Anesthesia Technique and Lower Limb Revascularization Patency

Association of Anesthesia Technique With Graft Patency Rates After Open Lower Limb Revascularization: a Retrospective Population Cohort Study

The role of regional anesthesia in lower extremity revascularization procedures on reducing graft failure and need for reoperation remains unclear. In this study, we will analyze data from the multicenter National Surgical Quality Improvement Program (ACS NSQIP®) to assess the association between regional anesthesia (RA) and graft outcomes, as compared to general anesthesia (GA). Our primary objective is to determine for patients undergoing elective open lower limb revascularization, whether RA (spinal, epidural, and peripheral nerve block), compared to GA or general anesthesia with regional anesthesia (GA+RA), is associated with higher rates of patent graft within 30 days postoperatively (primary outcome).

Study Overview

• Status: Completed
• Conditions: Regional Anesthesia, Vascular Grafting, Vascular Patency
• Intervention / Treatment: Procedure: NSQIP Lower Extremity Open (LEO) procedure-targeted dataset (i.e. undergoing Lower extremity open revascularization) from 2014-2019

Detailed Description

Lower limb (infrainguinal) revascularization surgeries are performed for patients with blood flow occlusion, with the goals of improving pain and function. Graft patency is associated with higher quality of life scores. However, open lower limb revascularization is associated with a significant risk of graft failure. Multiple anesthesia options exist for elective open lower limb revascularization, including general and regional (spinal, epidural, peripheral nerve block). The literature has shown mixed results regarding the superiority of regional anesthesia over general anesthesia for morbidity and mortality. In this study, we will analyze data from the multicenter National Surgical Quality Improvement Program (ACS NSQIP®) to assess the association between regional anesthesia (RA) and graft outcomes, as compared to general anesthesia (GA).Our primary objective is to determine for patients undergoing elective open lower limb revascularization, whether RA (spinal, epidural, and peripheral nerve block), compared to GA or general anesthesia with regional anesthesia (GA+RA), is associated with higher rates of patent graft within 30 days postoperatively (primary outcome). Our secondary outcomes are major reintervention, amputation, bleeding requiring transfusion or secondary procedure, venous thromboembolism (VTE), myocardial infarction (MI) or stroke, pneumonia, discharge destination, postoperative length of stay, readmission rate, and death, all within 30 days postoperatively. There will be two composite outcomes: thromboembolism, and morbidity and mortality. We hypothesize that the use of RA is associated with increased graft patency after elective lower limb revascularization compared to GA. Compared to GA, RA is associated with decreased rates of major reintervention, amputation, death (30 days), bleeding requiring transfusion or secondary procedure, VTE, MI or stroke, pneumonia, mortality, composite thromboembolism, and composite morbidity and mortality.; Compared to GA, RA is associated with increased rates of discharge destination being home.

• Study Type: Observational
• Enrollment (Actual): 8893

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St. Paul's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All elective cases within the NSQIP Lower Extremity Open (LEO) procedure-targeted dataset (i.e. undergoing Lower extremity open revascularization) from 2014-2019 will be included. The estimated sample size is 15,000 based on the NSQIP Participant Use Files.

Elective procedures will be identified using the NSQIP variable ELECTSURG=1. Urgent and emergency procedures are not included, as patients may not being offered RA due to insufficient time and/or unable to withhold anticoagulants/antiplatelets due to acute limb ischemia. Note that age 18 years and older is already part of the NSQIP inclusion criteria. Hybrid procedures (where patients had both open and endovascular repair) are included, as long as there is an open component.

Description

Inclusion Criteria:

• All elective cases within the NSQIP Lower Extremity Open (LEO) procedure-targeted dataset (i.e. undergoing Lower extremity open revascularization) from 2014-2019 will be included.
• Hybrid procedures (where patients had both open and endovascular repair) are included, as long as there is an open component.

Exclusion Criteria:

• Patients will be excluded if they underwent urgent or emergency surgery (identified using NSQIP variable EMERGNCY=1 OR ELECTSURG=0)
• local was the only anesthetic technique listed in principal and additional anesthesia technique.
• missing data on exposure, procedure name, or status of elective surgery. This includes having "other" or "unknown" for BOTH principal and additional anesthesia technique
• Patients with INR >= 1.5 on day of surgery

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Regional Anesthesia (RA); RA; Includes spinal, epidural, peripheral nerve block, excludes local infiltration (unlikely that any major open revascularization can be done under local); Defined as: NSQIP Principal (ANESTHES) or additional (ANESTHES_OTHER) anesthesia technique = regional, spinal, epidural, or MAC (in NSQIP RA/Spinal/Local + MAC are coded as MAC; while this includes local + MAC, it would be unlikely that local anesthesia would be sufficient for open revascularization)	Procedure: NSQIP Lower Extremity Open (LEO) procedure-targeted dataset (i.e. undergoing Lower extremity open revascularization) from 2014-2019; Infrainguinal, open lower extremity revascularization procedures
General Anesthesia (GA); GA; Defined as: NSQIP Principal or additional anesthesia technique = general; Since GA is selected as the principal anesthetic technique by default when multiple techniques are present, GA + RA could potentially have been coded as GA if the optional variable of additional anesthesia technique is not filled in, leading to differential misclassification of patients with GA + RA (most likely epidural and peripheral nerve block) in the GA group.	Procedure: NSQIP Lower Extremity Open (LEO) procedure-targeted dataset (i.e. undergoing Lower extremity open revascularization) from 2014-2019; Infrainguinal, open lower extremity revascularization procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft Patency	Derived using NSQIP variables "Most Severe Procedural Outcome" LEO_MOSTSEVOUTCOME and "Untreated Loss of Patency" (i.e. not patent and no procedure done) LEO_ULP; Yes if LEO_MOSTSEVOUTCOME is any of; Clinically Patent Graft; Patent graft, no stenosis; Patent graft with stenosis; No if LEO_MOSTSEVOUTCOME is any of; Death; Image-proven graft thrombosis or clinically evident thrombosis with no planned intervention; Major Amputation; New bypass in the treated arterial segment; Not documented; Other; Revised graft with stenosis; Revised graft, no current stenosis; No if LEO_ULP = "yes"	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pneumonia		30 days
length of postoperative hospital stay		30 days
Major reintervention	1. Major reintervention, using NSQIP variable "Major Reintervention on the Bypass" defined as ""Yes" if the patient underwent a subsequent procedure (new or revision lower extremity bypass operation, jump/interposition graft revision, bypass graft thrombectomy/thrombolysis) within 30 days of the original primary operation."	30 days
Amputation	2. Amputation, using NSQIP variable "Major Amputation (Transtibial or Proximal)", defined as ""Yes" if the patient underwent transtibial or more proximal amputation on the ipsilateral leg within 30 days of the original primary operation."	30 days
Bleeding requiring transfusion		30 days
Venous thromboembolism		30 days
MI or stroke		30 days
Discharge destination	dichotomize as home vs. not home	30 days
Readmission rate		30 days
death		30 days or in-hospital admission
Composite thromboembolism	combination of venothromboembolism, MI, stroke	30 days
Composite Morbidity and Mortality	combination of bleeding requiring transfusion, venothromboembolism, MI, stroke, pneumonia, death	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confounders	age, bleeding diathesis, severe COPD, total operating, time, renal failure, functional status, cardiac valvular disease, diabetes	day of surgery
Confounders	INR, PTT	day of surgery

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Dr. Xue Chen (Janny) Ke; Dr. Alana Flexman; Dr. Stephan Schwarz; Dr. P. Shaun MacDonald

Publications and helpful links

General Publications

• Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009 May 5;150(9):604-12. doi: 10.7326/0003-4819-150-9-200905050-00006. Erratum In: Ann Intern Med. 2011 Sep 20;155(6):408.
• Barbosa FT, Juca MJ, Castro AA, Cavalcante JC. Neuraxial anaesthesia for lower-limb revascularization. Cochrane Database Syst Rev. 2013 Jul 29;(7):CD007083. doi: 10.1002/14651858.CD007083.pub3.
• Nguyen LL, Moneta GL, Conte MS, Bandyk DF, Clowes AW, Seely BL; PREVENT III Investigators. Prospective multicenter study of quality of life before and after lower extremity vein bypass in 1404 patients with critical limb ischemia. J Vasc Surg. 2006 Nov;44(5):977-83; discussion 983-4. doi: 10.1016/j.jvs.2006.07.015.
• Grip O, Wanhainen A, Michaelsson K, Lindhagen L, Bjorck M. Open or endovascular revascularization in the treatment of acute lower limb ischaemia. Br J Surg. 2018 Nov;105(12):1598-1606. doi: 10.1002/bjs.10954. Epub 2018 Jul 25.
• Ghanami RJ, Hurie J, Andrews JS, Harrington RN, Corriere MA, Goodney PP, Hansen KJ, Edwards MS. Anesthesia-based evaluation of outcomes of lower-extremity vascular bypass procedures. Ann Vasc Surg. 2013 Feb;27(2):199-207. doi: 10.1016/j.avsg.2012.04.006. Epub 2012 Sep 1.
• Sgroi MD, McFarland G, Mell MW. Utilization of regional versus general anesthesia and its impact on lower extremity bypass outcomes. J Vasc Surg. 2019 Jun;69(6):1874-1879. doi: 10.1016/j.jvs.2018.08.190. Epub 2019 Feb 18.
• Fereydooni A, O'Meara T, Popescu WM, Dardik A, Ochoa Chaar CI. Utilization and Outcomes of Local Anesthesia and Peripheral Nerve Block for Hybrid Lower Extremity Revascularization. J Endovasc Ther. 2020 Feb;27(1):94-101. doi: 10.1177/1526602819887382. Epub 2019 Nov 20.
• Roberts DJ, Nagpal SK, Kubelik D, Brandys T, Stelfox HT, Lalu MM, Forster AJ, McCartney CJ, McIsaac DI. Association between neuraxial anaesthesia or general anaesthesia for lower limb revascularisation surgery in adults and clinical outcomes: population based comparative effectiveness study. BMJ. 2020 Nov 25;371:m4104. doi: 10.1136/bmj.m4104.
• Christopherson R, Beattie C, Frank SM, Norris EJ, Meinert CL, Gottlieb SO, Yates H, Rock P, Parker SD, Perler BA, et al. Perioperative morbidity in patients randomized to epidural or general anesthesia for lower extremity vascular surgery. Perioperative Ischemia Randomized Anesthesia Trial Study Group. Anesthesiology. 1993 Sep;79(3):422-34. doi: 10.1097/00000542-199309000-00004.
• Wiis JT, Jensen-Gadegaard P, Altintas U, Seidelin C, Martusevicius R, Mantoni T. One-week postoperative patency of lower extremity in situ bypass graft comparing epidural and general anesthesia: retrospective study of 822 patients. Ann Vasc Surg. 2014 Feb;28(2):295-300. doi: 10.1016/j.avsg.2013.01.027. Epub 2013 Sep 29.
• Jorgensen MS, Farres H, James BLW, Li Z, Almerey T, Sheikh-Ali R, Clendenen S, Robards C, Erben Y, Oldenburg WA, Hakaim AG. The Role of Regional versus General Anesthesia on Arteriovenous Fistula and Graft Outcomes: A Single-Institution Experience and Literature Review. Ann Vasc Surg. 2020 Jan;62:287-294. doi: 10.1016/j.avsg.2019.05.016. Epub 2019 Aug 2.
• Gao C, Weng C, He C, Xu J, Yu L. Comparison of regional and local anesthesia for arteriovenous fistula creation in end-stage renal disease: a systematic review and meta-analysis. BMC Anesthesiol. 2020 Aug 31;20(1):219. doi: 10.1186/s12871-020-01136-1.
• Goodney PP, Nolan BW, Schanzer A, Eldrup-Jorgensen J, Bertges DJ, Stanley AC, Stone DH, Walsh DB, Powell RJ, Likosky DS, Cronenwett JL; Vascular Study Group of Northern New England. Factors associated with amputation or graft occlusion one year after lower extremity bypass in northern New England. Ann Vasc Surg. 2010 Jan;24(1):57-68. doi: 10.1016/j.avsg.2009.06.015. Epub 2009 Sep 11.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (Actual): January 29, 2021

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: H20-03437

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: NSQIP data would be free to other researchers from central site.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No