BACKGROUND: The Telectronics 330-801 atrial J (801) lead was recalled after reports implicated lead fracture/retention wire protrusion in patient mortality and morbidity. Recent reports suggest that 801 lead extraction may be associated with substantial morbidity and, possibly, excess 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 consecutive 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 class II, and 29 class III fractures. The lead age was 39 +/- 17 months. The subclavian approach was successful in 58 of 60 patients (96%). Complications, three major and eight minor, occurred in 10 of 60 patients (16%). All complications were successfully treated. There were no deaths. Only concurrent ventricular lead extraction was associated with complications (p = 0.008 by Fisher's exact test). CONCLUSIONS: Telectronics 801 leads can be successfully extracted using the subclavian approach with acceptable short-term morbidity, low mortality, and excellent long-term results.
BACKGROUND: The Telectronics 330-801 atrial J (801) lead was recalled after reports implicated lead fracture/retention wire protrusion in patient mortality and morbidity. Recent reports suggest that 801 lead extraction may be associated with substantial morbidity and, possibly, excess 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 consecutive 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 class II, and 29 class III fractures. The lead age was 39 +/- 17 months. The subclavian approach was successful in 58 of 60 patients (96%). Complications, three major and eight minor, occurred in 10 of 60 patients (16%). All complications were successfully treated. There were no deaths. Only concurrent ventricular lead extraction was associated with complications (p = 0.008 by Fisher's exact test). CONCLUSIONS: Telectronics 801 leads can be successfully extracted using the subclavian approach with acceptable short-term morbidity, low mortality, and excellent long-term results.