Abstract
Background
Radiofrequency catheter ablation (RFCA) is a first-line treatment for paroxysmal atrial fibrillation (PAF). Complications such as silent cerebral lesion (SCL) may occur during ablation. Pulsed field ablation (PFA) is a non-thermal method thatablates cardiac tissue via irreversible electroporation. Limited studies have reported the incidence of SCL during PFA, with highly variable results. However, randomized controlled trials (RCTs) remain scarce. The objective of this study was to compare perioperative SCL incidence between PFA and RFCA, and to identify risk factors for SCL during PFA.
Methods
In this prospective pilot RCT (ChiCTR2400088774), 62 patients with PAF were randomized 1:1 to undergo PFA or RFCA. Cerebral MRI (3.0 T) was performed preoperatively and 24–48h postoperatively. SCL was defined as a new acute brain lesion on MRI without neurological deficits. Baseline and surgical data of the patients were collected.
Results
SCL was detected post-procedure in 6.45% (2/31) in the RFCA group, 12.90% (4/31) in the PFA group. No statistically significant difference in the incidence of postoperative SCL was detected between the two groups (p = 0.67). Left atrium dimension (LAD), left atrial operation time (LAOT), left ventricular end-diastolic dimension (LVEDD), and total operation time (TOT) were significantly higher in SCL group than those in no-SCL group (p < 0.05) through univariate analyses.
Conclusions
SCL incidence was 12.90% in the PFA group versus 6.45% in the RFCA group. While no statistically significant difference was detected between two groups, the numerically higher rate in the PFA group warrants larger studies to evaluate cerebral safety associated with PFA.
Keywords: Paroxysmal atrial fibrillation, pulsed field ablation, radiofrequency catheter ablation, silent cerebral lesion
Graphical Abstract
Key Messages
This is the first prospective RCT comparing incidence of SCL during the perioperative period between PFA and RFCA with pre- and post-procedure MRI in both arms to exclude pre-existing acute lesions.
The incidence of SCL in PFA group was double that in RFCA group (12.9% vs 6.45%). Although no statistically significant difference was detected, the trend toward higher SCL events in the PFA group might be considered.
These findings indicated that prolonged procedural duration may be associated with a higher risk of SCL among PFA patients.
1. Introduction
Atrial fibrillation (AF) is a common arrhythmia associated with various serious adverse events. Radiofrequency catheter ablation (RFCA) is the primary strategy for rhythm control in patients with AF [1,2]. Cerebral embolism is one of the most frequent complications associated with RFCA [3]. Although the incidence of symptomatic thromboembolic events, such as stroke or transient ischemic attack, is low during the perioperative period of RFCA, the occurrence of silent cerebral lesions (SCL) is relatively common [4,5].
In recent years, Pulsed field ablation (PFA), as a new non-thermal ablation modality, has been introduced to the ablation of AF [6–8]. To date, few studies have investigated the incidence of SCL during PFA, and the reported results have varied considerably [9–11]. In most studies, only postoperative MRI was performed, which may have included pre-existing SCLs and thus affected the conclusion [9,10, 12,13]. Moreover, randomized controlled trials (RCTs) remain scarce.
We performed a prospective, pilot RCT to compare the incidence of SCL during the perioperative period between PFA and RFCA groups, and to identify risk factors for acute SCL during PFA.
2. Method
2.1. Study population
Between October 2024 and May 2025, 104 patients with paroxysmal AF were prospectively enrolled and underwent ablation at the Affiliated Hospital of Xuzhou Medical University. Of these, 42 patients were excluded according to the predefined exclusion criteria. Details of the exclusion criteria and the number of excluded patients are shown in Table 1. Ultimately, 62 patients with paroxysmal AF were consecutively enrolled in this study. The participants were randomized into the PFA and RFCA groups at a 1:1 ratio. All patients underwent enhanced computed tomography (CT) of the left atrium and pulmonary veins before the procedure to rule out left atrial appendage thrombosis. This study was conducted in accordance with the ethical principles outlined in the Declaration of Helsinki. The study received approval from the Ethics Committee of the Affiliated Hospital of Xuzhou Medical University (XYFY2024-KL351-01). The study protocol was registered in the China Clinical Trial Registry (ChiCTR2400088774). Written informed consent was obtained from all patients prior to enrollment.
Table 1.
Exclusion criteria and numbers of excluded patients.
| Exclusion criteria | Numbers of excluded patients (n) |
|---|---|
| Presence of left atrium or left atrial appendage thrombosis | 0 |
| Contraindications to cerebral MRI examination | 3 |
| History of stroke or transient ischemic attack within the past three months, or presence of definite neurological deficits suggestive of stroke | 4 |
| Finding of fresh cerebral infarctions by preoperative MRI | 4 |
| Previous history of catheter ablation for atrial fibrillation | 0 |
| Severe comorbidities such as hepatic or renal insufficiency or severe respiratory dysfunction | 5 |
| Refusal to sign informed consent | 26 |
2.2. PFA procedure
All procedures were performed under local anesthesia and sedation with fentanyl. After anesthesia, a steerable deca-polar catheter was advanced through the right femoral vein into the coronary sinus, and a quadri-polar catheter was placed in the right ventricle via the right femoral vein. An 8.5-Fr Swartz SL1 sheath with dilator was also introduced from the right femoral vein. An 11-Fr sheath was inserted through the left femoral vein for the insertion of an intracardiac echocardiography (ICE) catheter (SoundStar 10 Fr, Biosense Webster) into the right atrium. After transseptal puncture under fluoroscopic and ICE guidance, a circular PFA catheter (Jinjiang Electronic) with magnetic sensors was advanced into the left atrium and used to perform pulmonary vein isolation (PVI). This 8 F disposable cardiac PFA catheter features a 5.5-Fr distal tip (8-Fr proximal shaft), a 7-electrode circular array with 4-mm interelectrode spacing, and a 15-mm loop diameter. It is integrated with magnetic sensors for real-time navigation. When coupled with the LEAD-Mapping 3D electroanatomic system (Sichuan Jinjiang Electronic Technology Co., Ltd.), this platform achieves submillimeter positioning accuracy (≤1 mm) through magnetoelectric fusion technology, high-resolution 3D left atrial reconstruction with voltage mapping, and continuous catheter shape visualization under magnetic guidance. The system delivers bipolar alternating current (AC) PFA energy (selectable at 1000, 1200, 1400, 1600, 1800, or 2000 V) as microsecond-range biphasic pulses between adjacent electrodes. All electrodes support dual functionality for mapping/pacing and ablation. The voltage applied for PVI was 1800 V. Successful PVI was confirmed by the following criteria: (I) disappearance or dissociation of pulmonary vein potentials; and (II) failure to capture the adjacent atrium during pacing from multiple sites along the antral ablation line using the PFA catheter [13]. After PVI was achieved, left atrial voltage mapping was performed during sinus rhythm using the same catheter. If atrial fibrillation persisted after PVI, electrical cardioversion was performed. Following a 20-min waiting period, PVI verification was repeated [14]. In cases of pulmonary vein-to-atrium reconduction, additional ablation was performed to re-establish PVI. Substrate modification was performed in patients with low-voltage areas (LVA) in the left atrium.
2.3. Radiofrequency procedure
All procedures were performed under local anesthesia and sedation with Fentanyl. After anesthesia, a steerable deca-polar catheter was advanced through the right femoral vein into the coronary sinus and a quadru-polar catheter was placed in the right ventricle via the right femoral vein. An 8.5 Fr Swartz SL1 sheath with dilator was also introduced from the right femoral vein. An 11 F sheath was inserted through the left femoral vein, and the insertion of an ICE catheter (SoundStar 10 F, Biosense Webster) via the 11 F sheath into the right atrium was performed. After transseptal puncture under the guidance of fluoroscope and ICE, an open irrigated-tip ablation catheter (STSF, Biosense Webster) was advanced into the LA. Under the guidance of an electroanatomic mapping system (Carto 3, Biosense Webster), PVI was performed by point-by-point ablation with power output up to 50 W and an irrigation rate of 15 mL/min to maintain a tip temperature of less than 45 °C. The endpoint of the ablation procedure was to obtain a complete bi-directional electrical isolation of the PVs. Then left atrial voltage was mapped after PVI in sinus rhythm. If atrial fibrillation persisted after pulmonary vein isolation, electrical cardioversion was performed. Substrate modification was performed in patients with LVAs in the left atrium [14].
2.4. Anticoagulation management
All patients received oral anticoagulants prior to the procedure. Anticoagulation was maintained uninterrupted throughout the ablation. Before transseptal puncture, activated clotting time (ACT) was measured using the ACT Plus system (Medtronic), and a weight-adjusted loading dose of heparin was administered based on the patient’s preoperative ACT. During the left atrial procedure, ACT was monitored every 30 min, and additional heparin was administered according to the intraoperative ACT levels. The target therapeutic ACT range was maintained at 300–350 s throughout the procedure [15].
2.5. Cerebral MRI examination
All patients underwent MRI using a 3.0 T scanner equipped with a 16-channel head coil. Three-dimensional (3D) T2 FLAIR images were acquired using a 3D inversion recovery sequence, with fat saturation achieved by the Spectral Presaturation with Inversion Recovery (SPIR) technique. Diffusion-weighted imaging (DWI) was performed using a two-dimensional echo planar imaging sequence, and SPIR was also applied for fat suppression. Acute cerebral lesions were defined as focal hyperintense areas showing restricted diffusion on DWI, accompanied by reduced apparent diffusion coefficient (ADC) values, as confirmed on ADC mapping to exclude shine-through artifacts. SCL was defined as a newly detected acute cerebral lesion on postoperative MRI without associated neurological deficits [16]. All MRI scans were independently analyzed by an experienced radiologist blinded to the patients’ clinical data.
2.6. Neurological findings after ablation
All patients underwent NIHSS assessments one day before and one day after the procedure.
2.7. Sample size estimation
This exploratory pilot randomized controlled trial used a precision-based approach to sample size rather than formal power calculations. We enrolled 31 participants per arm, in line with commonly recommended ranges for pilot feasibility trials [17,18]. The size was chosen to provide acceptable precision for estimating the periprocedural incidence of SCL with PFA while remaining feasible given MRI capacity, expected adherence, and ethical considerations.
2.8. Statistical analysis
The Shapiro–Wilk test was used to assess the normality of data distribution, and Levene’s test was applied to evaluate the homogeneity of variance. For normally or approximately normally distributed data, results were expressed as mean ± standard deviation (SD) and compared using independent samples t tests. For non-normally distributed data, results were presented as the median (interquartile range, IQR) and compared using the Mann–Whitney U test. Categorical variables were presented as numbers (n) and percentages (%), and between-group comparisons were performed using the chi-square (χ2) test. If the assumptions for the chi-square test were not met, Fisher’s exact test was applied. Statistical significance was defined as a two-tailed P value < 0.05.
3. Results
3.1. Patient characteristics
Patient characteristics are detailed in Table 2. A total of 62 patients with paroxysmal atrial fibrillation were prospectively enrolled (mean age, 62.5 years; 40.3% female) and randomized to either the PFA group (n = 31) or the RFCA group (n = 31).There were no significant differences in baseline characteristics between the two groups.
Table 2.
Baseline characteristics.
| All (n = 62) | RFCA (n = 31) | PFA (n = 31) | P value | |
|---|---|---|---|---|
| Age, years | 62.50 (59.00, 70.00) | 64.00 (58.00, 71.00) | 62.00(59.50, 70.00) | 0.838 |
| BMI, kg/m2 | 25.39 ± 3.45 | 25.09 ± 3.21 | 25.69 ± 3.71 | 0.503 |
| Woman, n (%) | 25 (40.32%) | 11 (35.48%) | 14 (45.16%) | 0.605 |
| CHA₂DS₂-VASc Score | 1.00 (1.00, 2.00) | 1.00 (1.00, 2.00) | 2.00 (1.00, 2.50) | 0.481 |
| LVEF(%) | 62.56 ± 3.80 | 61.94 ± 3.42 | 63.19 ± 4.10 | 0.195 |
| LAD, mm | 38.03 ± 4.19 | 38.06 ± 4.80 | 38.00 ± 3.57 | 0.952 |
| LVEDD, mm | 48.53 ± 3.03 | 48.10 ± 3.02 | 48.97 ± 3.04 | 0.262 |
| Drinking, n (%) | 1 (1.61%) | 0 (0.00%) | 1 (3.23%) | 1.000 |
| Smoking, n (%) | 5 (8.06%) | 3 (9.68%) | 2 (6.45%) | 1.000 |
| Comorbidities, n (%) | ||||
| Hypertension | 21 (33.87%) | 11 (35.48%) | 10 (32.26%) | 1.000 |
| Coronary artery disease | 7 (11.29%) | 5 (16.13%) | 2 (6.45%) | 0.425 |
| Diabetes | 6 (9.68%) | 4 (12.90%) | 2 (6.45%) | 0.671 |
| Dyslipidemia | 3 (4.84%) | 2 (6.45%) | 1 (3.23%) | 1.000 |
| Previous stroke | 5 (16.13%) | 0 (0.00%) | 5 (16.13%) | 0.053 |
| Medication use pre ablation, n (%) | ||||
| Rivaroxaban | 60 (96.77%) | 30 (96.77%) | 30 (96.77%) | 1.000 |
| Dabigatran etexilate | 2 (3.23%) | 1 (3.22%) | 1 (3.23%) | 1.000 |
| ß-Blocker | 29 (46.77%) | 15 (48.39%) | 14 (45.16%) | 1.000 |
| Amiodarone | 5 (8.07%) | 1 (3.23%) | 4 (12.90%) | 0.354 |
| Propafenone | 6 (9.68%) | 4 (12.90%) | 2 (6.45%) | 0.671 |
BMI = Body mass index, LAD = Left atrium dimension, LVEF = Left ventricular ejection fraction, LVEDD = Left ventricular end-diastolic dimension.
3.2. Procedural details
In our study, PVI was successfully achieved in all patients. One patient remained in atrial fibrillation after PVI and underwent electrical cardioversion. Left atrial voltage mapping was performed using the ablation catheter during sinus rhythm. Low-voltage areas (LVAs) were defined as regions containing ≥3 adjacent points with bipolar voltage <0.5 mV [19]. LVAs were detected in 10 of 62 patients. In the PFA group, 2 of 31 patients exhibited LVAs, and substrate modification was performed in one patient. In the RFCA group, LVAs were identified in 8 of 31 patients, and 3 patients underwent substrate modification. During the procedure, visible microbubble formation was detected on ICE, which appeared more pronounced at electrodes with poor tissue contact. But no quantitative analysis was performed. Specific procedural details of the two groups are shown in Table 3.
Table 3.
RFCA VS PFA procedural data.
| RFCA (n = 31) | PFA (n = 31) | P value | |
|---|---|---|---|
| LAOT, min | 54.00 (47.00, 67.50) | 53.00 (45.50, 64.50) | 0.652 |
| AT, min | 21.00 (20.50, 26.00) | 2.86 (2.36, 3.35) | <.001 |
| TOT, min | 120.00 (100.00, 130.00) | 94.00 (78.50, 103.00) | <.001 |
| Mean ACT, s | 289.00 (269.50, 311.50) | 275.00 (266.00, 289.00) | 0.123 |
| Total heparin dose, IU | 9265.48 ± 2373.76 | 9480.65 ± 2711.63 | 0.741 |
LAOT = left atrial operation time, AT = Ablation time, TOT = Total operation time, ACT = Activated clotting time.
3.3. SCL events
In the RFCA group, 6.45% of patients (2/31) developed SCL, while the incidence in the PFA group was 12.90% (4/31). No statistically significant difference in the incidence of postoperative SCL was detected between the two groups (p = 0.67). MRI revealed cerebral lesions distributed across multiple regions in six patients, including the bilateral parietal lobes, right cerebellar hemisphere, right frontal lobe, right centrum semiovale, head of the right caudate nucleus, and left occipital lobe. Three of the four patients in the PFA group who developed SCL underwent follow-up MRI within a short interval. In one patient, complete resolution of the lesions was observed by postoperative day 7, while the other two patients showed no significant changes on follow-up MRI performed on postoperative days 7 and 5, respectively. No patient exhibited any clinically apparent neurological deficits following the ablation procedure. In all patients, the baseline NIHSS score was 0, and did not change postoperatively.
3.4. Univariate associations with SCL in the PFA group
The PFA group was divided into SCL and no-SCL subgroups according to DW-MRI findings. Baseline characteristics and procedural data were compared between these two groups using univariate analyses. Left atrium dimension (LAD), left atrial operation time (LAOT), left ventricular end-diastolic dimension (LVEDD), and total operation time (TOT) were significantly higher in the SCL group than those in the no-SCL group (p < 0.05) (Tables 4 and 5).
Table 4.
PFA baseline characteristic.
| No-SCL (n = 27) | SCL (n = 4) | P value | |
|---|---|---|---|
| Age, years | 63.07 ± 7.23 | 67.75 ± 5.12 | 0.225 |
| BMI, kg/m2 | 25.54 ± 3.90 | 26.65 ± 2.14 | 0.587 |
| Woman, n (%) | 13 (48.15%) | 1 (25.00%) | 0.607 |
| CHA₂DS₂-VASc Score | 2.00 (1.00, 2.00) | 2.00 (0.75, 3.00) | 0.903 |
| LVEF (%) | 63.64 ± 4.15 | 59.50 ± 2.89 | 0.053 |
| LAD, mm | 37.37 ± 3.36 | 42.25 ± 1.26 | 0.008 |
| LVEDD, mm | 48.52 ± 2.91 | 52.00 ± 2.16 | 0.030 |
| Drinking, n (%) | 0 (0.00%) | 1 (25.00%) | 0.129 |
| Smoking, n (%) | 1 (3.70%) | 1 (25.00%) | 0.245 |
| Comorbidities, n (%) | |||
| Hypertension | 10 (37.04%) | 0 (0.00%) | 0.277 |
| Coronary artery disease | 2 (7.41%) | 0 (0.00%) | 1.000 |
| Diabetes | 1 (3.70%) | 1 (25.00%) | 0.245 |
| Dyslipidemia | 1 (3.70%) | 0 (0.00%) | 1.000 |
| Previous stroke | 4 (14.82%) | 1 (25.00%) | 0.525 |
| Medication use pre ablation, n (%) | |||
| Rivaroxaban | 26 (96.30%) | 4 (100.00%) | 1.000 |
| Dabigatran etexilate | 1 (3.70%) | 0 (0.00%) | 1.000 |
| ß-Blocker | 13 (48.15%) | 1 (25.00%) | 0.607 |
| Amiodarone | 4 (14.82%) | 0 (0.00%) | 1.000 |
| Propafenone | 2 (7.41%) | 0 (0.00%) | 1.000 |
BMI = body mass index, LAD = left atrium dimension, LVEF = left ventricular ejection fraction, LVEDD = left ventricular end-diastolic dimension, SCL = silent cerebral lesion.
Table 5.
PFA procedural data.
| No-SCL (n = 27) | SCL (n = 4) | P value | |
|---|---|---|---|
| LAOT, min | 52.00 (43.50, 59.00) | 94.00 (82.50, 98.50) | 0.010 |
| AT, min | 2.75 (2.28, 3.31) | 3.42 (2.82, 4.25) | 0.149 |
| TOT, min | 92.15 ± 21.09 | 116.75 ± 22.34 | 0.039 |
| PFA deliveries | 103.00 (85.50, 124.00) | 128.00 (105.50, 159.25) | 0.149 |
| Mean ACT, s | 275.00 (264.00, 289.00) | 292.00 (283.50, 314.25) | 0.175 |
| Total heparin dose, IU | 9000.00 (7800.00, 12250.00) | 8500.00 (6550.00, 10750.00) | 0.701 |
LAOT = left atrial operation time, AT = ablation time, TOT = total operation time, ACT = activated clotting time.
4. Discussion
Cerebral MRI with DWI is the standard method for detecting small acute cerebral infarctions [20,21]. The detection of SCL is influenced by MRI parameters such as magnetic field strength and image resolution, with slice thickness being a particularly critical factor [22–24]. In our study, 3D sequence on 3.0 T MRI scanner was applied to increase imaging resolution [25]. Compared with 1.5 T MRI, 3.0 T MRI provides higher signal intensity, greater magnetic susceptibility, and superior resolution, allowing for sharper images in less time and improved detection of SCL [26–28]. Furthermore, compared with traditional 2D MRI, 3D MRI enables more accurate detection of cerebral lesions through improved spatial triangulation and data connectivity [29].
PFA is a non-thermal ablation method that uses an irreversible electroporation mechanism to ablate cardiac tissue. Due to its tissue selectivity, PFA has a higher safety profile than RFCA. SCL during PFA has been reported in some clinical studies [30,31]. A significant variation in SCL incidence was observed among previous studies, with reported rates of 3% to 19% [6,9–11]. In most studies, patients only underwent postoperative MRI, which may include patients with pre-existing acute SCL and influence the conclusions. In our study, all patients received MRI scans preoperatively and 24–48 h postoperatively. Four patients were excluded due to the detection of fresh cerebral infarctions by preoperative MRI.
The incidence of SCL in the PFA group was 12.90% (4/31). The ADVENT subgroup reported 8.8% in the PFA (Farapulse) arm [31]. The differing SCL incidence between the two studies may be attributable to the following reasons. First, compared to the 1.5 T MRI used in the ADVENT study, our study employed high-resolution 3.0 T MRI, which demonstrates higher sensitivity in detecting subtle lesions. Second, the different parameters between the PFA catheters used in two studies may represent another possible critical factor. The incidence of SCL in the PFA group versus the RFCA group was 12.9% vs 6.45% in our study and 8.8% vs 0% in the ADVENT study. Although no statistically significant difference was detected between the PFA and RFCA groups in our pilot study, potentially due to a small sample size that increased the risk of Type II errors. The results of our study and the ADVENT study show that the trend toward higher SCL events in the PFA group might be a common signal.
The SCL rate in the RFCA group (6.45%) is lower compared to some previous studies (often >10%) [32,33]. The lower incidence may be attributed to the open irrigated-tip ablation catheter (STSF) used, reduced LAOT and a strict anticoagulation strategy.
Three patients in the PFA group who developed SCL underwent follow-up MRI after a short interval. In one patient, the lesions completely resolved by postoperative day 7, while the other two patients showed no significant changes in their lesions (Figure 1). These findings suggest that the underlying pathophysiological mechanisms of cerebral lesion formation may vary. Potential mechanisms of SCL during PFA include gaseous bubble formation from hydrolysis, nitrogen displacement from the blood and catheter manipulation, regional microthrombus formation at the ablation site, and thrombus adherence to the transseptal sheath and mapping catheter [34–40]. The complete resolution of cerebral lesions in the short term may be associated with microbubble embolism [41]. The pathological substrate of these persistent lesions may be associated with solid microemboli resulting from thrombus formation. Further studies are required to elucidate the specific mechanisms of SCL during PFA.
Figure 1.
Typical examples of acute silent cerebral lesions in two patients undergoing PFA. SCL was defined based on a hyperintense DWI lesion plus reduced ADC (arrow). In the PFA group, one patient had completely resolved 7days postoperatively and other patients showed no significant changes in their lesions.
In this study, univariate analyses revealed that LAD, LAOT, LVEDD, and TOT were significantly associated with the presence of SCL (p < 0.05). This finding suggests that prolonged procedural duration may be associated with a higher risk of SCL among PFA patients. Longer PFA procedures are associated with a greater number of energy applications and increased microbubble formation, which potentially contribute to a higher risk of SCL. In one case with SCL, the patient had an anomalous pulmonary vein anatomy (three veins in right side). During the procedure, the number of PFA deliveries increased to 193, leading to a prolonged LAOT. In addition, the PFA catheters used in this study were non-irrigated. Previous studies have demonstrated that the use of irrigated-tip catheters during RFCA reduces thrombus and crust formation [42]. Prolonged catheter dwell time may increase the risk of catheter-related microthrombus formation. Given the low incidence of SCL in the PFA group, to avoid the risk of overfitting associated with constructing a multivariate logistic regression model with insufficient event numbers, no further multivariate analysis was conducted. Further validation in prospective studies with larger sample sizes is warranted.
5. Study limitations
As a single-center pilot RCT with a modest sample size and few events, a major limitation is that effect estimates are imprecise and model coefficients may be unstable. No statistically significant difference was detected between the two groups, which may be prone to type II errors due to the small sample size in the pilot study. This finding requires validation through larger-scale, multi-center studies with sufficient statistical power. Second, given the differences in catheter shape, voltage, waveform, fundamental frequency, and pulse packet duration across various PFA catheters, these findings may not be generalizable to other PFA catheters or technologies. Finally, SCL may be associated with long-term cognitive dysfunction. Our study did not evaluate the potential long-term impact of these lesions on cognitive function.
6. Conclusion
This pilot study shows that the incidence of SCL in the PFA group was double that in the RFCA group (12.9% vs 6.45%). Although no statistically significant difference was detected potentially due to a small sample size, the trend toward higher SCL events in the PFA group might be considered, and larger studies are needed to confirm cerebral safety associated with PFA.
Supplementary Material
Acknowledgments
Peiqi Ding: Data Curation, Formal Analysis, Writing–Original Draft, Writing–Review and Editing. Wensu Chen: Methodology, Writing–Original Draft, Writing–Review and Editing. Jianfan Shen: Data Curation, Formal Analysis. Bowen Qiu: Data Curation, Formal Analysis. Xiaoqin Hu: Supervision, Data Curation. Lixiang Xie: Blinded analysis and interpretation of brain MRI data. Zhongxiao Liu: Design and optimization of MRI parameters and imaging methodology. Fei Li: Project Administration. Liqi Ge: Participant enrollment and data collection. Hui Wei: Participant enrollment and data collection. Baixiang Zhang: Project Administration. Quan Zhang: Validation of clinical data. Zhirong Wang: Supervision. Minglong Chen: Supervision. Chengzong Li: Methodology, Supervision. Chaoqun Zhang: Funding Acquisition, Resources, Writing–Review and Editing.
Funding Statement
Supported by the Construction Project of High Level Hospital of Jiangsu Province, Project Number: GSPJS202415, Research Code: 2024113015.
Disclosure statement
The authors declare that they have no competing interests.
Data availability statement
The original contributions presented in this study are included in the article supplementary material, which includes all tables (Tables 1–5). Further inquiries can be directed to the corresponding author.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
The original contributions presented in this study are included in the article supplementary material, which includes all tables (Tables 1–5). Further inquiries can be directed to the corresponding author.