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).

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.

Current State of Private Practice and Academic Interventional Radiology: Differences in Practice Structure, Case Mix, and Productivity.

PURPOSE: To investigate whether private practice interventional radiology (IR) groups self-report higher overall productivity given differing case mix and more diagnostic radiology interpretation. MATERIALS AND METHODS: A 60-question survey was distributed to 3,159 self-identified US IR physicians via the Society of Interventional Radiologists member search engine, with 357 responses (11.3% response rate). Of these responses, there were 258 unique practices from 34 US states. RESULTS: Out of 84 IR group responses, private practice IR (PPIR) physicians reported a minimal trend for higher annual work relative value units (wRVUs) per clinical full-time equivalent compared with academic IR physicians (8,000 versus 7,140, P = .202), but this did not reach statistical significance. PPIR groups reported fewer median weekly hours (50 versus 52), more frequent call (every 6 versus every 5 days), and significantly higher median tenured compensation ($573,000 versus $451,000, P = .000). Out of 179 responses, academic practices reported significantly higher case percentages of interventional oncology and complex hepatobiliary intervention (P <.001), and private practices reported significantly higher percentages of musculoskeletal intervention (P < .001) with a nonsignificant trend for stroke or neurologic intervention (P = .010). Private practices reported more wRVUs from the interpretation of diagnostic imaging, at 26% of total wRVU production compared with 7% of total wRVU production for academic practices (P < .001; n = 131). CONCLUSIONS: Self-reported data from private and academic IR groups suggest minimally higher wRVUs per clinical full-time equivalent among PPIRs with lower weekly work hours, more frequent call, differing case mix, and significantly higher tenured compensation among PPIR groups.

Antithrombotic Therapy After Venous Interventions: AJR Expert Panel Narrative Review.

Interventions for thrombotic and nonthrombotic venous disorders have increased with technical advances and more trained venous specialists. Antithrombotic therapy is essential to clinical and procedural success; however, postprocedural therapeutic regimens exhibit significant heterogeneity due to limited prospective randomized data and incomplete mechanistic understanding of the critical factors driving long-term patency. Postinterventional antithrombotic therapy for thrombotic venous disorders should adhere to existing venous thromboembolism management guidelines, which include 3-6 months of therapeutic anticoagulation at minimum and consideration of extended therapy in patients with higher risk of thrombosis because of procedural or patient factors. The added benefit of antiplatelet agents in the acute and intermediate period is unknown, having shown improved long-term stent patency in some retrospective studies. Dual- and/or triple-agent therapy should be limited based on individual risks of thrombosis and bleeding. The treatment of nonthrombotic disorders is more heterogeneous, though patients with limited flow, extensive stent material, or underlying prothrombotic states such as malignancy or chronic inflammation may benefit from single-agent or multiagent antithrombotic therapy. However, the agent, dose, and duration of therapy remain indeterminate. Future prospective studies are warranted to improve patient risk stratification and standardize postprocedural anti-thrombotic therapy in patients receiving venous interventions.

Optimal Medical Therapy Following Deep Venous Interventions: Proceedings from the Society of Interventional Radiology Foundation Research Consensus Panel.

The optimal medical management of patients following endovascular deep venous interventions remains ill-defined. As such, the Society of Interventional Radiology Foundation (SIRF) convened a multidisciplinary group of experts in a virtual Research Consensus Panel (RCP) to develop a prioritized research agenda regarding antithrombotic therapy following deep venous interventions. The panelists presented the gaps in knowledge followed by discussion and ranking of research priorities based on clinical relevance, overall impact, and technical feasibility. The following research topics were identified as high priority: 1) characterization of biological processes leading to in-stent stenosis/rethrombosis; 2) identification and validation of methods to assess venous flow dynamics and their effect on stent failure; 3) elucidation of the role of inflammation and anti-inflammatory therapies; and 4) clinical studies to compare antithrombotic strategies and improve venous outcome assessment. Collaborative, multicenter research is necessary to answer these questions and thereby enhance the care of patients with venous disease.

Reimagining the IR Workflow for a Better Work-Life Balance.

Several workflow changes were implemented in a large academic interventional radiology practice, including separation of inpatient and outpatient services, early start times, and using an adaptive learning system to predict case length tailored to individual physicians. Metrics including procedural volume, on-time start, accuracy at predicting case length, and room shutdown time were assessed before and after the intervention. Considerable improvements were seen in accuracy of first case start times, predicting block times, and last case encounter ending times. It is proposed that with improved role clarity, interventional radiologists can regain control over their schedules, utilize work hours more efficiently, and improve work-life balance.

Comparison of Anticoagulation Regimens Following Stent Placement for Nonthrombotic Lower Extremity Venous Disease.

PURPOSE: To determine whether subtherapeutic anticoagulation regimens are noninferior to therapeutic anticoagulation regimens following stent placement for nonthrombotic lower extremity venous disease. MATERIALS AND METHODS: Fifty-one consecutive patients (88% women; mean age, 44 years) who underwent stent placement for nonthrombotic lower extremity venous disease between 2002 and 2016 were retrospectively identified. The patients were divided into 2 cohorts: those who received prophylactic enoxaparin or no anticoagulation (subtherapeutic) after the procedure and those who received therapeutic doses of anticoagulation with enoxaparin, warfarin, and/or rivaroxaban (therapeutic) after the procedure. Baseline demographic characteristics, procedure characteristics, and outcomes were compared between the 2 groups using the Student t test, Fisher exact test, and χ2 test. The subtherapeutic and therapeutic anticoagulation groups did not differ significantly in the baseline demographic characteristics (eg, sex, race, and age) or procedure characteristics (eg, number of stents placed, stent brand, stent diameter, etc). RESULTS: The mean clinical follow-up time was 4.4 years (range, 0-16.3 years). There were no thrombotic adverse events or luminal obstructions due to in-stent restenosis in either group. There were 5 minor bleeding adverse effects in the therapeutic group and no bleeding adverse effects in the subtherapeutic group (P = .051). There were no statistically significant differences in subjective symptom improvement (P = .75). CONCLUSIONS: In this retrospective cohort, the subtherapeutic and therapeutic anticoagulation regimens produced equivalent outcomes in terms of adverse event rates, reintervention rates, and symptomatic improvement, suggesting that therapeutic doses of anticoagulation do not improve outcomes compared with subtherapeutic anticoagulation regimens following nonthrombotic venous stent placement.

Laser-Assisted Removal of Embedded Vena Cava Filters: A First-In-Human Escalation Trial in 500 Patients Refractory to High-Force Retrieval.

Background Many patients are subject to potential risks and filter-related morbidity when standard retrieval methods fail. We evaluated the safety and efficacy of the laser sheath technique for removing embedded inferior vena cava filters. Methods and Results Over an 8.5-year period, 500 patients were prospectively enrolled in an institutional review board-approved study. There were 225 men and 275 women (mean age, 49 years; range, 15-90 years). Indications for retrieval included symptomatic acute inferior vena cava thrombosis, chronic inferior vena cava occlusion, and/or pain from filter penetration. Retrieval was also offered to prevent risks from prolonged implantation and potentially to eliminate need for lifelong anticoagulation. After retrieval failed using 3X standard retrieval force (6-7 lb via digital gauge), treatment escalation was attempted using laser sheath powered by 308-nm XeCl excimer laser system (CVX-300; Spectranetics). We hypothesized that the laser-assisted technique would allow retrieval of >95% of embedded filters with <5% risk of major complications and with lower force. Primary outcome was successful retrieval. Primary safety outcome was any major procedure-related complication. Laser-assisted retrieval was successful in 99.4% of cases (497/500) (95% CI, 98.3%-99.9%) and significantly >95% (P<0.0001). The mean filter dwell time was 1528 days (range, 37-10 047; >27.5 years]), among retrievable-type (n=414) and permanent-type (n=86) filters. The average force during failed attempts without laser was 6.4 versus 3.6 lb during laser-assisted retrievals (P<0.0001). The major complication rate was 2.0% (10/500) (95% CI, 1.0%-3.6%), significantly <5% (P<0.0005), 0.6% (3/500) (95% CI, 0%-1.3%) from laser, and all were successfully treated. Successful retrieval allowed cessation of anticoagulation in 98.7% (77/78) (95% CI, 93.1%-100.0%) and alleviated filter-related morbidity in 98.5% (138/140) (95% CI, 96.5%-100.0%). Conclusions The excimer laser sheath technique is safe and effective for removing embedded inferior vena cava filters refractory to high-force retrieval. This technique may allow cessation of filter-related anticoagulation and can be used to prevent and alleviate filter-related morbidity. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01158482.

Diagnostic performance of lower extremity Doppler ultrasound in detecting iliocaval obstruction.

OBJECTIVE: To retrospectively evaluate the performance of two commonly used Doppler ultrasound parameters, namely, venous flow phasicity and response to Valsalva maneuver, in detecting iliocaval obstruction. METHODS: All imaging studies of patients seen by interventional radiology for lower extremity venous disease at a single institution from 1996 to 2018 were retrospectively identified. Lower extremity ultrasounds with a concurrent magnetic resonance, computed tomography, or conventional venogram performed within the next 7 days, which served as gold standard, were further identified (n = 192 examinations, including 313 limbs). Iliocaval obstruction were assessed by two ultrasound criteria: (1) nonphasic flow and/or (2) nonresponsive flow to Valsalva in the common femoral vein. The sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) for diagnosing iliocaval obstruction were calculated for each ultrasound criterion, and also for when the two criteria were assessed jointly. RESULTS: Of the 313 limbs assessed for venous flow phasicity, 133 (42.5%) had an iliocaval obstruction confirmed on subsequent venography. Nonphasic flow demonstrated a sensitivity of 69.2%, specificity of 82.8%, NPV of 78.4%, and PPV of 74.8% for diagnosing iliocaval obstruction. Of the 212 limbs assessed for Valsalva response, 88 (41.5%) had a confirmed iliocaval obstruction. Nonresponsive flow to Valsalva demonstrated a sensitivity of 13.6%, specificity of 97.6%, NPV of 61.6%, and PPV of 80.0% for diagnosing iliocaval obstruction. Joint assessment using phasicity and Valsalva criteria demonstrated a sensitivity of 68.2%, specificity of 87.2%, NPV of 79.6%, and PPV of 78.9%. CONCLUSIONS: In this tertiary care setting, Doppler ultrasound examination was not a reliable diagnostic tool for detecting iliocaval obstruction.

Analysis of patent, unstented lower extremity vein segment diameters in 266 patients with venous disease.

OBJECTIVE: The objective of this study was to characterize the average maximum diameters of widely patent lower extremity vein segments in patients with underlying venous disease and the demographic factors that affect these diameters. METHODS: Maximum axial diameters of each deep vein segment from the diaphragm to the knee were measured from computed tomography venography studies for all patients who underwent venous stent placement during a 20-year period at a single quaternary venous referral institution. Limbs containing only widely patent, unstented vein segments without variant anatomy were identified for inclusion. The final analysis involved diameter measurements from 870 imaging studies of 266 patients. Multivariate linear regression was used to identify factors associated with vein segment diameters. RESULTS: Average vein segment diameters ranged from 7.8 mm for the left and right femoral veins to 27.9 mm for the long axis of the suprarenal inferior vena cava. Multivariate linear regression demonstrated that women had larger IVC, common iliac vein, and external iliac vein diameters, whereas men had larger common femoral veins. Laterality, height, weight, and sex also had statistically significant associations with the diameters of select vein segments. CONCLUSIONS: This study provides an estimate of the average diameters of widely patent deep vein segments in the lower extremities from the diaphragm to the knees in patients with underlying venous disease and characterizes covariates that significantly affect vein diameter. These findings may help interventionalists better select devices for endovascular intervention.

Bronchial Artery Embolization for Hemoptysis in Cystic Fibrosis Patients: A 17-Year Review.

PURPOSE: To review safety and efficacy of bronchial artery embolization (BAE) for treatment of hemoptysis in adult patients with cystic fibrosis (CF) and to report 30-day, 1-year, and 3-year outcomes. MATERIALS AND METHODS: Between January 2001 and April 2018, 242 patients with CF were evaluated for hemoptysis. Thirty-eight BAEs were performed in 28 patients with hemoptysis. Technical success was defined as freedom from repeat embolization and hemoptysis-related mortality. Clinical success was defined as freedom from repeat embolization and mortality from any cause. Technical and clinical success were examined at 30 days, 1 year, and 3 years after initial BAE. Mean patient age was 32 years, and median follow-up was 4.8 years (range, 10 mo to 16.7 y). RESULTS: Technical and clinical success rates at 30 days were 89% (25/28) and 82% (23/28), respectively. Success rates at 1 year were 86% (24/28) and 79% (22/28), respectively, and at 3 years were 82% (23/28) and 75% (21/28), respectively. The 30-day overall complication rate was 7.9% (3/38) with 2.6% (1/38) major complication rate and 5.2% (2/38) minor complication rate. Overall 3-year mortality rate was 25% (7/28). CONCLUSIONS: BAE is safe and effective in patients with CF presenting with life-threatening hemoptysis. BAE results in high rates of long-term technical and clinical success in this patient population despite progressive chronic disease. Repeat embolization is necessary only in a minority of patients.

Automated Quantitative Imaging Measurements of Disease Severity in Patients with Nonthrombotic Iliac Vein Compression.

PURPOSE: An automated segmentation technique (AST) for computed tomography (CT) venography was developed to quantify measures of disease severity before and after stent placement in patients with left-sided nonthrombotic iliac vein compression. MATERIALS AND METHODS: Twenty-one patients with left-sided nonthrombotic iliac vein compression who underwent venous stent placement were retrospectively identified. Pre- and poststent CT venography studies were quantitatively analyzed using an AST to determine leg volume, skin thickness, and water content of fat. These measures were compared between diseased and nondiseased limbs and between pre- and poststent images, using patients as their own controls. Additionally, patients with and without postthrombotic lesions were compared. RESULTS: The AST detected significantly increased leg volume (12,437 cm3 vs 10,748 cm3, P < .0001), skin thickness (0.531 cm vs 0.508 cm, P < .0001), and water content of fat (8.2% vs 5.0%, P < .0001) in diseased left limbs compared with the contralateral nondiseased limbs, on prestent imaging. After stent placement in the left leg, there was a significant decrease in the water content of fat in the right (4.9% vs 2.7%, P < .0001) and left (8.2% vs 3.2%, P < .0001) legs. There were no significant changes in leg volume or skin thickness in either leg after stent placement. There were no significant differences between patients with or without postthrombotic lesions in their poststent improvement across the 3 measures of disease severity. CONCLUSIONS: ASTs can be used to quantify measures of disease severity and postintervention changes on CT venography for patients with lower extremity venous disease. Further investigation may clarify the clinical benefit of such technologies.

Lower Extremity Venous Stent Placement: A Large Retrospective Single-Center Analysis.

PURPOSE: To study short-term and long-term outcomes of lower extremity venous stents placed at a single center and to characterize changes in vein diameter achieved by stent placement. MATERIALS AND METHODS: A database of all patients who received lower extremity venous stents between 1996 and 2018 revealed 1,094 stents were placed in 406 patients (172 men, 234 women; median age, 49 y) in 513 limbs, including patients with iliocaval stents (9.4% acute thrombosis, 65.3% chronic thrombosis, 25.3% nonthrombotic lesions). Primary, primary assisted, and secondary patency rates were assessed for lower extremity venous stents at 1, 3, and 5 years using Kaplan-Meier analyses and summary statistics. Subset analyses and Cox regression were performed to identify risk factors for patency loss. Vein diameters and Villalta scores before and up to 12 months after stent placement were compared. Complication and mortality rates were calculated. RESULTS: Primary, primary assisted, and secondary patency rates at 5 years were 57.3%, 77.2%, and 80.9% by Kaplan-Meier methods and 78.6%, 90.3%, and 92.8% by summary statistics. Median follow-up was 199 days (interquartile range, 35.2-712.0 d). Patency rates for the subset of patients (n = 46) with ≥ 5 years of follow-up (mean ± SD 9.1 y ± 3.4) were nearly identical to cohort patency rates at 5 years. Patients with inferior vena cava stent placement (hazard ratio 2.11, P < .0001) or acute thrombosis (hazard ratio 3.65, P < .0001) during the index procedure had significantly increased risk of losing primary patency status. Vein diameters were significantly greater after stent placement. There were no instances of stent fracture, migration, or structural deformities. In patients with chronic deep vein thrombosis, Villalta scores significantly decreased after stent placement (from 15.7 to 7.4, P < .0001). Perioperative mortality was < 1%, and major perioperative complication rate was 3.7%. CONCLUSIONS: Cavo-ilio-femoral stent placement for venous occlusive disease achieves improvement of vein disease severity scores, increase in treated vein diameters, and satisfactory long-term patency rates.

Inferior Vena Cava Atresia: Characterisation of Risk Factors, Treatment, and Outcomes.

PURPOSE: To characterise (1) the risk factors associated with inferior vena cava (IVC) atresia, (2) the radiographic and clinical presentations of deep vein thrombosis (DVT) in patients with IVC atresia, and (3) the treatment and outcome of DVT in patients with IVC atresia. METHODS: The electronic medical record was systematically reviewed for thrombotic risk factors in patients who presented with lower-extremity DVT (n = 409) at a single centre between 1996 and 2017. Patients with IVC atresia were identified based on imaging and chart review. Differences in demographics and thrombotic risk factors between patients with and without IVC atresia were statistically assessed. Extent and chronicity of DVT on imaging, clinical presentation, treatment, and outcomes were evaluated for all patients with IVC atresia. RESULTS: 4.2% of DVT patients (17/409) were found to have IVC atresia; mean age at diagnosis was 25.5 ± 9.4 years. The rate of heritable thrombophilia was significantly higher in patients with IVC atresia compared to patients without IVC atresia (52.9% vs. 17.9%, p < 0.0001). There were bilateral DVT in 70.6% of IVC atresia patients; DVT was chronic in 41.2% and acute on chronic in 58.8%. Pre-intervention Villalta scores were 13.9 ± 9.8 in the left limb and 8.5 ± 7.0 in the right limb. DVT in IVC atresia patients was typically treated with catheter-directed thrombolysis followed by stent placement, achieving complete or partial symptom resolution in 78.6% of cases. CONCLUSION: Thrombotic risk factors such as heritable thrombophilia are associated with IVC atresia. IVC atresia patients can experience high burdens of lower-extremity thrombotic disease at a young age which benefit from endovascular treatment. LEVEL OF EVIDENCE: Level 4.

Toward Data-Driven Learning Healthcare Systems in Interventional Radiology: Implementation to Evaluate Venous Stent Patency.

We developed a code and data-driven system (learning healthcare system) for gleaning actionable clinical insight from interventional radiology (IR) data. To this end, we constructed a workflow for the collection, processing and analysis of electronic health record (EHR), imaging, and cancer registry data for a cohort of interventional radiology patients seen in the IR Clinic at our institution over a more than 20-year period. As part of this pipeline, we created a database in REDCap (VITAL) to store raw data, as collected by a team of clinical investigators and the Data Coordinating Center at our university. We developed a single, universal pre-processing codebank for our VITAL data in R; in addition, we also wrote widely extendable and easily modifiable analysis code in R that presents results from summary statistics, statistical tests, visualizations, Kaplan-Meier analyses, and Cox proportional hazard modeling, among other analysis techniques. We present our findings for a test case of supra versus infra-inguinal ligament stenting. The developed pre-processing and analysis pipelines were memory and speed-efficient, with both pipelines running in less than 2 min. Three different supra-inguinal ligament veins had a statistically significant improvement in vein diameters post-stenting versus pre-stenting, while no infra-inguinal ligament veins had a statistically significant improvement (due either to an insufficient sample size or a non-significant p value). However, infra-inguinal ligament stenting was not associated with worse restenosis or patency outcomes in either a univariate (summary-statistics and Kaplan-Meier based) or multivariate (Cox proportional hazard model based) analysis.

Electronic Patient-Reported Outcomes: Semi-Automated Data Collection in the Interventional Radiology Clinic.

INTRODUCTION: Patient-reported outcomes are important for clinical research and will likely be used in the near future as a metric for physician reimbursement. This study aims to evaluate the implementation of an electronic data collection system for deep vein thrombosis and lymphedema quality-of-life (QOL) questionnaires in a tertiary care interventional radiology practice. METHODS: A single provider's clinic patients were automatically e-mailed validated questionnaires 1 week before their appointments. If not completed via e-mail, the questionnaire was administered on an electronic tablet in clinic by a research coordinator. Patients were also sent postprocedure questionnaires. RESULTS: In all, 106 patients visited the clinic for a pre-intervention venous consultation. Of them, 96% (n = 102 of 106) completed the pre-intervention questionnaire: 48% (n = 47 of 98) via e-mail and 52% (n = 51 of 98) via tablet. Of the patients who had procedures and were sent questionnaires, 49% (n = 26 of 53) were seen in person. Of the postprocedure in-person clinic patients, 76% (n = 20 of 26) completed the questionnaire via e-mail, and the remainder with the tablet in clinic. Twenty-seven of the 53 (51%) patients did not return for follow-up and instead were sent an electronic questionnaire as their only source of follow-up, of which 74% (n = 20 of 27) complied. CONCLUSION: After an initial introduction to electronic QOL reporting, patients were more likely to complete the questionnaires remotely for their follow-up appointment. A semi-automated electronic QOL system allows physicians to collect patient outcome data even in the absence of a clinic visit.

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.