Comparison of Cryoballoon vs. Pulsed Field Ablation in Patients with Symptomatic Paroxysmal Atrial Fibrillation (SINGLE SHOT CHAMPION): Study protocol for a randomized controlled trial.

Background: Single-shot devices are increasingly used for pulmonary vein isolation (PVI) in atrial fibrillation (AF). The Arctic Front cryoballoon is the most frequently used single-shot technology. A recently developed novel pulsed field ablation (PFA) device (FARAPULSE) has been introduced with the aim to improve procedural safety and efficacy. Objective: This study will compare the novel FARAPULSE PFA device and the Arctic Front cryoballoon for first PVI in patients with symptomatic paroxysmal AF. Methods: SINGLE SHOT CHAMPION is a multicenter, randomized controlled trial with blinded endpoint adjudication by an independent clinical events committee. Overall, 210 patients with paroxysmal AF undergoing their PVI are randomized 1:1 between PFA and cryoballoon ablation. Continuous rhythm monitoring with an implantable cardiac monitor is performed in all patients. Results: The primary endpoint is time to first recurrence of any atrial tachyarrhythmia (AF and/or organized atrial tachyarrhythmia) lasting ≥120 seconds and identified by the implantable cardiac monitor within 91 and 365 days postablation. The composite procedural safety endpoint includes cardiac tamponade requiring drainage, persistent phrenic nerve palsy, vascular complications requiring intervention, stroke/transient ischemic attack, atrioesophageal fistula, and death occurring during or up to 30 days after the procedure. Key secondary endpoints include (1) increase in high-sensitivity troponin on day 1 postablation, (2) analysis of postablation 3-dimensional electroanatomic mapping (first 25 patients per study group), (3) AF burden, and (4) quality-of-life changes. Conclusion: SINGLE SHOT CHAMPION will evaluate the efficacy and safety of PVI using the novel FARAPULSE PFA for patients with symptomatic paroxysmal AF.

Successful Left Atrial Posterior Wall Isolation Including Roof Line Ablation Using a Cryoballoon for Persistent Atrial Fibrillation with Dextrocardia and Situs Inversus.

Cryoballoon ablation has been established as an effective method for pulmonary vein isolation and has recently been investigated for its efficacy of substrate modification on the left atrial roof area in patients with persistent atrial fibrillation. We herein report the first successful case of left atrial posterior wall isolation including roof line ablation using cryoballoons in a patient with persistent atrial fibrillation, dextrocardia, and situs inversus. Cryoballoon ablation proved to be a safe and straightforward approach to create lasting lesions along the left atrial roof line and left atrial posterior wall, even under challenging anatomical conditions.

Pulsed-field ablation versus thermal ablation for atrial fibrillation: A meta-analysis.

Background: Pulsed-field ablation (PFA) is an alternative to thermal ablation (TA) in patients with atrial fibrillation (AF) receiving catheter-based therapy for pulmonary vein isolation (PVI). However, its efficacy and safety have yet to be fully elucidated. Objective: The purpose of this study was to compare the acute and long-term efficacies and safety of PFA and TA. Methods: We performed a systematic review and meta-analysis of randomized and nonrandomized controlled trials comparing PFA and TA in patients with AF undergoing their first PVI ablation. The TA group was divided into cryoballoon (CB) and radiofrequency subgroups. AF patients were divided into paroxysmal atrial fibrillation (PAF) and persistent atrial fibrillation (PersAF) subgroups for further analysis. Results: Eighteen studies involving 4998 patients (35.2% PFA) were included. Overall, PFA was associated with a shorter procedure time (mean difference [MD] -21.68; 95% confidence interval [CI] -32.81 to -10.54) but longer fluoroscopy time (MD 4.53; 95% CI 2.18-6.88) than TA. Regarding safety, lower (peri-)esophageal injury rates (odds ratio [OR] 0.17; 95% CI 0.06-0.46) and higher tamponade rates (OR 2.98; 95% CI 1.27-7.00) were observed after PFA. In efficacy assessment, PFA was associated with a better first-pass isolation rate (OR 6.82; 95% CI 1.37-34.01) and a lower treatment failure rate (OR 0.83; 95% CI 0.70-0.98). Subgroup analysis showed no differences in PersAF and PAF. CB was related to higher (peri)esophageal injury, and lower PVI acute success and procedural time. Conclusion: Compared to TA, PFA showed better results with regard to acute and long-term efficacy but significant differences in safety, with lower (peri)esophageal injury rates but higher tamponade rates in procedural data.

Pulmonary vein reconnection and repeat ablation characteristics following cryoballoon-compared to radiofrequency-based pulmonary vein isolation.

BACKGROUND: Despite advances in efficacy and safety of pulmonary vein isolation (PVI), atrial fibrillation (AF) recurrence after PVI remains common. PV-reconnection is the main finding during repeat PVI procedures performed to treat recurrent AF. OBJECTIVE: To analyze pulmonary vein (PV) reconnection patterns during repeat ablation procedures in a large cohort of consecutive patients undergoing radio frequency or cryoballoon-based PVI. METHODS: Retrospective analysis of PV-reconnection patterns and analysis of re-ablation strategies in consecutive index RF- and CB-based PVI and their respective re-ablation procedures during concomitant usage of both energy sources at a single high-volume center in Germany. RESULTS: A total of 610 first (06/2015-10/2022) and 133 s (01/2016-11/2022) repeat ablation procedures after 363 (60%) RF- and 247 (40%) CB-based index PVIs between 01/2015 and 12/2021 were analyzed. PV-reconnection was found in 509/610 (83%) patients at first and 74/133 (56%) patients at second repeat procedure. 465 of 968 (48%) initially via CB isolated PVs were reconnected at first re-ablation but 796 of 1422 initially RF-isolated PV (56%) were reconnected (OR: 0.73 [95% CI: 0.62-0.86]; p < .001). This was driven by fewer reconnections of the left PVs (LSPV: OR: 0.60 [95% CI: 0.42-0.86]; p = .005 and LSPV: 0.67 [0.47-0.95]; p = .026). PV-reconnection was more likely after longer, RF-based index PVI and in older females. Repeat procedures were shorter after CB-compared to after RF-PVI. CONCLUSIONS: Reconnection remains the most common reason for repeat AF ablation procedures after PVI. Our data suggest to preferentially use of the cryoballoon during index PVI, especially in older women.

Efficacy and safety of pulsed field ablation compared to cryoballoon ablation in the treatment of atrial fibrillation: a meta-analysis.

Aims: Pulmonary vein isolation (PVI) represents the gold standard in the treatment of atrial fibrillation (AF) and the use of single-shot techniques, such as cryoballoon ablation (CBA) and pulsed field ablation (PFA) using a pentaspline catheter, has gained prominence. Recent studies hypothesize that PFA might be superior to CBA, although procedural efficacy and safety data are inconsistent. A meta-analysis was conducted to compare both energy sources for the treatment of AF. Methods and results: A structured systematic database search and meta-analysis were performed on studies investigating outcomes, periprocedural complications, and/or procedural parameters of AF patients treated by either CBA or PFA. Eleven studies reporting data from 3805 patients were included. Pulmonary vein isolation by PFA was associated with a significantly lower recurrence of atrial fibrillation/atrial tachycardia [odds ratio (OR) = 0.73, 95% confidence interval (CI) = 0.54-0.98, I2 = 20%] and fewer periprocedural complications (OR = 0.62, 95% CI = 0.40-0.96, I2 = 6%) compared to CBA. The lower complication rate following PFA was mainly driven by fewer phrenic nerve injuries (OR = 0.19, 95% CI = 0.08-0.43, I2 = 0%). However, there were more cases of cardiac tamponades after PFA (OR = 2.56, 95% CI = 1.01-6.49, I2 = 0%). Additionally, using PFA for PVI was associated with shorter total procedure times [mean difference (MD) = -9.68, 95% CI = -14.92 to -4.43 min, I2 = 92%] and lower radiation exposure (MD = -148.07, 95% CI = -276.50 to -19.64 µGy·mI2 = 7%). Conclusion: Our results suggest that PFA for PVI, compared to CBA, enables shorter procedure times with lower arrhythmia recurrence and a reduced risk of periprocedural complications. Randomized controlled trials need to confirm our findings.

Pulsed-field ablation for repeat procedures after failed prior thermal ablation for atrial fibrillation.

Background: Pulsed-field ablation (PFA) is a novel nonthermal ablation technology. Its potential value for repeat procedures after unsuccessful thermal ablation for atrial fibrillation has not been assessed. Objective: The purpose of this study was to summarize our initial experience with patients undergoing repeat procedures using PFA. Methods: Consecutive patients with arrhythmia recurrences after a prior thermal ablation undergoing a repeat procedure using a multipolar PFA catheter from May 2021 and December 2022 were included. After 3-dimensional electroanatomic mapping, reconnected pulmonary veins (PVs) were reisolated and veins with only ostial isolation wither ablated to widen antral PV isolation. Posterior wall ablation was performed if all PVs were durably isolated or in case of low-voltage areas on the posterior wall at the discretion of the operator. Patients underwent follow-up with 7-day Holter electrocardiography after 3, 6, and 12 months. Results: A total of 186 patients undergoing a repeat procedure using PFA were included. The median number of previous ablations was 1 (range 1-6). The prior ablation modality was radiofrequency in 129 patients (69.4%), cryoballoon in 51 (27.4%), and epicardial ablation in 6 (3.2%). At the beginning of the procedure, 258 of 744 PVs (35%) showed reconnections. Additional antral ablations were applied in 236 of 486 still isolated veins (49%). Posterior wall ablation was added in 125 patients (67%). Major complications occurred in 1 patient (transient ischemic attack 0.5%). Freedom from arrhythmia recurrence in Kaplan-Meier-analysis was 78% after 6 months and 54% after 12 months. Conclusion: PFA is a versatile and safe option for repeat procedures after failed prior thermal ablation.

Long-term clinical impact of early recurrence of atrial tachyarrhythmia after cryoballoon ablation in patients with atrial fibrillation.

INTRODUCTION: The impact of early recurrence of atrial tachyarrhythmia (ERAT) within the 90-day blanking period on long-term outcomes in atrial fibrillation (AF) patients undergoing cryoballoon ablation (CBA) is controversial. This study aimed to assess the relationship between ERAT and late recurrence of atrial tachyarrhythmia (LRAT) post-CBA. METHODS: Utilizing data from a multicenter registry in Korea (May 2018 to June 2022), we analyzed the presence and timing of ERAT (<30, 30-60, and 60-90 days) and its association with LRAT risk after CBA. LRAT was defined as any recurrence of AF, atrial flutter, or atrial tachycardia lasting more than 30 s beyond the 90 days. RESULTS: Out of 2636 patients, 745 (28.2%) experienced ERAT post-CBA. Over an average follow-up period of 21.2 ± 10.3 months, LRAT was observed in 874 (33.1%) patients. Patients with ERAT had significantly lower 1-year LRAT freedom compared to those without ERAT (42.6% vs. 85.5%, p < .001). Multivariate analysis identified ERAT as a potential predictor of LRAT, with a hazard ratio (HR) of 3.98 (95% confidence interval [CI], 3.47-4.57). Significant associations were noted across all examined time frames (HR, 3.84; 95% CI, 3.32-4.45 in <30 days, HR, 5.53; 95% CI, 4.13-7.42 in 30-60 days, and HR, 4.29; 95% CI, 3.12-5.89 in 60-90 days). This finding was consistently observed across all types of AF. CONCLUSION: ERAT during the 90-day blanking period strongly predicts LRAT in AF patients undergoing CBA, indicating a need to reconsider the clinical significance of this period.

Real-world evidence demonstrates an appropriate atrial fibrillation population for hybrid convergent approach versus stand-alone cryoballoon ablation: A long-term safety and efficacy study.

INTRODUCTION: A hybrid convergent approach (endocardial and epicardial ablation) demonstrated superior effectiveness in a recent randomized study for long-standing persistent atrial fibrillation (LSPAF). Yet, there is a lack of real-world, long-term evidence as to which patients are best candidates for a hybrid convergent approach compared to standard endocardial cryoballoon pulmonary vein isolation (CB PVI). METHODS AND RESULTS: This single-center, retrospective analysis spanning from 2010 to 2015 compared two distinctly different atrial fibrillation (AF) cohorts; one treated with stand-alone cryoablation and one treated with a hybrid convergent approach. Baseline characteristics described candidates for each approach. The following criteria were utilized to determine CB PVI candidacy: (1) paroxysmal AF (PAF) (stage 3A) with failed class I/III antiarrhythmic drug (AAD) or (2) persistent/LSPAF (stage 3B/3C/3D) with failed class I/III AAD unwilling to undergo hybrid procedure. Selection criteria for the hybrid procedure included: (1) PAF refractory to both class I/III AAD and prior CB PVI (stage 3D) or (2) persistent/LSPAF (stage 3B/3C/3D) with failed class I/III AAD agreeable to hybrid procedure. Prior sternotomy was excluded. Serial electrocardiograms and continuous monitoring evaluated primary efficacy outcome of time-to-first recurrence of atrial arrhythmia after a 90-day blanking period. Secondary outcomes were procedure-related complications and AAD use (at discharge, 12, and 36 months). Kaplan-Meier methods evaluated arrhythmia recurrence. Of 276 patients, 197 (64.2 ± 10.6 years old; 66.5% male; 74.1% 3A-PAF; 18.3% 3B/3D-persistent AF; 1.0% 3C-LSPAF; 6.6% undetermined) underwent CB PVI and 79 (61.4 ± 8.1 years old; 83.5% male; 41.8% 3D-PAF; 45.5% 3B/3D-persistent AF; 12.7% 3C/3D-LSPAF) underwent hybrid procedure. Arrhythmia freedom through 36 months was 55.2% for CB PVI and 50.4% for hybrid (p = .32). Class I AAD utilization at discharge occurred in 38 (19.3%) patients in the CB PVI group and 5 (6.3%) patients in the hybrid group (p = .01). CB PVI class I AAD utilization at 12 months occurred in 14 (9.0) patients versus 0 patients for hybrid convergent (p = .004). Patients with one or more adverse event were as follows: two (1.0%) in the CB PVI group (both transient phrenic nerve palsy) and three (3.7%) in the hybrid group (two with significant bleeding and one with wound infection) (p = .14). CONCLUSION: This study demonstrated that patients with more complex forms of AF (3D-PAF or 3B/3C/3D-persistent/LSPAF) could be well managed with a convergent approach. In a real-world evaluation, outcomes match safety and efficacy thresholds achieved for patients with earlier, less complex AF etiologies treated by CB PVI alone.

Feasibility and safety of cryoballoon ablation for atrial fibrillation and closing patent foramen ovale without implantation：A pilot study.

BACKGROUND: Patent foramen ovale (PFO) affects 20%-34% of adults and is associated with strokes and other disorders. The conventional treatment of PFO-related strokes is a closure procedure. The metal device is associated with some adverse events. OBJECTIVE: Our aim was to investigate the efficacy and safety of PFO closure using cryoablation without implantation in patients with atrial fibrillation (AF) who underwent pulmonary vein isolation (PVI). METHODS: We divided the 22 patients with both PFO and AF who underwent PVI via cryoablation into 2 groups: standard PVI + atrial septal (AS) cryoablation group (group 1, n = 11) and standard PVI group (group 2, n = 11). The guidewire accesses the left atrium through the PFO without AS puncture during the procedure. Standard PVI via cryoablation was performed. The cryoballoon was retracted to the right atrium and inflated against the AS post-PVI. Patients in group 1 had cryoablation for 120-150 seconds, whereas patients in group 2 received sham ablation. The co-primary end points were the PFO closure rate and a composite of AF recurrence and stroke/transient ischemic attack (TIA) events. RESULTS: There were no differences in procedure-related adverse events between the 2 groups. Neither group had an ischemic stroke report at 1-year follow-up. The PFO closure rate at 6 months in group 1 was significantly higher than that in group 2 (7 [63.6%] vs 1 [9.1%]; P = .002). AF recurrence post ablation was comparable in both groups at 3 months (3 [27.3%] vs 1 [9.1%]; P = .269), 6 months (0 vs 0), and 12 months (2 [18.2%%] vs 1 [9.1%]; P = .534) of follow-up. CONCLUSION: Cryoablation is a safe and effective approach to close PFO in patients with AF undergoing PVI in a single procedure.

Meta-analysis of high-power short-duration versus cryoballoon ablation for atrial fibrillation.

BACKGROUND: The existing literature regarding the treatment strategy for high-power short-duration (HPSD) ablation in patients diagnosed with atrial fibrillation (AF) is currently insufficient. The objective of this study is to perform a comparative analysis evaluating the effectiveness, safety, and procedural efficiency of HPSD versus cryoballoon ablation (CBA) for AF. METHODS: A comprehensive search was conducted in PubMed, EMBASE, Cochrane Library, Scopus, Web of Science, and ClinicalTrials.gov databases to identify trials comparing HPSD with CBA for AF from their inception until December 25, 2023. Treatment effect measures were expressed as odds ratio (OR), mean difference (MD), accompanied by a 95% confidence interval (CI). RESULTS: The analysis comprised six eligible trials involving a total enrollment of 2481 patients. No statistically significant disparities were observed in recurrent atrial arrhythmia (OR 0.90; 95% CI, 0.71-1.16) or total complications (OR 0.65; 95% CI, 0.38-1.12) between the two ablation techniques examined in this study. However, HPSD technique exhibited a significantly prolonged procedure time (MD 27.42; 95% CI, 19.03 to 35.81). Conversely, no significant differences were observed between the two modalities in terms of total fluoroscopy duration (MD -4.37; 95% CI -10.70 to 1.96) and ablation time (MD 7.95; 95% CI -3.97 to 19.88). Furthermore, HPSD demonstrated significantly higher odds of extrapulmonary vein (PV) trigger ablation compared to CBA (OR 18.86; 95% CI, 5.12-69.49). The subgroup analyses revealed that CBA continued to exhibit superior procedure time (except for the paroxysmal AF subgroup: [MD 29.52; 95% CI -4.25 to 63.60]), while no significant differences in safety and efficacy (except for the HPSD ≥ 70 W subgroup: [OR 0.44, 95% CI 0.20-0.97]) outcomes were still observed. CONCLUSION: Among patients undergoing ablation therapy for AF, both HPSD and CBA demonstrate comparable efficacy and safety profiles; however, HPSD is associated with longer procedural time and higher rates of extra-PV trigger ablation.

Micro-Costing Analysis for the Treatment of Atrial Fibrillation: An Economic Evaluation of the First Italian Experience of Same-Day Discharge Protocol for Cryoballoon Atrial Fibrillation Ablation.

Background: Atrial fibrillation (AF) is the most common cardiac arrhythmia, and its prevalence is expected to increase further due to the aging population, increasing prevalence of risk factors, improving detection methods, and broadening of catheter ablation indications. Along with limited healthcare resources and bed availability, these reasons led to the development of a same-day discharge (SDD) protocol. The aim of this study was to evaluate the health and economic impact of a routine adoption of same-day discharge after cryoballoon AF ablation. Methods: Consecutive patients with symptomatic and drug-refractory AF scheduled for first-time AF ablation were screened, and if deemed suitable, the SDD protocol was proposed and, if accepted, enrolled in the protocol. Results: A total of 324 patients were screened, and 118 were considered eligible for the SDD pathway. Fifty-two patients accepted the SDD pathway and were included in this study. The analysis showed that the variation in resource consumption associated with cryoablation in SDD is equal to EUR 739.85/patient. The analysis showed that the main cost driver for ordinary hospitalization was represented by the hospital stay, which was calculated to be 36% of the total cost. In total, there was a cost reduction of EUR 38.472 thanks to optimized AF patient management from the standard recovery setting to SDD. Conclusions: SDD after cryoballoon ablation of AF is feasible in selected patients with a standardized protocol.

Epicardial Atrial Fat at Cardiac Magnetic Resonance Imaging and AF Recurrence after Transcatheter Ablation.

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.

Validation of a prediction model for early reconnection after cryoballoon ablation.

BACKGROUND: We previously developed an early reconnection/dormant conduction (ERC) prediction model for cryoballoon ablation to avoid a 30-min waiting period with adenosine infusion. We now aimed to validate this model based on time to isolation, number of unsuccessful cryo-applications, and nadir balloon temperature. METHODS: Consecutive atrial fibrillation patients who underwent their first cryoballoon ablation in 2018-2019 at the Leiden University Medical Center were included. Model performance at the previous and at a new optimal cutoff value was determined. RESULTS: A total of 201 patients were included (85.57% paroxysmal AF, 139 male, median age 61 years (IQR 53-69)). ERC was found in 35 of 201 included patients (17.41%) and in 41 of 774 veins (5.30%). In the present study population, the previous cutoff value of - 6.7 provided a sensitivity of 37.84% (previously 70%) and a specificity of 89.07% (previously 86%). Shifting the cutoff value to - 7.2 in both study populations resulted in a sensitivity of 72.50% and 72.97% and a specificity of 78.22% and 78.63% in data from the previous and present study respectively. Negative predictive values were 96.55% and 98.11%. Applying the model on the 101 patients of the present study with all necessary data for all veins resulted in 43 out of 101 patients (43%) not requiring a 30-min waiting period with adenosine testing. Two patients (2%) with ERC would have been missed when applying the model. CONCLUSIONS: The previously established ERC prediction model performs well, recommending its use for centers routinely using adenosine testing following PVI.

Comparing cryoballoon and contact-force guided radiofrequency ablation in pulmonary vein isolation for atrial fibrillation in patients with hypertrophic cardiomyopathy.

BACKGROUND: Pulmonary vein isolation (PVI) employing cryoballoon (CB) or contact force-guided radiofrequency (CF-RF) catheter ablation has been established as an effective strategy for managing atrial fibrillation (AF). However, its efficacy in hypertrophic cardiomyopathy (HCM) remains to be further explored. METHODS: This retrospective study analyzed 60 consecutive AF patients with HCM (average age 67 ± 10 years; 41 men) who were consecutively admitted to our hospital from January 2014 to December 2022 and underwent initial PVI. RESULTS: The patients were treated with CB (26 patients) or CF-RF (34 patients). Successful PVI was achieved in both groups without significant complications. In the CF-RF group, additional ablations were performed on the cavotricuspid isthmus (14.7% of patients) and the anterior line (2.9%). The CB group benefited from reduced procedural times (93 ± 31 vs. 165 ± 60 min, p < 0.05) and decreased saline irrigation requirements (77.5 ± 31.4 vs. 870 ± 281.9 mL, p < 0.0001). Using a contrast medium was exclusive to the CB group (33.8 ± 4.2 mL). In a 12-month follow-up, the atrial tachyarrhythmia recurrence-free rates in the CB and CF-RF groups were comparable (77% and 76%, respectively; p = 0.63 according to the log-rank test). Notably, pulmonary vein reconnection was prevalent in most (7 out of 8) patients requiring a secondary ablation procedure. CONCLUSION: PVI is feasible as a strategy for AF in patients with HCM employing either CB or CF-RF techniques. While the recurrence-free rates were comparable in both groups, differences were noted in procedure duration, saline usage, and the need for a contrast medium.

Cryoballoon cardioneuroablation: New electrophysiological insights.

Background: Cardioneuroablation (CNA) targeting ganglionated plexi has shown promise in treating vasovagal syncope. Only radiofrequency ablation has been used to achieve this goal thus far. Objective: The purpose of this study was to investigate the utility of cryoballoon ablation (CBA) of the pulmonary veins (PVs) as a potential simplified approach to CNA. Methods: We report our observations of autonomic modulation in a series of 17 patients undergoing CBA for atrial fibrillation and our early experience using CBA of the PVs in 3 patients with malignant vagal syncope. In 17 patients undergoing CBA of AF, sinus cycle length was recorded intraprocedurally after ablation of individual PVs. Results: The most pronounced shortening of the sinus cycle length was observed after isolation of the right upper PV, which was ablated last. Reduced sinus node recovery time and atrioventricular (AV) nodal effective refractory period were observed after CBA. Resting heart rate was elevated by 6-7 bpm after CBA and persisted during 12-month follow-up. CBA of the PVs was performed in 3 patients with recurrent vagal syncope mediated by sinus arrest (n = 2) and AV block (n = 1). In all patients, isolation of the right upper PV resulted in marked shortening of sinus cycle length. During follow-up of 178 ± 43 days (134-219 days), CNA resulted in abolition of pauses, bradycardia-related symptoms, and syncope in all patients. Conclusion: CBA of the PVs (particularly the right upper PV) may be a predictable anatomic CNA approach in patients with refractory vagal syncope due to sinus arrest and/or AV block and may warrant systematic investigation as a tool to perform CNA.

PolarX vs Arctic Front for Cryoballoon Ablation of Paroxysmal AF: The Randomized COMPARE CRYO Study.

BACKGROUND: Pulmonary vein isolation is an effective treatment for atrial fibrillation (AF). Cryoballoon ablation using the Arctic Front cryoballoon (Medtronic) was found to be superior to antiarrhythmic drug treatment. Recently, a novel cryoballoon system was introduced (PolarX, Boston Scientific). OBJECTIVES: The purpose of this study was to compare the efficacy and safety of the 2 cryoballoons in a randomized controlled trial. METHODS: Patients with symptomatic paroxysmal AF were enrolled in 2 centers and randomized 1:1 to pulmonary vein isolation using the PolarX or the Arctic Front cryoballoon. All patients received an implantable cardiac monitor. The primary endpoint was first recurrence of atrial tachyarrhythmia (AF, atrial flutter, or atrial tachycardia [AT]) between days 91 and 365. Procedural safety was assessed by a composite of tamponade, phrenic nerve palsy lasting >24 hours, vascular complications, stroke/transient ischemic attack, atrioesophageal fistula or death up to 30 days. RESULTS: A total of 201 patients were enrolled. At 1 year, recurrence of atrial tachyarrhythmia had occurred in 41 of 99 patients (41.6%) assigned to the PolarX group and in 48 of 102 patients (47.1%) assigned to the Arctic Front group (HR: 0.85 [95% CI: 0.56-1.30]; P = 0.03 for noninferiority; P = 0.46 for superiority). The safety endpoint occurred in 5 patients (5%) in the PolarX group (n = 5 phrenic nerve palsies lasting >24 hours), whereas no safety endpoints occurred in the Arctic Front group (P = 0.03). CONCLUSIONS: In this randomized controlled trial using implantable cardiac monitors for continuous rhythm monitoring, the novel PolarX cryoballoon was noninferior compared with the Arctic Front cryoballoon regarding efficacy. However, the PolarX balloon resulted in significantly more phrenic nerve palsies. (Comparison of PolarX and the Arctic Front Cryoballoons for PVI in Patients With Symptomatic Paroxysmal AF [COMPARE-CRYO]; NCT04704986).

Pressure waveform analysis for occlusion assessment significantly reduces contrast medium use in cryoballoon pulmonary vein isolation.

BACKGROUND: Pulmonary vein (PV) occlusion is crucial for adequate lesion formation during cryoballoon-guided pulmonary vein isolation (CB-PVI). PV occlusion is usually confirmed by angiographies over the inflated balloon device. The aim of our study was to analyze the safety and efficacy of pressure waveform-based PV occlusion assessment during CB-PVI utilizing a novel fully integrated pressure analysis tool. METHODS: Consecutive patients with symptomatic atrial fibrillation (AF) scheduled for CB-PVI were prospectively enrolled for pressure waveform-based PV occlusion assessment. A patient cohort receiving conventional angiographies served as control group. Patients with common PV ostia were excluded. RESULTS: The study group consisted of 40 patients (16 females, mean age was 64.5 ± 9.7, 45% persistent AF). The control group consisted of 40 matched patients. All 160 PVs in the study group were successfully isolated without the use of additional venograms confirming PV occlusion. The mean procedure duration was 69 ± 12 min in the study group with a mean fluoroscopy duration of 11.5 ± 4.4 min. The mean contrast medium volume was 22 ± 9 ml in the study group and 36 ± 12 ml in the control group (p = 0.0001). Mean procedure duration, mean balloon temperatures, and mean ablation application durations did not differ significantly between the study and the control group. No periprocedural complications occurred. CONCLUSION: CB-PVI utilizing a fully integrated pressure waveform analysis tool to assess PV occlusion is feasible and safe and significantly reduces the amount of contrast medium without impact on procedural parameters and freedom from arrhythmia recurrence.

Diaphragm movement sensor for phrenic nerve monitoring during cryoballoon procedures: the first clinical evaluation.

Background and aims: Right phrenic nerve palsy is the most frequent complication of cryoballoon procedures. The SMARTFREEZE™ console (Boston Scientific, St. Paul, MN, USA) has integrated a new tool for diaphragm monitoring-the Diaphragm Movement Sensor; however, it has not been evaluated in clinical practice. We aimed to assess the diagnostic performance of the Diaphragm Movement Sensor based on compound motor action potential data recorded simultaneously. Methods: Thirty consecutive patients (mean age 63.2 ± 10.2 years) were included. We simultaneously recorded the compound motor action potential and the Diaphragm Movement Sensor during cryoapplications in the right pulmonary veins. The right phrenic nerve was paced at 60 per minute, 12 V and 2.9 ms. Compound motor action potential monitoring with a 30% decrease cutoff for the diagnosis of phrenic nerve threatening was considered the gold standard. The Diaphragm Movement Sensor decrease threshold was also set at 30%. Results: Considering compound motor action potential monitoring, phrenic nerve threatening occurred 11 times (in seven patients) among 84 cryoapplications (13.1%) at the right pulmonary veins. The sensitivity and specificity of the Diaphragm Movement Sensor were, respectively, 33% (95% CI: 7%-70%) and 49% (95% CI: 38%-61%; P < 0.001). The predictive positive and negative values for the Diaphragm Movement Sensor were, respectively, 7% (95% CI: 2%-20%) and 86% (95% CI: 72%-95%). The Diaphragm Movement Sensor gave an erroneous diagnosis in 44/84 cryoapplications (52.4%). Conclusions: The diagnostic performance of the Diaphragm Movement Sensor is low, and the relevance of its use in clinical practice may be debated.

Analysis of the effectiveness of the latest 4th-generation cryoballoon catheters in pulmonary vein isolation using high-resolution mapping.

BACKGROUND: Long-term data showed that up to 27% of pulmonary veins are reconnected using cryoballoon ablation. This study aimed to evaluate the efficacy of the latest 4th-generation cryoballoon catheters using ultra high-resolution mapping. METHODS: In patients with atrial fibrillation, a standard pulmonary vein isolation (PVI) with the latest 4th-generation cryoballoon catheter (Arctic Front Advance PRO, Medtronic Minneapolis, USA) and the spiral mapping catheter (Achieve Advance, Medtronic, Minneapolis, MN, USA) was performed. Subsequently, high-resolution mapping was achieved using the novel multipolar grid mapping catheter (Advisor HD Grid SE, Abbott Laboratories, USA). Follow-up was obtained after 6 months by means of a 7-day Holter electrocardiogram. RESULTS: In our study, acute PVI was successfully achieved in all 31 patients. The latest 4th-generation cryoballoon catheter is safe in the acute phase of PVI. Additional high-resolution mapping (mean points per map 21,001 ± 4911) using the multipolar grid mapping catheter enabled us to identify residual gaps only in the carina pulmonary vein region; therefore, no additional ablation was performed. Three of 31 patients (10%) presented with atrial arrhythmia recurrence always related with pulmonary vein reconnection; using high-resolution mapping had no additional benefit in identifying pulmonary veins in which reconnection will occur. CONCLUSION: The utility of additional high-density mapping, facilitated by the HD Grid catheter after PVI with the 4th-generation cryoballoon catheter do not substantiate a discernible advantage over conventional mapping methodologies, particularly, the spiral mapping catheter. Residual carinal conduction was observed in a substantial cohort of patients (48%), highlighting a persistent challenge in achieving complete electrical isolation.

Pulsed-field vs cryoballoon vs radiofrequency ablation: Outcomes after pulmonary vein isolation in patients with persistent atrial fibrillation.

BACKGROUND: Pulsed-field ablation (PFA) has shown promising data in terms of safety and procedural efficiency for pulmonary vein isolation (PVI), with similar long-term outcomes compared to radiofrequency ablation (RFA) and cryoballoon ablation (CBA) in patients with paroxysmal atrial fibrillation (AF). OBJECTIVE: The purpose of this study was to compare the procedural and long-term outcomes in patients with persistent AF undergoing PVI using PFA, CBA, or RFA. METHODS: Consecutive patients with persistent AF undergoing first PVI with PFA, CBA, or RFA were included. Patients underwent 7-day Holter electrocardiography at 3, 6, and 12 months postablation. The primary outcome was recurrence of any atrial arrhythmia after a 90-day blanking period. Safety outcomes included the composite of in-hospital major adverse events. RESULTS: A total of 533 patients with persistent AF underwent PVI using PFA (n = 214, 39%), CBA (n = 190, 36%), or RFA (n = 129, 24%). Procedures with PFA guided by fluoroscopy were shorter than those with CBA (median 60 minutes; interquartile range [IQR] 53-80 minutes vs 84 minutes; IQR 68-101 minutes; P ≤ .001), and procedures with PFA in combination with 3-dimensional electroanatomic mapping were shorter than those with RFA (median 101 minutes; IQR 85-126 minutes vs 171 minutes; IQR 141-204 minutes; P < .001). Acute safety events occurred in 2.3%, 2.6%, and 0.8% in the PFA, CBA, and RFA groups, respectively (P = .545). The 1-year confounder-adjusted estimate for freedom from atrial arrhythmias was 62.1% for CBA, 55.3% for PFA, and 48.3% for RFA (CBA vs PFA: P = .79; CBA vs RFA: P = .009; PFA vs RFA: P = .010). CONCLUSION: In patients with persistent AF undergoing first PVI, 1-year confounder-adjusted outcomes are better with PFA and CBA than with RFA.