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

Krishna Kancharla, Nancy G. Acker, Zhuo Li, Swetha Samineni, Cheng Cai, Raul Emilio Espinosa, Michael Osborn, Siva Mulpuru, Samuel J Asirvatham, Paul Andrew Friedman, Yong-Mei Cha

Research output: Contribution to journalArticle

4 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)174-182
Number of pages9
JournalJACC: Clinical Electrophysiology
Volume5
Issue number2
DOIs
StatePublished - Feb 1 2019

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Operating Rooms
Safety
Equipment and Supplies
Lead
Heart Rupture
Hospital Mortality
Blood Vessels
Survival
Incidence

Keywords

  • complication
  • lead extraction
  • operating room
  • risk stratification
  • safety

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Efficacy and Safety of Transvenous Lead Extraction in the Device Laboratory and Operating Room Guided by a Novel Risk Stratification Scheme. / Kancharla, Krishna; Acker, Nancy G.; Li, Zhuo; Samineni, Swetha; Cai, Cheng; Espinosa, Raul Emilio; Osborn, Michael; Mulpuru, Siva; Asirvatham, Samuel J; Friedman, Paul Andrew; Cha, Yong-Mei.

In: JACC: Clinical Electrophysiology, Vol. 5, No. 2, 01.02.2019, p. 174-182.

Research output: Contribution to journalArticle

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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.",
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AU - Kancharla, Krishna

AU - Acker, Nancy G.

AU - Li, Zhuo

AU - Samineni, Swetha

AU - Cai, Cheng

AU - Espinosa, Raul Emilio

AU - Osborn, Michael

AU - Mulpuru, Siva

AU - Asirvatham, Samuel J

AU - Friedman, Paul Andrew

AU - Cha, Yong-Mei

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