Lower Extremity Peripheral Vascular Disease Research Articles

Balloon angioplasty and stenting of lower extremity arteries in patients with critical limb ischemia

Lower extremity peripheral vascular disease is a typical, rapidly progressive, and disabling condition. In most patients, limb ischemia is detected at late stages of the disease. As a result, they are at high risk of limb loss, which makes a complete conventional treatment ineffective. In this situation, balloon angioplasty and stenting of lower extremity ar- teries are considered the optimal modern method of treating patients with critical limb ischemia. This study aims to evaluate the effectiveness of endovascular techniques to improve revascularization during the treatment of critical lower extremity ischemia. The research involved a comprehensive examination and endovascular treatment of 170 patients with occlusive-stenotic lesions of the lower extremity arteries. The patients were operated for critical ischemia between January 2016 and December 2022, and the effectiveness of the measures taken was analyzed. It was found that the pathology under the study requires timely diagnosis and identification of the severity of limb ischemia and circulatory disorders, with the subsequent preparation of an appropriate treatment plan. The authors discussed the main problems accompanying balloon angioplasty and stenting of the lower extremity arteries in patients with critical limb ischemia. Also, the experience of developed countries in the optimization and improvement of the studied tech- nique was studied. It has been proven that the diagnosis of lower extremity vascular disease is related to specific difficulties. However, it can be made on an outpatient basis by analyzing medical examination data and simple labor- atory methods. The authors also examined the feasibility and prospects of balloon angioplasty and stenting of the lower extremity arteries in patients with critical limb ischemia. The re-search findings have a practical value for improving the treatment of patients with occlusive and stenotic lesions of the lower extremities, as well as for improving the effec-tiveness of balloon angioplasty and stenting.

Nondipping blood pressure pattern predicts cardiovascular events and mortality in patients with atherosclerotic peripheral vascular disease.

Patients with peripheral vascular disease (PVD) are often underdiagnosed and undertreated. Nocturnal nondipping blood pressure (BP) pattern, as diagnosed by ambulatory BP monitoring (ABPM), is associated with increased cardiovascular risk, but has not been studied in patients with PVD. We aimed to investigate if a nondipping BP pattern predicts cardiovascular events or all-cause death in outpatients with PVD. Consecutive outpatients with carotid or lower-extremity PVD were examined with 24-hour ABPM (n = 396). Nondipping was defined as a < 10% fall in systolic BP level during night-time. We used Cox regression models adjusting for potential confounders. We also evaluated the incremental prognostic value of dipping status in the COPART risk score. Our primary composite outcome was cardiovascular events or all-cause death. In the cohort (mean age 70; 40% women), 137 events occurred during a 5.1-year median follow-up; incident rate of 7.35 events per 100 person-years. Nondipping was significantly associated with outcome (hazard ratio 1.55, 95% CI 1.07-2.26, p = 0.021) in a fully adjusted model. When adding nondipping to the risk markers in the COPART risk score, the model fit significantly improved (χ2 7.91, p < 0.005) and the C-statistic increased from 0.65 to 0.67. In a cohort of outpatients with PVD, nondipping was an independent risk factor for future cardiovascular events or mortality and seemed to be a strong predictor in patients with carotid artery disease but not in lower-extremity PVD. Additional studies are needed to evaluate the clinical utility of ABPM for improved prevention in these high-risk patients. (ClinicalTrials.gov Identifier: NCT01452165).

Reporting lower extremity CT angiography for treatment planning

Diagnostic radiologists play an important role in the evaluation of patients presenting with signs and symptoms of lower extremity peripheral vascular disease, including critical limb ischemia in both acute and chronic settings, and intermittent claudication. The complications associated with tissue and/or limb loss related to acute limb ischemia and critical limb ischemia of the lower extremity make rapid diagnosis and early intervention critical in the management of these patients. Computed tomography angiography (CTA) is an effective, widely available, easily reproducible, non-invasive imaging modality that offers a rapid and accurate means to diagnose and grade the extent of vascular disease. However, CTA run-off reports are usually dictated in free text form, and referring and treating physicians may be unsure whether an anatomic structure has been evaluated if it has not been specifically mentioned in the report. In this article, the vascular anatomy and anatomic variants of the lower extremity, the most common lower extremity vascular pathologies are reviewed and clinically important CTA imaging findings are outlined. This provides a framework for radiologists to accurately evaluate lower extremity vascular pathologies and convey clinically relevant imaging findings for management by vascular surgeons or interventional radiologists.

Tibial access for supra-inguinal embolization in extremely obese patients

Extreme obesity is a risk factor for hemorrhagic complications of femoral access (FA). Femoral lines, hematomas, pelvic binders and coagulopathy in the trauma scenario may also add difficulty and/or risk to FA. Radial access (RA) for routine peripheral endovascular procedures has been popularized owing to decreased hemorrhagic complications, increased patient satisfaction, and decreased operator radiation dose. However, though uncommon, cerebrovascular complications from RA approach are a known risk. Relatively recently, tibial access (TA) has been used for lower extremity peripheral vascular disease interventions. The advantages of TA mirror that of RA, with few and mostly minor complications, and the risk of iatrogenic cerebral embolization is nil. We report the feasibility of TA for supra-inguinal embolization in two extremely obese patients {body mass index > 40 kg/m2} following motor vehicle accidents. Commercially available base and microcatheters were used to perform embolization of the affected lower abdominal or pelvic arteries in standard fashion via a novel trans-tibial artery approach.

3:36 PM Abstract No. 312 Primary versus secondary retrograde pedal access for lower extremity peripheral vascular disease

Retrograde pedal access has been utilized with increasing frequency in patients who failed conventional femoral approach. Although routinely performed, there is limited data in its safety and efficacy, especially in patients with primary pedal access without previously failed femoral access. We report on patient outcomes with retrograde pedal access for lower extremity arterial recanalization and compare primary pedal access versus secondary pedal access after a failed femoral approach. Retrospective chart review was performed on patients who underwent pedal access with a minimum 6-month follow-up between February 2017 and February 2018. 51 patients were included, and charts were reviewed for the following: age, rutherford stage, comorbidities, technical and clinical success, procedural complications, hospitalization rates, and mortality. All interventions were classified as primary versus secondary (previously failed femoral approach). Of the 51 patients, 53 presenting complaints were noted: primary/recurrent ulcers (48.9%), rest pain (35.6%), claudication (17.8%), and gangrene (15.6%). All 51 patients were classified into Rutherford categories III (11.1%), IV (24.4%), V (60.0%), VI (2.2%). The target lesion was most commonly located in the anterior tibial artery (53.3%), followed by posterior tibial (40.0%), popliteal (35.6%), superficial femoral (17.8%), and dorsalis pedis artery (6.7%). The frequency of primary and secondary intervention was 28.9% (n = 13) and 71.1% (n = 32) respectively. No significant differences in complications, mortality, and hospitalization were noted between primary vs. secondary intervention. Additionally, technical success (primary– 100%, 13/13 vs. secondary– 90.6%, 29/32) were similar. Retrograde pedal access is an effective technique in patients with unsuccessful femoral approach and can be a primary approach in patients with advanced arterial disease.

Total Adiponectin and Risk of Symptomatic Lower Extremity Peripheral Vascular Disease in Type 2 Diabetes Mellitus

Total Adiponectin and Risk of Symptomatic Lower Extremity Peripheral Vascular Disease in Type 2 Diabetes Mellitus

Tips for pedal access: technical evolution and review.

Pedal access has become an indispensable technique for endovascular therapy of complex lower extremity peripheral vascular disease. From an option as a single access in a patient lacking traditional access approaches to a critical maneuver in combined antegrade-retrograde approaches during the treatment of complex chronic total occlusions, pedal access is an essential tool for any endovascular physician treating peripheral arterial disease. Anticipatory planning is critical in the successful utilization of pedal access. The appropriate tibiopedal vessel should be chosen and combined with the ideal access technique. Knowledge of the current medical devices available for pedal access and post-procedural hemostasis is key and can ease the learning curve. We present the evolution of pedal access with a review of the literature and technical tips to incorporate into everyday practice.

TCT-593 Caliber and Fitness of the Axillary Artery as a Conduit for Large-Bore Cardiovascular Procedures

Patients referred for advanced catheter-based therapies frequently have lower extremity peripheral vascular disease that is prohibitive for the use of large bore arterial catheters. Utilization of upper extremity peripheral vasculature is rarely considered as an alternative access strategy. This may

Safety and Effectiveness of Bone Marrow Cell Concentrate in the Treatment of Chronic Critical Limb Ischemia Utilizing a Rapid Point-of-Care System.

Critical limb ischemia (CLI) is the end stage of lower extremity peripheral vascular disease (PVD) in which severe obstruction of blood flow results in ischemic rest pain, ulcers and/or gangrene, and a significant risk of limb loss. This open-label, single-arm feasibility study evaluated the safety and therapeutic effectiveness of autologous bone marrow cell (aBMC) concentrate in revascularization of CLI patients utilizing a rapid point-of-care device. Seventeen (17) no-option CLI patients with ischemic rest pain were enrolled in the study. Single dose of aBMC, prepared utilizing an intraoperative point-of-care device, the Res-Q™ 60 BMC system, was injected intramuscularly into the afflicted limb and patients were followed up at regular intervals for 12 months. A statistically significant improvement in Ankle Brachial Index (ABI), Transcutaneous Oxygen Pressure (TcPO2), mean rest pain and intermittent claudication pain scores, wound/ ulcer healing, and 6-minute walking distance was observed following aBMC treatment. Major amputation-free survival (mAFS) rate and amputation-free rates (AFR) at 12 months were 70.6% and 82.3%, respectively. In conclusion, aBMC injections were well tolerated with improved tissue perfusion, confirming the safety, feasibility, and preliminary effectiveness of aBMC treatment in CLI patients.

Role of lower extremity run-off CT angiography in the evaluation of acute vascular disease.

In the acute care setting, radiologists are frequently asked to assist in the evaluation of patients presenting with signs and symptoms of lower extremity peripheral vascular disease. Non-traumatic peripheral vascular emergencies are most commonly the result of thrombosis, either in a native vessel or within a bypass graft or stent. Arterial emboli, peripheral aneurysm with embolus or thrombosis, and direct arterial trauma are additional, less common causes. Traumatic peripheral vascular emergencies include vessel occlusion, transection, pseudoaneurysms, active extravasation, and arteriovenous fistulas. The high morbidity and mortality associated with acute limb ischemia makes rapid diagnosis and early initiation of therapy critical in the management of such patients. Computed tomographic angiography (CTA) offers the vascular specialist a rapid, widely available, and accurate means to diagnose and grade the extent of vascular disease in the acute care setting. In this pictorial essay, the key elements of lower extremity run-off CTA are reviewed, including relevant anatomy, imaging approach, and spectrum of imaging findings.

Abstract 509: Screening for Carotid Occlusive Disease in Patients With Mild Peripheral Vascular Disease

Objectives: Peripheral vascular disease (PVD) is a systemic disorder, which can affect all territories of arteries. In order to maximize screening survey yield: we aimed to describe the association between positive lower extremity (LE) non-invasive flow studies in symptomatic patients and occult carotid occlusive disease (COD). Methods: A retrospective chart review was performed on 420 patients who underwent carotid duplex ultrasound and non-invasive flow studies (NIFS; aka Pulse volume recordings) for evaluation of COD and LE PVD respectively. Additional clinical variables collected included age, gender, and indication for NIFS and indication for carotid duplex. The respective studies were performed within a year of each other. Statistical analysis was performed using SPSSv20 software and SAS statistical software. Univariate analysis was performed using Mann-Whitney, student t-test and receiver operating curve (ROC). Results: 66% (266/420) of the patients were male and 43% (181/420) of patients had documented history of bruit. Patients with mild PVD (ABI between 0.81 and 1) were more likely to have clinically significant COD than patients with moderate to severe PVD (ABI &lt; 0.8) (25% vs 16.19%, P=0.03). Therefore, severity of peripheral vascular disease did not correlate with likelihood of clinically significant COD (p&gt;0.05). ROC analysis was performed (AUC=0.602, p=0.05). Low ABI 0.50 was found to be 92% sensitive (Se) but only 14% specific (Sp). The optimal ABI cutoff point for predicting COD was 0.95 (Se=40%,Sp 60%, Youden’s index 0.194) Conclusion: Therefore, routine screening for COD in patients with lower extremity peripheral vascular disease is unlikely to uncover clinically significant carotid stenosis. These findings do not indicate a population of patients for which a combined prospective screening is warranted.

Comprehensive non-contrast MR assessment of the iliofemoral arteries with visualization of vascular calcifications in TAVR candidates - initial experience

Background Transcatheter aortic valve replacement (TAVR) has emerged as an accepted therapeutic option for moderate and high-risk patients with severe aortic stenosis. In addition to vessel caliber, the presence and configuration of vascular calcifications by the iliofemoral access site is part of routine pre-interventional assessment with CTA and catheter angiography. Non-contrast MR angiography has been proven useful for evaluation of lower extremity peripheral vascular disease, however it cannot identify vascular calcifications using currently available sequences. Neutral contrast 3D and 3D point-wise encoding time reduction (PETRA) are novel MR techniques that can detect vascular calcifications and enable projection-like displays for review, similar to CT. We hypothesized that these techniques, associated with noncontrast Quiescent Interval Slice-Selective (QISS) MRA may be useful alternatives for pre-surgical planning in patients considered for TAVR.

Trends in the national outcomes and costs for claudication and limb threatening ischemia: Angioplasty vs bypass graft

Debate exists as to the benefit of angioplasty vs bypass graft in the treatment of lower extremity peripheral vascular disease. The associated costs are poorly defined in the literature. We sought to determine national estimates for the costs, utilization, and outcomes of angioplasty and bypass graft for the treatment of both claudication and limb threat. We searched the Nationwide Inpatient Sample (NIS) database (1999-2007), identifying patients who had an identifiable International Classification of Disease (ICD)-9 diagnosis code of atherosclerotic disease (claudication [440.21] or limb threat [440.22-440.24]). Of these, only patients who underwent intervention of angioplasty ± stent (percutaneous transluminal angioplasty [PTA; 39.50-39.90]), peripheral bypass graft (BPG; 39.29) or aortofemoral bypass (ABF; 39.25) were included. We compared demographics, costs, and comorbidities, as well as multivariable-adjusted outcomes of in-hospital mortality and major amputation. Additionally, we used the New Jersey State Inpatient and Ambulatory databases in order to better understand the influence of outpatient procedures on current volume and trends. There were 563,143 patients identified (PTA: 38%, BPG: 50%, ABF: 6%; 5.1%: multiple procedure codes). Patients who had PTA and BPG were similar in age (70.4 vs 69.5 years) but older than patients who had ABF (61.8 years, P < .01). Patients who underwent PTA were more often women (PTA: 46%, BPG: 42%, ABF: 45.2%; P < .01). Average costs for PTA increased over 60% for claudication between 2001 and 2007 ($8670 to $14,084) and limb threat ($13,903 to $23,196). For BPG, average costs increased 36% for both claudication ($9322 to $12,681) and limb threat ($16,795 to $22,910). In 2007, the average cost per procedure of PTA was higher than BPG for both claudication ($13,903 vs $12,681; P = .02) and limb threat ($23,196 vs $22,910; P = .04). The number of patients per year undergoing PTA increased threefold (15,903 to 46,138) for claudication and limb threat (6752 to 19,468). For BPG, procedures per year decreased approximately 40% for both claudication (13,625 to 9108) and limb threat (25,575 to 13,762). In-hospital mortality was similar for PTA and BPG groups for claudication (0.1% vs 0.2%; P = .04) and limb threat (2.1% vs 2.6%; P < .01). In-hospital amputation rates were significantly higher for patients who had PTA (7%) than BPG (3.9%, odds ratio [OR], 1.67 [1.49-1.85]; P < .01) or patients who underwent ABF (3.0%; OR, 2.32 [1.79, 3.03]; P < .01). PTA has altered the treatment paradigm for lower limb ischemia with an increase in costs and procedures. It is unclear if this represents an increase in patients or number of treatments per patient. Although mortality is slightly lower with PTA for all indications, amputation rates for limb-threat patients appear higher, as does the average cost. Longitudinal studies are necessary to determine the appropriateness of PTA in both claudication and limb-threat patients. The mortality benefit with PTA may be ultimately lost, and average costs elevated, if multiple interventions are performed on the same patients.

Abstract 5793: Lower Extremity Peripheral Vascular Disease is an Independent Predictor of Adverse Outcomes After Percutaneous Coronary Intervention

Background: A significant proportion of patients with coronary artery disease have coexistent peripheral vascular disease (PVD). Whether PVD is a predictor of adverse outcomes in patients undergoing percutaneous coronary intervention (PCI) in the drug eluting stent era is not known. Methods: Data was analysed from a total of 9110 patients from the Melbourne Intervention Group (MIG) database, a registry of patients undergoing PCI in Melbourne, Australia. Data was collected between April 2004 and July 2007 and analysed for baseline demographic data, traditional risk factors, procedural data and thirty day and twelve month major adverse cardiovascular events (MACE). Results: Of the 9110 patients undergoing PCI, 632(6.9%) had PVD. Patients with PVD had an average age of 70.6 years, were more frequently diabetic (41.3% vs. 22.6%, p&lt;0.01), were hypertensive (79.7% v 63.1%, p&lt;0.01), and had higher lipid levels (82.5% v 70.6%). In the PVD group patients were more likely to have left main (2.4% vs. 0.7%, p&lt;0.01) and ostial lesions(5.1% vs 3.4%, p=0.02) with no difference in acute procedural success between the 2 groups. 30 day MACE was higher in the PVD group (8.1% vs. 5% p&lt;0.01) with a significant increase in early mortality. 12 month MACE was also more frequent in the PVD group (21% vs. 12.4%, p&lt;0.01), with increased 12 month MI (9.8% vs. 4.3%, p&lt;0.01) and mortality (8.6%v 3.5% p&lt;0.01). On multivariate analysis, PVD independently increased the risk of 12 month MACE (OR 1.456, CI 1.07–1.99 p&lt;0.01). Conclusions: PVD is an independent predictor of adverse outcomes in patients undergoing PCI even correcting for traditional risk factors. In this study we found a significant increase in 30 day and 12 month mortality and MI in the PVD group, with diabetes and hypertension the most critical modifiable risk factors. Thus in patients undergoing PCI, the presence of peripheral vascular disease should be recognised as an additional factor in determining risk of cardiac events in the short and long term post PCI, with tighter diabetic control and lower blood pressure to be the primary targets of medical therapy in this group.

Use of magnetic guidewire navigation in the treatment of lower extremity peripheral vascular disease: Report of the first human clinical experience

The use of a magnetic navigation system (MNS) to facilitate catheter placement in electrophysiologic procedures has been increasingly documented over the past decade. Recently, the utilization of MNS to aid guidewire directionality in complex coronary lesions has also been described. Given the multifaceted ability of MNS to be applied to varying vascular beds, we describe the successful employment of this modality to facilitate treatment of lower extremity peripheral arterial disease in a symptomatic male with gangrenous toe ulceration.

Lower extremity peripheral vascular disease is an independent predictor of adverse outcomes after percutaneous coronary intervention

Lower extremity peripheral vascular disease is an independent predictor of adverse outcomes after percutaneous coronary intervention

C-reactive Protein Level and Traditional Vascular Risk Factors in the Prediction of Carotid Stenosis

There is no relationship between C-reactive protein (CRP) level and the presence and degree of carotid stenosis (null hypothesis). Institutional review board-approved cohort study. Tertiary care regional medical center. Patients (N = 146) referred to a vascular surgery clinic for possible carotid stenosis. Baseline serum high-sensitivity CRP level, low-density lipoprotein cholesterol (LDL-C) level, and other traditionally used vascular risk factors were assessed in all patients. All underwent vascular surgery clinical examination, including bilateral duplex ultrasonography of their carotid bifurcations. The potential relationship between serum CRP level and the presence and degree of carotid stenosis, as well as the strength of this association with traditionally established demographic, historical, and laboratory risk factors such as age, hypertension, and LDL-C level. In unadjusted analysis, CRP level, coronary artery disease (CAD), and lower extremity peripheral vascular disease (PVD) positively correlated with carotid stenosis (Pearson product moment correlation r < 0.02 for all). Low-density lipoprotein cholesterol level and other risk factors, including age, sex, race/ethnicity, smoking history, hypertension, diabetes mellitus, and neurologic history, did not. The mean +/- SD CRP level was higher among 72 patients with carotid stenosis compared with that among 74 patients without carotid stenosis (3.7 +/- 6.1 vs 1.9 +/- 2.1 mg/L [to convert to nanomoles per liter, multiply by 9.524], P =.02), as were the baseline prevalences of CAD (49% vs 29%), PVD (27% vs 11%), and (84% vs 61%) (P < .03 for all). The mean +/- SD LDL-C levels were similar between the groups (92.3 +/- 28.6 vs 95.8 +/- 29.0 mg/dL [to convert to millimoles per liter, multiply by 0.0259], P = .8), and differences in the prevalences of other risk factors were not statistically significant. In multivariate regression analysis adjusting for age, sex, race/ethnicity, smoking history, hypertension, diabetes mellitus, recent neurologic symptoms (<120 days), CAD, PVD, myocardial infarction, stroke or transient ischemic attack, hypercholesterolemia, aspirin or nonsteroidal anti-inflammatory drug use, and 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin) use, CRP level was independently associated with carotid stenosis (odds ratio [OR], 1.2; 95% confidence interval [CI], 1.1-1.5; P =.04), and LDL-C level was not (OR, 1.0; 95% CI, 0.98-1.01; P =.8). Several risk factors had larger ORs for carotid stenosis than CRP level; however, none were statistically significant. C-reactive protein level and CAD were independently associated with the actual degree of carotid stenosis in multivariate analysis. No corresponding associations for LDL-C level or other risk factors were observed. C-reactive protein level is a moderate but statistically significant marker of carotid stenosis and may be a useful adjunct to accurate global vascular risk assessment.

Duplex Ultrasonography Rarely Changes Management Decisions in Chronic Lower Extremity Ischemia

The purpose of this study was to determine the proportion of patients presenting with lower extremity pain whose treatment plan was altered by duplex ultrasonography. This prospective study evaluated all patients referred for lower extremity pain who had undergone a lower extremity arterial duplex scan. All patients underwent a history and physical examination by the same vascular surgeon. After the completion of the history and physical examination, the surgeon established a preliminary treatment plan. Subsequently, he reviewed the lower extremity duplex results and established a final treatment plan based on the history, physical examination, and duplex results. Treatment was labeled as either (1) conservative, (2) aggressive, or (3) the patient was considered to have no peripheral vascular disease. The proportion of patients whose primary treatment plan was altered by the addition of duplex ultrasonography was determined. Of 103 patients who entered the study, 7% had no peripheral vascular disease based on the history, physical examination, and duplex scan. Based on the history and physical examination alone, 48.5% were to be treated conservatively and 44.7% aggressively. After reviewing duplex results, the treatment plan was changed in only 5.9% of patients. There was no difference in treatment plan after the addition of the duplex results (p = 0.1025). Duplex ultrasonography remains a valuable tool in the evaluation of patients with lower extremity peripheral vascular disease; however, in most patients, the decision to treat conservatively or aggressively can be made without duplex scanning. All patients referred to the vascular clinic for lower extremity evaluation do not require a duplex scan.

Plaque Excision for the Treatment of Infrainguinal Arterial Occlusive Disease

Lower extremity peripheral vascular disease has a broad spectrum of presentations, ranging from intermittent claudication, rest pain, to limb threatening tissue loss and gangrene. Over the last 10 to 15 years, short focal stenoses or occlusions have been treated using endovascular techniques, but conventional angioplasty and stenting is limited by high restenosis rates especially in longer lesions. Moreover, multilevel, complex disease is still generally considered best managed by surgical intervention. However, with the improvements in atherectomy technology, namely plaque excision and laser plaque ablation, the full spectrum of arterial occlusive lesions may now be addressed by percutaneous means with excellent limb salvage rates. Excisional atherectomy is currently exemplified by the SilverHawk Plaque Excision System, which is available in four sizes for the treatment of all infrainguinal vessels. As the apparatus is advanced, the rotational cutting blade excises a ribbon of plaque that is concurrently collected into a nosecone. Multiple passes are made, during which the blade is directed sequentially toward all quadrants of the vessel lumen. The stenotic lesion is grossly debulked by this technique with the proposed advantage of avoiding the arterial wall barotrauma that hampers the durability of angioplasty and stenting.

Can the Perclose suture-mediated closure system be used safely in patients undergoing diagnostic and therapeutic angiography to treat chronic lower extremity ischemia?

Mechanical closure devices for arterial hemostasis after angiography, such as the Perclose suture-mediated closure system, are designed to decrease time to ambulation and improve patient comfort. Although these devices are safe and efficacious, to date there has been little reported about use of the Perclose device in a cohort consisting exclusively of patients with lower extremity peripheral vascular disease. The purpose of this study was to determine the safety and efficacy of routine use of the Perclose system in patients with documented peripheral vascular disease undergoing angiography to treat chronic lower extremity ischemia. The Perclose device was placed for arterial closure after femoral artery access in 500 consecutive patients with documented peripheral vascular disease (ankle-brachial index, <0.8) who underwent diagnostic angiography or percutaneous intervention because of chronic lower extremity ischemia. These 500 patients composed 91% of all patients who underwent angiography because of chronic lower extremity ischemia between January 1, 2001, and April 1, 2002. All complications associated with the Perclose device were identified and reviewed. Of the 500 arteries, 54% were accessed for diagnostic angiography and 46% for intervention. Perclose device placement was successful in 475 attempts (95%). Overall major complication rate was 1.4% (7 of 500 arteries). Complications included one death from retroperitoneal hemorrhage; three episodes of limb ischemia, two requiring operation and one requiring lytic therapy; two pseudoaneurysms; and one hematoma, which prolonged hospitalization. The hematoma was the only complication in the 25 patients with failed Perclose device placement. There were no infections requiring admission or operation. The Perclose suture-mediated closure device is efficacious and can be used safely in selected patients with documented peripheral vascular disease. Complications associated with this device tend to be more severe than those historically reported for manual compression. Substantial experience with use of this device is required to achieve excellent results in patients with difficult anatomy.