Complications according to intrathoracic versus extrathoracic venous access for cardiac device implantation: results from the PLACE (Planning Lead Access for Cardiac Electrostimulation) study

Abstract

Abstract Background and Aims The choice of the vascular access for cardiac pacing devices (CIED) implant may impact on patients outcome. Recent studies and consensus documents encourage the use of an extra-thoracic access to prevent adverse events. In this large, multicenter, retrospective study we report the impact of leads access on post-procedural outcome. Methods Consecutive patients receiving a CIED from 2008 to 2019 in 4 high-volume Italian hospitals were enrolled. Short- and long-term complications (i.e. pneumothorax, cardiac tamponade, pocket decubitus, pocket hematoma, lead dislodgement, lead failure) were collected and their relationship with the type of vascular access (extra- vs intra-thoracic, i.e. cephalic vein/extra-thoracic axillary vein vs subclavian vein puncture) was analyzed. Primary endpoint was the occurrence of at least one complication during follow-up. Results A total of 4,443 patients were enrolled; 3,374 (75.9%) received a pacemaker (PM) and 1,069 (24.1%) an implantable cardioverter defibrillator (ICD). Mean follow-up was 1,630±1,010 days. At least one complication occurred in 7.6% of patients. At multivariate Cox regression analysis, adjusted for baseline confounders, the presence of structural heart disease (HR 1.59, 95%CI 1.21-2.10; p=0.001), anticoagulant therapy at implantation [HR 1.31, 95%CI 1.0004-1.71; p=0.05) and female gender (HR 0.78, 95%CI 0.63-0.98; p=0.03) were associated with the primary outcome measure. Extra-thoracic access did not reduce the risk of complications compared to intra-thoracic access (HR 0.97, 95%CI 0.76-1.25 p=0.81). The use of both accesses in the same patient conferred a significant increase in the risk of complications (HR vs single approach:1.95, 95%CI 1.41-2.69; p <0.001). Conclusions The choice of a different vascular access (intra- vs extra-thoracic) does not impact on post-procedural complications in patients receiving CIED. In particular, the intra-thoracic subclavian vein puncture by experienced operators is not related to a poorer outcome. The need for both types of access in the same patient (i.e. increased procedure complexity) increases the risk of post-procedural complications.Graphical abstract