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To report a prospective, single-arm, multicenter clinical study evaluating the Zilver PTX drug-eluting stent for treating the above-the-knee femoropopliteal segment (NCT01094678; http://www.clinicaltrials.gov ).The Zilver PTX drug-eluting stent is a self-expanding nitinol stent with a polymer-free paclitaxel coating. Patients with symptomatic (Rutherford category 2-6) de novo or restenotic lesions (including in-stent stenosis) of the above-the-knee femoropopliteal segment were eligible for enrollment. Between April 2006 and June 2008, 787 patients (578 men; mean age 66.6±9.5 years) were enrolled at 30 international sites.Nine hundred lesions (24.3% restenotic lesions of which 59.4% were in-stent stenoses) were treated with 1722 Zilver PTX stents; the mean lesion length was 99.5±82.1 mm. The 12-month Kaplan-Meier estimates included an 89.0% event-free survival rate, an 86.2% primary patency rate, and a 90.5% rate of freedom from target lesion revascularization. There were no paclitaxel-related adverse events reported. The 12-month stent fracture rate was 1.5%. The ankle-brachial index, Rutherford score, and walking distance/speed scores significantly improved (p0.001) from baseline to 12 months.These results indicate that the Zilver PTX drug-eluting stent is safe for treatment of patients with de novo and restenotic lesions of the above-the-knee femoropopliteal segment. At 1 year, the overall anatomical and clinical effectiveness results suggest that this stent is a promising endovascular therapy.

The aim of the present article was to report the 12-month results of the Zilver® PTX® Single Arm StudyTASC C/D de novo lesion subgroup.The Zilver PTX Drug-Eluting Peripheral Stent is a self-expanding nitinol stent with a polymer-free paclitaxel coating. This is a prospective, single-arm, multicentre clinical study evaluating the Zilver PTX Drug-Eluting Peripheral Stent for treating patients with symptomatic lesions in the above-the-knee femoropopliteal artery. This study enrolled 787 patients (900 lesions) with Rutherford class 2 or higher treated with the Zilver PTX stent; 135 were long de novo lesions, corresponding to TASC II Class C or D.The 135 long lesions had a mean length of 226.1±43.6 mm. The 12-month Kaplan-Meier estimates included a 77.6% primary patency rate, an 84.7% event-free survival rate, and an 85.4% rate of freedom from target lesion revascularization (TLR). The 12-month stent fracture rate was 2.1%.The primary patency rates in the analysis of the TASC C/D de novo lesion subgroup of the Zilver PTX Single Arm Study indicate that endovascular therapy outcomes with a paclitaxel eluting stent may equal those of bypass surgery. Endovascular treatment with DES may play an important role for treatment of patients who present with TASC C or D femoropopliteal lesions.

Percutaneous treatment of thrombosis of occluded vascular access (VA) for haemodialysis (HD) has been an alternative to surgical and pharmacological treatments, but long term results are not well defined. The aim of our study was to analyse the long term results of percutaneous thrombectomy as a treatment of occluded VA for HD. We conducted a prospective study from june 1995 to april 1999, including 123 consecutive thrombectomies in 64 VA in patients submitted to our hospital because of recent thrombosis of VA for HD. We used two different techniques, hydrodynamic catheter thrombectomy (Hydrolyser) in the 42 first procedures (34.1%), and since october 1996 we used mechanical balloon thrombolysis in the remaining 81 patients (65.9%). Underlying stenoses were evaluated by angiography, and treated by angioplasty. After the procedure, intravenous heparin was administered for 24 hours. The VA were 28 Brescia-Cimino arteriovenous fistulae (30.4%) and 64 PTFE grafts (69.6%).mean age: 63 +/- 15 years (18-84), previous VA: 3.3 +/- 2.5 (0-9). The mean follow-up was 10.5 +/- 8.6 months (3-35). Percutaneous thrombectomy was able to remove the clots in 120 instances (technical success: 97.5%). After the thrombectomy 15 patients (16.3%) were immediately referred to the surgeon to perform a new VA due to vascular lesions in which percutaneous treatment was not indicated. Thirteen cases (14.1%) showed early thrombosis (72 hours). During the follow-up, 27 cases developed thrombosis (30%) and 26 VA were still patent (28.3%). In 23% of perfusion lung scans and in 2 of the 5 angiographies performed after thrombectomy, subsegmentary or segmentary perfusion defects were detected, without clinical significance. There were no relevant undesirable effects related to the technique and no symptomatic pulmonary embolism. In summary, percutaneous thrombectomy, whether hydrodynamic or mechanical, has shown to be an efficacious treatment of VA thrombosis for HD, preserving the VA with satisfactory long-term results.

in patients with cirrhosis, transjugular intrahepatic portosystemic shunt (TIPS) decreases the pressure in the portal vein by rerouting nearly all the portal blood flow to the systemic circulation. This may lead to hypoperfusion of the liver and worsening function. Our aim was to investigate whether TIPS actually reduced hepatic and splanchnic perfusion.we studied 25 patients who required placement of a TIPS (20 for variceal bleeding and 5 for refractory ascites). We evaluated the clinical condition, laboratory results, blood velocity in the portal vein and hepatic artery by echo-Doppler ultrasonography, systemic hemodynamic-oxygenation status and hemodynamic-oxygenation status in the portal and suprahepatic veins before TIPS, 15 min after the procedure, and 30 days later. Hepatic and splanchnic perfusion were evaluated as the arteriovenous difference in O2 content and as the O2 extraction rates in the hepatic and splanchnic territories.TIPS induced an immediate decrease in portal pressure, a significant increase in systemic hyperdynamic state, and an increase in blood flow velocity in the portal vein and hepatic artery. Thirty days after the procedure these changes persisted, although they were somewhat attenuated. Although splanchnic and liver perfusion were not changed 15 min or 30 days after TIPS, there was a slight tendency toward a decrease in liver perfusion during follow-up.TIPS increased the hyperdynamic state in the systemic side. However, portal blood shunting did not change liver or splanchnic perfusion.