Randomized comparison of active and passive fixation J-shaped atrial leads

Abstract

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<0.05 when AF compared wkh PF There were 11 cases (5.5%) of complications within one year (4-PF, 7-AF, P=NS), which included pericardial complications (typical pain and/or significant effusion:6-AF, 0- PF, P<0.01), dislocations (2-PF, 1AF, P=NS), and exit block (2-PF,0 - AF, P=NS). One year death rate (5-AF, 5-PF) and rate of development of permanent atrial fibrillation (8-AF, 6-PF) were similar. Conclusions: PF leads had shorter fluoroscopy times at implantation and better electrical measurements over one year, as well as a lower rate of pericardial complications. Therefore, PF leads should be preferred, except in cases where they cannot be satisfactorily positioned.