Background. The Telectronics 330-801 atrial J (801) lead was recalled
after reports implicated lead fracture/retention wire protrusion in pa
tient mortality and morbidity. Recent reports suggest that 801 lead ex
traction may be associated with substantial morbidity and, possibly, e
xcess mortality. We hypothesized that the 801 lead could be extracted
using the subclavian approach with a high success rate and acceptable
morbidity. Methods. We analyzed the clinical outcomes in 60 consecutiv
e patients who underwent 801 lead extraction. Results. Sixty patients
(34 women) with a mean age of 67 +/- 14.8 years had 18 class I, 13 cla
ss II, and 29 class III fractures. The lead age was 39 +/- 17 months.
The subclavian approach was successful in 58 of 60 patients (96%). Com
plications, three major and eight minor, occurred in 10 of 60 patients
(16%). All complications were successfully treated. There were no dea
ths. Only concurrent ventricular lead extraction was associated with c
omplications (p = 0.008 by Fisher's exact test). Conclusions. Telectro
nics 801 leads can be successfully extracted using the subclavian appr
oach with acceptable short-term morbidity, low mortality, and excellen
t long-term results.