Krishna Kancharla1, Nancy G Acker2, Zhuo Li3, Swetha Samineni4, Cheng Cai5, Raul E Espinosa2, Michael Osborn2, Siva K Mulpuru6, Samuel J Asirvatham7, Paul A Friedman2, Yong-Mei Cha8. 1. Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota; Department of Cardiovascular Diseases, University of Pittsburgh, Pittsburgh, Pennsylvania. 2. Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota. 3. Biostatistics Unit, Mayo Clinic, Jacksonville, Florida. 4. Internal Medicine, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. 5. Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota; Division of Cardiology, First Affiliated Hospital of Nanjing Medical University, Nanjing, China. 6. Department of Cardiovascular Medicine, Mayo Clinic Hospital, Phoenix, Arizona. 7. Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota; Division of Pediatric Cardiology, Mayo Clinic, Rochester, Minnesota. 8. Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota. Electronic address: ycha@mayo.edu.
Abstract
OBJECTIVES: 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. BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
OBJECTIVES: 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. BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
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