New image processing and noise reduction technology allows reduction of radiation exposure in complex electrophysiologic interventions while maintaining optimal image quality: a randomized clinical trial

Abstract

Background: Despite their carcinogenic potential, X-rays remain indispensable for electrophysiologic (EP) procedures.

Objective: The purpose of this study was to evaluate the dose reduction and image quality of a novel X-ray technology using advanced image processing and dose reduction technology in an EP laboratory.

Methods: In this single-center, randomized, unblinded, parallel controlled trial, consecutive patients undergoing catheter ablation for complex arrhythmias were eligible. The Philips Allura FD20 system allows switching between the reference (Allura Xper) and the novel X-ray imaging technology (Allura Clarity). Primary end-point was overall procedural patient dose, expressed in dose area product (DAP) and air kerma (AK). Operator dose, procedural success, and necessity to switch to higher dose settings were secondary end-points.

Results: A total of 136 patients were randomly assigned to the novel imaging group (n = 68) or the reference group (n = 68). Baseline characteristics were similar, except patients in the novel imaging group were younger (58 vs 65 years, P < .01). Median DAP and AK were 43% and 40% lower in the novel imaging group, respectively (P < .0001). A 50% operator dose reduction was achieved in the novel imaging group (P < .001). Fluoroscopy time, number of exposure frames, and procedure duration were equivalent between the two groups, indicating that the image quality was similarly adequate in both groups. Procedural success was achieved in 91% of patients in both groups; one pericardial tamponade occurred in the novel imaging group.

Conclusion: The novel imaging technology, Allura Clarity, significantly reduces patient and operator dose in complex EP procedures while maintaining image quality.

Trial registration: ClinicalTrials.gov NCT01593852.

Keywords: AF; AK; Ablation; Atrial fibrillation; BMI; DAP; Dose reduction; EP; EPD; Imaging; PVI; Pulmonary vein isolation; Radiation dose; VT; air kerma; atrial fibrillation; body mass index; dose area product; electronic pocket dosimeter; electrophysiologic; pulmonary vein isolation; ventricular tachycardia.