Randomized comparison of J-shaped atrial leads with and without active fixation mechanism.
In this prospective, randomized, controlled study, we compared the performance of J-shaped active fixation (AF) atrial leads with J-shaped passive fixation (PF) leads, over a 1-year follow-up period. A total of 200 consecutive patients were prospectively randomized for implantation with a Medtronic 5568 AF lead model (n = 103; Minneapolis, MN, USA) versus a Medtronic 5592 PF model (n = 97), and all lead-related measurements and complications were recorded over one year. All leads were successfully implanted with a nonsignificant difference in crossover rate to the alternative lead due to failed implantation (1 in the AF and 4 in the PF group, P = NS). Fluoroscopy time during implantation procedure was significantly shorter in the PF group (2.1 +/- 3.6 vs 3.3 +/- 4.5 minute, P < 0.05). Pacing thresholds during implantation were significantly lower in patients with PF leads (0.7 +/- 0.3 V vs 0.9 +/- 0.3 V, P < 0.001) and this difference persisted at 1-year follow-up (0.8 +/- 0.6 V vs 1.3 +/- 0.9 V in PF and AF leads respectively, P < 0.05). Lead-related complications occurred in PF and AF with similar frequency (4% and 9% respectively, P = 0.2). However, pericardial complications occurred only in the AF group (6 cases, P = 0.01). Lead dislodgement was observed in only two cases-both in the PF group (P = 0.3). Both types of J-shaped atrial leads had reasonable performance. PF leads required shorter fluoroscopy time for implantation, demonstrated a better pacing threshold over a 1-year follow-up period and had no pericardial complications, while AF lead implantation was complicated by pericardial irritation and/or effusion in 6% cases (P = 0.01).