European heart journal open · 2026
Context-dependent interactions between variable-loop pulsed field ablation and cardiac implantable electronic devices: a controlled preclinical study.
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Takigawa Masateru, Kato Ryosuke, Kawamura Iwanari, Toda Megumi, Honda Masaki, Negishi Miho, Tateishi Ryo, Yamaguchi Junji, Goto Kentaro, Nishimura Takuro, Tao Susumu, Miyazaki Shinsuke, Sasano Tetsuo
Аннотация
AIMS: Pulsed field ablation (PFA) is increasingly used for atrial fibrillation and is being extended beyond pulmonary vein isolation to right atrial (RA) and superior vena cava (SVC) targets. As its use expands, interactions with cardiac implantable electronic devices (CIEDs) have become an important yet incompletely defined safety concern. We aimed to evaluate context-dependent interactions between PFA and diverse CIED systems in a controlled pre-clinical model.
METHODS AND RESULTS: Thirteen swine underwent implantation of contemporary CIED systems. Seven animals received PFA across multiple device configurations, including dual-chamber pacemakers, transvenous ICD/CRT-D generator systems with single- or dual-coil ICD leads, a leadless ventricular pacemaker, and a subcutaneous ICD. Six control animals underwent catheter manipulation without energy delivery. PFA was performed in the left atrium (LA), RA, and SVC, including applications near transvenous leads and pre-specified delivery over exposed SVC defibrillator coils. Device parameters were assessed sequentially.
RESULTS: When performed at an anatomical distance from device components, LA-PFA was not associated with critical device dysfunction under the studied conditions, although minor parameter changes occurred in a minority of cases, particularly with septal atrial lead positioning. During RA/SVC procedures, parameter perturbations and atrial lead dislodgement were observed and were most consistent with catheter-lead mechanical interaction. PFA delivered overexposed ICD coils that produced localized electrical changes without evidence of acute global device failure. The leadless ventricular pacemaker and subcutaneous ICD maintained stable function.
CONCLUSION: PFA did not cause catastrophic CIED dysfunction under the studied conditions; however, device-PFA interactions were strongly context-dependent, influenced by anatomical proximity, conductive exposure, and mechanical interaction.
METHODS AND RESULTS: Thirteen swine underwent implantation of contemporary CIED systems. Seven animals received PFA across multiple device configurations, including dual-chamber pacemakers, transvenous ICD/CRT-D generator systems with single- or dual-coil ICD leads, a leadless ventricular pacemaker, and a subcutaneous ICD. Six control animals underwent catheter manipulation without energy delivery. PFA was performed in the left atrium (LA), RA, and SVC, including applications near transvenous leads and pre-specified delivery over exposed SVC defibrillator coils. Device parameters were assessed sequentially.
RESULTS: When performed at an anatomical distance from device components, LA-PFA was not associated with critical device dysfunction under the studied conditions, although minor parameter changes occurred in a minority of cases, particularly with septal atrial lead positioning. During RA/SVC procedures, parameter perturbations and atrial lead dislodgement were observed and were most consistent with catheter-lead mechanical interaction. PFA delivered overexposed ICD coils that produced localized electrical changes without evidence of acute global device failure. The leadless ventricular pacemaker and subcutaneous ICD maintained stable function.
CONCLUSION: PFA did not cause catastrophic CIED dysfunction under the studied conditions; however, device-PFA interactions were strongly context-dependent, influenced by anatomical proximity, conductive exposure, and mechanical interaction.