Background: Transvenous lead extraction for cardiac implantable electronic devices (CIED) is needed more often due to increased number of implanted devices. Lead malfunction and infection are the main reasons to perform lead extraction. Many centers perform lead extraction under general anesthesia to ensure safe conditions and as there is lack of data for extraction under deep sedation. 

Methods: 463 consecutive patients with indication for transvenous lead extraction have been enrolled in this prospective observational study between January 2011 and August 2018. Procedure was performed in the electrophysiology (EP) laboratory. Deep sedation was performed according to our protocol with intravenous (iv) piritramide and midazolam bolus to initiate and repetitive bolus injection if needed to achieve and uphold deep sedation. Other sedating medication was administered if necessary. Deep sedation was defined as unresponsiveness to vocal stimuli, breathing spontaneously and tolerating an oropharyngeal airway. Heart rate, blood pressure and oxygen saturation have been monitored continuously. Sedation was performed by nurses under supervision of the operator. For lead extraction a systematic approach with manual traction, lead locking devices, mechanical unpowered dilation sheets, mechanical controlled rotation sheets and snares was used. Local anesthesia was administered in every patient with 1% mepivacaine at intended surgical location. 

Results: Deep sedation was initiated with a 7.5 mg iv bolus injection (0.9 ± 0.3 mg/kg) of piritramide in 456 (98.5%) patients. Sufentanyl (0.22 ± 0.04 mg/kg) was given in 7 (1.5%) patients as side effects have been described with piritramide. If no adverse event occurred within 5 minutes, midazolam iv bolus of 2.5 mg (0.03 ± 0.01 mg/kg) was injected in 436 (94.2%) patients. In 27 (5.8%) patients iv propofol bolus was injected instead as side effects with midazolam have been described in these patients. 

Deep sedation was successful in 453 patients (97.8%). In 10 patients (2.2%) deep sedation was not successful as the desired level of sedation was not reached. In these patients lead extractions were performed under general anesthesia instead. 

In order to achieve acceptable level of deep sedation propofol was  added in 10 (2.2%) patients and etomidate was added in 89 (19.6%) of patients. 

Sedation related side effects occurred in 5 patients (1.1%). One patient (0.2%) was intubated due to hypoxia during the procedure and sedation strategy was converted to general anesthesia. Two patients (0.4%) accumulated carbon dioxide and received non-invasive ventilation after the procedure. Two patients (0.4%) experienced episodes of hypotension and received norepinephrine infusion to maintain systolic blood pressure above 90 mmHg during the procedure. There were no parameters associated with sedation related side effects. 

Of 780 planed lead extractions, complete extraction success rate was 93.1% and clinical success rate was 94.1%. 

Conclusion: Deep sedation in the EP lab is a safe and feasible anesthetic approach for transvenous lead extraction.