Multicentre experience with the variable-loop circular catheter pulsed-field ablation system for atrial fibrillation ablation

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Atrial fibrillation (paroxysmal and persistent) (n=361). Intervention: VARIPULSE variable-loop circular catheter pulsed-field ablation. Primary outcome: Procedure-related complications (safety of the VLCC classified according to EHRA/HRS).

Antonio Dello Russo; Yari Valeri; Giuseppe Ciconte; Marco Schiavone; Paolo Compagnucci; Sara Poggi; Raffaele Salerno; Antonio Di Monaco; Lorenzo Gigli; Daniela Aschieri; Stefania I. Riva; Matteo Anselmino; Livio Bertagnolli; Luca Carlo Rossi; Patrizio Mazzone; Giuseppe Stabile; Michela Casella; Massimo Grimaldi; Claudio Tondo; Carlo Pappone

doi:10.1093/europace/euag265

Key result

Variable-loop circular pulsed-field ablation yields a ~2.5% procedural complication rate in real-world use.

n=361

Why the study?

Does variable-loop circular catheter pulsed-field ablation safely and efficiently treat patients with atrial fibrillation in real-world practice?

Key Points

To evaluate the real-world safety, efficiency, and procedural characteristics of the variable-loop circular catheter pulsed-field ablation system for atrial fibrillation ablation.
Observational multicentre study across nine tertiary electrophysiology centres evaluating N=361 patients treated between April 2024 and July 2025.
Procedures were performed for paroxysmal AF (n=215) or persistent AF (n=146), utilizing pulmonary vein isolation alone (n=190) or PVI with additional extra-PV ablation (n=171).
Complete pulmonary vein isolation was achieved in 352 patients (98%), with a median total skin-to-skin time of 61.5 min [IQR 54–75] and LA dwell time of 35 min [IQR 29–45].
Overall procedure-related complications occurred in 9 patients (2.5%), including 7 minor complications (2%) and 2 major complications (one ischaemic stroke and one transient ischaemic attack).
Arrhythmia recurrence during hospitalization occurred in 16 patients (4%), showing higher rates in persistent AF than paroxysmal AF (8% vs. 2%, P=0.009).

Study Design

Type

Observational (n=361)

Multicenter

Yes

Structured PICO

Does variable-loop circular catheter pulsed-field ablation safely and efficiently treat patients with atrial fibrillation in real-world practice?

P

Population

361 patients (median age 63, 30% female) with paroxysmal or persistent atrial fibrillation undergoing pulsed-field ablation using the variable-loop circular catheter at 9 Italian centers, evaluated for acute procedural safety.

E

Exposure

Variable-loop circular catheter (VLCC) pulsed-field ablation system (VARIPULSE platform, TRUPULSE generator) delivering short-duration, high-voltage bipolar biphasic pulses (1800 V, three 250 ms applications spaced 10 s apart). Protocol involved at least four ablations per pulmonary vein (two closed-loop 25 mm, two open-loop 35 mm), with additional ablations at operator discretion.

O

Outcome

Safety of the VLCC, with complications classified according to the EHRA/HRS classification.safety

The VARIPULSE system showed a favorable safety profile (2.5% complication rate) and high procedural efficiency across various AF ablation scenarios, though strict adherence to periprocedural anticoagulation protocols remains critical to mitigate stroke risk.

Limitations

Absence of long-term follow-up to assess clinical efficacy in terms of arrhythmia recurrence
All procedures were performed at tertiary referral centres by experienced operators, potentially biasing the observed safety profile
Absence of long-term follow-up, which prevents formal assessment of clinical efficacy in terms of arrhythmia recurrence

Implication

Supports real-world acute safety of variable-loop PFA; leaves open randomized trials for long-term efficacy.

Abstract

No abstract yet. The journal hasn't published one we can show.

Discussion

No takes yet. Share an insight, caveat, or question.

Cite This Study

Russo et al. (2026) conducted an observational in Atrial fibrillation (paroxysmal and persistent) (n=361). VARIPULSE variable-loop circular catheter pulsed-field ablation was evaluated on Procedure-related complications (safety of the VLCC classified according to EHRA/HRS). Real-world use of the variable-loop circular catheter pulsed-field ablation system resulted in an overall procedural complication rate of 2.5%, demonstrating a favorable acute safety profile.

synapsesocial.com/papers/6acef82db08c3d2c78aa4d36 https://doi.org/10.1093/europace/euag265

View Full Paper

Ask AI

Bookmark

Share

Multicentre experience with the variable-loop circular catheter pulsed-field ablation system for atrial fibrillation ablation

Key Points

Study Design

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

Multicentre experience with the variable-loop circular catheter pulsed-field ablation system for atrial fibrillation ablation

Key Points

Study Design

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

Keep reading

Keep reading