RESULTS
Three hundred and twenty-five patients (average age of 59 years, 71% male) and 621 targeted leads (atrial: 38%; n=233; ventricle 59%; n=367; coronary sinus;3%; n=21) for TLE were obtained. The mean dwell time of the targeted leads averaged 105.9 months. Sixty-one percent of the targeted leads were pacemaker leads, 28% implantable cardioverter defibrillator leads and 11% cardiac resynchronization therapy Devices (CRTD). The mean number of leads extracted per device was 1.9.
The commonest indication for TLE was infection informed in 68% (222/325) of patients. Pathogens were identified in only 32% of cases. Bacterial culture data showed that staphylococcal infection was the most frequent (71%).
Leads removal for non-infective indications (32%) included lead dysfunction, abandoned lead dysfunction or other reasons (venous stenosis, access to magnetic resonance imaging, cardiac failure and arrhythmia). Demographic data including details on patients, leads and indications for removal are reported in Table 1.
Most procedures were performed by vascular or cardiovascular surgeons (81%) working in the majority of cases in standard operating theatre (79%). The remainder was performed by cardiologists or electrophysiologists, generally working in an electrophysiology laboratory (21%). Procedures performed by a cardiologist or electrophysiology with cardiac surgical stand-by were reported in 65% of cases. In the majority of TLE interventions, general anaesthesia (92%; n=299) was preferred.
Most lead extractions were performed using a percutaneous approach (98%). The majority began via identical route of lead implantation. Superior approach (subclavian/jugular/cephalic) was performed in 315 patients. Only in three cases, combination approaches (superior-femoral or inferior access) with additional snares or baskets were required. Simple traction without the use of specified tools (other than a standard stylet) was sufficient for removing 25% (158/621) of leads with a median dwell time of 33.3 months.
For leads that could not be removed using simple traction (75%; n=463), a multistep approach was performed. Locking stylet was generally used in these steps. Additional equipment preferred by operators were quite variable from dilator sheaths, snares, baskets or mechanical rotational dilator sheaths (Evolution and Evolution RL, Cook Medical, USA) and most of them used in combination with others. No laser extractions were performed.
A small minority of leads (7 patients=16 leads) were extracted by a simultaneous “hybrid approach” using a minithoracotomy/sternotomy (three patients with active endocarditis) including extracorporeal circulation and perfusionist.
Re-implant devices (leads + generator) during the same procedure was reported in 57% (185/325) of cases (permanent device: 65%=120/185).
Complications were categorized in accordance with current 2018 EHRA recommendations. 1 Overall complications rate were 4%. The investigators reported only one major complication (outcome related to the procedure involving disability, life threatening or death) in a patient who suffered a temporary ventricular fibrillation and sudden cardiac arrest with immediate cardiopulmonary resuscitation and recovery at 24 hours. No procedural mortality occurred in our cohort study.
Minor complications (outcome which did not limit patient ‘s function, life threatening or death) were observed in 12 patients (3.6%). Infection was the indication for lead extraction in more than half of these patients. Two patients experienced local haematoma related to lead extraction procedure due to extensive fibrosis. Vascular repair was informed in one patient with lead disruption during extraction and a femoral approach using a snare was required. Only one patient experienced an haemothorax which did not require intervention and an epicardial pacing was re-implanted at 24 hs. Details on incidence and types of complications are summarized in Table 2 .
Complete procedural success rates (removal of all targeted leads and material) were achieved for 96.2% (598/621) of leads. Procedural failure rates (inability to achieve a complete procedural) were 3.7%. Twenty-three leads were incompletely extracted and more than half of them were related to infection. The mean dwell time was 134 months. Extensive fibrosis, presence of calcification and venous stenosis or occlusion were commented by investigators. At hospital discharge, lead fragments did not result in any undesired outcomes. No permanent disabling complications or procedure-related death were reported