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Background: An increasing number of interventional procedures require large-sheath technology (>12F) with a favorable outcome with endovascular rather than open surgical access. However, vascular complications are a limitation for the management of these patients. This trial aimed to determine the effectiveness and safety of the Cross-Seal suture-mediated vascular closure device in obtaining hemostasis at the target limb access site following interventional procedures using 8F to 18F procedural sheaths., Methods: The Cross-Seal IDE trial (Investigational Device Exemption) was a prospective, single-arm, multicenter study in subjects undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheaths. The primary efficacy end point was time to hemostasis at the target limb access site. The primary safety end point was freedom from major complications of the target limb access site within 30 days post procedure., Results: A total of 147 subjects were enrolled between August 9, 2019, and March 12, 2020. Transcatheter aortic valve replacement was performed in 53.7% (79/147) and percutaneous endovascular abdominal/thoracic aortic aneurysm repair in 46.3% (68/147) of subjects. The mean sheath ID was 15.5±1.8 mm. The primary effectiveness end point of time to hemostasis was 0.4±1.4 minutes. An adjunctive intervention was required in 9.2% (13/142) of subjects, of which 2.1% (3/142) were surgical and 5.6% (8/142) endovascular. Technical success was achieved in 92.3% (131/142) of subjects. Freedom from major complications of the target limb access site was 94.3% (83/88)., Conclusions: In selected patients undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheath, Cross-Seal suture-mediated vascular closure device achieved favorable effectiveness and safety in the closure of the large-bore arteriotomy., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03756558., Competing Interests: Disclosures Dr Krishnan has served as a consultant to Abbott and Medtronic. Dr Nazif reports consulting fees or honoraria from Terumo Medical, Boston Scientific, Medtronic, Edwards Lifesciences, Teleflex, Opsens Medical, Encompass Technologies, and Columbia University Irving Medical Center. The other authors report no conflicts.

Objective: Despite the publication of various national/international guidelines, several questions concerning the management of patients with asymptomatic (AsxCS) and symptomatic (SxCS) carotid stenosis remain unanswered. The aim of this international, multi-specialty, expert-based Delphi Consensus document was to address these issues to help clinicians make decisions when guidelines are unclear., Methods: Fourteen controversial topics were identified. A three-round Delphi Consensus process was performed including 61 experts. The aim of Round 1 was to investigate the differing views and opinions regarding these unresolved topics. In Round 2, clarifications were asked from each participant. In Round 3, the questionnaire was resent to all participants for their final vote. Consensus was reached when ≥75% of experts agreed on a specific response., Results: Most experts agreed that: (1) the current periprocedural/in-hospital stroke/death thresholds for performing a carotid intervention should be lowered from 6% to 4% in patients with SxCS and from 3% to 2% in patients with AsxCS; (2) the time threshold for a patient being considered "recently symptomatic" should be reduced from the current definition of "6 months" to 3 months or less; (3) 80% to 99% AsxCS carries a higher risk of stroke compared with 60% to 79% AsxCS; (4) factors beyond the grade of stenosis and symptoms should be added to the indications for revascularization in AsxCS patients (eg, plaque features of vulnerability and silent infarctions on brain computed tomography scans); and (5) shunting should be used selectively, rather than always or never. Consensus could not be reached on the remaining topics due to conflicting, inadequate, or controversial evidence., Conclusions: The present international, multi-specialty expert-based Delphi Consensus document attempted to provide responses to several unanswered/unresolved issues. However, consensus could not be achieved on some topics, highlighting areas requiring future research., Competing Interests: Disclosures D.P.M. has given talks, acted as a consultant or attended conferences sponsored by Amgen and Novo Nordisk. J.F.M. receives funding from the United States National Institute of Neurologic Disorders and Stroke for work related to running the CREST-2 clinical trial (U01NS080168) and the CREST-2 Long-term Observational Extension study (U01NS119169). E.A.S. has received research grants from the United States Food and Drug Administration, BD, Boston Scientific, Cook, CSI, Laminate Medical, Medtronic and Philips; has received consulting/speaking fees from Abbott, Bayer, BD, Boston Scientific, Cook, Cordis, CSI, Inari, Infraredx, Medtronic, Philips, Shockwave and VentureMed. H.-H.E. is a local Principal Investigator for the ROADSTER 2 trial and a scientific committee member of SPACE-1, SPACE-2 and ACST-2. T.R. is funded by grants from the National Institutes of Health (R01 MD012467, R01 NS029993, R01NS040807, 1U24NS107267), and the National Center for Advancing Translational Sciences (UL1 TR002736, KL2 TR002737). J.S.M. has received institutional research grants from Abbott, Cook, Endologix, Gore and Medtronic., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background Fibromuscular dysplasia (FMD) is a nonatherosclerotic arterial disease that has a variable presentation including pulsatile tinnitus (PT). The frequency and characteristics of PT in FMD are not well understood. The objective of this study was to evaluate the frequency of PT in FMD and compare characteristics between patients with and without PT. Methods and Results Data were queried from the US Registry for FMD from 2009 to 2020. The primary outcomes were frequency of PT among the FMD population and prevalence of baseline characteristics, signs/symptoms, and vascular bed involvement in patients with and without PT. Of 2613 patients with FMD who were included in the analysis, 972 (37.2%) reported PT. Univariable analysis and multivariable logistic regression were performed to explore factors associated with PT. Compared with those without PT, patients with PT were more likely to have involvement of the extracranial carotid artery (90.0% versus 78.6%; odds ratio, 1.49; P =0.005) and to have higher prevalence of other neurovascular signs/symptoms including headache (82.5% versus 62.7%; odds ratio, 1.82; P <0.001), dizziness (44.9% versus 22.9%; odds ratio, 2.01; P <0.001), and cervical bruit (37.5% versus 15.8%; odds ratio, 2.73; P <0.001) compared with those without PT. Conclusions PT is common among patients with FMD. Patients with FMD who present with PT have higher rates of neurovascular signs/symptoms, cervical bruit, and involvement of the extracranial carotid arteries. The coexistence of the 2 conditions should be recognized, and providers who evaluate patients with PT should be aware of FMD as a potential cause.

Objective: The SCAFFOLD trial evaluated the GORE® Carotid Stent (GCS), a novel, mesh-covered device and evaluated outcomes at 1 year., Background: SCAFFOLD was a prospective, multicenter, single-arm clinical trial in patients with severe carotid artery stenosis (angiographically defined as symptomatic ≥50% or asymptomatic ≥80%) at increased risk for adverse events from carotid endarterectomy. Interim 30-day analysis demonstrated low rates of death/stroke/myocardial infarction (DSMI; 3.0%) and stroke (1.1%) in a high surgical risk population., Methods: The rate of DSMI within 30 days plus ipsilateral stroke between 31 days and 1 year (primary endpoint) was compared to a predetermined performance goal. Secondary outcomes of freedom from clinically driven target lesion revascularization (CD-TLR; diameter stenosis ≥80% by core lab angiography, or ≥50% with clinical symptoms) and restenosis (≥80% diameter stenosis by core lab angiography) are reported as Kaplan-Meier (KM) estimates., Results: Of the 312 patients enrolled and treated, 264 were eligible per protocol and evaluable for major adverse events at 30 days, and 244 (92%) of these were evaluable at 1 year. The proportion of patients with DSMI at 1 year was 4.5% and was significantly lower than the prespecified performance goal of 16.9% (p < .00001). The proportion with ipsilateral stroke from 31 to 365 days was 1.2%. The KM estimates of 1-year event probability were 1.6% for CD-TLR and 1.2% for restenosis., Conclusions: Use of the mesh-covered GCS in the SCAFFOLD trial demonstrated 100% technical success and low rates of both periprocedural and late stroke, with durable patency at 1 year. ClinicalTrials.gov Identifier: NCT01901874 (redacted)., (© 2019 Wiley Periodicals, Inc.)

Purpose: To evaluate the safety and effectiveness of the MANTA percutaneous vascular closure device in patients undergoing percutaneous endovascular aneurysm repair (PEVAR) or thoracic endovascular aortic repair (TEVAR). Materials and Methods: The SAFE MANTA Study ( ClinicalTrials.gov identifier NCT02908880) was a prospective, single-arm, multicenter trial in patients undergoing endovascular interventions using large-bore sheaths (transcatheter aortic valve replacement, PEVAR, or TEVAR) at 20 sites in North America. Patient selection intended to test the MANTA device in populations without morbid obesity, severe calcification, or a severely scarred femoral access area. Of the 263 patients enrolled in the primary analysis cohort, 53 (20.2%) patients (mean age 74.9±8.9 years; 41 men) underwent PEVAR (n=51) or TEVAR (n=2) procedures and form the cohort for this subgroup analysis. Per protocol a single MANTA device was deployed in all PEVAR/TEVAR cases. Results: The mean time to hemostasis in the PEVAR/TEVAR cohort was 35±91 seconds, with a median time of 19 seconds vs 24 seconds in the overall SAFE MANTA population. The MANTA device met the definition for technical success in 52 (98%) of 53 PEVAR/TEVAR cases compared with 97.7% in the overall SAFE MANTA population. One (1.9%) major complication (access-site stenosis) occurred in this subgroup compared to 14 (5.3%) events in the SAFE population. In the PEVAR/TEVAR group, 1 pseudoaneurysm was noted prior to discharge, another at 30-day follow-up, and one at 60 days. One (1.9%) of the 3 minor pseudoaneurysms was treated with ultrasound-guided compression and the other 2 required no treatment. Conclusion: The MANTA device demonstrated a short time to hemostasis and low complication rates compared with published literature results of other percutaneous closure devices. Time to hemostasis and complication rates were comparable between the PEVAR/TEVAR patients and the full SAFE MANTA study cohort. The MANTA device provides reliable closure with a single percutaneous device for PEVAR/TEVAR procedures.

Background: Open surgical closure and small-bore suture-based preclosure devices have limitations when used for transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or percutaneous thoracic endovascular aortic aneurysm repair. The MANTA vascular closure device is a novel collagen-based technology designed to close large bore arteriotomies created by devices with an outer diameter ranging from 12F to 25F. In this study, we determined the safety and effectiveness of the MANTA vascular closure device., Methods and Results: A prospective, single arm, multicenter investigation in patients undergoing transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or thoracic endovascular aortic aneurysm repair at 20 sites in North America. The primary outcome was time to hemostasis. The primary safety outcomes were accessed site-related vascular injury or bleeding complications. A total of 341 patients, 78 roll-in, and 263 in the primary analysis cohort, were entered in the study between November 2016 and September 2017. For the primary analysis cohort, transcatheter aortic valve replacement was performed in 210 (79.8%), and percutaneous endovascular abdominal aortic aneurysm repair or thoracic endovascular aortic aneurysm repair was performed in 53 (20.2%). The 14F MANTA was used in 42 cases (16%), and the 18F was used in 221 cases(84%). The mean effective sheath outer diameter was 22F (7.3 mm). The mean time to hemostasis was 65±157 seconds with a median time to hemostasis of 24 seconds. Technical success was achieved in 257 (97.7%) patients, and a single device was deployed in 262 (99.6%) of cases. Valve Academic Research Consortium-2 major vascular complications occurred in 11 (4.2%) cases: 4 received a covered stent (1.5%), 3 had access site bleeding (1.1%), 2 underwent surgical repair (0.8%), and 2 underwent balloon inflation (0.8%)., Conclusions: In a selected population, this study demonstrated that the MANTA percutaneous vascular closure device can safely and effectively close large bore arteriotomies created by current generation transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, and thoracic endovascular aortic aneurysm repair devices., Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02908880.

Objective: The objective of this study was to evaluate outcomes of endovascular treatment of aortic coarctation in adults., Methods: Clinical data and imaging studies of 93 consecutive patients treated at nine institutions from 1999 to 2015 were reviewed. We included newly diagnosed aortic coarctation (NCO), recurrent coarctation, and aneurysmal/pseudoaneurysmal degeneration (ANE) after prior open surgical repair (OSR) of coarctation. Primary end points were morbidity and mortality. Secondary end points were stent patency and freedom from reintervention., Results: There were 54 (58%) male and 39 (42%) female patients with a mean age of 44 ± 17 years. Thirty-two patients had NCO (mean age, 48 ± 16 years) and 61 had endovascular reinterventions after prior OSR during childhood (mean, 30 ± 17 years after initial repair), including 50 patients (54%) with recurrent coarctation and 11 (12%) with ANE. Clinical presentation included asymptomatic in 31 patients (33%), difficult to control hypertension in 42 (45%), and lower extremity claudication in 20 (22%). Endovascular treatment was performed using balloon-expandable covered stents in 47 (51%) patients, stent grafts in 36 (39%) patients, balloon-expandable uncovered stents in 9 (10%) patients, and primary angioplasty in 1 (1%) patient. Mean lesion length and diameter were 64.5 ± 50.6 mm and 19.5 ± 6.7 mm, respectively. Mean systolic pressure gradient decreased from 24.0 ± 17.5 mm Hg to 4.4 ± 7.4 mm Hg after treatment (P < .001). Complications occurred in nine (10%) patients, including aortic dissections in three (3%) patients and intraoperative ruptures in two patients; type IA endoleak, renal embolus, spinal headache, and access site hemorrhage occurred in one patient each. The aortic dissections and ruptures were treated successfully by deploying an additional covered stent proximal to the site of dissection or rupture. Two patients died within 30 days of the index procedure. After a mean follow-up of 3.2 ± 3.1 years, nearly all patients (98%) were clinically improved and all stents were patent. Reintervention was needed in 10 (11%) patients. Freedom from reintervention at 5 years was 85%. Two additional patients died during follow-up of coarctation-related causes, including rupture of an infected graft and visceral ischemia. Patient survival at 5 years was 89%., Conclusions: Endovascular repair is effective with an acceptable safety profile in the treatment of NCO and postsurgical complications of coarctation after initial OSR. Aortic rupture is an infrequent (2%) but devastating complication with high mortality. Balloon-expandable covered stents are preferred for NCO, whereas stent grafts are used for ANE. The rate of reinterventions is acceptable, with high procedural and long-term clinical success., (Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: The primary purpose of this study was the composite of major adverse events through 30 days post-index procedure or ipsilateral stroke from 30 days to 1 year (365 days). Presented here is the composite of death, stroke, and myocardial infarction (MI) through 30 days., Background: Rates of minor stroke have been higher with carotid artery stenting (CAS) compared with carotid endarterectomy (CEA). The study hypothesized that a stent with mesh covering may improve plaque stabilization during CAS, reduce plaque protrusion, and lead to reduced stroke rates., Methods: The SCAFFOLD trial, a prospective, multicenter, single-arm clinical trial evaluating the GORE carotid stent (GCS), enrolled patients at increased risk for adverse events from CEA with severe carotid artery stenosis (defined as symptomatic ≥50% or asymptomatic ≥80%). The SCAFFOLD trial screening committee was implemented to determine adherence to the study protocol. Patients were evaluated for the primary endpoint, the composite of death, stroke, and MI through 30 days., Results: A total of 312 patients were enrolled, treated, and reviewed by the SCAFFOLD trial screening committee, of which 265 were included in the primary analysis population. The 30-day rate of death, stroke, or MI was 3.0% (95% confidence interval: 1.3% to 5.9%) and the stroke or death rate was 1.5%. The 30-day stroke rate was 1.1%. The 2 deaths in the study were not stroke related., Conclusions: Low death, stroke, or MI rates were demonstrated with GCS in patients at high risk for CEA. The 30-day stroke rate of 1.1% suggests that the carotid stent mesh covering may reduce the neurologic events associated with CAS when used in appropriately selected patients., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The EMBOLDEN study was conducted to test the safety and efficacy of a novel emboli protection filter design for use in carotid artery stenting (CAS) in patients with severe carotid stenosis who were at high risk of operative complications from carotid endarterectomy (CEA)., Background: General considerations for filter design usually involve trade-offs between trackability/profile and wall apposition/capture efficiency. The GORE ® Embolic Filter (GEF) is intended to address these design goals via a hybrid construction., Methods: Patients at high risk for CEA (N = 250) were treated with CAS using the GEF study device paired with an FDA-approved carotid stent. The primary outcome was death, stroke, and myocardial infarction (MI) at 30 days, compared to a pre-determined performance goal. Neurologic outcomes were judged by an independent assessor and angiographic results evaluated by an independent central core lab., Results: The GEF study device was successfully deployed in 96.4% of procedures. The primary endpoint of 30-day death, stroke, and MI occurred in 4.0% of subjects and was significantly lower than the pre-defined performance goal (P < 0.001). The 30-day rate for death and major stroke was 1.2% and for death and any stroke was 3.6%. The rate of major adverse events was 5.4% among octogenarians and 3.2% among non-octogenarians., Conclusion: In patients at high risk for CEA undergoing CAS, the GEF not only showed high rates of successful deployment but also met the primary endpoint of low death, stroke, and MI rates, thus demonstrating safety and effectiveness., (© 2018 Wiley Periodicals, Inc.)

Aortoiliac occlusive disease results in varying degrees of pelvic and lower extremity arterial insufficiency. Treatment approach has evolved, and endovascular therapies are being successfully reported for high-grade lesions. However, Trans Atlantic Inter-Society Consensus D often necessitates open revascularization. Disease limited to the infrarenal segment does not typically affect intestinal perfusion in the absence of visceral aortic or mesenteric vessel involvement. Chronic mesenteric ischemia most commonly occurs due to atherosclerotic disease of 2 or 3 of the mesenteric vessels. The marginal artery of Drummond is an important component of the collateral network that allows for continued intestinal perfusion. We report a case of short-segment subtotal infrarenal aortic occlusion, proximal to the inferior mesenteric artery (IMA) in the absence of significant mesenteric disease. The patient had resultant lifestyle limiting claudication and chronic mesenteric ischemia. Angiographic evaluation demonstrated "mesenteric steal" physiology with retrograde flow via the arc of Riolan and IMA to perfuse the aortoiliac circulation. Successful endovascular recanalization with a balloon-expandable covered stent was achieved, resolving the arterial insufficiency in both the mesenteric and lower extremity vascular beds. The patient denied any symptoms on postoperative day 1 and at 1-month follow-up., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Fibromuscular dysplasia (FMD) is a noninflammatory arterial disease that predominantly affects women. The arterial manifestations may include beading, stenosis, aneurysm, dissection, or tortuosity., Objectives: This study compared the frequency, location, and outcomes of FMD patients with aneurysm and/or dissection to those of patients without., Methods: The U.S. Registry for FMD involves 12 clinical centers. This analysis included clinical history, diagnostic, and therapeutic procedure results for 921 FMD patients enrolled in the registry as of October 17, 2014., Results: Aneurysm occurred in 200 patients (21.7%) and dissection in 237 patients (25.7%); in total, 384 patients (41.7%) had an aneurysm and/or a dissection by the time of FMD diagnosis. The extracranial carotid, renal, and intracranial arteries were the most common sites of aneurysm; dissection most often occurred in the extracranial carotid, vertebral, renal, and coronary arteries. FMD patients with dissection were younger at presentation (48.4 vs. 53.5 years of age, respectively; p < 0.0001) and experienced more neurological symptoms and other end-organ ischemic events than those without dissection. One-third of aneurysm patients (63 of 200) underwent therapeutic intervention for aneurysm repair., Conclusions: Patients with FMD have a high prevalence of aneurysm and/or dissection prior to or at the time of FMD diagnosis. Patients with dissection were more likely to experience ischemic events, and a significant number of patients with dissection or aneurysm underwent therapeutic procedures for these vascular events. Because of the high prevalence and associated morbidity in patients with FMD who have an aneurysm and/or dissection, it is recommended that every patient with FMD undergo one-time cross-sectional imaging from head to pelvis with computed tomographic angiography or magnetic resonance angiography., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Since its advent in 1991, endovascular aortic aneurysm repair (EVAR) has become a mainstay of treatment for abdominal aortic aneurysms (AAA). Studies such as the comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR 1) trial, have demonstrated the effectiveness of EVAR in reducing perioperative mortality. Technological improvements in graft design and delivery account for an increasing utilization of endovascular repair. Newer branch and fenestrated graft designs have allowed for treatment of patients with complex aortic anatomy that previously could not be treated with EVAR. Endovascular repair, while dominant, is unlikely to eliminate the need for open repair or to relegate open surgery for AAA to historical interest only. The unprecedented adoption of EVAR has led to complications and modes of failure that were not seen with open repair. The rate of failure is markedly increased when endografts are used outside of the instructions for use (IFU). The long-term durability of fenestrated and investigational branch devices remains to be established. The demand for an endovascular approach by patients and the willingness of physicians to place endografts outside the anatomic IFU criteria may have resulted in the pendulum swinging too far away from open surgical management. The consequence of reduced open aortic surgeries is a concern for both patient care as well as training for vascular surgery fellows. Vascular surgery training programs will require innovative changes in training to assure that vascular surgery trainees will have the requisite skill and experience required to competently perform open surgical repair on what will undoubtedly be some of the most complex aortic pathology.

The American Board of Vascular Medicine (ABVM) was conceived through the Society for Vascular Medicine and this year will complete 10 years of certifying physicians who practice vascular medicine and endovascular medicine. The value of certification to our physicians, patients, and field cannot be understated. This paper reviews the highlights of the test development process, quality assurance measures, and management of these high stakes examinations., (© The Author(s) 2014.)

Objective: The first multicenter randomized controlled trial was designed and conducted to assess the safety and effectiveness of totally percutaneous endovascular aortic aneurysm repair (PEVAR) with use of a 21F endovascular stent graft system and either an 8 F or 10 F suture-mediated closure system (the PEVAR trial, NCT01070069). A noninferiority trial design was chosen to compare percutaneous access with standard open femoral exposure., Methods: Between 2010 and 2012, 20 U.S. institutions participated in a prospective, Food and Drug Administration-approved randomized trial to evaluate percutaneous femoral artery access and closure by a "preclose" technique in conjunction with endovascular abdominal aortic aneurysm repair. A total of 151 patients were allocated by a 2:1 design to percutaneous access/closure (n = 101) or open femoral exposure (n = 50 [FE]). PEVAR procedures were performed with either the 8 F Perclose ProGlide (n = 50 [PG]) or the 10 F Prostar XL (n = 51 [PS]) closure devices. All endovascular abdominal aortic aneurysm repair procedures were performed with the Endologix 21 F profile (outer diameter) sheath-based system. Patients were screened by computed tomography with three-dimensional reconstruction and independent physician review for anatomic suitability and adequate femoral artery anatomy for percutaneous access. The primary trial end point (treatment success) was defined as procedural technical success and absence of major adverse events and vascular complications at 30 days. An independent access closure substudy evaluated major access-related complications. Clinical utility and procedural outcomes, ankle-brachial index, blood laboratory analyses, and quality of life were also evaluated with continuing follow-up to 6 months., Results: Baseline characteristics were similar among groups. Procedural technical success was 94% (PG), 88% (PS), and 98% (FE). One-month primary treatment success was 88% (PG), 78% (PS), and 78% (FE), demonstrating noninferiority vs FE for PG (P = .004) but not for PS (P = .102). Failure rates in the access closure substudy analyses demonstrated noninferiority of PG (6%; P = .005), but not of PS (12%; P = .100), vs FE (10%). Compared with FE, PG and PS yielded significantly shorter times to hemostasis and procedure completion and favorable trends in blood loss, groin pain, and overall quality of life. Initial noninferiority test results persist to 6 months, and no aneurysm rupture, conversion to open repair, device migration, or stent graft occlusion occurred., Conclusions: Among trained operators, PEVAR with an adjunctive preclose technique using the ProGlide closure device is safe and effective, with minimal access-related complications, and it is noninferior to standard open femoral exposure. Training, experience, and careful application of the preclose technique are of paramount importance in ensuring successful, sustainable outcomes., (Published by Mosby, Inc.)

We describe a complex case of ascending aortic pseudoaneurysm after open repair of ascending aortic aneurysm and aortic valve replacement. Although treatment was complicated due to intra-operative graft migration, the patient was successfully treated with endovascular technique., (Copyright © 2011 Annals of Vascular Surgery Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: A prospective nonrandomized multicenter registry of 160 patients with severe carotid stenosis and high-risk features for carotid endarterectomy was conducted during the 3-month period from March to May 2005., Methods: Carotid artery stenting (CAS) was performed with the SpideRX™ Embolic Protection System (ev3, Inc., Plymouth, MN, USA) as part of an investigational device exemption from the Food and Drug Administration., Results: The primary end-point of major adverse cardiac and cerebrovascular events at 30 days after CAS was observed in nine patients (5.6%), including death in four patients (2.5%), nonfatal stroke in five patients (3.1%), and nonfatal myocardial infarction in one patient (0.6%). A secondary end-point of technical success (defined as successful deployment of all devices, filter retrieval, and final diameter stenosis <50%) was achieved in 156 of 160 patients (97.5%). The only independent predictor of death or stroke at 30 days was baseline stenosis severity (P < 0.05)., Conclusion: CAS with distal embolic protection using the SpideRX™ Embolic Protection System is a reasonable alternative for revascularization of some high-risk patients with severe carotid stenosis., (©2010, Wiley Periodicals, Inc.)

Objective: The multicenter ARMOUR (ProximAl PRotection with the MO.MA Device DUring CaRotid Stenting) trial evaluated the 30-day safety and effectiveness of the MO.MA Proximal Cerebral Protection Device (Invatec, Roncadelle, Italy) utilized to treat high surgical risk patients undergoing carotid artery stenting (CAS)., Background: Distal embolic protection devices (EPD) have been traditionally utilized during CAS. The MO.MA device acts as a balloon occlusion "endovascular clamping" system to achieve cerebral protection prior to crossing the carotid stenosis., Methods: This prospective registry enrolled 262 subjects, 37 roll-in and 225 pivotal subjects evaluated with intention to treat (ITT) from September 2007 to February 2009. Subjects underwent CAS using the MO.MA device. The primary endpoint, myocardial infarction, stroke, or death through 30 days (30-day major adverse cardiac and cerebrovascular events [MACCE]) was compared to a performance goal of 13% derived from trials utilizing distal EPD., Results: For the ITT population, the mean age was 74.7 years with 66.7% of the cohort being male. Symptomatic patients comprised 15.1% and 28.9% were octogenarians. Device success was 98.2% and procedural success was 93.2%. The 30-day MACCE rate was 2.7% [95% CI (1.0-5.8%)] with a 30-day major stroke rate of 0.9%. No symptomatic patient suffered a stroke during this trial., Conclusions: The ARMOUR trial demonstrated that the MO.MA(R) Proximal Cerebral Protection Device is safe and effective for high surgical risk patients undergoing CAS. The absence of stroke in symptomatic patients is the lowest rate reported in any independently adjudicated prospective multicenter registry trial to date., ((c) 2010 Wiley-Liss, Inc.)

Objective: The multicenter EPIC (FiberNet Embolic Protection System in Carotid Artery Stenting Trial) single-arm trial evaluated the 30-day outcomes of a new design concept for embolic protection during carotid artery stenting (CAS)., Background: Embolic protection filters available for use during CAS include fixed and over-the-wire systems that rely on embolic material capture within a "basket" structure. The FiberNet Embolic Protection System (EPS), which features a very low crossing profile, consists of a three-dimensional fiber-based filter distally mounted on a 0.014 inch guidewire with integrated aspiration during filter retrieval., Methods: The trial enrolled 237 patients from 26 centers. Demographics, clinical and lesion characteristics, as well as adverse events through a 30-day follow-up were recorded. The mean age of the patients was 74 years, 64% were male and 20% had symptomatic carotid artery disease., Results: The combined major adverse event (MAE) rate at 30 days for all death, stroke, and myocardial infarction was 3.0%. There were three major strokes (two ischemic and one hemorrhagic) and two minor strokes (both ischemic) for a 2.1% 30-day stroke rate. The procedural technical success rate was 97.5% and macroscopic evidence of debris was reported in 90.9% of the procedures., Conclusions: The FiberNet EPS, used with commercially available stents, produced low stroke rates following CAS in high surgical risk patients presenting with carotid artery disease. The unique filter design including aspiration during retrieval may have contributed to the low 30-day stroke rate reported during CAS in patients considered at high risk for complications following carotid endarterectomy (CEA)., (Copyright 2010 Wiley-Liss, Inc.)

Background: We analyzed the risk of adverse events following carotid angioplasty and stenting (CAS) in patients <80 years (group I) compared with those > or = 80 years of age (group II)., Methods: Prospective data from 224 patients who underwent 235 consecutive CAS procedures at three participating institutions were reviewed retrospectively. All subjects were enrolled in Food and Drug Administration-approved clinical trials of CAS in high-risk patients or in institutional protocols. Procedural details and angiographic morphology were reviewed in all cases. All patients underwent independent neurological evaluation at 24hr and 30 days following CAS., Results: Mean age was 69.9 years in the younger cohort and 83.5 years in the older group. Embolic protection devices were successfully deployed in 97.5% of cases in group I compared with 98.7% in group II (p=nonsignificant [NS]). Procedural success, defined as <30% residual stenosis after CAS, was achieved in all cases. Mean hospital stay was similar in the two groups. Transient ischemia attacks occurred in 1.9% in group I and 1.3% in group II (p=NS). Within 30 days of CAS, the risk of minor or major stroke (p=NS) as well as the composite risk of stroke (minor or major) and death was 2.5% in group I and 3.8% in group II (p=NS). Multivariate logistic regression analysis showed that absence of hypertension (odds ratioi [OR]=0.38, p=0.0352) and chronic renal insufficiency (OR=2.62, p=0.0238) were significant predictors of the composite end point of stroke and all-cause mortality. Kaplan-Meier analysis revealed that survival and freedom from the combined end point of stroke and all-cause mortality were similar for patients in groups I and II., Conclusion: Octogenarians are not at increased risk of periprocedural adverse events following CAS compared to younger patients. Exclusion of high-risk patients from CAS based on age alone is unjustified., (Copyright 2009 Annals of Vascular Surgery Inc. Published by Elsevier Inc. All rights reserved.)

Although relatively uncommon, isolated iliac artery aneurysms are associated with significant risk of rupture and death. Clinical presentation can be confusing and ultrasound or CT imaging is paramount in establishing the diagnosis and anatomical extent of disease. Important considerations prior to intervention include determination of proximal neck, involvement of the internal iliac artery, and status of the contralateral internal iliac artery. Endovascular repair has evolved as the first choice treatment option for patients with anatomically suitable iliac artery aneurysms. In uncommon circumstances when endovascular treatment may result in significant pelvic ischemia or the primary symptoms are related to extrinsic compression of adjacent structures, surgical repair may be the preferred option., (Copyright 2008 Wiley-Liss, Inc.)

Objectives: The purpose of this study was to determine the safety of carotid artery stenting with a unique distal embolic protection system in high-risk patients with severe carotid stenosis., Background: Previous studies suggest that some patients with carotid stenosis and serious comorbid conditions are at high risk for carotid endarterectomy, and may be safely treated by carotid artery stenting., Methods: A prospective non-randomized multicenter registry of 419 patients with severe carotid stenosis and high-risk features for carotid endarterectomy was conducted between April 2004 and October 2004. Carotid artery stenting was performed with the Protégé Self-Expanding Nitinol Stent and the SPIDER Embolic Protection System (ev3 Inc., Plymouth, Minnesota). Aspirin and clopidogrel were prescribed at least 24 h before and three months after revascularization. The primary outcome was the combined incidence of major adverse cardiac and cerebrovascular events at 30 days after intervention, including death, stroke, and myocardial infarction. A secondary outcome was the technical success, defined as successful deployment of all devices, filter retrieval, and final diameter stenosis <50%., Results: Technical success was achieved in 408 of 419 patients (97.4%). The primary end point was observed in 26 patients (6.2%), including death in 8 (1.9%), nonfatal stroke in 14 (3.3%), and nonfatal myocardial infarction in 4 (1%). Independent predictors of death or stroke at 30 days included duration of filter deployment, symptomatic carotid stenosis, and baseline renal insufficiency., Conclusions: For some patients with severe carotid stenosis and high-risk features for carotid endarterectomy, carotid artery stenting with distal embolic protection is a reasonable alternative for revascularization.

The use of suture-mediated arterial closure devices has dramatically increased with the increased number of percutaneous procedures being performed. Complications from suture-mediated closure devices have been underreported. Specifically, arterial stenosis resulting in claudication has not been previously described in detail. We present nine patients who presented with various leg symptoms after Perclose was used to achieve arterial hemostasis following percutaneous procedures. All cases were found to have significant arterial stenoses from the Perclose sutures. Once diagnosis was correctly made, the patients either underwent surgical repair or percutaneous balloon angioplasty and in all cases the symptoms abated., ((c) 2006 Wiley-Liss, Inc.)

Considerable interest exists in using endovascular techniques for assessing the renal circulation. The vasomotor response of the renal circulation in patients with hypertension and severe atherosclerotic renal artery stenosis was evaluated. Sixteen patients (5 men and 11 women) with a mean age of 73.2+/-7.1 years (range, 59-82 years) underwent noninvasive renal duplex ultrasonography and endovascular flow wire evaluation. The flow wire was positioned in the main renal artery distal to the stenosis and used to examine the reactivity of the renal circulation in response to intra-arterial papaverine before and after percutaneous revascularization. Resistive index was computed as (MPV - EDV)/MPV, where MPV is the maximum peak velocity and EDV is the end-diastolic velocity. Renal flow reserve was defined as the ratio of peak hyperemic response to baseline flow. Intervention was technically successful in 18/18 arteries. Heart rate (69+/-11 vs. 65+/-10 beats/min; P=NS) and systolic blood pressure (168+/-19 vs. 163+/-24 mm Hg; P=NS) remained constant following injection of intrarenal papaverine, while diastolic blood pressure decreased (77+/-13 vs. 65+/-11 mm Hg; P<0.006). Papaverine injection resulted in significant increases in average peak velocity (APV; 148% of baseline; P=0.0003), MPV (146% of baseline; P=0.001), and EDV (161% of baseline; P=0.0026), but had no effect on the endovascular resistive index (0.81+/-0.12 vs. 0.84+/-0.08; P=NS). Renal artery stenting produced no effect on APV or EDV, but a small increase in MPV (123% of baseline; P<0.05). In contrast, renal stenting resulted in a significant increase in the endovascular resistive index (0.77+/-012 vs. 0.84+/-0.08; P=0.003), pulsatility index (1.84+/-0.61 vs. 2.23+/-0.70; P<0.014), and renal flow reserve (1.49+/-0.44 vs. 1.86+/-0.73; P<0.0071). A correlation was found between the noninvasive and endovascular measures diastolic/systolic ratio (r=0.73; P<0.0009) and resistive index (r=0.63; P<0.0053). Patients with atherosclerotic renal artery stenosis have preserved vasomotor response to papaverine, as well as marked increases in renal flow and resistive index following successful renal artery stenting. Endovascular flow wire measurements are safe, easy to perform, and correlate well with noninvasive Doppler measurements., (Copyright (c) 2006 Wiley-Liss, Inc.)

Unsuspected subclavian or axillary disease may cause failure of axillofemoral bypass grafts. A 52-year-old woman who underwent left axillofemoral bypass grafting 5 years ago presented with 24 h of left foot pain. Routine duplex ultrasonography 2 months previously demonstrated velocities throughout the graft > 80 cm/s. Emergent angiography revealed thrombotic occlusion of the axillofemoral bypass graft. Both rheolytic thrombectomy and pulse spray thrombolysis using tissue plasminogen activator were used to restore graft patency. Arterial pressure waveform and pressure remained damped throughout the graft; a 50 mmHg gradient was found from the descending thoracic aorta to the mid-left subclavian artery. Angiography revealed a 70% diameter stenosis at the origin of the left subclavian artery. Following balloon angioplasty and stent placement, the pressure gradient was eliminated. In conclusion, careful evaluation of arterial inflow to bypass grafts is critical for ensuring long-term graft patency.

The purpose of this study was to evaluate the feasibility of carotid artery revascularization using a new system for carotid stenting and distal embolic protection in 30 patients with severe carotid stenosis and high risk for carotid endarterectomy (Carotid Revascularization With ev3 Arterial Technology Evolution, or CREATE). Previous studies suggest that patients with carotid stenosis and serious comorbid cardiopulmonary and anatomic conditions are at high risk for carotid endarterectomy. All patients underwent percutaneous revascularization using the Protégé GPS self-expanding nitinol stent (ev3, Plymouth, MN) and the Spider distal embolic protection system (ev3). In-hospital and 30-day outcomes were analyzed. High-risk features included age > 75 years (63%), left ventricular ejection fraction < 35% (20%), and restenosis after prior carotid endarterectomy (53%). Procedural success was 100%. In-hospital complications included severe vasovagal reactions in six patients (20%) and a popliteal embolus in one patient (3.3%), treated by successful embolectomy. During 30 days of follow-up, two patients (6.6%) experienced minor neurological deficits, including transient expressive aphasia that resolved without therapy in one patient and homonymous hemianopsia due to contralateral posterior circulation stroke in one patient. This study supports the feasibility of percutaneous carotid artery revascularization with the Protégé GPS self-expanding stent and Spider distal embolic protection system, which will be evaluated in a large multicenter pivotal trial (CREATE Pivotal Trial).

The objective of this study was to describe the development of a comprehensive surveillance program for monitoring the long-term follow-up of endoluminal stent graft (ELG) patients. Despite high procedural success rates, ELG patients remain at ongoing risk for aneurysm sac expansion, rupture, and other adverse events that make long-term surveillance imperative. As they perform more ELG, practitioners face increased logistical difficulty performing appropriate patient follow-up. A computer-based data ELG registry was created using Epi Info, a program developed by the Centers for Disease Control and Prevention that enables users to design a data entry form, enter data, and perform statistical analyses. The database has been used to track 259 patients (214 men and 45 women) who underwent ELG between November 1999 and October 2003. One-year follow-up was available for 182 patients, 2-year follow-up for 104 patients, and 3-year surveillance data for 40 patients, which represent follow-up rates of 89.6%, 78.8%, and 61.5%, respectively. There were 25 late deaths. The Kaplan-Meier estimate for 1-year survival was 92.5%. Twenty-one patients underwent 24 secondary angiographic procedures at a mean 8.6 +/- 10.3 months (range, 1-37.6) after stent-graft repair. No mortality was observed in association with a secondary intervention. There were no late conversions to open aneurysm repair. The Kaplan-Meier estimate for freedom from secondary intervention for all patients at 1 year was 91.0%. A computer-based registry facilitates appropriate and timely patient follow-up and may improve the long-term outcome from ELG., (Copyright 2004 Wiley-Liss, Inc.)

Endovascular techniques including angioplasty, stenting, and endoluminal stent grafts represent important therapeutic options for the treatment of vascular disease. Technologic advances have allowed for the treatment of aneurysmal disease as well as extra-cranial carotid disease that previously required surgical methods. The success of various endovascular therapies varies based on anatomic location and extent of disease. The clinical results in different arterial segments are increasingly recognized in the published literature. The aortoiliac arterial bed appears to respond most favorably, with less favorable results observed in the infra-inguinal and infrapopliteal locations. There is increasing evidence that stent-supported carotid angioplasty using cerebral protection will play an important future role in the treatment of carotid artery stenosis. Less invasive techniques to treat abdominal aortic aneurysms with endoluminal stent grafts have dramatically changed the available therapeutic options. Improved devices and delivery systems will likely increase the number of patients who can be successfully treated in this manner. The evolution of endovascular therapies will continue to change the way we treat vascular disease.

Purpose: To examine the effectiveness of intravascular ultrasound (IVUS) and digital subtraction angiography (DSA) for preoperative planning and intraoperative deployment of stent-grafts to treat abdominal aortic aneurysms., Methods: One hundred seventy patients (143 men; mean age 73.6+/-7.2 years, range 51-89) underwent successful DSA and IVUS to determine suitability for stent-graft repair. Patients subsequently received the AneuRx (n=157) or Ancure (n=13) device; intraprocedural IVUS was used to survey the proximal endograft for proper apposition to the aortic wall., Results: Reliable preoperative IVUS measurements were obtained in all patients. Plaque morphology was assessed in 140 (82.3%) aortic necks; in 36 (25.7%), preoperative IVUS showed high-grade atherosclerotic plaque in the nonaneurysmal abdominal aortic neck. The procedure was successful in 168 (98.8%) cases (1 [0.6%] acute conversion and 1 access failure). There were 2 (1.2%) periprocedural deaths related to bowel ischemia. Four (2.3%) patients developed graft occlusion/kinking and 2 (1.2%) developed renal failure requiring dialysis within 30 days. Multivariate logistic regression analysis revealed that female gender (p=0.0247), a short nonaneurysmal aortic neck (p=0.0185), and presence of high-grade atherosclerotic plaque (p=0.0185) correlated with major acute complications. Over a mean 10.4-month follow-up (range 1-25), 11 patients died of unrelated causes; there was no known AAA rupture or device failure. The Kaplan-Meier estimate of survival at 1 year was 91.0%+/-2.8%. Sixteen (9.4%) patients underwent 17 secondary procedures for endoleak or graft limb occlusion at a mean 5.4 months after stent-graft repair (freedom from secondary intervention at 1 year 86.5%+/-3.2%)., Conclusions: Our findings suggest that IVUS may identify patients at increased risk of major adverse complications following endovascular repair. The combination of IVUS and DSA for endoluminal stent-graft planning and placement provides excellent short- and mid-term patient outcomes.

Renal artery stenosis (RAS) may cause hypertension, azotemia, episodes of flash pulmonary edema and congestive heart failure. Renal artery angioplasty and stenting was performed in 207 patients from 1991 to 1997. Thirty-nine of these patients (19%) underwent renal artery stenting for the control of recurrent episodes of congestive heart failure and flash pulmonary edema. All patients had angiographic evidence of severe (>70%) bilateral RAS (n = 18) or severe RAS to a solitary functioning kidney (n = 21). Sixteen patients (41%) were male and 23 (59%) were female, mean age 69.9 years (range 50-85 years). Of the 18 patients with bilateral RAS, 12 (66.6%) underwent bilateral stenting. Mean blood pressure decreased from 174/85 +/- 32/23 mmHg to 148/72 +/- 24/14 mmHg (p < 0.001). Mean number of blood pressure medications decreased from 3 +/- 1 to 2.5 +/- 1 (p = 0.006). Twenty-eight patients (71.8%) had improvement in blood pressure control. The mean serum creatinine decreased from 3.16 +/- 1.61 to 2.65 +/- 1.87 (p = 0.06). Six of 39 patients (15.4%) used angiotensin converting enzyme (ACE) inhibitors prior to stenting whereas 19 of 39 patients (48.7%) used ACE inhibitors poststenting (p = 0.004). Twenty of 39 patients (51.4%) demonstrated improvement in serum creatinine, 10 of 39 patients (25.6%) had stabilization of serum creatinine and nine of 39 patients (23%) demonstrated worsening. The number of hospitalizations due to congestive heart failure in the year preceding renal artery stenting was 2.4 +/- 1.4 and poststenting was 0.3 +/- 0.7 (p < 0.001). The New York Heart Association Functional Class decreased from 2.9 +/- 0.9 prestenting to 1.6 +/- 0.9 poststenting (p < 0.001). Thirty of 39 patients (77%) had no hospitalizations for congestive heart failure during a mean follow-up period of 21.3 months. Nine patients expired during the course of follow up; eight of the nine patients died within the first year after renal artery stenting. Renal artery stenting decreased the frequency of congestive heart failure, flash pulmonary edema, and the need for hospitalization in most patients. Blood pressure was markedly improved in the majority of patients with improved or stabilized renal function. Evaluation for RAS is important in hypertensive patients who present with recurrent congestive heart failure or flash pulmonary edema.

Purpose: To determine whether intravascular ultrasound (IVUS) is more sensitive in identifying incomplete stent deployment or mechanical disruption compared to angiography., Methods: Over a 9-month period, 44 patients (25 men; mean age 63 years, range 36-88) treated for common or external iliac artery stenoses with balloon angioplasty and stenting underwent IVUS interrogation following completion arteriography., Results: One hundred nine stents were deployed in the 44 patients. Of these, 29 (27%) stents (in 45% of patients) were found by IVUS to be incompletely deployed or to have an associated mechanical disruption despite a normal completion arteriogram. Further treatment (repeat dilation or additional stenting) was performed in 28 cases; 1 hemodynamically insignificant dissection was not treated. Twenty-six (93%) of these interventions were successful as determined by IVUS; 2 underexpanded stents did not respond to redilation., Conclusions: Incomplete stent deployment or mechanical problems associated with stenting were common in this study, occurring in nearly half of the patients. IVUS has clinical utility in identifying incomplete deployment or mechanical problems in stents with an increased sensitivity compared to contrast angiography.

Stroke remains a major complication of atherosclerotic cerebrovascular disease, with extracranial carotid occlusive disease accounting for nearly one-third of all events. Although historical symptoms and physical examination findings are important, objective testing with carotid duplex ultrasonography and magnetic resonance arteriography represent the foundation for therapeutic decision making. Contrast arteriography is playing a decreasing role in the evaluation of patients with carotid artery disease. Options for therapy, based on the presence or absence of symptoms and degree of stenosis, include antiplatelet therapy with cardiovascular risk factor modification, carotid endarterectomy, and more recently, endovascular therapy.

Purpose: The initial and long-term results of angioplasty and primary stenting for the treatment of occlusive lesions involving the supra-aortic trunks were studied., Methods: All patients in whom angioplasty and stenting of the supra-aortic trunks was attempted were included in a prospective registry. Results are, therefore, reported on an intent-to-treat basis. The preprocedural and postprocedural clinical records, arteriograms, and noninvasive vascular laboratory examinations of 83 patients (41 men [49.4%] and 42 women [50.6%]; mean age at intervention, 63 years) in whom endovascular repair of the subclavian (66, 75.9%), left common carotid (14, 16.1%), and innominate (7, 8.0%) arteries was attempted were retrospectively reviewed., Results: Initial technical success was achieved in 82 of 87 procedures (94.3%). The inability to cross 4 complete subclavian occlusions and the iatrogenic dissection of 1 common carotid artery lesion accounted for the 5 initial failures. Complications occurred in 17.8% of 73 subclavian and innominate procedures, including access-site bleeding in 6 and distal embolization in 2. Ischemic strokes occurred in 2 of 14 common carotid interventions (14.3%), both of which were performed in conjunction with ipsilateral carotid bifurcation endarterectomy. The 30-day mortality rate was 4.8% for the entire group. By means of life-table analysis, 84% of the subclavian and innominate interventions, including initial failures, remain patent by objective means at 35 months. No patients have required reintervention or surgical conversion for recurrence of symptoms. Of the 11 patients available for follow-up study who underwent common carotid interventions, 10 remain stroke-free at a mean of 14.3 months., Conclusion: Angioplasty and primary stenting of the subclavian and innominate arteries can be performed with relative safety and expectations of satisfactory midterm success. Endovascular repair of common carotid artery lesions can be performed with a high degree of technical success, but should be approached with caution when performed in conjunction with ipsilateral bifurcation endarterectomy.

Purpose: This study reports the initial and late results of percutaneous transluminal angioplasty (PTA) and intravascular stenting for atherosclerotic occlusive disease of the iliac arteries., Methods: The preprocedural and postprocedural clinical records, arteriograms, segmental limb pressure measurements (ankle-brachial [ABI] and thigh-brachial [TBI] indexes), and pulse volume recordings of 288 patients who underwent PTA and primary stenting of the common iliac (354, 69.4%) and external iliac (156, 30.6%) arteries were reviewed. Initial and late clinical, hemodynamic, and angiographic success were assessed by objective criteria. Data on patients who underwent unsuccessful attempts at iliac stent placement are unavailable; results are not reported on an intent-to-treat basis., Results: Clinical follow-up data (mean, 11.9 months) are available for 268 of 288 patients (93.1%) and for 394 of 424 limbs (92.9%). The initial success rates, as determined by TBI, ABI, and clinical limb status, were 90.2%, 87.8%, and 74.6%, respectively. The Kaplan-Meier estimates of angiographic patency (101 arteries) were 96%, 81%, and 73% at 6, 12, and 24 months. Cumulative patency rates were 84%, 76%, and 57% on the basis of TBI, ABI, and clinical limb status at 24 months. Factors associated with initial success included the need for multiple stents (p = 0.0001), a higher degree of initial stenosis (p = 0.0001), lower severity of baseline ischemia (p = 0.007), younger age (p = 0.0015), and the preprocedural patency of the ipsilateral superficial femoral artery (p = 0.002). A higher degree of initial stenosis (p < 0.001) and superficial femoral artery patency (p = 0.004) were also associated with late success., Conclusions: PTA and stenting of the iliac arteries is associated with reasonable angiographic, hemodynamic, and clinical success. The outcome is favorably affected by higher initial severity of stenosis and greater extent of disease, lower severity of baseline ischemia, younger age, and by patency of the ipsilateral superficial femoral artery.

Purpose: Aneurysms of the upper extremity arteries are uncommon and may be difficult to manage with standard surgical techniques. We report the exclusion of three axillary-subclavian aneurysms with covered stents., Methods and Results: Palmaz stents were covered with either polytetrafluoroethylene (2 cases) or brachial vein and deployed to exclude pseudoaneurysms in 1 axillary (ruptured) and 2 left subclavian arteries. Two of the patients had advanced cancer and died within 52 days and 3 months of treatment, but their aneurysms were occluded at the time of their death. The repair in the third patient is patent at 9 months., Conclusions: Endovascular exclusion of axillary and subclavian aneurysms with covered stents may offer a useful alternative to operative repair, particularly in patients with significant comorbidities.

We report on two symptom-free patients with chronic thoracic aneurysms related to prior trauma and address the timing for surgical intervention. In addition, we reviewed our institutional experience with similar cases for the period 1970 to 1990. Although natural history data remain incomplete, we propose that in the setting of improved imaging modalities, it may be reasonable to manage this group of patients nonoperatively and intervene surgically only when symptoms develop or there is radiologic evidence of aneurysm change.