Reduction of Major Amputations after Surgery versus Endovascular Intervention: The BEST-CLI Randomised Trial.

OBJECTIVE: BEST-CLI, an international randomised trial, compared an initial strategy of bypass surgery with endovascular treatment in chronic limb threatening ischaemia (CLTI). In this substudy, overall amputation rates and risk of major amputation as an initial or subsequent outcome were evaluated. METHODS: A total of 1 830 patients were randomised to receive surgical or endovascular treatment in two parallel cohorts: patients with adequate single segment great saphenous vein (SSGSV) (n = 1 434) were assigned to cohort 1; and patients without adequate SSGSV (n = 396) were assigned to cohort 2. Differences in time to first event and number of amputations were evaluated. RESULTS: In cohort 1, there were 410 (45.6%) total amputation events in the surgical group vs. 490 (54.4%) in the endovascular group (p = .001) during a mean follow up of 2.7 years. Approximately one in three patients underwent minor amputation after index revascularisation: 31.5% of the surgical group vs. 34.9% in the endovascular group (p = .17). Subsequent major amputation was required significantly less often in the surgical group compared with the endovascular group (15.0% vs. 25.6%; p = .002). The first amputation was major in 5.6% of patients in the surgical group and 6.0% in the endovascular group (p = .72). Major amputation was required in 10.3% (74/718) of patients in the surgical group and 14.9% (107/716) in the endovascular group (p = .008). In cohort 2, there were 199 amputation events in 132 patients (33.3%) during a mean follow up of 1.6 years: 95 (47.7%) in the surgical group vs. 104 (52.3%) in the endovascular group (p = .49). Major amputation was required in 15.2% (30/197) of patients in the surgical group and 14.1% (28/199) in the endovascular group (p = .74). CONCLUSION: In patients with CLTI, surgical bypass with SSGSV was more effective than endovascular treatment in preventing major amputations, mainly due to a decrease in major amputations subsequent to minor amputations.

The Order of Operative Repair Does Not Influence Outcomes in Patients with Concomitant Popliteal Artery and Orthopedic Injuries.

BACKGROUND: The most challenging lower extremity traumatic injuries involve concomitant vascular and orthopedic injuries with amputation rates approaching 50%. Controversy exists as to how to prioritize the vascular and orthopedic repairs. We reviewed patients with popliteal artery and lower extremity orthopedic injuries to analyze the sequence of the vascular and orthopedic repairs on outcomes. METHODS: All adult patients with a diagnosis of concomitant popliteal artery and lower extremity fracture or dislocation were identified through a review of an institutional trauma registry performed at a level 1 trauma center from 2014 to 2019. Patient demographics, timing of presentation, injury severity score (ISS), surgical interventions, and limb outcome data were collected and examined. The sequence of operative repairs and factors influencing the operative order were analyzed. RESULTS: Twenty-nine patients were treated for popliteal artery injuries. Twelve of these 29 patients had concomitant popliteal artery and orthopedic fractures requiring surgical repair. Injury mechanisms included both blunt (50%, 6/12) and penetrating trauma (50%, 6/12); the majority involved femur fractures (58%, 7/12). Vascular repair included arterial bypass (75%, 9/12) or interposition grafts (25%, 3/12). Orthopedic repair included external fixation (83%, 10/12) and open reduction internal fixation (17%, 2/12). Vascular repair was performed first in 7/12 limbs (58%). Patients having vascular repair first had a trend toward lower blood pressure on arrival (P = 0.068). There was no significant difference in emergency department to operating room (OR) time, OR time, ISS, mangled extremity severity score, estimated blood loss, or blood transfusion for the sequence of operative repair. Fasciotomy was nearly ubiquitous, present in 11/12 patients (92%). There were no graft complications related to orthopedic manipulation, and there were no reported limb-length to graft-length discrepancies. Early limb salvage trended lower in the cohort with revascularization first (71% vs. 100%, P = 0.19). Of the remaining limbs available for follow-up, limb salvage at 4.25 years is 100%. CONCLUSIONS: In this small study of patients with concomitant lower extremity popliteal artery and orthopedic injuries, the order of operative repair does not appear to influence the success of revascularization.

Contemporary outcomes of concomitant suprainguinal bypass with infrainguinal revascularization procedures in patients with chronic limb-threatening ischemia.

OBJECTIVE: Combined suprainguinal and infrainguinal revascularization is sometimes necessary in the treatment of patients with chronic limb-threatening ischemia (CLTI). However, data on outcomes of concomitant revascularization procedures are lacking. We studied the outcomes of patients with CLTI who underwent suprainguinal bypass (SIB) alone, SIB with concomitant infrainguinal bypass (IIB), and SIB with concomitant infrainguinal peripheral endovascular intervention (IIPVI). METHODS: We reviewed all patients in the Vascular Quality Initiative with CLTI who underwent SIB from January 2010 to June 2020. Logistic regression, Kaplan-Meier survival estimates, log-rank tests, and Cox regression were used to analyze outcomes. Outcomes were 30-day mortality, perioperative myocardial infarction, perioperative major amputation, 1-year amputation-free survival, and 5-year survival. RESULTS: Of 8037 patients included, 81.3% (n = 6537) underwent SIB alone, 9.7% (n = 783) underwent SIB+IIB, and 8.9% (n = 717) underwent SIB+IIPVI. The indication for surgery was rest pain in 5040 (62.5%) and tissue loss in 3031 (37.6%). There were no significant differences in 30-day mortality and perioperative myocardial infarction rates. However, there was 2.8-fold increased odds of perioperative major amputation in both SIB+IIPVI (odds ratio [OR], 2.76; 95% confidence interval [CI], 1.30-5.88; P = .008) and SIB+IIB (OR, 2.79; 95% CI, 1.38-5.54; P = .004) among patients with rest pain as compared with SIB alone. Comparing SIB+IIPVI with SIB alone, there were no significant differences in 1-year freedom from amputation and amputation-free survival. SIB+IIPVI was associated with a 27% increased risk of 5-year mortality (hazard ratio [HR], 1.27; 95% CI, 1.03-1.55; P = .035). Compared with SIB alone, SIB+IIB was associated with 97% increased risk of 1-year major amputation among patients with rest pain (HR, 1.97; 95% CI, 1.06-3.69; P = .033), but a 47% decreased risk of 1-year major amputation or death for patients with tissue loss (HR, 0.53; 95% CI, 0.37-0.78; P = .001). SIB+IIPVI, compared with SIB+IIB, was associated with a two-fold increased risk of 1-year major amputation or death (HR, 2.04; 95% CI, 1.04-2.23), P = .003) and a 52% increased risk of 5-year mortality (HR,1.52; 95% CI, 1.04-2.24; P = .032) among patients with tissue loss. CONCLUSIONS: This study shows that SIB with concomitant infrainguinal revascularization in patients with rest pain is associated with an increased risk of amputation, whereas SIB+IIB in patients with tissue loss is associated with decreased risk of amputation or death. SIB+IIB outperformed SIB+IIPVI in patients with tissue loss. SIB with infrainguinal revascularization should be limited in patients with rest pain in line with current guidelines, but SIB+IIB may be preferred in patients with tissue loss.

Carotid lesion length independently predicts stroke and death after transcarotid artery revascularization and transfemoral carotid artery stenting.

OBJECTIVES: Prior data from the Carotid Revascularization Endarterectomy vs Stenting Trial suggested that the higher perioperative stroke or death event rate among patients treated with transfemoral carotid artery stenting (TFCAS) appears to be strongly related to the lesion length. Nonetheless, data regarding the impact of lesion length on outcomes of transcarotid artery revascularization (TCAR) with flow reversal are lacking. Herein, we aimed to compare the outcomes of TCAR vs TFCAS stratified by the length of the carotid lesion. METHODS: Our cohort was derived from the Vascular Quality Initiative database for carotid artery stenting between 2016 and 2021. Restricted cubic spline analysis was used to describe the relationship between the primary outcome (in-hospital stroke/death) and the exposure variable (lesion length) in the overall cohort. This relationship was not linear, and knots were identified where significant changes in the slope of the curve occurred. We therefore divided patients based on knot with the most significant inflection into two groups: lesion length <25 mm (short) and lesion length ≥25 mm. Clinically relevant and statistically significant variables on univariable analysis were added to the final logistic regression model clustered by center identifier to study the association between lesion length and in-hospital outcomes stratified by the stent approach. RESULTS: The study cohort included 17,931 TCAR (52.6% with long lesions) and 12,036 TFCAS (53.2% with long lesions) patients. Patients with long lesions had higher rates of being symptomatic among both TCAR (27.2% vs 24.3%, P < .001) and TFCAS (43.5% vs 38.5%, P < .001) and were more likely to undergo general anesthesia in TCAR (84.7% vs 81.9%, P < .001) and TFCAS (21.6% vs 15.8%, P < .001). After adjusting for potential confounders, long carotid lesions were associated with higher odds of stroke, stroke/transient ischemic attack (TIA), and stroke/death compared with short lesions among patients who underwent TCAR or TFCAS. However, when comparing TCAR vs TFCAS outcomes in patients with long lesions, TCAR was found to be associated with a 30% reduction in stroke/TIA (adjusted odds ratio [aOR]: 0.7, 95% confidence interval [CI]: 0.6-0.9, P = .015), stroke (aOR: 0.7, 95% CI: 0.5-0.9, P = .009), and extended length of stay (ELOS) (aOR: 0.7, 95% CI: 0.6-0.8, P < .001). There was also a 40% reduction in the odds of in-hospital stroke/death (aOR: 0.6, 95% CI: 0.5-0.8, P < .001) and a 70% reduction in mortality (aOR: 0.3, 95% CI: 0.2-0.4, P < .001) in TCAR compared with TFCAS. CONCLUSIONS: In this large contemporary retrospective national study, carotid lesion length appears to negatively impact in-hospital outcomes for TCAR and TFCAS. In the presence of lesions longer than 25 mm, TCAR appears to be safer than TFCAS with regard to the risk of in-hospital stroke, stroke/TIA, death, stroke/death, and ELOS. These favorable outcomes seem to confirm the relative advantage of flow reversal compared with distal embolic protection devices in terms of neuroprotection.

A single center's 15-year experience with palliative limb care for chronic limb threatening ischemia in frail patients.

OBJECTIVE: Our institution's multidisciplinary Prevention of Amputation in Veterans Everywhere (PAVE) program allocates veterans with critical limb threatening ischemia (CLTI) to immediate revascularization, conservative care, primary amputation, or palliative limb care according to previously reported criteria. These four groups align with the approaches outlined by the global guidelines for the management of CLTI. In the present study, we have delineated the natural history of the palliative limb care group of patients and quantified the procedural risks and outcomes. METHODS: Veterans prospectively enrolled into the palliative limb cohort of our PAVE program from January 2005 to January 2020 were analyzed. The primary outcome was mortality. The secondary outcomes included overall and limb-related readmissions, limb loss, and wound healing. The clinical frailty scale (CFS) score was calculated, and the 5-year expected mortality was estimated using the Veterans Affairs Quality Enhancement Research Initiative tool. Regression analysis was performed to establish associations among the following variables: mortality, wound, ischemia, and foot infection (WIfI) score, CFS score, overall admissions, and limb-related admissions. RESULTS: The PAVE program enrolled 1158 limbs during 15 years. Of the 1158 limbs, 157 (13.5%) in 145 patients were allocated to the palliative limb care group. The overall mortality of the group was 88.2% (median interval, 3.5 months; range, 0-91 months). Of the 128 patients who had died, 64 (50%) had died within 3 months of enrollment. The predicted 5-year mortality for the group was 66%. The average CFS score for the group was 6.2, denoting persons moderately to severely frail. Using the CFS score, 106 patients were considered frail and 39 were considered not frail. No differences were found in mortality between the frail and nonfrail patients. However, a statistically significant difference was found in early (<3 months) mortality (56.2% vs 37.5%; P = .032). The 30-day limb-related readmission rate was 4.7%. Eventual major amputation was necessary for 18 limbs (11.5%). Wound healing occurred in 30 patients (20.6%). Regression analysis demonstrated no association between the CFS score and mortality (r = 0.55; P = .159) or between the WIfI score and mortality (r = 0.0165; P = .98). However, a significant association was found between the WIfI score and limb-related admissions (r = 0.97; P < .001). CONCLUSIONS: Frail patients with CLTI had high early mortality and a low risk of limb-related complications. They also had a low incidence of deferred primary amputation or limb-related readmissions. In our cohort, the vast majority of patients had died within a few months of enrollment without requiring an amputation. A comprehensive approach to the treatment of CLTI patients should include a palliative limb care option because a significant proportion of these patients will have limited survival and can potentially avoid unnecessary surgery and major amputation.

Pediatric Renal Artery Stenosis: A 19-Year Experience in Management and Outcomes at a Tertiary Pediatric Hospital.

BACKGROUND: Renal artery stenosis (RAS) is an uncommon cause of pediatric hypertension. Guidelines for workup and management have not been established. The most widely reported etiology of the pediatric renovascular disease has been fibromuscular dysplasia; however, other etiologies including middle aortic syndrome (MAS) and vasculitides have been described. We reviewed cases of radiologically identified pediatric RAS and describe etiologies, management, and long-term clinical outcomes in our patients. METHODS: Reports for duplex ultrasound, computed tomography angiography, magnetic resonance imaging, and conventional angiography from an academic children's hospital between 2000 and 2019 were evaluated. Positive reports for RAS were confirmed by a vascular surgeon and a radiologist. Demographics, indications for evaluation, management, and long-term clinical outcomes were documented. Data are summarized as count (n), geometric mean, median, or standard deviation as appropriate. Univariate differences between treatment cohorts were analyzed using Chi-squared tests for categorical variables. Nonparametric paired Wilcoxon signed-rank test and Mann-Whitney U-test were used for the analysis of paired ordinal or continuous data. A statistical analysis was performed with SPSS software (SPSS Inc., Chicago, IL) with significance defined at a P < 0.05 level. RESULTS: Imaging for suspected RAS was performed on 984 children. Of the 38 patients with positive imaging for RAS, 60.5% were idiopathic, 31.5% (n = 12) had concomitant congenital/systemic comorbidity, and 21.0% (n = 8) had RAS and concomitant aortic pathology. Fibromuscular dysplasia only accounted for 13.2% (n = 5) of patients. Regarding management, 34.2% (n = 13) underwent invasive intervention, 23.7% (n = 9) underwent endovascular intervention alone, and 10.5% (n = 4) underwent endovascular plus surgical intervention. Conservative management was performed for 65.8% (n = 25) of patients at a long-term follow-up (33.8 months), 34.2% (n = 13) requiring only lifestyle changes, and 31.6% (n = 12) requiring only medical management. CONCLUSIONS: Pediatric RAS is a low-frequency disease and long-term outcomes have been under-reported. The incidence of associated aortic pathology in our intervention cohort appears higher than that was previously reported. A long-term follow-up demonstrated that up to 65.8% of patients could be managed successfully with conservative therapy.

Trends in Preoperative Imaging Prior to Elective Carotid Endarterectomy in the Southern California Vascular Outcomes Improvement Collaborative.

BACKGROUND: Duplex ultrasound (DUS) has been an important imaging modality for carotid bifurcation disease due to its low cost and noninvasive nature. Over the past decade, computed tomography angiography (CTA) has replaced conventional angiography (CA) due to safety and availability. There are significant differences in cost and patient exposures between CTA and DUS. The objective of this study is to analyze the trends in preoperative imaging modalities in the Southern California region for elective carotid endarterectomies (CEA). METHODS: A retrospective review of the Southern California Vascular Outcomes Improvement Collaborative (SoCal VOICe) was performed. All elective CEA procedures were identified from January 2011 through May 2020. Data included all preoperative imaging modalities used. An analysis was performed of the types and numbers of studies obtained. The trends in the usage of single and multiple preoperative studies and the trends in use of DUS versus CTA were analyzed. RESULTS: From January 2011 to May 2020, 2,519 elective CEAs were entered into the regional database. Of the 2,336 eligible cases (183 excluded due to incomplete data), 38% were for symptomatic (Sx) and 62% for asymptomatic (ASx) carotid disease. Preoperative imaging studies ordered included 56% DUS, 28% CTA, 6% magnetic resonance angiography, and 10% CA. Single imaging studies were used in 56.3% of cases, 2 studies in 40.4%, and >2 studies in 3.3%. A majority of both Sx and ASx patients undergoing elective CEA had only a single preoperative imaging study. ASx patients were more likely to have a single study than Sx patients (P = 0.0054). DUS was the most frequent single study ordered in both Sx and ASx patients, 37.4% and 41.4%, respectively. The trend over time shows a decreasing use of DUS and an increasing use of CTA for both Sx and ASx patients. In 2020, CTA overtook duplex as the most frequently ordered study for Sx patients. The average number of imaging studies per procedure per year for both Sx and ASx patients has not changed substantially at approximately 1.5 studies. In addition, the overall trend shows that although a single preoperative study was more common than 2 or more studies for elective CEA, single studies were more common for ASx patients, whereas the use of 2 or more studies was more common for Sx patients. The overall trend among three different time periods, 2011-2013, 2014-2016, and 2017-2020 shows that for both Sx and ASx patients, the use of single DUS studies has decreased over time (P < 0.001), whereas the use of single CTA studies has increased over time (P < 0.001). The use of CTA varied widely by a study center ranging from 12-53% for Sx and 10.5-75% for ASx patients. CONCLUSIONS: Over the past decade, most patients undergoing elective CEA in the SoCal VOICe had only a single preoperative imaging study with DUS as the most frequent sole study in both Sx and ASx patients. However, as a single study, CTA is becoming more frequently used than DUS. Further investigation into the variation in practice may help standardize imaging prior to CEA and control healthcare costs.

Analysis of Traumatic Axillo-Subclavian Vessel Injuries: Endovascular Management is a Viable Option to Open Surgical Reconstruction.

BACKGROUND: In traumatic axillo-subclavian vessel injuries, endovascular repair has been increasingly described, despite ongoing questions regarding infection risk and long-term durability. We sought to compare the clinical and safety outcomes between endovascular and surgical treatment of traumatic axillo-subclavian vessel injuries. METHOD: A search query of the prospectively maintained PROOVIT registry for patients older than 18 years of age with a diagnosis of axillary or subclavian vessel injury between 2014-2019 was performed at a Level 1 Trauma Center. Patient demographics, severity of injury, Mangled Extremity Severity Score (MESS), Injury Severity Score (ISS), procedural interventions, complications, and patency outcomes were collected and analyzed. RESULTS: Twenty-three patients with traumatic axillo-subclavian vessel injuries were included. There were similar rates of penetrating and blunt injuries (48% vs. 52%, respectively). Eighteen patients (78%) underwent intervention: 11 underwent endovascular stenting or diagnostic angiography; 7 underwent open surgical repair. There was similar severity of arterial injuries between the endovascular and open surgical groups: transection (30% vs. 40%, respectively), occlusion (30% vs. 40%, respectively). The open surgical group had worse initial clinical comorbidities: higher ISS scores (17.0 vs 13.5, p = 0.034), higher median MESS scores (6 vs. 3.5, P = 0.001). The technical success for the endovascular group was 100%. The endovascular group had a lower estimated procedural blood loss (27.5 mL vs. 624 mL, P = 0.03). The endovascular arterial group trended toward a shorter length of hospital stay (5.6 days vs. 27.6 days, P = 0.09) and slightly reduced procedural time (191.0 min vs. 223.5 min, P = 0.165). Regarding imaging follow up (average of 60 days post-discharge), 7 patients (54%) underwent surveillance imaging (5 with duplex ultrasound, 2 with computed tomography angiography CTA) that demonstrated 100% patency. Regardless of ISS or MESS scores, at long term clinical follow up (average of 214 days), there were no limb losses, graft infections or vascular complications in either the endovascular or open surgical group. CONCLUSIONS: Endovascular treatment is a viable option for axillo-subclavian vessel injuries. Preliminary results demonstrate that endovascular treatment, when compared to open surgical repair, can have similar rates of technical success and long-term outcomes in patency, infection and vascular complications.

Conservative Management of Non-Infected Diabetic Foot Ulcers Achieves Reliable Wound Healing and Limb Salvage in the Setting of Mild-Moderate Ischemia.

BACKGROUND: The Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system has been validated to predict wound healing among patients with critical limb threatening ischemia (CLTI). Our goal was to analyze the use of a previously reported conservative wound care approach to non-infected (foot infection score of zero), diabetic foot ulcers with mild-moderate peripheral arterial disease enrolled in a conservative tier of a multidisciplinary limb preservation program. METHODS: Veterans with CLTI and tissue loss were prospectively enrolled into our Prevention of Amputation in Veterans Everywhere (PAVE) program. All patients with wounds were stratified to a conservative approach based on perfusion evaluation and a validated pathway of care. Retrospective analysis of a prospectively maintained database was performed to evaluate all conservatively managed patients presenting without foot infection for the primary outcome of wound healing as well as secondary outcomes of time to wound healing, delayed revascularization, wound recurrence, and limb loss. RESULTS: Between January 2006 and December 2019, 1113 patients were prospectively enrolled into the PAVE program. A total of 241 limbs with 281 wounds (217 patients) were stratified to the conservative approach. Of these, 122 limbs (89 patients) met criteria of having diabetic foot wounds without infection at the time of enrollment and are analyzed in this report. Of the 122 limbs, 97 (79.5%) healed their index wound with a mean time to healing of 4.6 months (0.5-20 months). Wound recurrence ensued in 44 (45.4%) limbs, 93.2% of which healed again after recurrence. There were three (3.1%) limbs requiring major amputation in this group (one due to uncontrolled infection and two due to ischemic tissue loss). Of the 25 (20.5%) limbs that did not heal initially, four (16%) required amputation due to progressive symptoms of CLTI. CONCLUSIONS: In patients with diabetes and lower extremity wounds without infection in the setting of mild to moderate peripheral arterial disease, there appears to be an acceptable rate of index wound healing, and appropriate rate of recurrent wound healing with a low risk of limb loss. While wound recurrence is frequent, this can be successfully treated without the need for revascularization.

Risk of renal failure and death when renal arteries are involved in endovascular aortic aneurysm repair.

OBJECTIVE: Endovascular abdominal aortic repair can involve the incorporation of renal arteries. Revascularization after intentional or unintentional renal artery (RA) coverage is not always technically successful, and the loss of a single RA may result in the need for postoperative dialysis. Thus, we compared the outcomes after endovascular aneurysm repair (EVAR) stratified by RA involvement (RAI). METHODS: Patient data from the Vascular Quality Initiative from 2009 to 2018 registry were analyzed. The exclusion criteria were preoperative dialysis, missing RAI data, and repair above the superior mesenteric artery. The repair type cohorts were defined as (1) no RAI (NRAI), (2) RAI with revascularization (RAI-R), and (3) RAI with no revascularization (RAI-NR). A sensitivity analysis was performed by excluding ruptured presentations. The primary outcome was the need for postoperative dialysis. The secondary outcomes were 30-day mortality, dialysis at follow-up, postoperative renal function, and 2-year survival. Multivariate analysis was used to determine the independent predictors for postoperative dialysis. The 2-year survival analysis was performed using Kaplan-Meier log-rank test. RESULTS: Of 54,020 patients in the EVAR and TEVAR (thoracic EVAR)/complex EVAR modules in the Vascular Quality Initiative, 25,724 met the criteria for inclusion (NRAI, n = 24,879; RAI-R, n = 733; RAI-NR, n = 112). The demographics and comorbidities were similar among the three groups. The RAI-NR group had more frequently had ruptured or symptomatic aneurysms. The postoperative dialysis requirement was higher in the RAI-NR group (NRAI, 0.7%; RAI-R, 2.2%; RAI-NR, 17%; P < .0001), as were the 30-day mortality and dialysis requirement at follow-up. On multivariate analysis, RAI-R (odds ratio [OR], 2.2; P = .03) and RAI-NR (OR, 5.9; P < .0001) were independent predictors of postoperative dialysis and remained so after excluding ruptured presentations (RAI-R: OR, 3; P = .003; RAI-NR: OR, 22.3; P < .0001). Other independent predictors of the need for postoperative dialysis were worse preoperative renal function, a symptomatic presentation, any preoperative or intraoperative blood transfusion, and larger blood loss (≥200 mL). Excluding those with rupture, the overall survival at 2 years on Kaplan-Meier analysis was lower for the RAI-NR group (NRAI, 92%; RAI-R, 89%; RAI-NR, 80%; P = .004). CONCLUSIONS: RAI is highly predictive of the need for postoperative and permanent dialysis after EVAR. RAI-NR was associated with lower overall survival. These risks should be considered when planning and performing EVAR and should be weighed against the risks of open repair when considering the treatment options.

First Reported Case of Neointimal Hyperplasia in the Midportion of a Polytetrafluoroethylene Dialysis Graft.

We report a case of stenosis involving the midportion of a polytetrafluoroethylene graft caused by the infiltration of fibroblasts into the lumen of the graft with the development of fibrovascular tissue.

Multidisciplinary approach achieves limb salvage without revascularization in patients with mild to moderate ischemia and tissue loss.

OBJECTIVE: The Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system has been validated to predict wound healing and limb salvage of patients with peripheral artery disease (PAD). Our goal was to evaluate the association between WIfI stage and wound healing, limb salvage, and survival in a select cohort of patients with PAD and tissue loss undergoing an attempt of wound healing without immediate revascularization (conservative approach) in a multidisciplinary wound program. METHODS: Veterans with PAD and tissue loss were prospectively enrolled in our Prevention of Amputation in Veterans Everywhere (PAVE) program. Limbs were stratified to a conservative, revascularization, primary amputation, and palliative limb care approach based on the patient's fitness, ambulatory status, perfusion evaluation, and validated pathway of care. Rates of wound healing, wound recurrence, limb salvage, and survival were retrospectively analyzed by WIfI clinical stages (stage 1-4) in the conservative group. Cox regression modeling was used to estimate clinical outcomes by WIfI stage. RESULTS: Between January 2006 and October 2017, there were 961 limbs prospectively enrolled in our PAVE program. A total of 233 limbs with 277 wounds were stratified to the conservative approach. WIfI staging distribution included 19.7% stage 1, 20.2% stage 2, 38.6% stage 3, and 21.5% stage 4. All ischemia scores were classified as 1 or 2. Advanced wound interventions and minor amputations were performed on 40 limbs (16.6%) and 57 limbs (23.7%), respectively. Average long-term follow-up was 41.4 ± 29.0 months. Complete wound healing without revascularization was achieved in 179 limbs (76.8%) during 4.4 ± 4.1 months. Thirty-four limbs (14%) underwent deferred revascularization because of a lack of complete wound healing. At long-term follow-up, wound recurrence per limb was 39%. Overall limb salvage at long-term follow-up was 89.3%. Stratified by WIfI stage, there was no statistically significant difference between groups for wound healing (P = .64), wound recurrence (P = .55), or limb salvage (P = .66) after adjustment for significant patient, limb, and wound characteristics. CONCLUSIONS: In select patients with mild to moderate ischemia and tissue loss, a stratified approach can achieve acceptable rates of wound healing and limb salvage, with limited need for deferred revascularization. WIfI clinical staging did not predict wound healing, limb salvage, or survival in this cohort.

A conservative approach to select patients with ischemic wounds is safe and effective in the setting of deferred revascularization.

OBJECTIVE: The Wound, Ischemia, and foot Infection classification system has been validated to predict benefit from inmediate revascularization and major amputation risk among patients with peripheral arterial disease. Our primary goal was to evaluate wound healing, limb salvage, and survival among patients with ischemic wounds undergoing revascularization when intervention was deferred by a trial of conservative wound therapy. METHODS: All patients with peripheral arterial disease and tissue loss are prospectively enrolled into our Prevention of Amputation in Veterans Everywhere limb preservation program. Limbs are stratified into a validated pathway of care based on predetermined criteria (immediate revascularization, conservative treatment, primary amputation, and palliative care). Limbs allocated to the conservative strategy that failed to demonstrate adequate wound healing and were candidates, underwent deferred revascularization. Rates of wound healing, freedom from major amputation, and survival were compared between patients who underwent deferred revascularization with those who received immediate revascularization by univariate and multivariate analysis. RESULTS: Between January 2008 and December 2017, 855 limbs were prospectively enrolled into the Prevention of Amputation in Veterans Everywhere program. A total of 203 limbs underwent immediate revascularization. Of 236 limbs stratified to a conservative approach, 185 (78.4%) healed and 33 (14.0%) underwent deferred revascularization (mean, 2.7 ± 2.6 months). The mean long-term follow-up was 51.7 ± 37.0 months. Deferred compared with immediate revascularization demonstrated similar rates of wound healing (66.7% vs 57.6%; P = .33), freedom from major amputation (81.8% vs 74.9%; P = .39), and survival (54.5% vs 50.7%; P = .69). After adjustment for overall Wound, Ischemia, and foot Infection stratification stages, deferred revascularization remained similar to immediate revascularization for wound healing (hazard ratio [HR], 1.5; 95% confidence interval [CI], 0.7-3.2), freedom from major amputation (HR, 0.7; 95% CI, 0.3-1.7) and survival (HR, 1.2; 95% CI, 0.6-2.4). CONCLUSIONS: Limbs with mild to moderate ischemia that fail a trial of conservative wound therapy and undergo deferred revascularization achieve similar rates of wound healing, limb salvage, and survival compared with limbs undergoing immediate revascularization. A stratified approach to critical limb ischemia is safe and can avoid unnecessary procedures in selected patients.

Native Microchannel Recanalization with Orbital Atherectomy as a Viable Alternative to Failed Standard Recanalization of TASC II D Aortoiliac Occlusive Disease.

BACKGROUND: Endovascular treatment of Trans-Atlantic Inter-Society Consensus (TASC) II D aortoiliac lesions is now an accepted form of revascularization. We sought to demonstrate that native microchannel recanalization and orbital atherectomy is a successful recanalization method of TASC II D aortoiliac lesions refractory to standard recanalization techniques. METHODS: Four consecutive patients from 2016 to 2018 with symptomatic TASC II D aortoiliac occlusive disease prohibitive for open bypass and failed traditional prodding guidewire or device recanalization technique were identified and underwent advanced native microchannel selection and subsequent orbital atherectomy (Cardiovascular Systems, Inc, St Paul, MN). Native microchannels of the calcified lesions were probed and traversed with a 0.014″ wire. The atherectomy crown was tracked over the wire, and orbital atherectomy was initiated with a 1.25 mm crown starting at the lowest revolution and continued until the microchannel is sufficiently large to track a 1.2 mm-balloon for angioplasty. Serial microchannel angioplasty with exchange for stiffer and/or larger profile wires and balloons was achieved until a covered stent could be safely deployed across the target lesion. The kissing stent technique was then used to recreate the aortic bifurcation. A ViperSlide lubricant solution was used in all cases per indication for use. Patients were all heparinized to maintain an activated clotting time of 250. Lesion characteristics, survival, limb salvage, patency, and change in clinical symptoms were also analyzed. RESULTS: All 4 patients underwent successful native microchannel recanalization and orbital atherectomy of the common iliac artery (CIA). There were no intraoperative ruptures, embolizations, or dissections. All 4 patients presented with unilateral CIA occlusion with contralateral CIA stenosis. The average occlusion lesion length of the CIA was 6.0 cm. The average contralateral stenosis length was 2.3 cm. The kissing stent technique was used in all patients for reconstruction of the aortic bifurcation. At 30 days, all patients had improvement in pain and primary patency of 100%. Long-term follow-up at 21.6 months noted continued improvement in symptoms and primary patency of 75%. The fourth patient died at 4 months from lung cancer with occluded iliac stents by imaging at that time. CONCLUSIONS: Native microchannel recanalization with subsequent orbital atherectomy is an option in high-risk patients with TASC II D aortoiliac disease who have failed traditional recanalization techniques. Further work in proper patient selection and safe utilization of atherectomy devices in the CIA is needed.

Immediate Carotid Endarterectomy Is Associated with Higher Risk in Symptomatic Patients.

BACKGROUND: Guidelines recommend that patients with carotid artery stenosis ≥50% (Sx-CAS) undergo carotid endarterectomy (CEA) within 14 days of symptoms. However, perioperative risks, especially stroke, may be increased when CEA is performed within 48 hours. This study seeks to more fully evaluate the effect of timing of surgery on outcomes for Sx-CAS. METHODS: All CEAs in the Southern California Vascular Outcomes Improvement Collaborative (SoCal VOICe) from 2012 to 18 were reviewed. Ipsilateral cortical or visual symptoms within 6 months defined Sx-CAS. Timing from symptom occurrence to CEA was classified as immediate (0-2 days), early (3-14 days), or delayed (>14 days). Perioperative stroke, myocardial infarction (MI), and 30-day mortality rates were compared by time to surgery. RESULTS: Of 2203 CEAs, 436 (20%) were for Sx-CAS (52% stroke, 48% transient ischemic attack). Mean time from symptoms to CEA was 28.3 days (range, 0-172; median, 14 days). Sixty-one cases (14%) were immediate, 166 (38%) early, and 209 (48%) delayed. Perioperative stroke occurred in 2.8% and stroke/MI/30-day mortality in 5.7%. Stroke rate was significantly higher in the immediate group (vs. early and delayed): 8.2%, versus 3.0%, and 0.96%, respectively (P = 0.009). Stroke/MI/30-day mortality was also higher in the immediate group: 13.1%, versus 6.0%, and 3.3%, respectively (P = 0.001). Immediate surgery was associated with greater postoperative events (P = 0.009), and logistic regression confirmed decreased risk of postoperative stroke and stroke/MI/30-day mortality in delayed surgery using immediate surgery as a reference. Wide variability existed among centers in the timing of CEA (immediate-range, 0-50%; delayed-range, 41-83%; P = 0.01). CONCLUSIONS: In the SoCal VOICe, 52% of patients undergo CEA within 2 weeks of symptoms. Increased stroke rates occur when CEA is performed within 2 days, whereas stroke and death rates are decreased at 3-14 days and beyond. These data support avoidance of immediate CEA. Opportunity exists to standardize timing of CEA for Sx-CAS among SoCal VOICe participants. Further study is required to define the role of immediate CEA.

Analysis of Subjective and Objective Screening Techniques as Predictors of Safety for Radial Artery Intervention.

BACKGROUND: There is no currently accepted standard in safety evaluation for radial artery intervention. We sought to compare the accuracy of various subjective and objective screening techniques in predicting safety for radial artery intervention. METHODS: Fifty-four patients in a prospective cohort study at a single institution underwent subjective Allen's test, objective Barbeau test, and several objective hand ultrasound techniques to assess safety for radial artery intervention. These results were then compared to the gold standard of conventional hand angiography to document complete palmar arch. Statistical analysis including sensitivity, specificity, positive predictive values, negative predictive values, and accuracy were calculated. RESULTS: Compared to hand angiography, the subjective Allen's test and the objective Princeps Pollicis Artery ultrasound demonstrated the comparable levels of sensitivity (100% vs. 96.7%, respectively), specificity (100% vs. 100%, respectively), and accuracy (97.2% vs. 97.1%, respectively). The objective Barbeau test demonstrated similar results (sensitivity of 100%, accuracy of 98.2%) with the exception of a lower specificity (50%). CONCLUSIONS: There is no currently accepted standard in safety evaluation for radial artery intervention. However, preliminary data suggest that certain subjective and objective techniques such as Allen's testing, Princeps Pollicis artery ultrasound, and Barbeau testing are comparable options in predicting palmar arch patency.

Trans-Atlantic Inter-Society Consensus Class D Aortoiliac Lesions: A Comparison of Endovascular and Open Surgical Outcomes.

OBJECTIVE. The purpose of this study is to compare the clinical and safety outcomes between two groups of patients with Trans-Atlantic Inter-Society Consensus class D (TASC II D) aortoiliac occlusive disease (AIOD): those with higher-risk comorbidity who underwent endovascular reconstruction and those with lower-risk comorbidity who underwent surgical bypass. MATERIALS AND METHODS. Thirty-two consecutive patients with symptomatic TASC II D AOID who underwent surgical bypass or endovascular reconstruction from 2012 to 2017 were retrospectively reviewed. Lesion characteristics, technical approach, survival, limb salvage, patency, and change in clinical symptoms were analyzed. RESULTS. Nineteen patients with higher comorbidity underwent endovascular reconstruction, whereas 13 patients with lower comorbidity underwent surgical bypass. Patients undergoing endovascular reconstruction had an older median age (67.0 vs 62.0 years; p = 0.007), higher rates of hypertension (94.7% vs 61.5%; p = 0.018) and coronary artery disease (26.3% vs 0%; p = 0.044), and advanced renal impairment (mean [± SD] chronic kidney disease stage, 1.4 ± 1.5 vs 0.7 ± 1.3; p = 0.005). There were no significant differences in Rutherford classification between the groups. During long-term follow-up of 2.76 years, endovascular reconstruction and surgical bypass showed equivalent rates of survival (89.5% vs 84.6%; p = 0.683), limb salvage (100.0% vs 92.3%; p = 0.219), and primary or primary-assisted patency (85% vs 85%; p = 0.98). Groups showed similar clinical improvements in walking distance, rest pain, and tissue loss at 30 days (95% vs 85%; p = 0.158) and at long-term follow-up (74% vs 62%; p = 0.599). CONCLUSION. For properly selected patients, the clinical outcomes of endovascular reconstruction versus surgical bypass for TASC II D AOID may be equivalent at 2.5 years after the procedure. The decreased operative risk associated with endovascular reconstruction suggests that it is the technique of choice for high-risk patients.

Debranching of Supra-aortic Vessels via Femoral Artery Inflow for Late Ascending Aortic Rupture.

A 56-year-old man with a history of Marfan's syndrome, total arch replacement, descending thoracic endovascular aortic repair, and twice redo sternotomy for pseudoaneurysm repair, presented with a pulsatile chest mass secondary to a contained rupture of the ascending aorta. The patient underwent supra-aortic debranching via the superficial femoral artery and ascending thoracic stent-graft placement under continuous transesophageal echocardiography. Completion angiography demonstrated successful exclusion of the contained rupture. Postoperatively, the patient was neurologically intact, the pulsatile mass resolved, and the bypass grafts remained patent. Chronic respiratory failure and multidrug-resistant pneumonia led to late mortality. This case demonstrates that hybrid repair is effective in the emergent setting of ascending aortic rupture. Debranching of the ascending arch using the superficial femoral artery as inflow is feasible and provides adequate cerebral perfusion despite the length of the bypass. The use of transesophageal echocardiography during stent-graft deployment allows precise device placement in the high-risk area of the ascending aorta proximal to the innominate artery.

Early Surgical Referral for Penetrating Aortic Ulcer Leads to Improved Outcome and Overall Survival.

BACKGROUND: The natural history of penetrating aortic ulcer (PAU) has been variably described and clear guidelines are lacking. We reviewed our experience with PAUs in a tertiary referral center. METHODS: Imaging reports from January 2010 to December 2017 were retrospectively searched for the diagnosis of "penetrating aortic ulcer." Diagnosis was confirmed by review of imaging studies. Patient demographics, presenting symptoms, and anatomic characteristics were collected and analyzed for associations with need for surgical intervention, aortic complication, and overall survival. RESULTS: One hundred six patients with PAU were identified. Locations included 57 (53.8%) aortic arch, 24 (22.6%) descending thoracic, and 25 (23.5%) abdominal aorta. Dissection was present in 12 (11.4%) and acute rupture in 4 (3.8%) cases. At presentation, 57 (53.8%) patients were symptomatic. Forty-six (43.8%) patients were evaluated by cardiothoracic or vascular surgeons. Thirteen (12.3%) underwent surgical or endovascular repair and 10 (10.4%) had a change in medical management. Long-term follow-up (LTFU) was available in 30 patients for a mean of 36.5 ± 29.2 months. Twenty-one (70%, 21/30) demonstrated disease stability or resolution and 9 (30%, 9/30) worsened with 3 undergoing surgery. No PAU ruptured during follow-up. Patient demographics, presenting symptoms, and PAU morphology did not predict disease progression. Referral to a cardiovascular surgeon at initial presentation was associated with a 40% decreased likelihood of disease progression (P = 0.046) and a 60% survival advantage at LTFU (P = 0.037). CONCLUSIONS: PAU disease progression occurs in 30% of patients at LTFU of 36.5 ± 29.2 months. All patients identified with PAU on diagnostic imaging should be referred for a surgical evaluation and follow-up, as referral to cardiovascular surgeon is associated with improved disease course.

Analysis of intraoperative radiation use in vascular surgery: Catalyst for quality improvement in patient and personnel safety.

OBJECTIVES: There is paucity in the literature reporting radiation usage analysis in vascular surgery. In the era of endovascular surgeries, analyzing the surgeons' use of radiation in vascular procedures can help establish quality improvement initiatives. METHODS: A retrospective review was undertaken of intraoperative fluoroscopic-guided vascular surgery procedures at a single institution from 2010 to 2017. Mobile C-arms were utilized to gather the six radiation usage metrics and cases were categorized into 6 anatomic surgical fields and 10 surgical procedure types. RESULTS: Three hundred and eighteen vascular surgery cases were analyzed and notable trends in all radiation usage metrics were identified both across the surgical field location and type of surgical procedure. The highest cumulative dose was identified in embolization cases with a mean of 932.5 mGy. The highest fluoroscopic time was seen in atherectomies with a mean of 2629.6 s. In terms of surgical field, the highest cumulative does and fluoroscopic time was identified in abdomen/pelvis procedures with a mean of 352.1 mGy and 1186.8 s, respectively. Analysis of dose reduction techniques also demonstrated notable trends. CONCLUSIONS: There were notable trends in the analyzed radiation usage variables both across the surgical field location and type of surgical procedure. Specifically, cases that involve the abdomen/pelvis, embolization and atherectomy have the highest radiation use. These types of cases can be targeted for future improved dose reduction techniques or staged procedures. This data can serve as baseline information for future quality improvement initiatives for patient and personnel radiation exposure safety.