Five-year outcomes of fenestrated and branched endovascular repair of complex aortic aneurysms based on aneurysm extent.

OBJECTIVE: The aim of this study was to evaluate the 5-year outcomes of fenestrated/branched endovascular aortic repair (F/BEVAR) for the treatment of complex aortic aneurysms stratified by the aneurysm extent. METHODS: Patients with the diagnosis of complex aortic aneurysm, who underwent F/BEVAR at a single center were included in this study and retrospectively analyzed. The cohort was divided according to the aneurysm extent, comparing group 1 (types I-III thoracoabdominal aneurysms [TAAAs]), group 2 (type IV TAAAs), and group 3 (juxtarenal [JRAAs], pararenal [PRAAs], or paravisceral [PVAAs] aortic aneurysms). The primary endpoints were 30-day and 5-year survival. The secondary endpoints were technical success, occurrence of spinal cord ischemia, primary patency of the visceral arteries, freedom from target vessel instability, and secondary interventions. RESULTS: Of 436 patients who underwent F/BEVAR between July 2012 and May 2023, 131 presented with types I to III TAAAs, 69 with type IV TAAAs, and 236 with JRAAs, PRAAs, or PVAAs. All cases were treated under a physician-sponsored investigational device exemption protocol with a patient-specific company-manufactured or off-the-shelf device. Group 1 had significantly younger patients than group 2 or 3 respectively (69.6 ± 8.7 vs 72.4 ± 7.1 vs 73.2 ± 7.3 years; P < .001) and had a higher percentage of females (50.4% vs 21.7% vs 17.8%; P < .001). Prior history of aortic dissection was significantly more common among patients in group 1 (26% vs 1.4% vs 0.9%; P < .001), and mean aneurysm diameter was larger in group 1 (64.5 vs 60.7 vs 63.2 mm; P = .033). Comorbidities were similar between groups, except for coronary artery disease (P < .001) and tobacco use (P = .003), which were less prevalent in group 1. Technical success was similar in the three groups (98.5% vs 98.6% vs 98.7%; P > .99). The 30-day mortality was 4.5%, 1.4%, and 0.4%, in groups 1, 2, and 3, respectively, and was significantly higher in group 1 when compared with group 3 (P = .01). The incidence of spinal cord ischemia was significantly higher in group 1 compared with group 3 (5.3% vs 4.3% vs 0.4%; P = .004). The 5-year survival was significantly higher in group 3 when compared with group 1 (P = .01). Freedom from secondary intervention was significantly higher in group 3 when compared with group 1 (P = .003). At 5 years, there was no significant difference in freedom from target vessel instability between groups or primary patency in the 1652 target vessels examined. CONCLUSIONS: Larger aneurysm extent was associated with lower 5-year survival, higher 30-day mortality, incidence of secondary interventions, and spinal cord ischemia. The prevalence of secondary interventions in all groups makes meticulous follow-up paramount in patients with complex aortic aneurysm treated with F/BEVAR.

Gender disparities in patients with aortoiliac disease requiring open operative intervention.

OBJECTIVE: Peripheral artery disease is known to affect males and females in different proportions. Disparate surgical outcomes have been quantified after endovascular aortic aneurysm repair, arteriovenous fistula creation, and treatment of critical limb ischemia. The aim of this study is to objectively quantify the sex differences in outcomes in patients undergoing open surgical intervention for aortoiliac occlusive disease. METHODS: Patients were identified in the aortoiliac occlusive disease Vascular Quality Initiative database who underwent aorto-bifemoral bypass or aortic thromboendarterectomy as determined by Current Procedural Terminology codes between 2012 and 2019. Patients with a minimum of 1-year follow-up were included. Risk differences (RDs) by sex were calculated using a binomial regression model in 30-day and 1-year incidence of mortality and limb salvage. Additionally, incidence of surgical complications including prolonged length of stay (>10 days), reoperation, and change in renal function (>0.5 mg/dl rise from baseline), were recorded. Inverse probability weighting was used to standardize demographic and medical history characteristics. Multivariate logistic regression models were employed to conduct analyses of the before mentioned clinical outcomes, controlling for known confounders. RESULTS: Of 16,218 eligible patients from the VQI data during the study period, 6538 (40.3%) were female. The mean age, body mass index, and race were not statistically different between sexes. Although there was no statistically significant difference detected in mortality between males and females at 30 days postoperatively, females had an increased crude 1-year mortality with an RD of 0.014 (95% confidence interval, 0.01-0.02; P value < .001. Males had a higher rate of a postoperative change in renal function with an RD of -0.02 (95% confidence interval, -0.03 to -0.01; P < .001). CONCLUSIONS: Although there was no sex-based mortality difference at 30 days, there was a statistically significant increase in mortality in females after open aortoiliac intervention at 1 year based on our weighted model. Male patients are statistically significantly more likely to have a decline in renal function after their procedures when compared with females. Postoperative complications including prolonged hospital stay, reoperation, and wound disruption were similar among the sexes, as was limb preservation rates at 1 year. Further studies should focus on elucidating the underlying factors contributing to sex-based differences in clinical outcomes following aortoiliac interventions.

Outcome Analysis Comparing Asymptomatic Juxtarenal Aortic Aneurysms Treated with Custom-Manufactured Fenestrated-Branched Devices and the "Off-The-Shelf" Zenith p-Branch Device.

BACKGROUND: Numerous endovascular options have been used for the repair of juxtarenal aortic aneurysms (JRAAs) over the last 15 years. This study aims to compare the performance between the Zenith p-branch device and custom-manufactured fenestrated-branched devices (CMD) for the treatment of asymptomatic JRAA. METHODS: A single-center retrospective analysis of prospectively collected data was performed. Patients with a diagnosis of JRAA submitted to endovascular repair between July 2012 and November 2021 were included in the study, being divided into 2 groups: CMD and Zenith p-branch. The following variables were analyzed: preoperative information: demographics, comorbidities, and maximum aneurysm diameter; procedural data: contrast volume, fluoroscopy time, radiation dose, estimated blood loss, and technical success; and postoperative data: 30-day mortality, duration of intensive care unit and hospital stay, major adverse events, secondary interventions, target vessel instability, and long-term survival. RESULTS: From a total of 373 physician-sponsored investigational device exemption (Cook Medical devices) cases performed at our institution, 102 patients presented the diagnosis of JRAA. Of these, 14 patients were treated with the p-branch device (13.7%) and 88 (86.3%) with a CMD. Both groups presented similar demographic composition and maximum aneurysm diameter. All devices were successfully deployed, with no type I or III endoleaks observed at procedure completion. The contrast volume (P = 0.023) and radiation dose (P = 0.001) were significantly higher in the p-branch group. No significant difference was observed between the groups for the remaining intraoperative data. No paraplegia or ischemic colitis has been observed during the first 30 days after the surgical procedures. There was no 30-day mortality in either group. One major cardiac adverse event was registered in the CMD group. Early outcomes were similar in both groups. No significant difference was found between the groups with respect to the presence of type I or III endoleaks during the follow-up. From a total of 313 target vessels stented in the CMD group (mean of 3.55 per patient) and 56 in the p-branch group (mean of 4 per patient), 4.79% and 5.35% presented instability, respectively, with no difference observed between the groups (P = 0.743). Secondary interventions were required in 36.4% of the CMD cases and 50% of the p-branch group, but this was not statistically different (P = 0.382). In the p-branch cohort, 2 of 7 reinterventions (28.5%) were target vessel-related and in the CMD group, 10 of 32 secondary interventions (31.2%) were target vessel-related. CONCLUSIONS: Comparable perioperative outcomes were obtained when appropriately selected patients were treated with either the off-the-shelf p-branch or CMD for JRAA. The long-term target vessel instability does not appear impacted by the presence of pivot fenestrations in comparison to other target vessel configurations. Given these outcomes, delay in CMD production time should be considered when treating patients with large juxtarenal aneurysms.

Incidence of venous thromboembolism in patients with peripheral arterial disease after endovascular intervention.

OBJECTIVE: Venous thromboembolism (VTE) is a well-known postoperative complication; however, the incidence of VTE after peripheral vascular intervention (PVI) has not been well described. Despite the minimally invasive nature of these procedures, the patients undergoing PVI have significant risk factors for the development of VTE. In the present study, our objective was to describe the short-term incidence of VTE after PVI, identify differences between sexes, and examine the periprocedural antiplatelet and anticoagulation regimens. METHODS: We identified adults (age >66 years) who had undergone PVI from January 1, 2008 to September 30, 2015 from the inpatient Medicare claims data. The patients were followed for 365 days after the procedure. VTE events during follow-up were identified using the International Classification of Diseases, 9th revision, diagnosis codes. The covariate-standardized 30- and 90-day cumulative incidence of VTE events, overall and stratified by sex, were estimated using Aalen-Johansen estimators, accounting for death as a competing risk. Differences in sex between females and males were identified using Gray's test. Any antiplatelet or anticoagulant prescription fill was defined as any fill from 14 days before the endovascular intervention through the date of the VTE event. Persistence with antiplatelet and anticoagulant therapy was assessed by creating daily logs of antiplatelet and anticoagulant coverage using the dispensing dates and days of supply. Over-the-counter medications (ie, aspirin) were not evaluated. RESULTS: We identified 31,593 qualifying patients with a mean age of 76.8 ± 7.4 years. Of the 31,593 patients, 46% were male, and 12% had a history of VTE. After the procedure, deep vein thrombosis (DVT) was a commonly diagnosed complication (3.8% and 4.8% at 30 and 90 days, respectively). The cumulative incidence of pulmonary embolism was 0.9% and 1.2% at 30 and 90 days after the procedure, respectively. Throughout the 90-day postoperative period, females had had a slightly increased risk of DVT compared with males (30-day risk difference, 0.007; P < .01; 90-day risk difference, 0.008; P = .02). We found no sex-based differences in the risk of pulmonary embolism. Of the patients who had developed VTE at 90 days, 970 (55%) had had no prescription fill for an antiplatelet or anticoagulant. Assuming all the patients had been taking aspirin, only 15% of the patients who had developed VTE had been taking prescribed dual antiplatelet medication persistently after PVI. In addition, among the patients who had developed VTE at 90 days, females were less likely to have had a prescription fill for an anticoagulant. CONCLUSIONS: The findings from our study have demonstrated that the incidence of VTE after PVI is high, with an increased risk of deep vein thrombosis for females. We also found that females were less likely to have been prescribed an anticoagulant after PVI. Future studies are needed to characterize the variables associated with an increased risk of VTE after PVI and to identify strategies to increase dual antiplatelet therapy or anticoagulant prescription adherence to reduce the risk of VTE.

Routine use of concurrent fluoroscopic imaging during superficial endovenous interventions: A position statement of the International Union of Phlebology, the Australasian College of Phlebology, the Australia and New Zealand Society for Vascular Surgery, the American Venous Forum, the American Vein and Lymphatic Society, the European College of Phlebology and the Interventional Radiology Society of Australasia.

International evidence-based guidelines recommend preoperative duplex ultrasound mapping in the assessment of chronic venous disease, and concurrent ultrasound imaging to guide superficial endovenous interventions such as endovenous laser ablation, radiofrequency ablation, cyanoacrylate adhesive closure, and sclerotherapy (ultrasound-guided sclerotherapy). Other imaging modalities such as venography, alone or in combination with computed tomography scan or magnetic resonance imaging, may be included in the preoperative assessment of a small and select group of patients to exclude central venous obstruction, certain deep venous pathologies, pelvic origin extrapelvic varices, and complex vascular malformations. The signatory scientific and medical societies recommend against the routine use of fluoroscopy and other radiation-based imaging in the investigation and treatment of superficial venous disease.

Routine use of concurrent fluoroscopic imaging during superficial endovenous interventions: A position statement of the International Union of Phlebology (UIP), the Australasian College of Phlebology (ACP), the Australia and New Zealand Society for Vascular Surgery (ANZSVS), the American Venous Forum (AVF), the American Vein and Lymphatic Society (AVLS), the European College of Phlebology (ECoP) and the Interventional Radiology Society of Australasia (IRSA).

International evidence-based guidelines recommend preoperative duplex ultrasound mapping in the assessment of chronic venous disease, and concurrent ultrasound imaging to guide superficial endovenous interventions such as endovenous laser ablation, radiofrequency ablation, cyanoacrylate adhesive closure, and sclerotherapy (ultrasound-guided sclerotherapy). Other imaging modalities such as venography, alone or in combination with computed tomography scan or magnetic resonance imaging, may be included in the preoperative assessment of a small and select group of patients to exclude central venous obstruction, certain deep venous pathologies, pelvic origin extrapelvic varices, and complex vascular malformations. The signatory scientific and medical societies recommend against the routine use of fluoroscopy and other radiation-based imaging in the investigation and treatment of superficial venous disease.

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.

Gender Disparities in Aortoiliac Revascularization in Patients with Aortoiliac Occlusive Disease.

BACKGROUND: Gender disparities have been previously reported in aortic aneurysm and critical limb ischemia outcomes; however, limited info is known about disparities in aortoiliac occlusive disease. We sought to characterize potential disparities in this specific population. MATERIAL AND METHODS: Patients who underwent aortobifemoral bypass and aortic thromboendarterectomy (Current Procedural Terminology codes 35646 and 35331) between 2012 and 2019 were identified in the National Surgical Quality Improvement Program database. A binomial regression model was used to estimate gender differences in 30-day morbidity and mortality. Inverse probability weighting was used to standardize demographic and surgical characteristics. RESULTS: We identified 1,869 patients, of which 39.8% were female and the median age was 61 years. Age, body composition, and other baseline characteristics were overall similar between genders; however, racial data were missing for 26.1% of patients. Females had a higher prevalence of preexisting chronic obstructive pulmonary disease (20.9% vs. 14.7%, prevalence difference 6.1%, P < 0.01), diabetes mellitus (25.4% vs. 19.4%, prevalence difference 6.0%, P < 0.01), and high-risk anatomical features (39.4% vs. 33.7%, prevalence difference 5.8%, P = 0.01). Preprocedural medications included a statin in only 68.2% of patients and antiplatelet agent in 76.7% of patients. Females also had a higher incidence of bleeding events when compared to males (25.2% vs. 17.5%, standardized risk difference 7.2%, P < 0.01), but were less likely to have a prolonged hospitalization greater than 10 days (18.2% vs. 20.9%, standardized risk difference -5.0%, P = 0.01). The 30-day mortality rate was not significantly different between genders (4.7% vs. 3.6%, standardized risk difference 1.2%, P = 0.25). CONCLUSIONS: Female patients treated with aortobifemoral bypass or aortic thromboendarterectomy are more likely to have preexisting chronic obstructive pulmonary disease, diabetes mellitus, and high-risk anatomical features. Regardless of a patient's gender, there is poor adherence to preoperative medical optimization with both statins and antiplatelet agents. Female patients are more likely to have postoperative bleeding complications while males are more likely to have a prolonged hospital stay greater than 10 days. Future work could attempt to further delineate disparities using databases with longer follow-up data and seek to create protocols for reducing these observed disparities.

High Stroke Rate in Patients With Medically Managed Asymptomatic Carotid Stenosis at an Academic Center in the Southeastern United States.

BACKGROUND: Although the publication of randomized clinical trials defining the benefit of carotid endarterectomy (CEA) for asymptomatic carotid stenosis, medical management of carotid stenosis has changed significantly. With antiplatelet agents and statins, some question whether these trials are still relevant, suggesting that asymptomatic patients with >70% internal carotid artery (ICA) stenosis may do better with medial management alone, lessening the need for CEA and carotid stenting. The Vascular Quality Initiative (VQI) registry has shown that there are wide practice variations regarding the degree of stenosis that prompts surgical intervention but there are few reports of outcomes in patients who do not undergo intervention. We sought to determine the clinical outcomes of the >70% carotid stenosis patients who are treated with medical management alone at our institution. METHODS: We identified all patients with ICA stenosis >70% based on hemodynamic consensus criteria (peak systolic velocity >230 cm/s) in our peripheral vascular laboratory from January 2013 through December 2016. With a retrospective chart review, demographics, comorbid conditions, medications, radiographic studies, clinical follow-up, interventions, and outcomes at 2 years were included. Descriptive statistics were used to define these variables. RESULTS: One hundred and seventy three patients were identified with medically managed asymptomatic >70% ICA stenosis based on hemodynamic criteria on duplex ultrasound. The mean age was 67.5 years, 49% were male, 64% were White, 14% were Black, 13% race was undisclosed, 89% were prescribed antiplatelet therapy, 85% were prescribed a statin, and 60% had hypertension controlled to <140/90. Twenty patients (11.5%) experienced a cerebrovascular event during the 2-year study period. There were eight patients with transient ischemic attack, 10 with ipsilateral strokes, and 2 with strokes in unrelated territories. CONCLUSIONS: Despite good adherence to current recommendations for medical therapy, patients at our institution are developing symptomatic carotid disease at a rate similar to that reported in historical clinical trials. These data supports the concept that advances in medical management have not resulted in reduced stroke rates in asymptomatic patients with high-grade carotid stenosis at a large academic institution located in the southeastern United States. CEA and stenting provide a significant risk reduction and should be considered more often in this patient population.

Analysis of a Machine Learning-Based Risk Stratification Scheme for Chronic Limb-Threatening Ischemia.

Importance: Valid risk stratification schemes are key to performing comparative effectiveness research; however, for chronic limb-threatening ischemia (CLTI), risk stratification schemes have limited efficacy. Improved, accurate, comprehensive, and reproducible risk stratification models for CLTI are needed. Objective: To evaluate the use of topic model cluster analysis to generate an accurate risk prediction model for CLTI. Design, Setting, and Participants: This multicenter, nested cohort study of existing Project of Ex Vivo Vein Graft Engineering via Transfection (PREVENT) III clinical trial data assessed data from patients undergoing infrainguinal vein bypass for the treatment of ischemic rest pain or ischemic tissue loss. Original data were collected from January 1, 2001, to December 31, 2003, and were analyzed in September 2021. All patients had 1 year of follow-up. Exposures: Supervised topic model cluster analysis was applied to nested cohort data from the PREVENT III randomized clinical trial. Given a fixed number of clusters, the data were used to examine the probability that a patient belonged to each of the clusters and the distribution of the features within each cluster. Main Outcomes and Measures: The primary outcome was 1-year CLTI-free survival, a composite of survival with remission of ischemic rest pain, wound healing, and freedom from major lower-extremity amputation without recurrent CLTI. Results: Of the original 1404 patients, 166 were excluded because of a lack of sufficient feature and/or outcome data, leaving 1238 patients for analysis (mean [SD] age, 68.4 [11.2] years; 800 [64.6%] male; 894 [72.2%] White). The Society for Vascular Surgery Wound, Ischemia, and Foot Infection grade 2 wounds were present in 543 patients (43.8%), with rest pain present in 645 (52.1%). Three distinct clusters were identified within the cohort (130 patients in stage 1, 578 in stage 2, and 530 in stage 3), with 1-year CLTI-free survival rates of 82.3% (107 of 130 patients) for stage 1, 61.1% (353 of 578 patients) for stage 2, and 53.4% (283 of 530 patients) for stage 3. Stratified by stage, 1-year mortality was 10.0% (13 of 130 observed deaths in stage 1) for stage 1, 13.5% (78 of 578 patients) for stage 2, and 20.2% (105 of 521 patients) for stage 3. Similarly, stratifying by stage revealed major limb amputation rates of 4.2% (5 of 119 observed major limb amputations in stage 1) for stage 1, 10.8% (55 of 509 patients) for stage 2, and 18.4% (81 of 440 patients) for stage 3. Among survivors without a major amputation, the rates of CLTI recurrence were 9.2% (11 of 119 observed recurrences in stage 1) for stage 1, 24.9% (130 of 523 patients) for stage 2, and 29.6% (132 of 446 patients) for stage 3. Conclusions and Relevance: The topic model cluster analysis in this cohort study identified 3 distinct stages within CLTI. Findings suggest that CLTI-free survival is an end point that can be accurately and reproducibly quantified and may be used as a patient-centric outcome.

The Society for Vascular Surgery Objective Performance Goals for Critical Limb Ischemia are attainable in select patients with ischemic wounds managed with wound care alone.

BACKGROUND: To set therapeutic benchmarks, in 2009 the Society for Vascular Surgery defined objective performance goals (OPG) for treatment of patients with chronic limb threatening ischemia (CLTI) with either open surgical bypass or endovascular intervention. The goal of these OPGs are to set standards of care from a revascularization standpoint and to provide performance benchmarks for 1 year patency rates for new endovascular therapies. While OPGs are useful in this regard, a critical decision point in the treatment of patients with CLTI is determining when revascularization is necessary. There is little guidance in the comprehensive treatment of this patient population, especially in the nonoperative cohort. Guidelines are needed for the CLTI patient population as a whole and not just those revascularized, and our aim was to assess whether CLTI OPGs could be attained with nonoperative management alone. METHODS: Our cohort included patients with an incident diagnosis of CLTI (by hemodynamic and symptomatic criteria) at our institution from 2013-2017. The primary outcome measured was mortality. Secondary outcomes were limb loss and failure of amputation-free survival. Descriptive statistics were used to define the 2 groups - patients undergoing primary revascularization and patients undergoing primary wound management. The risk difference in outcomes between the 2 groups was estimated using collaborative-targeted maximum likelihood estimation. RESULTS: Our cohort included 349 incident CLTI patients; 60% male, 51% white, mean age 63 +/- 13 years, 20% Rutherford 4, and 80% Rutherford 5. Most patients (277, 79%) underwent primary revascularization, and 72 (21%) were treated with wound care alone. Demographics and presenting characteristics were similar between groups. Although the revascularized patients were more likely to have femoropopliteal disease (72% vs. 36%), both groups had a high rate of infrapopliteal disease (62% vs. 57%). Not surprisingly, the patients in the revascularization group were less likely to have congestive heart failure (34% vs. 42%), complicated diabetes (52% vs. 79%), obesity (19% vs. 33%), and end stage renal disease (14% vs. 28%). In the wound care group, 2-year outcomes were 65% survival, 51% amputation free survival, 19% major limb amputation, and 17% major adverse cardiac event. The wound care cohort had a 13% greater risk of death at 2 years; however, the risk of limb loss at 2 years was 12% less in the wound care cohort. CONCLUSIONS: A comprehensive set treatment goals and expected amputation free survival outcomes can guide revascularization, but also assure that appropriate outcomes are achieved for patients treated without revascularization. The 2-year outcomes achieved in this cohort provide an estimate of outcomes for nonrevascularized CLTI patients. Although multi-center or prospective studies are needed, we demonstrate that equal, even improved, limb salvage rates are possible.

Review of the current evidence for topical treatment for venous leg ulcers.

OBJECTIVE: The development of a venous leg ulcer (VLU) represents the most severe clinical manifestation of a chronic venous disease. Despite major progress, our understanding of the VLU pathogenesis and wound healing biology has remained limited. Treatment of VLUs remains a serious challenge for physicians of different specialties. In the present review, we focused on describing the rationale and scientific basis for topical wound care in the management of VLUs. METHODS: A literature review was performed to summarize the methods with proven efficacy in VLU management. A systematic search was also performed to identify new evidence from the randomized controlled trials reported from 2014 to 2021. The scientific challenges, clinical practice concerns, economic obstacles, and possible directions for further research have been discussed. RESULTS: Hundreds of topical products have been advertised for the treatment of VLUs. However, the reported data on the topical treatment of venous ulcers are insufficient, scattered, and weak, with significant methodologic flaws. A total of 43 randomized controlled trials on the topical treatment of VLUs were reported from 2014 to 2021. Thus, the clinical practice guidelines require updating. We identified major gaps in knowledge and have provided suggestions for future research directions. CONCLUSIONS: The American Venous Forum Research Committee would like to bring attention to the use of topical wound care for VLUs as a critical gap in knowledge and to encourage scientists, practitioners, and industry to collaborate to fill this gap.

Precision Medicine Enables More TNM-Like Staging in Patients With Chronic Limb Threatening Ischemia.

Introduction: In cancer, there are survival-based staging systems and tailored, stage-based treatments. There is little personalized treatment in vascular disease. The 2019 Global Vascular Guidelines on the Management of CLTI proposed successful treatment hinges upon Patient risk, Limb severity, and ANatomic complexity (PLAN). We sought to confirm a three axis approach and define how increasing severity affects mortality, not just limb loss. Methods: Patients revascularized for incident CLTI at our institution from 2013 to 2017 were included. Outcomes were mortality, limb loss, the composite endpoint of amputation-free survival. Using Bayesian machine learning, specifically supervised topic modeling, clusters of patient features associated with mortality were formed after controlling for revascularization type. Patients were assigned to the cluster they belonged to with highest probability; clusters were characterized by analyzing the characteristics of patients within them. Patient outcomes were used to order the clusters into stages with increasing mortality. Results: We defined three distinct clusters as the basis for patient- and limb-centered stages. Across stages, rates of 1-year mortality were 7.6, 13.8, 18.9% and rates of amputation-free survival were 84.8, 79.3, and 63.2%. Stage one had patients with rest pain and previous revascularization who were less likely to have wounds, diabetes, and renal disease. Stage two had doubled mortality, likely related to diabetes prevalence. Stage three is characterized by high rates of complicated comorbidities, particularly end stage renal disease, and significantly higher rate of limb loss (22.6 vs. 8% in stages one and two). Conclusion: Using precision medicine, we have demonstrated clustering of CLTI patients that can be used toward a robust staging system. We provide empiric evidence for PLAN and detail about how changes in each variable affect survival and amputation-free survival.

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.

Performance of Viabahn balloon-expandable stent compared with self-expandable covered stents for branched endovascular aortic repair.

OBJECTIVE: The objective of this study was to compare the performance between the Viabahn balloon-expandable stent (VBX; Viabahn [W. L. Gore & Associates, Flagstaff, Ariz]) and a covered self-expandable stent (SES; Fluency [Bard Peripheral Vascular, Tempe, Ariz]) used as bridging stents for directional branches during fenestrated or branched endovascular aneurysm repair of complex aortic aneurysms. METHODS: Patients with thoracoabdominal aortic aneurysms (type I-IV) or pararenal aortic aneurysms either at high risk for open repair or unsuitable for endovascular repair with commercially available devices were prospectively enrolled in a physician-sponsored investigational device exemption trial. Descriptive statistics of the cohort included demographics, risk factors, and anatomic and device characteristics. Individual branches were grouped as either VBX or SES and had data analyzed for primary patency, branch-related type I or type III endoleaks, branch instability, branch-related secondary intervention, and branch-related aortic rupture or death. Categorical variables were expressed as total and percentage, and continuous variables were expressed as median (interquartile range). Kaplan-Meier curves were used to estimate long-term results. Groups were compared with the log-rank test. P value <.05 was considered statistically significant. RESULTS: During the period from July 2012 through June 2019, there were 263 patients treated for complex aortic aneurysm (thoracoabdominal aortic aneurysm) with fenestrated or branched endografts. The devices used were either custom-manufactured devices or off-the-shelf p-Branch or t-Branch (Cook Medical, Bloomington, Ind) devices. The median age was 71 years (interquartile range, 66-79 years); 70% were male, and 81% were white. The most common cardiac risk factors were smoking (92%), hypertension (91%), hyperlipidemia (78%), and chronic obstructive pulmonary disease (52%). The total number of vessels incorporated into the repair was 977, with branches representing 18.4% (179 branches). Among these 179 branches, the celiac artery, superior mesenteric artery, right renal artery, and left renal artery received 54 (30%), 56 (31%), 38 (21%), and 31 (18%) branches, respectively. VBX and SES groups represented 96 (54%) and 81 (46%) of the branches implanted. The celiac artery, superior mesenteric artery, right renal artery, and left renal artery received VBX as a bridging stent in 40%, 46.7%, 33.8%, and 32.2% respectively. The overall cohort survival rate was 78.5% at 24 months. There was no branch-related rupture or mortality. Primary patency at 24 months (VBX, 98.1%; SES, 98.6%; log-rank, P = .95), freedom from endoleak (VBX, 95.6%; SES, 98.6%; log-rank, P = .66), freedom from secondary intervention (VBX, 94.7%; SES, 98.1%; log-rank, P = .33), and freedom from branch instability (VBX, 95.6%; SES, 97.2%; log-rank, P = .77) were similar between groups. CONCLUSIONS: This initial experience with VBX stents demonstrated excellent primary patency and similarly low rates of branch-related complications and endoleaks, with no branch-related aortic rupture or death. Our results demonstrate that in a high-volume, experienced aortic center, the VBX stent is a safe and effective bridging stent option during branched endovascular aortic repair. Multicenter studies with a larger cohort and longer follow-up are necessary to validate these findings.