Anesthesia Technique and Lower Limb Revascularization Patency
- Conditions
- Regional Anesthesia, Vascular Grafting, Vascular Patency
- Interventions
- Procedure: NSQIP Lower Extremity Open (LEO) procedure-targeted dataset (i.e. undergoing Lower extremity open revascularization) from 2014-2019
- Registration Number
- NCT04730310
- Lead Sponsor
- University of British Columbia
- Brief Summary
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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8893
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Regional Anesthesia (RA) NSQIP Lower Extremity Open (LEO) procedure-targeted dataset (i.e. undergoing Lower extremity open revascularization) from 2014-2019 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) General Anesthesia (GA) NSQIP Lower Extremity Open (LEO) procedure-targeted dataset (i.e. undergoing Lower extremity open revascularization) from 2014-2019 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.
- Primary Outcome Measures
Name Time Method Graft Patency 30 days * 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"
- Secondary Outcome Measures
Name Time Method MI or stroke 30 days Bleeding requiring transfusion 30 days Venous thromboembolism 30 days Pneumonia 30 days Major reintervention 30 days 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."
Amputation 30 days 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."
Readmission rate 30 days death 30 days or in-hospital admission length of postoperative hospital stay 30 days Discharge destination 30 days dichotomize as home vs. not home
Composite thromboembolism 30 days combination of venothromboembolism, MI, stroke
Composite Morbidity and Mortality 30 days combination of bleeding requiring transfusion, venothromboembolism, MI, stroke, pneumonia, death
Trial Locations
- Locations (1)
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada