Effect Of Fenestration Configuration On Renal Artery Outcomes During Fenestrated-Branched Endovascular Aortic Repair.

OBJECTIVES: To evaluate the effect of fenestration configuration and fenestration gap on renal artery outcomes during fenestrated-branched endovascular aortic repair (F/BEVAR). METHODS: A retrospective multicenter analysis was performed, including patients with complex aortic aneurysms treated with F/BEVAR that incorporated at least one small fenestration to a renal artery. The renal fenestrations were divided into groups 1 (8x6 mm) and 2 (6x6 mm). Primary patency, target vessel instability (TVI), freedom from secondary interventions (SIs), occurrence of type IIIc endoleak, all related to the renal arteries, were analyzed at 30-day, 1-year, and 5-year landmarks. The fenestration gap (FG) distance was analyzed as a modifier, and clustering was addressed at the patient level. RESULTS: Seven hundred and ninety-six patients were included in this study, 71.7% male, with a mean age of 73.3±8.1 years. The mean follow-up was 30.0±20.6 months. Of the 1474 small renal fenestrations analyzed, 47.6% were 8x6, and 52.4% were 6x6mm. At the 30-day landmark, primary patency (99.9% vs 98.0%, p-value <0.001 for groups 1 and 2, respectively), freedom from TVI (99.6% vs 97.1%, p-value <0.001 for groups 1 and 2, respectively), and freedom from SI (99.8% vs 98.4%, p-value = .022 for groups 1 and 2, respectively) were higher in 8x6 compared to 6x6 fenestrations, and the incidence of AKI was similar across the groups (92.6% vs 92.7%, p-value = .953 for groups 1 and 2 respectively). The primary patency at 1 and 5 years was higher in 8x6 fenestrations (1-year: 98.8% vs 96.9%; 5-year: 97.8% vs 95.7%, for groups 1 and 2, respectively, p values = .010 and 0.021 for 1 and 5 year comparisons, respectively). The freedom from SIs was significantly higher among 6x6 fenestrations at 5 years (93.1% vs 96.4%, for groups 1 and 2, respectively, p value = .007). The groups were equally as likely to experience a type Ic endoleak (1.3 % and 1.6% for 8x6 and 6x6mm fenestrations, respectively, p = .689). The 6x6 fenestrations were associated with higher risk of kidney function deterioration (17.8%) when compared with 8x6 fenestrations (7.6%) at 5 years (p <.001). The risk of type IIIc endoleak was significantly higher among 8x6 fenestrations at 5 years (4.9% and 2% for 8x6 and 6x6 mm fenestrations, respectively, p= .005). A FG ≥5 mm negatively impacted the cumulative 5-year freedom from TVI (group 1: FG ≥5 mm = 0.714, FG <5 mm = 0.857, p<.001; group 2: FG ≥5 mm = 0.761, FG <5 mm = 0.929, p<.001) and the cumulative 5-year freedom from type IIIc endoleak (group 1: FG ≥5 mm = 0.759, FG <5 mm = 0.921, p=.034; group 2: FG ≥5 mm = 0.853, FG <5 mm = 0.979, p<.001) in both groups and the cumulative 5-year patency in group 2 (group 1: FG ≥5 mm = 0.963, FG <5 mm = 0.948, p=.572; group 2: FG ≥5 mm = 0.905, FG <5 mm = 0.938, p=.036). CONCLUSIONS: Fenestration configuration for the renal arteries impacts outcomes. The 8x6 small fenestrations have better patency at 30-days, 1 year, and 5 years, while 6x6 small fenestrations are associated with lower rates of secondary interventions, primarily due to a lower incidence of type IIIc endoleaks. Fenestration gap ≥ 5 mm at the level of the renal arteries significantly impacts the freedom from TVI, freedom from type IIIc endoleak and 5-year patency independently of the fenestration size or vessel diameter.

Balancing evidence-based care with patient-centered individualized care.

Weak evidence, when manifested in clinical guidelines, can translate into biased vascular care. In vascular surgery, we have few randomized controlled trials with appropriate representation of females and persons of color, so generalizability of trial results can be problematic. Physicians are required to balance evidenced-based care (which is only as good as the underlying evidence) with personalized treatment recommendations that are often based on demographics, social circumstances, and/or existing therapeutic relationships. Biases, whether implicit or explicit, have an oversized effect on treatment decisions, and patient outcomes. In this commentary, we propose three principles to strengthen the vascular surgery evidence foundation and patient-centered decision-making going forward: (1) generating evidence designed for individualized care, (2) constructing clinical guidelines that are context specific and complexity aware, and (3) strengthening the training and support for surgeons to deliver patient-centered individualized care.

Medial arterial calcification score is associated with increased risk of major limb amputation.

OBJECTIVE: The pedal medial arterial calcification (MAC) score has been associated with risk of major limb amputation in patients with chronic limb-threatening ischemia. This study aimed to validate the pedal MAC scoring system in a multi-institutional analysis to validate its usefulness in limb amputation risk prediction. METHODS: A multi-institution, retrospective study of patients who underwent endovascular or open surgical infrainguinal revascularization for chronic limb-threatening ischemia was performed. MAC scores of 0 to 5 were assigned based on visible calcified arteries on foot X ray then trichotomized (0-1, 2-4, 5) for analysis. The primary outcome was major limb amputation at 6 months. Adjusted Kaplan-Meier models were used to analyze time-to-major amputation across groups. RESULTS: There were 176 patients with 184 affected limbs (mean age, 66 years; 61% male; 60% White), of whom 97% presented with a wound. The MAC score was 0 in 41%, 1 in 9%, 2 in 13%, 3 in 11%, 4 in 13%, and 5 in 13% of the limbs. There were 26 major amputations (14%) and 16 deaths (8.7%) within 6 months. Patients with MAC 5 had a significantly higher risk of major limb amputation than both the 0 to 1 and 2 to 4 groups (P = .001 and P = .044, respectively), and lower overall amputation-free survival (log-rank P = .008). CONCLUSIONS: Pedal MAC score is a reproducible and generalizable measure of inframalleolar arterial disease that can be used with Wound, Ischemia, and foot Infection staging to predict major limb amputation in patients with chronic limb-threatening ischemia.

Depression in Patients with Peripheral Artery Disease: An Underdiagnosis with Increased Mortality.

BACKGROUND: Among patients with peripheral artery disease (PAD), depression is diagnosed in 17-25% and negatively impacts wound healing, quality of life, and survival. We hypothesized that depression is underdiagnosed in patients with PAD. Additionally, given the associations between depression and mortality in PAD patients, there is an increased need to investigate the strength of this relationship. The present analysis includes 2 studies to address the following aims: (1) Investigation of the prevalence of concomitant PAD and depression in a cohort from the Southeastern United States, and (2) Examination of the association between depression and all-cause mortality in a cohort of Canadian patients with PAD. METHODS: STUDY 1: From June-August 2022, the Patient Health Questionnaire Module 9 (PHQ-9) was administered to all patients seeking PAD-related care including medical, wound/podiatric, or vascular interventional/surgical treatment, in the University of North Carolina-Chapel Hill Vascular, Wound, and Podiatry clinics. The PHQ-9 assesses symptoms over 2 weeks and is scored 0-27, with higher scores indicating increasingly severe depression. Demographics, primary diagnosis, depression history, and antidepressant prescription were determined through chart review. We compared the proportion of positive depression screenings (PHQ-9 ≥ 5) to known depression. Among those treated for depression, the PHQ-9 score severity was evaluated. T-tests and χ2 tests were used to compare means and proportions. STUDY 2: From July 2015 to October 2016, the Geriatric Depression Scale Short Form was administered to adult patients with PAD undergoing revascularization. The Geriatric Depression Scale Short Form is a self-report measure of depression with a score >5 consistent with depression. The prevalence of depression was determined; primary outcome was all-cause mortality at 6 months. RESULTS: STUDY 1: In 104 PAD patients (mean age 66.6 ± 11.3 years, 37% female), 37% of respondents scored ≥5 on the PHQ-9 survey, indicating at least mild depression. Only 18% of PAD patients had a history of depression, demonstrating a significant difference between the PHQ-9 findings and documented medical history. While depression was underdiagnosed in both men and women, men were more likely to have unrecognized depression (chi-squared statistic = 35.117, df = 1, P < 0.001). Among those with a history of depression, 74% had a current prescription for antidepressant medication, but 57% still had an elevated PHQ-9 score indicating possible undertreatment. STUDY 2: In 148 patients (mean age 70.3 ± 11.0 years, 39% female) the prevalence of screened depression was 28.4%, but only 3.3% had a documented history of depression suggesting significant underdiagnosis. Patients with depression were significantly more likely to die within 6 months of revascularization (9.5% vs. 0.9%; odds ratio 1.48, 95% confidence interval: 1.08 to 2.29). There was no association between depression and risk of length of stay, reintervention, or readmission. CONCLUSIONS: Depression is underdiagnosed and undertreated among patients with PAD, which has grave consequences as it is associated with 1.5 times the odds of mortality within 6 months of revascularization. There is a critical need for more robust screenings and comprehensive mental health treatment for patients with concomitant depression and PAD.

Analysis of wound healing time and wound-free period in patients with chronic limb-threatening ischemia treated with and without revascularization.

BACKGROUND: The traditionally reported outcomes for patients with ischemic wounds have centered on amputation-free survival. However, that discounts the importance of other patient-centered outcomes such as the wound healing time (WHT) and wound-free period (WFP). We evaluated the long-term wound outcomes of patients treated for chronic limb-threatening ischemia at our institution. METHODS: From 2014 to 2017, we identified all patients with chronic limb-threatening ischemia and ischemic wounds using symptomatic and hemodynamic criteria. The primary data included the wound size, wound location, WIfI (wound, ischemia, foot infection) grade, WHT, WFP, minor and major amputation, and death. Wounds were not considered healed if the patient had required a major amputation or had died before wound healing. The WHT was calculated as the interval in days between the diagnosis and determination of a healed wound. The WFP was calculated as the interval in days between a healed wound and wound recurrence, major amputation, death, or the end of the study period. A comparison of the wound healing parameters stratified by revascularization status was performed using the Student t test. A generalized linear model adjusted for age, sex, initial wound size, and WIfI grade was used to evaluate the risk of wound healing with and without revascularization. RESULTS: A total of 256 patients had presented with 372 wounds. Of the 256 patients, 48% had undergone revascularization. During the study period, 97 minor amputations and 100 major amputations had been required, and 132 patients had died. The average wound size was 13.9 ± 52.0 cm2; however, for the 155 wounds that had healed, the average size was only 4.0 ± 9.6 cm2 (P = .002). No differences were found in the wound size when stratified by revascularization status (P = .727). Adjusted for the initial wound size, the risk of wound healing was not different when stratified by revascularization (risk ratio, 1.22; 95% confidence interval, 0.80-1.87; P = .354). For those whose wounds had healed, the average WHT and WFP were 173 ± 169 days and 775 ± 317 days, respectively. The WHT was not faster for the revascularized group (155 days vs 188 days; P = .221). When stratified by revascularization status, the rate of wound recurrence was 4.6 vs 8.9 wounds per 100 person-years for the revascularized and nonrevascularized groups, respectively (P = .125). CONCLUSIONS: In our study, we found that, except for patients who presented with severe ischemia, revascularization was not associated with improved rates of wound healing. Among the wounds that healed, regardless of the initial ischemia grade, revascularization was not associated with a faster WHT or longer WFPs.

Increased long-term bleeding complications in females undergoing endovascular revascularization for peripheral arterial disease.

OBJECTIVE: Females with peripheral arterial disease (PAD) treated with endovascular interventions have increased limb-based procedural complications compared with males. Little is known regarding long-term bleeding risk in these patients who often require long-term antiplatelet or anticoagulation therapy. We hypothesize that females have a higher incidence of bleeding events compared with males in the year after endovascular intervention for PAD. METHODS: Adults (aged ≥65 years) who underwent endovascular revascularization for PAD between 2008 and 2015 in Medicare claims data were identified. Patients were allocated by prescribed postprocedural antithrombotic therapy, including (1) antiplatelet therapy, (2) anticoagulation therapy, (3) dual antiplatelet and anticoagulation therapy, and (4) no prescription antithrombotic therapy. Bleeding events were classified as gastrointestinal, intracranial, hematoma, airway, or other. Crude and covariate-standardized 30-, 90-, and 365-day cumulative incidence of bleeding events, overall and by sex, were estimated using Aalen-Johansen estimators accounting for death as a competing risk. Sex differences were identified using Gray's test. RESULTS: Of 31,593 eligible patients, 54% were females. Females were older (77.9 years vs 75.5 years) and tended to use antiplatelet therapy more often at 30, 90, and 365 days after the intervention. Clopidogrel was the most prescribed antiplatelet, and 32% of patients continued its use at 365 days. Anticoagulants were prescribed to 26.0% of patients at the time of the procedure, and only 8.8% continued anticoagulation at 365 days. Thirty-one percent of patients were diagnosed with a bleeding event within 1 year after the intervention. The cumulative incidence of any bleeding event during the postintervention period was higher in females compared with males with a risk difference of 3% between the sex cohorts (P < .01). Specifically, females had a higher incidence of gastrointestinal bleeding and hematoma (P < .01), but a lower incidence of airway-related bleeding at each time point as compared with males (P < .01). CONCLUSIONS: Sex disparities in bleeding complications after endovascular intervention for PAD persist in the long term. Females are more likely to be readmitted with a bleeding complication up to 1 year after the procedure. Antithrombotic therapy disproportionately increases the risk of bleeding in females. Further research is necessary to understand the mechanisms responsible for abnormal coagulopathy in females after endovascular therapy.

Early thrombosis after iliac stenting for venous outflow occlusion is related to disease severity and type of anticoagulation.

BACKGROUND: Stenting of the iliac venous system is often performed for symptomatic obstruction, with high patency rates reported. However, patients with post-thrombotic disease and those with more extensive obstruction have experienced poorer outcomes, including a higher rate of early post-stent thrombosis. In the present study, we examined the outcomes of patients with complete venous outflow occlusion. We focused on the variables associated with early post-stenting thrombosis to identify opportunities to reduce its incidence. METHODS: From 2010 to 2020, the patients who had undergone stenting for chronic obstruction of the common femoral vein, iliac veins, and/or inferior vena cava were retrospectively reviewed. The pre- and intraoperative imaging studies were examined to identify those who had had total occlusion of one venous outflow segment (type III disease) or multiple venous outflow segments (type IV disease). The patient characteristics and procedural and post-stent variables were recorded. The post-procedure follow-up visits and imaging studies were reviewed to determine stent patency and thrombotic complications. Key variables were studied to determine their association with early stent reocclusion. RESULTS: A total of 106 patients were identified, including 43 with type III (40.6%) and 63 with type IV (59.4%) disease. The mean patient age was 49.8 ± 13.7 years, and the mean stented length was 177.3 ± 63 mm. Stainless steel Wallstents were used solely in 44% of the cases, with a variety of nitinol stents used in the remainder. Femoral vein inflow was minimally diseased in 50% of the cases, moderately diseased in 26%, and severely diseased or occluded in 24%. Antiplatelet medications were prescribed after intervention for 52.8% and anticoagulation medication for 95.3% of the patients. Occlusion of the stented segment occurred within 3 months in 25.5%. Primary patency was 74.5% at 3 months, 63.9% at 12 months, and 58.5% at 3 years. Secondary patency was 93.4% at 3 months and 76.1% at 3 and 5 years. Univariate analysis of variables related to early stent thrombosis identified the presence of a hypercoagulable state, type IV obstruction, and the type of anticoagulation used after stenting were associated with early stent thrombosis. On multivariate analysis, each of these variables was independently associated with early stent thrombosis. The presence of type IV obstruction (odds ratio [OR], 4.596; 95% confidence interval [CI], 1.424-18.109) or a hypercoagulable state (OR, 3.835; 95% CI, 1.207-12.871) was associated with significantly greater odds of reocclusion than was class III obstruction and no hypercoagulable state. Treatment with low-molecular-weight heparin for >10 days was associated with significantly lower odds (OR, 0.012; 95% CI, 0.001-0.130) of reocclusion. CONCLUSIONS: Patients who require recanalization of a completely occluded venous outflow tract before stenting have a high rate of early reocclusion. Patients with more extensive occlusion and a hypercoagulable state have greater odds of reocclusion. Treatment with low-molecular-weight heparin for >10 days reduced the odds of early reocclusion.

Sex-related disparities in intervention rates and type of intervention in patients with aortic and peripheral arterial diseases in the National Inpatient Sample Database.

OBJECTIVE: The first annual Women's Vascular Summit highlighted sex- and gender-related knowledge gaps in vascular disease diagnosis and treatment. This finding suggests an opportunity for further research to improve care and outcomes in people who identify as women, specifically. The purpose of this study was to a large national dataset to identify all operations performed for abdominal aortic aneurysm (AAA), carotid artery stenosis (CAS), and peripheral arterial disease (PAD) in the United States, and to provide data on sex-related disparities in treatment. METHODS: All hospitalizations of adult patients (≥18 years old) diagnosed with AAA, CAS, or PAD who underwent vascular surgery from 2000 to 2016 were identified in the Healthcare Cost and Utilization Project National Inpatient Sample. Sex-stratified U.S. Census data and sex-specific population disease prevalence estimates from the National Institute of Health and Agency for Healthcare Research and Quality were used to calculate the number of U.S. adults with AAA, CAS, and PAD. Sex-stratified rates of surgery and incidence rate ratios were estimated using Poisson regression. Among those undergoing surgery, multivariable logistic regression was used to assess differences in endovascular vs open approach. RESULTS: Over 16 years, there were 1,021,684 hospitalizations for vascular surgery: 13% AAA (21% female, 79% male), 40% CAS (42% female, 58% male), and 47% PAD (42% female, 58% male). Females were older than males at time of surgery (median age, 71.3 years vs 69.7 years) and less likely to have private insurance (18% vs 23%); minimal differences were seen across race/ethnicity, comorbidities, and hospital characteristics. After accounting for disease prevalence, females were still 25% less likely to undergo surgery for AAA and 30% less likely to undergo surgery for PAD compared with males with the same disease. These results were consistent over time. After adjustment, females, compared with males, were less likely to receive an endovascular procedure compared with open for AAA or CAS, and more likely to receive one for PAD. CONCLUSIONS: From 2000 to 2016 in the United States, females were less likely to undergo intervention for AAA and PAD than males. This finding is particularly significant for PAD, because the prevalence is the same for both sexes, indicating that females are likely undertreated for PAD. Additionally, females were less likely to undergo endovascular surgery for AAA and more likely to undergo endovascular surgery for PAD than males. These findings suggest that improvement in AAA and PAD identification and management in females may improve outcomes.

Operative strategies for inferior vena cava repair in oncologic surgery.

OBJECTIVE: Tumor involvement of the inferior vena cava (IVC) can result from primary caval leiomyosarcoma, local invasion by retroperitoneal malignant neoplasm, or metastases. Whereas ligation of the IVC may be well tolerated if collateral circulation can be adequately preserved, collaterals must often be ligated during oncologic resection. Reconstruction of the IVC may be performed by primary repair, patch angioplasty, or interposition graft. The purpose of our study was to describe different strategies of IVC reconstruction and to measure outcomes associated with IVC reconstruction among patients with retroperitoneal malignant disease. METHODS: All patients undergoing IVC reconstruction at our quaternary care hospital between November 2004 and February 2018 were identified using billing data (Current Procedural Terminology code 34502). Patients who underwent resection of the IVC for tumor involvement were enrolled in our study; data were collected on demographics, operative intervention, type of reconstruction, postoperative course, and 1-year outcomes. Patency rates were assessed by reviewing postoperative imaging including computed tomography, magnetic resonance imaging, ultrasound, and venography. Two-year mortality and patency were calculated using Kaplan-Meier analysis methods. RESULTS: We identified 52 (46% female) patients who underwent IVC reconstruction for retroperitoneal malignant disease. The mean age was 53.6 years (range, 23-80 years). Procedures performed included primary repair (n = 17 [33%]), patch angioplasty (n = 18 [35%]), and interposition grafting (n = 17 [33%]). The mean length of stay was 16 days and did not vary significantly by group. Patients undergoing interposition graft were discharged on aspirin 81 mg daily. The 30-day survival rate was 96.2% (95% confidence interval [CI], 90.9-100), 1-year survival rate was 75.1% (95% CI, 62.8-87.4), and 2-year survival rate was 64.7% (95% CI, 50.5-78.9). There were no intraoperative deaths. The 30-day primary patency rate was 96% (95% CI, 90.7-100.0), 1-year primary patency rate was 88.8% (95% CI, 79.4-98.2), and 2-year primary patency rate was 77.5% (95% CI, 63.0-92.0). Seven patients (14%) developed nonocclusive thrombus within the IVC, and 16 patients (30%) developed postoperative symptoms of venous obstruction. CONCLUSIONS: IVC reconstruction is a safe option for patients requiring IVC resection during oncologic surgery as evidenced by 1-year survival of 75% and 1-year primary patency approaching 90%. The overall rate of postoperative thrombus development was low and similar across all groups. In the management of primary and secondary retroperitoneal malignant disease with IVC infiltration, IVC reconstruction should be considered to achieve appropriate oncologic resection while minimizing possible complications from caval interruption.