Author + information
- Received October 18, 2018
- Revision received December 31, 2018
- Accepted January 4, 2019
- Published online February 18, 2019.
- Krishna Kancharla, MDa,b,
- Nancy G. Acker, RNa,
- Zhuo Li, MSc,
- Swetha Samineni, MDd,
- Cheng Cai, MDa,e,
- Raul E. Espinosa, MDa,
- Michael Osborn, MDa,
- Siva K. Mulpuru, MDf,
- Samuel J. Asirvatham, MDa,g,
- Paul A. Friedman, MDa and
- Yong-Mei Cha, MDa,∗ ()
- aDepartment of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota
- bDepartment of Cardiovascular Diseases, University of Pittsburgh, Pittsburgh, Pennsylvania
- cBiostatistics Unit, Mayo Clinic, Jacksonville, Florida
- dInternal Medicine, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
- eDivision of Cardiology, First Affiliated Hospital of Nanjing Medical University, Nanjing, China
- fDepartment of Cardiovascular Medicine, Mayo Clinic Hospital, Phoenix, Arizona
- gDivision of Pediatric Cardiology, Mayo Clinic, Rochester, Minnesota
- ↵∗Address for correspondence:
Dr. Yong-Mei Cha, Department of Cardiovascular Medicine, Mayo Clinic, 200 First Street SW, Rochester, Minnesota 55905.
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.
The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
All authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page.
- Received October 18, 2018.
- Revision received December 31, 2018.
- Accepted January 4, 2019.
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