A randomized, placebo-controlled trial of canakinumab in patients with peripheral artery disease.

Extensive atherosclerotic plaque burden in the lower extremities often leads to symptomatic peripheral artery disease (PAD) including impaired walking performance and claudication. Interleukin-1ß (IL-1ß) may play an important pro-inflammatory role in the pathogenesis of this disease. Interruption of IL-1ß signaling was hypothesized to decrease plaque progression in the leg macrovasculature and improve the mobility of patients with PAD with intermittent claudication. Thirty-eight patients (mean age 65 years; 71% male) with symptomatic PAD (confirmed by ankle-brachial index) were randomized 1:1 to receive canakinumab (150 mg subcutaneously) or placebo monthly for up to 12 months. The mean vessel wall area (by 3.0 T black-blood magnetic resonance imaging (MRI)) of the superficial femoral artery (SFA) was used to measure plaque volume. Mobility was assessed using the 6-minute walk test. Canakinumab was safe and well tolerated. Markers of systemic inflammation (interleukin-6 and high-sensitivity C-reactive protein) fell as early as 1 month after treatment. MRI (32 patients at 3 months; 21 patients at 12 months) showed no evidence of plaque progression in the SFA in either placebo-treated or canakinumab-treated patients. Although an exploratory endpoint, placebo-adjusted maximum and pain-free walking distance (58 m) improved as early as 3 months after treatment with canakinumab when compared with placebo. Although canakinumab did not alter plaque progression in the SFA, there is an early signal that it may improve maximum and pain-free walking distance in patients with symptomatic PAD. Larger studies aimed at this endpoint will be required to definitively demonstrate this. ClinicalTrials.gov Identifier: NCT01731990.

Intersocietal Accreditation Commission Accreditation Status of Outpatient Cerebrovascular Testing Facilities Among Medicare Beneficiaries: The VALUE Study.

OBJECTIVES: Accreditation of cerebrovascular ultrasound laboratories by the Intersocietal Accreditation Commission (IAC) and equivalent organizations is supported by the Joint Commission certification of stroke centers. Limited information exists on the accreditation status and geographic distribution of cerebrovascular testing facilities in the United States. Our study objectives were to identify the proportion of IAC-accredited outpatient cerebrovascular testing facilities used by Medicare beneficiaries, describe their geographic distribution, and identify variations in cerebrovascular testing procedure types and volumes by accreditation status. METHODS: As part of the VALUE (Vascular Accreditation, Location, and Utilization Evaluation) Study, we examined the proportion of IAC-accredited facilities that conducted cerebrovascular testing in a 5% Centers for Medicare and Medicaid Services random Outpatient Limited Data Set in 2011 and investigated their geographic distribution using geocoding. RESULTS: Among 7327 outpatient facilities billing Medicare for cerebrovascular testing, only 22% (1640) were IAC accredited. The proportion of IAC-accredited cerebrovascular testing facilities varied by region (χ(2)[3] = 177.1; P < .0001), with 29%, 15%, 13%, and 10% located in the Northeast, South, Midwest, and West, respectively. However, of the total number of cerebrovascular outpatient procedures conducted in 2011 (38,555), 40% (15,410) were conducted in IAC-accredited facilities. Most cerebrovascular testing procedures were carotid duplex, with 40% of them conducted in IAC-accredited facilities. CONCLUSIONS: The proportion of facilities conducting outpatient cerebrovascular testing accredited by the IAC is low and varies by region. The growing number of certified stroke centers should be accompanied by more accredited outpatient vascular testing facilities, which could potentially improve the quality of stroke care.

Endofibrosis: an unusual cause of leg pain in an athlete.

Endofibrosis of the external iliac artery can occur as a rare complication of high endurance physical activities, particularly cycling, running, and rowing. Symptoms mimic claudication and typically occur with vigorous exercise and improve with rest. Patients can experience thigh pain, swelling and paresthesias in the affected extremity. The diagnosis of endofibrosis is often delayed given the patient's overall normal appearance and lack of significant medical history. This report outlines the presentation and evaluation of a case of endofibrosis of the external iliac artery in an otherwise healthy 42-year-old healthy woman. Her diagnosis was delayed for two years before appropriate diagnostic testing and subsequent surgical intervention allowed for return to a normal, active lifestyle.

Accreditation status and geographic location of outpatient vascular testing facilities among Medicare beneficiaries: the VALUE (Vascular Accreditation, Location & Utilization Evaluation) study.

OBJECTIVE: There is limited information on the accreditation status and geographic distribution of vascular testing facilities in the US. The Centers for Medicare & Medicaid Services (CMS) provide reimbursement to facilities regardless of accreditation status. The aims were to: (1) identify the proportion of Intersocietal Accreditation Commission (IAC) accredited vascular testing facilities in a 5% random national sample of Medicare beneficiaries receiving outpatient vascular testing services; (2) describe the geographic distribution of these facilities. METHODS: The VALUE (Vascular Accreditation, Location & Utilization Evaluation) Study examines the proportion of IAC accredited facilities providing vascular testing procedures nationally, and the geographic distribution and utilization of these facilities. The data set containing all facilities that billed Medicare for outpatient vascular testing services in 2011 (5% CMS Outpatient Limited Data Set (LDS) file) was examined, and locations of outpatient vascular testing facilities were obtained from the 2011 CMS/Medicare Provider of Services (POS) file. RESULTS: Of 13,462 total vascular testing facilities billing Medicare for vascular testing procedures in a 5% random Outpatient LDS for the US in 2011, 13% (n=1730) of facilities were IAC accredited. The percentage of IAC accredited vascular testing facilities in the LDS file varied significantly by US region, p<0.0001: 26%, 12%, 11%, and 7% for the Northeast, South, Midwest, and Western regions, respectively. CONCLUSIONS: Findings suggest that the proportion of outpatient vascular testing facilities that are IAC accredited is low and varies by region. Increasing the number of accredited vascular testing facilities to improve test quality is a hypothesis that should be tested in future research.

Current management of transplant renal artery stenosis: clinical utility of duplex Doppler ultrasonography.

OBJECTIVES: To perform a retrospective study to determine the clinical utility of Doppler ultrasonography (DUS) and to determine its role in the management of transplant renal artery stenosis (TRAS). METHODS: Patients undergoing DUS between January 1998 and January 2001 for clinical suspicion of TRAS were included in the study. A total of 51 patients were divided into two groups according to the peak systolic velocity. Additional management was based on the clinical and DUS findings and their congruence. Patients were followed up and their outcome was analyzed. RESULTS: Of the 51 patients who entered the study, 26 were in the low probability group (LPG) and 25 in the high probability group (HPG). Nine patients in the LPG underwent additional investigations; eight underwent magnetic resonance angiography and one angiography. Of these 9 patients, 6 had stenosis, 4 of whom required angiography. In total, 5 patients from the LPG underwent angioplasty, and 4 of them had stenosis (1 with TRAS, 2 with common iliac artery stenosis, and 1 with renal artery ostial stenosis). Three patients underwent angioplasty and 2 of them improved. In the HPG, 20 of 25 patients underwent additional investigations, including magnetic resonance angiography in 12 and angiography in 8, with stenosis in 15 patients. Of the HPG, 13 of 25 patients underwent angiography, with 10 requiring angioplasty--8 for TRAS and 2 for adjacent renal artery stenosis, with improvement in 8 patients. Congruent clinical and DUS findings were highly predictive of significant stenosis more amenable to improvement. CONCLUSIONS: The results of our study have shown that high-probability DUS and congruent clinical findings are likely to identify a significant stenosis that is amenable to treatment. Low-probability DUS findings do not eliminate the possibility of stenosis, but intervention in this group is less likely to result in improvement.