Why the study?
Catheter ablation of AF required technological advancement to combine the capabilities of single-tip catheters with the simplicity of balloon catheters.
Does pulmonary vein isolation using the Globe multielectrode array achieve acute isolation and 12-month freedom from AF in patients with symptomatic atrial fibrillation?
Does pulmonary vein isolation using the Globe multielectrode array achieve acute isolation and 12-month freedom from AF in patients with symptomatic atrial fibrillation?
The Globe multielectrode array demonstrates high acute procedural success for single-shot pulmonary vein isolation with promising 12-month efficacy in patients with symptomatic atrial fibrillation.
Answers are grounded in this paper and cite their sources.
Feasibility of single-shot Globe PVI shown in case series; leaves open comparative efficacy versus established catheters.
INTRODUCTION: The critical question for technological advancement of catheter ablation of atrial fibrillation (AF) is whether a creative new concept can combine and even improve the options of single-tip catheters with the simplicity of the use of balloon catheters. Herein are described the results from the first clinical study of a new multielectrode contact-mapping plus ablation array (Globe) offering such a complete solution. METHODS AND RESULTS: The multielectrode Globe array consists of 16 flat ribs with 122 gold-plated electrodes. Each electrode can record electrograms, ablate, pace, and can measure tissue contact and temperature. Single-shot pulmonary vein isolation (PVI) is possible with temperature-guided ablation of up to 24 electrodes simultaneously with automatic, individual power control of every electrode. Sixty patients with symptomatic AF underwent PVI using the Globe. In all sixty patients, acute PVI was achieved in 232 of 234 attempted PVs (99.1%). In 34 patients treated with "single-hot-shot" ablation, PVI was achieved in 136 of 136 PVs (100%). Single-procedure 12-month freedom from AF off antiarrhythmic drugs in the "single-hot-shot" group was 75.5% and freedom from AF/atrial tachycardia 72.3%. In two patients, pericardial tamponade was observed, one after a transseptal puncture, and one during array insertion with an over-advanced sheath. There were no other device-related serious adverse events, including stroke, PV stenosis, esophageal perforation, or phrenic nerve palsy. CONCLUSIONS: In this first clinical series, the Globe catheter was found to be an easy-to-use system for single-shot PVI. The continuously updated multielectrode voltage and activation mapping data indicate future options for mapping and ablation beyond PVI.
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Kottkamp et al. (2019) studied this question.
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