Introduction: This study examined the mechanisms of lead failure among three manufacturers (Boston Scientific (BSC), Medtronic (MDT), St Jude Medical (SJM).
Methods: This study included all leads implanted at Winthrop University Hospital between 1996 and 2011. Lead failure was defined by MDT Systems Longevity criteria: failure to capture/sense, abnormal pacing/defibrillator impedance, insulation defect, lead fracture, extracardiac stimulation, cardiac perforation, tricuspid valve entrapment, lead tip fracture, and/or lead dislodgement. Statistical analyses included Chi-Square and Fisher’s Exact tests.
Results: There were 153(4%) lead failures in 4078 leads. MDT leads had more high impedance failures (MDT=36, BSC=2, SJM=7; p=0.03) and insulation defects (MDT=6, BSC=1, SJM=0; p=0.007). SJM leads had more dislodgements (SJM=6, BSC=2, MDT=1; p=0.0016). Recalled leads had more sensing failures (recalled=14(18%) vs non-recalled=4(5%); p=0.001) and lead fractures (recalled=31(41%) vs non-recalled=13(17%); p < 0.001). Non-recalled leads had more dislodgements (non-recalled=9(12%) vs recalled=0; p=0.002) and abnormal thresholds (non-recalled=15(19%) vs recalled=6(8%); p=0.04). MDT and SJM recalled leads differed in low impedance failure (SJM=3(15%) vs MDT=0; p=0.003).
Conclusions: Lead failure mechanisms differ among manufacturers and between recalled and non-recalled leads. Lead failure continues to be a concern for patient safety.