Assessment of a novel radiation reduction protocol for pediatric and adult congenital device implantation

Purpose: Device implantation requires fluoroscopic guidance, which carries inherent risks of ionizing radiation. We evaluated the impact of a low-dose fluoroscopic protocol on radiation exposure during device implantation. Methods: All patients who underwent pacemaker or ICD implantation with new transvenous leads from July 2011 to January 2018 were included. A novel ALARA protocol consisting of ultra-low frame rates (2–3 frames/s), low dose/frame (6–18 mGy/frame), and use of the “air-gap” technique in patients < 20 kg was employed. Demographics, procedural data, and radiation exposure levels were collected and analyzed. Results: Thirty patients underwent device implantation without additional catheterization, electrophysiology study, or ablation procedure (median age 15 years; range 5–50) with a total of 43 leads placed. Forty-seven percent of patients had a primary rhythm disturbance, 33% had cardiomyopathy, and 20% had congenital heart disease. Fifty percent were pacemakers (53% dual-chamber, 27% ventricle, 20% atrial) and 50% of devices implanted were ICDs (87% single-chamber). All implants were acutely successful with acceptable atrial and ventricular sensing and capture thresholds. The median fluoroscopy time was 11.5 min (inter-quartile range (IQR) 8.0–18.2), median air kerma dose 4.0 mGy (IQR 2.5–19.5), and median dose-area product 27.8 μGy/m² (IQR 17.1–106.5). Median implant procedure time was 133 min. One patient required revision secondary to device migration without lead derangement 2 days post-procedure. Conclusions: Use of a novel fluoroscopic protocol may help decrease radiation exposure to patients and staff without affecting efficacy or risk. These data may represent benchmarks against which future device implantation procedures can be compared.