To grade or not to grade safety requirements for transvenous lead extraction: Experience with 2216 procedures.

Abstract

Transvenous lead extraction (TLE) procedures are now increasingly safe, but there is still a risk of major complications (MC). We aimed to assess the impact of TLE organization on the safety of procedures. We analyzed 2216 TLE procedures performed in two centers in the years 2006-2021 and compared three organizational procedural models: (1) TLE in an electrophysiology laboratory (EP-LAB) with intravenous analgesia/sedation; (2) TLE with grading of safety requirements (high-risk patients in the cardiac surgery operating theatre, others in EP-LAB); (3) TLE in the hybrid room in all patients under general anesthesia with transesophageal echocardiographic (TEE) monitoring. The safety of procedures and mortality after TLE in three-year follow-up were assessed. The rate of MC in the EP-LAB group was 1.55%, and the rate of procedure-related deaths (PRD) was 0.33%. While using the graded approach to safety requirements, the percentage of MC was 2.61% and PRD 0.29%. When performing TLE procedures in the hybrid room, the MC percentage was 1.33% and PRD 0.00%. Long-term survival after TLE was comparable in all study groups. A key factor in preventing TLE-related deaths is procedure organization that enables emergency cardiac surgery. TLE performed in a hybrid room with a collaborating cardiac surgeon and vital signs monitoring appears to be the safest possible option for the patient. A graded safety approach is associated with the risk of unexpected MC and PRD. Any newly established TLE center can achieve satisfactory results if the optimal organizational model of the procedure is used.