Novel vein closure procedure using a proprietary cyanoacrylate adhesive: 30-day swine model results.

PURPOSE: To conduct a pilot study to demonstrate a novel method of using a proprietary cyanoacrylate (CA) for closure of superficial veins. MATERIALS AND METHODS: Right and left superficial epigastric veins from two swine models were utilized due to the vein's similarities with the human great saphenous vein. Under ultrasound guidance, access was gained and a 5-F delivery catheter was advanced to the junction of the superficial epigastric and abdominus rectus veins. A dispenser gun was then utilized to inject 0.16 mL of CA while compression was applied cephalad to the end of the catheter. Immediately after delivery, the catheter was pulled back 3 cm and manual compression was employed for 30 seconds. After this first injection, the ultrasound probe was repositioned caudad to the injection and cephalad to the catheter tip and another 0.16 mL injection was delivered with immediate 3 cm pullback of the delivery system. Manual compression was applied at the caudad end of the treated vein for 30 seconds. This process was repeated until the entire target segment was treated. RESULTS: At 30 days postimplantation, the treated veins were occluded with no evidence of recanalization or migration. Histological findings revealed that the lumen was dilated by coalescing, arborizing clear spaces with entrapped lytic erythrocytes, demarcated by a thin band of granular eosinophilic material. Spindle cells with dense eosinophilic matrix replaced the tunica intima and disrupted the tunica media. CONCLUSION: Results of this initial study demonstrated that intravascular injection of CA is feasible for closure of superficial veins in animal models. These findings warrant further animal studies of this proprietary CA to assess efficacy, safety and its effects on perivenous structures.

Ultrasound-accelerated thrombolysis in arterial and venous peripheral occlusions: fibrinogen level effects.

PURPOSE: This study retrospectively assesses whether significantly accelerating thrombolysis with ultrasound affects fibrinogen levels in the treatment of peripheral arterial occlusions. MATERIALS AND METHODS: Between December 2005 and August 2007, 38 limbs in 38 patients (17 women; mean age, 60.5 +/- 19.7 years; age range, 17-94 years) were treated with ultrasound-accelerated thrombolysis for peripheral arterial occlusion (PAO) and deep vein thrombosis (DVT), with serum fibrinogen levels measured at baseline and every 24 hours. All occlusions were treated with alteplase (0.5-1.0 mg/h). RESULTS: Complete or partial lysis was achieved in 92.1% of patients. All patients received thrombolytic therapy with mean infusion time of 42.3 hours (range, 20-96 hours). As part of standard clinical practice, patients were not assessed angiographically overnight. Mean total alteplase dose was 40.6 mg (range, 18-96 mg). Across all patients, the fibrinogen level at the end of infusion decreased by an average of 18.5% from baseline, and no patient exhibited a fibrinogen level < 100 mg/dL during treatment. Fibrinogen depletion was more pronounced among patients with venous occlusions (26.4% from baseline) than those with arterial occlusions (15.8% from baseline). No major hemorrhagic complications occurred. One patient (2.6%) experienced a minor bleeding event at the access site, and use of thrombolytics was discontinued; and one patient with a chronic arterial occlusion and underlying coronary disease who did not respond to thrombolytic therapy, experienced an acute myocardial infarction. Of documented 30-day clinical outcomes in 20 patients, 80.0% remained patent at 30 days. CONCLUSIONS: Ultrasound-accelerated thrombolysis for the treatment of PAO and DVT is associated with a very low complication rate and nominal fibrinogen depletion.

One-year cognitive outcomes associated with carotid artery stent placement.

PURPOSE: To assess relatively long-term (ie, 1 year) neurocognitive outcomes of patients undergoing carotid artery stent (CAS) placement with cerebral protection. MATERIALS AND METHODS: Sixty-two patients (19 symptomatic; mean age, 73 years) with significant carotid stenosis (> or = 70% for symptomatic patients, > or = 80% for asymptomatic patients) underwent CAS placement with embolic protection. Cognitive function was assessed prospectively with use of a battery of standardized tests administered at baseline (1-5 days before CAS endovascular therapy) and at 3, 6, and 12 months after CAS placement. Diffusion-weighted imaging (DWI) was performed before the procedure and within 24 hours after CAS placement. RESULTS: Results of statistical modeling across occasions of measurement indicated significant main effects of occasion for the Dementia Rating Scale (DRS)-2 concept formation (P < .001), memory (P = .029), and total scores (P = .001); the DRS-2 total age- and education-corrected Mayo Older Americans Normative Studies score (P < .001); and the North American Adult Reading Test IQ score (P = .003). The vast majority of patients showed improvement or no change relative to baseline DRS-2 total scores at all time points. No significant relationship between DWI outcomes and cognition scores over time was found. Age influenced improvement on cognitive tests, whereas baseline symptom status did not. CONCLUSIONS: Revascularization with a carotid stent and neuroprotection, at a minimum, left cognitive function unchanged in patients receiving a CAS, and in many instances improved it. The preliminary findings of this prospective pilot study should be confirmed with a larger, controlled trial.

C-arm cone-beam CT: applications for spinal cement augmentation demonstrated by three cases.

Spinal canal narrowing as a result of retropulsion of spinal structures before or during cement augmentation has been considered a contraindication to therapy. The authors describe three cases of compression fractures safely treated with cement augmentation with the novel application of C-arm cone-beam computed tomography (CT). All cases involved small amounts of posterior cement extrusion, after which osteotomy needles were left in place during C-arm cone-beam CT. Rapidly reformatted images were viewed with the use of bone windows, yielding three-dimensional visualization of pertinent anatomy to confirm endpoints of posterior extrusion and adequate bone filling.

Ultrasound-accelerated thrombolysis for the treatment of deep vein thrombosis: initial clinical experience.

PURPOSE: To evaluate the success of lysis and clinical outcomes in patients treated with ultrasound (US)-accelerated thrombolysis for deep vein thrombosis (DVT). MATERIALS AND METHODS: Forty-seven patients with 53 cases of DVT were treated with US-accelerated thrombolysis at eight centers in the United States. Sixty percent of the occlusions were in the lower extremity, 36% were in the upper extremity, and 4% were hepatic. The clot was acute (< or =14 days) in 47% of cases, subacute (15-28 d) in 8%, chronic (>28 d) in 17%, acute-on-chronic in 17%, and not specified in 11%. Patients were treated with urokinase (UK), tissue plasminogen activator (tPA), recombinant plasminogen activator (rPA), or tenecteplase. RESULTS: Complete lysis (> or =90%) was seen in 37 of 53 cases (70%) and overall lysis (complete plus partial) was seen in 48 (91%). No lysis occurred in five cases (9%), four of which were chronic. The median thrombolysis infusion time was 22.0 hours. Major complications (hematoma at site of earlier surgery) occurred in only two patients (3.8%), with no incidence of intracranial or retroperitoneal hemorrhage. US-accelerated thrombolysis exhibited comparable or better lysis with a lower average drug dose and shorter median treatment times than reported in the National Venous Registry and a more recently published study of standard catheter-directed thrombolysis. CONCLUSIONS: US-accelerated thrombolysis was shown to be a safe and efficacious treatment for DVT in this multicenter experience. The addition of US reduces total infusion time and provides a greater incidence of complete lysis with a reduction in bleeding rates.

Clinical evaluation of the Zilver vascular stent for symptomatic iliac artery disease.

PURPOSE: To evaluate the safety and effectiveness of the Zilver vascular stent in the treatment of de novo or restenotic lesions in the external and common iliac arteries. MATERIALS AND METHODS: Regardless of the results of an initial percutaneous transluminal angioplasty (PTA), 151 consecutive patients were implanted with Zilver vascular stents (Cook, Bloomington, Ind) in up to two stenotic (< or =10 cm) or occluded (< or =5 cm) atherosclerotic lesions of the external or common iliac arteries. The primary endpoint was the rate of major adverse events within 9 months after the procedure. Major adverse events were defined as death, myocardial infarction, target lesion revascularization, and limb loss. Secondary endpoints included acute procedural success, 30-day clinical success, 9-month patency rate, 9-month functional status (on the basis of the validated Walking Impairment Questionnaire), and ankle-brachial index (ABI). RESULTS: of 1-, 6-, and 9-month follow-up are reported. Results The 9-month device and/or procedural-related major adverse event rate (adjudicated by an independent clinical events committee) was 2.7%. The all-cause major adverse event rate was 7.5%. Both rates were substantially below the prespecified objective performance criterion of 16%. The acute procedure success rate and 30-day clinical success rate were 98.0% and 94.0%, respectively. The 9-month patency rate, measured with duplex ultrasonography, was 92.9%. Significant improvement in the ABI and walking distance and walking speed scores, relative to preprocedural values, was seen at 1 month and was maintained through 9-month follow-up. CONCLUSIONS: The Zilver vascular stent is safe and effective as an adjunct to PTA in the treatment of symptomatic disease of the iliac arteries.

Evaluation of Legs For Life National Screening and Awareness Program for Peripheral Vascular Disease: results of a follow-up survey of screening participants.

PURPOSE: The Legs For Life(R) National Screening and Awareness Program for Peripheral Vascular Disease (PVD) was launched in 1999. A critical component of the screening program was an independent evaluation to provide additional information about the results of the program. This evaluation considers the health education impacts of the screening program; participants' knowledge about appropriate providers; and some of the outcomes associated with the program. MATERIALS AND METHODS: The evaluation is based on a representative sample of 700 individuals who participated in the screening program and responded to a six-page closed-ended mail questionnaire 6 months after the screening. The sample was drawn in a two-stage cluster. A sample of 1,000 individuals was drawn using random selection of low-risk participants and oversampling of all high- and medium-risk participants from 22 sites. RESULTS: More than 80% of the respondents remembered the name of the test (ankle-brachial index) given during the screening program. More than half the respondents reported being informed during the screening that leg pain when walking was a symptom of PVD, and 40% reported being told that numbness in the leg was a symptom. The majority of respondents were able to identify ways to prevent or slow the progression of PVD, whereas just under 50% were able to identify those individuals that would be at higher risk for PVD. Respondents most frequently identified vascular surgeons (42%), family or primary care physicians (22%), and cardiologists (19%) as the type of doctor to see for PVD treatment, whereas only 4.8% of screening participants recognized interventional radiologists as specialists appropriate to dealing with PVD. CONCLUSION: Evidence from participants in the Legs For Life(R) National Screening Program suggests that the program has met its initial goals of education, identification, and treatment for those identified with PVD. While many specialties manage this condition, the evaluation indicates there is much to be done in increasing the awareness of interventional radiologists and their role in the diagnosis and treatment of PVD.