Safety of Paclitaxel-Coated Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease.

OBJECTIVES: The aim of this study was to assess safety outcomes of femoropopliteal drug-coated balloon (DCB) angioplasty using patient-level data from the Lutonix clinical program. BACKGROUND: A recent systematic review and meta-analysis of heterogenous trials and summary-level data identified increased long-term mortality in patients treated with paclitaxel-coated balloons and stents. METHODS: We evaluated DCB angioplasty (n = 1,093) and uncoated balloon angioplasty (percutaneous transluminal angioplasty [PTA]) (n = 250) outcomes in LEVANT 1 (The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis), LEVANT 2 (Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries), and the LEVANT Japan Clinical Trial. Hazard ratios (HRs) were calculated with Cox proportional hazards modeling. RESULTS: There were no significant differences in mortality rates between DCB angioplasty and PTA. The 5-year HR was 1.01 (95% confidence interval [CI]: 0.68 to 1.52) in the aggregated LEVANT trials. The 2-year HR after DCB angioplasty was 0.99 (95% CI: 0.25 to 3.95) in LEVANT 1, 1.40 (95% CI: 0.62 to 3.14) in LEVANT 2, and 0.32 (95% CI: 0.05 to 1.92) in the LEVANT Japan Clinical Trial. The 5-year HR was 1.60 (95% CI: 0.94 to 2.72) in LEVANT 2. Adverse events and causes of death were balanced, without clustering between DCB angioplasty and PTA. Patients who underwent paclitaxel or nonpaclitaxel reinterventions had higher survival rates than those who did not undergo reinterventions. Baseline covariates predicting mortality included, among others, age (HR: 1.03 per year; p < 0.0001), prior treatment of target lesion (HR: 1.67; p = 0.022), arrhythmia (HR: 1.65; p = 0.031), and diabetes (HR: 1.18; p = 0.047), without differences between the 2 arms. No dose-response relationship was identified when adjusted for key predictors of mortality. CONCLUSIONS: Analyses of patient-level data identified no mortality differences between DCB angioplasty and PTA. Furthermore, the lack of dose-response relationships or clustering of causes of death argues against a causal relationship between paclitaxel and mortality. (LEVANT 1, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis [LEVANT 1], NCT00930813; Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries [LEVANT 2], NCT01412541; LEVANT 2 Continued Access Registry, NCT01628159; LEVANT Japan Clinical Trial, NCT01816412).

Mortality Assessment of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years.

BACKGROUND: A recent summary-level meta-analysis comprising randomized, controlled trials (RCTs) of femoropopliteal paclitaxel-coated balloon and stent intervention identified excess late mortality in the paclitaxel-treated patients. METHODS: We evaluated the safety of the Stellarex drug-coated balloon (DCB) for femoropopliteal artery disease with an independently performed meta-analysis of patient-level data from all patients in the Stellarex femoropopliteal clinical program. To compare mortality after DCB or uncoated percutaneous transluminal angioplasty (PTA), we aggregated data from 2 RCTs comprising 419 patients treated with DCB and 170 patients treated with PTA. In an additional analysis, data were aggregated from 6 poolable Stellarex DCB studies (2 RCTs, 3 single-arm studies, and 1 registry). All serious adverse events including deaths were adjudicated by a blinded, third-party, independent Clinical Events Committee. Kaplan-Meier estimates in the RCTs were compared with restricted mean survival time. Predictors of death were assessed with hazard ratios (HRs) and Cox proportional hazards modeling. RESULTS: Baseline characteristics were similar in the patients treated with DCB and PTA in the pooled RCT analysis, with the exception that the DCB cohort was younger (67.4±9.7 versus 69.4±9.4 years, P=0.02), smoked more frequently (86.6% versus 78.8%, P=0.02), and were less often treated for recurrent lesions (8.8% versus 14.7%, P=0.04). In the RCTs, patients treated with DCB had all-cause mortality rates that were not different from those of patients treated with PTA (Kaplan-Meier estimates 1.8±0.7% versus 1.3±0.9%, 6.5±1.2% versus 5.9±1.9%, and 9.3±1.5% versus 9.9±2.4% at 1, 2, and 3 years, respectively, P=0.86). All-cause mortality rates were similar in a 1906-patient pooled nonrandomized DCB data set (Kaplan-Meier estimates of 2.1%, 4.9%, and 7.0% at 1, 2, and 3 years, respectively). Clinical Events Committee-adjudicated causes of death were balanced between the DCB and PTA cohorts. Multivariable Cox modeling identified age (HR, 1.06; 95% CI, 1.04-1.08; P<0.001), diabetes mellitus (HR, 1.42; 95% CI, 1.01-2.00; P=0.04), congestive heart failure (HR, 1.88; 95% CI, 1.12-3.16; P=0.02), and renal insufficiency (HR, 2.00; 95% CI, 1.33-3.01; P<0.001) as predictors of mortality. Paclitaxel exposure was unrelated to mortality (HR, 1.04; 95% CI, 0.98-1.10; P=0.23). CONCLUSIONS: The mortality rates for patients treated with the DCB and uncoated PTA were indistinguishable over 3-year follow-up. Additional patient-level, adequately powered meta-analyses with larger RCT data sets will be needed to confirm the generalizability of these findings. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifiers: NCT02110524, NCT01858363, NCT01858428, NCT03421561, NCT01912937, NCT01927068, and NCT02769273.

A systematic review of venous aneurysms by anatomic location.

OBJECTIVE: Venous aneurysms are uncommon vascular abnormalities that may be identified anywhere in the body. Historically, they were often misdiagnosed as soft tissue lesions, but with the advent of readily available noninvasive imaging (such as duplex ultrasound), they can now be easily identified. Our aim was to review the presentation of venous aneurysms, available imaging modalities for defining them, and management. METHODS: The English-language literature before March 2017 was reviewed, and only reports of primary venous aneurysms of the deep veins were included. Reports were subdivided on the basis of the location of the venous aneurysm, and reports containing sample imaging studies were referenced from Elsevier publications. RESULTS: In total, our review identified reports of 35 head and neck venous aneurysms, 42 thoracic venous aneurysms, 152 intra-abdominal venous aneurysms, and 279 venous aneurysms of the extremities. Venous aneurysms of the lower extremity deep veins were most likely to be manifested by venous thromboembolic events, with approximately 25% to 50% of popliteal vein aneurysms presenting with pulmonary embolism. Diagnosis can be made by duplex ultrasound, computed tomography venography, magnetic resonance venography, or invasive venography. Management varies by location; most thoracic and head and neck aneurysms are observed, whereas venous aneurysms of the extremities are treated with surgical intervention, given the potential for venous thromboembolism. Few reports describe endovascular management of these lesions, so open surgical intervention remains the standard of care. CONCLUSIONS: Venous aneurysms are rare vascular malformations that occur throughout the body. Many are identified on routine imaging ordered for other indications, whereas venous aneurysms of the deep veins of the extremities are often manifested with venous thromboembolism. Management of these lesions is determined largely by location and the potential morbidity and mortality of the untreated aneurysms vs surgery; aneurysms of the head and neck and thorax are managed with observation and serial imaging over time, whereas those of the abdomen and extremities are treated with surgical intervention. Endovascular techniques continue to lack a defined role in their management, and the standard of care remains open repair, when indicated.

Clinical significance of reversal of flow in the vertebral artery identified on cerebrovascular duplex ultrasound.

BACKGROUND: Reversal of flow in the vertebral artery (RFVA) is an uncommon finding on cerebrovascular duplex ultrasound examination. The clinical significance of RFVA and the natural history of patients presenting with it are poorly understood. Our objective was to better characterize the symptoms and outcomes of patients presenting with RFVA. METHODS: A retrospective review was performed of all cerebrovascular duplex ultrasound studies performed at our institution between January 2010 and January 2016 (N = 2927 patients). Individuals with RFVA in one or both vertebral arteries were included in the analysis. RESULTS: Seventy-four patients (74/2927 patients [2.5%]) with RFVA were identified. Half of the patients were male. Mean age at the time of the first ultrasound study demonstrating RFVA was 71 years (range, 27-92 years); 78% of patients had hypertension, 28% were diabetic, and 66% were current or former smokers. Indications for the ultrasound examination were as follows: 44% screening/asymptomatic, 7% anterior circulation symptoms, 20% posterior circulation symptoms, 28% follow-up studies after cerebrovascular intervention, and 5% upper extremity symptoms. At the time of the initial ultrasound examination, 21 patients (28%) had evidence of a prior carotid intervention (carotid endarterectomy or carotid stenting), 21 patients had evidence of moderate (50%-79%) carotid artery stenosis (CAS) in at least one carotid artery, and 12 patients (16%) had evidence of severe (>80%) CAS. Of the 15 patients presenting with posterior circulation symptoms, 11 (73%) had evidence of concomitant CAS. In contrast, 22 of the 59 patients (37%) without posterior circulation symptoms had duplex ultrasound findings of CAS (P = .01). The mean duration of follow-up was 28 ± 22 months. Follow-up data were available for 63 patients (85%), including the 15 patients who presented with posterior circulation symptoms. Of these 15 patients, 5 underwent subclavian artery revascularization, including balloon angioplasty and stenting in 4 patients and open/hybrid revascularization in 1 patient. Five individuals were awaiting intervention. Three patients underwent carotid endarterectomy for CAS, with resultant improvement in posterior circulation symptoms. Finally, one patient was deemed too high risk for intervention, and one patient was found to have an alternative cause for symptoms. The remaining 59 patients continued to be asymptomatic during follow-up. One patient progressed to vertebral artery occlusion, and six patients had progression of CAS. CONCLUSIONS: Symptomatic RFVA responds well to intervention, including subclavian artery stenting and carotid intervention in patients with CAS. The majority of patients with this finding are asymptomatic at the time of presentation. Although progression of vertebral artery disease is rare, these patients may benefit from monitoring for progression of CAS with surveillance ultrasound.

Greater Frequency of Fruit and Vegetable Consumption Is Associated With Lower Prevalence of Peripheral Artery Disease.

OBJECTIVE: Although fruit and vegetable (F&V) consumption is associated with lower risk of coronary heart disease and stroke, its association with peripheral artery disease (PAD) is less certain. We, thus, sought to characterize F&V intake and investigate the association between F&V consumption and presence of PAD in a large community sample. APPROACH AND RESULTS: Self-referred participants at >20 000 US sites who completed medical and lifestyle questionnaires were evaluated by screening ankle brachial indices for PAD (ankle brachial index ≤0.9). Among 3 696 778 individuals, mean age was 64.1±10.2 years and 64.1% were female. Daily consumption of ≥3 servings of F&V was reported by 29.2%. Increasing age, female sex, white race, never smoking, being currently married, physical activity, increasing income, and frequent consumption of fish, nuts, and red meat were positively associated with daily consumption of F&V. After multivariable adjustment, there was a stepwise inverse association between F&V intake and PAD. Participants reporting daily intake of ≥3 servings of F&V had 18% lower odds of PAD than those reporting less than monthly consumption. In unadjusted and multivariable-adjusted models, the inverse association with F&V became stronger as ankle brachial index decreased. When stratified by smoking status, the association was present only among those subjects who currently or formerly smoked tobacco. CONCLUSIONS: Our study demonstrates an inverse association of F&V consumption with prevalent PAD and overall low F&V consumption. These observations suggest the need to further efforts to increase F&V consumption and for more rigorous evaluation of the role of F&V in PAD prevention.

Diabetes mellitus is a coronary heart disease risk equivalent for peripheral vascular disease.

Diabetes mellitus (diabetes) is associated with significantly increased risk of peripheral vascular disease. Diabetes is classified as a coronary heart disease (CHD) risk equivalent, but it is unknown whether diabetes is a CHD risk equivalent for peripheral vascular disease. The objective was to evaluate the odds of peripheral arterial disease (PAD) or carotid artery stenosis (CAS) among participants with diabetes, CHD, or both, compared with participants without diabetes or CHD, in a nationwide vascular screening database. We hypothesized that diabetes and CHD would confer similar odds of PAD and CAS. METHODS: A cross-sectional analysis of all eligible Life Line Screening Inc participants age 30 to 90 years with ankle brachial indices for PAD (ankle brachial index <0.9 in either leg) and carotid artery duplex ultrasonographic imaging for CAS (internal CAS ≥50%) was performed (N=3,522,890). RESULTS: Diabetes and CHD were present in 372,330 (10.7%) and 182,760 (5.8%) of participants, respectively; PAD and CAS were present in 155,000 (4.4%) and 130,347 (3.7%) of participants. After multivariable adjustment, PAD odds were 1.56 (95% CI 1.54-1.59) and 1.69 (95% CI 1.65-1.73) for participants with diabetes or CHD, respectively. Participants with both diabetes and CHD had 2.75-fold increased odds of PAD (95% CI 2.66-2.85). Findings were similar for CAS; compared with no diabetes or CHD, CAS odds increased for participants with diabetes alone (1.53, 95% CI 1.50-1.56), CHD alone (1.72, 95% CI 1.68-1.76), and both diabetes and CHD (2.57, 95% CI 2.49-2.66). Findings were consistent for women and men. CONCLUSION: In a large database of more than 3.5 million self-referred participants, diabetes was a CHD risk equivalent for PAD and CAS, and participants with comorbid diabetes and CHD had an especially robust association with PAD and CAS. Counseling regarding screening and prevention of peripheral vascular disease may be useful for patients with diabetes.

Increased Prevalence of Moderate and Severe Peripheral Arterial Disease in the American Indian (AI)/Alaskan Native (AN) Population; a Study of 96,000 AI/AN.

BACKGROUND: Peripheral arterial disease (PAD) disproportionally affects racial groups in the United States. Few studies have analyzed the rates of PAD in the American Indian (AI)/Alaskan Native (AN) population. In this article, we compare the prevalence of PAD in the AI/AN as compared with white and nonwhite Americans. METHODS: The study data were provided by Life Line Screening (Independence, OH). The cohort consists of self-referred individuals who paid for vascular screening tests. Mild-to-moderate and severe PAD were defined as having an ankle-brachial index (ABI) in at least one extremity of < 0.9 and < 0.5, respectively. Univariate and multivariate analyses were performed to compare the rates of PAD between AI/AN, Caucasians, and nonwhites. RESULTS: The original sample for which this study was obtained included 3,444,272 people. Of this group there was a predominance of females 64.5% (2,221,555) compared with 35.5% (1,222,716) males. The Native American/AN population was 2.8% of the sample (96,440). In our univariate analysis AI/AN had the highest rates of mild-moderate and severe PAD when compared with whites (odds ratio [OR] 1.78 and 2.14, respectively) and nonwhites (OR 1.52 and 1.82, respectively). We then controlled for atherosclerotic risk factors in our multivariate analysis, and the AI/NA cohort had persistently higher rates of both moderate and severe PAD compared with whites (OR 1.32 and 1.40) but not compared with nonwhites (OR 0.95 and 0.92). CONCLUSIONS: Here we present the largest epidemiology study of PAD in AI/AN to date. AI/NA people have disproportionately high rates of both mild to-moderate and severe PAD when compared with whites and nonwhite Americans. After controlling for atherosclerotic risk factors the rates of PAD remain high for AI/NA when compared with whites but not when compared with nonwhites. While it is possible that a combination of diet and lifestyle choices are responsible for the high rates of PAD in this population, genetic factors may be involved as well, and deserve further investigation. Optimal medical management may help to prevent the complications of PAD in this patient population.

Aberrant left vertebral artery transposition and concomitant carotid-subclavian bypass for treatment of acute intramural hematoma with thoracic endovascular aortic repair.

Aberrant left vertebral artery (LVA) origin off the aortic arch is an uncommon anatomic variant. Treatment of the thoracic aortic pathology that necessitates its coverage has not been described. We present a patient with an acute intramural hematoma with a dominant LVA originating from the aortic arch. A LVA-to-carotid artery transposition with shunt placement, carotid-to-subclavian bypass, and thoracic endovascular aortic repair were performed. The patient recovered uneventfully, without any evidence of stroke. This case study shows that aberrant left vertebral anatomy presents a unique and interesting challenge and that vertebral shunt techniques during revascularization can be performed without stroke.

Mesenteric vein thrombosis can be safely treated with anticoagulation but is associated with significant sequelae of portal hypertension.

BACKGROUND: Mesenteric venous thrombosis (MVT) is a relatively uncommon but potentially lethal condition associated with bowel ischemia and infarction. The natural history and long-term outcomes are poorly understood and under-reported. METHODS: A single-institution retrospective review of noncirrhotic patients diagnosed with MVT from 1999 to 2015 was performed using International Classification of Diseases, Ninth Revision and radiology codes. Patients were excluded if no radiographic imaging was available for review. Eighty patients were identified for analysis. Demographic, clinical, and radiographic data on presentation and at long-term follow-up were collected. Long-term sequelae of portal venous hypertension were defined as esophageal varices, portal vein cavernous transformation, splenomegaly, or hepatic atrophy, as seen on follow-up imaging. RESULTS: There were 80 patients (57.5% male; mean age, 57.9 ± 15.6 years) identified; 83.3% were symptomatic, and 80% presented with abdominal pain. Median follow-up was 480 days (range, 1-6183 days). Follow-up radiographic and clinical data were available for 50 patients (62.5%). The underlying causes of MVT included cancer (41.5%), an inflammatory process (25.9%), the postoperative state (20.7%), and idiopathic cases (18.8%). Pancreatic cancer was the most common associated malignant neoplasm (53%), followed by colon cancer (15%). Twenty patients (26%) had prior or concurrent lower extremity deep venous thromboses. Most patients (68.4%) were treated with anticoagulation; the rest were treated expectantly. Ten (12.5%) had bleeding complications related to anticoagulation, including one death from intracranial hemorrhage. Four patients underwent intervention (three pharmacomechanical thrombolysis and one thrombectomy). One patient died of intestinal ischemia. Two patients had recurrent MVT, both on discontinuing anticoagulation. Long-term imaging sequelae of portal hypertension were noted in 25 of 50 patients (50%) who had follow-up imaging available. Patients with long-term sequelae had lower recanalization rates (36.8% vs 65%; P = .079) and significantly higher rates of complete as opposed to partial thrombosis at the initial event (73% vs 43.3%; P < .005). Long-term sequelae were unrelated to the initial cause or treatment with anticoagulation (P = NS). CONCLUSIONS: Most cases of MVT are associated with malignant disease or an inflammatory process, such as pancreatitis. A diagnosis of malignant disease in the setting of MVT has poor prognosis, with a 5-year survival of only 25%. MVT can be effectively treated with anticoagulation in the majority of cases. Operative or endovascular intervention is rarely needed but important to consider in patients with signs of severe ischemia or impending bowel infarction. There is a significant incidence of radiographically noted long-term sequelae from MVT related to portal venous hypertension, especially in cases of initial complete thrombosis of the mesenteric vein.

Co-existence of vascular disease in different arterial beds: Peripheral artery disease and carotid artery stenosis--Data from Life Line Screening(®).

BACKGROUND: Atherosclerosis is a systemic vascular disorder, involving multiple arterial territories. This project sought to investigate the relationship between lower extremity peripheral artery disease (PAD) and carotid artery stenosis (CAS) in a large self-referred population. METHODS: Data from the ankle brachial index (ABI) and carotid duplex ultrasound were analyzed from 3.67 million US subjects in the Life Line Screening program between 2004 and 2008. PAD was defined by ABI<0.9 and CAS was defined by greater than 50% stenosis. Multivariate logistic regression analysis was used to estimate odds of CAS by PAD status and severity. RESULTS: Mean age of the population was 63.7 ± 10.6 years and 64% were women. The prevalence of PAD and CAS was 4.1% and 3.9%, respectively. Subjects with PAD had a higher prevalence of CAS than those without PAD (18.8% vs. 3.3%, P < 0.0001). In multivariate analysis, PAD was associated with greater odds of CAS (OR 3.28, 95% CI 3.22-3.34). Both symptomatic (OR 3.66, 95% CI 3.58-3.75) and asymptomatic PAD (OR 2.91, 95% CI 2.84-2.98) was associated with CAS. Increasing severity of PAD was associated with greater odds of CAS (OR 2.32, 3.61, 4.19, 5.14, and 7.59 for ABI categories 0.81-0.90, 0.71-0.80, 0.61-0.70, 0.41-0.60, ≤0.40, respectively). CONCLUSION: Presence and severity of PAD was associated with prevalence of CAS in the large self-referred and self-paying Life Line cohort, regardless of lower extremity symptoms.

Association between physical activity and peripheral artery disease and carotid artery stenosis in a self-referred population of 3 million adults.

OBJECTIVE: Although the relationship between physical activity and coronary heart disease is well characterized, a paucity of data exists on physical activity and vascular disease in other arterial territories. This study examined the prevalence of peripheral artery disease (PAD) and carotid artery stenosis (CAS) in association with physical activity. APPROACH AND RESULTS: The association between physical activity and vascular disease was examined in >3 million self-referred US participants in the United States from 2003 to 2008 who completed a medical and lifestyle questionnaire in the Life Line screening program. All subjects were evaluated by screening ankle brachial indices <0.90 for PAD and ultrasound imaging for CAS >50%. Multivariable logistic regression modeling was used to estimate odds of disease. Among 3 250 350 subjects, 63% of the population engaged in some leisure time vigorous physical activity. After adjustment for age, sex, race/ethnicity, hypertension, hypercholesterolemia, smoking status, diabetes mellitus, body mass index, and family history of cardiovascular disease, subjects who reported any physical activity had a significantly lower odds of PAD (odds ratio, 0.64; 95% confidence interval, 0.63-0.65) and CAS (odds ratio, 0.80; 95% confidence interval, 0.79-0.81). The association between physical activity with PAD and CAS was robust when stratified by sex, race, and age categories. Physical activity intensity frequency was associated with lower PAD and CAS in a graded manner (P trend <0.0001 for both). Findings seemed unaffected by confounding by comorbidity or indication. CONCLUSIONS: In a large population-based study, higher levels of physical activity were independently associated with lower odds of vascular disease in the lower extremities and carotid arteries.

Diabetes and vascular disease in different arterial territories.

OBJECTIVE: The aim of this study was to investigate the relationship between diabetes and different phenotypes of peripheral vascular disease (lower extremity peripheral artery disease [PAD], carotid artery stenosis [CAS], and abdominal aortic aneurysm [AAA]). RESEARCH DESIGN AND METHODS: Prevalence of vascular disease was evaluated in 3,696,778 participants of the Life Line Screening survey between 2003 and 2008. PAD was defined as ankle-brachial pressure index <0.90 or prior revascularization, CAS as ≥50% stenosis or prior revascularization, and AAA as infrarenal aortic diameter ≥3 cm or prior repair. Odds ratios (ORs) and 95% CIs were assessed using logistic regression modeling. RESULTS: Diabetes mellitus was present in 10.8% of participants (n = 399,884). Prevalence of PAD, CAS, and AAA was significantly higher (P < 0.0001) in participants with compared with those without diabetes. After multivariate adjustment for baseline demographics and clinical risk factors, a significant interaction existed between diabetes and vascular disease phenotype (P < 0.0001). Diabetes was associated with increased odds of PAD (OR 1.42 [95% CI 1.41-1.4]; P < 0.0001) and CAS (1.45 [1.43-1.47]; P < 0.0001) but decreased odds of AAA (0.86 [0.84-0.88]; P < 0.0001). The strength of association increased with increasing severity of disease in each vascular phenotype, and this association persisted in the population with asymptomatic vascular disease. CONCLUSIONS: In a large population-based study, the association between diabetes and vascular disease differed according to vascular phenotype. Future studies exploring the mechanism for these vascular-specific differences are needed.

Nationwide comparative impact of thoracic endovascular aortic repair of acute uncomplicated type B aortic dissections.

OBJECTIVE: Thoracic endovascular aortic repair (TEVAR) for acute uncomplicated type B aortic dissection (TBAD) remains controversial. This study aims to evaluate the impact of TEVAR on mortality, morbidity, length of stay (LOS), and discharge status in patients with acute uncomplicated TBAD. METHODS: We analyzed the National Inpatient Sample from 2009 and 2010. Patients were categorized according to the type of treatment: TEVAR or medical management. Outcomes, including mortality, stroke, myocardial infarction (MI), acute renal failure, discharge disposition, and LOS, were compared between the treatment groups. RESULTS: We identified 4706 patients with TBAD. Mean age was 67 years and 55% were male. Treatment options included TEVAR in 504 and medical management in 4202. The overall adjusted in-hospital mortality was similar for both the groups (8.5% for TEVAR vs 10.3% for medical management, P = .224). The TEVAR carried higher risk of stroke (odds ratio [OR] = 1.61, 95% confidence interval [CI] = [1.14-2.27]; P = .0073). The TEVAR was associated with prolonged LOS (12 vs 5.6 days, P < .0001) and patients were less likely to be discharged home (OR 0.73, 95% CI 0.54-0.99; P = .013). When stratified by age, all outcomes were similar between the 2 groups, with the exception of longer LOS with TEVAR. CONCLUSIONS: Thoracic endovascular aortic repair for acute uncomplicated TBAD was associated with similar in-hospital mortality, MI, and renal failure as compared to medical management. The TEVAR had higher rate of stroke up to the age 70 years and longer LOS. Because extending TEVAR to less complicated patients could only decrease TEVAR mortality rates, these findings support the more widespread use of TEVAR to treat patients with uncomplicated TBAD.

Concomitant unruptured intracranial aneurysms and carotid artery stenosis: an institutional review of patients undergoing carotid revascularization.

BACKGROUND: The incidence of concomitant carotid artery stenosis and unruptured intracranial aneurysms (UIAs) has been reported at between 0.5% and 5%. In these patients, treatment strategies must balance the risk of ischemic stroke with the risk of aneurysmal rupture. Several studies have addressed the natural course of UIAs in the setting of carotid revascularization; however, the final recommendations are not uniform. The purpose of this study was to review our institutional experience with concomitant UIAs and carotid artery stenosis. METHODS: We performed a retrospective review of all patients with carotid artery stenosis who underwent carotid artery endarterectomy (CEA) or carotid artery stenting (CAS) at our institution between 2003 and 2010. Only patients with preoperative imaging demonstrating intracranial circulation were included. Charts were reviewed for patients' demographic and clinical data, duration of follow-up, and aneurysm size and location. Patients were stratified into 2 groups: carotid artery stenosis with unruptured intracranial aneurysm (CS/UIA) and carotid artery stenosis without intracranial aneurysm (CS). RESULTS: Three hundred five patients met the inclusion criteria and had a total of 316 carotid procedures (CAS or CEA) performed. Eleven patients were found to have UIAs (3.61%) prior to carotid revascularization. Male and female prevalence was 2.59% and 5.26% (P = 0.22), respectively. Patients' demographics did not differ significantly between the 2 groups. The average aneurysm size was 3.25 ± 2.13 mm, and the most common location was the cavernous segment of the internal carotid artery. No patient in the study had aneurysm rupture, and the mean follow-up time was 26.5 months for the CS/UIA group. CONCLUSIONS: Concomitant carotid artery stenosis and UIAs is a rare entity. Carotid revascularization does not appear to increase the risk of rupture for small aneurysms (<10 mm) in the midterm. Although not statistically significant, there was a higher incidence of aneurysms found in females in our patient population.

Endovascular-first approach is not associated with worse amputation-free survival in appropriately selected patients with critical limb ischemia.

OBJECTIVE: Endovascular interventions for critical limb ischemia are associated with inferior limb salvage (LS) rates in most randomized trials and large series. This study examined the long-term outcomes of selective use of endovascular-first (endo-first) and open-first strategies in 302 patients from March 2007 to December 2010. METHODS: Endo-first was selected if (1) the patient had short (5-cm to 7-cm occlusions or stenoses in crural vessels); (2) the disease in the superficial femoral artery was limited to TransAtlantic Inter-Society Consensus II A, B, or C; and (3) no impending limb loss. Endo-first was performed in 187 (62%), open-first in 105 (35%), and 10 (3%) had hybrid procedures. RESULTS: The endo-first group was older, with more diabetes and tissue loss. Bypass was used more to infrapopliteal targets (70% vs 50%, P = .031). The 5-year mortality was similar (open, 48%; endo, 42%; P = .107). Secondary procedures (endo or open) were more common after open-first (open, 71 of 105 [68%] vs endo, 102 of 187 [55%]; P = .029). Compared with open-first, the 5-year LS rate for endo-first was 85% vs 83% (P = .586), and amputation-free survival (AFS) was 45% vs 50% (P = .785). Predictors of death were age >75 years (hazard ratio [HR], 3.3; 95% confidence interval [CI], 1.7-6.6; P = .0007), end-stage renal disease (ESRD) (HR, 3.4; 95% CI, 2.1-5.6; P < .0001), and prior stroke (HR, 1.6; 95% CI, 1.03-2.3; P = .036). Predictors of limb loss were ESRD (HR, 2.5; 95% CI, 1.2-5.4; P = .015) and below-the-knee intervention (P = .041). Predictors of worse AFS were older age (HR, 2.03; 95% CI, 1.13-3.7; P = .018), ESRD (HR, 3.2; 95% CI, 2.1-5.11; P < .0001), prior stroke (P = .0054), and gangrene (P = .024). CONCLUSIONS: At 5 years, endo-first and open-first revascularization strategies had equivalent LS rates and AFS in patients with critical limb ischemia when properly selected. A patient-centered approach with close surveillance improves long-term outcomes for both open and endo approaches.

Use of preoperative magnetic resonance angiography and the Artis zeego fusion program to minimize contrast during endovascular repair of an iliac artery aneurysm.

BACKGROUND: A 61-year-old man with a previous endovascular repair and stage 5 chronic kidney disease presented with a symptomatic 4.5-cm left internal iliac artery aneurysm. The decision was made to proceed with endovascular repair. METHODS: The preoperative magnetic resonance angiography (MRA) scan was linked to on-table rotational imaging using the Artis zeego Fusion program (Siemens AG, Forchheim, Germany). Using the fused image as a road map, we undertook coil embolization of the left internal iliac artery, and a tapered stent graft was extended from the previous graft into the external iliac artery. RESULTS: Completion angiography revealed exclusion of the aneurysm sac. Three milliliters of contrast were used throughout the procedure. A follow-up magnetic resonance angiography scan at 1 month and duplex ultrasonography at 1 year revealed continued exclusion of the aneurysm sac. The patient's renal function remained unchanged. CONCLUSIONS: This case shows that in a patient with severe chronic kidney disease, fusion of preoperative imaging with intraoperative rotational imaging is feasible and can limit significantly the amount of contrast used during a complex endovascular procedure.

Preoperative relative abdominal aortic aneurysm thrombus burden predicts endoleak and sac enlargement after endovascular anerysm repair.

BACKGROUND: Endoleak and sac growth remain unpredictable occurrences after EVAR, necessitating regular surveillance imaging, including CT angiography. This study was designed to identify preoperative CT variables that predict AAA remodeling and sac behavior post-EVAR. METHODS: Pre- and postoperative CT scans from 136 abdominal aortic aneurysms treated with EVAR were analyzed using M2S (West Lebanon, NH) software for size measurements. Preoperative total sac volume and proportion of thrombus and calcium in the sac were assessed. Sac change was defined as a 3-mm difference in diameter and a 10-mm3 difference in volume when compared with preoperative measurements. Univariate analysis was performed for age, gender, AAA size, relative thrombus/calcium volume, device type, presence of endoleak, and the effects on sac size. RESULTS: Gender, device type, age, AAA size, and percent calcium were not predictive of sac change post-EVAR. Increased proportion of thrombus on pre-EVAR resulted in a greater likelihood of sac shrinkage (P=0.002). Patients with aneurysms that grew on postoperative CT scan had less sac thrombus on pre-EVAR (mean 27.5%) than patients without evidence of endoleak (mean 41.9%, P<0.0001). Only 2 of 30 patients with >50% pre-EVAR thrombus developed endoleak. A>50% thrombus burden resulted in endoleak in significantly fewer patients (6.7%) compared with those who had <50% thrombus (43.1%). CONCLUSIONS: The proportion of thrombus on preoperative CT may predict sac behavior after EVAR and development of an endoleak. Greater than 50% thrombus appears to predict absence of endoleak after EVAR. Aneurysms with large thrombus burden are less likely to grow and may require less vigilant postoperative surveillance than comparable AAA with relatively little thrombus.

Endovascular versus medical therapy for uncomplicated type B aortic dissection: a qualitative review.

BACKGROUND: Uncomplicated type B dissections have been traditionally managed with antihypertensive therapy. In the endovascular era, this dictum has been revisited. This review pooled the available studies to compare the outcomes of best medical therapy (BMT) to thoracic endovascular aortic repair (TEVAR) for uncomplicated type B dissections. METHODS: A literature search was performed to identify studies on uncomplicated type B dissections managed with BMT with and without TEVAR. The primary outcome measures were mortality rates at 30 days and at 2 years following intervention. RESULTS: A total of 6 studies included 123 patients who underwent TEVAR/BMT, and 566 patients who had BMT alone. The mortality rates at 30 days (6.5% TEVAR/BMT vs 4.8% BMT, P = .21) and at 2 years (9.7% vs 11.9%, P = .32) were similar. Renal failure was greater in TEVAR/BMT (15.4% vs 2.1%, P < .01). Rates of surgical reintervention/intervention were similar (17.6% vs 20.1%, P = .31). CONCLUSION: The TEVAR with BMT does not provide survival benefit compared to BMT alone, 2 years following uncomplicated type B aortic dissection.

Modifiable risk factor burden and the prevalence of peripheral artery disease in different vascular territories.

BACKGROUND: The precise relationship between risk factor burden and prevalence of peripheral artery disease (PAD) in different vascular territories (PAD, carotid artery stenosis [CAS], and abdominal aortic aneurysms [AAAs]) is unclear. METHODS: We investigated the association of modifiable risk factors (hypertension, hypercholesterolemia, smoking, diabetes, and sedentary lifestyle) with any and type-specific peripheral vascular disease (PVD) among 3.3 million patients in the U.S., aged 40 to 99, who underwent screening bilateral ankle brachial indices, carotid duplex ultrasound, and abdominal aortic ultrasound in the Life Line Screening program between 2004 and 2008. Multivariate logistic regression analysis was used to estimate the odds of disease in different risk factor categories. Population-attributable risk was calculated to estimate the proportion of disease that could be potentially ascribed to modifiable risk factors. RESULTS: Among 3,319,993 participants, prevalence of any PVD was 7.51% (95% confidence interval [CI], 7.50%-7.53%). PAD was present in 3.56% (95% CI, 3.54%-3.58%), CAS in 3.94% (95% CI, 3.92%-3.96%), and AAAs in 0.88% (95% CI, 0.86%-0.89%). The multivariate-adjusted prevalence with the presence of 0, 1, 2, 3, 4, and 5 modifiable risk factors was 2.76, 4.63, 7.12, 10.73, 16.00, and 22.08 (P < .0001 for trend) for any PVD; 1.18, 2.09, 3.28, 5.14, 8.32, and 12.43 (P < .0001 for trend) for PAD; 1.41, 2.36, 3.72, 5.73, 8.48, and 11.58 (P < .0001 for trend) for CAS; and 0.31, 0.54, 0.85, 1.28, 1.82, and 2.39 (P < .0001 for trend) for AAAs, respectively. These associations were similar for men and women. For every additional modifiable risk factor that was present, the multivariate-adjusted odds of having vascular disease increased significantly (any PVD [odds ratio (OR), 1.58; 95% CI, 1.58-1.59]; PAD [OR, 1.62; 95% CI, 1.62-1.63]; CAS [OR, 1.57; 95% CI, 1.56-1.57]; and AAA [OR, 1.51; 95% CI, 1.50-1.53]). CONCLUSIONS: This very large contemporary database demonstrates that risk factor burden is associated with an increased prevalence of PVD, and there is a graded association between the number of risk factors present and the prevalence of PAD, CAS, and AAAs.