Anticoagulation in Patients with Premature Peripheral Artery Disease Undergoing Lower Extremity Revascularization.

BACKGROUND: Premature peripheral artery disease (PAD), defined by lower extremity revascularization (LER) at age ≤ 50 years, is associated with poor major adverse limb events. The early onset of disease is thought to be influenced by genetic factors that regulate homeostasis of the vascular wall and coagulation. The aim of this study is to investigate the effect of anticoagulation as an adjunct to antiplatelet therapy on the outcomes of LER in patients with premature PAD. METHODS: There were 8,804 patients with premature PAD on preoperative and postoperative antiplatelet therapy only and 1,236 patients on preoperative and postoperative anticoagulation plus antiplatelet therapy in the Vascular Quality Initiative peripheral vascular intervention, infrainguinal, and suprainguinal files. Propensity score matching (2:1) was performed between patients with premature PAD who were on antiplatelet therapy and those on anticoagulation plus antiplatelet therapy. Perioperative and 1-year outcomes were analyzed including reintervention, major amputation, and mortality. RESULTS: Patients on anticoagulation were more likely to have coronary artery disease (48.7% vs. 41.2%, P < 0.001), congestive heart failure (20.2% vs. 13.1%, P < 0.001), and have undergone prior LER (73.9% vs. 49.2%, P < 0.001) compared to patients on antiplatelet therapy only. They were also less likely to be independently ambulatory (74.2% vs. 81.8%, P < 0.001) and be on a statin medication (66.8% vs. 74.3%, P < 0.001) compared to patients on antiplatelet therapy only. Patients on anticoagulation were also less likely to be treated for claudication (38.1% vs. 48.6%, P < 0.001), and less likely to be treated with an endovascular procedure (64.8% vs. 73.8%, P < 0.001). After matching for baseline characteristics, there were 1,256 patients on antiplatelet therapy only and 628 patients on anticoagulation. Patients on anticoagulation were more likely to require a return to the operating room (3.7% vs. 1.6%, P < 0.001) and had higher perioperative mortality (1.1% vs. 0.3%, P = 0.032), but major amputation was not significantly different (1.8% vs. 1.6%, P = 0.798) compared to patients on antiplatelet therapy alone. At 1 year, amputation-free survival was higher in patients on antiplatelets only compared to patients on anticoagulation and antiplatelet medications (87.5% vs. 80.9%, log-rank P = 0.001). CONCLUSIONS: Anticoagulation in addition to antiplatelet therapy in patients with premature PAD undergoing LER is associated with increased reintervention and mortality at 1 year.

Intravascular Ultrasound Use is Associated with Improved Patency in Lower Extremity Peripheral Arterial Interventions.

BACKGROUND: Intravascular ultrasound (IVUS) facilitates detailed visualization of endoluminal anatomy not adequately appreciated on conventional angiography. However, it is unclear if IVUS use improves clinical outcomes of peripheral vascular interventions (PVIs) for peripheral arterial disease. This study aimed to evaluate the impact of IVUS on 1-year outcomes of PVI in the vascular quality initiative (VQI). METHODS: The VQI-PVI modules were reviewed (2016-2020). All patients with available 1-year follow-up after lower extremity PVI were included and grouped as IVUS-PVI or non-IVUS PVI based on use of IVUS. Propensity matching (1:1) was performed using demographics and comorbidities. One-year major amputation and patency rates were compared. A generalized estimating equation model was used to identify predictors of 1-year outcomes. Subgroup analysis based on Trans-Atlantic Intersociety Consensus (TASC) classification, treatment length and treatment modalities were performed using same modeling approaches. RESULTS: There were 56,633 procedures (non-IVUS PVI = 55,302 vs. IVUS-PVI = 1,331) in 44,042 patients. Propensity matching yielded a total cohort of 1,854 patients matched (1:1), with no baseline differences. Lower extremity revascularization for claudication was performed in 60.4%, while one-third (33.9%) had chronic limb threatening ischemia (CLTI). IVUS was more commonly used for lesions >15 cm in length (46.6% vs. 43.3%) and for aortoiliac disease (31.8% vs. 27.2%). Rates of atherectomy and stenting were significantly higher with IVUS-PVI (21.1% vs. 16.8%), while balloon angioplasty was less common (13.5% vs. 24.4%). One-year patency was better with IVUS-PVI (97.7% vs. 95.2%, P = 0.004). On subgroup analysis, IVUS (odds ratio [OR] 2.20, 95% confidence interval [CI] 1.29-3.75) was associated with improved patency in CLTI patients, TASC C or D lesions, and treatment length >15 cm. Adjunctive IVUS use during PVI did not significantly impact 1-year amputation (OR 1.7, 95% CI 0.78-3.91). On multivariable regression, adjunctive use of IVUS (OR 2.46 95% CI 1.43-4.25) and aortoiliac interventions (OR 2.91, 95% CI 1.09-7.75) were independent predictors of patency. Treatment modalities such as atherectomy, stenting or balloon angioplasty did not significantly impact patency at 1-year. CONCLUSIONS: IVUS during lower extremity PVI is associated with improved 1-year patency, when compared to angiography alone. Certain subgroups, such as CLTI patients, lesions>15 cm, and TASC C or D lesions might benefit from adjunctive use of IVUS.

Perioperative complications of minor and major reinterventions for peripheral arterial disease.

INTRODUCTION: Patients with peripheral arterial disease (PAD) frequently require reinterventions after lower-extremity revascularization (LER) to maintain perfusion. Current Society for Vascular Surgery guidelines define reinterventions as major or minor based on the magnitude of the procedure. While prior studies have compared primary LER procedures of different magnitudes, similar studies for reinterventions have not been performed. The objective of this study is to compare perioperative outcomes associated with major and minor reinterventions. METHODS: Patients undergoing LER for PAD at a tertiary care center from 2013 to 2017 were included. A retrospective review of electronic medical records was performed, and reinterventions were categorized as major or minor based on the procedure magnitude. Minor reinterventions included endovascular procedures and open revision with patch angioplasty, while major reinterventions were characterized by open surgical or endovascular LER with catheter-directed thrombolysis (CDT). Perioperative outcomes following LER were captured and compared for major and minor reinterventions. An additional subgroup analysis was performed comparing outcomes associated with major reinterventions stratified into open major surgical reinterventions and CDT. RESULTS: This study included 713 patients over a mean follow-up of 2.5 years. A total of 291 patients underwent 696 ipsilateral reinterventions (range = 1-12 reinterventions). Most reinterventions were minor (72.1%, N = 502) and 27.9% (N = 194) were major. Patients receiving reinterventions had an average age of 67.2 ± 11.5 and most were white (73.5%) males (60.1%) initially treated for claudication (58.2%) and CLTI (41.8%). There was significantly higher post-operative bleeding (9.8% vs 3.4%, p = .001), arterial thrombosis (3.1% vs 1.0%, p = .047), and acute renal failure (6.2% vs 2.4%, p = .014) after major reinterventions than minor. Additionally, major reinterventions had significantly higher return to the OR (17.0% vs 11.3%, p = .046) and longer hospital stays (7.5 vs 4.3 days, p = <.0001). Overall, major reinterventions were associated with significantly increased perioperative morbidity (37.6% vs 19.7%, p ≤ .001) with no difference in perioperative mortality. In the subgroup analysis, open reinterventions resulted in significantly longer hospital stays (8.6 days vs 5.5 days, p ≤ .001) and more wound infections than CDT (11.0% vs 0%, p = .017). However, there was no other significant difference in morbidity or mortality following treatment with open surgical reinterventions or CDT. CONCLUSIONS: In this study, major reinterventions after LER were associated with greater perioperative morbidity than minor reinterventions, with no difference in mortality. Major reinterventions performed via open surgery and CDT had similar morbidity and mortality.

High-Risk Characteristics for Clinical Failure after Isolated Femoropopliteal Peripheral Vascular Interventions.

BACKGROUND: Recent studies suggesting increased late mortality with paclitaxel-coated devices (PCDs) in femoropopliteal peripheral vascular interventions (PVIs) prompted the US Food and Drug Administration to recommend limiting the use of PCDs to "patients at particularly high risk for restenosis". This study's aim is to characterize patients at high risk for restenosis and develop a risk score to guide clinicians in selecting patients for treatment with PCDs. METHODS: Patients who underwent isolated femoropopliteal PVI for claudication or rest pain from 2016-2019 in the Vascular Quality Initiative were included. Patients who received intervention with a PCD, hybrid procedures, died within 1 year, or had missing follow-up data were excluded. The primary end point was clinical failure at 1 year defined as > 50% restenosis, loss of patency, reintervention, or major amputation. Data were split randomly into 2/3 for development and 1/3 for validation. A parsimonious multivariable hierarchical logistic regression for clinical failure was developed and a risk score was created using beta-coefficients. The risk score was applied to the validation dataset and tested for goodness-of-fit and discrimination. RESULTS: Among 4,856 treated patients, 718 (14.8%) experienced clinical failure within 1 year. Clinical failure was associated with age ≤ 50 years, female sex (48.1% vs. 39.5%), insulin-dependent diabetes (29.9% vs. 23.1%), creatinine > 2.0 mg/dL (9.9% vs. 5.7%), prior ipsilateral lower extremity revascularization (48.5% vs. 38.5%), prior ipsilateral minor amputation (5.3% vs. 1.7%), rest pain versus claudication (30.8% vs. 18.7%), occlusion length ≥ 20 cm (18.8% vs. 15.0%), and Trans-Atlantic Inter-Society Consensus II Classification C or D (40.4% vs. 28.0%), all P ≤ 0.01. Risk score development was performed using a multivariable regression. The model demonstrated good fit and discrimination (C-statistic 0.71 in development and 0.72 in validation dataset). Predicted clinical failure was 8.9% for standard-risk (45.9% of interventions), 15.5% for high-risk (44.2% of interventions), and 33.8% for very high-risk patients (9.8% of interventions). CONCLUSIONS: A novel risk score was created with good discrimination for identifying patients at high risk for clinical failure at 1 year after femoropopliteal PVI for claudication and rest pain. Patients at high risk and very high risk for clinical failure may benefit from alternative strategies including PCDs.

Effect of Doxycycline on Progression of Arterial Calcification in the Noninvasive Treatment of Abdominal Aortic Aneurysm Clinical Trial (N-TA(3)CT).

BACKGROUND: Doxycycline has been shown to prevent arterial calcification via attenuation of matrix metalloproteinases (MMP) in preclinical models. We assessed the effects of doxycycline on progression of arterial calcification in patients enrolled in the Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial (N-TA3CT). METHODS: Two hundred and sixty-one patients were randomized to 100 mg doxycycline twice daily or placebo. Arterial calcification was measured in abdominal vessels on noncontrast computed tomography scans. Patients with baseline computed tomography scan and 1 or more follow-up scans within the 2-year study were included for analysis. For individual arteries, mean change in iliofemoral artery calcification over time was calculated via linear regression. Serum MMP-3 and MMP-9 levels were measured at baseline and 6 months. RESULTS: Sixty-five patients in the doxycycline and 66 in the placebo arm were included in this analysis. Baseline characteristics between the groups were similar. The unadjusted mean change in iliofemoral calcium score per year trended toward higher values in patients treated with doxycycline compared with placebo (322 ± 399 units/year vs. 217 ± 307 units/year, P = 0.09). After 6 months, changes in serum MMP-3 and MMP-9 levels were not significantly different between study arms. CONCLUSIONS: In patients with small aortic aneurysm, treatment with doxycycline 100 mg twice daily did not decrease circulating levels of the matrix degrading enzymes MMP-3 and 9 or alter the progression of arterial calcification.

Major Adverse Limb Events Among Patients with Premature Peripheral Artery Disease Compared with Those at the Common Age Undergoing Revascularization in the Vascular Quality Initiative.

BACKGROUND: Premature peripheral artery disease (PAD), defined as ≤ 50 years of age, is associated with poor outcomes following lower extremity revascularization (LER). However, the specific characteristics and outcomes of this group of patients compared to those at the common age undergoing revascularization have not been examined. The aim of this study is to compare patients with early versus late onset premature PAD undergoing LER focusing on major adverse limb events (MALEs). METHODS: All LER procedures (open and endovascular) in the Vascular Quality Initiative (VQI) were reviewed. A histogram of patient age at the time of initial LER (no prior LER) was used to define the common age, which included all patients within one standard deviation of the mean. Characteristics and outcomes of patients with premature PAD were compared to patients treated at the common age of presentation undergoing LER. RESULTS: A histogram of all patients undergoing LER was used to define 60 to 80 years as the common age. Patients with premature PAD were more likely to be female, African American, and Hispanic compared to patients at the common age. Patients with premature PAD were also more likely to have insulin-dependent diabetes, be current smokers, on dialysis, and be treated for claudication. Patients with premature PAD were less likely to have Transatlantic Intersociety Consensus (TASC II) C or D disease and were less likely to be on antiplatelets and statins. These differences were more pronounced in patients with chronic limb-threatening ischemia (CLTI). Cox proportional hazards regression demonstrated that premature PAD was independently associated with major adverse limb events (MALEs) at 1-year for patients with claudication (HR:1.7, 95% CI:1.4-2.0) and CLTI (HR:1.3, 95% CI:1.2-1.5) compared to patients 60 to 80 years of age. CONCLUSIONS: Patients with premature PAD have significant differences in characteristics compared to patients treated at the common age. Vascular providers should emphasize medical therapy prior to LER given the lower rates of medical optimization and worse 1-year MALEs in patients with premature PAD.

The Impact of Clinical Follow-Up After Revascularization on the Outcomes of Patients with Chronic Limb Threatening Ischemia.

BACKGROUND: Guidelines for optimal follow-up for patients undergoing lower extremity revascularization (LER) for peripheral arterial disease recommend multiple visits with imaging during the first year followed by yearly monitoring thereafter. Critical limb-threatening ischemia (CLTI) patients are at a greater risk for mortality and limb amputation than claudicants and thus necessitate closer monitoring. The goal of this article is to study the effects of compliance with follow-up after revascularization for patients with CLTI on major amputation rates and mortality. METHODS: A single-center retrospective chart review of consecutive patients undergoing LER for CLTI was performed. Patients were stratified based on compliance with follow-up to compliant or noncompliant cohorts. Patient characteristics, reinterventions, and perioperative and long-term outcomes were compared between the 2 groups. RESULTS: There were 356 patients undergoing LER and 61% (N = 218) were compliant. There was no significant difference in baseline characteristics between the 2 groups. Noncompliant patients were more likely to undergo endovascular interventions compared to compliant patients (92.8% vs. 79.4%, P = 0.03). There was no difference in perioperative outcomes between the 2 groups with overall 30-day mortality of 0.6%. After mean follow-up of 2.7 years, compliant patients had greater ipsilateral reintervention rates (49.1% vs. 34.1%, P = 0.005) and overall reintervention rates (61% vs. 44.2%, P = 0.002) compared to noncompliant patients. There was no significant difference in mortality or ipsilateral major amputations between the 2 groups. CONCLUSIONS: Patients who were compliant with follow-up after LER for CLTI underwent more reinterventions with no difference in mortality or major limb amputation. Further research regarding the threshold for reintervention and the optimal schedule for follow-up in patients with CLTI is needed.

Reinterventions in Patients with Claudication and Chronic Limb Threatening Ischemia.

BACKGROUND: Patients with peripheral artery disease (PAD) present with claudication or chronic limb threatening ischemia (CLTI). CLTI patients have a more advanced stage of atherosclerosis and increased comorbidities compared to claudicants, and are at an elevated risk of major amputation and mortality after lower extremity revascularization (LER). However, the frequency of reinterventions for claudication and CLTI have not been compared. Our hypothesis is that patients with CLTI undergo more frequent reinterventions to prevent major amputation. METHODS: A single-center retrospective chart review of consecutive patients undergoing lower extremity revascularization (LER) for PAD in 2013-2015 was performed. Patients were stratified based on indication for revascularization into claudication or CLTI. Patient characteristics, outcomes, and reinterventions were compared between the 2 groups. RESULTS: There were 826 patients undergoing LER and 44% (N = 361) had CLTI. Patients treated for CLTI were more likely to be smokers (P < 0.001), to have diabetes (P< 0.001), chronic renal insufficiency (P< 0.001), end stage renal disease (P< 0.001), and cardiac disease (P< 0.001). CLTI patients were less likely to be on optimal medical management as reflected by decreased rate of aspirin (P< 0.001), ADP receptor/P2Y12 inhibitors (P< 0.001), and statins (P< 0.001) compared to patients with claudication. Patients with CLTI had significantly higher major amputation (3.7% vs. 0.2%, P< 0.001) and mortality (1.4% vs. 0.2%, P = 0.092) at 30 days. At long-term follow up, patients with CLTI had higher rates of major amputation (15.5% vs. 1.3%, P < 0.001) and mortality (37.1% vs. 18.1%, P < 0.001) compared to patients with claudication. There was a significant difference in mean follow-up time between the 2 cohorts (claudication: 3.7 ± 1.5 years versus CLTI: 2.6 ± 1.8 years, P < 0.001). There was no significant difference in the ipsilateral reintervention rate between the 2 groups (claudication: 39.6% vs. CLTI: 42.7%, P = 0.37) or the mean number of ipsilateral reinterventions (claudication: 2.0 ± 1.6 vs. CLTI: 2.0 ± 1.7). However, after adjusting for follow-up time, the mean number of reinterventions per year was significantly higher for CLTI patients compared to patients with claudication (1.4 ± 2.2 vs. .6 ± 0.7 intervention per year, P < 0.001). CONCLUSIONS: Patients undergoing LER for CLTI undergo more frequent reinterventions over time compared to patients treated for claudication. Research on reinterventions after LER should include reporting of the frequency of reintervention adjusted for the follow up period in addition to the reintervention rate defined as the percentage of patients undergoing reintervention.

Outcomes of bypass and endovascular interventions for advanced femoropopliteal disease in patients with premature peripheral artery disease.

OBJECTIVE: Patients with premature peripheral artery disease (PAD), defined as age ≤50 years at presentation, have had poor outcomes with open and endovascular lower extremity revascularization. It is unclear whether either strategy is associated with better outcomes because comparative studies have been limited to case series in this patient population. The aim of the present study was to compare the outcomes of patients with premature PAD who had undergone bypass or endovascular revascularization for advanced femoropopliteal disease. Our hypothesis was that open bypass would provide superior long-term outcomes compared with endovascular intervention for patients with premature advanced femoropopliteal PAD. METHODS: All the patients with premature PAD who had undergone isolated femoropopliteal lower extremity revascularization and included in the Vascular Quality Initiative infrainguinal bypass and peripheral vascular intervention files were reviewed from 2003 through 2019. Propensity score matching (1:1) was performed between patients who had undergone femoropopliteal bypass and endovascular interventions for isolated femoropopliteal Trans-Atlantic Classification System C or D lesions. The 1-year outcomes, including reintervention, patency, major amputation, and mortality, were analyzed. RESULTS: Of the 2538 included patients, 902 had undergone isolated femoropopliteal endovascular intervention and 1636 had undergone femoropopliteal bypass. The endovascular intervention group were more likely to have diabetes (68.9% vs 54.0%; P < .001), coronary artery disease (31.0% vs 23.0%; P < .001), renal failure requiring dialysis (14.2% vs 7.2%; P < .001), and claudication (45.1% vs 36.6%; P < .001) compared with the bypass group. After propensity score matching, 466 patients were in each group with no significant differences in the baseline characteristics. Perioperative morbidity was higher with femoropopliteal bypass compared with endovascular intervention (12.0% vs 7.9%; P = .038); however, the rates of major amputation and mortality were not different. At 1 year, patients who had undergone femoropopliteal bypass were less likely to require reintervention (17.0% vs 25.2%; P = .012). However, no differences were found in major amputation (7.7% vs 7.9%; P = .928) or mortality (5.2% vs 5.2%; P = 1.00). Propensity score matching was also performed between femoropopliteal bypass with the great saphenous vein and isolated femoropopliteal endovascular interventions, and the outcomes were similar. CONCLUSIONS: For patients with premature PAD and advanced femoropopliteal disease, bypass surgery decreased the reintervention rate at 1 year but was associated with increased perioperative morbidity and hospital length of stay compared with endovascular therapy. No differences were found in major amputation or mortality between the two strategies.

Outcomes of treatment with paclitaxel-coated devices for peripheral arterial disease.

OBJECTIVE: The treatment of femoropopliteal peripheral artery disease (PAD) using paclitaxel-coated devices (PCDs) has been shown to improve patency in several randomized trials. However, a recent meta-analysis of trial data suggested an increased risk of mortality with PCD usage. Although subsequent studies have found no association with mortality, the subject has remained controversial. Thus, the aim of the present study was to further investigate the outcomes and causes of mortality for patients treated with PCDs. METHODS: Patients who had undergone endovascular interventions for PAD from 2013 to 2016 at a single institution were reviewed. The patients were stratified by the use of PCDs, which included drug-coated balloons and drug-eluting stents. The cumulative dose of paclitaxel was calculated for the patients who had received multiple interventions. The causes of mortality were identified and compared between the two groups. RESULTS: Of the 366 included patients, 138 (38%) had received a PCD and 228 (62%) had received a non-drug-coated (NDC) device. Patients treated with PCDs were less likely to have undergone open surgery compared with patients treated with NDC devices. No differences were found in the indications or 30-day outcomes between the two groups. After a mean follow-up of 3.1 ± 1.8 years, no differences were found in the primary patency, reintervention rate, mean number of reinterventions, major amputation (5% vs 4%; P = .465), or mortality (16% vs 20%; P = .363) between the PCD and NDC groups. Also, no overall difference was found in the cause of mortality with and without PCD use or in the Kaplan-Meier survival curves. Furthermore, PCD use was not associated with an increased risk of mortality in Cox regression analysis. The cumulative dose of paclitaxel in patients treated with PCDs ranged from 383 to 49,259 µg (median, 7561 µg). A comparison of the patients treated with a cumulative dose of paclitaxel in the upper 50th percentile compared with the lower 50th percentile showed no significant differences in mortality (13% vs 19%; P = .333). CONCLUSIONS: PCD use was shown to be safe and not associated with an increased risk of long-term mortality in the present study. Continued monitoring of PCD use is warranted to ensure the safety of this technology.

Long-term outcomes of transposed femoral vein arteriovenous fistula for abandoned upper extremity dialysis access.

BACKGROUND: The number and longevity of patients with end-stage renal disease requiring dialysis access have continued to increase, leading to challenging situations, including exhausted upper extremity access and severe central venous stenosis. This has led to an increase in the use of alternative access sites, including the lower extremities. The transposed femoral vein arteriovenous fistula for dialysis access is a previously described alternative, although limited data are available on its long-term patency. METHODS: Patients treated with a transposed femoral vein fistula were retrospectively reviewed. A transposed femoral vein fistula was created by harvesting the femoral vein and transposing it to the distal superficial femoral artery at the level of the adductor canal. The demographic information, perioperative characteristics, complications, and long-term outcomes were recorded and analyzed. RESULTS: A total of 21 patients had undergone transposed femoral vein fistula for dialysis access after an average of 5.3 ± 2.8 failed dialysis access procedures and a duration of 6.1 ± 4.9 years from the initiation of dialysis. The average age at the procedure was 53.5 ± 12.8 years. Ten patients (47.6%) had a history of diabetes mellitus and nine (42.9%) had a history of coronary artery disease. Technical success was achieved in 100% of cases, and 16 patients (76.2%) were discharged with anticoagulation therapy. The primary patency at 1, 3, and 5 years was 93%, 74%, and 74%, respectively. The secondary patency at 1, 3, and 5 years was 100%, 89%, and 89%, respectively. Two patients had compartment syndrome requiring fasciotomy, and six patients experienced wound complications. CONCLUSIONS: Transposed femoral vein fistula for dialysis access is a viable alternative for patients with an exhausted upper extremity access, with good long-term patency.

A Review and Proposed Classification System for the No-Option Patient With Chronic Limb-Threatening Ischemia.

A growing, but poorly defined subset of patients with chronic limb-threatening ischemia (CLTI) have "no option" for revascularization. One notable subgroup includes patients with severe ischemia and advanced pedal artery occlusive disease, termed "desert foot," who are at high risk for major amputation due to a lack of conventional revascularization options. Although new therapies are being developed for no-option patients with desert foot anatomy, this subgroup and the broader group of no-option patients are not well defined, limiting the ability to evaluate outcomes. Based on a systematic review, a classification of the no-option CLTI patient was constructed for use in clinical practice and studies. Several no-option conditions were identified, including type I-severe and pedal occlusive disease (desert foot anatomy) for which there is no accepted method of repair; type II-lack of suitable venous conduit for bypass in the setting of an acceptable target for bypass; type III-extensive tissue loss with exposure of vital structures that renders salvage impossible; type IV-advanced medical comorbidities for which available revascularization options would pose a prohibitive risk; and type V-presence of a nonfunctional limb. While type I and type II patients may have no option for revascularization, type III and type V patients have wounds, infection, comorbidities, or functional status that may leave them with few options for revascularization. As treatment strategies continue to evolve and novel methods of revascularization are developed, the ability to identify no-option patients in a standardized fashion will aid in treatment selection and assessment of outcomes.

Patient Characteristics, Patterns, and Repair of Aneurysms in Human Immunodeficiency Virus-Positive Patients.

BACKGROUND: Human immunodeficiency virus (HIV) is a multisystem disease and is associated with vascular complications including aneurysm formation. HIV-associated aneurysms are well documented and may present in unusual locations with concerning features. However, the literature regarding aneurysms in HIV-positive patients is limited to case series with limited data regarding aneurysm patterns. Furthermore, several small series have documented poor outcomes with surgical repair. Thus, our aim was to investigate the characteristics, patterns, and repair of aneurysms in HIV-positive patients in a multicenter study. METHODS: All patients with a diagnosis of aneurysms and HIV were retrospectively identified from 2013 to 2018 across 2 institutions. Comorbidities, HIV-related characteristics, aneurysm characteristics, and repair were reviewed. RESULTS: There were a total of 104 HIV-positive patients with 129 aneurysms. The mean age at the time of diagnosis was 57.7 ± 10.3 years, 80.8% of patients were male, and 32.0% had a history of acquired immunodeficiency syndrome. The average time from HIV diagnosis to aneurysm diagnosis was 14.1 ± 10.1 years. There were 53 (41.1%) ascending aortic, 25 (19.4%) abdominal aortic, 14 (10.9%) cerebral artery aneurysms, 13 (10.1%) descending thoracic, 9 (7.0%) iliac, 6 (4.7%) femoropopliteal, 4 (3.1%) visceral, 3 (2.9%) axillosubclavian, 1 (0.8%) carotid, and 1 (0.8%) coronary artery aneurysms. There were 23 (22.1%) patients with aneurysms in multiple vascular beds, 10 (9.6%) saccular aneurysms, and 1 (0.8%) inflammatory aneurysm. There were 7 ruptures (cerebral, descending thoracic, and iliac), 3 type A dissections (ascending aorta), and 1 thrombosis (popliteal). There were 26 (25.0%) patients who underwent surgical repair. This included 8 endovascular aneurysm repairs for abdominal aortic aneurysms, 6 endovascular coiling, clipping, and stent procedures for cerebral aneurysms, 4 open ascending aorta repairs, 2 bypasses for popliteal artery aneurysms, 2 endovascular stents for axillosubclavian artery aneurysms, 1 open descending aortic aneurysm repair, 1 endovascular aneurysm repair for an iliac aneurysm, 1 endovascular coiling for a renal artery aneurysm, and 1 open repair of a femoral artery aneurysm. Perioperative complications were common at 46.2%, although mortality was low at 3.8%. CONCLUSIONS: Although aneurysms were widespread, most HIV-positive patients had large vessel aneurysms in this study. There was a high prevalence of saccular and multiple aneurysms, and repair was associated with low rates of mortality despite high rates of complications. Additional studies are necessary to characterize this rare entity.

Lower Extremity Revascularization for Chronic Limb-Threatening Ischemia among Patients at the Extremes of Age.

BACKGROUND: Patients with chronic limb-threatening ischemia (CLTI) at the extremes of age are thought to have distinct risk factor profiles and poor outcomes after lower extremity revascularization (LER). The aim of this study is to examine the relationships among age, risk factor profiles, and outcomes of LER in patients with CLTI in a large database focusing on the extreme age groups. METHODS: Patients undergoing LER for CLTI in the Vascular Quality Initiative suprainguinal bypass, infrainguinal bypass, and peripheral vascular intervention files were reviewed through 2019. Patients were stratified into 3 groups: premature peripheral artery disease (PAD) (≤50 years old), 51-84 years old, and elderly (≥85 years old). Trends in major amputation and mortality by age group were analyzed. RESULTS: There were 156,513 patients who underwent LER for CLTI. Of these, 9,063 (5.79%) patients had premature PAD, 131,694 (84.14%) patients were 51-84 years old, and 15,756 (10.07%) were elderly. Patients with premature PAD were more likely to have insulin-dependent diabetes, be dialysis-dependent, and be active smokers compared to patients 51-84 years old and the elderly. Elderly patients were more likely to undergo an endovascular procedure for tissue loss compared to younger groups. Perioperative and 1-year major amputation rates were highest among patients with premature PAD and decreased with increasing age (P < 0.001), while perioperative and 1-year mortality increased with age (P < 0.001). On multivariable analysis, premature PAD was associated with an increased risk of major amputation (odds ratio, OR = 1.41 [1.22-1.62]), while elderly age was associated with decreased odds of major amputation compared to patients 51-84 years old (OR = 0.61 [0.51-0.73]). CONCLUSIONS: Patients at the extremes of age have significantly different outcomes after LER for CLTI. Although mortality increases with age, the risk of major amputation decreases. Patients with premature PAD constitute a group of patients with a high risk of perioperative and 1-year major amputation.

Multiple Reinterventions for Claudication are Associated with Progression to Chronic Limb-Threatening Ischemia.

BACKGROUND: Claudication has a relatively benign natural history, associated with a low risk of limb loss. However, rates of progression to chronic limb-threatening ischemia (CLTI) following lower extremity revascularization (LER) for claudication remain unclear. This study examines the long-term outcomes and risk factors associated with progression to CLTI after LER for claudication. METHODS: A single-center retrospective review of patients undergoing LER for claudication was performed from 2013-2016. Patients were stratified based on whether they progressed to CLTI or not. RESULTS: There were 448 patients (502 limbs) treated for claudication, and 57 (12.7%) progressed to CLTI with a mean follow up time of 3.7 ± 1.5 years. Among patients who progressed, 23 (5.1%) developed tissue loss, 34 (7.6%) developed rest pain, and 6 (1.2%) underwent major amputation. The mean time of progression to CLTI was 1.6 ± 1.5 years after index LER. Patients who progressed to CLTI were more likely to have a history of congestive heart failure and prior open revascularizations compared with those who did not progress. There was no difference in type or level of index revascularization between the two groups and no difference in perioperative complications. Patients who developed CLTI had significantly higher rates of reinterventions and a mean number of reinterventions after index LER prior to developing CLTI compared to those who did not progress. Multivariable logistic regression demonstrated that history of congestive heart failure (OR = 2.8 [1.2-6.6]), stroke (OR = 2.6 [1.1-6.1]), prior open procedure (OR = 2.8 [1.3-5.9]) and increasing number of reinterventions after index LER (OR = 2.9 [1.5-5.7]) were independently associated with disease progression to CLTI. CONCLUSIONS: Multiple reinterventions and previous open revascularization are associated with progression to CLTI following LER for claudication. Patients with atherosclerosis in the coronary and cerebrovascular beds are also more likely to have a progression of claudication to CLTI after LER.

Multiple duplications of the superficial femoral artery - Case report and review of the literature.

OBJECTIVES: Lower extremity arterial anatomic variations are rare, with duplication of the superficial femoral artery being an extremely uncommon variant with few prior reports in the literature.Methods/Results: We report the case of a 68-year-old male with calf claudication who underwent angiography and was found to have two separate areas of vessel duplication along the superficial femoral artery, which has not previously been described in the literature. CONCLUSION: Although uncommon, recognition of a duplicated superficial femoral artery is important to avoid difficulties and complications that may arise during open or endovascular procedures.

Presentation and outcomes of carotid endarterectomy in active smokers.

OBJECTIVE: Smoking is a significant modifiable risk factor in the pathogenesis of carotid artery disease and has been shown to be a predictor of worse outcomes after vascular surgery. However, the effect of active smoking on outcomes of patients undergoing carotid endarterectomy is unknown. This study analyzed the outcomes of carotid endarterectomy by smoking status in a large national database. METHODS: The American College of Surgeons National Surgical Quality Improvement Program targeted carotid endarterectomy files (2011-2017) were reviewed. Patients were stratified according to smoking status, and outcomes were compared using propensity score matching (1:1) based on preoperative characteristics. RESULTS: During the study period, 26,293 patients underwent carotid endarterectomy, with 19,282 (73.34%) nonsmokers and 7011 (26.66%) smokers. Smokers were more likely to be younger, to have chronic obstructive pulmonary disease, to have a symptomatic presentation, and to have higher anatomic risk (P < .05). Smokers were also more likely to have emergent surgery, to have general anesthesia, and to be reintubated (P < .05). After propensity matching, 5354 nonsmokers were matched with 5354 smokers who underwent carotid endarterectomy. Smokers were at significantly higher risk for death, with an odds ratio of 1.93 (confidence interval, 1.18-3.13). CONCLUSIONS: Smokers are at increased risk for death after carotid endarterectomy compared with matched counterparts. Smoking should be considered an important risk factor for worse outcomes, and patients should be strongly counseled on the importance of smoking cessation before undergoing carotid endarterectomy.

New Innovations and Devices in the Management of Chronic Limb-Threatening Ischemia.

As the number of patients afflicted by chronic limb-threatening ischemia (CLTI) continues to grow, new solutions are necessary to provide effective, durable treatment options that will lead to improved outcomes. The diagnosis of CLTI remains mostly clinical, and endovascular revascularization remains mostly balloon-based. Multiple innovative techniques and technologies are in development or in early usage that may provide new solutions. This review categorizes areas of advancement, highlights recent developments in the management of CLTI and looks forward to novel devices that are currently under investigation.

Trends and perioperative outcomes of patients with human immunodeficiency virus (HIV) undergoing lower extremity revascularization.

The development of highly active antiretroviral therapy (HAART) has significantly improved the life expectancy of patients with human immunodeficiency virus (HIV), but has led to the rise of chronic conditions including peripheral artery disease (PAD). However, trends and outcomes among patients with HIV undergoing lower extremity revascularization are poorly characterized. The aim of this study was to investigate the trends and perioperative outcomes of lower extremity revascularization among patients with HIV and PAD in a national database. The National Inpatient Sample (NIS) was reviewed between 2003 and 2014. All hospital admissions with a diagnosis of PAD undergoing lower extremity revascularization were stratified based on HIV status. Outcomes were assessed using propensity score matching and multivariable regression. Among all patients undergoing lower extremity revascularization for PAD, there was a significant increase in the proportion of patients with HIV from 0.21% in 2003 to 0.52% in 2014 (p < 0.01). Patients with HIV were more likely to be younger, male, and have fewer comorbidities, including coronary artery disease and diabetes, at the time of intervention compared to patients without HIV. With propensity score matching and multivariable regression, HIV status was associated with increased total hospital costs, but not length of stay, major amputation, or mortality. Patients with HIV with PAD who undergo revascularization are younger with fewer comorbidities, but have increased hospital costs compared to those without HIV. Lower extremity revascularization for PAD is safe for patients with HIV without increased risk of in-hospital major amputation or mortality, and continues to increase each year.

The Use of Embolic Protection Devices during Lower Extremity Peripheral Vascular Interventions.

BACKGROUND: The use of embolic protection device (EPD) during lower extremity peripheral vascular interventions (PVI) has been reported, but its impact on outcomes is unclear. The goal of this study was to assess the use and outcomes of EPDs during PVI. METHODS: All PVI between 2010 and 2014 in the Vascular Study Group of New England (VSGNE) database were reviewed. The characteristics of patients and lesions treated with EPD were identified. A propensity-matched control group without EPD was selected. The outcomes of both groups were compared, and a multivariable analysis was performed. RESULTS: There were a total of 10,875 procedures. EPD was used in 2% of the procedures. From 2010 to 2014, EPD use significantly increased from 1.1 to 3.5% (P < 0.001). Patients undergoing PVI with EPD were less likely to be white but more likely to have diabetes, chronic obstructive pulmonary disease, coronary artery disease, and history of prior PVI. After propensity matching, there were 182 procedures with EPD and 604 controls with no significant difference in risk factors. There was no difference in indication or anatomic level treated, with claudication (52.7% vs. 49.8%) being most common indication and the superficial femoral artery (65.4% vs. 62.1%), the most commonly treated artery. Patients undergoing PVI with EPD were more likely to be treated with excisional atherectomy (26.4% vs. 12.6%), whereas patients without EPD were more likely to be treated with orbital atherectomy (31.9% vs. 41.6%, P = 0.017). There was no significant difference in the incidence of minor distal embolization (DE) (1.1% vs. 1.5%) or DE requiring endovascular treatment (2.8% vs. 2.6%) between the two groups, but EPD use was significantly associated with increased fluoroscopy time (P < 0.001). There was no difference in technical success, patency, amputation, or mortality between the two groups. On multivariable analysis, there was no significant association between the use of EPD and patency (incidence relative risk (IRR) [95% CI] = 1.1 [0.9-1.3]), amputation (IRR = 0.7 [0.2-2.1]), or mortality (IRR = 0.8 [0.6-1.2]). However, there was a significant difference in fluoroscopy time (mean ratio [95% CI] = 1.2 [1.1-1.3]). The analysis was repeated after eliminating all procedures with DE in the EPD group (assuming that EPD use is 100% effective in preventing DE), and the results were no different. CONCLUSIONS: EPD use during PVI has significantly increased. Despite EPDs increasing procedural complexity and time, they do not seem to have any impact on PVI outcomes. Additional studies are needed to characterize which patients would benefit from EPDs.