PFA noninferior to cryoablation in preventing atrial tachyarrhythmia recurrence

Pulsed field ablation (PFA) was noninferior to cryoballoon ablation (CBA) in preventing atrial tachyarrhythmia recurrence among patients with symptomatic paroxysmal atrial fibrillation (AF), according to the SINGLE SHOT CHAMPION trial presented at EHRA 2025.

At 1 year, with a 90-day blanking period, the rate of freedom from first recurrence of atrial tachyarrhythmia lasting ≥30 secs, as detected by continuous rhythm monitoring, was significantly higher in the PFA group than the CBA group (62.9 percent vs 49.3 percent). [Reichlin, et al, EHRA 2025]

This finding corresponded to a between-group difference in the cumulative incidence of –13.6 percentage points (95 percent confidence interval [CI], –26.9 to –0.3), indicating that the criteria for noninferiority (p<0.001) and superiority (p=0.046) were met, said lead author Dr Tobias Reichlin from the University Hospital of Bern in Switzerland.

However, “the sample size of our trial was modest and the superiority test was of borderline statistical significance, so the superior efficacy of PFA should be further investigated in larger outcome trials,” he noted.

When a secondary analysis of the primary endpoint was performed without the use of a blanking period, the result also favoured PFA over CBA with regard to the percentage of patients free from recurrence at 3 months (61.9 percent vs 41.9 percent; p<0.001) and 12 months (55.2 percent vs 37 percent; p=0.001).

“We could see that in the first 90 days, the difference between the two modalities was most striking, and I think this is the most important because it means that the difference in the mechanism of cardiac injury during ablation also translates into differences in the pattern of cardiac recovery in the months following ablation,” said Reichlin.

This investigator-initiated, noninferiority trial included 210 patients (mean age 64 years, 28 percent female) with symptomatic paroxysmal AF who underwent pulmonary-vein isolation with either PFA using the FARAPULSE PFA system (n=105) or CBA using the Arctic Front catheter (n=105).

PFA was associated with a significantly shorter procedure time (55 vs 73 mins; p<0.001) and left atrial dwell time (36 vs 52 mins; p<0.001) compared with CBA, but with a similar fluoroscopy time (15 mins in each group; p=0.63).

Secondary endpoints

The rate of atrial arrhythmia burden was significantly lower in the PFA group than the CBA group between days 1 and 90 (p<0.001), but no significant difference was observed between days 91 and 365 (p=0.17).

There were also no significant differences between the two groups in the rate of AF readmission (p=0.08), cardioversion (p=0.42), or reablation (p=0.22) during the first 12 months.

Safety endpoints

The composite safety endpoint of procedural complications was low in both groups, with one patient in the PFA group having a minor stroke and two patients in the CBA group having a cardiac tamponade.

Fewer serious adverse events were also observed with PFA compared with CBA (2 vs 4).

However, Reichlin acknowledged several limitations of the study. First, the results were only obtained with the pentaspline PFA system and might not apply to other PFA systems. Second, no data on AF burden reduction was available before the procedure.

“Overall, the randomized SINGLE SHOT CHAMPION trial showed that for symptomatic paroxysmal AF, PFA performed by operators with prior PFA experience was noninferior to CBA and associated with a lower rate of recurrences as assessed by continuous rhythm monitoring,” Reichlin said.