A "just in time" educational intervention for opioid overprescribing in dialysis access surgery.

BACKGROUND: Despite widespread efforts to combat the opioid epidemic, an ongoing contributor to opioid misuse remains post-operative opioid overprescribing by residents. The goal of this study was to evaluate the impact of a low-cost, reproducible "just in time" intervention on opioid prescribing in dialysis access operations. METHODS: Standardized opioid prescribing guidelines were emailed to residents on the vascular service on the first day of the rotation. Opioid prescriptions were reviewed for four years before and one year after this intervention. Wilcoxon rank-sum test and tests of proportions were used to compare groups. RESULTS: Overall, 299 patients underwent dialysis access procedures. There was a decrease in patients discharged with opioids following the intervention from 58% to 36% (p â€‹= â€‹0.003). For patients prescribed opioids, the median quantity decreased from 90 to 45 oral morphine equivalents (p â€‹= â€‹0.03). CONCLUSIONS: This low-cost and timely learning intervention may be a useful adjunct to reduce post-operative opioid prescriptions.

Predictors of amputation-free survival and wound healing after infrainguinal bypass with alternative conduits.

OBJECTIVE: Inadequate vein quality or prior harvest precludes use of autologous single segment greater saphenous vein (ssGSV) in many patients with chronic limb-threatening ischemia (CLTI). Predictors of patient outcome after infrainguinal bypass with alternative (non-ssGSV) conduits are not well-understood. We explored whether limb presentation, bypass target, and conduit type were associated with amputation-free survival (AFS) after infrainguinal bypass using alternative conduits. METHODS: A single-center retrospective study (2013-2020) was conducted of 139 infrainguinal bypasses performed for CLTI with cryopreserved ssGSV (cryovein) (n = 71), polytetrafluoroethylene (PTFE) (n = 23), or arm/spliced vein grafts (n = 45). Characteristics, Wound, Ischemia, and foot Infection (WIfI) stage, and outcomes were recorded. Multivariable Cox proportional hazards and classification and regression tree analysis modeled predictors of AFS. RESULTS: Within 139 cases, the mean age was 71 years, 59% of patients were male, and 51% of cases were nonelective. More patients undergoing bypass with cryovein were WIfI stage 4 (41%) compared with PTFE (13%) or arm/spliced vein (27%) (P = .04). Across groups, AFS at 2 years was 78% for spliced/arm, 79% for PTFE, and 53% for cryovein (adjusted hazard ratio for cryovein, 2.5; P = .02). Among cases using cryovein, classification and regression tree analysis showed that WIfI stage 3 or 4, age >70 years, and prior failed bypass were predictive of the lowest AFS at 2 years of 36% vs AFS of 58% to 76% among subgroups with less than two of these factors. Although secondary patency at 2 years was worse in the cryovein group (26% vs 68% and 89% in arm/spliced and PTFE groups; P < .01), in patients with tissue loss there was no statistically significant difference in wound healing in the cryovein group (72%) compared with other bypass types (72% vs 87%, respectively; P = .12). CONCLUSIONS: In patients with CLTI lacking suitable ssGSV, bypass with autogenous arm/spliced vein or PTFE has superior AFS compared with cryovein, although data were limited for PTFE conduits for distal targets. Despite poor patency with cryovein, wound healing is achieved in a majority of cases, although it should be used with caution in older patients with high WIfI stage and prior failed bypass, given the low rates of AFS.

Relevance of BEST-CLI trial endpoints in a tertiary care limb preservation program.

OBJECTIVE: Major adverse limb event-free survival (MALE-FS) differed significantly by initial revascularization approach in the BEST-CLI randomized trial. The BEST-CLI trial represented a highly selected subgroup of patients seen in clinical practice; thus, we examined the endpoint of MALE-FS in an all-comers tertiary care practice setting. METHODS: This is a single-center retrospective study of consecutive, unique patients who underwent technically successful infrainguinal revascularization for chronic limb-threatening ischemia (2011-2021). MALE was major amputation (transtibial or above) or major reintervention (new bypass, open bypass revision, thrombectomy, or thrombolysis). RESULTS: Among 469 subjects, the mean age was 70 years, and 34% were female. Characteristics included diabetes (68%), end-stage renal disease (ESRD) (16%), Wound, Ischemia, and foot Infection (WIfI) stage 4 (44%), Global Limb Anatomic Staging System (GLASS) stage 3 (62%), and high pedal artery calcium score (pMAC) (22%). Index revascularization was autogenous vein bypass (AVB) (30%), non-autogenous bypass (NAB) (13%), or endovascular (ENDO) (57%). The composite endpoint of MALE or death occurred in 237 patients (51%) at a median time of 189 days from index revascularization. In an adjusted Cox model, factors independently associated with MALE or death included younger age, ESRD, WIfI stage 4, higher GLASS stage, and moderate-severe pMAC, whereas AVB was associated with improved MALE-FS. Freedom from MALE-FS, MALE, and major amputation at 30 days were 90%, 92%, and 95%; and at 1 year were 63%, 70%, and 83%, respectively. MALE occurred in 144 patients (31%) and was associated with ESRD, WIfI stage, GLASS stage, pMAC score, and index revascularization approach. AVB had superior durability, with adjusted 2-year freedom from MALE of 72%, compared with 66% for ENDO and 51% for NAB. Within the AVB group, spliced vein conduit had higher MALE compared with single-segment vein (hazard ratio, 1.8; 95% confidence interval, 0.9-3.7; P = .008 after inverse propensity weighting), but there was no statistically significant difference in major amputation. Of the 144 patients with any MALE, the first MALE was major reintervention in 47% and major amputation in 53%. Major amputation as first MALE was associated with non-AVB index approach. Indications for major reintervention were symptomatic stenosis/occlusion (54%), lack of clinical improvement (28%), asymptomatic graft stenosis (16%), and iatrogenic events (3%). Conversion to bypass occurred after 6% of ENDO cases, two-thirds of which involved distal bypass targets at the ankle or foot. CONCLUSIONS: In this consecutive, all-comers cohort, disease complexity was associated with procedural selection and MALE-FS. AVB independently provided the greatest MALE-FS and freedom from MALE and major amputation. Compared with the BEST-CLI randomized trial, MALE after ENDO in this series was more frequently major amputation, with relatively few conversions to open bypass.

Descending thoracic aortic mural ulceration is associated with postoperative spinal cord ischemia after branched endovascular aortic aneurysm repair.

OBJECTIVE: Paraplegia is one of the most feared complications after thoracoabdominal aortic aneurysm repair. The purpose of this study is to determine whether aortic thrombus characteristics are associated with spinal cord ischemia (SCI) after branched endovascular aneurysm repair (BEVAR). METHODS: From April 2011 to April 2020, 62 patients underwent elective BEVAR for thoracoabdominal aortic aneurysm and pararenal aortic aneurysms using a low-profile device and had a complete preoperative computed tomography angiography of the aorta from the sinotubular junction to the aortic bifurcation. Aortic thrombus was evaluated for thrombus thickness ≥5 mm, thrombus >2/3 of aortic circumference, and the presence of an ulcer-like thrombus. One point was assigned at each 5 mm axial image if all 3 criteria were met, resulting in a total "shaggy score" for the entire aorta. Data on demographics, procedural details, and outcomes were collected prospectively. All patients underwent a standard spinal cord protection protocol, including routine cerebrospinal fluid drainage. In July 2016, an insulin infusion protocol (IIP) was initiated to maintain postoperative blood glucose levels <120 mg/dL for 48 hours. The primary clinical end point was postoperative SCI. RESULTS: 10 (16%) patients developed postoperative SCI: 6 with transient paraparesis, 2 with persistent paraparesis, and 2 with persistent paraplegia. Patients with SCI were older, had higher shaggy scores, and were less likely to have been on an IIP. There were no significant differences in demographics, aneurysm type, or operative parameters. In a logistic multivariate regression model for SCI, age (odds ratio [OR]: 1.2 [1.1-1.4], P = .02) and shaggy score (OR: 1.2 [1.1-1.4], P = .02) were independently associated with increased risk of SCI, whereas treatment with the IIP was associated with lower risk of SCI (OR: 0.04 [0.006-0.50], P = .05). Of the individual components of the shaggy score, higher descending thoracic aortic ulcer scores were the most strongly associated with postoperative SCI (P = .009). CONCLUSIONS: Preoperative characterization of aortic wall thrombus is an important adjunctive tool for individualized clinical decision-making and patient counseling about the risk of SCI after BEVAR.

Risk factors and associated outcomes of postoperative delirium after open abdominal aortic aneurysm repair.

OBJECTIVE: Open abdominal aortic aneurysm repair (OAR) is a major vascular procedure that incurs a large physiologic demand, increasing the risk for complications such as postoperative delirium (POD). We sought to characterize POD incidence, identify delirium risk factors, and evaluate the effect of delirium on postoperative outcomes. We hypothesized that POD following OAR would be associated with increased postoperative complications and resource utilization. METHODS: This was a retrospective study of all OAR cases from 2012 to 2020 at a single tertiary care center. POD was identified via a validated chart review method based on key words and Confusion Assessment Method assessments. The primary outcome was POD, and secondary outcomes included length of stay, non-home discharge, 90-day mortality, and 1-year survival. Bivariate analysis as appropriate to the data was used to assess the association of delirium with postoperative outcomes. Multivariable binary logistic regression was used to identify risk factors for POD and Cox regression for variables associated with worse 1-year survival. RESULTS: Overall, 198 OAR cases were included, and POD developed in 34% (n = 67). Factors associated with POD included older age (74 vs 69 years; P < .01), frailty (50% vs 28%; P < .01), preoperative dementia (100% vs 32%; P < .01), symptomatic presentation (47% vs 27%; P < .01), preoperative coronary artery disease (44% vs 28%; P = .02), end-stage renal disease (89% vs 32%; P < .01) and Charlson Comorbidity Index score >4 (42% vs 26%; P = .01). POD was associated with 90-day mortality (19% vs 5%; P < .01), non-home discharge (61% vs 30%; P < .01), longer median hospital length of stay (14 vs 8 days; P < .01), longer median intensive care unit length of stay (6 vs 3 days; P < .01), postoperative myocardial infarction (7% vs 2%; P = .045), and postoperative pneumonia (19% vs 8%; P = .01). On multivariable analysis, risk factors for POD included older age, history of end-stage renal disease, lack of epidural, frailty, and symptomatic presentation. A Cox proportional hazards model revealed that POD was associated with worse survival at 1 year (hazard ratio, 3.8; 95% confidence interval, 1.6-9.0; P = .003). CONCLUSIONS: POD is associated with worse postoperative outcomes and increased resource utilization. Future studies should examine the role of improved screening, implementation of delirium prevention bundles, and multidisciplinary care for the most vulnerable patients undergoing OAR.

Abdominal lymphocele following multi-level anterior lumbar interbody fusion (ALIF) managed with a laparoscopic peritoneal window: case report and review of the literature.

PURPOSE: Lymphocele formation following anterior lumbar interbody fusion (ALIF) is not common, but it can pose diagnostic and treatment challenges. The purpose of this case is to report for the first time the treatment of a postoperative lymphocele following a multi-level ALIF using a peritoneal window made through a minimally invasive laparoscopic approach. METHODS: Case report. RESULTS: A 74-year-old male with a history of prostatectomy and pelvic radiation underwent a staged L3-S1 ALIF (left paramedian approach) and T10-pelvis posterior instrumented with L1-5 decompression/posterior column osteotomies for degenerative scoliosis and neurogenic claudication. Three weeks after surgery, swelling of the left abdomen and entire left leg was reported. Computed tomography of the abdomen/pelvis demonstrated a large (19.2 × 12.0 × 15.4 cm) retroperitoneal fluid collection with compression of the left ureter and left common iliac vein. Fluid analysis (80% lymphocytes) was consistent with a lymphocele. Percutaneous drainage for 4 days was ineffective at clearing the lymphocele. For more definitive management, the patient underwent an uncomplicated laparoscopic creation of a peritoneal window to allow passive drainage of lymphatic fluid into the abdomen. Three years after surgery, he had no back or leg pain, had achieved spinal union, and had no abdominal swelling or left leg swelling. Advanced imaging also confirmed resolution of the lymphocele. CONCLUSIONS: In this case report, creation of a peritoneal window minimally invasively via a laparoscope allowing passive drainage of lymphatic fluid into the abdomen was safe and effective for management of an abdominal lymphocele following a multi-level ALIF.

Iliac artery calcification score stratifies mortality risk estimation in patients with chronic limb-threatening ischemia undergoing revascularization.

OBJECTIVE: Patients with chronic limb-threatening ischemia (CLTI) are at high risk for adverse limb outcomes and mortality. Using the Vascular Quality Initiative (VQI) prediction model to estimate mortality after revascularization can assist with clinical decision-making. We aimed to improve the discrimination of the 2-year VQI risk calculator by incorporating a common iliac artery (CIA) calcification score based on computed tomography scans. METHODS: This was a retrospective analysis of patients who underwent infrainguinal revascularization for CLTI from January 2011 to June 2020 and had a computed tomography scan of the abdomen/pelvis 2 years before or up to 6 months after revascularization. CIA calcium morphology, circumference, and length were scored. Bilateral scores were summed for the total calcium burden (CB) score, which was trichotomized (mild, 0-15; moderate, 16-19; severe, 20-22). The VQI CLTI model was used to categorize patients as low, medium, or high risk for mortality. RESULTS: A total of 131 patients with a mean age of 69±12 years were included in the study, and 86 (66%) were men. CB scores were mild in 52 (40%), moderate in 26 (20%), and severe in 53 (40%) patients. Older patients (P = .0002) and those with coronary artery disease (P = .06) had higher CB scores. Patients with severe CB scores were more likely to undergo infrainguinal bypass compared with those with mild or moderate CB scores (P = .006). The 2-year VQI mortality risk was calculated to be low in 102 (78%), medium in 23 (18%), and high in 6 (4.6%) patients. In the "low-risk" VQI mortality subgroup, 46 (45%) patients had mild, 18 (18%) had moderate, and 38 (37%) had severe CB scores, and patients with severe CB scores had significantly higher risk of mortality compared with those with mild or moderate scores (hazard ratio, 2.5; 95% confidence interval, 1.2-5.1; P = .01). In this "low-risk" VQI mortality subgroup, CB score further stratified the risk of mortality (P = .04). CONCLUSIONS: Higher total CIA calcification was significantly associated with mortality in patients undergoing infrainguinal revascularization for CLTI, and preoperative assessment of CIA calcification may help with perioperative risk stratification and guide clinical decision making in this population.

Structured discharge documentation reduces sex-based disparities in statin prescription in vascular surgery patients.

OBJECTIVE: Perioperative statin use has been shown to improve survival in vascular surgery patients. In 2018, the Northern California Vascular Study Group implemented a quality initiative focused on the use of a SmartText in the discharge summary. We hypothesized that structured discharge documentation would decrease sex-based disparities in evidence-based medical therapy. METHODS: A retrospective analysis was conducted using Vascular Quality Initiative eligible cases at a single institution. Open or endovascular procedures in the abdominal aorta or lower extremity arteries from 2016 to 2021 were included. Bivariate analysis identified factors associated with statin use and sex. Multivariate logistic regression was performed with the end point of statin prescription at discharge and aspirin prescription at discharge. An interaction term assessed the differential impact of the initiative on both sexes. Analysis was then stratified by prior aspirin or statin prescription. An interrupted time series analysis was used to evaluate the trend in statin prescription over time. RESULTS: Overall, 866 patients were included, including 292 (34%) female and 574 (66%) male patients. Before implementation, statins were prescribed in 77% of male and 62% of female patients (P < .01). After implementation, there was no statistically significant difference in statin prescription (91% in male vs 92% in female patients, P = .68). Female patients saw a larger improvement in the adjusted odds of statin prescription compared with male patients (odds ratio: 3.1, 95% confidence interval: 1.1-8.6, P = .04). For patients not prescribed a statin preoperatively, female patients again saw an even larger improvement in the odds of being prescribed a statin at discharge (odds ratio: 6.4, 95% confidence interval: 1.8-22.7, P < .01). Interrupted time series analysis demonstrated a sustained improvement in the frequency of prescription for both sexes over time. The unadjusted frequency of aspirin prescription also improved by 3.5% in male patients vs 5.5% in female patients. For patients not prescribed an aspirin preoperatively, we found that the frequency of aspirin prescription significantly improved for both male (19% increase, P = .006) and female (31% increase, P = .001) patients. There was no significant difference in the perioperative outcomes between male and female patients before and after standardized discharge documentation. CONCLUSIONS: A simple, low-cost regional quality improvement initiative eliminated sex-based disparities in statin prescription at a single institution. These findings highlight the meaningful impact of regional quality improvement projects. Future studies should examine the potential for structured discharge documentation to improve patient outcomes and reduce disparities.

Presenting limb severity is associated with long-term outcomes after infrainguinal revascularization for chronic limb-threatening ischemia.

OBJECTIVE: The SVS Wound, Ischemia, foot Infection (WIfI) limb staging system was established to estimate risk of major amputation in chronic limb-threatening ischemia (CLTI) and better stratify outcomes comparisons. There is little data on treatment outcomes beyond 1 year based on presenting WIfI stage. METHODS: This is a single-institution retrospective study of 413 patients who underwent infrainguinal revascularization for CLTI (2011-2021) with data available for WIfI staging. Patient characteristics and outcomes were gathered from the electronic medical record. Data were analyzed based on presenting WIfI stage and initial treatment received at our center. RESULTS: Presenting WIfI stages were 1 to 2 (23%), 3 (27%), and 4 (50%). Index revascularization approach was endoluminal (59%), autogenous vein bypass (29%), or non-autogenous bypass (13%). Operative mortality within 30 days was 2.9% and was not associated with WIfI stage or revascularization approach. Median limb follow-up time was 502 days (interquartile range [IQR], 112-1256 days), and median survival follow-up time was 932 days (IQR, 343-1770 days). Major amputation or death occurred in 19% and 46% of patients at median times of 119 days (IQR, 28-314 days) and 739 days (IQR, 204-1475 days), respectively. WIfI stage was independently associated with major amputation (P = .001), as was initial revascularization approach (P = .01). In a Cox proportional hazards model, factors independently associated with major amputation were male sex (hazard ratio [HR], 1.4; 95% confidence interval [CI], 1.04-2.0; P = .03), diabetes (HR, 1.8; 95% CI, 1.3-2.5; P = .001), WIfI stage 4 (HR, 2.3; 95% CI, 1.5-3.5; P < .001), and non-autogenous bypass (HR, 2.9; 95% CI, 2.1-4.2; P < .001). In a Cox proportional hazards model for mortality, independently associated factors were age (HR, 1.04; 95% CI, 1.02-1.05; P < .001), end-stage renal disease (HR, 2.8; 95% CI, 1.9-4.0; P < .001), congestive heart failure (HR, 1.9; 95% CI, 1.4-2.5; P < .001), chronic obstructive pulmonary disease (HR, 1.5; 95% CI, 1.1-2.1; P = .02), and WIfI stage 4 (HR, 1.6; 95% CI, 1.04-2.2; P = .03). Among those presenting with WIfI stage 4 limbs, Kaplan-Meier estimated rates of freedom from major amputation or death at 2 years were 71% ± 3.7% and 68% ± 3.5%, respectively. In an inverse propensity weighted Cox proportional hazards model, non-white race (HR, 1.5; 95% CI, 1.01-2.2; P = .047), diabetes (HR, 2.0; 95% CI, 1.2-3.3; P = .008), Global Anatomic Staging System infrapopliteal grade (HR, 1.2; 95% CI, 1.05-1.3; P = .005), non-autogenous bypass (HR, 3.2; 95% CI, 1.9-5.3; P < .001), and endoluminal revascularization (HR, 2.6; 95% CI, 1.6-4.3; P < .001) were independently associated with major amputation in the WIfI stage 4 subgroup. CONCLUSIONS: Presenting WIfI stage is strongly associated with long-term risks of major amputation and death following infrainguinal revascularization for CLTI and should be used to stratify outcomes comparisons. Effective revascularization is critical in WIfI stage 4 disease, and autogenous vein bypass provides durable long-term limb preservation.

Association of Intraoperative and Perioperative Transfusions with Postoperative Cardiovascular Events and Mortality After Infrainguinal Revascularization.

BACKGROUND: Patients undergoing open or endovascular infrainguinal revascularization are at an elevated risk for postoperative cardiovascular complications due to high rates of comorbidities and the physiologic stress of surgery. Transfusions are known to be associated with adverse events but knowledge of specific risks associated with transfusion timing, product type, and long-term outcomes while accounting for preoperative cardiovascular risk factors is not well understood in this population. This study aimed to characterize the association of intraoperative and perioperative transfusion, anemia, and cardiovascular risk factors with cardiovascular events and mortality in patients undergoing infrainguinal revascularization. METHODS: A single-center retrospective study was performed on 564 infrainguinal revascularization procedures, including both open (n = 250) and endovascular (n = 314) approaches (2016-2020). Comprehensive clinical data were collected including patient demographics, cardiovascular risk factors, preoperative hemoglobin, and detailed transfusion data. Multivariable logistic regression tested the association of transfusions with composite 30-day outcomes of cardiac complications (postoperative myocardial infarction [postop-MI], congestive heart failure, or dysrhythmia) and with major adverse cardiovascular events (MACE-postop-MI or death). Kaplan-Meier analysis and Cox proportional hazard modeling examined the association of transfusions, anemia, and cardiovascular risk factors with mortality up to 1 year. RESULTS: Intraoperative transfusion was performed in 15% of cases and 13% underwent transfusion in the early postoperative period. Intraoperative transfusion was associated with higher Revised Cardiac Risk Index (RCRI), lower preoperative hemoglobin, increased blood loss, and open procedures (all P < 0.05). Within each RCRI score, intraoperative transfusion was associated with 2-4-fold increased MACE at 30 days. Intraoperative packed red blood cells transfusion and early postoperative packed red blood cells transfusion was associated with more than 2-fold adjusted odds of any cardiovascular complication and intraoperative transfusion was also associated with MACE (all P < 0.05). Intraoperative transfusion was associated with mortality at 1 year on unadjusted analysis, but after adjustment for RCRI, age, and preoperative hemoglobin, only RCRI scores of 2 and 3+ and preoperatively hemoglobin remained significant risk factors for mortality. CONCLUSIONS: Intraoperative and early perioperative transfusions are strongly associated with worse cardiovascular outcomes after infrainguinal revascularization. These findings may have a prognostic value for further risk stratifying patients perioperatively at a high risk for complications. However, prospective studies are needed to elucidate whether optimizing transfusion strategies mitigates these risks.

Racial and ethnic disparities in major adverse limb events persist for chronic limb threatening ischemia despite presenting limb threat severity after peripheral vascular intervention.

OBJECTIVE: Racial and ethnic disparities have been well-documented in the outcomes for chronic limb threatening ischemia (CLTI). One purported explanation has been the disease severity at presentation. We hypothesized that the disparities in major adverse limb events (MALE) after peripheral vascular intervention (PVI) for CLTI would persist despite controlling for disease severity at presentation using the WIfI (Wound, Ischemia, foot Infection) stage. METHODS: The Vascular Quality Initiative PVI dataset (2016-2021) was queried for CLTI. Patients were excluded if they were missing the WIfI stage. The primary end point was the incidence of 1-year MALE, defined as major amputation (through the tibia or fibula or more proximally) or reintervention (endovascular or surgical) of the initial treatment limb. A multivariate hierarchical Fine-Gray analysis was performed, controlling for hospital variation, competing risk of death, and presenting WIfI stage, to assess the independent association of Black/African American race and Latinx/Hispanic ethnicity with MALE. A Cox proportional hazard regression model was used for the 1-year survival analysis. RESULTS: Overall, 47,830 patients (60%) had had WIfI scores reported (73% White, 20% Black, and 7% Latinx). The 1-year unadjusted cumulative incidence of MALE was 13.1% (95% confidence interval [CI], 12.6%-13.5%) for White, 14.3% (95% CI, 13.5%-15.3%) for Black, and 17.0% (95% CI, 15.3%-18.9%) for Latinx patients. On bivariate analysis, the occurrence of MALE was significantly associated with younger age, Black race, Latinx ethnicity, coronary artery disease, cerebrovascular disease, congestive heart failure, hypertension, diabetes, dialysis, intervention level, any prior minor or major amputation, and WIfI stage (P < .001). The cumulative incidence of 1-year MALE increased by increasing WIfI stage: stage 1, 11.7% (95% CI, 10.9%-12.4%); stage 2, 12.4% (95% CI, 11.8%-13.0%); stage 3, 14.8% (95% CI, 13.8%-15.8%); and stage 4, 15.4% (95% CI, 14.3%-16.6%). The cumulative incidence also increased by intervention level: inflow, 10.7% (95% CI, 9.8%-11.7%), femoropopliteal, 12.3% (95% CI, 11.7%-12.9%); and infrapopliteal, 14.1% (95% CI, 13.5%-14.8%). After adjustment for WIfI stage only, Black race (subdistribution hazard ratio [SHR], 1.30; 95% CI, 1.17-1.44; P < .001) and Latinx ethnicity (SHR, 1.58; 95% CI, 1.37-1.81; P < .001) were associated with an increased 1-year hazard of MALE compared with White race. On adjusted multivariable analysis, MALE disparities persisted for Black/African American race (SHR, 1.12; 95% CI, 1.01-1.25; P = .028) and Latinx/Hispanic ethnicity (SHR, 1.34; 95% CI, 1.16-1.54; P < .001) compared with White race. CONCLUSIONS: Black/African American and Latinx/Hispanic patients had a higher associated hazard of MALE after PVI for CLTI compared with White patients despite an adjustment for WIfI stage at presentation. These results suggest that disease severity at presentation does not account for disparities in outcomes. Further work should focus on better understanding the underlying mechanisms for disparities in historically marginalized racial and ethnic groups presenting with CLTI.

Lower extremity amputation protocol: a pilot enhanced recovery pathway for vascular amputees.

Vascular patients, an inherently older, frail population, account for >80% of major lower extremity amputations (transtibial or transfemoral) in the United States. Retrospective data have shown that early physical therapy and discharge to an acute rehabilitation facility decreases the postoperative length of stay (LOS) and expedites ambulation. In the present study, we sought to determine whether patients treated with the lower extremity amputation protocol (LEAP) will have improved outcomes. We performed a nonrandomized prospective study of vascular patients undergoing an amputation from January 2019 to February 2020. Patients who were nonambulatory or had undergone a previous contralateral major amputation were excluded. LEAP is a multidisciplinary team approach to the perioperative care of amputees using an outlined protocol. The prospective patients were compared with historic controls treated before the initiation of LEAP (January 2016 to December 2018). The primary outcomes included the postoperative LOS, time to receipt of a prosthesis, and time to ambulation. Of the 141 included patients, 130 were in the retrospective group and 11 in the LEAP group. The demographics and comorbidities were similar. All 11 LEAP patients had undergone a below-the-knee amputation, with 1 requiring revision to an above-the-knee amputation. Of the 130 retrospective patients, 122 (94%) had undergone a below-the-knee amputation, with 1 requiring revision to an above-the-knee amputation. The LEAP patients were more likely to be discharged to acute rehabilitation (100% vs 27%; P < .001), receive a prosthesis (100% vs 45%; P < .001), and ambulate with the prosthesis (100% vs 43%; P < .001). The LEAP patients had received physical therapy 2 days sooner than had the retrospective controls (P = .006) with a shorter postoperative LOS (3 days vs 6 days; P < .001). Of the patients who had received their prosthesis, the LEAP patients had received their prosthesis, on average, 2 months sooner than had the retrospective cohort (81 ± 39 days vs 137 ± 97 days, respectively; P = .002) and had ambulated with their prosthesis sooner (86 ± 53 days vs 146 ± 104 days, respectively; P = .002). No differences were found in the incidence of surgical site complications or unplanned readmissions between the two groups. The results from the present pilot study have demonstrated that the use of LEAP can significantly decrease postoperative LOS and expedite the time to independent ambulation with a prosthesis for vascular patients undergoing a major lower extremity amputation. These findings suggest a powerful ability to bridge the healthcare gap for this high-risk, underserved, and ethnically diverse population using a disease-specific standardized protocol.

Clinical Predictors and Outcomes Associated with Postoperative Delirium Following Infrainguinal Bypass Surgery.

BACKGROUND: Post-operative delirium (POD) is common yet often underdiagnosed following vascular surgery. Elderly patients with advanced peripheral artery disease may be at particular risk for POD yet understanding of the clinical predictors and impact of POD is incomplete. We sought to identify POD predictors and associated resource utilization after infrainguinal lower extremity bypass. METHODS: This single center retrospective analysis included all infrainguinal bypass cases performed for peripheral arterial disease from 2012-2020. The primary outcome was inpatient POD. Delirium sequelae were also evaluated. Key secondary outcomes were length of stay, nonhome discharge, readmission, 30-day amputation, post-operative myocardial infarction, mortality, and 2-year survival. Regression analysis was used to evaluate risk factors for delirium in addition to association with 2-year survival and amputation free survival. RESULTS: Among 420 subjects undergoing infrainguinal lower extremity bypass, 105 (25%) developed POD. Individuals with POD were older and more likely to have non-elective surgery (P < 0.05). On multivariable analysis, independent predictors of POD were age 60-89 years old, chronic limb threatening ischemia, female sex, and nonelective procedure. Consultations for POD took place for 25 cases (24%); 13 (52%) were with pharmacists, and only 4 (16%) resulted in recommendations. The average length of stay for those with POD was higher (17 days vs. 9 days; P < 0.001). POD was associated with increased non-home discharge (61.8% vs. 22.1%; P < 0.001), 30-day major amputation (6.7% vs. 1.6%; P < 0.01), 30-day postoperative myocardial infarction (11.4% vs. 4.1%; P < 0.01), and 90-day mortality (7.6% vs. 2.9%; P = 0.03). Survival at 2 years was lower in those with delirium (89% vs. 75%; P < 0.001). In a Cox proportional hazards model, delirium was independently associated with decreased survival (HR = 2.0; 95% CI = 1.15-3.38; P = 0.014) and decreased major-amputation free survival (HR = 1.9; 95% CI = 1.18-2.96; P = 0.007). CONCLUSIONS: POD is common following infrainguinal lower extremity bypass and is associated with other adverse post-operative outcomes and increased resource utilization, including increased hospital length of stay, nonhome discharge, and worse 2-year survival. Future studies should evaluate the role of routine multidisciplinary care for high-risk patients to improve perioperative outcomes for vulnerable older adults undergoing infrainguinal lower extremity bypass.

Pedal arterial calcification score is associated with hemodynamic change and major amputation after infrainguinal revascularization for chronic limb-threatening ischemia.

OBJECTIVE: Pedal medial arterial calcification (pMAC) is associated with major amputation in patients with chronic limb-threatening ischemia (CLTI). We hypothesize that this association would be related to unresolved distal ischemia. We investigated relationships across pMAC score, hemodynamic change, and major amputation after infrainguinal revascularization for CLTI. METHODS: This is a single-institution, retrospective study of 306 patients who underwent technically successful infrainguinal revascularization for CLTI (2011-2020) and had foot x-rays for blinded pMAC scoring (0-5). A total of 136 (44%) patients had toe pressure measurements performed within 90 days before and 60 days after revascularization. Ischemia grade (0-3) was assigned using the Society for Vascular Surgery Wound, Ischemia, foot Infection (WIfI) system. RESULTS: The revascularization approach was open bypass in 118 (38%) and endovascular in 188 (62%) patients. pMAC scores were trichotomized (0-1 [125; 41%], 2-4 [116; 38%], 5 [65; 21%]). Post-revascularization WIfI ischemia grade was improved in 78 of 136 (57%) and unchanged/worsened in 58 of 136 (43%). A lower pMAC score was associated with hemodynamic improvement (P = .004). Failure to improve the ischemia grade was associated with major amputation (P = .0002). In the endovascular subgroup, WIfI ischemia grade was improved in 43 of 90 (48%) with available measurements, and 37 of 188 (20%) underwent major amputation. In a multivariate logistic model, pMAC 5 was the only factor independently associated with unimproved ischemia grade after endovascular treatment (odds ratio: 4.0 [1.1-16.6], P = .04). In a Cox proportional hazards model, factors independently associated with major amputation after endoluminal revascularization were WIfI stage 4 (hazard ratio [HR]: 2.7 [1.3-5.7], P = .007) and pMAC score (pMAC: 2-4: HR: 10.6 [1.4-80.7], P = .02; pMAC: 5: HR: 15.5 [2.0-119], P = .008). In the bypass subgroup, WIfI ischemia grade was improved in 35 of 46 (76%) with available measurements but was not associated with pMAC score (P = .88) or any other baseline patient or limb characteristics. A total of 19 of 118 (16%) patients underwent major amputation. In a Cox proportional hazards model including bypass conduit, WIfI stage, and pMAC score, the only factor independently associated with major amputation after bypass was use of nonautologous conduit (HR: 5.6 [1.8-17.6], P = .003). CONCLUSIONS: The pMAC score is independently associated with persistent distal ischemia and major amputation after technically successful revascularization for CLTI. These data suggest that pMAC may be a marker for hemodynamic response to revascularization and risk of limb loss, and it may have a stronger influence on the outcome of endoluminal interventions.

Limb-based patency as a measure of effective revascularization for chronic limb-threatening ischemia.

OBJECTIVE: In 2019, the Global Vascular Guidelines on chronic limb-threatening ischemia (CLTI) introduced the concept of limb-based patency (LBP) defined as maintained patency of a target artery pathway after intervention. The purpose of this study was to investigate the relationship between LBP and major adverse limb events (MALE) after infrainguinal revascularization for CLTI. METHODS: Consecutive patients undergoing revascularization for CLTI between 2016 and 2019 at a single tertiary institution with a dedicated limb preservation team were included. Subjects with aortoiliac disease, prior infrainguinal stents, or existing bypass grafts were excluded. Demographics, Global Limb Anatomic Staging System scores, Wound, Ischemia, foot Infection (WIfI) stages, revascularization details, and limb-specific outcomes were reviewed. LBP was defined by the absence of reintervention, occlusion, critical stenosis (>70%), or hemodynamic compromise with ongoing symptoms of CLTI. MALE included thrombectomy or thrombolysis, new bypass, open surgical graft revision and/or major amputation. RESULTS: We analyzed 184 unique limbs in 163 patients. This cohort was composed of 66.9% male patients with a mean age of 72 years. Baseline characteristics included diabetes (66%), tissue loss (91%), and advanced WIfI stages (30% stage 3, 51% stage 4). Global Limb Anatomic Staging System stage 3 anatomic patterns were common (n = 119 [65%]). Sixty limbs were treated with open bypass (65% involving tibial targets) and 124 underwent endovascular intervention (70% including infrapopliteal targets). The 12-month freedom from MALE and loss of LBP were 74.0% ± 3.7% and 48.6% ± 4.2%, respectively. Diabetes (hazard ratio [HR], 2.56; 95% confidence interval [CI], 1.13-5.83; P = .025) and loss of LBP (HR, 4.12; 95% CI, 1.96-8.64; P < .001) were independent predictors of MALE in a Cox proportional hazard model. Loss of LBP was the sole independent predictor of major limb amputation after revascularization (HR, 4.97; 95% CI, 1.89-13.09; P = .001). Loss of LBP impacted both intermediate-risk limbs (HR, 2.85; 95% CI, 1.02-7.97; P = .047 in WIfI stages 1-3) and high-risk limbs (HR, 3.99; 95% CI, 1.32-12.11; P = .014 in WIfI stage 4). However, the loss of LBP had the greatest impact on patients presenting with WIfI stage 4 disease (31% vs 8% major limb amputation at 12 months in limbs without vs with maintained LBP). CONCLUSIONS: The anatomic durability of revascularization, as measured by LBP, is a key determinant of treatment outcomes in CLTI regardless of the initial mode of intervention undertaken. Loss of LBP is most detrimental in patients presenting with advanced limb threat (WIfI stage 4).

Capturing the complexity of open abdominal aortic surgery in the endovascular era.

OBJECTIVE: Volume and quality benchmarks for open abdominal aortic surgery and particularly open aortic aneurysm repair (OAR) in the endovascular era are guided by the Society for Vascular Surgery guidelines, but the Vascular Quality Initiative (VQI) OAR module fails to capture the full spectrum of complex OAR. We hypothesized that VQI-ineligible complex OAR would be the dominant form of open repairs performed at a VQI-participating tertiary center. METHODS: All OAR cases performed at a single tertiary care center from 2007 to 2020 were reviewed. The VQI OAR criteria were applied with exclusions (non-VQI) defined as concomitant renal bypass, clamping above the superior mesenteric artery or celiac artery, repairs performed for trauma, anastomotic aneurysm, isolated iliac aneurysm, or infected aneurysms. Linear regression was used to assess temporal trends. RESULTS: Among a total of 481 open abdominal aortic operations, 355 (74%) were OAR. The average annual OAR volume remained stable over 14 years (25 ± 6; P = .46). Non-VQI OAR comprised 54% of all cases and persisted over time (R2 = 0.047, P = .46). Supraceliac clamping (35%) was often necessary. The proportion of endograft explantation cases significantly increased over time from 4% in 2007 to 20% in 2019 (P = .01). Infectious indications represented 20% (n = 70) of cases. Visceral branch grafts were performed in 16% of all cases. OAR for ruptured aneurysm constituted 10% of cases. Thirty-day mortality was significantly higher in non-VQI vs VQI-eligible OAR cases (10% vs 4%; P = .04). CONCLUSIONS: Complex OAR comprises a majority of OAR cases in a contemporary tertiary referral hospital, yet these cases are not accounted for in the VQI. Creation of a "complex OAR" VQI module would capture these cases in a quality-driven national registry and help to better inform benchmarks for volume and outcomes in aortic surgery.

Applicability of the Vascular Quality Initiative mortality prediction model for infrainguinal revascularization in a tertiary limb preservation center population.

OBJECTIVE: Patients undergoing revascularization for chronic limb-threatening ischemia (CLTI) are at elevated risk for both mortality and limb loss. To facilitate therapeutic decision-making, a mortality prediction model derived from the Vascular Quality Initiative (VQI) database has stratified patients into low, medium, and high risk, defined by 30-day mortality estimates of ≤3%, 3%-5%, or >5% and 2-year mortality estimates of ≤30%, 30%-50%, or ≥50%, respectively. The purpose of this study was to compare expected mortality risk derived from this model with observed outcomes in a tertiary center. METHODS: Consecutive patients treated at a single center between 2016 and 2019 were analyzed. Baseline demographics, approach, and mortality events were reviewed. Observed mortality was obtained using life-table methods and compared using a log-rank test with the expected mortality risk that was calculated using the VQI model. RESULTS: This study cohort consisted of 195 revascularization procedures in 169 unique patients stratified into 128 (66%) low-, 50 (26%) medium-, and 17 (8%) high-risk cases based on the VQI model. Ninety percent of revascularizations were performed for tissue loss. Compared with the VQI population, comorbidities were prevalent and included unstable angina or myocardial infarction within 6 months (6% vs 2.4% in VQI; P < .001), congestive heart failure (30% vs 23%; P < .001), and dialysis dependence (14% vs 0.9%; P < .001). Patients were also older (31% vs 21% ≥80 years old; P < .001) and more likely to be frail (45% vs 64% independent; P < .001). High-risk patients were more prevalent in the endovascular group (11% of 132 endovascular interventions vs 3% of 63 bypasses; P = .056). Thirty-day observed mortality exceeded expected VQI prediction model mortality in all groups, although was not statistically significant. The VQI model adequately stratified the studied population into risk groups (P < .001). Low-risk patients with CLTI (65% of the overall cohort) experienced 2-year mortality of 18.9%. However, observed mortality rates for medium- and high-risk VQI strata were similar. After a median follow-up of 28 months, medium-risk patients incurred a significantly higher mortality than predicted (53.5% ± 2.1% vs 36.8% ± 1.1%; P = .016). CONCLUSIONS: The VQI mortality prediction model discriminates mortality risk after limb revascularization in CLTI, accurately identifying a majority subgroup of patients who are suitable for either open or endovascular intervention. However, it may underestimate mortality in a tertiary referral population with high comorbidity burden and was not well calibrated for the medium-risk group. It may be more appropriate to dichotomize patients with CLTI who are candidates for limb salvage into an average-risk and high-risk group.

Risk factors for venous thromboembolism after vascular surgery and implications for chemoprophylaxis strategies.

OBJECTIVE: Venous thromboembolism (VTE) is an important cause of postoperative morbidity and mortality. However, the reported incidence after major vascular surgery has ranged from as low as 1% to >10%. Furthermore, little is known about optimal chemoprophylaxis regimens or rates of postdischarge VTE in this population. In the present study, we aimed to better characterize the rates of in-hospital and postdischarge VTE after major vascular surgery, the role of chemoprophylaxis timing, and the association of VTE with mortality. METHODS: A single-center retrospective study of 1449 major vascular operations (2013-2020) was performed and included 189 endovascular abdominal aortic aneurysm repairs (13%), 169 thoracic endovascular aortic aneurysm repairs (12%), 318 open aortic operations (22%), 640 lower extremity bypasses (44%), and 133 femoral endarterectomies (9%). The baseline characteristics, anticoagulant and antiplatelet medications, and outcomes were abstracted from an electronic database with medical record auditing. Postoperative VTE (pulmonary embolism and deep vein thrombosis) within 90 days of surgery was classified by the location, symptoms, and treatment. A cut point analysis using Youden's index identified the most VTE discriminating timing of chemoprophylaxis (including therapeutic vs prophylactic anticoagulant and antiplatelet medications) and Caprini score. Multivariable logistic regression was used to test the association of VTE with chemoprophylaxis timing, Caprini score, and additional risk factors. Cox proportional hazard modeling was used to measure the association between VTE and mortality. RESULTS: The overall VTE incidence was 3.4% (65% deep vein thrombosis; 25% pulmonary embolism; 10% both), and 37% had occurred after discharge. The rate of symptomatic VTE was 2.4%, which was lowest for endovascular abdominal aortic aneurysm repair (0.0%) and highest for open aortic surgery (4.1%; P = .02). Those who had developed VTE had had a longer length of stay, higher rates of end-stage renal disease and prior VTE, and higher Caprini scores (8 vs 5 points; P < .01 for all). Those who had developed VTE were also more likely to have received ≥2 U of blood postoperatively, required an unplanned return to the operating room, had delayed chemoprophylaxis, anticoagulation, and/or antiplatelet initiation of >4 days postoperatively, and had increased 90-day mortality (P < .01 for all). A Caprini score of ≥7 (29% of patients) was associated with postdischarge VTE (2.6% vs 0.7%; P = .01), and chemoprophylaxis, anticoagulation, and antiplatelet timing of >4 days was associated with an increased adjusted odds of VTE (odds ratio, 2.4; 95% confidence interval, 1.1-4.9). Although no fatal VTEs were identified, VTE was an independent predictor of 90-day mortality (adjusted hazard ratio, 2.7; 95% confidence interval, 1.3-5.9). CONCLUSIONS: These data have shown that patients undergoing major vascular surgery are particularly prone to the development of VTE, with frequent hypercoagulable comorbidities. The earlier initiation of chemoprophylaxis was associated with a reduced risk of VTE development. Furthermore, the postdischarge VTE rates might reach thresholds warranting postdischarge chemoprophylaxis, especially for patients with a Caprini score of ≥7.

Pedal arterial calcification score is associated with the risk of major amputation in chronic limb-threatening ischemia.

OBJECTIVE: The medial arterial calcification (MAC) score is a simple metric that describes the burden of inframalleolar calcification using a plain foot radiograph. We hypothesized that a higher MAC score would be independently associated with the risk of major amputation in patients with chronic limb-threatening ischemia (CLTI). METHODS: We performed a single-institution, retrospective study of 250 patients who had undergone infrainguinal revascularization for CLTI from January 2011 to July 2019 and had foot radiographs available for MAC score calculation. A single blinded reviewer assigned MAC scores of 0 to 5 using two-view minimum plain foot radiographs, with 1 point each for calcification of >2 cm in the dorsalis pedis, plantar, and metatarsal arteries and >1 cm in the hallux and non-hallux digital arteries. RESULTS: The MAC score was 0 in 36%, 1 in 5.2%, 2 in 8.4%, 3 in 14%, 4 in 14%, and 5 in 21%. The MAC score was trichotomized to facilitate analysis and clinical utility (mild, MAC score 0-1; moderate, MAC score 2-4; and severe, MAC score 5). The variables independently associated with a higher MAC score were male sex, diabetes, end-stage renal disease, and the global limb anatomic staging system pedal score. The MAC score was not associated with the Society for Vascular Surgery WIfI (wound, ischemia, foot infection) grade or overall WIfI stage (P = .58). The median follow-up was 759 days (interquartile range, 264-1541 days). A higher MAC score was significantly associated with the risk of major amputation (P < .0001). In a Cox proportional hazards multiple regression model for major amputation that included the trichotomized MAC score, diabetes, end-stage renal disease, and WIfI stage (1-3 vs 4). The MAC score (MAC score 5: hazard ratio [HR], 4.9; 95% confidence interval [CI], 1.9-13.1; P = .001; MAC score 2-4: HR, 3.4; 95% CI, 1.3-8.8; P = .01) and WIfI stage (WIfI stage 4: HR, 2.1; 95% CI, 1.1-3.9; P = .03) were significantly associated with the risk of major amputation. In the subsets of patients with the most advanced WIfI stage of 3 to 4 (191 of 250; 76%) and patients with diabetes (185 of 250; 74%), the MAC score further stratified the risk of major amputation on univariate and multivariate analyses. CONCLUSIONS: The MAC score is a simple, practical tool and a strong independent predictor of major amputation in patients with CLTI. It provides novel clinical data that are currently unmeasured using any validated CLTI staging system. The MAC score is a promising standardized measure of inframalleolar disease burden that can be used in conjunction with the WIfI staging system to help improve outcomes stratification and determine the optimal treatment strategies for patients with CLTI.

Utility of a Simplified Iliac Artery Calcium Scoring System to Guide Perioperative Management for Renal Transplantation.

Non-contrast computed tomography scans of the abdomen and pelvis (CTAP) are often obtained prior to renal transplant to evaluate the iliac arteries and help guide surgical implantation. The purpose of this study was to describe the association of iliac calcification scores with operative and clinical outcomes using a simplified scoring system. A retrospective review of 204 patients who underwent renal transplant from 1/2013 to 11/2014 and who had a CTAP within 3 years prior to transplant was performed. Data were collected from the electronic medical record. Common iliac artery (CIA) and external iliac artery (EIA) calcification on CTAP were assessed using a simple scoring system. Descriptive statistics, logistic regression, and survival analyses were performed. A total of 204 patients were included in the analysis. The mean age was 57.4 ± 11.2 years and 134/204 (66%) were men. Nineteen patients (9%) had a history of peripheral artery disease (PAD), 78 (38%) had coronary artery disease, and 22 (11%) had a previous cerebrovascular accident (CVA). Patients with severe right EIA plaque morphology were significantly more likely to require arterial reconstruction compared to those without severe plaque (3/14[21%] 4/153 [3%], p = 0.03). Eleven patients (5%) had one or more amputations (toe, foot, or transtibial) following transplant. In UV logistic regression, severe EIA plaque morphology (OR 8.1, CI 2.2-29.6, p = 0.002) and PAD (OR 10.7, CI 2.8-39.9, p = 0.0004) were associated with increased odds of amputation. In the MV model containing both variables, EIA plaque morphology (OR 4.4, CI 0.99-18.3, p = 0.04) and PAD (OR 6.3, CI 1.4-26.4, p = 0.01) remained independently associated with increased odds of amputation. Over a median follow up of 3.3 years (IQR 2.9-3.6), 21 patients (10%) had post-operative major adverse cardiac events (MACE, defined as myocardial infarction, coronary intervention, or CVA), and 23 patients died (11%). In unadjusted Kaplan Meier analysis, CIA plaque (p = 0.00081) and >75% CIA length calcification (p = 0.0015) were significantly associated with MACE. Plaque burden in the EIA is associated with increased need for intra-operative arterial reconstruction and post-operative lower extremity amputations, while CIA plaque is associated with post-operative MACE. Assessment of CIA and EIA calcification scores on pre-transplant CT scans in high risk patients may guide operative strategy and perioperative management to improve clinical outcomes.