Cerebral Embolism in Catheter Ablation of Atrial Fibrillation - CE-AF

Feb 08, 2019
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Date Published:
12/26/2018
Date Updated:
02/08/2019
Original Posted Date:
02/08/2019
References

Contribution To Literature:

Among patients with AF undergoing pulmonary vein isolation, ablation using the 9-electrode non-irrigated PVAC Gold catheter resulted in a greater incidence of asymptomatic cerebral embolic lesions on MRI and microembolic signals on transcranial Doppler compared with the irrigated Thermocool catheter, despite shorter procedural and ablation times with the former catheter.

Description:

The goal of the trial was to compare the incidence of asymptomatic cerebral embolism between a novel 9-electrode non-irrigated ablation catheter (PVAC Gold) and an irrigated radiofrequency catheter (Navistar Thermocool) among patients with atrial fibrillation (AF) undergoing pulmonary vein isolation. 

Study Design

Patients meeting inclusion criteria were randomized in a 1:1 fashion to ablation with the PVAC Gold catheter (n = 35) or the Thermocool catheter (n = 35). All patients were maintained on vitamin K antagonists from ≥2 months before until 3 months after the procedure. Ablation was performed under continued vitamin K antagonist therapy with a targeted periprocedural international normalized ratio (INR) of 2.0-3.0.

  • Total number of enrollees: 70
  • Duration of follow-up: 3 months
  • Mean patient age: 61 years
  • Percentage female: 39%

Inclusion criteria:

  • Need for pulmonary vein isolation

Exclusion criteria:

  • Patients with previous AF ablation
  • Patients with persistent AF
  • Contraindications for magnetic resonance imaging (MRI)
  • Inability to perform neuropsychological testing

Other salient features/characteristics:

  • INR at time of ablation: 2.7
  • Ablation time for PVAC Gold vs. Thermacool: 28 vs. 48, p < 0.001

Principal Findings:

The primary outcome, for PVAC Gold vs. Thermacool, new asymptomatic cerebral embolic lesions on brain MRI at 21 hours post-ablation, was 23% vs. 6%, p = 0.042.

Secondary outcomes, for PVAC Gold vs. Thermacool:

  • Median number of microembolic signals on transcranial Doppler: 1,111 vs. 787, p < 0.001
  • Thirty-day MRI, persistent asymptomatic cerebral embolic: 11% vs. 0% patients, p > 0.05
  • One-year antiarrhythmic drug-free AF survival: 49% vs. 63%, p = 0.23
  • No significant differences in test performance observed between the PVAC Gold and the Thermocool groups for all cognitive domains

Interpretation:

The results of this trial indicate that, among patients with AF undergoing pulmonary vein isolation, ablation using the 9-electrode non-irrigated PVAC Gold catheter resulted in a greater incidence of asymptomatic cerebral embolic lesions on MRI compared with the irrigated Thermocool catheter, despite shorter procedural and ablation times with the former catheter. Similarly, a larger burden of microembolic signals was noted on transcranial Doppler with the PVAC Gold catheter. Clinically, the PVAC Gold catheter had a numerically lower rate of antiarrhythmic drug-free AF survival, and there was one instance of asymptomatic pulmonary vein stenosis.


References:

Keçe F, Bruggemans EF, de Riva M, et al. Incidence and Clinical Significance of Cerebral Embolism During Atrial Fibrillation Ablation With Duty-Cycled Phased-Radiofrequency Versus Cooled-Radiofrequency: A Randomized Controlled Trial. JACC Clin Electrophysiol 2018;Dec 26:[Epub ahead of print].

Keywords: Anti-Arrhythmia Agents, Anticoagulants, Arrhythmias, Cardiac, Atrial Fibrillation, Catheter Ablation, Cognition, Electrodes, Embolism, International Normalized Ratio, Intracranial Embolism, Magnetic Resonance Imaging, Pulmonary Veins, Vitamin K


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