The toolbox of acute DVT intervention.

Although the thrombectomy system is very important, there are many other devices and supportive tools that build the foundation for a successful interventional procedure. We suggest a toolbox of acute DVT intervention to aid in all likely strategies to effectively remove thrombus from the deep venous vasculature.

Editor's Choice - Management of Lower Extremity Venous Outflow Obstruction: Results of an International Delphi Consensus.

OBJECTIVE: The endovascular treatment of venous obstruction has expanded significantly in recent years. Best practices for optimal patient outcomes are not well established and the evidence base is poor. The purpose of this study was to obtain consensus on management criteria for patients with lower extremity venous outflow obstruction. METHODS: The study was conducted as a two round Delphi consensus. Statements addressed imaging, symptoms and other baseline measures, differential diagnosis, treatment algorithm, indications for stenting, inflow and outflow assessment, successful procedural outcomes, post-procedure therapies and stent surveillance, and clinical success factors. Statements were prepared by six expert physicians (round 1, 40 statements) and an expanded panel of 24 physicians (round 2, 80 statements) and sent to a pre-identified group of venous experts who met qualifying criteria. A 9 point Likert scale was used and consensus was defined as ≥ 70% of respondents rating a statement between 7 and 9 (agreement) or between 1 and 3 (disagreement). Round 1 results were used to guide rewording and splitting compound statements for greater clarity in round 2. RESULTS: In round 1, 75 of 110 (68%) experts responded, and 91 of 121 (75%) experts responded in round 2. Round 1 achieved consensus in 32/40 (80%) statements. Consensus was not reached in the treatment algorithm section. Round 2 achieved consensus in 50/80 (62.5%). Statements reaching consensus were imaging (2/3, 66%), symptoms and other baseline measures (12/24, 50%), differential diagnosis (2/8, 25%), treatment algorithm (10/17, 59%), indications for stenting (10/10, 100%), inflow and outflow assessment (2/2, 100%), procedural outcomes (2/2, 100%), post-procedure therapies and stent surveillance, (5/7, 71%), and clinical success factors (5/7, 71%). CONCLUSION: This study demonstrated that considerable consensus was achieved between venous experts on the optimal management of lower extremity venous outflow obstruction. There were multiple domains where consensus is lacking, highlighting important areas for further investigation and research.

Safety and Efficacy of Rotational Thrombectomy for Treatment of Arterial Occlusions of the Lower Extremities: A Large Single-Center Retrospective Study.

PURPOSE: To evaluate the safety and efficacy of rotational thrombectomy (RT) in a large single-center real-world cohort for total vascular occlusions of the lower extremity. MATERIALS AND METHODS: The clinical records and images of all patients between 2010 and 2020 treated via RT (Rotarex, BD) were assessed. Patient demographics, clinical data, procedural characteristics, and outcome parameters were documented. In total, 397 procedures in 293 patients were included (mean age 69.8 ±â€Š12.0 years; 64.8 % male). Occlusions were acute (47.5 %), subacute and acute-on-chronic (22.2 %), and chronic (30.3 %). The target lesions were the iliac artery (7.1 %), iliac/femoropopliteal (5.0 %), femoropopliteal (59.4 %), femoropopliteal/below-the-knee (27.0 %), below-the-knee (1.5 %), and after bypass surgery (14.9 %). Lesion length was > 20 cm in 61.5 % of cases. RESULTS: Clinically successful revascularization was achieved in 90.4 % of cases. Additional thrombolysis was necessary for 32.0 % of procedures. The arithmetic mean ankle-brachial index increased from 0.33 ±â€Š0.29 to 0.81 ±â€Š0.25 (p < 0.0001). Bypass grafts were less likely to be fully treatable and required additional lysis (p < 0.001). The overall primary patency (no clinically driven target lesion revascularization) was 93.2 %, 88.8 %, 79.1 %, and 72.4 % at 1, 3, 6, and 12 months, respectively. Adverse events occurred in 46.1 % of cases, of which peripheral embolization (22.4 %) was most frequent, requiring interventional treatment in 67.4 % of cases. RT was directly associated with 7.1 % (n = 28) of complications, which consisted of perforations 2.8 %, arteriovenous fistula 1.3 %, and dissections 2.0 %. CONCLUSION: Rotational thrombectomy is a safe and efficient method for the treatment of occlusions of the arterial circulation of the lower extremity with bypass occlusions having a higher propensity for residual thrombi requiring further lysis therapy. KEY POINTS: · Rotational thrombectomy was safe and efficacious for treating occlusions of the lower extremities.. · Rotational thrombectomy was associated with 7.1 % of complications.. · Distal embolization occurred in 22.4 % of cases with 67.4 % requiring interventional treatment.. · Primary patency was 93.2 %, 88.8 %, 79.1 %, 72.4 % after 1, 3, 6, and 12 months, respectively.. CITATION FORMAT: · Artzner C, Martin I, Hefferman G et al. Safety and Efficacy of Rotational Thrombectomy for Treatment of Arterial Occlusions of the Lower Extremities: A Large Single-Center Retrospective Study. Fortschr Röntgenstr 2023; 195: 406 - 415.

Venovo venous stent for treatment of non-thrombotic or post-thrombotic iliac vein lesions - long-term efficacy and safety results from the Arnsberg venous registry.

Background: Endovascular venous stenting with dedicated venous stents for the treatment of chronic venous outflow obstruction is developing as efficacious alternative to conservative therapy or open surgery. However, so far, mid- and long-term evidence on effectiveness and safety is poor. Patients and methods: The prospective, single-center, observational study enrolled consecutive patients with chronic non-thrombotic iliac vein lesions (NIVL) or post-thrombotic iliofemoral obstructions (PTO). From February 2016 to April 2017, patients underwent implantation of open cell, self-expandable dedicated venous stents. Short-term symptomatic improvement, patency, and complication rate were favorable. Evaluation at 2-years included improvement in the revised venous clinical severity score (rVCSS), patency, stent migration, major target limb events, clinically important pulmonary embolism, major bleeding, and all-cause mortality. Results: A total of 79 patients (57 ± 16 years, 44 female) were evaluated. At 2 years, rVCCS improved by 4.3 ± 2.7 (p < 0.001). Substantial clinical improvement of ≥ 2 score points was achieved in 86.4% (38 of 44) of patients. Improvement was not associated with thrombotic pathogenesis (regression coefficient [B] with PTO = 0.6 [95%CI: -1.1 to 2.3], p = 0.48). At 2 years, all ulcers (in 8 of 79 patients) were healed and none recurred. Two-year primary patency was 95.5% (95%CI: 86.5 to 98.5) with no difference between NIVL- and PTO-patients (log-rank p = 0.83). Target vessel revascularization was conducted in two PTO- and one NIVL-patients in the period of 34 days to 156 days from index procedure, resulting in a secondary patency of 100%. No stent migration, target limb deep vein thrombosis, major amputation, pulmonary embolism, or death occurred. Conclusions: Venovo venous open cell self-expanding stent implantation for chronic outflow obstruction was efficacious and provided a sufficient level of safety throughout 2 years.

Illusory Angiographic Signs of Significant Iliac Vein Compression in Healthy Volunteers.

OBJECTIVE: Iliac vein compression syndrome can cause severe leg symptoms. In clinical practice, it remains a challenge to differentiate which compression is clinically relevant. The aim of the current study was to assess the general treatment indications and the prevalence of angiographic signs of iliac vein compression in a group of healthy participants. METHODS: This was a prospective cohort study. A total of 20 healthy volunteers (median age 21, range 20-22 years) were recruited through advertisement and underwent angiography of the iliac veins. When no compression signs were present, a balloon occlusion was performed. Additionally, a 10 item survey regarding indications for venous stenting was developed and sent to 30 vascular specialists treating patients with deep venous obstruction. RESULTS: In 16 (80%) participants, at least two signs indicative of May-Thurner compression were seen. In three (15%) subjects, narrowing of the common iliac vein without collaterals was shown and one (5%) did not show any signs of obstruction. In 23 (70%) of the survey responders, collaterals were found to be the most typical sign indicative of significant venous obstruction. An angiographic sign of >50% compression was found to be an indication to stent in 55% of responders. CONCLUSION: This study demonstrates a remarkably high percentage of generally accepted signs of significant iliac vein obstruction (May-Thurner compression) on venography in healthy young subjects. Diagnosis of true iliac vein obstruction remains a major challenge, which mostly leans on improvement of clinical symptoms rather than imaging findings. Treating the patient rather than the image seems to be a valid principle all the more.

Just How Attractive is the ATTRACT Trial?

Venous thromboembolism (VTE) is a major public health issue; deep vein thrombosis (DVT) affects about 1/1000 patients. Each year, VTE kills more patients in Western Europe than breast cancer, prostate cancer, acquired immune deficiency syndrome (AIDS) and road traffic accidents combined and is responsible for the deaths of approximately 370,000 European citizens (Cohen et al. in Thromb Haemost 98:756-764, 2007; Belohlávek et al. in Exp Clin Cardiol 18(2):129-138, 2013). The recently published ATTRACT trial (Acute Venous Thrombosis Thrombus Removal with Adjunctive Catheter-directed Thrombolysis) (Vedantham et al. in N Engl J Med 377:2240-2252, 2017) concluded that the addition of catheter-directed thrombolysis to standard therapy with anticoagulation and compression stockings offers no significant clinical benefit over standard therapy in terms of reduction in the rate of post-thrombotic syndrome (PTS) at 2 years. It is the largest, prospective, multi-centre, randomised controlled trial (RCT) and represents the culmination over a decade of planning, execution and analysis. In this opinion article, we analyse why it was needed, what it demonstrated, some limitations, and the directions in which this important publication will take us.

The Effect of Stenting on Venous Hypertension: Results Using a Treadmill Stress Test with Invasive Pressure Measurements in Patients with Iliofemoral Venous Obstruction.

OBJECTIVES: The primary aim was to investigate whether stenting of post-thrombotic iliofemoral obstruction reduces venous hypertension. The secondary aim was to establish whether improvement in haemodynamic parameters impacts on quality of life. METHODS: In this prospective observational study, 12 participants with unilateral post-thrombotic obstruction of the iliac and/or common femoral veins (CFVs) underwent a treadmill stress test with invasive pressure measurements in the CFVs and dorsal foot veins of both affected and non-affected limbs. This was performed the day before and 3 months after stenting the obstructed tract. Paired sample t-tests were used to compare the treatment effect and univariable linear regression analysis to determine the association with improvement in quality of life. RESULTS: Before treatment, CFV pressure increased 34.8 ± 23.1 mmHg during walking in affected limbs compared with 3.9 ± 5.8 mmHg in non-affected limbs. This pressure rise decreased to 22.3 ± 24.8 mmHg after 3 months follow up compared with a 4.0 ± 6.0 mmHg increase in non-affected limbs (-26.2 mmHg difference; 95% CI -41.2 to -11.3). No such effect was found in the dorsal foot veins. The VEINES-QOL increased 25.3 ± 11.3 points after stenting and was significantly associated with a decrease in CFV pressure rise during walking (regression coefficient 0.4; 95% CI 0.1-0.6). CONCLUSION: Stenting of post-thrombotic iliofemoral obstruction significantly reduces venous hypertension in the common femoral vein and correlates with an improvement in the quality of life. Larger studies with a broader range of degree of obstruction need be performed to assess whether pre-stenting pressure measurements can predict post stenting clinical success.

A randomised controlled trial comparing venous stenting with conservative treatment in patients with deep venous obstruction: research protocol.

INTRODUCTION: Deep venous obstruction (DVO) has a great impact on quality of life (QoL) comparable to angina pectoris or chronic pulmonary disease. Post-thrombotic scar formation and May-Thurner syndrome (MTS) are the most common causes of DVO. Conventional treatment of DVO focuses on reducing pain or leg swelling by use of (pain) medication and therapeutic elastic stockings. In the past, a venous bypass was offered in severe post-thrombotic cases, but this procedure showed bad clinical and patency outcomes. With the introduction of percutaneous angioplasty and dedicated venous stents new opportunities were created. Deep venous stenting has been shown to be effective in retrospective case series. However, there is no prior research in which QoL after interventional treatment is compared with QoL after conventional treatment. Currently, there is a debate about the true additional value of interventional treatment. We investigate whether those patients who are treated with stenting experience a change in short form 36 (SF-36) and the Veines-QoL/Sym questionnaires compared with conventionally treated patients. METHODS AND ANALYSIS: This is a randomised trial comparing conservative deep venous management to interventional treatment. A total of 130 patients with post-thrombotic syndrome (PTS) or MTS, eligible for interventional percutaneous treatment, who did not have previous deep venous intervention will be included. Patients will be randomised to conservative treatment or venous stenting and stratified for the PTS or MTS subgroup. Conservative treatment consists of either one or a combination of pain medications, manual lymphatic drainage, compression stockings and regular post-thrombotic anticoagulant therapy.The primary outcome is the QoL change after 12 months compared with baseline QoL. Secondary outcomes are QoL changes at 6 weeks, clinical assessment of DVO, recurrence rate of deep venous thrombosis at 6 weeks and 12 months, and the total amount of working days lost. Intervention-specific outcomes include complications and patency. ETHICS AND DISSEMINATION: The protocol is approved by the Medical Ethics Committee of Academisch ziekenhuis Maastricht/Universiteit Maastricht, The Netherlands (protocol number NLNL55641.068.15 / METC 161008).We aim to publish the results of this study in a peer reviewed journal and present our findings at national or international conferences. TRIAL REGISTRATION NUMBER: The study protocol was registered at www.clinicaltrials.gov (registration number: NCT03026049) on 17 January 2017.

Endovascular Treatment of a Renocaval Arteriovenous Fistula Induced Inferior Vena Cava Aneurysm.

Caval aneurysms are very rare but potentially lethal. Discussion about the need for treatment rises on individual basis. Based on the underlying etiology, a well-considered treatment plan should be made. Possible complications for invasive treatment and conservative management should be carefully weighed against each other. We present a patient with a caval aneurysm due to an arteriovenous fistula which we treated with endovascular embolization. Six months after treatment the patient is asymptomatic and the aneurysm size is decreased.

Abdominal and pubic collateral veins as indicators of deep venous obstruction.

OBJECTIVE: Chronic deep venous obstruction can cause a significant loss of quality of life, although it can be treated successfully by stenting. A clear referral pattern for additional imaging is warranted in patients with lower limb complaints. The aim of this study was to determine the value of clinically visible abdominal wall collateral veins in the diagnosis of a potentially treatable deep venous obstruction. METHODS: A total of 295 patients referred for evaluation at a tertiary venous clinic with a collateral vein on the abdominal wall or pubic bone, visible on physical examination, were retrospectively analyzed and compared with a randomly selected control group of 365 patients without such a collateral vein. Duplex ultrasound, magnetic resonance venography, computed tomography venography, and conventional venography were used to determine the presence or absence of deep venous obstruction. RESULTS: Mean age of the group with a positive collateral was 43.5 ± 13.7 (6-76) years compared with 44.7 ± 14.2 (16-89) years in the control group. In the collateral group, 66.1% were female compared with 63.3% in the control group. Sensitivity of the abdominal wall collateral vein for any obstruction at the level of the groin or more proximal was 53% (95% confidence interval [CI], 48-57); specificity, 86% (95% CI, 79-91); positive predictive value, 93% (95% CI, 90-96); and negative predictive value, 32% (95% CI, 28-37). Sensitivity was 68% (95% CI, 62-73) for higher degrees of post-thrombotic obstruction and 27% (95% CI, 19-36) in iliac vein compression. CONCLUSIONS: A collateral vein on the abdominal wall or across the pubic bone in patients with complaints of the lower limb has an excellent positive predictive value for deep venous obstructive disease at the level of the groin or higher. Such collateral veins should therefore not be removed, and symptomatic patients could be offered further diagnostics and treatment.

Revision techniques for failed PD catheters: outcome in a University Hospital.

PURPOSE: A disfunctioning peritoneal dialysis (PD) catheter has been reported in upto 35%. We report different salvage techniques used and its outcome. METHODS: We retrospectively reviewed our database on PD patients from 2009 to 2014. Operational data and data on PD catheter function were checked. RESULTS: From 2009 to 2014, we operated on 32 patients. Malfunction of their PD catheter was found in 23 patients and hernias in nine patients. Different laparoscopic techniques were used, including reposition of the catheter, fixation of the catheter, removal of adhesions and omentectomy. Of these 23 patients, 18 (78%) had a normal functioning catheter after the operation. Nine patients of the total of 32 patients had a correction of their hernia. In all cases, a non-absorbable mesh was used. Of those nine patients with a hernia, eight (89%) had a normal functioning catheter after the procedure. CONCLUSIONS: The salvage of the catheter by means of a laparoscopic procedure or correction of a hernia is worthwhile and can save up to 81% of the catheters.

Radiation exposure of abdominal cone beam computed tomography.

PURPOSE: To evaluate patients radiation exposure of abdominal C-arm cone beam computed tomography (CBCT). METHODS: This prospective study was approved by the institutional review board; written, informed consent was waived. Radiation exposure of abdominal CBCT was evaluated in 40 patients who underwent CBCT during endovascular interventions. Dose area product (DAP) of CBCT was documented and effective dose (ED) was estimated based on organ doses using dedicated Monte Carlo simulation software with consideration of X-ray field location and patients' individual body weight and height. Weight-dependent ED per DAP conversion factors were calculated. CBCT radiation dose was compared to radiation dose of procedural fluoroscopy. CBCT dose-related risk for cancer was assessed. RESULTS: Mean ED of abdominal CBCT was 4.3 mSv (95 % confidence interval [CI] 3.9; 4.8 mSv, range 1.1-7.4 mSv). ED was significantly higher in the upper than in the lower abdomen (p = 0.003) and increased with patients' weight (r = 0.55, slope = 0.045 mSv/kg, p < 0.001). Radiation exposure of CBCT corresponded to the radiation exposure of on average 7.2 fluoroscopy minutes (95 % CI 5.5; 8.8 min) in the same region of interest. Lifetime risk of exposure related cancer death was 0.033 % or less depending on age and weight. CONCLUSIONS: Mean ED of abdominal CBCT was 4.3 mSv depending on X-ray field location and body weight.

Minimally invasive treatment of chronic iliofemoral venous occlusive disease.

BACKGROUND: As one of the primary etiologies of the post-thrombotic syndrome, chronic venous occlusion is a huge burden on patient quality of life and medical costs. In this study, we evaluate the short-term and midterm results of endovenous recanalization by angioplasty and stenting in chronic iliofemoral deep venous occlusions. METHODS: This is a retrospective observational study set in a tertiary medical referral center. Patients with venous claudication or C4-6 venous disease combined with duplex and magnetic resonance-confirmed iliofemoral or caval occlusion were included. Patients with recent deep vein thrombosis (<1 year) were excluded. The intervention was endovascular deep venous recanalization, followed by angioplasty and stenting. Safety and feasibility were clinically evaluated during the procedure and during follow-up. Reocclusions and other treatment failures were evaluated during a maximum follow-up of 31 months by ultrasound imaging and venography. RESULTS: Seventy-five procedures were performed in 63 patients (average age, 44 years; range, 18-75 years), of whom 86% had a history of deep venous thrombosis. The mean time between the initial deep venous thrombosis and treatment with PTA and stenting was 12 years (maximum, 31 years). May-Thurner syndrome was present in 57%. Forty-two procedures were performed in the left, six in the right, and 11 in both lower extremities. The vena cava inferior was partially stented in 25 patients. An average of 2.6 stents (median, 2) were used per procedure. Primary patency was 74% after 1 year. Assisted primary and secondary patency rates were 81% and 96%, respectively, at 1 year. Secondary procedures included restenting, catheter-directed thrombolysis, endophlebectomy of the common femoral vein, and creation of an arteriovenous fistula. No clinically evident pulmonary emboli were noted. A bleeding complication occurred after six procedures and was deemed major in two. No patients died. Relief or significant improvement of symptoms of chronic venous occlusive disease was achieved in 81% of patients. CONCLUSIONS: Endovenous recanalization by angioplasty and stenting of chronically occluded iliofemoral vein segments is a safe and effective treatment with good short-term results, even when treatment takes place decades after the initial deep venous thrombosis. Most reocclusions can be adequately treated by a secondary procedure.

Ultrasound-accelerated catheter-directed thrombolysis in acute iliofemoral deep venous thrombosis.

BACKGROUND: Iliofemoral deep venous thrombosis (DVT) is associated with a high incidence of the post-thrombotic syndrome. The current CHEST guidelines suggest that catheter-directed thrombolysis can be used for patients with acute iliofemoral DVT and severe leg complaints. Current literature shows that catheter-directed thrombolysis increases patency of the affected tract and may reduce post-thrombotic complications, but treatment time and bleeding complications are high. Ultrasound-accelerated catheter-directed thrombolysis (UACDT) uses ultrasound waves to enhance clot lysis, which should lower treatment time and bleeding complications with the same or higher patency rates. We report our clinical experience with UACDT on patency and complications in patients with acute iliofemoral DVT. METHODS: Patients treated with UACDT for acute iliofemoral DVT were included in our analyses. Diagnosis of iliofemoral DVT was confirmed using duplex sonography and magnetic resonance venography. In addition to thrombolysis, stents were placed or an arteriovenous fistula was created to ensure patency of the treated vein, if indicated. The main outcome is patency after 1 year. Secondary outcome measures are treatment time, bleeding complications, and pulmonary embolism. Patency was assessed using duplex sonography. RESULTS: In total, 37 patients (average age at intervention, 42 years; range, 5-76 years) were included. The DVT location was unilateral in 33 patients (20 left side, 13 right side), and four were bilateral. The average treatment time was 43 ±17 hours. The success rate of thrombolysis was 95% (n = 35); re-thrombosis occurred in 11 (30%) patients. Major bleeding occurred in one patient (3%), and three minor bleedings occurred at the insertion side of the catheter (8%). One pulmonary embolism was encountered (3%). One patient had fever with positive blood cultures for Staphylococcus aureus. Additional procedures were required in 54% (n = 20) of patients. Primary patency was 70% at 1 year; secondary patency was 87% after 1-year follow up. CONCLUSIONS: UACDT of acute iliofemoral DVT is feasible and safe. Supplementary percutaneous transluminal angioplasty and stenting play an important role in preventing re-thrombosis.

Chlamydia pneumoniae aggravates vein graft intimal hyperplasia in a rat model.

BACKGROUND: Along with angioplasty, autologus vein grafts are commonly used for artery bypass grafting in patients with advanced arterial stenosis and drug-resistant angina pectoris. Although initially a successful procedure, long-term functionality is limited due to proliferation and migration of smooth muscle cells. Like in atherosclerosis, common chronic infections caused by viruses and bacteria may contribute to this process of vein graft failure. Here we investigated the possible role of Chlamydia pneumoniae (Cpn) in the pathogenesis of venous graft failure in an experimental animal model. In 2 groups (n = 10 rats/group), an epigastric vein-to-common femoral artery interposition graft was placed. Immediately thereafter, rats were infected with Cpn (5*108 IFU) or injected with control solutions. Rats were sacrificed three weeks after surgery and the grafts were harvested for morphometrical and immunohistochemical analysis. RESULTS: Cpn administration immediately after vein grafting resulted in a significant increase in medial cross-sectional area, wall thickness and total wall area. There were no significant differences in T-cell or macrophage influx. Likewise, although positive immunostaining for both HSP60 and CRP could be detected, no differences were found between groups. Based on the observation that the number of cells/microm2 was also not altered, we conclude that Cpn infection stimulates smooth muscle cell proliferation by hereunto unknown molecular mechanisms, resulting in a significant increase in intimal hyperplasia. CONCLUSION: In conclusion, in a well defined animal model we present here for the first time evidence for a role of Chlamydia pneumoniae in the process of venous graft failure.

C-reactive protein in peripheral arterial disease: relation to severity of the disease and to future cardiovascular events.

BACKGROUND: Serum C-reactive protein (CRP) has proven to be an independent marker of the extent of atherosclerosis in patients with coronary, cerebrovascular, and peripheral arterial disease. In this prospective observational study, we wanted to assess the relationship between serum CRP and extent of disease transversely and longitudinally in time, as well as future cardiovascular complications in patients with peripheral arterial disease (PAD). Hypothesizing that CRP not only is a marker of but also actively participates in atherogenesis, we explored the possibility of CRP production by femoral atherosclerotic plaques. METHODS: Serum CRP was measured as highly sensitive (hsCRP) in 387 patients with PAD attending the vascular clinic of a university and 2 affiliated teaching hospitals. Serum hsCRP was related to the ankle-brachial pressure index (ABPI) as an indication of severity of disease at inclusion and at 12 months' follow-up and to future events (death and coronary, cerebral, and peripheral arterial events). In femoral plaques, the production of CRP was analyzed with reverse transcription-polymerase chain reaction, and CRP plaque localization was assessed with immunostaining on serial tissue sections with antibodies toward CRP, smooth muscle cells, T cells, and macrophages. RESULTS: The hsCRP (average +/- SD) was 3.26 +/- 2.41 mg/L. Serum hsCRP showed a correlation with baseline and 12-month follow-up ABPI (Spearman rank correlation; P < .05 for both correlations). When the patients were divided into three equally sized groups according to baseline serum hsCRP, the ABPI at baseline and at 12 months decreased significantly from the low- to the high-hsCRP group (baseline ABPI: 0.70, 0.65, and 0.57, P < .01; 12-month follow-up ABPI: 0.78, 0.70, and 0.65, P < .01). These associations persisted after correction for conventional risk factors. Furthermore, serum hsCRP was related to the combined end point "death and/or any cardiovascular event" (log-rank test; P = .04) during a median 24-month follow-up period. Reverse transcription-polymerase chain reaction analysis showed CRP production in 4 of 14 femoral plaques. CRP was detected in all femoral plaques, but not in healthy brachial arteries. Immunoreactivity for CRP was observed in smooth muscle cells, macrophages, and T cells. CONCLUSIONS: Serum hsCRP was related to the severity of PAD, showing a relation to future hemodynamic function and cardiovascular events in PAD patients. In addition to coronary plaques, aneurysmal aortas, and failed venous coronary bypasses, femoral plaques also produce CRP, thus illustrating that the production of CRP may represent a universal response to vascular injury and suggesting that vascular CRP may contribute to plaque development.