Risks of spontaneous injury and extraction of an active fixation pacemakerlead - Report of the Accufix Multicenter Clinical Study and Worldwide Registry

Background-The Telectronics Accufix pacing leads were recalled in November 1994 after 2 deaths and 2 nonfatal injuries were reported. This multicenter clinical study (MCS) of patients with Accufix leads was designed to determ ine the rate of spontaneous injury related to the J retention wire and resu lts of lead extraction. Methods and Results-The MCS included 2589 patients with Accufix atrial paci ng leads that were implanted at or who were followed up at 12 medical cente rs. Patients underwent cinefluoroscopic imaging of their lead every 6 month s. The risk of J retention wire fracture was approximate to 5.6%/y at 5 yea rs and 4.7%/y at 10 years after implantation. The annual risk of protrusion was 1.5%. A total of 40 spontaneous injuries were reported to a worldwide registry (WWR) that included data from 34 672 patients (34 892 Accufix lead s), including pericardial tamponade (n = 19), pericardial effusion (n = 5), atrial perforation (n = 3), J retention wire embolization (n = 4), and dea th (n = 6). The risk of injury was 0.02%/y (95% CI, 0.0025 to 0.072) in the MCS and 0.048%/y (95% CI, 0.035 to 0.067) in the WWR. A total of 5299 lead s (13%) have been extracted worldwide. After recall in the WWR, fatal extra ction complications occurred in 0.4% of intravascular procedures (16 of 402 3), with life-threatening complications in 0.5% (n = 21), Extraction compli cations increased with implant duration, female sex, and J retention wire p rotrusion. Conclusions-Accufix pacing leads pose a low, ongoing risk of injury. Extrac tion is associated with substantially higher risks, and a conservative mana gement approach is indicated for most patients.