Midterm Results of Low-Profile Stents to Treat Atherosclerotic Iliac Artery Disease.

PURPOSE: To evaluate the safety and effectiveness of low-profile 4-F stents for the treatment of atherosclerotic iliac artery lesions. METHODS: Between January 2009 and December 2015, 63 patients (mean age 69.3 years; 42 men) received low-profile stents (Astron Pulsar or Pulsar-18) at the discretion of the operator to treat iliac artery occlusive disease. The majority of patients (40, 63.5%) had critical limb ischemia; 36 of 82 lesions were total occlusions. All procedures were performed with 4-F equipment. Outcomes evaluated included mortality, patency (primary, assisted primary, and secondary), absence of target lesion revascularization (TLR), and limb salvage. Associations of patient and procedure variables with patency and TLR outcomes were sought with univariate and multivariate analysis. RESULTS: Via a brachial (n=46/63) or femoral (n=17/63) access, 82 stents were successfully deployed to treat the 82 lesions, with <30% residual stenosis. The overall access-related complication rate was 1.6% (brachial artery occlusion). Mean duration of follow-up was 24.1±22.3 months (range 1-72), during which 3 patients died and 1 major amputation occurred at 10 months. The 4-year Kaplan-Meier estimate of primary patency was 76.9% (95% CI 70.2% to 83.6%); the assisted primary and secondary patency estimates were 79.3% (95% CI 73% to 85.6%) and 91% (95% CI 84.5% to 97.5%). The 4-year freedom from TLR estimate was 73.8% (95% CI 67.4% to 80.2%). On multivariate analysis, the only associations confirmed involved Rutherford category 5/6 with primary patency (hazard ratio [HR] 5.7, 95% CI 4.4 to 7, p=0.02) and assisted primary patency (HR 6.1, 95% CI 4.9 to 7.3, p=0.01). CONCLUSION: Use of a low-profile 4-F stent in atherosclerotic iliac lesions was safe and effective. At 4 years, the overall patency and the absence of TLR were good. Midterm outcomes were poor in patients with Rutherford category 5/6 ischemia. Finally, the use of stents with a ≥6-mm diameter and postdeployment balloon dilation are recommended in all cases.

Use of Tapered Balloons to Recanalize Occluded Below-the-Knee Arteries in Diabetic Patients with Critical Limb Ischemia.

BACKGROUND: The aim of this study was to evaluate the outcome of tapered balloon use in recanalization of long occlusions of below-the-knee (BTK) arteries in diabetic patients with critical limb ischemia (CLI). METHODS: Forty-nine occluded BTK arteries in 35 diabetic patients with CLI were revascularized in our Diabetic Foot Center between January and September 2014 using tapered balloons. Twelve-month outcomes were evaluated in terms of healing of the lesions, survival, limb salvage, primary patency, primary assisted patency, and secondary patency. RESULTS: The patients were predominantly male (27/35, 77.1%) with a mean age of 70.9 years (±10.3 standard deviation [SD]). During the follow-up (mean duration 12.4 months ± 4 SD), healing of the lesions was obtained in 27 of the 35 cases (77.1%). Estimated 12-month survival and limb salvage were 85.7% and 91.1%, respectively. Estimated 12-month primary patency, primary assisted patency, and secondary patency were 78.3%, 79%, and 88.9%, respectively. Univariate analysis demonstrated that the presence of chronic renal failure affected survival (P = 0.005), and assignment to Rutherford class 6 affected limb salvage (P = 0.005), primary patency (P < 0.001), and primary assisted patency (P < 0.001). Furthermore, the presence of coronary artery disease affected primary patency (P = 0.001) and primary assisted patency (P = 0.05). CONCLUSIONS: Tapered balloons are a safe and effective means to recanalize long occlusions of BTK arteries in diabetic patients with CLI. Outcomes are poorer in patients with major tissue loss and with a history of coronary artery disease. Further experience with larger groups is needed to validate these outcomes.

Freeway paclitaxel-releasing balloons to treat recurrent stenosis of arteriovenous fistula in hemodialysis patients.

BACKGROUND: To evaluate early and mid-term outcomes of Freeway paclitaxel-releasing balloons (Eurocor GmbH, Bonn, Germany) in hemodialysis patients with recurrent stenosis of arteriovenous fistula. METHODS: Between July 2013 and December 2016 27 hemodialysis patients with recurrent stenosis of arteriovenous fistula underwent endovascular treatment with a Freeway balloon. About inclusion criteria, all patients were previously treated at the target lesion with a standard balloon angioplasty (BA). The intervals in months between standard BA and procedure with DCB (time BA-DCB) and between procedure with DCB and new restenosis (time DCB-restenosis) were evaluated and compared with T-test. 2-year estimated outcomes in terms of survival, primary patency, primary assisted patency, secondary patency, and freedom from target lesion restenosis (TLR) were assessed with Kaplan-Meier curves. RESULTS: Technical success was obtained in 96.3% of the cases. During the follow-up (mean duration 13.6 months, range 1-33) 13 patients (48.1%) had a new restenosis. Mean time BA-DCB was 4.8 months, and the mean time DCB-restenosis was 7.6 months with a statistically significant difference at T-test (P<0.001). Estimated 2-year rates of primary patency, primary assisted patency, secondary patency, and freedom from TLR were 31.8%, 76.4%, 90.5%, and 30.2%, respectively. CONCLUSIONS: In our experience Freeway paclitaxel-releasing balloons were effective in the treatment of recurrent stenosis in hemodialysis patients previously treated with standard BA. At follow-up about half of patients had no new target lesion restenosis and the time to a new restenosis was much longer compared to recurrence of stenosis after standard BA.