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.

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.

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.

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.

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.

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.

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.

Comparison of nonenhanced MR angiographic subtraction techniques for infragenual arteries at 1.5 T: a preliminary study.

PURPOSE: To evaluate diagnostic performance of three nonenhanced methods: variable-refocusing-flip angle (FA) fast spin-echo (SE)-based magnetic resonance (MR) angiography (variable FA MR) and constant-refocusing-FA fast SE-based MR angiography (constant-FA MR) and flow-sensitive dephasing (FSD)-prepared steady-state free precession MR angiography (FSD MR) for calf arteries, with dual-injection three-station contrast material-enhanced MR angiography (gadolinium-enhanced MR) as reference. MATERIALS AND METHODS: This prospective study was institutional review board approved and HIPAA compliant, with informed consent. Twenty-one patients (13 men, eight women; mean age, 62.6 years) underwent calf-station variable-FA MR, constant-FA MR, and FSD MR at 1.5 T, with gadolinium-enhanced MR as reference. Image quality and stenosis severity were assessed in 13 segments per leg by two radiologists blinded to clinical data. Combined constant-FA MR and FSD MR reading was also performed. Methods were compared (logistic regression for correlated data) for diagnostic accuracy. RESULTS: Of 546 arterial segments, 148 (27.1%) had a hemodynamically significant (≥ 50%) stenosis. Image quality was satisfactory for all nonenhanced MR sequences. FSD MR was significantly superior to both other sequences (P < .0001), with 5-cm smaller field of view; 9.6% variable-FA MR, 9.6% constant-FA MR, and 0% FSD MR segmental evaluations had nondiagnostic image quality scores, mainly from high diastolic flow (variable-FA MR) and motion artifact (constant-FA MR). Stenosis sensitivity and specificity were highest for FSD MR (80.3% and 81.7%, respectively), compared with those for constant-FA MR (72.3%, P = .086; and 81.8%, P = .96) and variable-FA MR (75.9%, P = .54; and 75.6%, P = .22). Combined constant-FA MR and FSD MR had superior sensitivity (81.8%) and specificity (88.3%) compared with constant-FA MR (P = .0076), variable-FA MR (P = .0044), and FSD MR (P = .0013). All sequences had an excellent negative predictive value (NPV): 93.2%, constant-FA MR; 94.7%, variable-FA MR; 91.7%, FSD MR; and 92.9%, combined constant-FA MR and FSD MR. CONCLUSION: At 1.5 T, all evaluated nonenhanced MR angiographic methods demonstrated satisfactory image quality and excellent NPV for hemodynamically significant stenosis. SUPPLEMENTAL MATERIAL: http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.12120859/-/DC1.

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.

Mid- and long-term results of the treatment of infrainguinal arterial occlusive disease with precuffed expanded polytetrafluoroethylene grafts compared with vein grafts.

BACKGROUND: Prosthetic grafts for lower-extremity bypass have limited patency compared with autologous vein grafts. Precuffed expanded polytetrafluoroethylene (ePTFE) grafts alter the geometry of the distal hood to improve patency. This study reports the authors' long-term results on the use of precuffed ePTFE grafts for infrainguinal bypasses in patients with arterial occlusive disease and compares these with results of reversed great saphenous vein grafts (rSVG). METHODS: A retrospective review of billing codes identified 101 polytetrafluoroethylene (PTFE) and 47 rSVG bypasses performed over a 6-year period. Femoral to below-knee popliteal and femoral to tibial bypasses were analyzed. Data collected consisted of risk factors, Rutherford classification, bypass inflow and outflow, runoff vessels, patency, amputation, and death. Primary end points consisted of primary, assisted-primary, and secondary patency along with limb salvage. RESULTS: Mean age of the patients was 76 years in the PTFE group and 69.8 years in the rSVG group. For femoral to below-knee popliteal bypasses, primary patency at 1, 3, and 5 years in the PTFE group was 76.9%, 48.7%, and 43.3%, respectively, compared with 77.1%, 77.1%, and 77.1%, respectively, in the rSVG group (P = 0.225). Secondary patency was 89.2%, 70.9%, and 50.6% in the PTFE group compared with 84.4%, 84.4%, and 84.4% in the rSVG group (P = 0.269). Limb salvage was similar in the PTFE compared with the rSVG group (97.7%, 90.5%, and 79.4% vs. 83.3%, 83.3%, and 83.3%; P = 0.653). For femoral to tibial bypasses, primary patency in the PTFE group at 1, 3, and 5 years was 57.1%, 40.4%, and 22.1%, respectively, compared with 67.4%, 67.4%, and 50.6%, respectively, for the rSVG group (P = 0.246). Secondary patency was 75.5%, 44.9%, and 22.7% in the PTFE group compared with 91.8%, 91.8%, and 52.5% in the rSVG group (P = 0.022). Limb salvage at 1, 3, and 5 years was 79.2%, 55.7%, and 55.7%, respectively, in the PTFE group compared with 96.4%, 96.4%, and 64.3%, respectively, in the rSVG group (P = 0.046). CONCLUSIONS: Precuffed ePTFE grafts demonstrate similar 1-year patency to that of rSVG. However, mid- and long-term patency is reduced compared with saphenous vein grafts (SVG), especially to tibial targets. PTFE grafts to the popliteal demonstrate limb salvage rates similar to those of SVG. In the tibial vessels, limb salvage rates for PTFE grafts are significantly worse compared with SVG.

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.

Presentation and management of carotid artery aneurysms and pseudoaneurysms.

OBJECTIVE: The objective of this study was to review a single-institution contemporary experience with extracranial aneurysms of the carotid artery. METHODS: A retrospective review was conducted of patients evaluated for an aneurysm of the extracranial carotid artery from 2005 to 2010. Demographics, presentation, and operative management were reviewed. The mean follow-up was 22 months (range, 1-58 months). RESULTS: Over the study period, 16 aneurysms and pseudoaneurysms were identified in 15 patients. Of these, 14 aneurysms (in six men and eight women with mean age of 63 years) underwent surgical repair. The mean aneurysm size was 2.45 cm (range, 0.8-5 cm). One aneurysm (7.1%) was associated with neurologic symptoms, and 13 were asymptomatic. The underlying etiology was trauma in five (35.7%), prior carotid endarterectomy in five (35.7%), and degenerative atherosclerosis in four (28.6%). Aneurysms were isolated to the common carotid artery in six (42.9%), internal carotid artery in five (35.7%), and carotid bifurcation in three (21.4%). Five patients underwent aneurysmectomy with primary repair, seven underwent repair with an interposition graft, one required an innominate to common carotid artery bypass, and one patient had a plication and patch angioplasty. No mortalities or neurologic events were documented within 30 days. One patient had transient cranial nerve palsy. One patient required reintervention at 4 months for stenosis of the bypass graft, and one patient died at 10 months from an unrelated condition. There were no neurologic events on follow-up. CONCLUSIONS: Carotid artery aneurysms and pseudoaneurysms are uncommon and usually asymptomatic. Prior trauma and carotid surgery were common etiologies. The location of the aneurysms was equally distributed between the internal and common carotid arteries. Surgical repair was safe and effective with no significant morbidity or mortality and good midterm stroke prevention.

Outcome of endovascular repair of popliteal artery aneurysm using the Viabahn endoprosthesis.

OBJECTIVE: This study reviews a single-center experience of endovascular popliteal aneurysm (PAA) repair. METHODS: A retrospective review was performed to identify all endovascular PAA repairs performed between September 2004 and January 2011. RESULTS: We identified 21 patients (mean age, 74 ± 9 years, 91% men) with PAAs (mean size, 2.89 ± 1.0 cm) in 26 limbs, of which 38% were symptomatic. All patients underwent endovascular repair with a Viabahn covered stent graft (W. L. Gore & Assoc, Inc, Flagstaff, Ariz). Postoperatively, all patients were maintained on antiplatelet therapy with clopidogrel or aspirin, or both. Mean follow-up was 22 ± 17 months (range, 1-57 months). One patient with one aneurysm was lost to follow-up. Primary and secondary patencies were both 91.2% at 1 year and were 85.5% and 91.2%, respectively, at 2 years. The limb salvage rate was 100%. Four stent graft failures occurred at a mean of 12.3 ± 11 months. One technical failure due to stent graft infolding required conversion to an open femoral-popliteal bypass. Three additional graft failures occurred in patients with poor (single-vessel) runoff. Compared with patients with two- or three-vessel runoff, the graft failure rate in patients with single-vessel runoff was statistically significant (P = .02). Two of the graft failures were successfully treated with open thrombectomy, and one required a tibial artery bypass for limb salvage. CONCLUSIONS: Endovascular repair of PAAs is feasible and has acceptable midterm patency rates. Poor distal runoff predicted graft failure.

Endovascular solutions to arterial injury due to posterior spine surgery.

Iatrogenic arterial injury is an uncommon but recognized complication of posterior spinal surgery. The spectrum of injuries includes vessel perforation leading to hemorrhage, delayed pseudoaneurysm formation, and threatened perforation by screw impingement on arterial vessels. Repair of these injuries traditionally involved open direct vessel repair or graft placement, which can be associated with significant morbidity. We identified five patients with iatrogenic arterial injury during or after posterior spinal surgery between July 2004 and August 2009 and describe their endovascular treatment. Intraoperative arterial bleeding was encountered in two patients during posterior spinal surgery. The posterior wounds were packed, temporarily closed, and the patient was placed supine. In both patients, angiography demonstrated arterial injury necessitating repair. Covered stent grafts were deployed through femoral cutdowns to exclude the areas of injury. In three additional patients, postoperative computed tomography imaging demonstrated pedicle screws abutting/penetrating the thoracic or abdominal aorta. Angiography or intravascular ultrasound imaging, or both, confirmed indention/perforation of the aorta by the screw. Aortic stent graft cuffs were deployed through femoral cutdowns to cover the area of aortic contact before hardware removal. All five patients did well and were discharged home in good condition. Endovascular repair of arterial injuries occurring during posterior spinal procedures is feasible and can offer a safe and less invasive alternative to open repair.

Hormone replacement therapy is associated with a decreased prevalence of peripheral arterial disease in postmenopausal women.

BACKGROUND: The effect of hormone replacement therapy (HRT) in postmenopausal women on the development of peripheral atherosclerosis remains in question. The goal of this study was to analyze the use of HRT in a large population of postmenopausal women and to determine its association with the prevalence of peripheral arterial disease (PAD). METHODS: A prospective database of patients who underwent voluntary vascular screening was used. Identification of patients as postmenopausal, and their use of HRT, was based on patient questionnaires. PAD was defined to be present if either lower extremity ankle-brachial index was ≤0.9. RESULTS: Analysis was performed on data from 847,982 postmenopausal women; 433,178 (51.1%) reported having used HRT. HRT subjects were slightly older than patients who had not used HRT (64.5 years vs. 63.6 years). Caucasian women were significantly more likely to have used HRT than non-Caucasian women (52.4% vs. 47.6%). HRT subjects were significantly more likely to have smoked cigarettes (42.8% vs. 40.6%), to have hypertension (47.9% vs. 45.1%), and to have hypercholesterolemia (55% vs. 51.5%) than women who had not used HRT (all P < 0.001). However, HRT subjects were significantly less likely to have diabetes mellitus (8.6% vs. 10.2%, P < 0.001). Despite the increased prevalence of several atherosclerotic risk factors among women who used HRT, they were significantly less likely to have PAD (3.3% vs. 4.1%, P < 0.001). Multivariate analysis adjusting for age, race, and medical comorbidities that predispose toward the development of atherosclerosis confirmed that HRT was independently associated with a decreased risk of PAD (odds ratio: 0.8, 95% confidence interval: 0.78-0.82). In subsets of postmenopausal women with known atherosclerotic risk factors, the significant effect of HRT on the prevalence of PAD was maintained; in women with either a smoking history, hypertension, hypercholesterolemia, diabetes, or age of ≥70 years, the odds ratio of HRT use with regard to PAD remained approximately 0.8. CONCLUSIONS: The use of HRT in postmenopausal women appears to be associated with a significant reduction in the prevalence of PAD in this population-based study. This association appeared to be significant even in postmenopausal women with known atherosclerotic risk factors. These observational data may suggest a relationship between HRT and the prevalence of PAD that has not been the specific subject of previous randomized prospective studies.

Existing trauma and critical care scoring systems underestimate mortality among vascular trauma patients.

BACKGROUND: The impact of vascular injuries on patient mortality has not been well evaluated in multi-trauma patients. This study seeks to determine (1) whether the presence of vascular trauma negatively affects outcome compared with nonvascular trauma (NVT) and (2) the utility of existing severity scoring systems in predicting mortality among vascular trauma (VT) patients. METHODS: A retrospective review of our trauma database from January 2005 to December 2007 was conducted. Demographics, Injury Severity Scores (ISS), Revised Trauma Scores (RTS), Trauma Score-Injury Severity Scores (TRISS), Acute Physiology and Chronic Health Evaluation II (APACHE II) scores, and mortality rates were compared. Control patients were selected from a matching cohort based on ISS. Comparisons were made between groups based on the above scoring systems. Statistical analysis used χ(2) analysis and Student t-tests. RESULTS: Fifty VT and 50 NVT patients were identified with no significant differences in age, gender, mechanism of injury, ISS, RTS, or TRISS. The mean APACHE II score was higher in VT compared with NVT (12.3 vs 8.8, P < .05). Overall mortality was higher in VT compared with NVT but did not reach statistical significance (24% vs 11.8%, P = .108). VT patients with RTS score >5 had a higher mortality rate (26% vs 2.2%, P = .007). VT patients with an ISS score >24 had a higher mortality compared with NVT patients (61% vs 28.6%, P = .04). VT patients with an APACHE II score <14 also had a higher mortality rate (18.2% vs 0%, P = .007). Finally, VT patients with a TRISS probability of survival of >80% had a higher mortality rate (13.9% vs 0%, P = .05). CONCLUSIONS: In multi-trauma patients, the presence of vascular injury was associated with increased mortality in less severely injured patients based on the RTS, TRISS, and APACHE II scores. These scoring systems underestimated mortality in patients with vascular trauma. Level of care and future trauma algorithms should be adjusted in the presence of vascular trauma.

Outcome of carotid artery interventions among female patients, 2004 to 2005.

BACKGROUND: The benefit of carotid endarterectomy (CEA) in female patients has been questioned by various randomized, prospective trials, particularly in asymptomatic cases; several have noted an increase in perioperative stroke among women after CEA. The outcome of carotid angioplasty and stenting (CAS) has not been extensively examined in women. This study examined the outcome of CEA and CAS in women vs men by using a national database. METHODS: Outcomes of CEA and CAS were stratified by sex using discharge data from the Nationwide Inpatient Sample (NIS), Healthcare Cost and Utilization Project (HCUP), Agency for Healthcare Research and Quality. The NIS was used to identify patient discharges that occurred during 2004 and 2005. Appropriate International Classification of Diseases, 9th Revision (ICD-9) procedure and diagnosis codes were used to identify CEA and CAS cases. Outcome measures included in-hospital perioperative stroke and death. Comparisons of demographics, procedures, and outcome were performed between men and women. Additional analysis was performed among women alone to attempt to identify whether improved outcome was noted with either procedure. RESULTS: Of 54,658 procedures, 94.2% were CEA and 5.8% were CAS. Women comprised 42.3% of the analyzed cases. Women and men were equally likely to be symptomatic (5.3% vs 5.3%, P = .8). Women were significantly less likely to undergo CAS than men (5.4% vs 6.1%, P < .001). Women and men had equivalent rates of perioperative stroke when undergoing CEA (1.0% vs 1.0%, P = .9) and CAS (2.7% vs 2.0%, P = .2). Symptomatic women had a significantly higher rate of perioperative stroke overall than did symptomatic men (3.8% vs 2.3%, P = .03). Asymptomatic women had a significantly lower perioperative stroke rate after CEA than after CAS (0.9% vs 2.1%, P < .001). Rates of perioperative showed a trend favoring CEA vs CAS among symptomatic women (3.4% vs 6.2%, P = .1). CONCLUSIONS: The concern regarding an increased perioperative stroke rate after CEA among asymptomatic women appears to be unfounded. The perioperative stroke rate among symptomatic women was higher than that of symptomatic men, but still well within the acceptable range for symptomatic patients undergoing a cerebrovascular intervention. Nationally, women underwent CAS significantly less frequently than did men. Outcome among women for perioperative stroke favored CEA over CAS, particularly in asymptomatic patients. CEA may be the preferred treatment in women seeking intervention for cerebrovascular disease, unless compelling reasons exist to perform CAS.