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 Lukas R.C. Dekker, MD, * Pepijn H. van der Voort, MD, * Timothy A. Simmers, MD, * Xander A.A.M. Verbeek, PhD, † Roland W.M. Bullens, PhD, † Marcel van’t Veer, PhD, ‡ Peter J.M. Brands, MTD, ‡ Albert Meijer, MD * From the * Department of Cardiology, Catharina Hospital Eindhoven, Eindhoven, The Netherlands, † Philips Healthcare, Best, The Netherlands, and ‡ Department of Medical Physics, Catharina Hospital Eindhoven, Eindhoven, The Netherlands. 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 ¼ 68) or the reference group (n ¼ 68). Baseline characteristics were similar, except patients in the novel imaging group were younger (58 vs 65 years, P o .01). Median DAP and AK were 43% and 40% lower in the novel imaging group, respectively (P o .0001). A 50% operator dose reduction was achieved in the novel imaging group (P o .001). Fluoroscopy time, number of exposure frames, and procedure duration were equiv- alent 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, sig- nificantly reduces patient and operator dose in complex EP procedures while maintaining image quality. KEYWORDS Ablation; Atrial fibrillation; Dose reduction; Imaging; Pulmonary vein isolation; Radiation dose ABBREVIATIONS AF ¼ atrial fibrillation; AK ¼ air kerma; BMI ¼ body mass index; DAP ¼ dose area product; EP ¼ electrophysiologic; EPD ¼ electronic pocket dosimeter; PVI ¼ pulmonary vein isolation; VT ¼ ventricular tachycardia (Heart Rhythm 2013;10:1678–1682) I 2013 Heart Rhythm Society. All rights reserved. Introduction The number of ablations for complex arrhythmias such as atrial fibrillation (AF) and ventricular tachycardia (VT) has grown substantially over recent years due to better under- standing of arrhythmia substrates and development of advanced electroanatomic mapping systems. Despite the growing use of these nonfluoroscopic mapping systems, fluoroscopy still constitutes an indispensable tool for various steps in these procedures, such as initial catheter placement, performance of transseptal punctures, and handling of sheaths. 1,2 Moreover, for some techniques and in several institutions, imaging still completely depends on X-rays. 3–5 Use of fluoroscopy is associated with risks on determin- istic effects such as radiation injury to the skin caused by high-peak skin dose, stochastic effects such as increased radiation-induced cancer risk, and genetic effects. Previous studies have shown that exposure to radiation necessary for catheter treatment of arrhythmia patients varies widely, sometimes even exceeding the threshold dose required for the onset of radiation-induced skin injuries. 6,7 Radiation- associated risks are of particular concern for young or obese patients, and for patients undergoing long and complex or repeated procedures. 8 Operators, including technicians and This study was supported by Philips Healthcare. Drs. Verbeek and Bullens are employees of Philips Healthcare. This trial is registered with ClinicalTrials.gov Number NCT01593852. Address reprint requests and correspondence: Dr. Lukas Dekker, Department of Cardiology, Catharina Hospital Eindhoven, PO Box 1350, 5602 ZA Eindhoven, Netherlands. E-mail address: lukas.dekker@catharina_ziekenhuis.nl. 1547-5271/$-see front matter B 2013 Heart Rhythm Society. All rights reserved. http://dx.doi.org/10.1016/j.hrthm.2013.08.018