Effect of balloon angioplasty in femoropopliteal arteries assessed by intravascular ultrasound

Objective: To study the effects of balloon angioplasty (PTA) of the femoropopliteal artery with intravascular ultrasound (IVUS). Materials and methods: Corresponding IVUS cross-sections (n = 1033) obtained before and after PTA from 115 procedures were analysed. Vascular damage including plaque rupture, dissection and media rupture was assessed. Free lumen area (FLA), media-bounded area (MBA) and plaque area (PLA) were measured. Results: After PTA vascular damage was seen at the target site in 83 (72%) arteries: plaque rupture in 30 (26%), dissection in 66 (57%) and media rupture in 20 (17%) arteries. The FLA increased from 5.4 ± 3.4 mm2 to 14.1 ± 5.0 mm2 (p < 0.001), MBA increased from 26.9 ± 10.0 mm2 to 32.9 ± 10.7 mm2 (p < 0.001) and PLA decreased from 21.6 ± 8.5 mm2 to 18.8 ± 8.0 mm2 (p < 0.001). The increase in MBA accounted for 68% of lumen gain. The frequency of vascular damage and the relative contribution of MBA increase and PLA decrease to luminal gain were not different in procedures with balloon diameter ≤ 5 mm and ≤ 6 mm. Conclusions: Vascular damage is common following PTA. Lumen gain is mainly due to vessel expansion and, to a lesser extent, to a decrease in plaque area

Automated entire thrombus density measurements for robust and comprehensive thrombus characterization in patients with acute ischemic stroke

Background and Purpose: In acute ischemic stroke (AIS) management, CT-based thrombus density has been associated with treatment success. However, currently used thrombus measurements are prone to inter-observer variability and oversimplify the heterogeneous thrombus composition. Our aim was first to introduce an automated method to assess the entire thrombus density and then to compare the measured entire thrombus density with respect to current standard manual measurements. Materials and Method: In 135 AIS patients, the density distribution of the entire thrombus was determined. Density distributions were described usingmedians, interquartile ranges (IQR), kurtosis, and skewedness. Differences between themedian of entire thrombusmeasurements and commonly applied manualmeasurements using 3 regions of interest were determined using linear regression. Results: Density distributions varied considerably with medians ranging from 20.0 to 62.8 HU and IQRs ranging from 9.3 to 55.8 HU. The average median of the thrombus density distributions (43.5 ± 10.2 HU) was lower than the manual assessment (49.6 ± 8.0 HU) (p<0.05). The difference between manual measurements and median density of entire thrombus decreased with increasing density (r = 0.64; p<0.05), revealing relatively higher manual measurements for low density thrombi such that manual density measurement tend overestimates the real thrombus density. Conclusions: Automatic measurements of the full thrombus expose a wide variety of thrombi density distribution, which is not grasped with currently used manual measurement. Furthermore, d

Two-year clinical follow-up of the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in The Netherlands (MR CLEAN): Design and statistical analysis plan of the extended follow-up study

Background: MR CLEAN was the first randomized trial to demonstrate the short-term clinical effectiveness of endovascular treatment in patients with acute ischemic stroke caused by large vessel occlusion in the anterior circulation. Several other trials confirmed that endovascular treatment improves clinical outcome at three months. However, limited data are available on long-term clinical outcome. We aimed to estimate the effect of endovascular treatment on functional outcome at two-year follow-up in patients with acute ischemic stroke. Secondly, we aimed to assess the effect of endovascular treatment on major vascular events and mortality during two years of follow-up. Methods: MR CLEAN is a multicenter clinical trial with randomized treatment allocation, open-label treatment, and blinded endpoint evaluation. Patients included were 18 years or older with acute ischemic stroke caused by a proven anterior proximal artery occlusion who could be treated within six hours after stroke onset. The intervention contrast was endovascular treatment and usual care versus no endovascular treatment and usual care. The current study extended the follow-up duration from three months to two years. The primary outcome is the score on the modified Rankin scale at two years. Secondary outcomes include all-cause mortality and the occurrence of major vascular events within two years of follow-up. Discussion: The results of our study provide information on the long-term clinical effectiveness of endovascular treatment, which may have implications for individual treatment decisions and estimates of cost-effectiveness. Trial registration:NTR1804. Registered on 7 May 2009; ISRCTN10888758. Registered on 24 July 2012 (main MR CLEAN trial); NTR5073. Registered on 26 February 2015 (extended follow-up study)

Multicenter randomized controlled trial of the costs and effects of noninvasive diagnostic imaging in patients with peripheral arterial disease: The DIPAD trial

OBJECTIVE. The purpose of our study was to compare the costs and effects of three noninvasive imaging tests as the initial imaging test in the diagnostic workup of patients with peripheral arterial disease. MATERIALS AND METHODS. Of 984 patients assessed for eligibility, 514 patients with peripheral arterial disease were randomized to MR angiography (MRA) or duplex sonography in three hospitals and to MRA or CT angiography (CTA) in one hospital. The outcome measures included the clinical utility, functional patient outcomes, quality of life, and actual diagnostic and therapeutic costs related to the initial imaging test during 6 months of follow-up. RESULTS. With adjustment for potentially predictive baseline variables, the learning curve, and hospital setting, a significantly higher confidence and less additional imaging were found for MRA and CTA compared with duplex sonography. No statistically significant differences were found in improvement in functional patient outcomes and quality of life among the groups. The total costs were significantly higher for MRA and duplex sonography than for CTA. CONCLUSION. The results suggest that both CTA and MRA are clinically more useful than duplex sonography and that CTA leads to cost savings compared with both MRA and duplex