Near-zero fluoroscopy technique for cardiac electronic device implantation: long-term outcomes

Abstract

Abstract Introduction Radiation hazards are a major concern for both patients and staff. We have previously described a near-zero fluoroscopy technique for cardiac electronic device implantation. In this study, we aimed to investigate the long-term safety of this technique and compare outcomes and procedural metrics with a conventional approach in a larger population. Methods Low-dose fluoroscopy technique. Radiation exposure during fluoroscopy is directly proportional to the time the unit is activated. Typically, the pedal switch is depressed for at least a few seconds per imaging sequence in order to visualize "live" movements of either the leads during their positioning or the needle during a fluoroscopy-guided puncture of the subclavian vein. Our technique consists of setting a low frame rate per second (0.5-3.75fps) and momentarily triggering the foot pedal switch only to obtain screenshots of the position of the leads/needle. Use of live electrograms to assist spatial awareness of lead position (e.g. Atrial, Coronary Sinus, Ventricular signals) acts as an adjunct to guidance. Study design We included consecutive patients undergoing permanent pacemaker (PPM) or cardiac defibrillator (ICD) implant at our center from July 2018 to December 2022 using the near-zero fluoroscopy technique. Procedures were performed by three operators (AC, MD, MF). Cumulative radiation dose was measured using dose-area product (DAP). We assessed procedure success and complication rate during long-term follow-up. We compared the procedural metrics and outcomes with a cohort of patients with PPM or ICD implanted in our centre by senior operators, using a traditional fluoroscopic approach. Propensity score was adopted to match baseline characteristics between the study and control group. Results The total population consisted of 412 patients (74.2±13.9 years, 60.9% male). We included 206 who underwent PPM or ICD implantation using the low-dose fluoroscopy technique, and 206 matched-control. A PPM or ICD was successfully implanted in all patients. Fluoroscopy time and DAP were significantly lower in the low-dose fluoroscopy group, mean 2.3±2.0 seconds versus 258.4±252.1 seconds (P<0.001) and 3.4±3.5 µGym2 versus 29.8±55.4 µGym2 (P<0.001), respectively. Mean procedure time was 49.0±20.8 minutes in the low fluoroscopy group and 65.7±26.8 minutes in the control group (P<0.001). Median frame per second setting was 0.5 in the low-dose cohort. After a mean follow-up of 441±470 days, the rate of complications was identical across groups (2.4%, p = 1.0). Conclusion This near-zero dose fluoroscopy technique is effective and safe, enabling a 10x reduction in radiation exposure during device implant. Modification of traditional implant and imaging techniques can provide material reductions in fluoroscopy dose to even below that for a standard PA chest radiograph.