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To assess the midterm patency and long-term safety of placement of a dedicated venous stent (Vici Venous Stent System) for the treatment of venous lesions of the iliofemoral outflow tract.Patients with unilateral obstructive disease of the iliofemoral veins and a Clinical, Etiological, Anatomical, Pathophysiological class of 3 or higher or a Venous Clinical Severity Score of 2 or greater were enrolled in this prospective, multicenter, single-arm study at 23 sites in the United States and Europe. The patients were followed up for 36 months after the index procedure for the assessment of patency and up to 60 months for the assessment of safety. The clinical outcomes in 11 patients with a stent fracture were assessed.A total of 200 patients enrolled in 2 cohorts (ie, feasibility cohort, n = 30; pivotal cohort, n = 170) were combined for this analysis. The overall 36-month primary patency rate was 71.7% (86/120), and the 36-month primary patency rate was 96.4% (27/28) for the nonthrombotic group and 64.1% (59/92) for the postthrombotic group. The freedom from major adverse events was 81.2% (53/65) through 60 months. The 60-month Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) was 84.3%. In 9 of the 11 patients who had a stent fracture (1 patient with nonthrombotic etiology and 10 patients with postthrombotic etiology) identified at 12 months, the stents extended into the common femoral vein. The TVR rates and clinical outcomes were similar between patients with and without a stent fracture.The results of the VIRTUS study demonstrated good midterm patency and long-term safety following the placement of a dedicated venous stent for iliofemoral obstruction.

PURPOSE To report safety and efficacy of a skip stent technique using nitinol stents in patients with chronic bilateral iliocaval venous occlusions. MATERIALS AND METHODS A retrospective analysis of 48 consecutive patients (32 men; mean age, 40.7 years; age range, 18-68 years) with chronic bilateral iliocaval obstructions treated using a nonoverlapping stent technique was conducted at a single center. None of the patients had May-Thurner syndrome. Iliocaval confluence was treated by deploying a nitinol stent in inferior vena cava (IVC) and a nitinol stent in each common iliac vein close to the caval stent. Patency of stents was assessed by duplex US at 2 weeks, 3 months, and 6 months and yearly thereafter. RESULTS Recanalization and stent reconstruction was technically successful in 47 (98%) patients. The sinus-XL venous stent was used to treat IVC (95 [100%]). Common iliac and external iliac veins were treated with sinus-Venous and VENOVO stents (80 [83%] and 16 [17%] limbs, respectively). External iliac and common femoral veins were treated with sinus-Venous and VENOVO stents (83 [92%] and 7 [18%] limbs, respectively). Early thrombosis (< 30 days) of the iliac vein with stent occurred in 2 limbs. Cumulative primary, assisted primary, and secondary patency rates at 30 months were 74%, 83%, and 97%. CONCLUSIONS Findings of this study suggest that leaving a skipped lesion at the level of iliocaval confluence may not adversely affect stent patency. Patency rates were comparable with other reported techniques of stent reconstruction at the level of iliocaval confluence.

Purpose This study sought to assess the performance of the LIFESTREAM balloon-expandable covered stent for the treatment of iliac artery atherosclerotic lesions. Methods A total of 155 patients were treated in a prospective, single-arm study at 17 centers in the United States, Europe, and New Zealand. The primary endpoint was a composite of device- or procedure-related death or myocardial infarction (MI) over the course of 30 days, or target lesion revascularization (TLR), major amputation of the target limb, or re-stenosis through 9-months. Secondary endpoints included primary patency, TLR, sustained clinical success, quality of life, and major adverse events (MAE). Results At 9 months, the primary composite endpoint rate was 16.2% (93.5% confidence interval [CI]: 10.6%–23.2%), primary patency was 89.1% (95% CI: 82.6%–93.7%), and freedom from TLR was 96%. There was a cumulative clinical improvement of at least one Rutherford category from baseline to 9 months of 90.5% (95% CI: 84.3%–94.9%). Quality of life, assessed by using the Walking Impairment Questionnaire (WIQ), demonstrated a mean change in total score from baseline through 9 months of 32.1 ± 26.84; overall, improvements were noted from baseline in each WIQ category. Seven of one-hundred fifty patients (4.7%; 95% CI: 1.9%–9.4%) experienced MAEs, but none were determined to be related to device or procedure. Conclusions The LIFESTREAM balloon-expandable covered stent provided satisfactory 9-month clinical outcomes including a low rate of target lesion revascularization for the treatment of stenotic and occlusive lesions of the iliac arteries.

2 With the move toward an “endovascular-first” approach in patients with symptomatic peripheral arterial disease, treatment of failing and failed bypass grafts appears to have also moved in that direction. This trend away from an open surgical revision of such grafts and toward an endovascular approach reflects the increasing familiarity of vascular surgery community with the endovascular techniques, rather than solid data. A critical review of the literature confirms a paucity of high-level robust data to support an endovascular or an open surgical approach in such patients. Endovascular therapies appear to be safer, and open surgical approaches appear more “durable.” Hence, the therapeutic decisions appear to be based on local expertise as well as personal experiences and biases of vascular specialists rather than robust prospective comparative analyses. In this issue of JVIR, Baumann et al (1) add the results of their experience to the relatively scant literature on the subject. The unique features of this study include their reporting of “clinical improvement” as well as the distinction between repeat intervention at the previous angioplasty site (ie, target lesion revascularization) and new lesions elsewhere (ie, target vessel revascularization) (1). Most studies to date have limited their reporting to measures such as patency (ie, graft salvage), limb salvage, and amputationfree survival (2–7), the latter two reflecting disease stability and not necessarily clinical improvement. Although the study of Baumann et al (1) is a small study, the reported improvements in the Rutherford-Becker class and the separation of target lesion versus target vessel revascularization are welcome new additions to the literature. The authors studied the effect of variables such as patients’ presenting symptoms (critical limb ischemia [CLI]

Purpose To elucidate the mechanism of persistence or recurrence of varicoceles after surgical repair by examining the venographic anatomy, and to review the efficacy of treatment of these patients with n-butyl cyanoacrylate (NBCA) embolization. Materials and Methods From 2001 to 2007, 17 patients with persistent or recurrent varicoceles were studied by retrograde venography 4 months to 18 years after open surgical repair. All patients were then treated with NBCA glue embolization of the entire gonadal vein and the venographically identified duplications and collateral vessels, with three patients undergoing bilateral procedures. Venographic anatomy and clinical success were retrospectively analyzed. Results The majority of patients (65%) exhibited duplications draining into a single left gonadal vein. Duplications were most frequently found to be confined to the pelvis and inguinal canal. Communication with other retroperitoneal veins, including the renal hilar, lumbar, iliac, and circumaortic renal vein, was relatively uncommon. NBCA embolization effectively treated the main gonadal vein as well as the duplications and communications, with only one patient developing thrombophlebitic complications. Conclusions Duplication of the gonadal vein in the pelvic or inguinal region with apparent incomplete ligation or resection is a common finding in patients with persistence or recurrence of varicocele after surgery. NBCA embolization effectively treats these duplicated vessels, resulting in a high rate of clinical success on short-term follow-up.

To summarize the preliminary experience with the Trellis-8 infusion catheter (TIC) in the treatment of deep venous thrombosis (DVT) and compare the outcome to that with catheter-directed thrombolysis (CDT) by using a meta-analysis of published reports.Technical success, bleeding complications, and costs for patients treated with the TIC for DVT were reported through a voluntary, company-sponsored registry. Technical success was classified by using the National Venous Registry grading scale for DVT lysis (50% lysis = grade I, 50%-99% lysis = grade II, and 100% lysis = grade III). The cost of treatment with the TIC was based on equipment (catheters) needed to perform the intervention, thrombolytic agents used, bleeding episodes, procedure time in the angiography and/or interventional suite, and monitoring time in a critical care unit. Outcomes with the TIC were compared against outcomes with CDT by using literature-derived outcomes derived from a meta-analysis.Thrombolytic doses and infusion durations were less with TIC than with conventional CDT. Grade II and III lysis was achieved in 93% of patients treated with the TIC and 79% of patients treated with CDT (P = .03). Major hemorrhage was reported in none of the TIC patients and in 8.5% of patients treated with CDT (P.001). The per-patient cost of therapy was $3,697 for TIC and $5,473 for CDT (P = .03).Thrombolysis in DVT with the TIC is associated with a greater technical success rate, a lower rate of bleeding, and a lower cost than that reported for CDT. These preliminary results indicate that further evaluation of the TIC in the treatment of DVT is warranted.

Five patients with pseudoaneurysms of the carotid artery ( n = 4) and an arteriovenous fistula of the vertebral artery ( n = 1) were treated with stent-grafts. Commercially made devices were used in all but one of the patients. In four of the five patients, the pathology was successfully excluded. One patient had a small type-I endoleak. There were no immediate procedure-related complications or neurologic sequalae. All experienced immediate resolution of symptoms. One patient was lost to follow-up after discharge and another died 2 weeks after intervention. The remaining patients remained asymptomatic with patent stent-grafts after follow-up periods of 14, 16, and 46 months, respectively.

This report describes new techniques to perform TIPS reduction in patients with post-TIPS complications. Methods included hourglass-shaped stents and stent-grafts, and parallel stents and stent-grafts. All procedures were technically successful, resulting in increased portosystemic gradients and decreased symptoms, although patient outcomes were mixed. None of the patients experienced recurrent variceal hemorrhage or ascites in short-term follow-up. Stent-grafts have the advantage of immediate exclusion of blood flow outside the reducing stent, resulting in an immediate reduction of the caliber of the shunt. Techniques that allow fine adjustment of shunt diameters may have further advantages.

Absence of urokinase from the United States market for the past 4 years has resulted in increasing experience with other plasminogen activators in catheter-directed thrombolytic therapy. The differences in the pharmacologic properties and biologic behavior of these agents may translate into clinical outcomes that are distinct. Some of these manifestations can be predicted based on the existing large clinical trials in the acute myocardial infarction literature. However, because of the fundamental differences in techniques and thrombolytic regimens, extrapolation of the coronary data may not always predict the performance of these agents in peripheral catheter-directed fibrinolysis. In this article, the current status of the available lytic agents in the treatment of limb ischemia is reviewed.

PURPOSE To evaluate the potential of covered stents to replace surgery in the treatment of subclavian artery aneurysms and traumatic injuries. MATERIALS AND METHODS Nine patients (five men, four women; age range, 20–83 years; mean, 54 years) with subclavian artery aneurysms ( n = 5) or fistulas ( n = 4) were treated with stent-grafts. All devices used were custom-made, consisting of polytetrafluoroethylene (PTFE)-covered Palmaz ( n = 5), Wallstent ( n = 2), Z stents ( n = 8), or a polyester-covered Z stent ( n = 1). One patient was lost to follow-up after 2 months. All others were followed up with clinical evaluation, computed tomography (CT), and/or ultrasound. RESULTS All devices were deployed successfully with exclusion of the aneurysms and fistulas. There were two procedure-related complications (22%), consisting of groin pseudoaneurysms requiring surgical repair 3 and 9 days after the procedure. One of those patients required additional oral antibiotic therapy for a postsurgical groin wound infection. One patient developed a stenosis at 12 months, which required angioplasty. The stent-graft thrombosed in one patient because of a kink 2 months after placement, which was successfully treated by thrombolysis and placement of a Wallstent. The primary and secondary patencies are 89% and 100%, respectively, after a mean follow-up of 29 months (2–66 mo). CONCLUSION Mid-term results of stent-graft therapy of subclavian artery aneurysms and fistulas are encouraging, with low morbidity and excellent clinical outcome.

Purpose To compare diagnostic yield and complication rates of magnetic resonance (MR)-guided versus computed tomography (CT)- and ultrasound (US)-guided liver biopsies. Materials and Methods MR-, CT-, and US-guided liver biopsies performed between 9/96 and 9/98 were compared. Sixty patients (21 men and 39 women, mean age 60 years) underwent MR-guided biopsy of liver lesions. Thirty patients (16 men and 14 women, mean age 59 years) underwent CT-guided biopsy. Eighteen patients (seven men and 11 women, mean age 50 years) underwent US-guided biopsy. MR procedures were performed in an open-configuration 0.5-T Signa SP MR unit. Lesion localization used standard Tl and T2 sequences, whereas biopsies were performed with multiplanar spoiled gradient recalled echo and fast gradient recalled echo sequences. A coaxial system with an MR-compatible 18-gauge stabilizing needle and a 21-gauge aspiration needle was used to obtain all samples. In CT and US procedures, a 19-gauge stabilizing needle and a 21-gauge aspiration or a 20-gauge core biopsy needle were used. A cytotechnologist was present to determine the adequacy of samples. Results MR had a diagnostic yield of 61%. CT and US had diagnostic yields of 67% and 61%, respectively. No serious complications were reported for MR and US procedures. Two CT biopsies resulted in postprocedural hemorrhage. One patient required surgical exploration and died. Conclusions MR-guided biopsy of liver lesions with use of a 0.5-T open-configuration magnet is safe and accurate when compared with CT and US. No statistical difference was observed between the diagnostic yield of biopsies performed with MR, CT, and US guidance. MR enabled biopsy of a number of lesions in the hepatic dome and lesions with low contrast, which would normally be difficult to sample safely with use of CT or US.

Purpose To evaluate the feasibility of a percutaneously created type-B aortic dissection as an experimental model for percutaneous therapy. This model was used to evaluate the hemodynamic effects of single-balloon fenestration of the intimal flap. Materials and Methods Acute type-B dissections were created in descending aortae of 15 swine via a femoral ( n = 6) or carotid ( n = 9) approach. The initial subintimal tear was made with use of a Colapinto needle. The dissections were extended to a predefined position in the aorta. The proximal and distal tears were balloon dilated. The mural flap was balloon fenestrated in six animals, just above the celiac artery. Aortograms were obtained to establish the presence and extent of the dissection. Manometry was performed in both lumina to evaluate the hemodynamics of the dissected aorta and the effects of balloon fenestration in this model. Pathologic specimens were also examined. Results Creation of dissection was successful in 11 of 15 animals, with six developing true lumen narrowing (group A). The other five animals (group B) had flow in both lumina without evidence of true lumen narrowing. After the creation of a single-balloon fenestration in the group A swine, the arteriograms revealed no evidence of blood admixture between the true and false lumina, and there was no change in the intravascular pressures. Examination of the explanted aortae showed a more extensive circumferential dissection in group A animals as compared with group B. Conclusion The percutaneously created acute type-B aortic dissection is a feasible model for experimentation. The hemodynamics of the aorta did not change after single-balloon fenestration in this model.

Purpose Standard therapy of mycotic aneurysms in the descending aorta consists of thoracotomy and in situ graft placement or extraanatomic bypass. The alternative use of endovascular stent-grafts was evaluated for management of infected aneurysms of the thoracic aorta. Materials and Methods In a retrospective analysis during a 5-year period, 112 patients underwent stent-graft placement for thoracic aortic aneurysms. Three patients (mean age, 68.6; range, 64–70 years) had mycotic thoracic aneurysms. Stent-grafts were constructed from Z stents covered with polyester fabric and were delivered remotely through a catheter under fluoroscopic guidance. Results Complete thrombosis of the mycotic aneurysms was achieved in all patients. One patient required a second separate stent-graft placement procedure because of migration of the initial device; the second patient underwent surgical repair of a ruptured mycotic abdominal aortic aneurysm followed immediately by stent-graft placement for a chronic mycotic thoracic aneurysm; a third patient underwent repair of two infected false aneurysms secondary to complete rupture of a surgical interposition graft. There were no complications of persistent bacteremia despite placement of the stent-graft device at the site of primary infection, reinfection, delayed rupture, paraplegia, distal emboli, or surgical conversion. One patient died of cardiac arrest at 25 months; there were no perioperative deaths (≤ 30 days). The remaining two patients were alive and well at median follow-up of 24 months (range, 4–25 months). Conclusion Endovascular stent-grafts combined with antibiotic therapy may be an alternative to conventional thoracotomy in managing mycotic aneurysms of the descending thoracic aorta.

Purpose The authors describe their experience with the use of single-piece, tapered stent-grafts for the treatment of abdominal aortic or aortoiliac aneurysms. Materials and Methods Single-piece, tapered stent-grafts were placed in 15 patients for the treatment of abdominal aortic aneurysms with small distal necks ( n = 13), and aortoiliac aneurysms ( n = 2). There were 13 men and two women who ranged in age from 59 to 83 years (mean, 71 years). Usual open surgery was considered high risk in all patients because of comorbid medical conditions. The stent-grafts were made of Z stents covered with polytetrafluoroethylene (PTFE). Additional stent-grafts needed to treat perigraft leaks were made of Z stents covered with woven polyester ( n = 5), Wallstents covered with PTFE ( n = 2), Z stents covered with PTFE ( n = 1), and a PTFE-covered Palmaz stent ( n = 1). After stent-graft placement, the contralateral iliac artery was occluded by a blocking device composed of either a PTFE-covered Palmaz ( n = 1) or Z stent ( n = 13), and a femoral-femoral bypass was created. Results After placement of the stent-grafts, immediate perigraft leaks were observed in eight patients (53%). These were at the proximal ( n = 5) or the distal end ( n = 3). All, except one, were treated successfully with additional stent-grafts. The one failure was in a patient who developed aortic rupture after balloon dilation, requiring open surgical repair. Second procedures were required in four patients (27%), including three leaks treated successfully with coil embolization and/or a back-up stent-graft, and one stent-graft migration and thrombosis treated by thrombolysis and placement of an additional stent-graft. One patient died of respiratory failure 23 days after placement of the stent-graft. The mean follow-up was 12 months (range, 4–26 months). On the last follow-up, the aneurysms in the 13 living patients remained thrombosed. Conclusion Treatment of aortoiliac aneurysms with use of single-piece, tapered stent-grafts is feasible in selected patients. The morbidity and mortality rates compare favorably with those of the open surgical procedures in a high-risk population. Further improvements in the technique and longer follow-up data are needed before this procedure can be recommended for the treatment of all aortoiliac aneurysms.