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

Abstract

In the Endotak Reliance G defibrillating leads (Guidant Corporation, St. Paul, MN, USA), coils are covered with expanded polytetrafluoroethylene (ePTFE) to prevent tissue ingrowth. The aim of the study was to evaluate transvenous extraction performance, outcomes, and fibrotic adherences rate of ePTFE defibrillating leads in comparison to traditional non-ePTFE cardiac defibrillator (ICD) leads. 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%). 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. ePTFE-covered leads may be removed more easily and quickly than non-ePTFE leads, requiring less frequently mechanical dilatation.