.999). From the secondary endpoints, CRYO was a procedure of significantly shorter duration (75.15 ± 17.21 in CRYO vs. 136.6 ± 43.33 in RF group, p <.05). Conclusion: CRYO and RF ablation appear to be equally effective for rhythm control in patients with persistent AF. CRYO ablation is advantageous in terms of procedure duration. [ABSTRACT FROM AUTHOR]

Abstract Background The acute success rate of pulmonary vein isolation (PVI) with cryoballoon (CB) is reported to be lower in the right inferior pulmonary vein (RIPV). This study aimed to investigate the utility of the “balloon lever technique (BLT)” for RIPV CB ablation. Methods We retrospectively studied consecutive patients who underwent CB‐PVI for atrial fibrillation between February 21, 2020 and June 3, 2022. RIPV cryoablation was performed according to a specific protocol. The patients underwent RIPV cryoablation using the conventional method. If the method was found ineffective, BLT cryoablation was performed. The acute success rate of RIPV CB ablation was examined. We also investigated the RIPV isolation rate and procedural parameters during conventional and BLT cryoablation. Results Ninety‐three patients were included in the analysis. RIPV isolation was achieved in 89.2% (83/93) of the patients using conventional method and subsequent BLT cryoablation. Meanwhile, 68 patients underwent BLT cryoablation because the conventional method was ineffective. RIPV was isolated with BLT in 85.3% (58/68) of patients. Additionally, BLT was found to be superior to conventional cryoablation in terms of nadir balloon temperature, freezing time, and thawing time to a specific temperature in patients who underwent both conventional and BLT cryoablations. Conclusions BLT is useful in RIPV cryoablation when the conventional method is ineffective. BLT cryoablation may be helpful, mainly because of the BLT‐mediated contact of the balloon with the bottom of the RIPV, which leads to optimal RIPV occlusion.

Abstract Aims Limited data are available on the outcomes of cryoballoon ablation (CBA)‐based pulmonary vein isolation (PVI) for atrial fibrillation (AF) in patients with heart failure (HF) with preserved ejection fraction (HFpEF) and mildly reduced ejection fraction (HFmrEF). The present study aimed to evaluate the safety and effectiveness of CBA in such patients. Methods and results Consecutive patients with AF referred for CBA‐based PVI from two highly experienced electrophysiology centres were included in this retrospective study. Of 651 patients undergoing CBA, 471 cases were divided into four groups: No HF (n = 255), HFpEF (n = 101), HFmrEF (n = 78), and HF with reduced ejection fraction (n = 37). Similar early recurrence of atrial arrhythmia was found among groups (16.2% vs. 15.4% vs. 14.9% vs. 12.2%, P = 0.798), and no significant difference of long‐term sinus rhythm (SR) maintenance was identified among the HFmrEF, HFpEF, and No HF groups (71.8% vs. 75.2% vs. 79.6%, P = 0.334). CBA is safe for patients with HFmrEF and HFpEF with similar complications compared with the No HF group (3.8% vs. 4.0% vs. 3.1%, P = 0.814). The reassessment of cardiac function after CBA showed that patients with HF indicated beneficial outcomes. Left atrial diameter (LAD) and left ventricular ejection fraction were significantly improved in the HFmrEF group. There were 41.6% of patients in the HFpEF group who were completely relieved from HF. LAD and New York Heart Association (NYHA) were associated with recurrence in the HFpEF and HFmrEF groups, and the maintenance of SR was an independent predictor of NYHA improvement for all HF groups. Conclusions Patients with HFmrEF and HFpEF could benefit from CBA with high SR maintenance and significant HF improvement.

Abstract Background Facing an increasing number of radiofrequency ablation (RF) and cryoballoon ablation (CB) procedures for treatment of AF radiation exposure and its reduction is a focus point for interventional electrophysiologists. Objective This study evaluated the procedural parameters of the different ablation methods focusing on radiation exposure and the BMI of the patients. Methods One thousand one hundred and thirty‐three first procedural cases of pulmonary vein isolation in patients with paroxysmal and persistent AF treated with RF and CB‐based techniques were analyzed retrospectively over a period of 7 years focusing on the endpoints dose area product (DAP, cGycm2), fluoroscopy time (FT, min) and procedural time (PT, min). Results Of the 1133 patients (mean age 63.4 ± 11.4 years, BMI 28.9 ± 4.7) 335 patients received an RF procedure, 211 patients were treated with the cryoballoon first generation (CB1), and 587 patients with cryoballoon second generation (CB2), respectively. The mean DAP for the PVI was 508 ± 654 cGycm2 in RF procedures, 1077 ± 683 cGycm2 in CB1‐procedures, and 587 ± 489 cGycm2 in CB2‐procedures with fluoroscopy times significantly shorter in RF procedures (9.6 ± 5.2 min) as compared to 17.7 ± 5.9 min in CB1‐ and 16.3 ± 6.3 min in CB2‐procedures (p

Backgrounds: Catheter ablation for non‐paroxysmal atrial fibrillation (non‐PAF) remains challenging and more effective strategy has been required to reduce postoperative arrhythmia recurrences. This study aims to investigate the efficacy and safety of a novel extensive ablation strategy for non‐PAF, that is based on a combination of cryoballoon (CBA), radiofrequency (RFA), and Marshall‐vein ethanol ablations (EA‐VOM). Methods: The study was a single‐center, retrospective observational study. We enrolled 171 consecutive patients who underwent de‐novo catheter ablation for non‐PAF under conscious sedation with a novel extensive ablation strategy that included CBA for pulmonary vein isolation (PVI) and left atrial roof ablation (LARA), RFA for mitral isthmus (MI) ablation, superior vena cava isolation, and other linear ablations and EA‐VOM. Recurrence of atrial arrhythmias over 1 year, procedure outcomes, and procedure‐related complications were investigated. Results: A total of 139 (81.3%) patients remained in sinus rhythm during 1‐year follow‐up. Of the 139 patients, 51 patients (29.8%) received antiarrhythmic drugs. The mean procedure time was 204 ± 45 min. PVI and LARA ablation by CBA and MI block by RFA and EA‐VOM were completed in 171 (100%) and 166 (97.1%) patients, respectively. No serious procedure‐related complications were observed except for one case of delayed pericardial effusion. Conclusion: Approximately 80% of the study patients were AF‐free during 1‐year follow‐up period after a single procedure based on the novel extensive ablation strategy combining CBA, RFA, and EA‐VOM. This strategy for non‐PAF may be preferred in terms of maintenance of sinus rhythm, safety even in high‐risk patients, and relatively short procedure time. [ABSTRACT FROM AUTHOR]

Aims: Pulmonary vein isolation (PVI) is achievable and effective using radiofrequency (RF) catheter (CA) or cryoballoon (CB) ablation. The newly introduced high RF-power short-duration ablation (HPSD) technique has shown promising results. Data comparing HPSD- to CB-PVI is sparse. We sought to investigate success rates and procedural differences of HPSD-PVI vs. CB-PVI in patients undergoing ablation for PAF and persAF. Methods: Consecutive patients undergoing de novo PVI (HPSD or CB) were included. A power setting of 70W/7 s (70W/5 s at posterior wall) using a flexible tip catheter with enhanced irrigation was considered as true HPSD. Follow-up consisted of out-clinic pts visits, tele-consultation, 48-h Holter ECG, app-based telemonitoring and cardiac implanted electronic devices (CIED) interrogation. Results: 721 patients (46 HPSD, 675 CB) were analyzed. In all HPSD (27 persAF [59%]) and CB patients (423 persAF [63%]), PVI was successfully achieved. Procedure duration was significantly longer for HPSD (91 ± 19 min vs. 72 ± 18 min, p < 0.01). Ablation time was similar in both groups (HPSD: 44 ± 19 min vs. CB: 40 ± 17 min; p = 0.347). No major complications occurred in HPSD. For CB-PVI, in 25 (3.7%; p = 0.296) patients, complications occurred. At a follow-up of 290 ± 135 days, arrhythmia-free survival using HPSD was non-inferior to CB-PVI in the Kaplan–Meier survival analysis (p = 0.096). Conclusion: PVI using HPSD is equally effective and safe to CB-PVI. This analysis revealed a similar arrhythmia-free survival after HPSD and CB with low complication rates. Procedure duration for CB was significantly shorter while LA dwell time excluding mapping was equal. Currently, a prospective trial is conducted to corroborate these findings. [ABSTRACT FROM AUTHOR]

Preventing phrenic nerve injury (PNI) during balloon-based ablation is essential. The superior vena cava-right atrial (SVC-RA) junction is located just opposite the balloon position during right superior pulmonary vein (RSPV) ablation, and the phrenic nerve runs nearby on the lateral side. We compared the occurrence of PNI between the two balloon-based ablation systems and also the lesions created at the SVC-RA junction, which were expected to represent the effect on extra-PV structures. Cryoballoon ablation (CBA, n = 110) and hot-balloon ablation (HBA, n = 90) were performed in atrial fibrillation patients. High-density maps of the SVC-RA junction were created in 93 patients (CBA = 53, HBA = 40), and the damaged area (< 1.0 mV) was determined as an "SVC lesion". CBA had a higher occurrence of transient PNI (7.3% vs 1.1%, p = 0.035), but all recovered during the 6-month follow-up. An apparent SVC lesion was documented in 43% of the patients (40/93), and all patients with PNI had this lesion. CBA created a frequent (CBA vs HBA = 55% vs 28%, p = 0.008) and wider (0.8[0.4–1.7] cm2 vs 0.5[0.3–0.7] cm2, p = 0.005) SVC lesion than HBA. A multivariate analysis revealed that the use of a CBA system was a predictive factor of the occurrence of SVC lesions. CBA had a higher occurrence of transient PNI but not a permanent form. Every patient with PNI had lesions on the SVC-RA junction, and CBA revealed more substantial ablation effects at the SVC-RA junction than HBA. This may be caused by the different characteristics of the two balloon-based ablation systems and their balloon positions. [ABSTRACT FROM AUTHOR]

Deep brain stimulation (DBS) is a well-established therapy for drug-refractory Parkinson's disease. As 100–200 Hz signals from DBS are transmitted from the generator implanted subcutaneously in the anterior chest wall, there is a risk of central nervous system damage by radiofrequency energy or cardioversion. A 76-year-old female with a DBS was admitted for catheter ablation because of palpitation and syncope by paroxysmal atrial fibrillation. There may have been a risk of central nervous system damage and DBS electrode malfunction by radiofrequency energy and defibrillation shocks. In addition, cardioversion by an external defibrillator had the possibility to cause brain injury in patients with DBS. Therefore, pulmonary vein isolation by cryoballoon and cardioversion using an intracardiac defibrillation catheter were performed. Despite continued application of DBS during the procedure, no complications occurred. This is the first case report of cryoballoon ablation accompanied with intracardiac defibrillation under continued DBS. Cryoballoon ablation may be an alternative atrial fibrillation ablation method to radiofrequency catheter ablation for patients with DBS. Additionally, intracardiac defibrillation may reduce the risk of central nervous system damage and DBS malfunction. Deep brain stimulation (DBS) is a well-established therapy for Parkinson's disease. In patients with DBS, there is a risk of central nervous system damage by radiofrequency energy or cardioversion by an external defibrillator. Cryoballoon ablation may be an alternative atrial fibrillation ablation method to radiofrequency catheter ablation for patients with continued DBS. In addition, intracardiac defibrillation may reduce the risk of central nervous system damage and DBS malfunction. [ABSTRACT FROM AUTHOR]

Aims The development of intracardiac echocardiography (ICE) has enabled fluoroless atrial fibrillation (AF) ablation using three-dimensional electroanatomical mapping systems. However, fluoroless cryoballoon ablation (CBA) remains challenging, mainly because of the lack of a visual mapping system. Hence, this study aimed to investigate the safety and efficacy of fluoroless CBA for AF under ICE guidance. Methods and results Patients (n = 100) who underwent CBA for paroxysmal AF were randomly assigned to zero-fluoroscopic (Zero-X) and conventional groups. Intracardiac echocardiography was used to guide the transseptal puncture and catheter and balloon manipulation in all enrolled patients. The patients were prospectively followed for 12 months after CBA. The mean age was 60.4 years, and the left atrial (LA) size was 39.4 mm. Pulmonary vein isolation (PVI) was achieved in all patients. In the Zero-X group, fluoroscopy was used in only one patient because of unstable phrenic nerve capture during right-sided PVI. The procedure time and LA indwelling time in the Zero-X group were not statistically different compared with that in the conventional group. Fluoroscopic time (9.0 vs. 0.008 min) and radiation exposure (29.4 vs. 0.02 mGy) were significantly shorter in the Zero-X group than in the conventional group (P < 0.001). The complication rate did not differ between the two groups. During a mean follow-up of 663.3 ± 172.3 days, the recurrence rate was similar (16.0 vs. 18.0%; P = 0.841) between the groups. Multivariate analysis revealed that LA size was the only independent predictor of clinical recurrence. Conclusion Intracardiac echocardiography–guided fluoroless CBA for AF was a feasible strategy without compromising acute and long-term success or complication rates. [ABSTRACT FROM AUTHOR]

Introduction: Pulmonary vein isolation (PVI) is well established as a primary treatment for atrial fibrillation (AF). The POLAR ICE study was designed to collect prospective real world data on the safety and effectiveness of the POLARxTM cryoballoon for PVI to treat paroxysmal AF. Methods: POLAR ICE, a prospective, non‐randomized, multicenter (international) registry (NCT04250714), enrolled 399 patients across 19 European centers. Procedural characteristics, such as time to isolation, cryoablations per pulmonary vein (PV), balloon nadir temperature, and occlusion grade were recorded. PVI was confirmed with entrance block testing. Results: Data on 372 de novo PVI procedures (n = 2190 ablations) were collected. Complete PVI was achieved in 96.8% of PVs. Procedure and fluoroscopy times were 68.2 ± 24.6 and 15.6 ± 9.6 min, respectively. Left atrial dwell time was 46.6 ± 18.3 min. Grade 3 or 4 occlusion was achieved in 98.2% of PVs reported and 71.2% of PVs isolation required only a single cryoablation. Of 2190 cryoapplications, 83% had a duration of at least 120 s; nadir temperature of these ablations averaged −56.3 ± 6.5°C. There were 6 phrenic nerve palsy events, 2 of which resolved within 3 months of the procedure. Conclusion: This real‐world usage data on a novel cryoballoon suggests this device is effective, safe, and relatively fast in centers with cryoballoon experience. These data are comparable to prior POLARx reports and in keeping with reported data on other cryoballoons. Future studies should examine the long‐term outcomes and the relationship between biophysical parameters and outcomes for this novel cryoballoon. [ABSTRACT FROM AUTHOR]

Objective To investigate the efficacy, safety and recurrence risk factors of cryoballoon ablation for atrial fibrillation(AF). Methods One hundred and fourteen patients were divided into paroxysmal AF group (n = 61) and persistent AF group (n = 53). Circumferential pulmonary vein cryoablation (CPVC) was performed in all the patients, and persistent AF patients underwent pulmonary vein antrum cryoablation in addition. The operation time, X-ray exposure time, immediate and long-term success rate of CPVC, and procedure-related complications were analyzed in the two groups. The recurrence rate and related recurrence factors of AF within one year after operation were compared between the two groups. Results The immediate success rates of pulmonary vein isolation are both 100% in the two groups. There are significant differences of the operation time, X-ray exposure time and intraoperative heparin dosage between the two groups (P < 0. 05). No serious complication is found in either of the two groups. After 12 months of follow-up, the success rates of AF ablation in the paroxysmal and persistent AF groups are 85. 25% and 81. 13%, respectively ( P = 0. 62). AF duration and left atrial diameter ( LAD) are associated with the recurrence of persistent AF. Conclusion Cryoballoon ablation is both effective and safe for patients with paroxysmal and persistent AF. AF duration and LAD before ablation are independent risk factors for postoperative recurrence in persistent AF patients. [ABSTRACT FROM AUTHOR]

Objectives: The study aimed at assessing the outcome of pulmonary vein isolation (PVI) using second-generation cryoballoon, Arctic Front Advance, Medtronic (CB-Adv) as a rhythm control strategy for drug-resistant paroxysmal atrial fibrillation (PAF) in a cardiac tertiary care center of Pakistan. Methodology: Fifty patients had PVI with CB-Adv for symptomatic drug-resistant PAF at the National Institute of Cardiovascular Diseases, Karachi, Pakistan, during 2017-2022. Patients were followed-up in the clinic on the 1st, 3rd, and 6th month after the ablation. Twenty-four hours of Holter monitoring of electrocardiogram was obtained on each visit. We conducted a retrospective chart review after approval from the ethical review committee. We collected all the patients' demographic and clinical data, procedural results, and reports of Holter monitoring. The primary outcome was successful PVI and freedom from atrial tachyarrhythmia (Ata) on a 6-month follow-up. Results: We enrolled all 50 patients (34 male, 68%; mean age 55.14 ± 7.94 years) treated with PVI using CB-Adv. The mean duration of symptoms was 30.28 ± 13.48 months. PVI with CBAdv was found to be curative in 49 patients (98%). Following the procedure, pericardial effusion was found in one patient (2%), whereas one patient (2%) had a retroperitoneal hematoma. On a six-month follow-up, only one patient (2%) had a recurrence of Ata, which was PAF. Conclusion: Our experience of PVI with CB-Adv has shown a high success rate of the procedure for rhythm control in patients who have PAF, which is resistant to antiarrhythmic drugs (AADs). [ABSTRACT FROM AUTHOR]

BackgroundNewly developed catheter ablation (CA) techniques, such as laser balloon ablation (LBA) and cryoballoon ablation (CBA), have been introduced in recent years and emerged as valuable alternatives to conventional radiofrequency CA strategies for paroxysmal atrial fibrillation (PAF) patients. However, evidence comparing LBA and CBA remain controversial. Thus, we conducted this meta-analysis to assess the efficacy and safety between these two techniques.MethodsScientific databases (PubMed, Embase) and relevant websites (the Cochrane Library, ClinicalTrials.gov) were systematically searched from inception to March 2023. The primary outcomes of interest were the AF recurrence and the procedure-related complications. Secondary outcomes included procedural time, fluoroscopy time, and left atrial (LA) dwell time.ResultsSeven clinical trials with a total of 637 patients were finally enrolled. No significant differences were found between LBA and CBA in terms of AF recurrence [16.3% vs. 22.7%, odds ratio (OR) = 0.66, 95% confidence interval (CI): 0.42–1.05, p = 0.078] or total procedural-related complications (8.4% vs. 6.4%, OR = 1.33, 95% CI: 0.71–2.51, p = 0.371). LBA had a significantly longer procedural time [weighted mean difference (WMD) = 38.03 min, 95% CI: 13.48–62.58 min, p = 0.002] and LA dwell time (WMD = 46.67 min, 95% CI: 14.63–78.72 min, p = 0.004) than CBA, but tended to have shorter fluoroscopy time.ConclusionsLBA and CBA treatment have comparable efficacy and safety for PAF patients. LBA was associated with longer procedural and LA dwell times compared with CBA. Further large-scale studies are warranted to compare these two techniques with the newest generations.Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=426513, identifier (CRD42023426513).

BackgroundFew studies have explored the use of machine learning models to predict the recurrence of atrial fibrillation (AF) in patients who have undergone cryoballoon ablation (CBA). We aimed to explore the risk factors for the recurrence of AF after CBA in order to construct a nomogram that could predict this risk.MethodsData of 498 patients who had undergone CBA at Ruijin Hospital, Shanghai Jiaotong University School of Medicine, were retrospectively collected. Factors such as clinical characteristics and biophysical parameters during the CBA procedure were collected for the selection of variables. Scores for all the biophysical factors—such as time to pulmonary vein isolation (TTI) and balloon temperature—were calculated to enable construction of the model, which was then calibrated and compared with the risk scores.ResultsA 36-month follow-up showed that 177 (35.5%) of the 489 patients experienced AF recurrence. The left atrial volume, TTI, nadir cryoballoon temperature, and number of unsuccessful freezes were related to the recurrence of AF (P

Background: Patients with obesity are at higher risk of developing atrial fibrillation (AF) and benefit from radiofrequency ablation. Potentially, cryoballoon ablation (CBA) may be equally effective and safe in such patients. Methods: We conducted a prospective, single-center study to investigate whether CBA for pulmonary vein isolation is as effective and safe in obese patients as it is in non-obese controls. Primary efficacy endpoint was recurrence of AF, atrial flutter or atrial tachycardia after a 90-day blanking period. Safety endpoints were death, stroke or procedure-associated complications. Conduction of a subgroup analysis regarding the impact of additional diabetes was predefined in case the primary efficacy endpoint was met. The study was event driven and powered for noninferiority. Results: A total of 949 patients underwent CBA (251 obese with mean body-mass-index 33.5 ± 3 kg/m2 and 698 non-obese with mean body-mass-index 25.3 ± 3 kg/m2) during a 5-year recruitment period. Median follow-up was 15 months. The primary efficacy endpoint occurred in 78/251 obese and 247/698 non-obese patients (12-months Kaplan-Meier event-rate estimates, hazard ratio 0.79; 95% confidence interval [CI], 0.58 to 1.07; log-rank P = 0.0002 for noninferiority). No differences were observed in safety end point occurrence (P = 0.78). The occurrence of primary efficacy end point was found to be unaffected by the presence of diabetes in the prespecified subgroup analysis (log-rank P = 0.57). Conclusion: CBA is effective and safe in obese and DM patients. Weighing the high cardiovascular risk of obese patients against a reduction of cardiovascular events by early rhythm control, CBA should be offered to this patient population.

BackgroundBalloon-based catheter ablation (CA) technologies, including hot balloon ablation (HBA), laser balloon ablation (LBA) and cryoballoon ablation (CBA) have been introduced in recent years as alternatives to conventional radiofrequency ablation therapy for atrial fibrillation (AF). However, the results remain controversial concerning the optimal approach. Thus, we conducted a network meta-analysis (NMA) to comprehensively evaluate the efficacy and safety of HBA, LBA and CBA.MethodsClinical trials comparing the efficacy and safety of HBA, LBA and CBA were identified through a systematic search up to October 2022. The primary outcomes of interest were the recurrence of AF and procedure-related complications.ResultsTwenty clinical trials with a total of 1,995 patients were included in the meta-analysis. The NMA results demonstrated that HBA, LBA and CBA had comparable AF recurrence rates (HBA vs. CBA: odds ratio OR = 0.88, 95% credible interval CrI: 0.56–1.4; LBA vs. CBA: OR = 1.1, 95% CrI: 0.75–1.5; LBA vs. HBA: OR = 1.2, 95% CrI: 0.70–2.0) and procedure-related complications (HBA vs. CBA: OR = 0.93, 95% CrI: 0.46–2.3; LBA vs. CBA: OR = 1.1, 95% CrI: 0.63–2.1; LBA vs. HBA: OR = 1.2, 95% CrI: 0.44–2.8). The surface under the cumulative ranking curve (SUCRA) suggested that HBA may be the optimal approach concerning the primary outcomes (SUCRA = 74.4%; 61.1%, respectively). However, HBA (40.1%) had a significantly higher incidence of touch-up ablation (TUA) than LBA (8.5%, OR = 2.8, 95% CrI: 1.1–7.1) and CBA (11.9%, OR = 3.7, 95% CrI: 1.9–7.5). LBA required more procedure time than CBA [mean difference (MD = 32.0 min, 95% CrI: 19.0–45.0 min)] and HBA (MD = 26.0 min, 95% CrI: 5.6–45.0 min), but less fluoroscopy time than HBA (MD = −9.4 min, 95% CrI: −17.0–−2.4 min).ConclusionsHBA, LBA and CBA had comparable efficacy and safety as initial treatments for AF. HBA ranked highest in the primary outcomes, but at the cost of a higher incidence of TUA and longer fluoroscopy time.Systematic Review Registrationwww.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022381954, identifier: CRD42022381954.

Background: Adding electroanatomical left atrial (LA) voltage mapping to cryoballoon ablation (CBA) improves validation of acute pulmonary vein isolation (PVI). Aims: To determine whether the addition of mapping can improve outcome and PVI durability. Methods: One-year outcome and PV reconnection (PVR) rate at first repeat ablation were studied in 400 AF patients in a propensity-matched analysis (age, AF type, CHA2DS2-VASc score) between Achieve catheter-guided CBA with additional EnSite LA voltage maps performed pre- and post-CBA (mapping group; N = 200) and CT- and Achieve catheter-guided CBA (control group; N = 200). Clinical success was defined as freedom of documented AF or atrial tachycardia (AT) > 30 s. PV reconnection patterns were characterized in repeat ablations. Results: At 1 year, 77 (19.25%) patients had recurrence of AF/AT, significantly lower than in the mapping group: 21 (10.5%) vs. 56 (28%), p < 0.001. Procedure time was shorter (72.2 ± 25.4 vs. 78.2 ± 29.3 min, p = 0.034) and radiation exposure lower (4465.0 ± 3454.6 Gy.cm2 vs. 5940.5 ± 4290.5 Gy.cm2, p = 0.037). Use of mapping was protective towards AF/AT recurrence (HR = 0.348; 95% CI 0.210–0.579; p < 0.001), independent of persistent AF type (HR = 1.723; 95% CI 1.034–2.872; p = 0.037), and LA diameter (HR = 1.055; 95% CI 1.015–1.096; p = 0.006). At repeat ablation (N = 90), persistent complete PVI was seen in 14/20 (70.0%) versus 23/70 (32.9%) in the mapping and conventional group, respectively (p = 0.03). Reconnection rate of the right inferior PV was lower with mapping (10.0% vs. 34,3%, p = 0.035). Conclusions: Adding electroanatomical LA voltage mapping to CBA improves 1-year clinical outcome and lowers both procedure time and radiation exposure. At repeat, use of mapping increases complete persistent PVI mainly by improving PVI durability of the RIPV.

The author discusses a study by Pongratz et al, published within the issue, which performed an elegant subanalysis of FREEZE data to examine outcomes in 1906 cryoballoon ablation (CBA) patients undergoing pulmonary vein isolation (PVI) only. Topics include technological advances that have improved ablation success rates while decreasing procedural risks, rate of repeat hospitalizations in the intracardiac echocardiography (ICE) group, and the role that ICE should plan in AF ablations.

Abstract Background Early recurrence (ER) after catheter ablation for atrial fibrillation (AF) has been considered as a common phenomenon but its mechanism and implication in long-term outcome has not been fully elucidated. We aimed to clarify the relation between post-ablation inflammation and ER after cryoballoon ablation (CBA) or radio-frequency ablation (RFA) and evaluate the clinical significance of ER. Methods A total of 154 patients with paroxysmal AF undergoing ablation were consecutively recruited, including 90 patients undergoing RFA (RF group) and 64 patients undergoing CBA (CB group). Myocardial injury and inflammation biomarkers were analyzed before and 6 h, 24 h and 48 h after ablation. Acute early recurrence (AER), non-acute early recurrence (NAER) and late recurrence (LR) was defined as recurrence of atrial tachyarrhythmia during 0–3, 4–90 days and beyond a 90-day blanking period after ablation. Results Cardiac troponin I was significantly higher in CB group while C reactive protein (CRP) and Ratio Neutrophil/Lymphocyte were more elevated in RF group. Higher CRP level after RFA was significantly associated with AER in RF group and lower CRP level after CBA was predictive of AER in CB group. In addition, average cryoablation duration was positively correlated with CRP level after CB group. Cox regression revealed that NAER and left atrial diameter were associated with LR in RF group, while AER and NAER were predictive of LR after CBA. Conclusions Post-ablation inflammation was greater in RFA than in CBA. Excessive inflammatory response may be an important factor of AER after RFA. AER after CBA was related with lower inflammation and predictive of LR. Further investigations are still warranted to address on these findings.

Aim. To determine the clinical, morphological, and biochemical pre­dictors of substrate-specific, non-vein-dependent atrial fibrillation (AF) by morphological and immunological examinations in patients with recurrent AF after pulmonary vein (PV) isolation.Material and methods. The study included 100 people (58 men and 42 women) with paroxysmal (n=89) and persistent (n=11) AF with a mean age of 58,2±9,4 years. After the primary operation, 15 people withdrew from the study due to refusal of reintervention, and 1 person withdrew due to suppuration of loop recorder bed and its explantation. A total of 100 patients underwent primary cryoballoon PV isolation with myocardial biopsy from the interventricular and interatrial septa, while 60 patients had subsequent hematoxylin-eosin and Van Gieson stains. Also, 100 patients were simultaneously implanted with ECG loop recorders for AF monitoring and blood was taken (before the intervention) for subsequent analysis of inflammation markers and antimyocardial antibodies. Patients underwent clinical observation during the year (visits after 3, 6, 12 months). Patients with relapses were referred for repeat electrophysiological examination and segmental ablation if PV ruptures were detected. After repeated intervention, the follow-up period was extended for a year with the same schedule of visits. According Two groups of patients were formed: without relapses (vein-dependent AF, group I) and with relapses (non-vein-dependent AF, group II), despite the achieved PV isolation as a result of 1 or 2 operations.Results. An analysis of morphological changes showed that an increase in AF recurrence risk by an average of 6,14 times (95% confidence interval: 1,14-47,6 (p=0,0462)) is associated with stage 2 interventricular septal fibrosis. Lymphocyte infiltration of the interventricular septum was associated with higher AF recurrence by an average of 9 times (95% confidence interval: 0,89-95,37) (p=0,0519).Among the laboratory parameters, a significantly higher concentration of the N-terminal pro-brain natriuretic peptide and a significantly lower concentration of antimyocardial antibodies were found in the group of patients with recurrent AF after LV isolation (p=0,0101).Conclusion. Inflammatory myocardium changes are an important link in the pathogenesis of AF and are associated with its recurrence.

BackgroundA one-stop procedure involving catheter ablation and left atrial appendage occlusion (LAAO) is an option for high-risk atrial fibrillation patients. Few studies have reported the efficacy and safety of cryoballoon ablation (CBA) combined with LAAO, and no studies have compared the combination of LAAO with CBA or radiofrequency ablation (RFA).MethodsA total of 112 patients were enrolled in the present study; 45 patients received CBA combined with LAAO (group 1), and 67 patients received RFA combined with LAAO (group 2). Patient follow-up was performed for 1 year to detect peri-device leaks (PDLs) and safety outcomes (defined as a composite of peri-procedural and follow-up adverse events).ResultsThe number of PDLs at the median 59 days follow-up was comparable between the two groups (33.3% in group 1 vs. 37.3% in group 2, p = 0.693). Safety outcomes were also comparable between the two groups (6.7% in group 1 vs. 7.5% in group 2, p = 1.000). Multivariable regression showed that PDLs risk and safety outcomes were all similar between the two groups. Subgroup analysis of PDLs indicated no significant differences. Follow-up safety outcomes were related to anticoagulant medication, and patients without PDLs were more likely to discontinue antithrombotic therapy. The total procedure and ablation times were all significantly shorter for group 1.ConclusionWhen compared with left atrial appendage occlusion combined with radiofrequency, left atrial appendage occlusion combined with cryoballoon ablation has the same risk of peri-device leaks and safety outcomes, but the procedure time was significantly reduced.

Introduction: Reconnections to pulmonary vein (PV) triggers of atrial fibrillation (AF) are the primary cause of AF recurrence after PV isolation (PVI) with radiofrequency (RF) or cryoballoon catheter ablation (CRYO), but method‐specific contributions to PV reconduction pattern and conductive gap location are incompletely understood. Methods: The objective of this radiofrequency versus cryoballoon catheter ablation for paroxysmal atrial fibrillation substudy was to determine procedure‐specific patterns of PV reconduction in a randomized population with protocol‐mandated repeat procedures, irrespective of AF recurrence. Each PV was assessed in turn and PV reconnection sites were identified by high‐density electroanatomical mapping and locating the earliest activation site. Gap locations were verified by PV re‐isolation. Results: In 98 patients, 81% versus 76% previously isolated PVs remained isolated after CRYO versus RF (risk ratio [RR]: 1.06; 95% confidence interval [CI]: 0.96–1.18; p =.28). There were no significant differences for any PV: left superior PV: 90% versus 80%; left inferior PV: 80% versus 78%; right superior PV: 81% versus 80%, and right inferior PV: 76% versus 73%. For each reconnected PV, 34% of ipsilateral PVs were also reconnected after CRYO compared with 64% after RF (RR: 0.54; 95% CI: 0.32–0.90; p =.01). After RF, gaps were clustered by the carina and adjacent segments, whereas they were more heterogeneously distributed after CRYO. Conclusion: Although RF and CRYO produce similar proportions of durably isolated PVs, gap locations appear to develop in procedure‐specific patterns. After RF, ipsilateral PV reconduction is more frequent and gap sites cluster by the carina, suggesting that this region should be selectively ablated for more durable PVI. [ABSTRACT FROM AUTHOR]

Introduction: Data on first-line ablation treatment for patients with symptomatic atrial fibrillation (AF) are scarce. This study indirectly compared the efficacy and safety of cryoballoon ablation (CBA) versus radiofrequency ablation (RFA) as initial therapy for symptomatic AF. Methods: We searched the EMBASE, PubMed, Cochrane Library, and ClinicalTrials.gov databases for randomized controlled trials (RCTs) that compared CBA or RFA with antiarrhythmic drugs (AADs) as first-line treatment for AF from the time of database establishment up to December 2021. The odds ratio (OR) with a 95% confidence interval (CI) was used as a measure of the treatment effect. Results: Six RCTs (3 CBA, 3 RFA) that enrolled a total of 1,215 patients were included in this analysis. There were no significant differences in atrial arrhythmia (AA) (OR 0.993, 95% CI: 0.602–1.638), symptomatic AA (OR 0.638, 95% CI: 0.344–1.182), or serious adverse events (OR 1.474, 95% CI: 0.404–5.376) between the two ablation techniques. The incidences of additional CBA therapy (OR 2.693, 95% CI: 1.277–5.681) and patients who crossed over to AAD therapy (OR 0.345, 95% CI: 0.179–0.664) in the CBA group were significantly lower than those in the RFA group. Conclusion: Among patients with paroxysmal AF receiving initial therapy, CBA and RFA share a similar efficacy and safety profile. When pulmonary vein isolation is performed by CBA, study crossover and the need for additional ablation are substantially lower. [ABSTRACT FROM AUTHOR]

Background: Thermal injury to the esophagus during cryoablation for pulmonary vein isolation is a concern despite pre- and intraoperative assessment using conventional techniques. Navik 3D (APN Health, Waukesha, WI) is a novel 3D mapping system that can measure cryoballoon orientation and distance from the esophagus, both factors that correlate with esophageal injury. Purpose: This study assessed Navik 3D for cryoballoon localization and tried to assess the factors determining esophageal injury. Methods: Fifty consecutive patients undergoing cryoballoon ablation for pulmonary vein isolation, roof ablation, and posterior wall debulking were studied retrospectively. Results: Navik 3D was able to accurately compute the distance between the cryoballoon and the esophageal temperature probe in all cases, and also determine its orientation. Since the front half of the cryoballoon is the freezing surface, orientation toward (TOW) the esophagus as well as the actual distance were independent factors determining a decrease in esophageal temperature. Orientation TOW was associated with a lower esophageal temperature by 5.88°C (95% CI -7.20, -4.56; p<0.01) and a decrease in distance by 1 mm was associated with an esophageal temperature lowering of 0.05°C (95% CI 0.03, 0.06; p<0.01). Conclusion: Navik 3D allows accurate, real-time assessment of cryoballoon location and orientation in relation to the esophagus during ablation procedures; this may help prevent thermal injury. [ABSTRACT FROM AUTHOR]

Background: Single-shot ablation has emerged as an effective technique for index atrial fibrillation (AF) ablation, with an advantage of short procedure time. Although recent guidelines recommend peri-procedural uninterrupted oral anticoagulants (OACs), the intra-procedural anticoagulation strategy remains uncertain under non-vitamin K OACs (NOACs). We investigated procedural safety of a single bolus administration of heparin without activated clotting time (ACT) measurement during cryoballoon ablation (CBA). Methods: Two hundred patients (64.2 ± 10.0 years, 70% with non-paroxysmal AF) who underwent CBA with uninterrupted NOACs were randomly assigned to No-ACT group and ACT group. A bolus of heparin (100 U/kg) was routinely administered immediately after transseptal puncture. In the ACT group, an additional injection of heparin (30 U/kg) was administered if ACT at 30 min after the initial bolus was < 300 s. Results: There were no differences in baseline characteristics including CHA2DS2-VASc score between the two groups. The left atrium indwelling and procedure times were 60.4 ± 13.1 min and 78.9 ± 13.9 min, respectively, and not significantly different between the two groups. The mean ACT was 335.2 ± 59.9 s in the ACT group. Any bleeding rate was 3.2% in all patients and there was no statistically significant difference in bleeding complications between the two groups. In the ACT group, groin hematoma, laryngopharyngeal bleeding, and hemoptysis occurred in 3, 1, and 1 patient, respectively. Cardiac tamponade occurred in 1 patient in the No-ACT group. No thromboembolic events occurred during the 30-day follow-up after CBA. Conclusions: Single bolus administration of heparin without ACT measurement is a feasible anticoagulation strategy for CBA in patients with uninterrupted NOAC intake. [ABSTRACT FROM AUTHOR]

Background: The 12-month follow-up (F/U) efficacy of CBA PVI performed at community hospitals for treatment of symptomatic paroxysmal and persistent atrial fibrillation (AF) is unknown. This study determined the 12-month efficacy of pulmonary vein isolation (PVI) using cryoballoon ablation (CBA) performed at community hospitals with limited annual case numbers. Methods: This registry study included 983 consecutive patients (pts) from 19 hospitals, each with an annual procedural volume of < 100 PVI procedures/year. Pts underwent CBA PVI for paroxysmal AF (n = 520), persistent AF (n = 423), or redo PVI (n = 40). The primary endpoint was frequency of documented recurrent AF, the occurrence of atrial flutter or tachycardia following a 90-day period after the index ablation and up to 12 months. The frequency of repeat ablation was determined. Results: Isolation of all PVs was documented in 98% of pts at the end of the procedure. Twelve-month F/U data could be obtained in 916 pts. A 24-h ECG registration was performed in 641 pts (70.0%); in 107 pts (16.7%) of them, recurrent AF was documented. The primary endpoint was met in 193 F/U pts (21.1%). It occurred in 80/486 F/U pts with paroxysmal AF (16.4%), and in 107/390 F/U pts with persistent AF (27.4%). Redo PVI was performed in 71 pts (7.8%), and atrial flutter ablation was performed in 12 pts (1.4%). Conclusions: CBA PVI for paroxysmal or persistent AF can be performed at community hospitals with adequate rates of 12-month symptom freedom and arrhythmia recurrence. The study was registered at the German register of clinical studies (DRKS00016504). [ABSTRACT FROM AUTHOR]

Introduction: Late‐gadolinium enhancement magnetic resonance (LGE‐MRI) imaging is increasingly used in management of atrial fibrillation (AFib) patients. Here, we assess the usefulness of LGE‐MRI‐based fibrosis quantification to predict arrhythmia recurrence in patients undergoing cryoballoon ablation. Our secondary goal was to compare two widely used fibrosis quantification methods. Methods: In 102 AF patients undergoing LGE‐MRI and cryoballoon ablation (mean age 62 years; 64% male; 59% paroxysmal AFib), atrial fibrosis was quantified using the pixel intensity histogram (PIH) and image intensity ratio (IIR) methods. PIH segmentations were completed by a third‐party provider as part of the standard of care at our hospital; Image intensity ratio (IIR) segmentations of the same scans were carried out in our lab using a commercially available software package. Fibrosis burdens and spatial distributions for the two methods were compared. Patients were followed prospectively for recurrent arrhythmia following ablation. Results: Average PIH fibrosis was 15.6 ± 5.8% of the left atrial (LA) volume. Depending on threshold (IIRthr), the average IIR fibrosis (% of LA wall surface area) ranged from 5.0 ± 7.2% (IIRthr = 1.2) to 37.4 ± 10.9% (IIRthr = 0.97). An IIRthr of 1.03 demonstrated the greatest agreement between the methods, but spatial overlap of fibrotic areas delineated by the two methods was modest (Sorenson Dice coefficient: 0.49). Fourty‐two patients (41.2%) had recurrent arrhythmia. PIH fibrosis successfully predicted recurrence (HR 1.07; p =.02) over a follow‐up period of 362 ± 149 days; regardless of IIRthr, IIR fibrosis did not predict recurrence. Conclusions: PIH‐based volumetric assessment of atrial fibrosis was modestly predictive of arrhythmia recurrence following cryoballoon ablation in this cohort. IIR‐based fibrosis was not predictive of recurrence for any of the IIRthr values tested, and the overlap in designated areas of fibrosis between the PIH and IIR methods was modest. Caution must therefore be exercised when interpreting LA fibrosis from LGE‐MRI, since the values and spatial pattern are methodology‐dependent. [ABSTRACT FROM AUTHOR]

Background: The acute success rate of pulmonary vein isolation (PVI) with cryoballoon (CB) is reported to be lower in the right inferior pulmonary vein (RIPV). This study aimed to investigate the utility of the "balloon lever technique (BLT)" for RIPV CB ablation. Methods: We retrospectively studied consecutive patients who underwent CB‐PVI for atrial fibrillation between February 21, 2020 and June 3, 2022. RIPV cryoablation was performed according to a specific protocol. The patients underwent RIPV cryoablation using the conventional method. If the method was found ineffective, BLT cryoablation was performed. The acute success rate of RIPV CB ablation was examined. We also investigated the RIPV isolation rate and procedural parameters during conventional and BLT cryoablation. Results: Ninety‐three patients were included in the analysis. RIPV isolation was achieved in 89.2% (83/93) of the patients using conventional method and subsequent BLT cryoablation. Meanwhile, 68 patients underwent BLT cryoablation because the conventional method was ineffective. RIPV was isolated with BLT in 85.3% (58/68) of patients. Additionally, BLT was found to be superior to conventional cryoablation in terms of nadir balloon temperature, freezing time, and thawing time to a specific temperature in patients who underwent both conventional and BLT cryoablations. Conclusions: BLT is useful in RIPV cryoablation when the conventional method is ineffective. BLT cryoablation may be helpful, mainly because of the BLT‐mediated contact of the balloon with the bottom of the RIPV, which leads to optimal RIPV occlusion. [ABSTRACT FROM AUTHOR]

Background: Although catheter ablation (CA) has become a standard therapeutic approach to atrial fibrillation (AF), it imposes a low but relevant risk of thromboembolic complications of around 0.5%–1%, including ischemic strokes, and has an additional risk of clinically silent cerebral embolisms (SCEs) of 10%–40%. Both cryoballoon (CB) and radiofrequency (RF) ablation are routinely used clinically worldwide, yet there are few prospective data comparing the incidence of cerebral embolism after CA of AF between CB and RF ablation. Methods: The aim of the Embo‐Abl study will be to compare the incidence of cerebral embolisms on 3 T diffusion‐weighted image magnetic resonance imaging (MRI) after CA of AF between CB and RF ablation in patients with AF in a prospective, multicenter, open‐label, controlled, randomized fashion. The primary endpoint of the Embo‐Abl study will be the occurrence of MRI‐detected SCE 1–3 days after CA. The patients will be registered and randomly assigned to either the CB or RF ablation group in a 1:1 ratio. The study cohort will include 230 patients with AF from a multicenter in Japan. Results: The results of this study are currently under investigation. Conclusion: The Embo‐Abl study will be the first to compare the incidence of periprocedural cerebral embolisms caused by CA of AF between CB and RF ablation in a prospective, multicenter, randomized, controlled fashion. [ABSTRACT FROM AUTHOR]

Background: Atrial fibrillation (AF) is an uncommon arrhythmia in young adults without structural heart disease, and cryoballoon pulmonary vein isolation (CB‐PVI) is an important therapeutic strategy for rhythm control in patients with drug‐refractory AF. The aim of this analysis was to evaluate efficacy and safety of CB‐PVI in a large cohort of young patients in comparison with middle‐aged adults in a real‐world setting. Methods: From 2012 to 2020, a total of 3033 patients with AF underwent CB‐PVI and were followed prospectively in the framework of the 1STOP Clinical Service project, involving 34 Italian centers. Out of 3033 total 1STOP project subjects, a subgroup of 1318 patients were defined which included a YOUNG group (age ≤ 45 years; n = 368) and a MIDDLE‐AGED group (age 60–65 years; n = 950). Results: The acute success rate of PVI did not differ between the two cohorts (99.9 ± 1.3% vs. 99.8 ± 3.2%, p = 0.415). There was no difference in procedural characteristics, and periprocedural complication rates were similar among the two cohort (1.9% vs. 2.3%, p = 0.646). The 12‐month freedom from AF recurrence was 88.9% (95% confidence interval [CI]: 84.7–92.0) in the YOUNG cohort and 85.6% (95% CI: 82.9–88.0) in the MIDDLE‐AGED group. At 36‐month follow‐up, freedom from AF recurrence was 72.4% (65.5%–78.2%) and 71.8% (67.7%–75.6%), respectively with no significant difference among groups (p = 0.550). Conclusion: CB‐PVI had similar efficacy and safety in YOUNG and MIDDLE‐AGED patients. Younger age did not affect acute procedural results, complication rate, or AF recurrence after a single procedure. WHAT'S NEW?: This is the first multicenter analysis to evaluate the differences in efficacy and safety of a single ablation technique (cryoballoon pulmonary veins isolation) for atrial fibrillation between young and middle‐aged patients.Our analysis demonstrated the same rate of acute success, freedom from recurrent atrial fibrillation between young and middle‐aged patients, despite (as expected) older patients having more comorbidities.Safety outcomes of the procedure did not differ between young and middle‐aged patients, with a very low complication rate overall in both cohorts.The rate of repeat ablations following the index procedure was higher in young as compared to middle‐aged [ABSTRACT FROM AUTHOR]

Aims: Limited data are available on the outcomes of cryoballoon ablation (CBA)‐based pulmonary vein isolation (PVI) for atrial fibrillation (AF) in patients with heart failure (HF) with preserved ejection fraction (HFpEF) and mildly reduced ejection fraction (HFmrEF). The present study aimed to evaluate the safety and effectiveness of CBA in such patients. Methods and results: Consecutive patients with AF referred for CBA‐based PVI from two highly experienced electrophysiology centres were included in this retrospective study. Of 651 patients undergoing CBA, 471 cases were divided into four groups: No HF (n = 255), HFpEF (n = 101), HFmrEF (n = 78), and HF with reduced ejection fraction (n = 37). Similar early recurrence of atrial arrhythmia was found among groups (16.2% vs. 15.4% vs. 14.9% vs. 12.2%, P = 0.798), and no significant difference of long‐term sinus rhythm (SR) maintenance was identified among the HFmrEF, HFpEF, and No HF groups (71.8% vs. 75.2% vs. 79.6%, P = 0.334). CBA is safe for patients with HFmrEF and HFpEF with similar complications compared with the No HF group (3.8% vs. 4.0% vs. 3.1%, P = 0.814). The reassessment of cardiac function after CBA showed that patients with HF indicated beneficial outcomes. Left atrial diameter (LAD) and left ventricular ejection fraction were significantly improved in the HFmrEF group. There were 41.6% of patients in the HFpEF group who were completely relieved from HF. LAD and New York Heart Association (NYHA) were associated with recurrence in the HFpEF and HFmrEF groups, and the maintenance of SR was an independent predictor of NYHA improvement for all HF groups. Conclusions: Patients with HFmrEF and HFpEF could benefit from CBA with high SR maintenance and significant HF improvement. [ABSTRACT FROM AUTHOR]

Introduction: Pulmonary vein isolation (PVI) using freezing method, known as cryoballoon ablation (CBA), involves reaching temperatures as low as -70°C. As a novel method for cardiac ablation, it has proven to be equally effective compared to radiofrequency ablation. CBA is primarily used in treating atrial fibrillation (AF) in individuals who continue to have symptoms despite therapy or have developed resistance or intolerance to antiarrhythmic drugs. While generally considered safe, complications can still occur. This paper discusses gastroparesis, a rare but potential complication following CBA. Gastroparesis results in delayed gastric emptying.¹ Case report: We present a 59-year-old female patient, who was treated with CBA for paroxysmal AF. Her medical history included breast cancer surgery, chemotherapy, radiotherapy, and ongoing hormone therapy. After chemotherapy, episodes of AF began, initially brief and infrequent but becoming more frequent and intense over time, for which she was examined in Emergency Department (ED) multiple times. During her hospital stay CBA was performed. She remained hemodynamically stable throughout the procedure, with the lowest temperature reaching -56°C. The patient had no immediate complaints and was discharged the next day in a stable condition. However, two days after the procedure, the patient returned to the ED with severe abdominal distension caused by food retention. Fluoroscopy revealed a highly distended stomach extending to the pelvic inlet, with weakened peristalsis but no pyloric damage. Gastroscopy showed solid food remnants in the esophagus and stomach. Oral intake was suspended, and gastrointestinal decompressions were performed multiple times. After seven days of hospitalization, the patient’s condition improved, and she was discharged with dietary recommendations. Conclusion: It is crucial to emphasize that complications from CBA may not always manifest during or immediately after the procedure. In rare cases, symptoms can develop several days later. Patients may not associate these symptoms with the procedure, highlighting the importance of thorough patient education. Medical staff should also be aware of potential complications and trained to manage them efficiently, ensuring timely and effective care.2,3 [ABSTRACT FROM AUTHOR]

Introduction: The aim of this study is to assess the accuracy of the injection-based occlusion (IBO) tool utilizing saline and glucose solution in verifying pulmonary vein (PV) occlusion during cryoballoon ablation guided by a novel dielectric system (KODEX–EPD system). Methods: In this retrospective study, we enrolled 34 consecutive patients with paroxysmal atrial fibrillation (AF) who underwent their initial cryoballoon ablation procedure guided by the KODEX-EPD system. PV occlusion was firstly assessed by the IBO tool utilizing saline or glucose solution and then verified by direct contrast angiography. Patients were divided into two groups according to the fluid used in the IBO tool: the Saline Group and the Glucose Group. Results: The overall procedure time and fluoroscopy time were comparable between the Saline Group and the Glucose Group (113.7 ± 18.3 vs. 108.4 ± 15.9 min; p = 0.375 and 10.1 ± 3.7 vs. 9.3 ± 3.5 min; p = 0.559). The IBO tool was utilized a total of 138 times in the Saline Group and 135 times in the Glucose Group. When assessing PV occlusion, the IBO tool using saline demonstrated a sensitivity of 92.6% and a specificity of 95.2% compared to angiography. Similarly, the IBO tool utilizing glucose solution showed a sensitivity of 93.2% and a specificity of 96.1%. Conclusions: The IBO tool utilizing non-contrast fluid, saline and glucose solution, demonstrates a high level of sensitivity and specificity in accurately predicting PV occlusion during cryoablation procedures. Both the saline and glucose solutions used in the IBO tool show promising results in effectively assessing PV occlusion.