This study was designed to assess the effect of calcium on the efficacy of DEB during revascularization of steno-obstructive SFA lesions. Sixty patients with de novo lesions of the superficial femoral artery underwent endovascular treatment with drug eluting balloons (DEB). DEB was selected according to vessel reference diameter (1:1). In case of residual stenosis > 50 % or flow-limiting dissection, postdilatation with conventional balloon or provisional stenting was done. Patients were classified into eight groups according to circumferential distribution of calcium on CT-angiography axial images (from 0° to 360°) and to its length (length < or > 3 cm) evaluated with digital-subtraction-angiography. Ankle-brachial index (ABI), late lumen loss (LLL), target lesion revascularization (TLR), primary (PP) and secondary (SP) patency, major adverse events (MAE), and Rutherford shift were evaluated at 1-year follow-up and correlated with the amount of calcium. Revascularization was successful in all cases. Flow-limiting dissection occurred in five cases (8.3 %) with a higher circumferential degree of calcium and solved in three cases with postdilatation and in the other two with provisional stenting. DEB effect was lower in patients with higher degree of calcium (>270° vs. <90°): ABI 0.71 ± 0.07 versus 0.92 ± 0.07; LLL 0.75 ± 0.21 versus 0.45 ± 0.1; PP 50 versus 100 %; SP 50 versus 100 %; TLR 25 versus 0 %; MAE 25 versus 0 %. Calcium represents a barrier to optimal drug absorption. Circumferential distribution seems to be the most influencing factor with the worst effect noticed in 360° calcium presence.

Purpose To report 6-month results of the DEBELLUM (Drug-Eluting Balloon Evaluation for Lower Limb MUltilevel TreatMent) randomized trial to evaluate the efficacy of a drug-eluting balloon (DEB) to reduce restenosis after treatment of multilevel lower limb occlusive disease vs. a conventional angioplasty balloon (AB). Methods Between September 2010 and March 2011, 50 consecutive patients (37 men; mean age 66 ± 4 years) with 122 lesions (96 stenoses and 26 occlusions) of the femoropopliteal (92, 75.4%) or below-the-knee (BTK) arteries (30, 24.6%) were enrolled and randomly assigned to the DEB (25 patients with 57 lesions) or AB (25 patients with 65 lesions) group. Twenty patients presented multilevel lesions. Mean lesion length was 7.5 ± 3.5 cm. Thirty-one (62%) of the patients were Fontaine stage IIb, while 19 (38%) were stage III or IV. DEBs or ABs were used for dilation of de novo lesions or for postdilation after primary stenting (superficial femoral artery only). Patients requiring provisional stenting after angioplasty secondary to flow-limiting dissection or residual stenosis >50% were ineligible. Primary endpoint was late lumen loss at 6 months. Secondary endpoints were target lesion revascularization (TLR), amputation, and thrombosis. Results Late lumen loss was lower in the DEB group (0.5 ± 1.4 vs. 1.6 ± 1.7 mm, p<0.01). TLR was necessary in 6.1% of the DEB group vs. 23.6% of the AB group (p=0.02). Comparing the DEB to AB groups, the thrombosis rates were 3.0% vs. 5.2% (p=0.6), and the amputation rates were 3.0% vs. 7.9% (p=0.36). The binary restenosis rates were 9.1% (3/33 limbs) in the DEB group vs. 28.9% (11/38 limbs) in the control group (p=0.03). The anklebrachial index improved to a greater degree in the DEB group: 0.87 ± 0.22 vs. 0.70 ± 0.13 (p<0.05). The Fontaine stage improved in both groups but more so in patients treated with DEBs (p=0.04). Conclusion The DEBELLUM trial confirmed the ability of paclitaxel-eluting balloons to reduce restenosis vs. conventional balloons at 6 months after treatment of multilevel (femoropopliteal and BTK) arterial disease in patients affected by claudication and CLI. A lower TLR rate and better clinical outcomes appear to be associated with the use of DEBs regardless of stent placement.

OBJECTIVE. The purpose of this study was to review the use of an hourglass-shaped expanded polytetrafluoroethylene (ePTFE) stent-graft to reduce transjugular intrahepatic portosystemic shunts in patients with hepatic encephalopathy refractory to conventional medical therapy.MATERIALS AND METHODS. From January 2000 through December 2008, 189 transjugular intrahepatic portosystemic shunt procedures were performed with self-expanding stent-grafts. After a mean period of 43.4 ± 57 weeks, hepatic encephalopathy developed in 12 patients and did not respond to conventional medical therapy with lactulose, nonabsorbable antibiotics, and a protein-restricted diet. In all cases, shunt reduction was performed with an hourglass-shaped balloon-expandable ePTFE stent-graft inserted into the original shunt.RESULTS. Technically successful shunt reduction with an immediate increase in portosystemic gradient was achieved in all patients. Symptoms of hepatic encephalopathy disappeared a mean of 22.3 hours (range, 18–26 hours...