Arina van Breda

Guidelines for development and use of transluminally placed endovascular prosthetic grafts in the arterial system

THE feasibility of placing prosthetic grafts within the arterial tree by inserting them via a remote site, guiding them intraluminally to the appropriate location, and fixing them there with attachment systems, such as a variety of expandable stents, has been demonstrated in animals and human subjects (1–3). There is a potential for these transluminally placed endovascular grafts (TPEGs) to provide improved treatment for a variety of arterial lesions including aneurysms, traumatic injuries, and arteriosclerotic occlusions. TPEG repairs of all three kinds of lesions have been carried out at various levels of the arterial tree with short-term success (1,4–17). Because TPEG repairs can be performed less invasively, their risks and costs may be less than those of standard vascular graft operations. They will, therefore, be extremely attractive to both patients and physicians, and consequently there will be enormous pressures to develop and use these devices rapidly. The purpose of this document is to foster the development of safe, effective devices for performing TPEG repairs of various arterial lesions at all levels of the arterial tree. To this end, it will provide guidelines for the careful and structured evaluation and monitoring that is necessary to document the safety, efficacy, and effectiveness of these devices in various settings before they undergo widespread clinical use. Although these guidelines are not a regulatory document, they are intended to help avoid premature and potentially harmful usage of TPEGs.

Early Results from a United States Trial of Prostatic Artery Embolization in the Treatment of Benign Prostatic Hyperplasia

PURPOSE To report early findings from a prospective United States clinical trial to evaluate the efficacy and safety of prostatic artery embolization (PAE) for benign prostatic hyperplasia (BPH). MATERIALS AND METHODS From January 2012 to March 2013, 72 patients were screened and 20 patients underwent treatment. Patients were evaluated at baseline and selected intervals (1, 3, and 6 mo) for the following efficacy variables: American Urological Association (AUA) symptom score, quality of life (QOL)-related symptoms, International Index of Erectile Function score, peak urine flow rate, and prostate volume (on magnetic resonance imaging at 6 mo). Complications were monitored and reported per Society of Interventional Radiology guidelines. RESULTS Embolization was technically successful in 18 of 20 patients (90%); bilateral PAE was successful in 18 of 19 (95%). Unsuccessful embolizations were secondary to atherosclerotic occlusion of prostatic arteries. Clinical success was seen in 95% of patients (19 of 20) at 1 month, with average AUA symptom score improvements of 10.8 points at 1 month (P < .0001), 12.1 points at 3 months (P = .0003), and 9.8 points at 6 months (P = .06). QOL improved at 1 month (1.9 points; P = .0002), 3 months (1.9 points; P = .003), and 6 months (2.6 points; P = .007). Sexual function improved by 34% at 1 month (P = .11), 5% at 3 months (P = .72), and 16% at 6 months (P = .19). Prostate volume at 6 months had decreased 18% (n = 5; P = .05). No minor or major complications were reported. CONCLUSIONS Early results from this clinical trial indicate that PAE offers a safe and efficacious treatment option for men with BPH.

Low-dose direct fibrinolysis in peripheral vascular disease

One hundred thirty patients underwent low-dose, catheter-directed fibrinolytic therapy for arterial and graft occlusions present for various periods of time. In 65 consecutive patients the therapeutic parameters were identical, and a careful hematologic evaluation was performed. In the subsequent 65 patients, varying doses of fibrinolytic agents were employed. Fibrinolytic therapy was found to be beneficial in a diverse group of clinical situations and in patients whose occlusions had occurred at varying lengths of time. Early study demonstrated that effective fibrinolysis can be achieved at approximately one-twentieth of the systemic level and that systemic effects could be avoided in all patients during 24-hour infusions and in many patients infused up to 96 hours. Bleeding complications occurred only in patients in whom concomitant heparinization was employed, and this was thought to be the causative factor. Therapeutic success and avoiding complications are strongly dependent on close monitoring of patients and joint decision making by the vascular surgeon and radiologist.

Utility of cone-beam CT imaging in prostatic artery embolization.

PURPOSE To evaluate the utility of cone-beam computed tomography (CT) in patients undergoing prostatic artery (PA) embolization (PAE) for benign prostatic hyperplasia. MATERIALS AND METHODS From January 2012 to January 2013, 15 patients (age range, 59-81 y; mean, 68 y) with moderate- or severe-grade lower urinary tract symptoms, in whom medical management had failed were enrolled in a prospective United States trial to evaluate PAE. During pelvic angiography, 15 cone-beam CT acquisitions were performed in 11 patients, and digital subtraction angiography was performed in all patients. Cone-beam CT images were reviewed to assess for sites of potential nontarget embolization that impacted therapy, a pattern of enhancement on cone-beam CT suggesting additional PAs, confirmation of prostatic parenchymal perfusion before embolization, and contralateral prostatic parenchymal enhancement. RESULTS Cone-beam CT was successful in 14 of 15 acquisitions, and PAE was successful in 14 of 15 patients (92%). Cone-beam CT provided information that impacted treatment in five of 11 patients (46%) by allowing for identification of sites of potential nontarget embolization. Duplicated prostatic arterial supply and contralateral perfusion were each identified in 21% of patients (three of 11). Prostatic perfusion was confirmed before embolization in 50% of acquisitions (seven of 14). CONCLUSIONS Cone-beam CT is a useful technique that can potentially mitigate the risk of nontarget embolization. During treatment, it can allow for the interventionalist to identify duplicated prostatic arterial supply or contralateral perfusion, which may be useful when evaluating a treatment failure.

Percutaneous Transluminal Angioplasty of the Abdominal Aorta

PURPOSE To determine the long-term results of percutaneous transluminal angioplasty (PTA) of focal infrarenal abdominal aortic stenoses. PATIENTS AND METHODS Over a 10-year period, 15 focal infrarenal abdominal aortic stenoses were treated with PTA in 14 patients (13 women and one man; mean age, 53.2 years; range, 43-78 years). RESULTS The initial technical success rate was 100%. Clinical patency, as defined by continued absence or improvement in symptoms after PTA, was achieved in 14 of the 15 angioplasty procedures (93%) with a mean duration of clinical follow-up of 4.3 years (range, 0.6-9.8 years) in the 14 patients. Long-term noninvasive follow-up demonstrated continued patency of the angioplasty site in 11 of 11 patients available for study. The mean ankle-arm index in these 11 patients was 0.95 (range, 0.9-1.0) at a mean follow-up of 4.8 years (range, 0.6-9.8 years). There was no significant morbidity or mortality associated with the angioplasty procedures. CONCLUSION In view of the high degree of technical success and the excellent long-term patency, we believe that PTA should be considered a primary method of treatment in properly selected patients with focal abdominal aortic stenoses.

Percutaneous Placement of a Hepatic Vein Stent in the Treatment of Budd-Chiari Syndrome

The authors describe the first reported use, to their knowledge, of an intravascular stent to relieve hepatic vein stenosis causing the Budd-Chiari syndrome. A patient with severe stenosis of the left hepatic vein is described. Multiple balloon angioplasty procedures were performed over a period of several months and provided only transient relief of symptoms. As an alternative to surgical management, an intravascular stent was placed, with complete resolution of symptoms. Intravascular stent placement may play an important role in treatment of the Budd-Chiari syndrome.

Relative Cost-Effectiveness of Urokinase versus Streptokinase in the Treatment of Peripheral Vascular Disease☆

A retrospective case control study of 271 patients with peripheral arterial occlusion (PAO) who were treated with urokinase (UK) or streptokinase (SK) at two clinical centers, Alexandria Hospital and the Cleveland Clinic, was performed. The primary objective was to evaluate the relative cost-effectiveness of thrombolytic therapy with SK or UK in the treatment of PAO. A secondary objective was to identify factors to which any major differences in cost-effectiveness between these two agents could be attributed. All available patients hospitalized at the two centers for PAO who underwent treatment with UK or SK from 1979 to 1987 were included. Therapeutic success was defined as complete clot lysis or partial clot lysis judged to be of clinical benefit by the attending physician, with no major bleeding or other serious complication such as renal insufficiency or death. Success rates with UK were higher than those with SK at both centers. The advantage with UK could not be explained by baseline patient characteristics. A cost-effectiveness ratio--dollars expended on medical care for up to 2 days after infusion per therapeutic success--was calculated for each of the treatments. Overall, at Alexandria Hospital,

Use of digital subtraction angiography for evaluation of vascular access for hemodialysis.

10,700 was expended per therapeutic success with UK therapy compared with

Standards for Interventional Radiology

14,500 for successful SK therapy. At the Cleveland Clinic, differences were more pronounced, with

Guidelines for Development and Use of Transluminally Placed Endovascular Prosthetic Grafts in the Arterial System

15,000 expended per therapeutic success for UK treatment and