Aortoiliac occlusive disease in patients with known or suspected peripheral vascular disease: safety and efficacy of gadofosveset-enhanced MR angiography--multicenter comparative phase III study.

PURPOSE: To prospectively determine the safety and efficacy of the gadolinium-based blood pool magnetic resonance (MR) imaging contrast agent gadofosveset in patients known to have or suspected of having peripheral vascular disease. MATERIALS AND METHODS: Ethical committee approval and patient written informed consent were obtained. This study was compliant with the Health Insurance Portability and Accountability Act. Adults known or suspected to have peripheral vascular disease received gadofosveset (0.03 mmol per kilogram of body weight) for MR angiography of the aortoiliac region. Gadofosveset-enhanced MR angiography and unenhanced two-dimensional time-of-flight MR angiography were compared with the reference standard, conventional angiography, for the presence of vascular stenosis. All patients were monitored for adverse events with hematologic analysis, analysis of blood chemistry, urinalysis, and electrocardiographic parameters; these methods were analyzed to determine safety. RESULTS: A total of 274 patients were enrolled at 37 centers. Gadofosveset-enhanced MR angiography showed significant improvement (P < .001) compared with unenhanced MR angiography for each of the readers for diagnosis of clinically significant (> or = 50%) stenosis. Specificity and accuracy were significantly greater for three readers, and sensitivity increased significantly for two readers. For all readers, the area under the receiver operator characteristic curve for both quantitative and qualitative measures of significant disease increased (P < .001) for gadofosveset-enhanced MR angiography versus two-dimensional time-of-flight MR angiography. All readers also expressed more confidence in diagnosis (P < .001) and found fewer images to be uninterpretable (0.5% vs 11.0%). The most common adverse events were as follows: feeling hot, 12 (4.4%) patients; nausea, 10 (3.6%) patients; headache, nine (3.3%) patients; and burning sensation, eight (2.9%) patients. Only four serious adverse events were reported, in three patients, and all events were rated as unlikely related to the drug. No patients were excluded because of adverse events or laboratory abnormalities. There were no clinically important trends in the findings of hematologic analysis, blood chemistry, urinalysis, electrocardiography, or physical examination. CONCLUSION: On the basis of substantial improvements over non-contrast MR angiography in efficacy and a minimal and transient side-effect profile, gadofosveset was found to be safe and effective for MR angiography in patients known or suspected to have peripheral vascular disease.

Percutaneous femoral closure following stent-graft placement: use of the Perclose device.

PURPOSE: To describe our early clinical experience using the Prostar Perclose device for arterial closure after placement of a stent-graft. METHODS: Sixty-three patients had stent-graft devices placed for iliac (n = 7), abdominal aortic (n = 43) or thoracic applications (n = 13). The devices were introduced through 18 Fr (22 Fr O.D.) (n = 3), 16 Fr (20 Fr O.D.) (n = 15), 14 Fr (18 Fr O.D.) (n = 44) or 12 Fr (14 Fr O.D.) (n = 38) sheaths. After Perclose deployment, the arteriotomies were dilated to the appropriate sizes for the deployment sheaths. All patients were anticoagulated during the procedure. After stent-graft deployment, hemostasis was achieved by the Perclose sutures that were in place. All the femoral sites were followed with physical examination and CT angiography (CTA). RESULTS: The follow-up periods have ranged from 2 to 18 months (mean 7.5 months). All 100 femoral sites were closed without the need for surgical closure. In 4% (4/100) of the femoral sites, the Perclose sutures were pulled out while securing the knots and these patients required manual compression. In 2% (2/100) of the sites, additional manual compression was required after successful deployment of the Perclose devices. In 1% (1/100) of the femoral sites, there was acute femoral popliteal thrombosis perhaps related to common femoral artery narrowing at the site of Perclose deployment. In 5% (5/100) of the femoral sites, pseudoaneurysms were seen on follow-up CTA examinations. In 1% (1/100) of patients, there was infection at the puncture site requiring surgical bypass. In 1% (1/100) of patients, there was a stable, asymptomatic intimal dissection at the puncture site. By CTA criteria, none of the patients have developed stenotic lesions at the sites of Perclose deployment with follow-up periods limited to 6 months. Fifty-one of 63 patients (81%) patients ambulated within 4-6 hr. CONCLUSION: The Perclose device, when placed prior to arterial dilatation, can be used to achieve hemostasis for stent-graft procedures. The device used in this manner is associated with complications, the most common being pseudoaneurysm formation. The long-term effect on the femoral arteries is uncertain.

Percutaneous inferior vena cava-to-portal vein shunt (PIPS) using a stent-graft: preliminary results.

PURPOSE: To present preliminary results of an inferior vena cava (IVC)-to-portal vein shunt (PIPS) that is created through the caudate lobe of the liver. METHODS: Sixteen patients (13 men; mean age 50 years, range 32-63) were referred for PIPS procedures because of bleeding varices (n = 11), intractable ascites (n = 4), and hepatorenal syndrome (n = 1). The severity of liver disease was Child's B in 2 and Child's C in 14. The PIPS was created by a transhepatic puncture through the IVC and the portal vein; an endograft made of polytetrafluoroethylene sutured to a Palmaz stent was placed through a jugular approach. RESULTS: In 13 (81%) patients, the portal vein-to-IVC tracts were successfully created. The postprocedural portal vein-IVC gradients varied from 1 to 9 mm Hg (mean 5). There were 2 deaths in the 30-day periprocedural period from adult respiratory distress syndrome and hepatorenal syndrome. A third patient died at 31 days from liver failure owing to continuing alcohol abuse. In addition, there was 1 case of peritoneal bleeding treated with blood product replacement. The follow-up period ranged from 14 to 671 days (mean 343). None of the patients treated for variceal bleeding had another bleeding episode, but 2 patients who had a PIPS procedure for refractory ascites did not benefit from the procedure. Postprocedure, 46% (6/13) of the patients had hepatic encephalopathy, which was unchanged from baseline. The primary and secondary patency rates at 365 days were 60% and 65%, respectively. CONCLUSIONS: The preliminary results using a stent-graft to create an IVC-portal vein shunt are encouraging and support further work to better determine the role of this procedure.

Percutaneous placement of a low-profile stent-graft device for aortic dissections.

PURPOSE: The use of stent-grafts has proved to be safe and effective treatment for complicated aortic dissections but usually requires surgical cutdown to accommodate large-profile devices. Preliminary results of the use of a low-profile design that allows percutaneous access are presented. MATERIALS AND METHODS: Fifteen patients with aortic dissection were treated with use of a low-profile stent-graft. Dissection types included Stanford type A (n = 6) and type B (n = 9). The procedures were performed with use of Perclose devices to achieve hemostasis. The stent-graft device was composed of Gianturco stents connected with longitudinal wire struts covered with radially expanded polytetrafluoroethylene. The delivery sheath sizes were 14-20 F. RESULTS: In 87% of patients (13 of 15), the entry tear was excluded completely. Successful femoral closures were achieved in 93% of patients (14 of 15) with use of the suture-mediated devices. In 7% of patients (one of 15), surgical closure of the femoral arteries was required. The rate of pseudoaneurysm occurrence was 7% (one of 15). Hospitalization ranged from 1 to 30 days with a mean duration of 6.5 days. The 30-day mortality rate was 27% (four of 15). In the remaining 11 patients, entry tear sites were excluded and, on follow-up CT examinations, there was thrombosis and retraction of the false lumen and enlargement of the true lumen. CONCLUSION: Preliminary results of the use of a low-profile stent-graft device to treat aortic dissections show that, in most patients, it can be used with a suture-mediated device without surgical exposure of the common femoral artery.