The Randomized Freeway Stent Study: Drug-Eluting Balloons Outperform Standard Balloon Angioplasty for Postdilatation of Nitinol Stents in the SFA and PI Segment.

PURPOSE: The prospective randomized multicenter Freeway study evaluated the possible hemodynamic and clinical benefits of primary stent insertion followed by percutaneous transluminal angioplasty (PTA) with drug-eluting balloons (DEB) over post-stent insertion PTA with standard balloons in the treatment of symptomatic femoropopliteal arteriosclerotic lesions. METHODS: In total, 204 patients in 13 centers in Germany and Austria were enrolled and randomized to primary stenting followed by either FREEWAY™ drug-eluting balloon or standard PTA balloon angioplasty. The primary endpoint was the rate of clinically driven target lesion revascularization (TLR) at 6 months; the secondary endpoints include TLR rate at 12 months and primary patency, shift in Rutherford classification, ankle-brachial index (ABI) and major adverse events (MAE) at 6 and 12 months. Lesion characteristics and vessel patency were analyzed by an independent and blinded corelab. RESULTS: At 6-month and 12-month follow-up, TLR rate was lower in the DEB arm compared to standard PTA but did not reach statistical significance (4.1% vs. 9.0% p = 0.234 and 7.9% vs. 17.7% p = 0.064, respectively). Primary patency was significantly better for patients treated with the DEB at 6 months (90.3% vs. 69.8% p = 0.001) and 12 months (77.4% vs. 61.0% p = 0.027). Improvement in Rutherford classifications was likewise significantly better for patients in the DEB group at 6 (94.9% vs. 84.3% p = 0.027) and 12 months (95.5% vs. 79.9% p = 0.003). The percentage of patients with an improved ABI of 1.0-1.2 was significantly higher in the DEB group compared to the PTA group at 6 months (55.3% vs. 35.3%; p = 0.015) but without significant difference at 12 months (48.2% vs. 32.9%; p = 0.055). At 6 months, rate of major adverse events (MAE) was 1% in both arms, and at 12 months 2.2% for the DEB and 3.8% for the PTA group. CONCLUSION: The Freeway Stent Study shows that the usage of DEB as a restenosis prophylaxis seems to be safe and feasible. The 12-month follow-up results give a clear sign in favor of the DEB group.

Prospective evaluation of interobserver variability of the hydronephrosis index and the renal resistive index as sonographic examination methods for the evaluation of acute hydronephrosis.

OBJECTIVE: To confirm the reliability of assessements of the renal resistive index (RRI) and the hydronephrosis index (HI) comprising two sonographic techniques providing additional information in patients with acute renal colic. PATIENTS AND METHODS: Sonographic measurement of hydronephrosis and assessment of common clinical criteria was performed in 22 consecutive patients presenting with unilateral stone-related renal colic. RRI and HI were separately recorded by two investigators within a prospective study. Interobserver agreement and comparison of sonographic with computed tomography (CT) findings were assessed with the Cohen's kappa statistic (κ) for attributive ordinal characteristics and Spearman's rank correlation/rho (ρ) for attributive metric characteristics. RESULTS: There was a significant correlation between HI and the sonographically-evaluated grade of hydronephrosis, although not between RRI and the grade of hydronephrosis. For all procedures (RRI, HI, sonography and CT), significant differences between the symptomatic and the asymptomatic kidney were assessed. Interobserver agreement was excellent for the grade assessment of hydronephrosis by conventional sonography (κ = 0.82; P < 0.001), good to very good for HI (ρ = 0.60; P = 0.003) and acceptable to good for RRI (ρ = 0.49; P = 0.021). CONCLUSIONS: The RRI and HI methods are both easily practicable as stageless examination methods in patients presenting with stone-related renal colic, and both also reliably distinguish between obstruction and non-obstruction. Exact thresholds for both methods must still be defined based on further successive studies. Additionally, changes of values under medical expulsive therapy and correlation with the functional status of the obstructed kidney remain to be examined.

Whole-body computed tomography in polytrauma: techniques and management.

An interdisciplinary team should be involved in the diagnosis and management of severely injured patients. The adoption of criteria for starting treatment for multiple trauma avoids underestimation of seriousness of injury. These criteria are established by the circumstances of the accident, the patterns of trauma, and the vital findings. Basic diagnosis comprises a limited number of plain films in the trauma room, including supine chest, lateral cervical spine, and pelvis, and ultrasound of abdomen, pleura, and pericardium. Organ diagnosis using CT is complementary and depends on the clinical findings and findings from the basic investigations. We recommend spiral CT (skull base 2/2/4 mm, cerebrum 8/8/8 mm native) and after intravenous contrast medium thoracic (5/7.5/5 mm) and abdominal CT (8/12/8 mm). Image reconstruction of bony structures can be added. The CT and the trauma center should be in close proximity; time-consuming transfers must be avoided. If this is not possible, a CT can be integrated in the trauma room. Our hospital trauma registry contains over 2200 entries. A quality committee has been established and external quality control is implemented.