Background Children requiring permanent pacing have a lifelong need for follow-up and re-intervention. Epicardial leads have traditionally fared worse than endocardial counterparts. We sought to test the hypothesis that steroid-eluting epicardial and endocardial leads had equivalent outcomes.
Methods We reviewed the medical records of 160 children, mean age 7.4 ± 5.5 yrs (range, 0.4 to 18 yrs), in whom a pacemaker system with steroid-eluting leads from a single manufacturer was implanted. Primary outcomes were early and late mortality. Secondary outcomes included freedom from lead failure and pacemaker system re-intervention. Loss of capture/sensing, lead displacement/fracture, exit block and high thresholds constituted lead failure. Re-intervention included the need for lead revision or generator change.
Results There was no early mortality. Late mortality occurred once (0.5 ± 0.5 deaths/1000 pt.-mos) and 8 times (3.4 ± 1.2 deaths/1000 pt.-mos) in the endocardial and epicardial groups, respectively. The relative hazard of endocardial vs. epicardial site for lead failure was 0.408 (p=0.038) and for re-intervention was 0.629 (p=0.002). Endocardial and epicardial groups differed in important ways: concomitant cardiac surgery 5% (3/61) vs. 27% (27/99), congenital heart disease 33% (20/61) vs. 90% (89/99), single ventricle physiology 13% (8/61) vs. 52% (51/99), and age (10.5 ± 4.5 yrs. vs. 5.5±± 5.2 yrs.). Adjusting for these co-variants by a proportional hazards (Cox) model, the relative hazard for freedom from lead failure for endocardial vs. epicardial leads was 0.546 (p=0.360). The adjusted relative hazard for freedom from re-intervention was 0.157 (p=0.045).
Conclusions Present technological advances render no important differences in lead failure rates between endocardial and epicardial steroid-eluting pacing leads in children thus bridging the performance gap between these fixation sites.
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