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Background: 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. Methods: 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. Results: 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). Conclusion: 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).

Purpose: in a previous randomized controlled study we showed the advantage of J-shaped over straight screw-in leads in the atrium. In the present study we compared J-shaped tined passive fixation (PF) to screw-in active fixation (AF) leads. Methods: two hundred consecutive patients (pts) were randomized to have either a Medtronic 5568 J-shaped screw-in atrial lead (AF group, n=97) or a Medtronic 5592 J-shaped tined lead (PF group, n=103) implanted in the atrium. We documented implant data and electrical measurements at implant, pre-discharge, 3 months and one year; echocardiography and chest X-ray were performed at one day post implantation. All implant and follow-up complications were documented. Results: two hundred pts were included (103 males), aged 75.44-10.4, EF = 53 4- 11, of whom 39 (19.5%) had previously undergone cardiac surgery. In 5 cases (4 with a PF and one with an AF lead, P = 0.39), there was crossover to the alternate lead at implant due to inability to achieve a satisfactory position. Fluoroscopy times were shorter with PF: 2.14-3.6 vs. 3.3 4- 4.5 min (P=0.04). Bipolar electrical measurements are listed in the table. Lead Implant Pre-discharge 3 months One year 5568 (AF) Pwave mVoks 4.2±2.1 3.1±1.5 3.0±1.5 3.0±1.4 Impedance Ohm 434±133 533±126 531±142 529±139 Threshold Voks 0.9±0.3* 0.8±0.4* 1.2±0.7" 1.3±0.9" 5592 (PF) P wave mVoks 4.8±2.2 3.3±1.4 3.3±1.4 3.2±1.4 Impedance Ohm 448±100 476±88 498±84 500±77 Threshold Voks 0.7±0.5* 0.6±0.3* 0.7±0.6* 0.8±0.6* *P