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Purpose: To report 12-month outcomes following application of sirolimus-eluting stents (SES) in infrapopliteal arteries in patients with chronic limb ischemia., Methods: A prospective single-center study was conducted involving 146 consecutive patients (102 men; mean age 73+/-9 years) with Rutherford-Becker categories 2 to 5 lower limb ischemia who underwent SES placement. The average degree of stenosis at baseline was 86%+/-5%; there were 44 (30%) occlusions. The main study endpoint was the 1-year primary patency rate, defined as freedom from in-stent restenosis (luminal narrowing > or =70%) detected with angiography or, if appropriate, with duplex ultrasound. Secondary endpoints included the 6-month primary patency rate, secondary patency rate, ankle-brachial index (ABI), and changes in the Rutherford-Becker classification., Results: Fifteen (10%) patients were lost to follow-up, and 27 (18%) patients died during the follow-up period, leaving 104 patients undergoing the 6- and 12-month follow-up examinations. After 6 months and 1 year, the primary patency rates were 88.5% and 83.7%, respectively. The mean ABI increased from 0.6+/-0.4 at baseline to 0.8+/-0.2 after 6 months and remained significantly improved during 1-year follow-up (p<0.0001). The mean Rutherford-Becker classification decreased from 3.3+/-0.8 at baseline to 0.9+/-1.1 (p<0.0001) after 1 year., Conclusion: Treatment of infrapopliteal arteries with SES yields encouraging long-term results that compare favorably with previously published data on bare metal stents or plain balloon angioplasty.

Purpose: To report the outcome of a prospective randomized safety and performance trial of 2 access site closure devices versus a wound dressing., Methods: Between October 2005 and July 2006, 852 consecutive patients (605 men; mean age 67 years) undergoing diagnostic or interventional catheterization procedures thru a 5- or 6-F femoral sheath were randomized to one of the 3 closure methods: a collagen plug device (Angio-Seal), a clip (StarClose), or a wound dressing (D-Stat Dry). The efficacy of the devices was assessed, as well as the complications occurring at the puncture site during the hospital stay. The primary endpoint of the study was the cumulative incidence of access site pseudoaneurysm, major access site bleeding requiring transfusion, access site vascular surgery, or death from all causes., Results: There were no significant differences in baseline characteristics between the 3 treatment groups. The primary endpoint was reached in 20 (7.1%) of 281 patients treated with D-Stat Dry and in 11 (1.9%) of 571 patients treated with the mechanical closure devices (p<0.0001). There was no significant difference among the mechanical closure devices concerning the incidence of the primary endpoint (Angio-Seal 1.1% versus StarClose 2.8%; p = 0.13)., Conclusion: The collagen plug device had the lowest rates of major and minor access site-related complications after removal of 5- or 6-F femoral sheaths. The difference between the mechanical closure devices concerning the incidence of the primary endpoint did not reach statistical significance. The wound dressing showed significantly higher major and minor complication rates.

Purpose: To investigate the impact of carbofilm coating and low-profile rapid exchange stent devices on the restenosis rate after stent-angioplasty of atherosclerotic renal artery stenosis (RAS)., Methods: During a 2-year period (7/2002-7/2004), 143 consecutive patients with 179 primary ostial atherosclerotic RAS>or=70% diameter stenosis were treated with stents selected at the discretion of the operator. Eighteen patients (32 lesions) treated with 9 different types of stents were excluded from the analysis, leaving 125 patients (69 men; mean age 67 years, range 42 to 90) with 147 lesions who received either a Radix carbofilm-coated stent in 78 (53%) lesions (68 [54%] patients) or a Palmaz Genesis bare stainless steel stent in 69 (47%) lesions (57 [46%] patients). The target vessel diameter ranged from 5 to 7 mm., Results: Baseline characteristics were similar in both groups except the mean stent diameter, which was larger in the bare stent cohort (6.4+/-0.7 versus 5.9+/-0.5 mm, p<0.001). Primary success was 100% in both groups; the initial mean diameter stenosis was reduced from 79%+/-14% and 80%+/-14% in the coated versus bare stent groups to 3+/-5% and 2+/-6%, respectively. After a mean follow-up of 22+/-5 months, the restenosis rate was 6.4% for the coated stent and 5.8% for the bare stent (p=0.87). For the entire cohort, restenosis rates varied significantly (p<0.05) according to stent diameter: 19% (5/26) for 5 mm, 4% (3/81) for 6 mm, and 2.5% (1/40) for 7 mm. In a binary logistic regression analysis including carbofilm coating, stent diameter, gender, diabetes, smoking status, and body mass index, stent diameter was the only independent predictor of restenosis (odds ratio 0.12, 95% CI 0.03 to 0.48 [p=0.003] for a 1-mm increase in vessel diameter)., Conclusions: Using modern low-profile stent devices, carbofilm coating does not significantly reduce the restenosis rate compared to a bare metal stent. With contemporary stent devices, the restenosis rate has been decreasing compared to earlier reports in the literature.

Purpose: To report the early and 6-month results after atherectomy of femoropopliteal lesions using a new atherectomy device compatible with a 7-F sheath., Methods: Fifty-two patients (36 men; mean age 67+/-7 years) with stable, chronic lower limb occlusive disease were enrolled prospectively in a study of percutaneous directional atherectomy using the SilverHawk Atherectomy Catheter. The 71 femoropopliteal stenoses were grouped for analysis according to pathology: 30 (42%) primary stenoses, 27 (38%) native vessel restenoses, and 14 (20%) in-stent restenoses. The overall average stenosis length was 48+/-64 mm (range 10-300). There were more diabetics in the primary lesion cohort, whereas the lesion length of the in-stent restenoses was nearly twice as long as the other groups., Results: After atherectomy alone, residual stenosis was < or =50% in 68 (96%) lesions and < or =30% in 54 (76%). Additional balloon angioplasty was used in 41 (58%) lesions, primarily to smooth the arterial contour; stents were implanted in 4 (6%) arteries. Acute results after atherectomy and additional therapy were identical for the 3 groups (mean residual stenosis 15% in primary lesions, 8% in restenoses, and 14% in in-stent lesions). At the beginning of the study, 5 cases of tissue embolism were successfully treated with aspiration (device modification solved this problem). Restenosis rates after 6 months were not significantly lower in primary lesions (27%) compared with the other groups (41% for restenoses and 36% for in-stent restenoses). Reintervention after 6 months was also lowest for primary lesions (20% versus 37% for restenoses and 29% for in-stent lesions; p=NS). The ankle-brachial index was significantly improved after 6 months in all groups. At the 6-month follow-up, >80% of all patients were symptom free or had no lifestyle-limiting claudication., Conclusions: Short and medium-length femoropopliteal lesions can be treated successfully and safely in most cases with this new atherectomy catheter. Technical and 6-month clinical outcomes seem to favor primary lesions compared with restenoses.

Purpose: Prospective evaluation of the 3- and 6-month results after atherectomy of below-knee arterial lesions with a reference diameter of at least 2.0 mm with use of the Silverhawk device., Materials and Methods: Fifty-two below-knee lesions in 33 patients (61% men; mean age, 70 years +/- 11) with chronic peripheral occlusive disease of the lower limbs were treated with directional atherectomy. Target lesions were the popliteal artery (segment 3), n = 4 (8%); tibioperoneal trunk, n = 22 (42%); peroneal artery, n = 18 (34%); anterior tibial artery, n = 5 (10%); posterior tibial artery, n = 3 (6%); and in-stent lesions, n = 8 (16%). All interventions were performed via a 6-F sheath. The average degree of diameter stenosis was 89% +/- 10% (range, 70%-100%; n = 12 [23%] occlusions) and the mean lesion length was 48 mm +/- 28., Results: All but one lesion (2%) could be treated with the atherectomy catheter. After additional balloon angioplasty, all but one lesion was treated, with a residual stenosis no greater than 30% (98%), with 7.2 passes per lesion +/- 2.8 (range, 1-12) performed with the device. Fifteen lesions (29%) were treated after predilation and 37 (71%) were treated with primary atherectomy. In 15 lesions (29%), additional balloon angioplasty was performed, and two lesions required stent implantation as a result of dissection. The mean stenosis diameter after atherectomy was 12% +/- 18% (range, 0-100%). After additional therapy, the mean stenosis diameter was 6% +/- 9% (range, 0%-30%). A residual stenosis no greater than 30% was achieved in 50 lesions (96%). The mean ankle-brachial index significantly increased from 0.46 +/- 0.27 to 0.80 +/- 0.34 before discharge and remained improved during follow-up. One procedural complication (3%) was observed in which an intermittent occlusion of the target vessel occurred after an unsuccessful attempt to cross the lesion with the atherectomy device; this was then treated successfully with local lysis. One patient with one treated lesion died during follow-up. The rates of restenosis of at least 70% (diagnosed by duplex ultrasonography) were 14% (seven of 51 lesions) after 3 months and 22% (11 of 51) after 6 months. The 3-month and 6-month cumulative event-free survival were 91% +/- 4.1% and 76.9% +/- 5.8% and the 3-month and 6-month cumulative patency rates were 98% +/- 1.9% and 94.1% +/- 3.3%, respectively., Conclusion: Below-knee native vessel lesions with a diameter of at least 2.0 mm can be treated with the Silverhawk catheter with a high success rate and a low complication rate. Midterm technical and clinical results are encouraging. Additional balloon angioplasty might be necessary in selected cases.

Diagnosis of non-specific aorto-arteritis (NSAA, Takaysu's arteritis) is typically based on clinical and investigational parameters. We report here about two patients with clinically suspected diagnosis of a Takayasu's arteritis already under anti-inflammatory therapy in whom percutaneous transluminal atherectomy of subclavian and axillary artery stenoses was performed to relief the patients from symptoms--intermittent dyspraxia of the arms--and to verify the clinical diagnosis by histology. In the first case aorto-arteritis could be histologically confirmed through the analysis of plaque material including media structures excised from the subclavian and axillary arteries using a new device for atherectomy. The biopsy showed diffuse inflammation and granulomatous lesions with giant cells typically for Takayasu's disease. In the second patient, biopsy showed no acute or chronic inflammatory signs but only atherosclerotic lesions. Percutaneous transluminal atherectomy is therefore not only an interventional but also a diagnostic tool and should be used in every case of interventional therapy of suspected aorto-arteritis to make the clinical diagnosis and as a major consequence the initiation of an aggressive anti-inflammatory medical therapy more reliable.