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September 14, 2026European Heart Journal OpenOpen Access

Context-dependent interactions between variable-loop pulsed field ablation and cardiac implantable electronic devices: a controlled preclinical study

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Why the study?

Does pulsed field ablation cause critical device dysfunction in a preclinical swine model with implanted cardiac electronic devices?

Population

13 female swine implanted with contemporary cardiac implantable electronic device systems, including…

Comparison

Pulsed field ablation using the VARIPULSE system… vs Catheter manipulation without energy delivery.

Design

Preclinical

Follow-up

Acute experimental session

Key result

Pulsed field ablation did not cause catastrophic CIED dysfunction, but right atrial and superior vena cava procedures were associated with localized parameter changes and mechanical lead perturbation.

Authors

MTMasateru TakigawaRKRyosuke KatoIKIwanari Kawamura

Discussion

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Member takes

Overview

PFA-CIED interactions in this swine model warrant procedural caution; leaves open translation to human device patients.

Key Points

  • To evaluate context-dependent electrical and mechanical interactions between pulsed field ablation and diverse cardiac implantable electronic device systems in a controlled animal model.
  • Thirteen swine were implanted with contemporary device systems, including dual-chamber pacemakers, transvenous ICD/CRT-D systems with single- or dual-coil leads, leadless ventricular pacemakers, and subcutaneous ICDs.
  • Seven swine received pulsed field ablation (PFA) across the left atrium, right atrium, and superior vena cava (including applications near leads and over exposed coils), while six control animals received catheter manipulation without energy delivery.
  • Left atrial PFA remote from device hardware caused no acute catastrophic device failures, though minor parameter shifts occurred in a minority of cases with septal atrial leads.
  • Right atrial and superior vena cava procedures led to lead dislodgements and parameter alterations, which were primarily driven by mechanical catheter-lead interactions.
  • Direct PFA delivery over exposed defibrillator coils caused localized electrical perturbations without acute system-wide failure, while leadless pacemakers and subcutaneous ICDs maintained stable function throughout.

Structured PICO

Does pulsed field ablation cause critical device dysfunction in a preclinical swine model with implanted cardiac electronic devices?

P
Population
13 female swine implanted with contemporary CIED systems underwent pulsed field ablation or catheter manipulation to evaluate acute device interactions.
I
Intervention
Pulsed field ablation (PFA) using the VARIPULSE system delivered in the left atrium, right atrium, and superior vena cava, including applications near transvenous leads and pre-specified delivery over exposed SVC defibrillator coils.
C
Comparator
Catheter manipulation without energy delivery (n=6 swine).
O
Outcome
Critical device malfunction (power-on reset, electrical reset, transition to backup pacing mode, sudden battery loss, loss of telemetry) and changes in device parameters (sensing amplitude, pacing threshold, lead impedance, shock impedance).safety

In a preclinical swine model, pulsed field ablation did not cause catastrophic CIED dysfunction, but device-PFA interactions were context-dependent, highlighting the risk of mechanical interactions during right-sided procedures.

Limitations

  • Acute swine model with newly implanted leads did not reproduce chronic lead fixation or maturation in humans.
  • Smaller swine SVC/RA anatomy may have increased susceptibility to catheter-lead interaction.
  • Catheter manipulation was not continuously monitored or recorded throughout all RA/SVC manoeuvers, so exact timing of lead displacement could not always be captured.
  • Ventricular PFA was not evaluated.
  • Limited sample size
  • Acute experimental setting without chronic lead maturation, tissue ingrowth, or fibrotic encapsulation

Cite This Study

Takigawa et al. (2026) studied Cardiac implantable electronic devices (CIEDs) undergoing pulsed field ablation (n=13). Pulsed field ablation (PFA) vs. Catheter manipulation without energy delivery was evaluated on Critical device malfunction, lead dislodgement, sustained parameter shift, or out-of-range sensing/impedance. Pulsed field ablation did not cause catastrophic CIED dysfunction, but right atrial and superior vena cava procedures were associated with localized parameter changes and mechanical lead perturbation.

synapsesocial.com/papers/6aa7afef79e9260bc85aaca6https://doi.org/10.1093/ehjopen/oeag124
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