Background: Direct anchoring of PM and ICD leads over cephalic vein body is officially discouraged by manufactures due to a supposed risk of conductor fracture or insulation failure, however careful tightening of anchoring knots can probably prevent lead damage. Direct anchoring (DA) technique is routinely used in our center for all leads inserted by cephalic vein while standard anchoring sleeves are used to secure subclavian leads only. Aim of the study is to assess short- and long-term safety of cephalic direct anchoring technique.
Methods: All patients undergoing PM and ICD implantation in our center from November 2014 to March 2016 were consecutively enrolled. Primary endpoints were acute lead fracture, lead dislodgement and chronic lead failure. Secondary endpoint was a composite of short-term surgical complications (pocket hematoma, pneumothorax, and pericardial effusion) plus device infections. Subclavian leads secured with sleeve anchoring (SA) were used as control.
Results: A total of 550 leads were implanted in 310 consecutive patients. DA involved 323 leads (59%) while SA was used for 227 (41%). Median follow-up was 50 months (IQR 24-62 months). 17 lead malfunctions (3.1%) were observed during follow-up. No difference was observed between groups (10 DA vs. 7 SP, P=ns). Survival analysis found no difference between groups. Secondary endpoints were not statistically different between groups (5 vs. 1, P=0.08).
Conclusions: Direct anchoring technique of PM and ICD leads is a safe technique and does not increase lead malfunction risk.