Endpoints and adverse events
haemothorax, haematoma, tamponade, pericardial effusion, infection
HAEMOTHORAX, PNEUMOTHORAX, DEEP VEIN THROMBOSIS, HAEMATOMA, PERICARDIAL EFFUSION, INFECTION, SECONDARY, BRACHIAL PLEXUS PALSY, COMPLICATIONS, COMPLICATIONS
The primary endpoint of this study was the success of insertion of all leads using the first assigned venous access technique (i.e. IPUS-AVP or CVC). Concerning dual-chamber CIED, if different venous accesses were required, the primary endpoint was not met. The decision to change the vascular access technique was at the discretion of the operator. There was no limit in the duration of the procedure or in the number of attempts, to reflect daily medical practice.The secondary endpoints were time to venous access (from skin incision to presence of all required guidewires in the SVC), time from venous access to skin closure, total procedure duration (from skin incision to skin closure), fluoroscopy time, X-ray exposure (dose area product), and complications. Secondary endpoints were assessed for the entire strategy (i.e. all the vascular access techniques, if required) leading to a successful implantation of all leads.Complications were monitored for up to 3 months after the intervention and were defined as: brachial plexus palsy; major pocket haematoma requiring evacuation or transfusion or prolongation of hospitalization; pneumothorax; haemothorax; pericardial effusion and tamponade; lead dislodgement or malfunction requiring revision; deep vein thrombosis; device infection requiring extraction. Electrical parameters of CIED including sensing, impedance, and pacing threshold were recorded at the end of implantation and at each follow-up visit.