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Irreversible Electroporation Therapy / Magnetic Resonance Imaging · Journal article
Annals of Medicine · March 3, 2026
Early or partial results. Treat as a signal, not a conclusion.
This prospective pilot RCT enrolled 62 patients with paroxysmal atrial fibrillation randomized to pulsed field ablation (PFA) or radiofrequency catheter ablation (RFCA), using pre- and post-procedure 3.0T MRI to detect silent cerebral lesions (SCL). SCL incidence was 12.90% with PFA versus 6.45% with RFCA, with no statistically significant difference (p=0.67), though the numerical trend warrants larger confirmatory studies.
Prospective, pilot, randomized controlled trial. Patients with paroxysmal atrial fibrillation; 104 screened, 42 excluded per predefined criteria, 62 enrolled. Intervention: Pulsed field ablation (PFA) using circular catheter with 1800V bipolar alternating current for pulmonary vein isolation. Compared with: Radiofrequency catheter ablation (RFCA). n = 62. The Affiliated Hospital of Xuzhou Medical University, China.
SCL incidence was 12.90% (4/31) in the PFA group and 6.45% (2/31) in the RFCA group No statistically significant difference in postoperative SCL incidence between groups (p=0.67) 62 patients with paroxysmal AF were randomized 1:1 to PFA or RFCA
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
While the difference was not statistically significant, the numerically double SCL rate with PFA (12.9% vs 6.45%) suggests cerebral safety requires evaluation in adequately powered trials. Prolonged procedural duration may increase SCL risk during PFA and warrants attention in clinical practice.
Small pilot RCT (n=62) found numerically higher but not statistically significant silent cerebral lesion rates with PFA versus RFCA, underpowered to detect differences.
As stated by the source record.
Quoted from the source exactly as published.
While the difference was not statistically significant, the numerically double SCL rate with PFA (12.9% vs 6.45%) suggests cerebral safety requires evaluation in adequately powered trials. Prolonged procedural duration may increase SCL risk during PFA and warrants attention in clinical practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
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.
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