PULSED FIELD ABLATION VERSUS CRYOBALLOON ABLATION IN PERSISTENT ATRIAL FIBRILLATION: A SYSTEMATIC REVIEW AND BAYESIAN META-ANALYSIS

PULSED FIELD ABLATION VERSUS CRYOBALLOON ABLATION IN PERSISTENT ATRIAL FIBRILLATION: A SYSTEMATIC REVIEW AND BAYESIAN META-ANALYSIS | Authorea try { document.documentElement.classList.add('js'); } catch (e) { } var _gaq = _gaq || []; _gaq.push(['_setAccount', 'G-8VDV14Y67G']); _gaq.push(['_trackPageview']); (function() { var ga = document.createElement('script'); ga.type = 'text/javascript'; ga.async = true; ga.src = ('https:' == document.location.protocol ? 'https://ssl' : 'http://www') + '.google-analytics.com/ga.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(ga, s); })(); Skip to main content Preprints Collections Wiley Open Research IET Open Research Ecological Society of Japan All Collections About About Authorea FAQs Contact Us Quick Search anywhere Search for preprint articles, keywords, etc. Search Search ADVANCED SEARCH SCROLL This is a preprint and has not been peer reviewed. Data may be preliminary. 8 July 2025 V1 Latest version Share on PULSED FIELD ABLATION VERSUS CRYOBALLOON ABLATION IN PERSISTENT ATRIAL FIBRILLATION: A SYSTEMATIC REVIEW AND BAYESIAN META-ANALYSIS Authors : Marian Abedua Harrison 0000-0001-7348-6222 , Luena Seferasi , Ramiro Julian Nin Albonico , Udochukwu Godswill Anosike , and Leonardo Antunes Mesquita [email protected] Authors Info & Affiliations https://doi.org/10.22541/au.175194204.40735640/v1 235 views 154 downloads Contents Abstract Information & Authors Metrics & Citations View Options References Figures Tables Media Share Abstract Background: Persistent atrial fibrillation (AF) remains a therapeutic challenge, with one‐year arrhythmia‐free survival after a single ablation often below 60%. Pulsed field ablation (PFA) has emerged as an alternative to single-shot pulmonary vein isolation (PVI) technique with cryoballoon ablation (CBA). Methods: We conducted a systematic review and meta-analysis of studies comparing PFA and CBA in patients with persistent AF. Odds ratios (OR) for binary outcomes and mean differences (MD) for continuous outcomes were pooled using a random-effects model. Bayesian model was fitted for the main endpoint. Main outcome was freedom from atrial arrhythmia at 12 months. Results: Seven studies comprising 1,151 patients were included. At 12 months, 68.4% of PFA and 66.0% of CBA were free from any atrial arrhythmia (OR 1.14; 95% CI 0.89 to 1.47; p = 0.29). Bayesian analysis revealed an 84% probability that the true value favored PFA, but this finding was statistically non-significant (OR 1.13; 95% CrI 0.88 to 1.45). PVI with posterior-wall isolation did not result in better outcome compared to PVI alone (OR 1.02 vs 1.28; p-interaction=0.38), and 3D mapping use did not alter relative outcomes (OR 1.16 vs 1.21; p-interaction = 0.90). Conclusion: In patients with persistent AF, PFA and CBA achieve similar one-year arrhythmia-free survival. Given the non-inferiority finding observed with PFA, further larger and randomized studies should be performed to investigate PFA role in persistent AF management. Introduction Persistent atrial fibrillation (AF) is characterised by extensive atrial remodeling, diffuse fibrosis, and complex conduction abnormalities that reduce the efficacy of established thermal ablation techniques 1-2 . Lifetime risk of AF development is one in three adults aged 45 and older 5 , and persistent AF is responsible for 25% of new AF diagnoses 6 . Pulmonary vein isolation (PVI) is a Class I, Level A recommendation for symptomatic persistent AF after failure of anti-arrhythmic drug therapy 8-9 . Still, one-year arrhythmia-free survival after a single PVI ablation remains suboptimal in 40–50% of cases 10 often requiring repeat interventions, which increases annual healthcare costs 12 . Cryoballoon ablation (CBA) is the most widely performed single-shot PVI technique, with acute isolation rates exceeding 90% in persistent AF 13-14 . However, CBA has non-selective thermal energy that may affect the oesophagus and the phrenic nerve. Incidence of major complications is estimated to range between 2% and 4% 15 . Pulsed-field ablation (PFA) is a non-thermal alternative that uses irreversible electroporation to selectively target cardiomyocytes while preserving non-cardiac tissues 16 . This promising technique is showing more than 95% of acute isolation and major complication rates below 1% 17 . Although several studies compared these two ablation techniques, most focus primarily on paroxysmal or mixed AF cohorts. No meta-analysis has yet synthesized PFA versus CBA outcomes specifically for persistent AF. Therefore, we conducted a systematic review and meta-analysis comparing PFA with CBA in patients with persistent AF. Methods This systematic review was conducted following Cochrane Handbook for Systematic Reviews of Interventions and Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement guidelines 18 . The study protocol was prospectively registered in the International Prospective Register of Systematic Reviews (PROSPERO; ID: CRD420251058807). Literature search strategy We systematically searched PubMed, Cochrane Central Register of Controlled Trials, Embase, and Clinicaltrial.gov databases for studies published from inception to May 31, 2025. A detailed search strategy is provided in supplementary materials. The reference lists of relevant research articles and reviews were evaluated to capture additional studies. Eligibility criteria and study selection Studies were included if they met all the following: (1) randomized or observational studies (cohorts, case-control, or cross-sectional); (2) comparing PFA with CBA; (3) in patients aged 18 years or older; (4) undergoing catheter ablation for persistent AF; and (4) reporting at least one prespecified outcome of interest. Studies comparing PFA to CBA in mixed AF cohorts were included if they reported endpoints in persistent AF subgroup. Studies that performed PVI alone or in combination with additional ablation beyond the PVI, such as left atrial posterior wall isolation (LAPWI), were eligible. We excluded any study that: (1) failed to provide sufficient data on our outcomes; (2) was a conference abstract; (3) had an overlapping population. Two reviewers (M.A.H. and R.J.N.A.) independently and manually excluded duplicates, screened titles, abstracts, and full texts for eligibility using Rayyan software (Rayyan Systems Inc), with discrepancies resolved by consensus or by a third reviewer (L.A.M.). No filters were used. Figure 1: PRISMA Diagram of the Selection Process for Studies Included in the Meta-analysis Outcomes of interest Our main outcome of interest is the proportion of patients free from any atrial arrhythmia recurrence at 12 months follow‐up. Atrial arrhythmia recurrence was defined as AF, atrial flutter, or atrial tachycardia events documented by electrocardiogram (ECG), Holter ECG, or the recurrence of symptoms identical to those preceding ablation (lasting more than 30 seconds and at least 2 months after the ablation). Additional outcomes were: (1) success rate of acute PVI after first-pass isolation; (2) rate of need to repeat ablation procedure; (3) overall rate of post-procedural complications such as phrenic nerve injury, stroke or transient ischemic attack, esophageal injury, and cardiac tamponade. We also extracted data and analysed the following subgroups: (1) PVI only versus PVI with LAPWI; and (2) PVI with versus without the use of 3D-electroanatomic mapping (3D-EAM). Baseline characteristics extracted were sample size in each treatment arm, mean duration of follow up in months, mean age in years, gender, percentage of patients with hypertension, stroke and prior antiarrhythmic drug use, mean CHADS-VASc score, mean left atrial diameter (mm) and left ventricular ejection fraction. Risk of Bias Assessment Two authors independently conducted the risk of bias assessment (L.S. and R.N.), disagreements were resolved through consensus discussion. Non-randomized studies were assessed using the Risk Of Bias In Non-randomised Studies - of Interventions (ROBINS-I) V2 tool. Additionally, we used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) tool to assess the certainty of evidence for each outcome and relevant subgroup analyses for both the frequentist and Bayesian analyses. Statistical Analysis All analyses were conducted using R software version 4.5.0 (R Foundation for Statistical Computing). We performed both frequentist and Bayesian meta-analyses using the ‘meta’, ‘metafor’, ‘tidyverse’, and ‘bmr’ packages. For the frequentist approach, binary endpoints were analysed using pooled odds ratios (OR) with 95% confidence intervals (CI). We chose OR to include in the same analysis both case-control and cohort studies. Continuous outcomes were combined as mean differences (MDs) using the ‘metacont’ function. We used a DerSimonian-Laird random-effects model (REML) for continuous endpoints and Mantel–Haenszel for binary endpoints. Heterogeneity was assessed with the Cochran Q test and I2 statistics; p values less than 0.1 and I2 greater than 25% were considered significant for heterogeneity. To complement our frequentist analysis, we fitted a random-effects Bayesian model using brms (version 2.22.0) running on Stan (version 2.30) for our primary outcome. A normal-normal hierarchical model treated each study’s effect estimate and its standard error as inputs, yielding a pooled treatment effect as log OR and a study-level heterogeneity parameter. We used weak informative priors for the overall effect (Normal [0, 1]) and the between-study standard deviation (half-Cauchy [0, 0.5]). Four parallel Markov chains with 10,000 iterations each, including 2,000 warm-up, produced 32,000 post-warm-up draws without thinning. Convergence satisfied stringent criteria of R̂ 400 for every parameter. Simulated effect-size distributions closely mirrored the observed data. We present posterior medians with 95 % credible intervals (CrI) and report the posterior probability that the true effect exceeds the null. Results As detailed in Figure 1, after an initial search across databases, 427 studies were identified. After removing 129 duplicate records and excluding 284 studies based on title and abstract screening, 15 studies were retrieved for full-text review. Of these, seven observational studies with 1,151 patients were included in this systematic review and meta-analysis. One was a case-control 19 , four were prospective cohort 20-23 , and two were retrospective cohort studies 24,25 . PFA was used in 613 patients (53.3%), while 538 underwent CBA (46.7%). The mean follow-up was 12 months. Three studies evaluated only patients with persistent AF, while four studies evaluated mixed AF with the primary outcome reported for the persistent AF cohort. Across the three studies of the persistent AF cohort only, the mean age was 68 years and 75% were male. Table 1 summarizes the baseline characteristics of the included studies. Table 1: Baseline characteristics of included studies PFA CBA PFA CBA PFA CBA PFA CBA PFA CBA PFA CBA PFA CBA PFA CBA PFA CBA Issenegger (2025) Prospective cohort 12months 113 107 65 67 78 74 59 65 NR NR NR NR 2 3 43 42 54 56 Pannone (2024) Retrospective cohort 12months 80 80 68 67 73 68 74 70 1.2 1.2 84 81 2.1 1.9 NR NR 54 55 Kueffer (2024) Prospective cohort 12months 214 190 69 68 77 73 61 68 5.6 10.5 40 27 3 3 42 40 55 55 * Chaumont (2024) Prospective cohort 12months 40 41 61 63 43 43 58 61 5 10 92 90 1 2 NR NR 57 56 * Rattka (2024) Case control 12months 41 23 63 64 62 74 78 55 7 4 30 34 3 3 NR NR NR NR * Urbanek (2023) Prospective cohort 13months 84 73 71 68 59 54 66 70 5 7.5 NR NR 2 3 41 40 NR NR * Badertscher(2023) Retrospective cohort 13months 41 24 63 65 63 64 60.4 46.7 NR NR NR NR NR NR 41 40 57 58 PFA: Pulsed field ablation, CBA: Cryoballon ablation, HTN: Hypertension, AAD: Anti-arrhythmic drug, LAVI: Left atrial volume index, LVEF: Left ventricular ejection fraction, NR: Not reported, *Baseline characteristics reported for mixed AF group. Atrial arrhythmia-free survival at 12 months At 12 months, 68.4% of patients treated with PFA and 66.0% of those treated with CBA remained free from atrial arrhythmia. Pooled across seven studies (613 PFA vs 538 CBA), we found no difference between groups (OR 1.14; 95% CI 0.89 to 1.47; p = 0.29; I² = 0%; Figure 2A). Our subgroup analysis, stratified by lesion set, found similar results with no difference for both PVI-only studies (319 PFA vs 268 CBA; OR 1.28; 95% CI 0.87 to 1.89; p = 0.20; I² = 12.7 %; Figure 2B) and PVI + LAPWI (294 PFA vs 270 CBA; OR 1.02; 95% CI 0.71 to 1.45; I² = 0 %; Figure 2B). Test of interaction between the two lesion sets was non-significant (p = 0.3; Figure 2B). Among studies using 3D-EAM (448 PFA vs 400 CBA), and studies without the use of 3D-EAM (165 PFA vs 138 CBA), no difference was found (OR = 1.15; 95% CI 0.88 to 1.50; p = 0.29; I² =0%; Figure 2C). Bayesian analysis yielded a pooled OR of 1.13 (95% CrI 0.88 to 1.45), with an 84% posterior probability that PFA improves one-year AF-free survival compared with CBA (Figure 3A). Study-level posterior densities were centred at log-OR > 0, but every individual 95% Crl crossed the null (Figure 3B). Figure 2A. Freedom from atrial arrhythmia at 12 months: PFA versus cryoablation Figure 2B. Sub-group comparison of freedom from atrial arrhythmia at 12 months by lesion set: PFA versus cryoablation after PVI only and after PVI + LAPWI. Figure 2C. Forest plot of one-year atrial arrhythmia-free survival comparing pulsed-field ablation versus cryoballoon ablation, stratified by use of 3-D electro-anatomical mapping Figure 3A. Posterior distribution of the pooled treatment effect (log-odds ratio) for one-year atrial arrhythmia-free survival Figure 3B. Study-level posterior distributions of the log-odds ratio for one-year atrial arrhythmia-free survival. Black dots and horizontal bars denote posterior medians and 95 % credible intervals; the dashed line marks the null (log OR = 0, OR = 1), with values to the right favouring PFA and the left favouring cryoablation Acute PVI success rate Acute PVI was achieved in 100% of PFA veins (of 448 patients) and in 99% of CBA veins (of 400 patients). Repeat ablation procedure There was the need for repeat ablation in 53 out of 407 PFA patients (13%) versus 79 in 377 CBA patients (21%), with no difference between groups found (OR 0.53; 95% CI 0.24 to 1.17; p = 0.1; I² = 0%; supplementary Figure S2). Peri-procedural complications Complications were uncommon, occurring in 8/407 PFA cases (2.0%) and 8/377 CBA cases (2.1 %). The pooled estimate yielded no difference between techniques (OR 0.93; 95 % CI 0.35 to 2.48; p = 0.89; I ² = 0%; supplementary Figure S3). We found a slight association with lower rates of phrenic nerve injuries in the PFA compared with CBA (OR 0.12; 95% CI 0.01–0.92; p=0.04; I ²=0 %, supplementary Figure S4). There was no difference in the rate of cardiac tamponade (OR 0.15; 95% CI 0.2 to 6.5; p = 0.87; I ² = 0 %; supplementary Figure S5). Two events of stroke were recorded in the PFA group and none in the CBA group; no difference was found. Discussion In this systematic review and meta-analysis focused specifically on patients with persistent AF, we compared the efficacy and safety of PFA with CBA. Our main findings were as follows: (1) compared with CBA, PFA was non-inferior for both efficacy and safety, with an 84% posterior probability the true effect favored PFA; (2) we found no difference for subgroups using or not using LAPWI or 3D-EAM; (3) rate of phrenic nerve injury was lower in PFA compared with CBA. PFA is a new ablation technology developed with the premise of improving procedural safety 26 . Unlike conventional thermal ablation techniques, PFA delivers high-voltage electrical fields over microseconds to induce irreversible electroporation 27 . This mechanism increases cardiomyocyte membrane permeability, leading to cell death 16 while sparing surrounding non-cardiac tissues such as the phrenic nerve. Due to procedural similarities, particularly single-shot ablation, PFA is commonly compared to CBA rather than to point-by-point radiofrequency ablation. Previous studies, including a recent meta-analysis, have demonstrated a clinical benefit of PFA over CBA in patients with paroxysmal AF 28,32-35 . However, our analysis focused specifically on the persistent AF population, which typically has a more complex electrophysiological substrate, characterized by greater atrial remodeling and a higher arrhythmogenic burden 2 , conditions traditionally linked to lower success rates with single-shot ablation strategies. In such cases, additional lesion sets, such as posterior wall isolation or linear lesions, are often employed to improve procedural efficacy 29 . When analyzing our results using a conventional frequentist approach, we observed no overall difference between PFA and CBA for the rate of patients remaining free of atrial arrhythmia at 12 months. Studies however demonstrated heterogenous outcomes with some favouring CBA, some favouring PFA and several remaining neutral. This may be have been influenced by an operator learning curve for PFA in centers initially adopting PFA. Urbanek, for instance, excluded the first 25 patients in an attempt to minimize this bias. In the Bayesian analysis, however, all studies leaned towards PFA even though the 95% Crl included the null, reflecting a consistent directional effect. This behavior may be explained by the nature of Bayesian modeling, which integrates the totality of the evidence while accounting for the uncertainty of individual studies. By integrating both within-study variance and between-study heterogeneity, it retains the collective directional signal, in this case favouring PFA, yet widens the credible interval to acknowledge residual uncertainty. Consequently, even studies with modest effects or wide CrI contributed to a posterior distribution that favored PFA. This finding aligns with previous studies on paroxysmal AF, like ADVENT randomized trial 30 and Vetta’s meta-analysis 28 . This favouring of PFA with no significant difference might be caused by the low rate of the event and the low sample size. It may reflect inadequate power rather than true equivalence, emphasizing the need for high-powered randomized controlled trials. Four studies in our meta-analysis incorporated 3D-EAM to guide ablation 19,21,23,25 . While 3D mapping can enhance electroanatomical precision, particularly when targeting non-PVI substrates such as the atrial posterior wall or the mitral isthmus, its benefit in single-shot persistent FA remains debatable. In paroxysmal AF, where PVI alone is usually sufficient, mapping may not be essential. In persistent AF, however, additional anatomical and functional information provided by 3D mapping could help optimize lesion placement and improve procedural outcomes. Nonetheless, our subgroup analysis showed no difference in arrhythmia-free survival between procedures performed with or without 3D-EAM. This is consistent with prior data, including findings from Badertscher et al. who reported similar result 31 . This finding suggests that in procedures relying primarily on single-shot PVI, the routine use of 3D mapping may not be critical to procedural success. Similarly, LAPWI did not impact procedural outcomes in our analysis. Cases requiring adjunctive linear lesions, such as mitral isthmus lines, cavotricuspid isthmus ablation, or scar homogenization, may be better suited to point-by-point ablation modalities 32 , regardless of whether thermal (radiofrequency) or non-thermal (PFA) energy is used 8 . This may explain why we did not observe a significant difference between the two single-shot technologies in this persistent AF population. Moreover, this finding is consistent with the current lack of conclusive evidence supporting routine posterior wall ablation in persistent AF 36 . Of note, acute PVI success exceeded 99% in both PFA and CBA groups, suggesting that both single‐shot modalities reliably achieve electrical isolation at the index procedure, and that any observed differences in long-term arrhythmia recurrence are more likely driven by lesion durability, tissue healing, and underlying substrate complexity rather than acute procedural efficacy. Safety events such as cardiac tamponade and esophageal injury were rare across both modalities. Three events were recorded for cardiac tamponade in PFA versus two in CBA, but this difference was not significant. We found a minor association of a lower risk of phrenic nerve injury with PFA, reinforcing its myocardial selectivity and safety advantages over thermal ablation. Yet, this finding should be interpreted with caution, given that this event was rare (0 in PFA and 7 in CBA), which may lead to a type 2 error. Our study has limitations that should be considered when interpreting the findings. First, all seven included studies were non‐randomized, observational studies. Although we observed low statistical heterogeneity, the limited evidence base and potential for selection bias warrant cautious interpretation. Future large-scale studies comparing PFA and CBA, particularly in persistent AF, are needed to clarify the true comparative efficacy and safety, and refine patient selection for each ablation modality. Second, with a limited sample size of 1,151 patients, subgroup analyses for PVI + LAPWI and 3D‐EAM use were underpowered to detect modest between‐group differences. Finally, the included studies varied in how and when they assessed pulmonary vein reconnection or late lesion durability, precluding any pooled analysis of long-term isolation integrity. Long‐term rhythm control depends on durable PVI, and inconsistent or missing reporting of late pulmonary‐vein reconnection across studies limits our ability to assess whether PFA offers superior lesion durability. Conclusion Our meta-analysis showed that compared with CBA, a non-inferiority was found for PFA in patients with persistent AF undergoing ablation therapy in both efficacy and safety outcomes. Bayesian analyses found an 84% probability that PFA achieves superior rhythm control at one year in patients with persistent AF, though this difference was not significant. Neither LAPWI nor 3D‐EAM influenced outcomes for either modality. These findings reinforce the efficacy of single-shot PVI with CBA or PFA. Larger and randomized studies are needed to further investigate PFA’s potential benefit in this challenging population. REFERENCES 1. Horrach CV, Bevis L, Nwanna C, et al. Atrial fibrosis in atrial fibrillation: Mechanisms, mapping techniques and clinical applications. J Physiol . Published online May 28, 2025. doi:10.1113/JP288680 2. Griffin, M., Calvert, P. & Gupta, D. Persistent Atrial Fibrillation Ablation: Ongoing Challenges Defining the Target Population and Substrate. Curr Treat Options Cardio Med 25, 461–475 (2023). https://doi.org/10.1007/s11936-023-01011-5 3. Chugh SS, Havmoeller R, Narayanan K, et al. 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J Cardiovasc Electrophysiol . 2020;31(8):2136-2147. doi:10.1111/jce.14414 36. Pranata R, Kamarullah W, Karwiky G, Achmad C, Iqbal M. Left atrial posterior wall isolation in addition to pulmonary vein isolation using a pentaspline catheter in pulsed-field ablation for atrial fibrillation: A systematic review and meta-analysis. Heart Rhythm O2 . 2024;5(10):720-727.Published 2024 Sep 28. doi:10.1016/j.hroo.2024.08.006 Information & Authors Information Version history V1 Version 1 08 July 2025 Copyright This work is licensed under a Non Exclusive No Reuse License. Keyword clinical: catheter ablation – atrial fibrillation Authors Affiliations Marian Abedua Harrison 0000-0001-7348-6222 University of Ghana Medical School View all articles by this author Luena Seferasi Universiteti Metropolitan Tirana View all articles by this author Ramiro Julian Nin Albonico Sanatorio Americano View all articles by this author Udochukwu Godswill Anosike Nnamdi Azikiwe University Faculty of Medical Sciences View all articles by this author Leonardo Antunes Mesquita [email protected] Hospital Madre Teresa View all articles by this author Metrics & Citations Metrics Article Usage 235 views 154 downloads .FvxKWukQNSOunydq8rnd { width: 100px; } Citations Download citation Marian Abedua Harrison, Luena Seferasi, Ramiro Julian Nin Albonico, et al. PULSED FIELD ABLATION VERSUS CRYOBALLOON ABLATION IN PERSISTENT ATRIAL FIBRILLATION: A SYSTEMATIC REVIEW AND BAYESIAN META-ANALYSIS. Authorea . 08 July 2025. 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