Efficacy and Safety of Transvenous Lead Extraction in the Device Laboratory and Operating Room Guided by a Novel Risk Stratification Scheme

• Published in: JACC. Clinical electrophysiology 2019-02, Vol.5 (2), p.174-182
• Main Authors: Kancharla, Krishna, Acker, Nancy G., Li, Zhuo, Samineni, Swetha, Cai, Cheng, Espinosa, Raul E., Osborn, Michael, Mulpuru, Siva K., Asirvatham, Samuel J., Friedman, Paul A., Cha, Yong-Mei
• Format: Article
• Language: English
• Subjects: Adult; Aged; complication; Device Removal - adverse effects; Device Removal - methods; Device Removal - statistics & numerical data; Female; Humans; Incidence; lead extraction; Male; Middle Aged; operating room; Operating Rooms; Patient Safety; Postoperative Complications - epidemiology; Postoperative Complications - prevention & control; Prospective Studies; Risk Assessment; Risk Factors; risk stratification; safety; Treatment Outcome
• ISSN: 2405-500X; 2405-5018
• DOI: 10.1016/j.jacep.2019.01.001

The goal of this study was to evaluate a novel risk stratification scheme to categorize patients on the basis of risk to either an operating room or device laboratory with rescue strategy. Lead extraction can be complicated by lethal issues such as vascular and cardiac rupture. Currently, the optimal site for lead extraction has not been well established. A risk stratification scheme was developed from previously available risk factors for major complications. Patients were prospectively risk stratified between October 2013 and January 2016. High-risk procedures were performed in the operating room with ready surgical services; intermediate-risk procedures were performed in the device laboratory. In total, 349 leads were removed from 187 patients (age 61.0 ± 17.2 years; 66.3% men) over 27 months. Seventy-two patients (38.5%) were categorized as high risk. Median implant duration of the oldest lead per patient was 11.2 years (interquartile range: 7.9 to 14.9 years) in the operating room group versus 2.6 years (interquartile range: 1.6 to 4.9 years) in the device laboratory group (p < 0.001). Clinical success in the operating room (95.8%) and device laboratory (99.1%) groups was similar (p = 0.16). A higher incidence of major complications occurred in the high-risk group (operating room group: 6.9%; device laboratory: 0.0%; p = 0.007). In-hospital mortality (operating room group: 8.3%; device laboratory: 2.6%; p = 0.09) and long-term (2-year) survival (operating room: 70.8%; device laboratory: 84.4%; p = 0.07) rates were similar. Use of a novel risk stratification scheme in guiding the selection of operating room versus device laboratory for lead extraction is feasible, safe, and efficacious. Intermediate-risk procedures can be performed safely in the device laboratory with rescue strategy, without excess surgical resource utilization. [Display omitted]