Pulsed Field Ablation for Atrial Fibrillation

Schaack, David; Schmidt, Boris; Bordignon, Stefano; Urbanek, Lukas; Ebrahimi, Ramin; Hirokami, Jun; Efe, Tolga Han; Chen, Shaojie; Chun, Julian

doi:10.15420/aer.2022.45

Cited by 10 publications

(5 citation statements)

References 38 publications

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“…A recent article reviewing clinical studies about PFA arrived at the same conclusion. [ 26 ] However, several limitations regarding the data need to be considered, and we likely underestimate the full extent of oesophageal involvement. Most patients (88%) this far have been treated with a single ablation system featuring a pentaspline catheter.…”

Section: Discussionmentioning

confidence: 99%

Endocardial Pulsed Field Ablation and the Oesophagus: Are Atrio-oesophageal Fistulas Now History?

Nies,

Watanabe,

Kawamura

et al. 2024

Arrhythm Electrophysiol Rev

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Pulsed field ablation (PFA) is a novel energy form for the catheter ablation of cardiac arrhythmias, which uses electrical fields to mediate myocardial death via irreversible electroporation and other modalities. It is believed to offer relative tissue specificity, lowering – or even eliminating – the risk of complications associated with thermal energy, such as atrio-oesophageal fistulas. The proposed superior safety profile compared to thermal ablation has contributed to the enthusiastic implementation of PFA into clinical practice and is supported by early preclinical and clinical data. However, data about the effects of PFA on the oesophagus remain limited. This organ’s susceptibility to PFA has important clinical ramifications and there are two highly relevant questions. First, is the oesophagus absolutely spared by PFA or is there susceptibility to injury at higher field strengths? Second, if oesophageal injury can occur, can atrio-oesophageal fistulas ensue? The aim of this article is to provide a literature review on the effects of PFA on the oesophagus and to address these questions based on the data described.

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Section: Discussionmentioning

confidence: 99%

Endocardial Pulsed Field Ablation and the Oesophagus: Are Atrio-oesophageal Fistulas Now History?

Nies,

Watanabe,

Kawamura

et al. 2024

Arrhythm Electrophysiol Rev

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“…Some studies also proved durability of lesions with remapping at 90 days post initial procedure. 3 , 4 …”

Section: Discussionmentioning

confidence: 99%

“…Some studies also proved durability of lesions with remapping at 90 days post initial procedure. 3,4 In a recent meta-analysis comparing PFA to other thermal energy sources, that is, RF and CA, 24 landmark studies were compared in terms of safety (perioprocedural complications) and efficacy (total procedure times/LA dwell times) and freedom for atrial arrhythmias at 1 year. It concluded that there were significantly lower complications with PFA compared to other thermal ablations, PFA group (2.05%; 95% CI 0.94-3.46) compared to the thermal ablation group (7.75%; 95% CI 5.40-10.47) (p 0.001).…”

Section: Discussionmentioning

confidence: 99%

Use of pulse field ablation in the treatment of an atrial tachycardia: A case report

Elbanhawy

2024

Clinical Case Reports

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Key Clinical MessageThis case illustrates the safety and efficacy of pulse field ablation (PFA) in the short and medium term. It could be used to isolate extra pulmonary sites including the posterior wall. PFA could be used in the treatment of atrial tachycardias both focal and reentrant in combination with ultrahigh density electroanatomic mapping. It is also important to understand that different catheter shapes are available and their use can be tailored to the targeted anatomical site.

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“…Pulsed field ablation (PFA) is a novel, minimally thermal catheter ablation technology that creates lesions in myocardial tissue through irreversible electroporation [ 11 ]. It is currently limited to high-volume centers, but its adoption rate continues to grow for smaller centers.…”

Section: Introductionmentioning

confidence: 99%

Comparative Safety of Pulsed Field Ablation and Cryoballoon Ablation Technologies for Pulmonary Vein Isolation in Patients with Paroxysmal Atrial Fibrillation: A Critical Literature Review and Indirect Treatment Comparison

Maccioni,

Sharma,

Lee

et al. 2024

Adv Ther

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Introduction Cryoballoon ablation (CBA) is a standard catheter ablation technology with demonstrated clinical effectiveness for the treatment of paroxysmal atrial fibrillation (PAF); however, it can be associated with major adverse events, including phrenic nerve paralysis. Pulsed field ablation (PFA) is a novel, minimally thermal technology with comparable effectiveness and low safety risk. This study aimed to compare the safety profiles of PFA and CBA through critical analyses of the literature and indirect treatment comparisons. Methods Studies were identified by searching the MEDLINE database and the Clinicaltrials.gov registry. Registered clinical trials and/or Food and Drug Administration Investigation Device Exemption (FDA IDE) studies evaluating PFA or CBA in adult patients with drug-refractory PAF between January 2008 and March 2023 were selected. Comparative safety between PFA and CBA was assessed for major and prespecified adverse events. Indirect comparisons were conducted using the proportion of patients experiencing adverse events and confirmed with single-arm meta-analyses and sensitivity analyses. Results Data were extracted from three PFA publications including a total of 497 patients and six CBA studies including a total of 1113 patients. The analysis revealed that PFA was associated with significantly lower risk of major adverse events {risk difference − 4.3% [95% confidence interval (CI) − 5.8, − 2.8]; risk ratio 0.16 [95% CI 0.07, 0.45]} and prespecified adverse events [risk difference − 2.5% (95% CI − 4.4, − 0.5); risk ratio 0.53 (95% CI 0.31, 0.96)]. Meta-analyses confirmed the lower rate of major adverse events for PFA [0.4% (95% CI 0.0, 1.3)] vs. CBA [5.6% (95% CI 2.6, 8.6)] and prespecified adverse events for PFA [2.7% (95% CI 1.2, 4.1)] vs. CBA [5.8% (95% CI 2.7, 9.0)]. Sensitivity analyses exploring heterogeneity across studies confirmed robustness of the main analyses. Conclusion The findings of this study show that PFA has a more favorable safety profile than CBA, with significantly lower risks of major and prespecified adverse events. These indirect comparisons help contextualize the safety of PFA compared to CBA for the treatment of drug-refractory PAF in the absence of head-to-head studies. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-023-02765-x.

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Pulsed Field Ablation for Atrial Fibrillation

Cited by 10 publications

References 38 publications

Endocardial Pulsed Field Ablation and the Oesophagus: Are Atrio-oesophageal Fistulas Now History?

Endocardial Pulsed Field Ablation and the Oesophagus: Are Atrio-oesophageal Fistulas Now History?

Use of pulse field ablation in the treatment of an atrial tachycardia: A case report

Comparative Safety of Pulsed Field Ablation and Cryoballoon Ablation Technologies for Pulmonary Vein Isolation in Patients with Paroxysmal Atrial Fibrillation: A Critical Literature Review and Indirect Treatment Comparison

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