Improved long-term functional outcomes and mortality of patients with vascular-related amputations utilizing the lower extremity amputation pathway.

BACKGROUND: Enhanced recovery after surgery pathways lead to improve perioperative outcomes for patients with vascular-related amputations; however, long-term data and functional outcomes are lacking. This study evaluated patients treated by the lower extremity amputation pathway (LEAP) and identified predictors of ambulation. METHODS: A retrospective review of LEAP patients who underwent major amputation from 2016 to 2022 for Wound, Ischemia, and foot Infection stage V disease was performed. LEAP patients were matched 1:1 with retrospective controls (NOLEAP) by hospital, need for guillotine amputation, and final amputation type (above knee vs below knee). The primary end point was the Medicare Functional Classification Level (K level) (functional classification of patients with amputations) at the last follow-up. RESULTS: We included 126 patients with vascular-related amputations (63 LEAP and 63 NOLEAP). Seventy-one percent of the patients were male and 49% were Hispanic with a mean state Area Deprivation Index of 9/10. There were no differences in baseline demographics or comorbidities. All patients had a K level of >0 (ambulatory) before amputation and an average Modified Frailty Index of 4. The median follow-up was 270 days (interquartile range, 84-1234 days) in the NOLEAP group and 369 days (interquartile range, 145-481 days) in the LEAP group. Compared with NOLEAP patients, LEAP patients were more likely to receive a prosthesis (86% vs 44%;P > .001). LEAP patients were more likely to have a K level of >0 (60% vs 25%; P = .003). On multivariable logistic regression, participation in LEAP increased the odds of a K level of >0 at follow-up by 5.8-fold (odds ratio, 5.8; 95% confidence interval, 2.5-13.6). Patients with a K level of >0 had significantly higher survival at 4 years (93% vs 59%; P = .001). In a Cox proportional hazards model, adjusted for demographics, comorbidities and amputation level, a K level of >0 at follow-up was associated with an 88% decrease in the risk of mortality compared with a K level of 0. CONCLUSIONS: LEAP leads to improved ambulation with a prosthesis in a socioeconomically disadvantaged and frail patient population. Patients with a K level of >0 (ambulatory) have significantly improved mortality.

Race, sex, and socioeconomic disparities affect the clinical stage of patients presenting for treatment of superficial venous disease.

OBJECTIVE: Superficial venous disease has a U.S. prevalence of nearly 30%, with advanced disease contributing to a significant healthcare burden. Although the risk factors for venous disease are well known, the correlation between race, sex, socioeconomic status, and disease severity on presentation is not well established. The area deprivation index (ADI) is a validated metric with respect to regional geography, social determinants of health, and degree of socioeconomic disadvantage. In the present study, we aimed to identify the disparities and the effect that the ADI, in addition to race and sex, has among patients associated with an advanced venous disease presentation. METHODS: A retrospective review between 2012 and 2022 was performed at four tertiary U.S. institutions to identify patients who underwent endovenous closure of their saphenous veins. Patient demographics, state ADI, comorbidities, CEAP (clinical, etiologic, anatomic, pathophysiologic) classification, and periprocedural outcomes were included. Pearson's correlation was performed between the CEAP classification and ADI. Poisson regression analysis was performed to identify factors predicting for an increasing CEAP classification at presentation. Variables with P < .05 were deemed significant. RESULTS: A total of 2346 patients underwent endovenous saphenous vein closure during the study period, of whom 7 were excluded because of a lack of follow-up data. The mean age was 60.4 ± 14.9 years, 65.9% were women, and 55.4% were White. Of the 2339 patients, 73.3% presented with an advanced CEAP class (≥3). The mean state ADI for the entire cohort was 4.9 ± 3.1. The percent change in the CEAP classification is an increase of 2% and 1% for every level increase in the state ADI for unadjusted (incidence rate ratio [IRR] = 1.02; P < .001) and adjusted (IRR = 1.01; P < .001) models, respectively. Black race has a 12% increased risk of a higher CEAP class on presentation compared with White race (IRR = 1.12; P = .005). Female sex had a 16% lower risk of a higher CEAP presentation compared with male sex (IRR = 0.84; P < .01). CONCLUSIONS: Low socioeconomic status, Black race, and male sex are predictive of an advanced CEAP classification on initial presentation. These findings highlight the opportunity for improved mechanisms for identification of venous disease and at-risk patients before advanced disease progression in known disadvantaged patient populations.

Community-wide feasibility of the Lower Extremity Amputation Protocol amongst vascular amputees.

BACKGROUND: The Lower Extremity Amputation Protocol (LEAP) is a multidisciplinary enhanced recovery after surgery pathway for vascular amputees. The objective of this study was to examine feasibility and outcomes of community-wide implementation of LEAP. METHODS: LEAP was implemented at three safety net hospitals for patients with peripheral artery disease or diabetes requiring major lower extremity amputation. Patients who underwent LEAP (LEAP) were matched 1:1 with retrospective controls (NOLEAP) on hospital location, need for initial guillotine amputation, and final amputation type (above- vs below-knee). Primary endpoint was postoperative hospital length of stay (PO-LOS). RESULTS: A total of 126 amputees (63 LEAP and 63 NOLEAP) were included with no difference between baseline demographics and co-morbidities between the groups. After matching, both groups had the same prevalence of amputation level (76% below-knee vs 24% above-knee). LEAP patients had shorter duration of postamputation bed rest (P = .003) and were more likely to receive limb protectors (100% vs 40%; P ≤ .001), prosthetic counseling (100% vs 14%; P ≤ .001), perioperative nerve blocks (75% vs 25%; P ≤ .001), and postoperative gabapentin (79% vs 50%; P ≤ .001). Compared with NOLEAP, LEAP patients were more likely to be discharged to an acute rehabilitation facility (70% vs 44%; P = .009) and less likely to be discharged to a skilled nursing facility (14% vs 35%; P = .009). The median PO-LOS for the overall cohort was 4 days. LEAP patients had a shorter median PO-LOS (3 [interquartile range, 2-5] vs 5 [interquartile range, 4-9] days; P < .001). On multivariable logistic regression, LEAP decreased the odds of a PO-LOS of ≥4 days by 77% (odds ratio, 0.23; 95% confidence interval, 0.09-0.63). Overall, LEAP patients were significantly less likely to have phantom limb pain (5% vs 21%; P = .02) and were more likely to receive a prosthesis (81% vs 40%; P ≤ .001). In a multivariable Cox proportional hazards model, LEAP was associated with an 84% reduction in time to receipt of prosthesis (hazard ratio, 0.16; 95% confidence interval, 0.085-0.303; P < .001). CONCLUSIONS: Community wide implementation of LEAP significantly improved outcomes for vascular amputees demonstrating that utilization of core ERAS principles in vascular patients leads to decreased PO-LOS and improved pain control. LEAP also affords this socioeconomically disadvantaged population a greater opportunity to receive a prosthesis and return to the community as a functional ambulator.

Type IV Hypersensitivity Reaction after Cyanoacrylate Venous Closure.

BACKGROUND: Nonthermal endovenous closure techniques are routinely utilized to treat superficial axial venous reflux. Cyanoacrylate closure is a safe and effective modality implemented for truncal closure. However, an adverse reaction of type IV hypersensitivity (T4H), unique to cyanoacrylate, is a known risk. This study aims to evaluate the real-world incidence of T4H and examine risk factors that may predispose its development. METHODS: A retrospective review between 2012- and 2022 was performed at four tertiary US institutions to examine patients who underwent cyanoacrylate vein closure of their saphenous veins. Patient demographics, comorbidities, CEAP (Clinical [C], Etiological [E], Anatomical [A], and Pathophysiological [P]) classification, and periprocedural outcomes were included. The primary endpoint was development of T4H post procedure. Logistic regression analysis for risk factors predictive of T4H was performed. Variables with a P-value of <0.05 were deemed significant. RESULTS: 595 patients underwent 881 cyanoacrylate venous closures. Mean age was 66.2 ± 14.9, and 66% of patients were female. There were 92 (10.4%) T4H events in 79 (13%) patients. Oral steroids were administered to 23% for persistent and/or severe symptoms. There were no systemic allergic reactions to cyanoacrylate. Multivariate analysis revealed younger age (P = 0.015), active smoking status (P = 0.033), and CEAP 3 (P < 0.001) and 4 (P = 0.005) classifications as independent risk factors associated with development of T4H. CONCLUSIONS: This real-world multicenter study shows the overall incidence of T4H to be 10%. CEAP 3 and 4 patients of younger age and smokers predicted a higher risk of T4H to cyanoacrylate.

Exploring the perception of venous disease within vascular surgery.

BACKGROUND: Biases and gender disparities influence career pathways within medicine, and vascular surgery is no exception. Venous disease comprises an estimated 1% to 3% of total health care expenditures. However, its value among vascular surgeons is poorly understood. This study aims to investigate the factors that influence vascular surgeons' current perceptions of superficial and deep venous disease treatments. METHODS: An anonymous survey was distributed electronically to practicing vascular surgeons in December 2021. The respondents were stratified by gender and practice breakdown. A venous-heavy practice was defined as a practice with venous work comprising ≥25% of the total volume. Changes in practice patterns over the respondent's career were also explored. Descriptive, univariate, and multivariate analyses were performed using STATA (StataCorp). RESULTS: A total of 315 practicing vascular surgeons responded, with 81.5% from the United States. Their mean age was 46.6 ± 9.6 years, and most identified as men (63.3%). The race and ethnicity breakdown was as follows: White (non-Hispanic), 63.0%; Asian or Asian Indian, 17.1%; Hispanic, Latinx, or Spanish, 8.4%; Black, 1.6%; and unknown, 9.9%. The practice settings were academic for 47.0%, private practice for 26.5%, hospital employed for 23.3%, and other for 3.2%. The female respondents were significantly younger (P < .0001), with fewer years in practice (P < .0001) and were more likely to perceive a gender bias within a career encompassing venous disease compared with the male respondents (P = .02). Of the 315 participants, 143 (45.4%) had a venous-heavy practice. No differences were found in age or gender between the venous-heavy and venous-light practices. Those with a venous-heavy practice had significantly more years in practice statistically (P = .02), had sought more venous training after graduation (P < .0001), were more likely to be in private practice (P < .0001), and were more likely to desire a practice change (P = .001) compared with those with a venous-light practice. Overall, 74.3% of respondents indicated that venous work might be less "valued" than arterial work in the field of vascular surgery. On multivariable regression, the predictors for the perception of venous work being less valued were female gender (odds ratio, 2.01; 95% confidence interval, 1.14-4.03) and completion of a vascular surgery fellowship (odds ratio, 2.0; 95% confidence interval, 1.15-3.57). CONCLUSIONS: Vascular surgeons overwhelmingly perceived the management of venous disease to be of less value than that of arterial disease, particularly by women and fellowship-trained vascular surgeons. The prevalence of venous disease, as measured by its proportion of the U.S. healthcare budget, cannot be overstated. Thus, efforts to elevate the importance of chronic venous disease within the scope of vascular surgery practices are essential to ensure patients are provided with appropriate specialty care.

Carotid Artery Operation Delay During the Covid-19 Pandemic: Results of a Multicenter International Study.

BACKGROUND: To measure the impact of the COVID-19 pandemic on the management of patients with carotid artery stenosis. METHODS: We prospectively collected data from 25 centers (19 centers in the United States and 6 centers internationally) on postponed carotid artery operations between March 2020 and January 2022. We describe the characteristics of these patients and their planned operations, along with outcomes including mortality and neurological deterioration during the period of operative delay due to the COVID-19 pandemic. RESULTS: A total of 1,220 vascular operations were postponed during the pandemic, of them 96 patients presented with significant carotid stenosis (median stenosis of 71%; interquartile range; 70-80) and 80% of them were planned for carotid endarterectomy. Most patients were asymptomatic (69%), and 31% of patients were symptomatic (16% of patients had a stroke, 15% of patients had a transient ischemic attack, and 1% of patients experienced amaurosis fugax). The median length of surgical delay was 71 days (interquartile range: 45.5, 115.5). At the data entry time, 62% of patients had their carotid operations postponed and successfully completed. Most postponements (72%) were due to institutional policies aimed at resource conservation. During the delay, no patient decompensated or required an urgent operation. A total of 5 patients (5%) with carotid stenosis died while awaiting operations due to COVID-19. CONCLUSIONS: Our study of a cohort of patients with carotid artery stenosis who underwent a median delay of 71 days during the COVID-19 pandemic showed a disparate operation delay between US regions and internationally, most postponements were due to hospital policy, and none of the patients deteriorated or required an emergency surgery during the delay.

Lack of patient-centered evaluation of outcomes in intermittent claudication literature.

BACKGROUND: Peripheral arterial disease, characterized as arterial atherosclerotic disease, can lead to insufficient flow in the lower extremities and ischemia, with the most common clinical manifestation being intermittent claudication (IC). In 2022, the Society for Vascular Surgery (SVS) developed appropriate use criteria for the management of IC that used this systematic review as a source of evidence. The objective of this study is to synthesize the findings of the systematic review and identify evidence gaps. METHODS: A comprehensive search of literature databases including MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Scopus was conducted from January 1, 2000, to November 30, 2022. Noncomparative and comparative observational studies and randomized controlled trials were included. Included studies evaluated exercise therapy, endovascular or open revascularization for the treatment of IC. Outcomes of interest (freedom from major adverse limb event, health-related quality of life, and walking distance) were compared in various subgroups (age, sex, diabetes, smoking status, anatomical location of disease, and optimal medical therapy). RESULTS: Twenty-six studies reported the outcomes of interest for the evidence map. The general conclusions of the studies that reported freedom from major adverse limb events were that reintervention rates for endovascular therapy at ≥2 years were >20%, major amputation rates were often not reported, and, after endovascular therapy, the 1-month mortality was low (<2%). Quality of life and walking distance data were sparse, limited to only endovascular intervention, and insufficient to make any strong conclusions. CONCLUSIONS: IC in patients with peripheral arterial disease poses a significant socioeconomic and health care burden. Major, consequential gaps exist in the IC literature with respect to the assessment of patient reported outcome measures, standardized measures of walking distance and the comparative effectiveness of initial exercise therapy vs invasive intervention. The evidence gaps identified by the Society for Vascular Surgery appropriate use criteria on IC systematic review serve as a guide for future research efforts to optimize care for this patient population.

Outcomes of vascular trauma associated with an evolution in the use of endovascular management.

OBJECTIVE: The availability of endovascular techniques has led to a paradigm shift in the management of vascular injury. Although previous reports showed trends towards the increased use of catheter-based techniques, there have been no contemporary studies of practice patterns and how these approaches differ by anatomic distributions of injury. The objective of this study is to provide a temporal assessment of the use of endovascular techniques in the management of torso, junctional (subclavian, axillary, iliac), and extremity injury and to evaluate any association with survival and length of stay. METHODS: The American Association for the Surgery of Trauma (AAST) Prospective Observational Vascular Injury Treatment registry (PROOVIT) is the only large multicenter database focusing specifically on the management of vascular trauma. Patients in the AAST PROOVIT registry from 2013 to 2019 with arterial injuries were queried, and radial/ulnar, and tibial artery injuries were excluded. The primary aim was to evaluate the frequency in use of endovascular techniques over time and by body region. A secondary analysis evaluated the trends for junctional injuries and compared the mortality between those treated with open vs endovascular repair. RESULTS: Of the 3249 patients included, 76% were male, and overall treatment type was 42% nonoperative, 44% open, and 14% endovascular. Endovascular treatment increased an average of 2% per year from 2013 to 2019 (range, 17%-35%; R2 = .61). The use of endovascular techniques for junctional injuries increased by 5% per year (range, 33%-63%; R2 = .89). Endovascular treatment was more common for thoracic, abdominal, and cerebrovascular injuries, and least likely in upper and lower extremity injuries. Injury severity score was higher for patients receiving endovascular repair in every vascular bed except lower extremity. Endovascular repair was associated with significantly lower mortality than open repair for thoracic (5% vs 46%; P < .001) and abdominal injuries (15% vs 38%; P < .001). For junctional injuries, endovascular repair was associated with a non-statistically significant lower mortality (19% vs 29%; P = .099), despite higher injury severity score (25 vs 21; P = .003) compared with open repair. CONCLUSIONS: The reported use of endovascular techniques within the PROOVIT registry increased more than 10% over a 6-year period. This increase was associated with improved survival, especially for patients with junctional vascular injuries. Practices and training programs should account for these changes by providing access to endovascular technologies and instruction in the catheter-based skill sets to optimize outcomes in the future.

The Characteristics and Results of Endovascular Devices in Trauma (CREDiT) study: Multi-institutional results.

INTRODUCTION: Endovascular techniques are increasingly used to repair major traumatic vascular injuries, but most endovascular implants are not designed/approved for trauma-specific indications. No inventory guidelines exist for the devices used in these procedures. We aimed to describe the use and characteristics of endovascular implants used for repair of vascular injuries to allow for better inventory management. METHODS: This CREDiT study is a six-year retrospective cohort analysis of endovascular procedures performed for repair of traumatic arterial injuries at five participating US trauma centers. For each treated vessel, procedural and device details were recorded and outcomes assessed with the aim of defining the range of implants and sizes used for these interventions. RESULTS: A total of 94 cases were identified; 58 (61%) were descending thoracic aorta, 14 (15%) axillosubclavian, 5 carotid, 4 abdominal aortic, 4 common iliac, 7 femoropopliteal, and 1 renal. Vascular surgeons performed 54% of cases, trauma surgeons 17%, IR/CT Surgery 29%. Systemic heparin was administered in 68% and procedures were performed a median of 9 h after arrival (IQR 3-24 h). Primary arterial access was femoral in 93% of cases, 49% were bilateral. Brachial/radial access was used primarily in 6 cases, and secondary to femoral in 9. The most common implant was self-expanding stent graft; 18% used >1 stent. Implants ranged in diameter and length based on vessel size. Five of 94 implants underwent reintervention (1 open surgery) at a median of 4d postop (range 2-60d). Two occlusions and 1 stenosis were present at follow-up at a median of 1 month (range 0-72 m). CONCLUSIONS: Endovascular reconstruction of injured arteries requires a broad range of implant types, diameters, and lengths which should be readily available in trauma centers. Stent occlusions/stenoses are rare and can typically be managed by endovascular means.

A review of the current literature of ethnic, gender, and socioeconomic disparities in venous disease.

Venous disease is prevalent, undertreated, and frequently unrecognized. During the past two decades, new treatment modalities have changed how venous disease is approached. Some of these treatment modalities are only available in certain centers or locations and access to care could be inequitable. Although venous disease affects millions in the United States, we have little understanding of the gender, socioeconomic, and ethnic disparities in both superficial and deep venous disease presentation. In an effort to better understand the treatment of male and female patients from different gender, ethnic, and socioeconomic backgrounds, literature searches were conducted to investigate how these patients were evaluated and treated. PubMed was used to search literature using the terms "venous insufficiency," "superficial venous disease," "venous thromboembolism," "deep vein thrombosis," "DVT," "May-Thurner," and "pulmonary embolism," with gender, sex, racial, and socioeconomic disparities and differences within the keywords. In addition, once articles were discovered, the "similar articles" function was used to expand the search. The included studies were restricted to those reported from 1995 to the present. Given the paucity of data, no study was excluded. It is readily apparent that there is not enough data to make decisions that would modify treatment to affect the outcomes of patients with differing backgrounds and gender. Studies currently are limited to evaluating patients by sex assigned at birth without interrogation of their identified gender. It is imperative that consideration is given to evaluating gender and ethnic differences, because treatment options might need to be tailored accordingly. Outreach and education for underserved patient populations with improvement in access to care must also be incorporated into the healthcare system. Additional work in this area is required. Further data collection and research related to demographic disparities among patients with venous disease is necessary to better understand the differences that could change treatment algorithms tailored to specific groups.

Carotid endarterectomy is safe for octogenarians.

BACKGROUND: Carotid endarterectomy (CEA) has demonstrated superior results in stroke risk reduction for patients with symptomatic and asymptomatic high-grade carotid stenosis. However, this benefit has long been questioned for the elderly and high-risk populations. In the present study, we aimed to provide high-volume, single-institution data with long-term follow-up examining the risk factors for postoperative stroke and stroke-free survival stratified by age for asymptomatic and symptomatic patients undergoing CEA. METHODS: A single-institution retrospective review of 840 consecutive patients who had undergone CEA from 2011 to 2018 was performed, inclusive of both symptomatic and asymptomatic operative indications. The primary end point was perioperative stroke within 30 days of surgery. The secondary end points were late stroke, death, and myocardial infarction. Patients aged >80 years were compared with those aged <80 years to examine freedom from stroke and death. Statistically significant differences were defined as those with P < .05. RESULTS: A total of 840 patients were evaluated with a median follow-up of 416 ± 1244 days. Of the 840 patients, 499 (59%) were men, and 604 (72%) were White. The mean age was 72 ± 9 years, with 202 (24%) aged ≥80 years. CEA was performed for symptomatic disease in 305 patients (36%), of whom 143 (47%) had had strokes and 162 (53%) had had transient ischemic attacks. The overall 30-day postoperative stroke rate was 1.0% (eight patients; 0.6% for asymptomatic and 1.6% for symptomatic; P = .147). Compared with younger patients, octogenarians had had a similar stroke rate after CEA (1.5% vs 0.8%; P = .407). Hispanic race was an independent risk factor for postoperative stroke. White race and preoperative statin use both appeared to be protective. Kaplan-Meier survival curves demonstrated decreased a 5-year stroke-free survival in patients aged ≥80 years (P = .031). However, overall, the estimated 5-year survival was similar to the U.S. general population across both age groups. CONCLUSIONS: CEA for octogenarians is safe and effective for both symptomatic and asymptomatic populations with excellent 30-day outcomes and long-term survival mirroring that of the general population.

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.