Final 3-Year Study Outcomes from the Evaluation of the Zilver Vena Venous Stent for the Treatment of Symptomatic Iliofemoral Venous Outflow Obstruction (The VIVO Clinical Study).

PURPOSE: To report 3-year outcomes from a prospective, multicenter, nonrandomized, single-arm study designed to assess the safety and effectiveness of the Zilver Vena Venous Stent for the treatment of symptomatic iliofemoral venous outflow obstruction. MATERIALS AND METHODS: The VIVO study included patients with symptomatic obstruction of 1 iliofemoral venous segment (ie, 1 limb), characterized by a Clinical, Etiological, Anatomic, Pathophysiology (CEAP) clinical classification of ≥3 or a Venous Clinical Severity Score (VCSS) for pain of ≥2. Patients were retrospectively grouped based on baseline clinical presentation as postthrombotic syndrome (PTS), nonthrombotic iliac vein (NIVL) obstruction, or acute deep vein thrombosis (aDVT). Clinical improvement was assessed by change in VCSS, Venous Disability Score, Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) scores, and CEAP C classification. Stent performance was evaluated by rates of patency by ultrasound (US), freedom from clinically driven reintervention, and freedom from stent fracture. RESULTS: The 3-year results for the 243 patients in the VIVO cohort included a 90.3% rate of patency by US and a 92.6% rate of freedom from clinically driven reintervention. The 3-year rates of patency by US for the NIVL, aDVT, and PTS groups were 100%, 84.0%, and 86.1%, respectively. Sustained clinical improvement through 3 years was demonstrated by changes in VCSS, Venous Disability Score, CIVIQ-20, and CEAP C classification. No stent fractures were observed. CONCLUSIONS: The VIVO study demonstrated sustained high rates of patency and freedom from clinically driven reintervention and improvements in venous clinical symptoms through 3 years. Each patient group (NIVL, aDVT, and PTS) showed clinical improvement and sustained patency through 3 years; some variation existed among groups (eg, only the NIVL group had a 100% patency rate).

Common femoral vein obstruction secondary to femoral sheath lipoma.

Common femoral vein obstruction secondary to femoral sheath lipomas are rare. We describe the case of a 49 year-old male that presented to the clinic with a 3 month history of progressive right lower extremity pain, edema and discoloration. Venous duplex imaging was consistent with proximal venous obstruction and led to Computerized Tomographic Venography (CTV) which demonstrated a large mass obstructing the external iliac vein (EIV) and common femoral vein (CFV) consistent with a femoral sheath lipoma. Surgical exploration revealed a large well encapsulated lipoma in the right femoral sheath posterior to the CFV and external iliac vein causing near occlusion. We present an overview of the diagnosis and surgical management of symptomatic femoral vein obstruction caused by a large femoral sheath lipoma.

Endovascular Thrombus Removal for Acute Iliofemoral Deep Vein Thrombosis.

BACKGROUND: The ATTRACT trial (Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis) previously reported that pharmacomechanical catheter-directed thrombolysis (PCDT) did not prevent postthrombotic syndrome (PTS) in patients with acute proximal deep vein thrombosis. In the current analysis, we examine the effect of PCDT in ATTRACT patients with iliofemoral deep vein thrombosis. METHODS: Within a large multicenter randomized trial, 391 patients with acute deep vein thrombosis involving the iliac or common femoral veins were randomized to PCDT with anticoagulation versus anticoagulation alone (No-PCDT) and were followed for 24 months to compare short-term and long-term outcomes. RESULTS: Between 6 and 24 months, there was no difference in the occurrence of PTS (Villalta scale ≥5 or ulcer: 49% PCDT versus 51% No-PCDT; risk ratio, 0.95; 95% CI, 0.78-1.15; P=0.59). PCDT led to reduced PTS severity as shown by lower mean Villalta and Venous Clinical Severity Scores ( P<0.01 for comparisons at 6, 12, 18, and 24 months), and fewer patients with moderate-or-severe PTS (Villalta scale ≥10 or ulcer: 18% versus 28%; risk ratio, 0.65; 95% CI, 0.45-0.94; P=0.021) or severe PTS (Villalta scale ≥15 or ulcer: 8.7% versus 15%; risk ratio, 0.57; 95% CI, 0.32-1.01; P=0.048; and Venous Clinical Severity Score ≥8: 6.6% versus 14%; risk ratio, 0.46; 95% CI, 0.24-0.87; P=0.013). From baseline, PCDT led to greater reduction in leg pain and swelling ( P<0.01 for comparisons at 10 and 30 days) and greater improvement in venous disease-specific quality of life (Venous Insufficiency Epidemiological and Economic Study Quality of Life unit difference 5.6 through 24 months, P=0.029), but no difference in generic quality of life ( P>0.2 for comparisons of SF-36 mental and physical component summary scores through 24 months). In patients having PCDT versus No-PCDT, major bleeding within 10 days occurred in 1.5% versus 0.5% ( P=0.32), and recurrent venous thromboembolism over 24 months was observed in 13% versus 9.2% ( P=0.21). CONCLUSIONS: In patients with acute iliofemoral deep vein thrombosis, PCDT did not influence the occurrence of PTS or recurrent venous thromboembolism. However, PCDT significantly reduced early leg symptoms and, over 24 months, reduced PTS severity scores, reduced the proportion of patients who developed moderate-or-severe PTS, and resulted in greater improvement in venous disease-specific quality of life. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00790335.

Pharmacomechanical Catheter-Directed Thrombolysis for Deep-Vein Thrombosis.

BACKGROUND: The post-thrombotic syndrome frequently develops in patients with proximal deep-vein thrombosis despite treatment with anticoagulant therapy. Pharmacomechanical catheter-directed thrombolysis (hereafter "pharmacomechanical thrombolysis") rapidly removes thrombus and is hypothesized to reduce the risk of the post-thrombotic syndrome. METHODS: We randomly assigned 692 patients with acute proximal deep-vein thrombosis to receive either anticoagulation alone (control group) or anticoagulation plus pharmacomechanical thrombolysis (catheter-mediated or device-mediated intrathrombus delivery of recombinant tissue plasminogen activator and thrombus aspiration or maceration, with or without stenting). The primary outcome was development of the post-thrombotic syndrome between 6 and 24 months of follow-up. RESULTS: Between 6 and 24 months, there was no significant between-group difference in the percentage of patients with the post-thrombotic syndrome (47% in the pharmacomechanical-thrombolysis group and 48% in the control group; risk ratio, 0.96; 95% confidence interval [CI], 0.82 to 1.11; P=0.56). Pharmacomechanical thrombolysis led to more major bleeding events within 10 days (1.7% vs. 0.3% of patients, P=0.049), but no significant difference in recurrent venous thromboembolism was seen over the 24-month follow-up period (12% in the pharmacomechanical-thrombolysis group and 8% in the control group, P=0.09). Moderate-to-severe post-thrombotic syndrome occurred in 18% of patients in the pharmacomechanical-thrombolysis group versus 24% of those in the control group (risk ratio, 0.73; 95% CI, 0.54 to 0.98; P=0.04). Severity scores for the post-thrombotic syndrome were lower in the pharmacomechanical-thrombolysis group than in the control group at 6, 12, 18, and 24 months of follow-up (P<0.01 for the comparison of the Villalta scores at each time point), but the improvement in quality of life from baseline to 24 months did not differ significantly between the treatment groups. CONCLUSIONS: Among patients with acute proximal deep-vein thrombosis, the addition of pharmacomechanical catheter-directed thrombolysis to anticoagulation did not result in a lower risk of the post-thrombotic syndrome but did result in a higher risk of major bleeding. (Funded by the National Heart, Lung, and Blood Institute and others; ATTRACT ClinicalTrials.gov number, NCT00790335 .).

Relationships between the use of pharmacomechanical catheter-directed thrombolysis, sonographic findings, and clinical outcomes in patients with acute proximal DVT: Results from the ATTRACT Multicenter Randomized Trial.

Few studies have documented relationships between endovascular therapy, duplex ultrasonography (DUS), post-thrombotic syndrome (PTS), and quality of life (QOL). The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial randomized 692 patients with acute proximal deep vein thrombosis (DVT) to receive anticoagulation or anticoagulation plus pharmacomechanical catheter-directed thrombolysis (PCDT). Compression DUS was obtained at baseline, 1 month and 12 months. Reflux DUS was obtained at 12 months in a subset of 126 patients. Clinical outcomes were collected over 24 months. At 1 month, patients who received PCDT had less residual thrombus compared to Control patients, evidenced by non-compressible common femoral vein (CFV) (21% vs 35%, p < 0.0001), femoral vein (51% vs 70%, p < 0.0001), and popliteal vein (61% vs 74%, p < 0.0001). At 12 months, in the ultrasound substudy, valvular reflux prevalence was similar between groups (85% vs 91%, p = 0.35). CFV non-compressibility at 1 month was associated with higher rates of any PTS (61% vs 46%, p < 0.001), a higher incidence of moderate-or-severe PTS (30% vs 19%, p = 0.003), and worse QOL (difference 8.2 VEINES-QOL (VEnous INsufficiency Epidemiological and Economic Study on Quality of Life) points; p = 0.004) at 24 months. Valvular reflux at 12 months was associated with moderate-or-severe PTS at 24 months (30% vs 0%, p = 0.01). In summary, PCDT results in less residual thrombus but does not reduce venous valvular reflux. CFV non-compressibility at 1 month is associated with more PTS, more severe PTS, and worse QOL at 24 months. Valvular reflux may predispose to moderate-or-severe PTS. ClinicalTrials.gov Identifier NCT00790335.

Endovascular therapy for advanced post-thrombotic syndrome: Proceedings from a multidisciplinary consensus panel.

Patients with advanced post-thrombotic syndrome (PTS) and chronic iliac vein obstruction suffer major physical limitations and impairment of health-related quality of life. Currently there is a lack of evidence-based treatment options for these patients. Early studies suggest that imaging-guided, catheter-based endovascular therapy can eliminate iliac vein obstruction and saphenous venous valvular reflux, resulting in reduced PTS severity; however, these observations have not been rigorously validated. A multidisciplinary expert panel meeting was convened to plan a multicenter randomized controlled clinical trial to evaluate endovascular therapy for the treatment of advanced PTS. This article summarizes the findings of the panel, and is expected to assist in developing a National Institutes of Health-sponsored clinical trial and other studies to improve the care of patients with advanced PTS.

Adaptive compression therapy for venous leg ulcers: a clinically effective, patient-centred approach.

A prospective, randomised, 12-week study was performed to evaluate the efficacy and tolerability of two compression methods for venous leg ulcers (VLUs); a new adaptive compression therapy (ACT) system, combining intermittent and sustained pneumatic compression (n = 38) and a conventional four-layer bandage system (n = 52). Primary outcomes were ulcer healing and safety. Secondary outcomes were comfort, compliance, ulcer pain, patient-perceived product performance and quality of life. Ulcer healing rate was similar (31·6% versus 42·3%, respectively, P = 0·30) between the treatments. Adverse events and patient-rated comfort were also similar. Average daily usage for the dual system was 10·5 and 1·8 hours in the sustained and intermittent modes, respectively, representing its use during 71% of waking hours. Predicted final ulcer pain was also similar (P = 0·68). Performance was subjectively better for adaptive compression and significantly higher for exudate management (P = 0·04), skin protection (P < 0·001), removal ease (P = 0·0007), bathing (P < 0·0001) and sleep comfort (P = 0·0405). The adjusted final quality-of-life score was 0·1025 higher for adaptive compression (P = 0·0375). Subjects with healed ulcers attained higher final scores than unhealed subjects (P = 0·0004). This study provides evidence that ACT is comparably efficacious to successfully heal VLUs compared with four-layer bandage management but is better accepted and achieves higher patient-reported quality-of-life scores in these challenging patients.

Clinical outcomes and cost-effectiveness of initial treatment strategies for nonembolic acute limb ischemia in real-life clinical settings.

OBJECTIVE: The optimal initial treatment for patients with acute limb ischemia (ALI) remains undefined. Although clinical outcome data are inconsistent, catheter-directed thrombolysis (CDT) with tissue plasminogen activator is increasingly used. Patient-level analysis combining clinical and economic data in a real-life setting is lacking. This study compared clinical outcomes and cost-effectiveness of initial treatment strategies for nonembolic ALI using real-life patient-level data. METHODS: Medical records and data for hospital costs were analyzed for nonembolic ALI patients treated in four hospitals over 3 years. A cost-effectiveness analysis was performed using a decision tree analytic model. All costs were valued based on cost-to-charge ratios. RESULTS: In 205 patients, initial treatments were CDT alone in 68 or with angioplasty in 16, open surgery in 60, endovascular in 33, and hybrid in 28. Although clinical outcomes did not differ significantly among the groups, reintervention rates during hospital stay, readmission rates, and costs were highest in the CDT group. Reintervention was required in 62% of patients after CDT compared with 7% after open surgery, and 16% of the CDT patients needed more than one reintervention. The mean total hospital cost was $34,800 per patient in CDT group compared with $10,677 in open surgery group. CONCLUSIONS: In this real-life study, initial treatment of nonembolic ALI with currently available CDT options was associated with greater health care resource consumption and cost compared with other initial treatment options.

Lumbar artery pseudoaneurysm in a patient with inferior vena cava filter and history of strenuous physical exercise.

Lumbar artery pseudoaneurysms (LAPs) are a rare complication of inferior vena cava (IVC) filters. The few reports in the literature describe treatment of patients presenting with ruptured LAPs. This case report describes the successful management of a symptomatic LAP because of an IVC filter, which initially presented as a retroperitoneal hematoma resulting from lumbar artery laceration by a filter strut. We hypothesize that the strenuous abdominal exercises performed by the patient may have facilitated IVC penetration by the filter, leading to development of a retroperitoneal hematoma and subsequent LAP. This case suggests that patients with IVC filters should avoid strenuous exercise and underscores the importance of timely retrieval of nonpermanent IVC filters.

Managing iliofemoral deep venous thrombosis of pregnancy with a strategy of thrombus removal is safe and avoids post-thrombotic morbidity.

BACKGROUND: Extensive deep venous thrombosis (DVT) during pregnancy is usually treated with anticoagulation alone, risking significant post-thrombotic syndrome (PTS) in young patients. Catheter-directed thrombolysis (CDT) and operative venous thrombectomy have been safely and effectively used in nonpregnant patients, demonstrating significant reduction in post-thrombotic morbidity. This report reviews short- and long-term outcomes of 13 patients with extensive DVT of pregnancy treated with a strategy of thrombus removal. METHODS: From 1999 to 2013, 13 patients with iliofemoral DVT during pregnancy were offered CDT, pharmacomechanical thrombolysis (PMT), and/or venous thrombectomy. Gestational age ranged from 8 to 34 weeks. Fetal monitoring was performed throughout hospitalization. Radiation exposure was minimized with pelvic lead shields, focal fluoroscopy, and limited angiographic runs. Follow-up included objective vein evaluation using venous duplex and PTS assessment using the Villalta scale. RESULTS: CDT and/or PMT were used in 11 patients. Two patients underwent venous thrombectomy alone, and one patient had operative thrombectomy as an adjunct to CDT and PMT. Each patient had complete or near-complete thrombus resolution and rapid improvement in clinical symptoms. Eight of 11 having CDT or PMT underwent venoplasty and stenting of the involved iliac veins. Twelve of the 13 delivered healthy infants at term. One patient opted for termination of her pregnancy. Mean patient and gestational ages were 26 years and 26 weeks, respectively. Mean follow-up was 1.3 years, with only one recurrence. Duplex ultrasonography demonstrated patent veins in all but one patient and normal valve function in 10 patients. Eleven patients had Villalta scores <5 (considered normal), with a mean score of 0.7. CONCLUSIONS: Extensive DVT of pregnancy can be effectively and safely treated with a strategy of thrombus removal, resulting in a patent venous system, normal valve function in many, prevention of PTS, and reduction in recurrence.

Catheter-directed thrombolytic intervention is effective for patients with massive and submassive pulmonary embolism.

BACKGROUND: Massive pulmonary embolism (MPE) is a significant cause of mortality and, with submassive pulmonary embolism (SPE), is associated with chronic thromboembolic pulmonary hypertension, resulting in ongoing patient morbidity. Standard treatment is anticoagulation, although systemic thrombolytic therapy has been shown to reduce early mortality in patients with MPE and improve cardiopulmonary hemodynamics in patients with SPE. However, systemic lysis is associated with significant bleeding risk. Early reports of catheter-directed techniques (CDT) suggest favorable outcomes in patients with MPE and SPE with reduced risk of hemorrhage. The purpose of this study is to evaluate efficacy and safety outcomes in MPE and SPE patients treated with CDT. METHODS: Seventeen patients treated with CDT for MPE and SPE were clinically and hemodynamically evaluated. Patients were grouped by severity of pulmonary embolism: MPE (n = 5) or SPE (n = 12). Pre- and post-interventional measures were assessed, including pulmonary artery pressures (PAPs), cardiac biomarkers, tricuspid regurgitation, right ventricular (RV) dilatation, and systolic function. Nine patients had contraindications to systemic thrombolytic therapy. RESULTS: PAP was elevated in 94% at presentation. The average dose of recombinant tissue plasminogen activator (rt-PA) was 31 mg; 44 mg in MPE and 26 mg in SPE. Pre- and post-intervention PAPs were recorded in 13 patients. All demonstrated an acute reduction in posttreatment PAP, averaging 37%. At presentation, all MPE and 10 (83%) SPE patients showed both RV dilatation and reduced function on echocardiography, which normalized in 76% (13/17) and improved in 24% (4/17) after CDT. Patients who demonstrated left ventricle underfilling before CDT (2 [40%] MPE and 2 [20%] SPE) normalized after CDT. All MPE and 11 (92%) SPE patients had tricuspid regurgitation on echocardiography pretreatment, which resolved in 60% and 58% of MPE and SPE patients, respectively. One delayed mortality occurred in an MPE patient who was hypotensive and hypoxic at presentation. There was one puncture site bleed. CONCLUSIONS: CDT was successful in the acute management of patients with MPE and SPE. CDT rapidly restores cardiopulmonary hemodynamics using reduced doses of rt-PA. These observations suggest that CDT should be considered in MPE and SPE patients to rapidly restore cardiopulmonary hemodynamics, reduce acute morbidity and mortality, reduce bleeding complications, and potentially avoid long-term morbidity.

Supervised exercise versus primary stenting for claudication resulting from aortoiliac peripheral artery disease: six-month outcomes from the claudication: exercise versus endoluminal revascularization (CLEVER) study.

BACKGROUND: Claudication is a common and disabling symptom of peripheral artery disease that can be treated with medication, supervised exercise (SE), or stent revascularization (ST). METHODS AND RESULTS: We randomly assigned 111 patients with aortoiliac peripheral artery disease to receive 1 of 3 treatments: optimal medical care (OMC), OMC plus SE, or OMC plus ST. The primary end point was the change in peak walking time on a graded treadmill test at 6 months compared with baseline. Secondary end points included free-living step activity, quality of life with the Walking Impairment Questionnaire, Peripheral Artery Questionnaire, Medical Outcomes Study 12-Item Short Form, and cardiovascular risk factors. At the 6-month follow-up, change in peak walking time (the primary end point) was greatest for SE, intermediate for ST, and least with OMC (mean change versus baseline, 5.8±4.6, 3.7±4.9, and 1.2±2.6 minutes, respectively; P<0.001 for the comparison of SE versus OMC, P=0.02 for ST versus OMC, and P=0.04 for SE versus ST). Although disease-specific quality of life as assessed by the Walking Impairment Questionnaire and Peripheral Artery Questionnaire also improved with both SE and ST compared with OMC, for most scales, the extent of improvement was greater with ST than SE. Free-living step activity increased more with ST than with either SE or OMC alone (114±274 versus 73±139 versus -6±109 steps per hour), but these differences were not statistically significant. CONCLUSIONS: SE results in superior treadmill walking performance than ST, even for those with aortoiliac peripheral artery disease. The contrast between better walking performance for SE and better patient-reported quality of life for ST warrants further study. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov/ct/show/NCT00132743?order=1. Unique identifier: NCT00132743.

Reintervention after EVAR and open surgical repair of AAA: a 15-year experience.

OBJECTIVE: This study examined the frequency and reason for reinterventions and their impact on survival in contemporaneously treated cohorts of EVAR and open surgical repair (OSR) patients. BACKGROUND: EVAR has largely replaced OSR for anatomically appropriate AAA because of improved short-term outcomes. However, EVAR is associated with a notable reintervention rate. METHODS: Data for patients undergoing elective AAA repair between 1996 and 2011 were collected and analyzed to assess time from initial procedure to reintervention and rate of reintervention. Patient demographics, comorbidities, number and type of reinterventions, graft type, and timing of reintervention were analyzed. RESULTS: A total of 1144 patients underwent AAA repair; 558 had EVAR and 586 had OSR. In 76 EVAR patients, 123 reinterventions were performed; 46 reinterventions were performed in 30 OSR patients (P < 0.0001). Endoleak was responsible for 66% of EVAR reinterventions; colonic ischemia, bleeding, and incisional hernias caused 30%, 22%, and 22% of OSR reinterventions, respectively. Time to first reintervention was shorter in OSR patients (P < 0.001) and was related to AAA size (P < 0.001). Early reintervention at the index procedure in OSR patients had a 23% mortality rate. If reinterventions were not required, survival curves were similar. Current endografts require fewer reinterventions than earlier generation endografts. CONCLUSIONS: Reintervention was more common with EVAR and occurred later. Early reintervention after OSR is associated with significant mortality. If early reintervention in OSR patients can be avoided, there is no early survival advantage to EVAR. Current endografts require fewer reinterventions than earlier devices.

Rationale and design of the ATTRACT Study: a multicenter randomized trial to evaluate pharmacomechanical catheter-directed thrombolysis for the prevention of postthrombotic syndrome in patients with proximal deep vein thrombosis.

BACKGROUND: Current standard therapy for patients with acute proximal deep vein thrombosis (DVT) consists of anticoagulant therapy and graduated elastic compression stockings. Despite use of this strategy, the postthrombotic syndrome (PTS) develops frequently, causes substantial patient disability, and impairs quality of life. Pharmacomechanical catheter-directed thrombolysis (PCDT), which rapidly removes acute venous thrombus, may reduce the frequency of PTS. However, this hypothesis has not been tested in a large multicenter randomized trial. STUDY DESIGN: The ATTRACT Study is an ongoing National Institutes of Health-sponsored, Phase III, multicenter, randomized, open-label, assessor-blinded, parallel two-arm, controlled clinical trial. Approximately 692 patients with acute proximal DVT involving the femoral, common femoral, and/or iliac vein are being randomized to receive PCDT + standard therapy versus standard therapy alone. The primary study hypothesis is that PCDT will reduce the proportion of patients who develop PTS within 2 years by one-third, assessed using the Villalta Scale. Secondary outcomes include safety, general and venous disease-specific quality of life, relief of early pain and swelling, and cost-effectiveness. CONCLUSION: ATTRACT will determine if PCDT should be routinely used to prevent PTS in patients with symptomatic proximal DVT above the popliteal vein.

Thrombolysis for deep venous thrombosis.

The key questions addressed in this summary are whether clot removal should be part of the preferred therapy for patients with acute deep venous thrombosis (DVT), and whether there is evidence that a strategy of thrombus removal offers better outcomes for patients than anticoagulation alone. Evidence is defined as an outward sign or something that furnishes proof. Evidence in medicine is not limited to direct, blinded comparisons of one form of treatment compared with another but rather the body of knowledge that provides insight to clinicians to offer patient care. Evidence-based medicine follows from information available to form the foundation for the use of a treatment for a specific disease. Reports of strategies of thrombus removal for acute DVT, especially in patients with iliofemoral DVT, consistently demonstrate improved outcomes relative to postthrombotic morbidity. This summary reviews the evidence supporting this strategy as the preferred initial management of patients with extensive proximal DVT.

Comparison of vein valve function following pharmacomechanical thrombolysis versus simple catheter-directed thrombolysis for iliofemoral deep vein thrombosis.

BACKGROUND: Successful catheter-directed thrombolysis (CDT) for iliofemoral deep vein thrombosis (IFDVT) reduces post-thrombotic morbidity and is a suggested treatment option by the American College of Chest Physicians for patients with IFDVT. Pharmacomechanical thrombolysis (PMT) is also suggested to shorten treatment time and reduce the dose of plasminogen activator. However, concern remains that mechanical devices might damage vein valves. The purpose of this study is to examine whether PMT adversely affects venous valve function compared to CDT alone in IFDVT patients treated with catheter-based techniques. METHODS: Sixty-nine limbs in 54 patients (39 unilateral, 15 bilateral) who underwent catheter-based treatment for IFDVT form the basis of this study. Lytic success and degree of residual obstruction were analyzed by reviewing postprocedural phlebograms. All patients underwent bilateral postprocedure duplex to evaluate patency and valve function. Phlebograms and venous duplex examinations were interpreted in a blinded fashion. Limbs were analyzed based on the method of treatment: CDT alone (n = 20), PMT using rheolytic thrombolysis (n = 14), and isolated pharmacomechanical thrombolysis (n = 35). The validated outcome measures were compared between the treatment groups. RESULTS: Sixty-nine limbs underwent CDT with or without PMT. The average patient age was 47 years (range, 16-78). Venous duplex was performed 44.4 months (mean) post-treatment. Of the limbs treated with CDT with drip technique, 65% demonstrated reflux vs 53% treated with PMT (P = .42). There was no difference in long-term valve function between patients treated with rheolytic and isolated pharmacomechanical thrombolysis. In the bilateral group, 87% (13/15) demonstrated reflux in at least one limb. In the unilateral group, 64% (25/39) had reflux in their treated limb and 36% (14/39) in their contralateral limb. There was no correlation effect of residual venous obstruction on valve function, although few patients had >50% residual obstruction. CONCLUSIONS: In patients undergoing catheter-based intervention for IFDVT, PMT does not adversely affect valve function compared with CDT alone. A higher than expected number of patients had reflux in their uninvolved limb.

Common femoral endovenectomy with iliocaval endoluminal recanalization improves symptoms and quality of life in patients with postthrombotic iliofemoral obstruction.

BACKGROUND: The postthrombotic syndrome is a debilitating condition occurring in 30% to 50% of patients with lower extremity deep vein thrombosis (DVT). Following iliofemoral DVT, however, postthrombotic morbidity is especially severe, due to occlusion of the common femoral vein (CFV) and iliac veins. While endoluminal recanalization appears effective in restoring patency to the iliac venous system, infrainguinal obstruction of the CFV remains a problem. The purpose of this study is to report preliminary observations of common femoral endovenectomy and intraoperative endoluminal recanalization of the iliac veins in patients with incapacitating postthrombotic iliofemoral obstruction. METHODS: Ten patients underwent common femoral endovenectomy with endoluminal iliocaval recanalization. The Venous Clinical Severity Score (VCSS), a validated tool to assess chronic venous disease, the Villalta scale, a validated tool to quantify postthrombotic syndrome, the clinical classification of CEAP, and the Venous Insufficiency Epidemiological and Economic Study-Quality of Life (VEINES-QOL)/Sym questionnaires were completed preoperatively and readministered postoperatively at 8.8 months (mean). RESULTS: Five patients were followed for more than 6 months and form the basis of the long-term analysis. All demonstrated significant improvement in their venous scores postoperatively. The VCSS preoperatively was 17 and fell to 9.8 postoperatively (P = .02). The Villalta scale dropped from 13.6 preoperatively to 6.0 postoperatively (P = .002). The VEINES-QOL/Sym questionnaire, a sensitive marker of patient quality of life and symptom status, was improved (P = .01 and .02, respectively). CONCLUSION: Chronic postthrombotic iliofemoral venous obstruction treated with common femoral endovenectomy and endoluminal recanalization improves objective outcome measures of patients with chronic postthrombotic obstruction. By restoring unobstructed venous drainage through the CFV to the vena cava, patients' postthrombotic morbidity is reduced and quality of life is improved.

Postthrombotic morbidity correlates with residual thrombus following catheter-directed thrombolysis for iliofemoral deep vein thrombosis.

BACKGROUND: Iliofemoral deep vein thrombosis (DVT) is associated with severe postthrombotic morbidity when treated with anticoagulation alone. Catheter-directed thrombolysis (CDT), with or without the addition of mechanical techniques, is increasingly recommended for patients with iliofemoral DVT, although its effect on postthrombotic syndrome is not established. This study examined the correlation of residual thrombus with postthrombotic syndrome after catheter-based attempts at thrombus removal in patients with iliofemoral DVT. METHODS: Seventy-one consecutive patients with iliofemoral DVT were treated with CDT. Pretreatment and posttreatment phlebograms were evaluated for quantity of residual thrombus by physicians blinded to clinical patient outcomes. Postthrombotic syndrome was assessed using CEAP and Villalta scores by examiners blinded to phlebographic results. Patients were grouped by the amount of residual thrombus in treated vein segments (group 1, ≤50%; group 2, >50%). Clinical score and postthrombotic outcomes were plotted vs residual thrombus. RESULTS: Sixty-three of 71 patients completed CEAP and Villalta analyses. Groups 1 and 2 had median CEAP scores of 1 and 4 (P = .025) and mean Villalta scores of 2.21 and 7.13, respectively (P = .011). There was a direct and significant correlation of clinical class of CEAP with residual thrombus (R(2) = .74; P = .004) and a direct linear correlation of Villalta score with residual thrombus (R(2) = .61; P = .0014). CONCLUSIONS: In patients with iliofemoral DVT treated with catheter-based techniques of thrombus removal, postthrombotic morbidity is related to residual thrombus. When thrombus clearance was complete, the postthrombotic syndrome was avoided. Residual thrombus is associated with an increasing risk of postthrombotic syndrome.

Early thrombus removal strategies for acute deep venous thrombosis: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum.

BACKGROUND: The anticoagulant treatment of acute deep venous thrombosis (DVT) has been historically directed toward the prevention of recurrent venous thromboembolism. However, such treatment imperfectly protects against late manifestations of the postthrombotic syndrome. By restoring venous patency and preserving valvular function, early thrombus removal strategies can potentially decrease postthrombotic morbidity. OBJECTIVE: A committee of experts in venous disease was charged by the Society for Vascular Surgery and the American Venous Forum to develop evidence-based practice guidelines for early thrombus removal strategies, including catheter-directed pharmacologic thrombolysis, pharmacomechanical thrombolysis, and surgical thrombectomy. METHODS: Evidence-based recommendations are based on a systematic review and meta-analysis of the relevant literature, supplemented when necessary by less rigorous data. Recommendations are made according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology, incorporating the strength of the recommendation (strong: 1; weak: 2) and an evaluation of the level of the evidence (A to C). RESULTS: On the basis of the best evidence currently available, we recommend against routine use of the term "proximal venous thrombosis" in favor of more precise characterization of thrombi as involving the iliofemoral or femoropopliteal venous segments (Grade 1A). We further suggest the use of early thrombus removal strategies in ambulatory patients with good functional capacity and a first episode of iliofemoral DVT of <14 days in duration (Grade 2C) and strongly recommend their use in patients with limb-threatening ischemia due to iliofemoral venous outflow obstruction (Grade 1A). We suggest pharmacomechanical strategies over catheter-directed pharmacologic thrombolysis alone if resources are available and that surgical thrombectomy be considered if thrombolytic therapy is contraindicated (Grade 2C). CONCLUSIONS: Most data regarding early thrombus removal strategies are of low quality but do suggest patient-important benefits with respect to reducing postthrombotic morbidity. We anticipate revision of these guidelines as additional evidence becomes available.