Cryoballoon ablation using the sheath-in-sheath technique in a patient with a tortuous common iliac vein.

The sheath-in-sheath technique, utilizing a 15Fr cryoballoon delivery sheath inserted into a 25 cm 16Fr sheath, effectively navigates tortuous iliac veins during cryoballoon ablation for atrial fibrillation, ensuring safe delivery and maintaining essential device performance without complications.

Comprehensive analysis of recurrence factors in cryoballoon AF ablation: integrating clinical, biomarkers, and echocardiographic parameters.

Atrial fibrillation (AF) poses substantial challenges in cardiovascular diseases, impacting patient health and economic burdens. Understanding the mechanical effects of AF on the left atrium (LA) and assessing the influence of treatment modalities on LA functions are critical. This study aims to assess the efficacy of echocardiographic and biochemical parameters in predicting AF recurrence following second generation cryoballoon ablation (CB-2). Ninety-two patients with symptomatic AF, treated with CB-2 at Istanbul University-Cerrahpasa, Faculty of Medicine, Department of Cardiology, were prospectively examined from January 2021 to July 2023. The study endeavors to develop a predictive model for AF recurrence, investigating the relationship between echocardiographic measurements and serum biomarkers with recurrence. The follow-up duration for echocardiographic assessments and biochemical analyses was systematically documented. The study revealed a significant enhancement in LA mechanical functions during echocardiographic follow-ups three months post-procedure. Specifically, LA strain parameters emerged as significant predictors of recurrence (LAsr: 95%CI 1.004-1.246, p = 0.047; LAsct: 95%CI 1.040-1.750, p = 0.024). Biochemical analyses demonstrated a correlation between elevated PRO-BNP levels and an increased risk of recurrence (95%CI 1.000-1.003, p = 0.012). Moreover, specific biomarkers such as MYBPHL, which demonstrated increased levels post-procedure, were deemed indicative of atrial damage, suggesting potential additional atrial substrate modification beyond PVI. Consequently, improvements in LA function post-cryoballoon ablation and biochemical markers have surfaced as potential indicators for predicting AF recurrence. This study elucidates the effectiveness of CB-2 in treating AF and its impact on LA functions. Notably, LA strain measurements and PRO-BNP levels have emerged as reliable indicators for predicting recurrence. Beyond clinical implications, our research establishes a foundation for a deeper understanding of the role of CB-2 in AF management and factors associated with recurrence.

Clinical impact of cryoballoon posterior wall isolation using the cross-over technique in persistent atrial fibrillation.

BACKGROUND AND AIMS: Successful left atrial posterior wall isolation (LAPWI) using only the cryoballoon (CB) is technically challenging for the treatment of atrial fibrillation (AF). This study aimed to evaluate the efficacy of the cross-over technique, wherein an overlapped ablation is performed by placing the CB from both directions in contact with the LAPW. METHODS: This was a single-center, retrospective, observational study of 194 consecutive patients with persistent atrial fibrillation (PerAF) who underwent a first-time procedure of pulmonary vein isolation (PVI) + PWI (108 patients) or PVI-only (86 patients) using the CB. The cross-over technique was applied in all LAPWI. RESULTS: For ablation of the LA roof and bottom, respectively, a mean of 8.6 ± 1.0 (right to left [R→L] 4.3 ± 1.1 and left to right [L→R] 4.3 ± 1.1) and 9.1 ± 1.2 (R→L 4.6 ± 1.6 and L→R 4.5 ± 1.2) CB applications were delivered. LAPW was successfully isolated solely using the CB in 99.1% of patients. Although the PVI + PWI group had significantly longer procedure time, no severe adverse events were observed in either group. During a median follow-up of 19 months, freedom from recurrence of all atrial tachyarrhythmias was achieved in 93.5% of the PVI + PWI group and 72.9% of the PVI-only group (p = .011). CONCLUSIONS: LAPWI performed solely with the CB using the cross-over technique is feasibly, safe, and was independently associated with a significantly higher freedom from recurrence of atrial tachyarrhythmias compared with PVI alone in patients with PerAF.

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.

Incidence of pulmonary vein stenosis in two types of cryoballoon systems.

Background: Currently, two types of cryoballoon (CB) systems are available for catheter ablation of atrial fibrillation (AF). Since the POLARx (Boston Scientific) is softer during freezing than the Arctic Front Advance Pro (AFA-Pro; Medtronic), it tends to go more deeply into the pulmonary vein (PV), risking PV stenosis. Methods: Ninety-one patients underwent initial CB ablation for paroxysmal AF (AFA-Pro 56; POLARx 35). Twenty-six from each group were extracted using propensity score matching. The PV cross-sectional area (PVA) was measured by tracing the area within the PV plane at 5-mm intervals from the PV ostium in a distal direction for 20 mm or to the bifurcation in each PV. The PVA was compared before and 3 months after ablation. Results: Time to balloon temperatures of -30 and - 40°C was significantly shorter and the nadir temperature was significantly lower with POLARx than with AFA-Pro. In the left inferior (LI) PV and right superior (RS) PV, the freezing balloon position was significantly deeper in POLARx than in AFA-pro. The freezing position in RSPV with mild to moderate narrowing was deeper than those without (10.2 ± 3.3 mm vs. 8.2 ± 1.8 mm, p = .01). In RSPV, the reduction of PVA tended to be greater with the POLARx than with the AFA-Pro (26.1% ± 14.1% vs. 19.9% ± 10.3%, p = .07). Conclusion: There was no significant difference in the incidence of PV stenosis between POLARx and AFA-Pro. However, if POLARx goes deep into the PVs, we will still have to be careful.

Electrophysiology lab efficiency using cryoballoon for pulmonary vein isolation in central and eastern Europe: A sub-analysis of the cryo global registry study.

BACKGROUND: Cryoballoon ablation for treatment of atrial fibrillation (AF) reduces procedure times, but limited data is available about its impact on electrophysiology (EP) lab efficiency in Central and Eastern Europe (CEE). Using CEE-specific procedure data, the present study modeled cryoballoon ablation procedures on EP lab resource consumption to improve efficiency. METHODS: A discrete event simulation model was developed to assess EP efficiency with cryoballoon ablation. Model inputs were taken from CEE sites within the Cryo Global Registry, namely Czech Republic, Hungary, Poland, Serbia, and Slovakia. The main endpoints were percentage of days that resulted in overtime and percentage of days with time for one extra simple EP procedure. Use of the 'figure of 8' (Fo8) closure technique to reduce procedure time was also examined. RESULTS: The mean lab occupancy time across all CEE sites was 133 ± 47 minutes (min: 104 minutes, max:181 minutes). Cryoballoon ablation in the base-case scenario resulted in 14.6% of days with overtime and 64.8% of days with time for an extra simple EP procedure. Use of the Fo8 closure technique enhanced these values to 5.5% and 85.3%, respectively. Model endpoints were most sensitive to changes in lab occupancy times and overtime start time. CONCLUSIONS: In this CEE-specific analysis of EP lab efficiency it was found that 3 cryoballoon ablation procedures could be performed in 1 lab day, leaving time for a 4th simple EP procedure on most days. As such, use cryoballoon ablation for PVI is an effective way to improve EP lab efficiency.

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.

Cryoballoon-Assisted Pulmonary Vein Isolation and Left Atrial Roof Ablation Using a Simplified Sedation Strategy without Esophageal Temperature Monitoring: No Notable Thermal Esophageal Lesions and Low Arrhythmia Recurrence Rates after 2 Years.

BACKGROUND: Atrial fibrillation (AF) ablation is increasingly effective for managing heart rhythm but poses risks like esophageal fistulas. Minimizing esophageal thermal lesions while simplifying procedures is crucial. METHODS: This prospective study involved 100 consecutive AF patients undergoing cryoballoon ablation with simplified sedation, without esophageal temperature monitoring. Patients with paroxysmal AF (Group A) received pulmonary vein isolation only, while those with persistent AF (Group B) also had left atrial roof ablation. Gastroesophageal endoscopy was performed post-procedure to detect lesions, and cardiological follow-ups were conducted at 3, 12, and 24 months. RESULTS: The cohort included 69% men, with a median age of 65.5 years. Post-ablation endoscopy was performed in 92 patients; esophageal lesions were found in 1.1% of Group A and none of Group B. GERD was diagnosed in 14% of patients, evenly distributed between groups and not linked to lesion occurrence. Gastric hypomotility was observed in 16% of patients, with no significant difference between groups. At 24 months, arrhythmia-free survival was 88% in Group A and 74% in Group B. CONCLUSION: Cryoballoon-assisted pulmonary vein isolation, with or without additional left atrial roof ablation and without esophageal temperature monitoring during a simplified sedation strategy, shows low risk of esophageal thermal injury and effective ablation outcomes.

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.

Current Balloon Devices for Ablation of Atrial Fibrillation.

Balloon-based catheter ablation is a valuable option for the treatment of atrial fibrillation (AF) because contiguous lesions can be created to achieve pulmonary vein isolation (PVI), and the method is less dependent than traditional ablation methods on the operator's skill and experience. Cryoballoon ablation is used universally worldwide, with its efficacy and safety being comparable to the efficacy and safety of standard radiofrequency ablation, and the procedure can be completed in a relatively short time. Hot balloon ablation was developed in Japan. The balloon maintains its compliance even during the energy delivery, and a large areal ablation lesion is created. Furthermore, the hot balloon system is the only system for which oesophageal cooling is a standard feature. Laser balloon ablation, which is performed under direct endoscopic vision, has proven to be effective and safe for achieving a PVI. The laser balloon system provides an improved field of view and automated circumferential ablation for a rapid and effective PVI. The authors have reviewed the currently available balloon systems as used for AF ablation, i.e., PVI, and have provided detailed insight and perspectives on the currently available cryoballoon and hot balloon technologies, plus laser balloon technology.

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.

Pulmonary Vein Isolation with Pulsed Field Ablation and Size-Adjustable Cryo-Balloon: A Comparative Procedural Analysis of First-Time Use.

Background: Pulmonary vein isolation (PVI) is the standard of care for the treatment of symptomatic atrial fibrillation (AF). Novel techniques for PVI are the thermal size-adjustable cryo-balloon (CB) system and non-thermal pulsed field ablation (PFA) system. There are currently no data available for a direct comparison between these two systems. Furthermore, with new techniques, it is important to ensure a high level of efficiency and safety during treatment right from initial use. Therefore, the aim of this study was to directly compare the procedural data and safety of these two new PVI techniques in first-time users. Methods: We conducted a single-center prospective study involving 100 consecutive patients with symptomatic atrial fibrillation who underwent first-time PVI using either size-adjustable CB PVI or PFA PVI from July 2023 to March 2024. Results: Acute PVI was achieved in 100% of patients in both groups. First-pass isolation (FPI) was more frequently achieved in the PFA group compared to the size-adjustable CB group. The mean procedural duration and fluoroscopy dose were significantly shorter in the PFA cohort (p < 0.001). Furthermore, a significant reduction in fluoroscopy time was observed during the learning curve within the PFA group (p = 0.023). There were no major complications in both groups. Conclusions: Both systems demonstrate good effectiveness and safety during PVI performed by first-time users. However, the PFA group exhibited a significantly shorter procedural duration.

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.

A randomized controlled trial of the size-adjustable cryoballoon vs conventional cryoballoon for paroxysmal atrial fibrillation: The CONTRAST-CRYO II trial rationale and design.

Background: Pulmonary vein isolation (PVI) with cryoballoon technology is a well-established therapy for treatment of atrial fibrillation (AF). Recently, a size-adjustable cryoballoon (POLARxTM FIT) that enables delivery in a standard 28-mm or an expanded 31-mm size was introduced. Objective: The purpose of this study was to perform a randomized clinical trial to evaluate the safety and efficacy of this novel cryoballoon compared to the conventional cryoballoon. Methods: The CONTRAST-CRYO II trial is a multicenter, prospective, open-label, randomized controlled trial in which 214 patients with paroxysmal AF will be randomized 1:1 to cryoballoon ablation with either a conventional cryoballoon (Arctic Front AdvanceTM Pro) or a size-adjustable cryoballoon (POLARx FIT). The study was approved by the Institutional Review Boards at all investigational sites and has been registered in the UMIN Clinical Trials Registry (UMIN000052500). Results: The primary endpoint of this study will be the incidence of phrenic nerve injury. Secondary endpoints include procedural success, chronic success through 12 months, procedure-related adverse events, biophysiological parameters during applications for each pulmonary vein (PV), total procedural and fluoroscopy times, level of PVI and isolation area, and probability of non-PV foci initiating AF. Conclusion: The CONTRAST-CRYO II trial is a multicenter, prospective, randomized controlled trial designed to assess the safety and efficacy of the POLARx FIT vs the Arctic Front Advance Pro. The findings from this trial will provide additional utility data on the efficacy of the size-adjustable cryoballoon for isolating PVs in patients with paroxysmal AF.

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.

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.