Radiation exposure during cardiac device implantation: Lessons learned from a multicenter registry.

BACKGROUND: Little data are available about radiation exposure during cardiac electrical device implantation, and no dose reference levels have been published. This multicenter, prospective, observational study assesses patient and staff radiation exposure during cardiac device implantations, and aims at defining dose reference levels. METHODS: Patient demographic, procedural, and radiation data were obtained for 657 procedures from nine institutions. Physician and staff exposure were measured using real-time dosimeters worn beneath and above lead apron. Statistical analysis included fluoroscopy time (FT), dose-area product (DAP), and DAP adjusted for FT and body mass index. RESULTS: Pacemakers and cardioverter defibrillators were implanted in 481 and 176 patients, respectively. Of these, 152 were treated with cardiac resynchronization therapy (CRT). Median FTs were 837s (interquartile range [IQR]: 480-1323), 117s (IQR: 69-209), and 101s (IQR: 58-162), and median DAPs were 1410 (IQR: 807-2601), 150 (IQR: 72-338), and 129 (IQR: 72-332) cGy.cm² for biventricular, dual chamber, and ventricular device implantation, respectively. Dose reference levels correspond to the third quartile values. During CRT, higher exposure was observed with four X-ray systems than with the two newer and customizable ones (adjusted DAP of 0.90 [IQR: 0.26-1.01] and 0.29 [IQR: 0.23-0.39], respectively; P < .001). CONCLUSION: Based on real-life measurements, this multicenter registry provides dose reference levels and may help centers assess radiation exposure. Although biventricular device implantation was responsible for the highest radiation exposure, FT was meaningfully shortened compared to previously reported values. For a same FT, the use of new generators and custom settings has significantly reduced DAP.

Early Detection and Treatment of Atrial Arrhythmias Alleviates the Arrhythmic Burden in Paced Patients: The SETAM Study.

BACKGROUND: Remote monitoring (RM) can remotely detect atrial tachyarrhythmias (ATAs). The benefit of RM compared to conventional follow-up in the detection and management of ATA was assessed in recipients of dual-chamber pacemakers. METHODS: The multicenter randomized SETAM study enrolled 595 patients in sinus rhythm with a CHA2 DS2 -VASc score ≥2, without ATA history and untreated with antiarrhythmics and antithrombotics, randomly assigned to RM (RM-ON; n = 291) versus ambulatory follow-up (RM-OFF; n = 304) during 12.8 ± 3.3 months. ATA occurrence, burden, and management were analyzed together with adverse clinical events. RESULTS: Patients were 79 ± 8 years old, 63% men, with a CHA2 DS2 -VASc score of 3.7± 1.2. ATA were detected in 83 patients (28%) in the RM-ON versus 66 (22%) in the RM-OFF group (P = 0.06). The median time between the pacemaker implantation and the first treated ATA was 114 days [44; 241] in the RM-ON versus 224 days [67; 366] in the RM-OFF group (hazard ratio [HR] = 0.56; 95% confidence interval [CI]: 0.37-0.86; P = 0.01). Therapies for ATA were initiated in 92 patients and the time to treatment of ATA was shortened by 44% in the RM-ON group (HR = 0.565; 95% CI: 0.37-0.86; P = 0.01). Over the last 4 months of follow-up, the mean ATA burden was alleviated by 4 hours/day (18%) in the RM-ON group. The rate of adverse clinical events was similar in both groups. CONCLUSION: Remotely monitored patients were diagnosed and treated earlier for ATA, and subsequently had a lower ATA burden.