Transvenous Extraction Performance of Expanded Polytetrafluoroethylene Covered ICD Leads in Comparison to Traditional ICD Leads in Humans

Methods: Seventeen consecutive ICD recipients (ePTFE Group A, 16 men, mean age 66 +/- 12 years) with 17 Endotak Reliance G dual-coil ICD leads (mean implantation time 23 +/- 26 months) underwent a transvenous removal procedure. They were compared with two control groups, including 20 Sprint Quattro 6944 (non-ePTFE Group B; Medtronic Inc., Minneapolis, MN, USA) and 36 Riata 1570 ICD leads (non-ePTFE Group C; St. Jude Medical, St. Paul, USA). The indication for lead extraction was local infection in 35 patients (48%), sepsis in 24 patients (33%), and lead malfunction in 14 patients (19%). Results: In all groups, all leads were successfully and completely removed without major complications. Overall manual traction was effective in six patients (8%) and more effective in the ePTFE Group (29%) compared to Group B (0%) and Group C (3%) (P = 0.001). Sixty-seven leads (92%) required mechanical dilatation by the venous entry site approach, with a shorter extraction time in the ePTFE Group (5 +/- 11 min) compared to Group B (21 +/- 22 min) and Group C (16 +/- 22 min) (P = 0.003). ePTFE leads showed a lower rate of fibrotic adherences at the superior vena cava level (P = 0.01) without statistically significant differences in the other sites. Conclusions: ePTFE-covered leads may be removed more easily and quickly than non-ePTFE leads, requiring less frequently mechanical dilatation. (PACE 2010; 1376-1381).