Regional Anesthesia, Vascular Grafting, Vascular Patency
Conditions
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.
Interventions
PROCEDURENSQIP Lower Extremity Open (LEO) procedure-targeted dataset (i.e. undergoing Lower extremity open revascularization) from 2014-2019
Infrainguinal, open lower extremity revascularization procedures
Sponsors
University of British Columbia
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Bleeding requiring transfusion | 30 days | — |
| Venous thromboembolism | 30 days | — |
| MI or stroke | 30 days | — |
| Pneumonia | 30 days | — |
| Discharge destination | 30 days | dichotomize as home vs. not home |
| Readmission rate | 30 days | — |
| death | 30 days or in-hospital admission | — |
| 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 |
| length of postoperative hospital stay | 30 days | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Confounders | day of surgery | age, bleeding diathesis, severe COPD, total operating, time, renal failure, functional status, cardiac valvular disease, diabetes |
Countries
Canada
Outcome results
None listed