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Introduction Objective of our study was to determine the agreement between version 1 (v1) and v2 of the Prostate Imaging Reporting and Data System (PI-RADS) for evaluation of multiparametric prostate MRI (mpMRI) and to compare their diagnostic accuracy, their inter-observer agreement and practicability. Material and Methods mpMRI including T2-weighted imaging, diffusion-weighted imaging (DWI) and dynamic contrast-enhanced imaging (DCE) of 54 consecutive patients, who subsequently underwent MRI-guided in-bore biopsy were re-analyzed according to PI-RADS v1 and v2 by two independent readers. Diagnostic accuracy for detection of prostate cancer (PCa) was assessed using ROC-curve analysis. Agreement between PI-RADS versions and observers was calculated and the time needed for scoring was determined. Results MRI-guided biopsy revealed PCa in 31 patients. Diagnostic accuracy for detection of PCa was equivalent with both PI-RADS versions for reader 1 with sensitivities and specificities of 84%/91% (AUC = 0.91 95%CI[0.8–1]) for PI-RADS v1 and 100%/74% (AUC = 0.92 95% CI[0.8–1]) for PI-RADS v2. Reader 2 achieved similar diagnostic accuracy with sensitivity and specificity of 74%/91% (AUC = 0.88 95%CI[0.8–1]) for PI-RADS v1 and 81%/91% (AUC = 0.91 95%CI[0.8–1]) for PI-RADS v2. Agreement between scores determined with different PI-RADS versions was good (reader 1: κ = 0.62, reader 2: κ = 0.64). Inter-observer agreement was moderate with PI-RADS v2 (κ = 0.56) and fair with v1 (κ = 0.39). The time required for building the PI-RADS score was significantly lower with PI-RADS v2 compared to v1 (24.7±2.3 s vs. 41.9±2.6 s, p

To report on a prospective two-center study to evaluate safety and effectiveness of a self-expanding nitinol coil stent in patients with femoropopliteal obstructive disease.The IntraCoil nitinol stent was used in 37 patients (28 men and nine women; mean age, 62.4 y plus minus 10.7; range, 43-81 y) presenting with high-grade stenoses (n = 23) or short (3 cm) occlusions (n = 17) of the superficial femoral artery (SFA; n = 33) or popliteal artery (n = 4). Indications for stent placement were significant residual stenosis (30%) or dissection after angioplasty. Follow-up evaluations with measurement of the Doppler ankle-brachial index (ABI), assessment of Rutherford clinical stage, and color-coded duplex sonography were performed at discharge and 1, 3, 6, 12, and 18 months thereafter. Primary endpoints of the study were immediate technical and clinical success and 1-year patency.Initial technical success was achieved in all patients. In 10 patients (27%), more than one 40-mm-long device had to be implanted for total lesion coverage; in three patients (8.1%), stents were placed in two separate segments of the SFA simultaneously. The total number of stents deployed was 50. Stent placement induced an initial improvement of the ABI from 0.54 plus minus 0.2 to 0.92 plus minus 0.11 (P.01). Follow-up data for 12 months after treatment are available for 29 of 37 patients (78.4%); mean follow-up is 15.6 months (range, 1-26 mo). Primary patency rates at 6 and 12 months were 97.1% (SE = 2.9) and 86.2% (SE = 6.5). The primary assisted patency rate was 100% at 12 months.Endovascular placement of the IntraCoil self-expanding nitinol coil stent for salvage of failed angioplasty in patients with femoropopliteal obstructive disease is an effective and safe procedure with promising mid-term results.

The purpose of developing percutaneously placed endoluminal stent-grafts for the treatment of aortic aneurysms is to avoid major intra-abdominal surgery and related morbidity and mortality. To define its clinical utility, the authors prospectively studied polyester-covered nitinol stents for the treatment of infrarenal abdominal aortic aneurysms (AAAs). Since 1994, the authors implanted in a total of 228 patients nonbifurcated or bifurcated stent-grafts based on a self-expandable nitinol framework covered with a thin polyester fabric for the endovascular repair of infrarenal AAA. The patient cohort was divided into two subgroups: Group 1 (n = 120) consisted of patients treated with use of the original stent-graft; Group 2 (n = 108) comprised patients treated with the refined stent-graft. Preprocedural evaluation with precise determination of the length and diameter of the proximal neck and the common iliac arteries was based on spiral computed tomography, intra-arterial angiography, and magnetic resonance angiography. The initial technical success rates in patients of Group 1 presenting with a type A aneurysm (n = 9), and type B or C aneurysms (n = 111) were 78% and 82%, respectively. Minor and major complications, including one 30-day mortality, were observed in 14 patients (11.7%). With refinement of the polyester cover as a consequence from our initial experiences, we achieved in Group 2 for type A (n = 8), and type B or C aneurysms (n = 100) primary success rates of 100% and 97%, respectively. The rate of local and remote complications in this group was 6.5%. Based on our initial and mid-term results, endoluminal repair of infrarenal AAA with use of straight or bifurcated stent-grafts is a feasible alternative to conventional surgical repair associated with a low rate of morbidity and mortality.

To evaluate treatment of infrarenal abdominal aortic aneurysm (AAA) with a new endoluminal stent-graft.In 26 male patients, straight or bifurcated nitinol stents covered with woven Dacron graft material were implanted to treat eccentric saccular AAA (n = 3) or AAA involving the bifurcation and common iliac arteries (n = 23), with follow-up from 8 days to 8 1/2 months.Implantation was technically successful in all but one of the 26 (96%) patients (leak of the stent-graft for more than 3 months necessitated implantation of an additional covered stent). In seven of the 26 patients, minor residual perfusion persisted immediately after implantation, but complete thrombosis occurred within 7 days. Five procedure-related complications occurred: distal embolization (n = 2); local hematoma, which necessitated surgery (n = 1); acute hepatic failure due to gastric bleeding, in a patient with liver cirrhosis (n = 1); and stent-graft occlusion due to emboli originating from the left atrium (n = 1).Exclusion of AAA from circulation was feasible, safe, and clinically effective with the new stent-graft.

To report a prospective study to evaluate safety, effectiveness, and midterm patency of self-expanding stent-grafts in patients with femoropopliteal occlusive disease.Sixty-three Hemobahn stent-grafts were used in 52 patients for treatment of medium- or long-segment (3 cm) occlusions (82.7%) and stenoses (17.3%) of the femoropopliteal artery. The mean length of vessel segments covered was 10.9 cm +/- 5.13. Follow-up with documentation of clinical symptoms, assessment of Rutherford clinical stage of peripheral vascular disease, and color-coded duplex sonography was performed at discharge, at 1, 3, 6, 12, 18, and 24 months after implantation, and yearly thereafter. Mean follow-up duration was 23.8 months +/- 6.9 (range, 8-36 mo). Follow-up data at 12 and 24 months after treatment were available for 47 of 52 (90.4%) and 31 of 52 patients (59.6%), respectively.Device implantation was technically successful in all 52 patients, yielding an overall technical success rate of 100%. Procedure-related complications were observed in 12 of 52 patients (23.1%) and consisted of distal embolization (n = 4, 7.7%), minor groin hematoma (n = 7, 13.5%), and arteriovenous fistula (n = 1, 1.9%), but prolonged hospitalization and further medical, interventional, or surgical measures were not required. Stent-graft placement induced an initial improvement of the mean resting ankle-brachial index from 0.54 +/- 0.12 to 0.89 +/- 0.14 (P.01). Primary patency rates at 12 and 24 months were 78.4% +/- 5.8 and 74.1% +/- 6.2, respectively. Primary assisted patency rates were 82.4% +/- 5.3 at 12 months and 80.3% +/- 5.6 at 24 months. Secondary patency rates at 12 and 24 months were 88.3% +/- 4.5 and 83.2% +/- 5.5, respectively. There was no significant difference (log-rank test, P.3) between primary patency rates in patients grouped according to lengths of implanted grafts (ie, length of the treated lesions).Endovascular placement of Hemobahn stent-grafts for percutaneous treatment of medium- to long-segment high-grade stenoses and occlusions of the femoropopliteal artery is a safe procedure with excellent initial success rates and promising midterm results.

The purpose of this study was to define the clinical utility of stent-grafts for endoluminal treatment of infrarenal abdominal aortic aneurysms (AAAs). In a prospective study involving three centers, bifurcated stent-grafts for endovascular repair of infrarenal AAAs were implanted in 295 patients. Patient selection was based on anatomic suitability. For analysis of the initial and follow-up results the patients were divided in three subgroups. Group 1 included patients treated between August 1994 and April 1996 with use of the original stent-graft device; group 2 comprised patients treated between May 1996 and December 1997 with the refined stent-graft device, and group 3 comprised patients treated with a newly designed bifurcated stent-graft device. In group 1 (n = 111) the primary technical success was 82%. The procedure had to be converted to surgery in four patients. Endoleaks immediately after the procedure were observed in 16 patients. The initial technical success in subgroup 2 (n = 159) was 96%. One patient required surgical repair, and five others had immediate perigraft flow due to reperfusion via lumbar arteries. For group 3 (n = 28) the primary technical success rate was 89%. Endoleaks due to back-bleeding via lumbar arteries were demonstrated in three patients. Minor and major complications related to the intervention, including two perioperative deaths, were observed in 24 patients (8%). Serious problems such as distal migration or disconnection of the stent-graft were detected during follow-up in five patients. Delayed aortic rupture occurred in three patients who survived after successful surgical repair. Based on the initial results and a limited follow-up of 35 months, we believe endoluminal repair of infrarenal AAA with use of bifurcated endografts may be a feasible alternative to conventional surgery, especially for patients at high surgical risk. However, at the present time there are major concerns with respect to the structural integrity of stent-graft material and the fate of the proximal aortic cuff in the long-term time frame.

The treatment of aortic aneurysms with endovascular stents or stent-graft prostheses is receiving increasing attention as an alternative to major abdominal surgery. To define the clinical value of this technique, we prospectively studied the use of stent-graft endoprostheses made of nitinol and covered with polyester fabric for the treatment of infrarenal abdominal aortic aneurysms.We treated a total of 154 patients at three academic hospitals. Twenty-one patients with aortic aneurysms not involving the aortic bifurcation received straight stent-grafts, and 133 patients with aortic aneurysms involving the bifurcation and the common iliac arteries received bifurcated stent-grafts. After a unilateral surgical arteriotomy, the endoprostheses were advanced through the femoral arteries and placed under fluoroscopic guidance. Computed tomography and intraarterial angiography were performed during an average follow-up of 12.5 months.The primary success rate, defined as complete exclusion of the abdominal aortic aneurysm from the circulation, was 86 percent in the group receiving straight grafts and 87 percent in the group receiving bifurcated grafts. In three patients the procedure had to be converted to an open surgical operation. Minor (n=13) or major (n=3) complications associated with the procedure (including 1 death) occurred in 10 percent of the patients. All patients had a postimplantation syndrome, with leukocytosis and elevated C-reactive protein levels.Our results suggest that endovascular treatment of infrarenal abdominal aortic aneurysms is technically feasible and can effectively exclude abdominal aortic aneurysms from the circulation. With further refinement, endoluminal repair may emerge as an interventional strategy to treat infrarenal aortic aneurysms, especially in patients at high surgical risk.