Lead extraction technique
The variable technical properties of both mechanical dilator sheaths were defined in Supplementary File 1. The TLE procedure was performed in the Electrophysiology Laboratory under deep sedation and local anesthesia with invasive blood pressure monitoring via femoral or radial route, non-invasive oxygen saturation monitoring, and a cardiothoracic surgery team standby. A thorough evaluation of pacemaker (PM/ICD) was performed before the intervention, including assessing the degree of pacemaker dependency and temporary transvenous pacing was established if necessary. After the skin preparation, the generator pocket was opened, and the device generator was disconnected from the leads. The leads were separated from the scar tissue by blunt dissection. Simple manual traction via standard stylet was initially attempted. If manual traction was not successful, a systematic approach using locking stylet (Liberator Universal Locking Stylet in Evolution®group, Cook Medical) (Lead Locking Device EZ in the TightRailTM group, Spectranetics Corp.) for TLE. If this systematic approach was unsuccessful, mechanical dilator sheaths were used for both atrial, right ventricular, and coronary sinus leads.
The mechanical dilator sheath was then positioned over the targeted lead. The operator pulls the handle of the dilator sheath, which causes rotation of the cutting tip. The dilator sheath moves along the lead body by cutting fibrous adhesions via the distal metal tip or blade. In the Evolution® mechanical dilator sheath system, the outer polymer sheath covers the distal tip while advancing over the lead in the tracts free from adherences to protect the venous wall from damage and when fibrous attachments are met, the cutting tip uncovered from the outer sheath. In the TightRailTM mechanical dilator sheath system, the shielded blade cuts the fibrous attachments by rotating 270° clockwise and 270° counterclockwise with each full trigger activation while extending the blade just 0.5 mm. Once the fibrous attachments are cut, the outer sheath is advanced until another area of attachment is encountered. After the release of leads from fibrous tissue, the leads were pulled back into the sheath and removed. In case of failure with an antegrade approach and presence of free-floating lead remnants, a femoral or jugular approach with Multisnare (Multi-Snare, PFM, Köln, Germany) was used to grasp the remaining part and to complete the procedure. For patients requiring replacement of their lead, a new lead system was implanted through the same vein in case of lead malfunction or upgrade to new technology. In the case of device infection, the subclavian vein on the opposite side was used after eradicating infectious microorganisms according to the recommendations of the recent guidelines 1. In PM-dependent patients, re-implantation was performed in the same session if the extraction was due to non-infectious causes. In PM-dependent patients with cardiac device infection, a temporary PM was implanted through the contralateral jugular vein.
During the first 48 h after the procedure, continuous non-invasive blood pressure, oxygen saturation, and electrocardiographic monitoring were made, and echocardiographic evaluation just after the intervention and before discharge was performed. At each follow-up visit, a particular device interrogation was added to the patient assessment with clinical evaluation, electrocardiography, chest X-ray, and transthoracic echocardiography when necessary.