Safety and feasibility of pulsed field ablation with a pentaspline catheter in patients with cardiac implantable electronic devices: a multicentre experience

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Atrial Fibrillation in patients with cardiac implantable electronic devices (CIEDs) (n=72). Intervention: FARAPULSE pulsed field ablation. Primary outcome: Device malfunctions or required reprogramming immediately following PFA and during follow-up.

Q: What does this research mean for the field?

Pulsed field ablation using a pentaspline catheter is safe and feasible in patients with cardiac implantable electronic devices, resulting in no device malfunctions, inappropriate therapies, or significant lead parameter alterations. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Saverio Iacopino; Claudio Tondo; Stefano Bianchi; Antonio Dello Russo; Ruggero Maggio; Giovanni Rovaris; Matteo Bertini; Marco Galeazzi; Antonio Rossillo; Gianluca Zingarini; Francesco Solimene; Stefano Bandino; Mario Volpicelli; Andrea Di Cori; Maurizio Malacrida; Sakis Themistoclakis

doi:10.1093/europace/euaf132

June 26, 2025EP EuropaceOpen Access

Safety and feasibility of pulsed field ablation with a pentaspline catheter in patients with cardiac implantable electronic devices: a multicentre experience

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Key result

Pulsed field ablation appears safe and feasible in CIED patients with zero device malfunctions observed.

n=72

Why the study?

Safety and feasibility data on pulsed field ablation in patients with cardiac implantable electronic devices have been limited to case studies or small cohorts.

Does pulsed field ablation safely treat atrial fibrillation without causing device malfunctions or parameter alterations in patients with cardiac implantable electronic devices?

Key Points

To assess the safety and feasibility of pulsed field ablation using a pentaspline catheter for atrial fibrillation in patients with pre-existing cardiac implantable electronic devices.
Multicentre study evaluating 72 consecutive patients with active cardiac implantable electronic devices (30 pacemakers, 42 ICDs) and 56 with implantable loop recorders undergoing ablation with the FARAPULSE PFA system across 14 Italian centres (ATHENA study, NCT05617456).
Devices were interrogated before and on the same day after ablation to evaluate lead sensing amplitude, pacing thresholds, and impedance, accompanied by fluoroscopy to assess lead stability.
Pulmonary vein isolation was successfully achieved in 100% of patients with a median of 32 [32–42] PFA deliveries, and 23 patients (31.9%) received additional non-pulmonary vein ablations with a median of 20 [16–29] deliveries.
No device malfunctions, lead dislodgements, unintended anti-tachycardia pacing, or ICD shocks occurred, with no significant differences in pre- and post-ablation sensing, threshold, or impedance across right atrial, right ventricular, or left ventricular leads.
No major complications occurred; one patient (1.4%) experienced a minor vascular haematoma, and eight patients (11.1%) experienced atrial fibrillation recurrence over a median follow-up of 193 [183–275] days.

Study Design

Type

Observational (n=72)

Multicenter

Yes

Structured PICO

Does pulsed field ablation safely treat atrial fibrillation without causing device malfunctions or parameter alterations in patients with cardiac implantable electronic devices?

P

Population

72 adult patients (mean age 64.3, 26.4% female) with atrial fibrillation and pre-existing cardiac implantable electronic devices underwent pulsed field ablation and were followed for a median of 193 days.

I

Intervention

FARAPULSE pulsed field ablation (PFA) system for pulmonary vein isolation (median 32 applications), with additional lesions outside PVs performed at operator discretion.

O

Outcome

Device safety and procedural feasibility, including assessment of standard diagnostics (sensing amplitude, lead threshold, impedance) before and after ablation, and device malfunctions.safety

Limitations

Findings specific to the Farapulse technology and may not be generalizable to other PFA systems
Observational design
Relatively small sample size
Lack of prospective data on leadless pacemakers and subcutaneous ICDs
Specific to Farapulse technology
Small sample size
Need for prospective studies regarding leadless pacemakers and S-ICDs

Implication

Pulsed field ablation appears feasible and safe for treating atrial fibrillation in patients with pre-existing cardiac implantable electronic devices, showing no adverse effects on lead parameters or device function.

Abstract

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Discussion

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Cite This Study

Iacopino et al. (2025) conducted an observational in Atrial Fibrillation in patients with cardiac implantable electronic devices (CIEDs) (n=72). FARAPULSE pulsed field ablation was evaluated on Device malfunctions or required reprogramming immediately following PFA and during follow-up. Pulsed field ablation was successfully performed in all 72 patients with cardiac implantable electronic devices without any device malfunctions, inappropriate therapies, or significant parameter alterations.

synapsesocial.com/papers/6a6e2f80ce524a4339c2eb3a https://doi.org/10.1093/europace/euaf132

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Safety and feasibility of pulsed field ablation with a pentaspline catheter in patients with cardiac implantable electronic devices: a multicentre experience

Key Points

Study Design

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

Safety and feasibility of pulsed field ablation with a pentaspline catheter in patients with cardiac implantable electronic devices: a multicentre experience

Key Points

Study Design

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

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