SPONTANEOUS VERSUS EXTRACTION RELATED INJURIES ASSOCIATED WITH ACCUFIX J-WIRE ATRIAL PACEMAKER LEAD - TRACKING CHANGES IN PATIENT-MANAGEMENT

To make recommendations for management of potentially fatal failure of the Accufix series of atrial J-wire permanent pacemaker leads, we clo sely monitored the number of injuries and fatalities resulting either from spontaneous fracture of the J-wire or from attempts to extract th e lead. In a population of 30,357 patients, 2,298 patients are enrolle d in a prospective follow-up Multicenter Study, the remainder are pati ents with known clinical status from voluntary reporting, and 2,992 pa tients died following implant. In the remaining 27,365 patients, 6 dea ths have been attributed to J-wire related injury (J-inj) while 13 wer e complications (E-inj) associated with 4,076 lead extraction procedur es (3,974 intravascular (intra)/102 primary thoracotomy (PT). The date of occurrences were from 1994 to November 1997. Conclusions: (1) Sinc e lead extractions were not conducted in a controlled study, it is not known whether the deaths associated with lead extraction is in excess of what would have occurred if these leads had not been removed in th is specific subset. (2) Awareness of the procedure related complicatio n rate appears to have moderated the rate of lead extraction and may u ltimately lead to management that reasonably balances the risks of pat ient injury.