Contemporary nationwide trends and in-hospital outcomes of adjunctive stenting in patients undergoing catheter-directed thrombolysis for proximal deep venous thrombosis.

OBJECTIVE: Outflow venous stenting as an adjunct to catheter-directed thrombolysis (CDT) is performed to prevent recurrent thrombosis and to reduce the risk of post-thrombotic syndrome. Historical data show that stenting improves outcomes of surgical thrombectomy in patients with iliofemoral deep venous thrombosis (DVT), and recent observational data suggest that stenting improves long-term outcomes of CDT. However, the impact of stenting during CDT on acute safety outcomes is unknown. We sought to investigate the contemporary trends, safety outcomes, and resource utilization of adjunctive stent placement in patients undergoing CDT. METHODS: Patients with proximal lower extremity and caval DVT were identified within the National Inpatient Sample from January 2005 to December 2013. From this data set, we stratified our patients into three groups: patients who received CDT alone, patients who received CDT plus angioplasty, and patients who received CDT plus angioplasty with stenting. We used an inverse probability treatment weighting algorithm to create three weighted cohorts. Cochran-Armitage test was used to evaluate the trends of stent placement among patients treated with CDT. The primary outcome was a composite end point of all-cause mortality, gastrointestinal bleed, or intracranial hemorrhage. RESULTS: A total of 138,049 patients were discharged with a principal diagnosis of proximal and caval DVT; 7097 of these patients received CDT (5.1%). From this group, 2854 (40.2%) were treated with CDT alone, 2311 (32.6%) received adjunctive angioplasty alone, and 1932 (27.2%) received adjunctive angioplasty and stent. Adjunctive stenting had a significantly lower rate of primary composite outcome compared with CDT alone (2.7% vs 3.8%; P = .04). Stent placement was associated with a similar length of stay compared with angioplasty and CDT alone groups (6.8 vs 6.9 vs 7.1 days, respectively; P = .94) and higher in-hospital charges ($115,164.01 ± $76,985.31 vs $98,089.82 ± $72,921.94 vs $80,441.63 ± $74,024.98; P < .001). CONCLUSIONS: This nationwide study suggests that one in four patients undergoing CDT is treated with adjunctive stent placement in the United States. This observational study showed that adjunctive stenting does not adversely affect the acute safety outcomes of CDT; however, it was associated with increased hospital charges.

Intermittent pneumatic compression is a cost-effective method of orthopedic postsurgical venous thromboembolism prophylaxis.

BACKGROUND: Venous thromboembolism (VTE) is a major complication after lower-limb arthroplasty that increases costs and reduces patient's quality of life. Using anticoagulants for 10-35 days following arthroplasty is the standard prophylaxis, but its cost-effectiveness after accounting for bleeding complications remains unproven. METHODS: A comprehensive, clinical model of VTE was created using the incidences, clinical effects (including bleeding), and costs of VTE and prophylaxis from randomized controlled trials, meta-analyses, and large observational studies. Over 50 years, the total health care costs and clinical impact of three prophylaxis strategies, that are as follows, were compared: low-molecular-weight heparin (LMWH) alone, intermittent pneumatic compression (IPC), and IPC with LMWH (IPC+LMWH). The cost per VTE event that was avoided and cost per quality-adjusted life year (QALY) gained in both the US and Australian health care settings were calculated. RESULTS: For every 2,000 patients, the expected number of VTE and major bleeding events with LMWH were 151 and 6 in the USA and 160 and 46 in Australia, resulting in a mean of 11.3 and 9.1 QALYs per patient, respectively. IPC reduced the expected VTE events by 11 and 8 in the USA and Australia, respectively, compared to using LMWH alone. IPC reduced major bleeding events compared to LMWH, preventing 1 event in the US and 7 in Australia. IPC+LMWH only reduced VTE events. Neither intervention substantially impacted QALYs but both increased QALYs versus LMWH. IPC was cost-effective followed by IPC+LMWH. CONCLUSION: IPC and IPC+LMWH are cost-effective versus LMWH after lower-limb arthroplasty in the USA and Australia. The choice between IPC and IPC+LMWH depends on expected bleeding risks.

Program requirements for fellowship education in venous and lymphatic medicine.

Background In every field of medicine, comprehensive education should be delivered at the graduate level. Currently, no single specialty routinely provides a standardized comprehensive curriculum in venous and lymphatic disease. Method The American Board of Venous & Lymphatic Medicine formed a task force, made up of experts from the specialties of dermatology, family practice, interventional radiology, interventional cardiology, phlebology, vascular medicine, and vascular surgery, to develop a consensus document describing the program requirements for fellowship medical education in venous and lymphatic medicine. Result The Program Requirements for Fellowship Education in Venous and Lymphatic Medicine identify the knowledge and skills that physicians must master through the course of fellowship training in venous and lymphatic medicine. They also specify the requirements for venous and lymphatic training programs. The document is based on the Core Content for Training in Venous and Lymphatic Medicine and follows the ACGME format that all subspecialties in the United States use to specify the requirements for training program accreditation. The American Board of Venous & Lymphatic Medicine Board of Directors approved this document in May 2016. Conclusion The pathway to a vein practice is diverse, and there is no standardized format available for physician education and training. The Program Requirements for Fellowship Education in Venous and Lymphatic Medicine establishes educational standards for teaching programs in venous and lymphatic medicine and will facilitate graduation of physicians who have had comprehensive training in the field.

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.

Comparative outcomes of catheter-directed thrombolysis plus anticoagulation vs anticoagulation alone to treat lower-extremity proximal deep vein thrombosis.

IMPORTANCE: The role of catheter-directed thrombolysis (CDT) in the treatment of acute proximal deep vein thrombosis (DVT) is controversial, and the nationwide safety outcomes are unknown. OBJECTIVES: The primary objective was to compare in-hospital outcomes of CDT plus anticoagulation with those of anticoagulation alone. The secondary objective was to evaluate the temporal trends in the utilization and outcomes of CDT in the treatment of proximal DVT. DESIGN, SETTING, AND PARTICIPANTS: Observational study of patients with a principal discharge diagnosis of proximal or caval DVT from 2005 to 2010 in the Nationwide Inpatient Sample (NIS) database. We compared patients treated with CDT plus anticoagulation with the patients treated with anticoagulation alone. We used propensity scores to construct 2 matched groups of 3594 patients in each group for comparative outcomes analysis. MAIN OUTCOMES AND MEASURES: The primary study outcome was in-hospital mortality. The secondary outcomes included bleeding complications, length of stay, and hospital charges. RESULTS: Among a total of 90,618 patients hospitalized for DVT (national estimate of 449,200 hospitalizations), 3649 (4.1%) underwent CDT. The CDT utilization rates increased from 2.3% in 2005 to 5.9% in 2010. Based on the propensity-matched comparison, the in-hospital mortality was not significantly different between the CDT and the anticoagulation groups (1.2% vs 0.9%) (OR, 1.40 [95% CI, 0.88-2.25]) (P = .15). The rates of blood transfusion (11.1% vs 6.5%) (OR, 1.85 [95% CI, 1.57-2.20]) (P < .001), pulmonary embolism (17.9% vs 11.4%) (OR, 1.69 [95% CI, 1.49-1.94]) (P < .001), intracranial hemorrhage (0.9% vs 0.3%) (OR, 2.72 [95% CI, 1.40-5.30]) (P = .03), and vena cava filter placement (34.8% vs 15.6%) (OR, 2.89 [95% CI, 2.58-3.23]) (P < .001) were significantly higher in the CDT group. The CDT group had longer mean (SD) length of stay (7.2 [5.8] vs 5.0 [4.7] days) (OR, 2.27 [95% CI, 1.49-1.94]) (P < .001) and higher hospital charges ($85,094 [$69,121] vs $28,164 [$42,067]) (P < .001) compared with the anticoagulation group. CONCLUSIONS AND RELEVANCE: In this study, we did not find any difference in the mortality between the CDT and the anticoagulation groups, but evidence of higher adverse events was noted in the CDT group. In the context of this observational data and continued improvements in technology, a randomized trial with outcomes such as mortality and postthrombotic syndrome is needed to definitively address this comparative effectiveness.

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.

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.

Anticoagulation monitoring by an anticoagulation service is more cost-effective than routine physician care.

BACKGROUND: Vitamin K antagonists (VKAs) are the mainstay of long-term anticoagulation but require careful monitoring for effectiveness and safety. Physicians manage anticoagulation for most patients, although anticoagulation services are becoming increasingly popular. A new anticoagulation service (AS) run by nurses and overseen by a physician was established and its effectiveness vs usual physician care was independently assessed using costs of emergency department (ED) visits and hospitalizations resulting from failure or complication of anticoagulation. We report the results of this independent analysis of anticoagulation monitoring of patients treated with VKAs. METHODS: The AS-treated patients received VKAs according to a written protocol, whereas physician monitoring was performed according to individual practice. An independent analysis of ED visits and hospitalizations due to complications of anticoagulation in patients receiving long-term VKAs between July 1, 2008, and December 31, 2008, was performed. The average cost of ED visits and hospitalizations was calculated for each patient cohort. The expense of each was amortized for a 12-month period to determine the annual cost of anticoagulation morbidity per 100 patients treated. RESULTS: Long-term VKAs were used to treat 2397 patients. Physicians managed 2266 patients (95%; group I) and the AS monitored 131 patients (5%; group II). In group I, 247 patients (10.9%) visited the ED, with an average cost of $288 per visit; the ED cost per patient treated was $31. In group II, two patients (1.5%) visited the ED, with an average cost of $139 per patient. The ED cost per patient treated was $2, leading to annual savings of $5800 per 100 patients (P = .0006). Complications of anticoagulation required hospitalization in 289 group I patients (12.8%), with an average cost of $15,125 per hospitalization and $1929 per patient treated and in three group II patients (2.3%), with an average cost of $17,794 per hospitalization and an average cost of $401 per patient treated. When the savings from ED visits and hospitalizations were combined, AS-managed anticoagulation led to annual savings of $305,600 (P = .0004). Subtracting the cost of staff services resulted in a yearly net savings of $241,400 per 100 patients (P ≤ .0001) managed by the AS. CONCLUSIONS: Management of long-term VKA therapy by an AS using established protocols appears to reduce anticoagulation morbidity and results in significant cost savings by reducing the number of ED visits and hospitalizations.

Claudication: exercise vs endoluminal revascularization (CLEVER) study update.

The Claudication: Exercise vs Endoluminal Revascularization (CLEVER) Study is a prospective multicenter randomized clinical trial designed to compare the relative clinical and cost-effectiveness of invasive revascularization with stents to supervised exercise rehabilitation in a cohort with moderate to severe claudication due to aortoiliac insufficiency. The study is currently enrolling at twenty-eight sites in the US and Canada. Enrollment of 217 participants is planned, with data collected at baseline, six months, and 18 months. The primary study endpoint is maximum walking duration (MWD) on a graded treadmill test; secondary endpoints include community-based walking, markers of cardiovascular disease risk (body mass index, waist circumference, blood pressure, lipid profile, glucose tolerance, and plasma fibrinogen), health-related quality of life, and cost effectiveness. There are currently sixty randomized participants; recruitment is projected to end in July 2010 and final study results reported in June 2012.

The Claudication: Exercise Vs. Endoluminal Revascularization (CLEVER) study: rationale and methods.

Intermittent claudication is the primary symptom of peripheral arterial disease, affecting between 1 and 3 million Americans. Symptomatic improvement can be achieved by endovascular revascularization, but such procedures are invasive, expensive, and may be associated with procedural adverse events. Medical treatment options, including claudication medications and supervised exercise training, are also known to be effective, albeit also with associated limitations. The CLEVER (Claudication: Exercise Vs. Endoluminal Revascularization) study, funded by the Heart, Lung, and Blood Institute of the National Institutes of Health, is a prospective, multicenter, randomized, controlled clinical trial evaluating the relative efficacy, safety, and health economic impact of four treatment strategies for people with aortoiliac peripheral arterial disease and claudication. The treatment arms are: (1) optimal medical care (claudication pharmacotherapy); (2) primary stent placement; (3) supervised exercise rehabilitation; and (4) combined stenting with supervised exercise rehabilitation. The CLEVER study is a 5-year randomized, controlled clinical trial to be conducted at approximately 25 centers in the United States that will monitor 252 patients and their responses to treatment during an 18-month follow-up period. The primary end point is change in maximum walking duration on a graded treadmill test. Secondary end points include the change at 18 months in maximum walking duration from baseline, comparisons of free-living daily activity levels assessed by pedometer, health-related quality of life, and cost-effectiveness. Other analyses include the effect of these treatment strategies on anthropomorphic and physiologic variables, including body mass index, waist circumference, blood pressure, pulse pressure, and resting pulse as well as biochemical markers of cardiovascular health, including fasting lipids, fibrinogen, C-reactive protein, and hemoglobin A 1c values.