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OBJECTIVE: The objective of this study was to describe the polar orientation of renal chimney grafts within the proximal seal zone and to determine whether graft orientation is associated with early type Ia endoleak or renal graft compression after chimney endovascular aneurysm repair (ch-EVAR). METHODS: Patients who underwent ch-EVAR with at least one renal chimney graft from 2009 to 2015 were included in this analysis. Centerline three-dimensional reconstructions were used to analyze postoperative computed tomography scans. The 12-o’clock polar position was set at the takeoff of the superior mesenteric artery. Relative polar positions of chimney grafts were recorded at the level of the renal artery ostium, at the mid-seal zone, and at the proximal edge of the graft fabric. Early type Ia endoleaks were defined as evidence of a perigraft flow channel within the proximal seal zone. RESULTS: There were 62 consecutive patients who underwent ch-EVAR (35 double renal, 27 single renal) for juxtarenal abdominal aortic aneurysms with a mean follow-up of 31.2 months; 18 (29%) early type Ia “gutter” endoleaks were identified. During follow-up, the majority of these (n = 13; 72%) resolved without intervention, whereas two patients required reintervention (3.3%). Estimated renal graft patency was 88.9% at 60 months. Left renal chimney grafts were most commonly at the 3-o’clock position (51.1%) at the ostium, traversing posteriorly to the 5- to 7-o’clock positions (55.5%) at the fabric edge. Right renal chimney grafts started most commonly at the 9-o’clock position (n = 17; 33.3%) and tended to traverse both anteriorly (11 to 1 o’clock; 39.2%) and posteriorly (5 to 7 o’clock; 29.4%) at the fabric edge. In the polar plane, the majority of renal chimney grafts (n = 83; 85.6%) traversed 90 degrees were independently associated with early type Ia endoleaks (odds ratio, 11.5; 95% confidence interval, 2.1–64.8) even after controlling for other device and anatomic variables. Polar orientation of the chimney grafts was not associated with graft kinking or compression (P = .38) or occlusion (P = .10). Takeoff angle of the renal arteries was the most significant predictor of chimney graft orientation. Caudally directed arteries (takeoff angle >30 degrees) were less likely to have implanted chimney grafts that traversed >90 degrees in polar angle (odds ratio, 0.09; 95% confidence interval, 0.01–0.55). CONCLUSIONS: Renal chimney grafts vary considerably in both starting position and their polar trajectory within the proximal seal zone. Grafts that traverse >90 degrees in polar angle within the seal zone may be at increased risk of early type Ia endoleaks and require more frequent imaging surveillance. Caudally directed renal arteries result in a more favorable polar geometry (eg, cranial-caudal orientation) with respect to endoleak risk and thus are more ideal candidates for parallel graft strategies.

Objective This study analyzed 1-year outcome after thoracic endovascular aortic repair (TEVAR) in patients with complicated type B aortic dissection (cTBAoD) who had rupture or malperfusion and symptom onset ≤14 days (acute), 15 to 30 days (subacute), and 31 to 90 days (chronic) until required intervention. The main focus of this report is primarily on the acute cohort. Methods Clinical data were systematically collected from five physician-sponsored investigational device exemption (IDE) clinical trials between 2000 and 2008 using standardized definitions and forms. Adverse events were reported early (≤30 days) and late (>30 days) by body system. Major adverse events included death, stroke, myocardial infarction, renal failure, respiratory failure, paralysis, and bowel ischemia. Results There were 99 cTBAoD patients: 85 were acute, 11 were subacute, and 3 were chronic. Among the acute patients, 31.8% had rupture and 71.8% had malperfusion, including 55.7% lower extremity, 36.1% renal, 19.7% visceral, 8.2% other, and 3.3% spinal cord (patients may have more than one source). Rupture and malperfusion were both reported for three acute patients. Additional findings for the acute cohort included pain (76.5%), hypertension (43.5%), and bleeding (8.2%); comorbidities included hypertension (83.5%), current/past smoking history (69.8%), and diabetes (12.9%). The main focus of this analysis was the acute cohort (n = 85). Age averaged 59 years (72.9% male). Early adverse events included pulmonary (36.5%), vascular (28.2%), renal (25.9%), and neurologic (23.5%). Early major adverse events occurred in 37.6% of patients, including death (10.6%), stroke (9.4%), renal failure (9.4%), and paralysis (9.4%); late adverse events included vascular (15.8%), cardiac (10.5%), gastrointestinal (6.6%), and hemorrhage (5.3%). The point-estimate mortality rate was 10.8 (95% confidence interval [CI], 4.1-17.5) at 30 days and 29.4 (95% CI, 18.4-40.4) at 1 year, when 34 patients remained at risk. Conclusions Emergency TEVAR for patients with cTBAoD (malperfusion or rupture) provided acceptable mortality and morbidity results out to 1 year. Manufacturers can use this 30-day mortality point-estimate of 10.8 (95% CI, 4.1-17.5) for the acute cohort to establish a performance goal for use in single-arm commercial IDE trials if the Food and Drug Administration and other regulatory bodies concur.

Endovascular aneurysm repair (EVAR) of ruptured thoracoabdominal aortic aneurysms may be compromised or even impossible due to short proximal and/or distal necks or landing zones, respectively. Supra-aortic branches may limit the proximal anchorage and visceral or renal arteries the distal anchorage of endografts. While solutions have been proposed to overcome the problem of a short proximal neck, no technique has been described that solves the problem of a short distal neck. We present the "periscope technique," which allows extension of the distal landing zone and complete endovascular treatment of ruptured thoracoabdominal aneurysms with short distal necks using devices already stocked in most centers performing EVAR procedures.

ObjectiveThis study was undertaken to determine whether a complicated aortic neck is associated with unfavorable outcome after abdominal aortic aneurysm (AAA) endografting.MethodsIn a prospective pivotal clinical trial, 237 consecutive patients underwent implantation of the bifurcated Talent Low Profile System. Patients were divided into 2 groups, those with complicated aortic necks (short, 28 mm; angulated, >45 degrees; calcified; and thrombus-lined) versus those with uncomplicated neck anatomy. Major outcome parameters included procedure time, operative blood loss, transfusion requirements, volume of contrast medium used during the implant procedure, endoleaks, migration, limb patency, AAA regression, conversion to open repair, morbidity, and mortality. Mean follow-up was 620.5 days.ResultsOverall, 32% of aortic necks were short, 19% were very short, 20% were dilated, 18% were calcified, 8.5% were thrombus-lined, and 19.9% were angulated. Thirty percent and 70% of patients, respectively, were stratified to the uncomplicated and complicated groups (P < .01. Procedure time, operative blood loss, transfusions, volume of contrast medium used in the implant procedure, migration, endograft patency, AAA sac regression, conversion to open repair, and mortality were not significantly different in necks with complicated versus uncomplicated anatomy. At 21 months, sacs were regressing or stable in 98% (complicated) versus 96% (uncomplicated). Primary graft limb patency was 100% in both groups. The endoleak rate was 4.3% (complicated) versus 17% (uncomplicated) at 18 months, but this difference was not statistically significant. Adverse renal events, however, occurred in 27.5% (complicated) versus 13.6% (uncomplicated; P = .04).ConclusionsComplicated aortic neck is not associated with unfavorable outcome at midterm follow-up after AAA endografting. However, statistically more adverse renal events occur in patients with complicated neck anatomy.

Purpose: We tested the clinical applicability, technical results, and morbidity of carotid angioplasty-stenting (CAS) in the treatment of severe stenosis of the internal carotid artery (ICA) in patients deemed to be high-risk candidates for carotid endarterectomy (CEA). Method: After an initial series (1994-1997) of 52 interventions, we adopted the use of a transfemoral access technique and self-expanding stents in late 1997. From Dec 1, 1997, to Mar 31, 2001, 135 CAS procedures were performed on 132 patients with more than 70% (symptomatic) or more than 80% (asymptomatic) stenoses of the ICA. Sixty percent of the patients had no symptoms, and 40% of patients had symptoms. The interventional technique was standardized with the use of a 7F long interventional sheath, balloon pre-dilatation of the stenotic lesion, placement of a self-expanding stent (Wallstent in 12 patients and a SMART stent in 120 patients), and post-balloon dilatation when necessary. Brain protection devices were not used. Patients were given clopidogrel and aspirin before and after the procedure and heparin during the intervention. Results: All procedures except two were completed as planned, with access failure in three patients (2.2%). Residual in-stent stenosis of less than 20% was detected in 14 of 132 stented vessels (11%) and accepted as a satisfactory angiographic outcome. Neurologic complications included one patient with a single-episode transient ischemic attack (TIA; motor-sensory deficit of the hand) occurring 2 hours after CAS. One patient sustained a major stroke after thrombosis of the stented ICA, which occurred 3 days after the CAS procedure and 24 hours after open-heart surgery. A third patient sustained a minor stroke that began intraprocedurally after post-balloon dilatation of the stent, and a fourth patient had another minor stroke with transient aphasia (beginning during the procedure and resolving after 4 hours) and monoparesis of the hand, which resolved after 1 week. All stented vessels remained patent during the follow-up period (range, 2-41 months; mean, 16 ± 9 months), with four instances of hemodynamically significant in-stent restenosis. Re-intervention with balloon angioplasty was undertaken successfully at 4 months in one patient with restenosis. The periprocedural mortality rate was 0. Conclusion: Carotid stenting can be performed with acceptable safety on carefully selected patients by using meticulous, standardized interventional techniques. It may offer a possibly superior therapeutic alternative for non-CEA candidates. Evolving technological improvements and brain protection devices are likely to enhance its role in the treatment of carotid artery disease in the future. Surgical endarterectomy remains the standard of care for most patients at the present time. (J Vasc Surg 2002;35:430-4.)

Purpose: Phase I and phase II trials were conducted to determine the safety and efficacy of the Talent aortic stent-graft (Medtronic World Medical, Sunrise, Fla) in the treatment of infrarenal abdominal aortic aneurysms (AAA). This is a preliminary report of the technical results and 30-day clinical outcome of these trials. Methods: Multicenter prospective trials were conducted to test the Talent stent-graft in high-risk and low-risk patient populations with AAA, including phase I feasibility and phase II clinical trials. The low-risk study included concurrent surgical controls. Results: In the phase I trial, deployment success was achieved in 92% (23/25 patients), and initial technical success was 78% (18/23 implants without endoleak). The 30-day technical success rate was 96%, with six endoleaks that resolved spontaneously (without need for further intervention); and the 30-day mortality rate was 12% (3/25 patients). The phase II high-risk trial demonstrated a deployment success of 94% (119/127 patients) and an initial technical success of 86% (102/119 implants). The 30-day technical success rate was 96%, and the 30-day mortality rate was 1.5% (2/127 patients). The phase II low-risk trial included a first-generation and a second-generation Talent stent-graft. Deployment success rates were 97% and 99%, respectively, and technical success rates at 30 days were 97% and 96%, respectively. The 30-day mortality rate was 2% in the phase II low-risk first-generation device trial, and the adverse-event rate was 20%. Corresponding figures for the second-generation device were 0% and 1.8%, respectively. Conclusion: The Talent stent-graft can be deployed successfully and achieves endovascular exclusion in a large proportion of patients with AAA. Morbidity and mortality rates are acceptable. One-year clinical results and the comparison with concurrent surgical control subjects remain to be evaluated. (J Vasc Surg 2001;33:S146-9.)

Purpose: The purpose of this study was to evaluate the safety and effectiveness of Palmaz stents as a less morbid alternative to traditional surgery for focal aortic arch branch lesions. Methods: Twenty-two patients with symptoms and a mean age of 61.3 years were treated from July 1991 to May 1995 with 26 stents at the following locations: 8 innominate artery, 5 left common carotid artery, 1 right common carotid artery, and 12 left subclavian. Procedures were carried out in an operating room with patients receiving either local anesthetic in 12 cases or general anesthetic in 10. Surgical exposure of either the cervical common carotid or brachial artery allowed precautionary distal clamping before retrograde stent deployment to prevent atheroembolization. Results: Initial success was possible in 92.3% (24 of 26) of cases. There were no strokes or deaths. During a mean follow-up period of 27 months, 22 of 26 (85%) vessels have remained patent and the patients symptom free. Conclusion: Focal aortic branch lesions can be effectively and safely treated with Palmaz stents. (J VASC SURG 1996;23:368-75.)

Purpose: The purpose of this study was to review our 10-year experience with carotid-axillary artery bypass in the treatment of occlusive lesions of the proximal subclavian artery. Methods: Our 10-year experience with 26 carotid axillary bypasses for occlusive disease of the subclavian artery was reviewed retrospectively. The review focused on the indication for the operation, the surgical technique used, and the development of immediate and late postoperative complications. Long-term bypass graft patency and clinical success were determined on the basis of information gleaned from the office records of all patients. Only three patients were lost to follow-up at 12, 36, and 38 months. Results: There were no operative deaths. Two patients had small cervical wound hematomas, and two others experienced transient symptoms of brachial plexus irritation, which subsided spontaneously. Permanent nerve or lymphatic complications did not occur. In a mean follow-up of 47 months, carotid-axillary bypass graft patency was 96%, and 88% of the patients enjoyed symptom-free sustained clinical success. Conclusions: This retrospective review demonstrates that a carotid-axillary bypass constructed with ringed synthetic graft material tunneled under the clavicle performs well and can be considered a reasonable alternative to the more standard carotid-subclavian bypass for the same indications. (J VASC SURG 1995;22:717-23.)

Purpose: The purpose of this study was to explore the feasibility of iliofemoral endarterectomy performed through a single groin incision. Methods: Thirty-two patients aged 34 to 75 years (mean age 63.4 years) with a male/female ratio of 20:12 underwent 36 lower extremity inflow reconstructions from July 1989 to September 1994. Surgical indications were for limb-threatening ischemia in 24 patients and for claudication in eight patients. The procedures were done for occlusive disease of the external iliac artery and common femoral artery with patients under either spinal ( n = 24) or local ( n = 12) anesthesia. Intraoperative balloon angioplasty with fluoroscopic guidance preceded open retrograde iliofemoral endarterectomy. Adjunctive procedures included 18 profundaplasties, eight femorofemoral, nine femoropopliteal, and one femorotibial bypasses. Results: Thirty-three of the 36 cases were initially successful. The three failures were in patients with extensive calcification. The mean follow-up has been 36.4 months, and the patency rate was 80.5% at 3 and 4 years. The four failures noted on follow-up were caused by three common iliac artery stenoses and one iliac system occlusion. The former group was successfully treated with balloon angioplasty/stent, and the latter patient required an aortofemoral bypass. No operative deaths or limb loss occurred in this series. Conclusions: Retrograde iliofemoral endarterectomy facilitated by balloon angioplasty is a safe, easy-to-perform, and viable option for patients with combined external iliac artery and common femoral artery occlusive disease. Midterm results (36.4 months) are favorable, and most hemodynamic failures are easy to correct with standard endovascular techniques. (J VASC SURG 1995;22:742-50.)

Objectives The Society for Vascular Surgery Outcomes Committee, including ad hoc members from Society of Thoracic Surgeons, American Association of Thoracic Surgery, and Society for Interventional Radiology, collected outcomes of patients with traumatic thoracic aortic transections treated with endovascular grafts. Results through 1 year of follow-up are reported. Methods Data from five physician-sponsored investigational device exemption clinical trials from 2000 to 2008 were entered using standardized forms and definitions. Adverse events were reported early (≤30 days) and late (>30 days) by body system. Major adverse events included one or more of the following: death, stroke, myocardial infarction, renal failure, respiratory failure, paralysis, or bowel ischemia. Results There were 60 symptomatic patients (68.3% men; mean age, 46 years) with traumatic aortic transections, of which 97% were due to a motor vehicle accident and 3% were related to other blunt trauma. The average total injury severity score was 39, most with involvement of the chest and abdomen. The average surgical time was 125 minutes. The mean hospital length of stay was 17 days. Associated procedures for the management of nonaortic injuries occurred in 51.7%. All-cause mortality was 9.1% at 30 days and 14.4% at 1 year. One or more major adverse events occurred in 23.3% of the patients, major adverse events occurred early in 20.0% and late in 3.6%. Death accounted for 41.7% of the early and all of the late major adverse events. Early adverse events included 16.7% pulmonary, 13.3% neurologic, and 11.7% vascular complications. Late adverse events included one patient (1.8%) with pulmonary failure and one patient (1.8%) who died of an unknown cause. Conclusions One-year results of endograft placement for the management of patients with traumatic aortic injury are acceptable. Most cases treated were due to motor vehicle accident and associated with multiple coexisting injuries. Approximately three-quarters of the deaths occurred ≤30 days, indicating the acute severity of the condition. Although the relatively low rates of adverse and major adverse events are consistent with what is anticipated in an otherwise healthy population, future device and procedural developments may facilitate improved outcomes in the future.

From July 1988 through December 1988 laser "hot tip" angioplasties coupled with balloon dilations were performed on 95 patients at the Union Memorial and University of Maryland hospitals. The patients ranged in age from 42 to 84 years (mean, 66.4 years), and there were 61 men and 34 women in the study. Indications for the procedure included claudication in 70 (74%) and severe ischemia in 25 (26%). Noninvasive studies were performed on all patients before and after the procedure. One hundred seventeen segments were treated in 28 iliac arteries and 89 superficial femoral/popliteal arteries. No tibial arteries were treated. Fifty-two stenoses and 65 occlusions occurred. The procedures were performed percutaneously in 52 patients (55%), and open surgical technique was used in 43 patients (45%). Nine immediate failures (9.5%) and 86 successes (90.5%) were noted within 24 hours of the procedure. Follow-up ranged from 1 to 6 months with a mean of 3.2 months. Late failures within this time period occurred in 21 patients (22%). The total failure rate was 30/95 or 31.5%. Only one of the patients was made worse by a failed laser-assisted balloon angioplasty. Immediate complications consisted of formation of subcutaneous hematoma in 20 of the 52 patients having percutaneous procedures (38%) and healing difficulty in 3 of the 43 patients having open surgical procedures (7%). Hospital stay was usually 1 day longer in the latter group. No patient required surgical intervention for bleeding as a result of a vessel perforation. However, this phenomenon was noted during the course of three superficial femoral artery laser-assisted balloon angioplasties.(ABSTRACT TRUNCATED AT 250 WORDS)

Ankle ulcers associated with venous disease have been traditionally treated by Unna's compressive bandages. However, successful healing of an ulcer with this therapeutic modality is slow and tedious. The purpose of this study is to investigate whether adjunctive sclerotherapy of large venous channels near the ulcers enhances healing. Twenty-eight patients with perimalleolar venous ulceration were entered into this study. Ulcer size ranged from 6.0 to 25 cm2. All were examined for the presence of large venous channels adjacent to the ulcer bed. A portable continuous-wave Doppler supplemented digital examination of the area. Twenty-five out of 28 patients had easily detectable venous channels, and these were randomized into two groups: group I, treated by weekly changes of Unna's compressive boots; group II, treated by weekly change of Unna's compressive boots and sclerotherapy with 3% sodium tetradecyl sulfate (Sotradecol). All patients had the size of the ulcer measured during their weekly visits. Patients in group II took a mean of 2.1 weeks to exhibit 50% healing and 4.3 weeks to fully heal. Conversely patients in group I took a mean of 3.2 weeks to achieve 50% healing and 6.1 weeks to fully heal. Thus, healing was significantly faster (p less than 0.05) in group II. In conclusion, the therapeutic efficiency of Unna's compressive bandaging is significantly enhanced by the adjunctive sclerotherapy of adjacent venous channels.

Purpose: We report results of a pivotal prospective clinical trial that compared standard surgical repair with endovascular exclusion of abdominal aortic aneurysm (AAA) with the Talent LPS stent graft system. Methods: Between March 24, 1999, and September 19, 2000, 240 patients with AAA who underwent stent graft placement and 126 patients who concurrently underwent surgery to treat AAA were enrolled at 17 centers in the United States. All patients were considered to be at low risk from aortic surgery. Patients who underwent endovascular repair received a bifurcated Talent LPS stent graft; surgical control subjects underwent standard operative techniques. Inclusion criteria were AAA larger than 4.0 cm in diameter, with proximal neck > 5 mm long and 14 to 32 mm in diameter, and a 15 mm landing zone in at least one common iliac artery. Access requirements included one external iliac artery of 7 mm caliber or larger. Preoperative anatomic evaluation included computed tomography and angiography. After stent-graft placement, evaluation involved plain radiography and computed tomography performed before discharge and at 1, 6, and 12 months and yearly thereafter. Results: There was no significant difference in early (

Background: Thoracic aortic aneurysms (TAAs) and type B aortic dissections (ADs) are relatively frequent, serious conditions that are often managed nonoperatively because of perceived poor outcome of standard surgical reconstruction. Recently developed stent graft techniques represent a more attractive, less invasive option. We sought to determine the technical feasibility and safety of endovascular repair in the thoracic aorta with a retrospective review of our experience with such an approach. Methods: Forty-seven patients received thoracic stent graft implants during the 4-year period ending March 31, 2002. All patients signed an Institutional Review Board-approved informed consent. Thirty-one patients had TAAs, and 16 had ADs. Device design and implant strategy were on the basis of evaluation of morphology with angiography and computed tomographic scan. The procedures were done with fluoroscopic guidance, with local anesthesia in five cases, spinal anesthesia in 19 cases, and general anesthesia in 23 cases. Endovascular access was achieved with femoral cutdown in 41 cases and a temporary iliac conduit in six cases. A Talent patient-specific device, with 4-mm to 6-mm oversize, was used in all. Proximal endograft attachment was in the descending thoracic aorta in 16 cases, parasubclavian in 21 cases, and the suprasubclavian aorta in 10 cases. Eight patients had adjunctive cervical reconstruction to transpose or revascularize the left subclavian or left common carotid arteries, enabling more proximal endograft attachment in the aortic arch. Results: Access failure occurred in one patient (2.1%). One patient (2.1%) died within 30 days of access-related iliac artery rupture. Another death occurred at 60 days from a ruptured thoracoabdominal aneurysm with type I endoleak. No instances of paraplegia, stroke, or surgical conversion were seen. Five patients (TAA) were found to have endoleak on 30-day computed tomographic scan. Repair of type I endoleak was undertaken in three cases at 1, 4, and 6 months. Eight patients (17%) had adverse events within the first 30 days. Length of follow-up ranged from 1 to 44 months, with a mean of 18 months. Two patients were lost to follow-up, and one withdrew from the study. Four additional mortalities were observed, none related to the endograft or aortic pathology. Conclusion: Stent graft repair of TAA and AD is feasible and can be achieved with technical success and relatively low rates of perioperative morbidity and mortality. The Talent customized design proved versatile in various morphologies. More information is needed on indications, clinical efficacy, and long-term results. (J Vasc Surg 2002;36:1121-8.)

Purpose: Endovascular treatment of abdominal aortic aneurysms (AAAs) is a technically demanding procedure that is based on the complexity and multiplicity of steps and the guidewire and catheter manipulations required. Brachial artery catheterization is an adjunctive technique that can facilitate the placement of an endoluminal prosthesis. Methods: Brachial access was used during endoluminal AAA repair in 79 of 103 consecutive patients with a modular-design stent-graft prosthesis at two institutions. Results: Left brachial access facilitated (1) angiography to guide juxtarenal device deployment, (2) antegrade contralateral limb access, (3) device delivery through disadvantaged iliac arteries by means of a brachial femoral wire, (4) access to renal arteries when necessary, and (5) catheter exchanges and a reduction in fluoroscopic positional changes. Complications included one puncture-site pseudoaneurysm, seven hematomas, and 29 patients with extensive ecchymosis. The length of stay was not prolonged in any case. There were no embolic, oculocerebral, or ischemic upper extremity events. Conclusions: Brachial artery catheterization, as an adjunctive technique to endoluminal AAA repair, offers noteworthy technical advantages with few, but self-limiting complications. (J Vasc Surg 2000;32:1137-41.)

Purpose: During endovascular grafting of an abdominal aortic aneurysm (AAA), iliac limb extension to the external iliac artery may be indicated when the common iliac artery is ectatic or aneurysmal. Preliminary or concomitant coil embolization of the internal iliac artery (IIA) is thus necessary to prevent potential reflux and endoleak. We sought to determine the safety of hypogastric flow interruption in this setting. Methods: We retrospectively reviewed 156 patients who underwent stent-graft AAA repair at two institutions between February 1, 1998, and January 31, 1999. Coil embolization of one or both IIAs was undertaken when the diameter of the common iliac artery was more than 20 mm to enable limb endograft extension to the external iliac artery. Bilateral procedures were staged. Results: Thirty-nine (25%) of 156 patients were selected for coil embolization of one (n = 28) or both (n = 11) IIAs. The interventions were performed before (n = 31) or during (n = 8) the stent-graft procedure. Complications included groin hematomas in 3 patients, iliac artery dissection in 1, failure to catheterize the IIA in 2, and transient rise in the serum creatinine level in 3. One patient had erectile dysfunction, and five patients (13%) had buttock claudication after unilateral occlusion. Serious ischemic complications were not observed. Conclusion: Coil embolization of one or both IIAs appears to be safe in the setting of endovascular grafting of AAA. Buttock claudication is a relatively significant problem and may limit applicability of this strategy to patients who are unfit for standard open repair. (J Vasc Surg 2000;32:684-8.)

Objective We report the 5-year outcomes of thoracic endovascular aneurysm repair (TEVAR) using the Medtronic Vascular Talent Thoracic Stent Graft System (Medtronic Vascular, Santa Rosa, Calif) in patients considered low or moderate risk for open surgical repair. Methods The Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms (VALOR) trial was a prospective, nonrandomized, multicenter, pivotal study conducted at 38 U.S. sites. Between December 2003 and June 2005, VALOR enrolled 195 patients who were low or moderate risk (0, 1, and 2) per the modified Society for Vascular Surgery and American Association for Vascular Surgery criteria. The patients had fusiform thoracic aortic aneurysms (TAAs) and/or focal saccular TAAs/penetrating atherosclerotic ulcers. Standard follow-up interval examinations were conducted at 1 month, 6 months, 1 year, and annually thereafter. Results Over the 5-year follow-up, 76 deaths occurred (43.9%). Freedom from all-cause mortality was 83.9% at 1 year and 58.5% at 5 years. Most deaths were due to cardiac, pulmonary or cancer-related causes. Freedom from aneurysm-related mortality (ARM) was 96.9% at 1 year and 96.1% at 5 years. There was only 1 case of ARM after the first year of follow-up. Over the 5-year follow-up period, four patients were converted to open surgery and four patients experienced aneurysm rupture. The 5-year freedom from aneurysm rupture was 97.1% and the 5-year freedom from conversion to surgery was 97.1%. The incidence of stent graft migration (>10 mm) was ≤1.8% in each year of follow-up. The rate of type I endoleak was 4.6% at 1 month, 6.3% from 1 month to 1 year, and 3.8% during year 5. The rate of type III endoleak was 1.3% at 1 month, 1.9% from 1 month to 1 year, and 1.9% during year 5. Through 5 years, 28 patients (14.4%) underwent 31 additional endovascular procedures on the original target lesion. The 5-year freedom from secondary endovascular procedures was 81.5%. Conclusions Through 5-year follow-up in patients who were candidates for open surgical repair, TEVAR using the Talent Thoracic Stent Graft System has demonstrated sustained protection from ARM, aneurysm rupture, and conversion to surgery, and durable stent graft performance. Close patient follow-up remains essential after TEVAR.

Ankle ulcers associated with venous disease have been traditionally treated by Unna's compressive bandages. However, successful healing of an ulcer with this therapeutic modality is slow and tedious. The purpose of this study is to investigate whether adjunctive sclerotherapy of large venous channels near the ulcers enhances healing. Twenty-eight patients with perimalleolar venous ulceration were entered into this study. Ulcer size ranged from 6.0 to 25 cm2. All were examined for the presence of large venous channels adjacent to the ulcer bed. A portable continuous-wave Doppler supplemented digital examination of the area. Twenty-five out of 28 patients had easily detectable venous channels, and these were randomized into two groups: group I, treated by weekly changes of Unna's compressive boots; group II, treated by weekly change of Unna's compressive boots and sclerotherapy with 3% sodium tetradecyl sulfate (Sotradecol). All patients had the size of the ulcer measured during their weekly visits. Patients in group II took a mean of 2.1 weeks to exhibit 50% healing and 4.3 weeks to fully heal. Conversely patients in group I took a mean of 3.2 weeks to achieve 50% healing and 6.1 weeks to fully heal. Thus, healing was significantly faster (p less than 0.05) in group II. In conclusion, the therapeutic efficiency of Unna's compressive bandaging is significantly enhanced by the adjunctive sclerotherapy of adjacent venous channels.

Objectives: The purpose of this study was (1) to find out whether preoperative inferior mesenteric artery (IMA) patency (on radiographic imaging) predicts IMA-related endoleaks after endovascular repair of infrarenal abdominal aortic aneurysms, (2) to determine feasibility of measuring aneurysm sac pressures in patients with endoleaks, and (3) to report early evidence of effective endovascular obliteration of IMA endoleaks. Methods: We studied 76 consecutive cases of infrarenal aortic aneurysms that were repaired with an endovascular approach (March 1998–April 1999). Results: There were 13 (17%) endoleaks persistent 30 days after the procedure. Eleven (85%) of these 13 were IMA-related endoleaks, which were documented with selective superior mesenteric artery angiography. The preoperative finding (on computed tomographic scan) of a patent IMA does not always predict an IMA-related endoleak, but results in a statistically and clinically significant higher ratio of patients with IMA-related endoleaks in the immediate postoperative period (24% versus 3%, P

Objective: We sought to define the learning curve relative to the incidence and range of intraoperative problems and to establish guidelines for troubleshooting during the endovascular repair of infrarenal aortic aneurysms. Methods: We prospectively evaluated our first 75 consecutive cases over a 12-month period and focused on perioperative critical events and adjunctive procedures as categorical outcome measures collected during the operation. Patients were separated into three groups on the basis of the date of their operation, such that group 1 consisted of our first 25 cases, group 2 our next 25 cases, and group 3 our last 25 cases. Results: At least one critical event and adjunctive procedure marked 67 (89%) of 75 cases. In 51%, there were at least two critical events and adjunctive procedures. There were no immediate open conversions or intraoperative deaths. Access problems occurred in 28% of the 75 cases and were addressed by use of brachial-femoral artery access (30%), iliac artery/aortic bifurcation balloon angioplasty (8%), and iliofemoral conduits (4%). Graft foreshortening was the most common deployment event (44%), necessitating distal covered extensions. Iliac graft limb twists and kinks occurred in 12% of cases and were managed with balloon angioplasty and uncovered stents. General incidents included balloon ruptures (10%), arterial dissections (6%), iliac artery rupture (2.6%), and lower extremity ischemia (4%). The two cases of iliac artery rupture were managed with distal covered extensions, and there were no cases of atheroemboli. Intraoperative endoleaks were encountered in 44% of the cases and included proximal attachment sites (15%), distal attachment sites (9%), type 2 sources, and "blushes." Management of intraoperative endoleaks included proximal/distal covered extensions and re-ballooning. Our 30-day endoleak rate was 20%. The incidence of critical events did not decrease in the latter one third compared with the first two thirds of cases. Conclusions: Critical events occur frequently during endovascular repair of aortic aneurysms. The intraoperative problems range from the common endoleaks, access and deployment issues, and balloon ruptures, to rare but life-threatening complications such as iliac artery rupture. A toolbox of accessories that includes wires, catheters, large balloons, covered proximal and distal extensions, and uncovered stents is essential given the frequency of adjunctive procedures. Successful aortic endografting requires more than mere familiarity with basic endovascular techniques. (J Vasc Surg 2001;33:1226-32.)

Purpose: The purpose of this study was to determine the effectiveness of a new surgical procedure for interrupting incompetent perforating calf veins in patients with recalcitrant venous ulcers. Methods: Eighteen patients with venous ulcerations in 26 limbs had incompetent perforators diagnosed by duplex scanning. All were taken to the operating room, where the fascial defects through which the perforators coursed were obliterated by a "pursestring" permanent suture placed on the leg fascia. Follow-up duplex scanning was carried out within 2 weeks of the procedure and every 6 months thereafter. The mean follow-up in this series was 22 months. Results: Initial success in obliterating the perforators was noted in 24 (92.3%) of 26 legs. Three subsequent failures occurred within 6 months for a midterm success rate of 80.7%. No wound complications or infections occurred. All ulcers healed within 6 weeks of the procedure (mean, 23 days) in the successfully treated patients. Conclusions: Miniincisional ligation of incompetent perforating veins is easy to perform and has very encouraging early results. (J Vasc Surg 1997;25:437-41.)

Objective Complete exclusion and depressurization of the aneurysm sac is the prime goal of endovascular repair (EVAR) of abdominal aortic aneurysms. Thus, any EVAR that results in a type I or III endoleak has been classified as a technical failure. The current method to detect endoleaks uses intraoperative aortography. However, aortography is limited by its subjective nature, inability to quantify the significance of the endoleak, and artifacts such as bowel gas that may mimic an endoleak. In addition, repetitive contrast injection may impair renal function. To increase the efficacy and safety of intraoperative endoleak detection, a wireless pressure-monitoring system has been developed and tested in the clinical setting. Methods The APEX trial (Acute Pressure Measurement to Confirm Aneurysm Sac EXclusion) is a prospective, multicenter/international trial sponsored by CardioMEMS to evaluate the safety and efficacy of the EndoSure wireless pressure sensor for EVAR. The 30 × 5 × 1.5-mm sensor contains no battery and is powered externally with radiofrequency energy. The sensors are extremely stable, operate over the full physiologic range of pressures, and have a resolution of 1 mm Hg. A total of 90 patients were enrolled at 12 sites, 76 of whom were eligible for analysis. The sensor was implanted via the contralateral femoral artery at the time of EVAR. The sac pulse pressure was measured with both an angiographic catheter and the sensor after deployment of the main endograft but before the deployment of the contralateral limb (type I endoleak equivalent). Sac pressure was again measured with the sensor after deployment of the contralateral limb and completion of the EVAR. Data were collected in a prospective manner. Results In all of the eligible patients (n = 76), the initial sensor pressure measurement agreed closely with the angiographic catheter pressure measurement of the type I endoleak equivalent. At the completion of the procedure, there was agreement between the sensor measurement and angiography regarding the presence or absence of a type I or III endoleak in 92.1% (n = 70) of the measurements. Overall, the sensitivity was 0.94 and the specificity was 0.80 for detecting type I or III endoleaks. Final pulse pressures decreased significantly compared with baseline measurements. Conclusions Implantation of the wireless pressure sensor is safe, and remote aneurysm sac pressure sensing is feasible. It was a valuable guide in evaluating the completeness of the EVAR procedure. Long-term study will be needed to prove its efficacy for postoperative surveillance.

ObjectivesThe pivotal trial of the Talent enhanced Low Profile System (eLPS; Medtronic Vascular, Santa Rosa, Calif) stent graft evaluated short and long-term safety and efficacy of endovascular aneurysm repair (EVAR). These data and a confirmatory group assessing the performance of the CoilTrac delivery system supported the United States premarket approval application for the device.MethodsThe pivotal trial was a prospective, nonrandomized study conducted at 13 sites from February 2002 to April 2003. The study group (n = 166) underwent EVAR using the Talent eLPS stent graft. The control group (n = 243) underwent open surgical AAA repair. Data for this group were obtained from the Society for Vascular Surgery Endovascular AAA Surgical Controls project. Outcomes were compared at 30 days and 12 months. Additional 5-year follow-up was obtained for the eLPS group. A single-center cohort of 137 patients was the confirmatory group for the assessment of the clinical performance of the CoilTrac delivery system, with analysis of outcomes ≤30 days from the procedure.ResultsAAA anatomy with neck length as short as 3 mm and maximum neck diameter of 32 mm were included in the eLPS group. EVAR was superior to open repair for periprocedural outcomes, including mean procedure duration (167.3 vs 196.4 minutes, P < .001), blood transfusion (18.2% vs 56.8%, P < .001), median intensive care unit stay (19.3 vs 74.3 hours, P < .001), and mean hospital stay (3.6 vs 8.2 days, P < .001). Freedom from major adverse events was 89.2% for EVAR at 30 days vs 44.0% (P < .001) and 81.3% vs 42.4% at 1 year (P < .001). Freedom from all-cause mortality and aneurysm-related mortality (ARM) was 93.7% and 98.2% for EVAR vs 92.4% and 96.7% for the controls. Through 5 years for the EVAR group, rates of freedom from all-cause mortality, ARM, aneurysm rupture, and conversion to surgery were 69.8%, 96.5%, 98.2%, and 99.1%, respectively, with one conversion to surgery, 25 secondary reinterventions, and five site-reported instances of stent graft migration. The technical success rate for the CoilTrac confirmatory group was 100%, with no aneurysm rupture or conversion to open repair at 30 days. The 30-day all-cause mortality rate was 1.5% (2 of 137).ConclusionsIn a population with challenging anatomic characteristics, EVAR with the Talent eLPS and use of the CoilTrac delivery system compared favorably with open repair through 1 year. Sustained protection from ARM, with minimal reinterventions, was attained through 5 years.