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.

Common Reasons for Malpractice Lawsuits Involving Pulmonary Embolism and Deep Vein Thrombosis.

BACKGROUND: Pulmonary embolism and deep vein thrombosis are common clinical entities, and the related malpractice suits affect all medical subspecialties. Claims from malpractice litigation were analyzed to understand the demographics of these lawsuits and the common reasons for pursuing litigation. METHODS: Cases entered into the Westlaw database from March 5, 1987, to May 31, 2018, were reviewed. Search terms included "pulmonary embolism" and "deep vein thrombosis." RESULTS: A total of 277 cases were identified. The most frequently identified defendant was an internist (including family practitioner; 33%), followed by an emergency physician (18%), an orthopedic surgeon (16%), and an obstetrician/gynecologist (9%). The most common etiology for pulmonary embolism was prior surgery (41%). The most common allegation was "failure to diagnose and treat" in 62%. Other negligence included the failure to administer prophylactic anticoagulation while in the hospital (18%), failure to prescribe anticoagulation on discharge (8%), failure to administer anticoagulation after diagnosis (8%), and premature discontinuation of anticoagulation (2%). The most frequently claimed injury was death in 222 cases (80%). Verdicts were found for the defendant in 57% of cases and for the plaintiff in 27% and settled in 16%. CONCLUSIONS: The most frequently cited negligent act was the failure to give prophylactic anticoagulation, even after discharge. The trends noted in this study may potentially be addressed and therefore prevented by systems-based practice changes. The most common allegation, "failure to diagnose and treat," suggests that first-contact doctors such as emergency physicians and primary care practitioners must maintain a high index of suspicion for deep vein thrombosis/pulmonary embolism.

In-hospital outcomes of catheter-directed thrombolysis versus anticoagulation in cancer patients with proximal deep venous thrombosis.

OBJECTIVE: The objective of this study was to determine the rate of complications of catheter-directed thrombolysis (CDT) in cancer patients with deep venous thrombosis (DVT) compared with anticoagulation therapy alone. METHODS: This observational study used the National Inpatient Sample database to screen for any cancer patients who were admitted with a principal discharge diagnosis of proximal lower extremity or caval DVT between January 2005 and December 2013. Patients treated with CDT plus anticoagulation were compared with those treated with anticoagulation alone using propensity score matching for comorbidities and demographic characteristics. The primary end point was in-hospital mortality. Secondary end points were acute intracranial hemorrhage, inferior vena cava filter placement, acute renal failure, blood transfusion rates, length of stay, and hospital charges. RESULTS: We identified 31,124 cancer patients with lower extremity proximal or caval DVT, and 1290 (4%) patients were treated with CDT. Comparative outcomes as assessed in the two matched groups of 1297 patients showed that there was no significant difference in in-hospital mortality of patients undergoing CDT plus anticoagulation compared with those treated with anticoagulation alone (2.6% vs 1.9%; P = .23). However, CDT was associated with increased risk of intracranial hemorrhage (1.3% vs 0.4%; P = .017), greater blood transfusion rates (18.6% vs 13.1 %; P < .001), and higher rates of procedure-related hematoma (2.4% vs 0.4%; P < .001). The length of stay (6.0 [4.0-10.0] days vs 4.0 [2.0-7.0] days; P < .001) and hospital charges ($81,535 [$50,968-$127,045] vs $22,320 [$11,482-$41,005]; P < .001) were also higher in the CDT group compared with the control group. CONCLUSIONS: There was no significant difference in in-hospital mortality of cancer patients who underwent CDT plus anticoagulation compared with anticoagulation alone. CDT was associated with increased in-hospital morbidity and resource utilization compared with anticoagulation alone. Further studies are needed to examine the effect of CDT on the development of PTS in this population.

Analysis of venous thromboembolism in neurosurgical patients undergoing standard versus routine ultrasonography.

Routine screening of high-risk asymptomatic trauma or surgical patients for venous thromboembolism (VTE) is controversial. Studies suggest against screening while others recognize that some patients at high risk may benefit. The purpose of this pilot study is to evaluate the benefit of routine screening using doppler ultrasonography for the early detection of deep venous thrombosis (DVT) in post-operative neurosurgical patients. This was a quasi-experimental study at a major academic tertiary care medical center. A total of 157 adults underwent cranial or spinal surgical interventions from March through August 2017 and received either standard screening (n = 104) versus routine ultrasonography screening (n = 53). There was no significant difference in incidence of DVT between the two groups: 11 (11%) in the standard screening group versus 5 (9%) in the routine screening group, p = 0.823. Upper and lower extremity ultrasonography was performed in 43 (41%) of the standard screening group versus 53 (100%) in the routine screening group, p < 0.001. DVT was identified in nearly one of every 6 ultrasonography screenings in the standard screening group versus 27 ultrasonography screenings required to identify one DVT in the routine screening group. There were the same number of screenings for upper extremity ultrasonography, but they did not yield or detect DVT; instead only superficial, untreatable, DVTs were reported. Total cost to diagnose one DVT, including screening and labor, averaged $13,664 in the standard group versus $56,525 in the routine group. Routine screening in neurosurgical patients who received VTE prophylaxis was not associated with lower incidence of VTE and mortality attributed to PE. Thus, routine screening may not be cost effective to prevent complications from DVT incidence.

Contemporary Trends and Comparative Outcomes With Adjunctive Inferior Vena Cava Filter Placement in Patients Undergoing Catheter-Directed Thrombolysis for Deep Vein Thrombosis in the United States: Insights From the National Inpatient Sample.

OBJECTIVES: The aim of this study was to investigate the contemporary trends and comparative effectiveness of adjunctive inferior vena cava filter (IVCF) placement in patients undergoing catheter-directed thrombolysis (CDT) for treatment of proximal lower extremity or caval deep vein thrombosis. BACKGROUND: CDT is being increasingly used in the management of proximal deep vein thrombosis. Although a significant number of patients treated with CDT undergo adjunctive IVCF placement, the benefit of this practice remains unknown. METHODS: The National Inpatient Sample database was used to identify all patients with proximal or caval deep vein thrombosis who underwent CDT (with and without adjunctive IVCF placement) in the United States between January 2005 and December 2013. A propensity score-matching algorithm was then used to derive 2 matched groups of patients (IVCF and no IVCF) for comparative outcomes (mortality and major and minor bleeding) and resource use analysis. RESULTS: Of the 7,119 patients treated with CDT, 2,421 (34%) received IVCFs. There was no significant difference in in-hospital mortality (0.7% vs 1.0%; p = 0.20), procedure-related hemorrhage (1.4% vs. 1.0%; p = 0.23), or intracranial hemorrhage (0.7% vs. 0.6%; p = 0.70) between the IVCF (n = 2,259) and no-IVCF (n = 2,259) groups, respectively. Patients undergoing IVCF placement had higher rates of hematoma (3.4% vs 2.1%; p = 0.009), higher in-hospital charges ($104,049 ± 75,572 vs. $92,881 ± 80,194; p < 0.001) and increased length of stay (7.3 ± 5.6 days vs. 6.9 ± 6.9 days; p = 0.046) compared with the no-IVCF group. CONCLUSIONS: This nationwide observational study suggests that one-third of all patients undergoing CDT receive IVCFs. IVCF use was not associated with a decrease in in-hospital mortality but was associated with higher inpatient charges and longer length of stay.

Home versus in-patient treatment for deep vein thrombosis.

BACKGROUND: Deep vein thrombosis (DVT) occurs when a blood clot blocks blood flow through a vein, which can occur after surgery, after trauma, or when a person has been immobile for a long time. Clots can dislodge and block blood flow to the lungs (pulmonary embolism (PE)), causing death. DVT and PE are known by the term venous thromboembolism (VTE). Heparin (in the form of unfractionated heparin (UFH)) is a blood-thinning drug used during the first three to five days of DVT treatment. Low molecular weight heparins (LMWHs) allow people with DVT to receive their initial treatment at home instead of in hospital. This is an update of a review first published in 2001 and updated in 2007. OBJECTIVES: To compare the incidence and complications of venous thromboembolism (VTE) in patients treated at home versus patients treated with standard in-patient hospital regimens. Secondary objectives included assessment of patient satisfaction and cost-effectiveness of treatment. SEARCH METHODS: For this update, the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register (last searched 16 March 2017), the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 2), and trials registries. We also checked the reference lists of relevant publications. SELECTION CRITERIA: Randomised controlled trials (RCTs) examining home versus hospital treatment for DVT, in which DVT was clinically confirmed and was treated with LMWHs or UFH. DATA COLLECTION AND ANALYSIS: One review author selected material for inclusion, and another reviewed the selection of trials. Two review authors independently extracted data and assessed included studies for risk of bias. Primary outcomes included combined VTE events (PE and recurrent DVT), gangrene, heparin complications, and death. Secondary outcomes were patient satisfaction and cost implications. We performed meta-analysis using fixed-effect models with risk ratios (RRs) and 95% confidence intervals (CIs) for dichotomous data. MAIN RESULTS: We included in this review seven RCTs involving 1839 randomised participants with comparable treatment arms. All seven had fundamental problems including high exclusion rates, partial hospital treatment of many in the home treatment arms, and comparison of UFH in hospital versus LMWH at home. These trials showed that patients treated at home with LMWH were less likely to have recurrence of VTE events than those given hospital treatment with UFH or LMWH (fixed-effect risk ratio (RR) 0.58, 95% confidence interval (CI) 0.39 to 0.86; 6 studies; 1708 participants; P = 0.007; low-quality evidence). No clear difference was seen between groups for major bleeding (RR 0.67, 95% CI 0.33 to 1.36; 6 studies; 1708 participants; P = 0.27; low-quality evidence), minor bleeding (RR 1.29, 95% CI 0.94 to 1.78; 6 studies; 1708 participants; P = 0.11; low-quality evidence), or mortality (RR 0.69, 95% CI 0.44 to 1.09; 6 studies; 1708 participants; P = 0.11; low-quality evidence). The included studies reported no cases of venous gangrene. We could not combine patient satisfaction and quality of life outcomes in meta-analysis owing to heterogeneity of reporting, but two of three studies found evidence that home treatment led to greater improvement in quality of life compared with in-patient treatment at some point during follow-up, and the third study reported that a large number of participants chose to switch from in-patient care to home-based care for social and personal reasons, suggesting it is the patient's preferred option (very low-quality evidence). None of the studies included in this review carried out a full cost-effectiveness analysis. However, a small randomised economic evaluation of the two alternative treatment settings involving 131 participants found that direct costs were higher for those in the in-patient group. These findings were supported by three other studies that reported on their costs (very low-quality evidence).Quality of evidence for data from meta-analyses was low to very low. This was due to risk of bias, as many of the included studies used unclear randomisation techniques, and blinding was a concern for many. Also, indirectness was a concern, as most studies included a large number of participants randomised to the home (LMWH) treatment group who were treated in hospital for some or all of the treatment period. A further issue for some outcomes was heterogeneity that was evident in measurement and reporting of outcomes. AUTHORS' CONCLUSIONS: Low-quality evidence suggests that patients treated at home with LMWH are less likely to have recurrence of VTE than those treated in hospital. However, data show no clear differences in major or minor bleeding, nor in mortality (low-quality evidence), indicating that home treatment is no worse than in-patient treatment for these outcomes. Because most healthcare systems are moving towards more LMWH usage in the home setting it is unlikely that additional large trials will be undertaken to compare these treatments. Therefore, home treatment is likely to become the norm, and further research will be directed towards resolving practical issues by devising local guidelines that include clinical prediction rules, developing biomarkers and imaging that can be used to tailor therapy to disease severity, and providing training for community healthcare workers who administer treatment and monitor treatment progress.

Sex differences in utilization and outcomes of catheter-directed thrombolysis in patients with proximal lower extremity deep venous thrombosis - Insights from the Nationwide Inpatient Sample.

Catheter-directed thrombolysis (CDT) is being increasingly used for the treatment of proximal lower extremity (LE) deep venous thrombosis (DVT). However, sex differences in utilization and safety outcomes of CDT in these patients are unknown. The Nationwide Inpatient Sample (NIS) database was used to identify all patients with a principal discharge diagnosis of proximal LE or caval DVT who underwent CDT between January 2005 and December 2011 in the United States. We evaluated the comparative safety outcomes of CDT among a propensity-matched group of 1731 men versus 1731 women. Among 108,243 patients with proximal LE or caval DVT, 4826 patients (4.5%) underwent CDT. Overall, women underwent CDT less often compared to men (4.1% vs 4.9%, p<0.01, respectively). The rates of CDT increased between 2005 and 2011 for both women (2.1% to 5.9%, p<0.01) and men (2.5% to 7.5%, p<0.01). There was no significant difference in in-hospital mortality (1.2% vs 1.3%, p=0.76). Women were noted to have higher rates of blood transfusions (11.7% vs 8.8%, p<0.01), but lower rates of intracranial hemorrhage (0.5% vs 1.2%, p=0.03) and gastrointestinal bleeding (0.9% vs 2.2%, p<0.01) compared with men. Women were more likely to undergo inferior vena cava filter placement (37.0% vs 32.1%, p<0.01). In this large nationwide cohort, women with proximal DVT were less likely to receive CDT compared to men. Although mortality rates were similar, women were noted to have higher blood transfusion rates while men had more episodes of intracranial and gastrointestinal bleeding.

Sex-based disparities in venous thromboembolism outcomes: A National Inpatient Sample (NIS)-based analysis.

Venous thromboembolism (VTE) contributes to significant morbidity, mortality, and socioeconomic burden. There is a paucity of literature regarding sex-based sociodemographic differences in VTE presentation and short-term outcomes. We aimed to compare clinical outcomes between men and women hospitalized for VTE management. We performed a retrospective analysis using data from the National Inpatient Sample (NIS) database from 2012 to 2013. Inclusion criteria were age 18 years and older and a primary discharge diagnosis of VTE. Sociodemographic features and medical comorbidities were analyzed, as were hospital length of stay and in-hospital mortality rates. A total of 107,896 patients met the inclusion criteria; 53% were female. Median age was 65 years (interquartile range 51-77) and women were older than men (65 vs 62 years, p<0.001). There were significant differences between men and women with respect to race, primary insurance payer and medical comorbidities, and small differences with respect to VTE location. Female sex was associated with a small but significantly longer hospital length of stay (mean ratio 1.04, 95% CI 1.03-1.05, p<0.001) but no significant difference in in-hospital mortality (2.2% vs 2.1%, p=0.15). In a multivariate model, there was no significant difference between women and men with respect to hospital length of stay or in-hospital mortality. In conclusion, we used data from the NIS to study over 100,000 patients hospitalized for VTE, and identified several sex-based disparities in sociodemographic factors and location of VTE. However, in a multivariable analysis correcting for these factors, sex was not associated with significant differences in clinical outcomes.

The Clots in Legs Or sTockings after Stroke (CLOTS) 3 trial: a randomised controlled trial to determine whether or not intermittent pneumatic compression reduces the risk of post-stroke deep vein thrombosis and to estimate its cost-effectiveness.

BACKGROUND: Venous thromboembolism (VTE) is a common cause of death and morbidity in stroke patients. There are few data concerning the effectiveness of intermittent pneumatic compression (IPC) in treating patients with stroke. OBJECTIVES: To establish whether or not the application of IPC to the legs of immobile stroke patients reduced their risk of deep vein thrombosis (DVT). DESIGN: Clots in Legs Or sTockings after Stroke (CLOTS) 3 was a multicentre, parallel-group, randomised controlled trial which allocated patients via a central randomisation system to IPC or no IPC. A technician blinded to treatment allocation performed compression duplex ultrasound (CDU) of both legs at 7-10 days and 25-30 days after enrolment. We followed up patients for 6 months to determine survival and later symptomatic VTE. Patients were analysed according to their treatment allocation. SETTING: We enrolled 2876 patients in 94 UK hospitals between 8 December 2008 and 6 September 2012. INCLUSION CRITERIA: patients admitted to hospital within 3 days of acute stroke and who were immobile on the day of admission (day 0) to day 3. EXCLUSION CRITERIA: age < 16 years; subarachnoid haemorrhage; and contra-indications to IPC including dermatitis, leg ulcers, severe oedema, severe peripheral vascular disease and congestive cardiac failure. INTERVENTIONS: Participants were allocated to routine care or routine care plus IPC for 30 days, or until earlier discharge or walking independently. MAIN OUTCOME MEASURES: The primary outcome was DVT in popliteal or femoral veins, detected on a screening CDU, or any symptomatic DVT in the proximal veins, confirmed by imaging, within 30 days of randomisation. The secondary outcomes included death, any DVTs, symptomatic DVTs, pulmonary emboli, skin breaks on the legs, falls with injury or fractures and duration of IPC use occurring within 30 days of randomisation and survival, symptomatic VTE, disability (as measured by the Oxford Handicap Scale), quality of life (as measured by the European Quality of Life-5 Dimensions 3 Level questionnaire) and length of initial hospital stay measured 6 months after randomisation. RESULTS: We allocated 1438 patients to IPC and 1438 to no IPC. The primary outcome occurred in 122 (8.5%) of 1438 patients allocated to IPC and 174 (12.1%) of 1438 patients allocated to no IPC, giving an absolute reduction in risk of 3.6% [95% confidence interval (CI) 1.4% to 5.8%] and a relative risk reduction of 0.69 (95% CI 0.55 to 0.86). After excluding 323 patients who died prior to any primary outcome and 41 who had no screening CDU, the primary outcome occurred in 122 of 1267 IPC participants compared with 174 of 1245 no-IPC participants, giving an adjusted odds ratio of 0.65 (95% CI 0.51 to 0.84; p = 0.001). Secondary outcomes in IPC compared with no-IPC participants were death in the treatment period in 156 (10.8%) versus 189 (13.1%) (p = 0.058); skin breaks in 44 (3.1%) versus 20 (1.4%) (p = 0.002); and falls with injury in 33 (2.3%) versus 24 (1.7%) (p = 0.221). Among patients treated with IPC, there was a statistically significant improvement in survival to 6 months (hazard ratio 0.86, 95% CI 0.73 to 0.99; p = 0.042), but no improvement in disability. The direct cost of preventing a DVT was £1282 per event (95% CI £785 to £3077). CONCLUSIONS: IPC is an effective and inexpensive method of reducing the risk of DVT and improving survival in immobile stroke patients. FUTURE RESEARCH: Further research should test whether or not IPC improves survival in other groups of high-risk hospitalised medical patients. In addition, research into methods to improve adherence to IPC might increase the benefits of IPC in stroke patients. TRIAL REGISTRATION: Current Controlled Trials ISRCTN93529999. FUNDING: The start-up phase of the trial (December 2008-March 2010) was funded by the Chief Scientist Office of the Scottish Government (reference number CZH/4/417). The main phase of the trial was funded by the National Institute for Health Research Health Technology Assessment programme (reference number 08/14/03). Covidien Ltd (Mansfield, MA, USA) lent its Kendall SCD™ Express sequential compression system controllers to the 105 centres involved in the trial and donated supplies of its sleeves. It also provided logistical help in keeping our centres supplied with sleeves and training materials relevant to the use of their devices. Recruitment and follow-up were supported by the National Institute for Health Research-funded UK Stroke Research Network and by the Scottish Stroke Research Network, which was supported by NHS Research Scotland.

The cost-utility of dabigatran etexilate compared with warfarin in treatment and extended anticoagulation of acute VTE in the UK.

The relative efficacy and safety of dabigatran etexilate and warfarin have been evaluated in two head-to-head, phase III, treatment of acute venous thromboembolism (VTE) trials, and one extended prophylaxis trial, in patients with high risk of recurrent VTE. Dabigatran etexilate demonstrated similar efficacy to warfarin, and was associated with a reduced risk of major or clinically relevant bleeds. Based on results of these trials, and real-life disease prognosis following discontinuation of anticoagulation treatment, we evaluated the cost-utility of dabigatran etexilate compared with warfarin in six months anticoagulation, and in extended, up to 24 months anticoagulation, in patients with acute VTE, acute deep-vein thrombosis (DVT) or acute, symptomatic, pulmonary embolism (PE). Costs were analysed from the perspective of the National Health Services (NHS) and Public Social Services (PSS) in England and Wales. Outcomes were quantified in quality-adjusted life years (QALY). The estimated incremental, lifetime cost/QALY gain following acute, symptomatic VTE (DVT or PE) was £1,252/QALY when dabigatran etexilate or warfarin were administered for up to six months treatment. In treatment of acute, symptomatic PE and in DVT respective ratios were £1,767/QALY and £1,075/QALY. In extended, up to 24 months anticoagulation, dabigatran etexilate projected costs/QALY of £8,242/QALY, when compared with warfarin. Results obtained herein were robust across a number of sensitivity analyses and suggest dabigatran etexilate to be a cost-effective alternative to current standard of care when evaluated in six months treatment and in extended anticoagulation following acute VTE (DVT and/or PE).

Hepatectomy for hepatocellular carcinoma larger than 10 cm: preoperative risk stratification to prevent futile surgery.

OBJECTIVES: Appropriate patient selection is important to achieving good outcomes and obviating futile surgery in patients with huge (≥10 cm) hepatocellular carcinoma (HCC). The aim of this study was to identify independent predictors of futile outcomes, defined as death within 3 months of surgery or within 1 year from early recurrence following hepatectomy for huge HCC. METHODS: The outcomes of 149 patients with huge HCCs who underwent resection during 1995-2012 were analysed. Multivariate logistic regression analysis was performed to identify preoperative independent predictors of futility. RESULTS: Independent predictors of 3-month mortality (18.1%) were: total bilirubin level >34 µmol/l [P = 0.0443; odds ratio (OR) 16.470]; platelet count of <150 000 cells/ml (P = 0.0098; OR 5.039), and the presence of portal vein tumour thrombosis (P = 0.0041; OR 5.138). The last of these was the sole independent predictor of 1-year recurrence-related mortality (17.2%). Rates of recurrence-related mortality at 3 months and 1 year were, respectively, 6.3% and 7.1% in patients with Barcelona Clinic Liver Cancer (BCLC) stage A disease, 12.5% and 14% in patients with BCLC stage B disease, and 37.8% (P = 0.0002) and 75% (P = 0.0002) in patients with BCLC stage C disease. CONCLUSIONS: According to the present data, among patients submitted to hepatectomy for huge HCC, those with a high bilirubin level, low platelet count and portal vein thrombosis are at higher risk for futile surgery. The presence of portal vein tumour thrombosis should be regarded as a relative contraindication to surgery.

Operative versus nonoperative treatment of geriatric ankle fractures: a Medicare Part A claims database analysis.

BACKGROUND: The incidence of ankle fractures is increasing in the geriatric population, and several studies suggest them to be the third most common extremity fracture in this age group. Previous work has reflected relatively low complication rates during operative treatment. Little is known, however, about the association between these injuries and overall mortality, nor whether operative intervention has any effect on mortality. We hypothesized that geriatric ankle fractures would be correlated with an elevated mortality rate and that operative intervention would be associated with a reduced mortality when compared to nonoperative management. METHODS: Following Institutional Review Board approval we retrospectively assessed all relevant 2008 part A inpatient claims from the Medicare database. We queried diagnosis codes for ankle fractures, and then excluded any patients whose age was less then 65 or had an admission related to an ankle fracture during the previous year. Operative patients were then identified by their ICD-9 procedure codes occurring within 30 days of their initial diagnosis code; all other patients were presumed to be treated without operative intervention, thereby creating 2 groups for comparison. We then analyzed this database for specific variables including overall mortality, length of stay, age distribution, and other demographical characteristics. Groups were compared with Elixhauser and Deyo-Charlson scores to determine the level of comorbidities in each group. Multivariate logistic regression analysis was used to determine if operative intervention had a protective effect. RESULTS: In all, 19 648 patients with an ankle fracture were identified. Of those, 15 193 underwent operative intervention (77.3% ) and 4455 were treated nonoperatively (22.7% ). The mean ages for nonoperative and operative intervention were 80.9 and 76.5, respectively (P < .0001). The average length of stay for nonoperative management was 4.5 days, while operative intervention resulted in a length of stay of 4.6 days (P = .43). One-year mortality was 21.5% for the nonoperative group and 9.1% for the operative group (P < .0001). The mean Elixhauser score for the nonoperative group was 2.5 and 2.2 for the operative group (P < .0001). The mean Deyo-Charlson score was 1.3 and 1.0 for the nonoperative and operative groups, respectively (P < .0001). Multivariate logistic regression analysis demonstrated an odds ratio of 0.534 of death within 1 year for patients undergoing operative intervention as compared to nonoperative intervention (95% CI 0.483-0.591, P < .0001). CONCLUSION: The incidence of geriatric ankle fractures continue to increase as our population continues to grow older. A significantly larger number of those patients were treated with operative intervention, at a ratio of approximately 3:1 versus nonoperative management. Despite a relatively low overall reported complication rate with treatment of these injuries, they are associated with substantially increased 1-year mortality in both patient groups. Compared to the operative group, the nonoperative cohort demonstrated a 2-fold elevated mortality rate, although this may be related to them being an arguably more frail population as suggested by both comorbidity indexes. In spite of the difference in comorbidities, logistic regression analysis demonstrated operative intervention to have a protective effect. LEVEL OF EVIDENCE: Level III, comparative series.

Thrombosis: a major contributor to global disease burden.

BACKGROUND: Thrombosis is the common pathology underlying ischemic heart disease, ischemic stroke, and venous thromboembolism (VTE). The Global Burden of Disease Study 2010 (GBD 2010) documented that ischemic heart disease and stroke collectively caused 1 in 4 deaths worldwide. GBD 2010 did not report data for VTE as a cause of death and disability. OBJECTIVE: To review the literature on the global burden of disease caused by VTE. APPROACH AND RESULTS: We performed a systematic review of the literature on the global disease burden because of VTE in low-, middle-, and high-income countries. Studies from Western Europe, North America, Australia, and Southern Latin America (Argentina) yielded consistent results with annual incidences ranging from 0.75 to 2.69 per 1000 individuals in the population. The incidence increased to between 2 and 7 per 1000 among those aged ≥70 years. Although the incidence is lower in individuals of Chinese and Korean ethnicity, their disease burden is not low because of population aging. VTE associated with hospitalization was the leading cause of disability-adjusted life-years lost in low- and middle-income countries, and second in high-income countries, responsible for more disability-adjusted life-years lost than nosocomial pneumonia, catheter-related blood stream infections, and adverse drug events. CONCLUSIONS: VTE causes a major burden of disease across low-, middle-, and high-income countries. More detailed data on the global burden of VTE should be obtained to inform policy and resource allocation in health systems and to evaluate whether improved use of preventive measures will reduce the burden.

DVT surveillance program in the ICU: analysis of cost-effectiveness.

BACKGROUND: Venous Thrombo-embolism (VTE--Deep venous thrombosis (DVT) and/or pulmonary embolism (PE)--in traumatized patients causes significant morbidity and mortality. The current study evaluates the effectiveness of DVT surveillance in reducing PE, and performs a cost-effectiveness analysis. METHODS: All traumatized patients admitted to the adult ICU underwent twice weekly DVT surveillance by bilateral lower extremity venous Duplex examination (48-month surveillance period--SP). The rates of DVT and PE were recorded and compared to the rates observed in the 36-month pre-surveillance period (PSP). All patients in both periods received mechanical and pharmacologic prophylaxis unless contraindicated. Total costs--diagnostic, therapeutic and surveillance--for both periods were recorded and the incremental cost for each Quality Adjusted Life Year (QALY) gained was calculated. RESULTS: 4234 patients were eligible (PSP--1422 and SP--2812). Rate of DVT in SP (2.8%) was significantly higher than in PSP (1.3%) - p<0.05, and rate of PE in SP (0.7%) was significantly lower than that in PSP (1.5%) - p<0.05. Logistic regression demonstrated that surveillance was an independent predictor of increased DVT detection (OR: 2.53 - CI: 1.462-4.378) and decreased PE incidence (OR: 0.487 - CI: 0.262-0.904). The incremental cost was $509,091/life saved in the base case, translating to $29,102/QALY gained. A sensitivity analysis over four of the parameters used in the model indicated that the incremental cost ranged from $18,661 to $48,821/QALY gained. CONCLUSIONS: Surveillance of traumatized ICU patients increases DVT detection and reduces PE incidence. Costs in terms of QALY gained compares favorably with other interventions accepted by society.

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.

Initial transcatheter thrombolysis for acute superior mesenteric venous thrombosis.

AIM: To determine the optimal initial treatment modality for acute superior mesenteric vein thrombosis (ASMVT) in patients with circumscribed peritonitis. METHODS: A retrospective review was made of the Vascular Surgery Department's medical records to identify adult patients (≥ 18 years old) presenting with circumscribed peritonitis and diagnosed with ASMVT by imaging or endoscopic examination. Patients were selected from the time period between October 2009 and October 2012 to assess the overall performance of a new first-line treatment policy implemented in May 2011 for patients with circumscribed peritonitis, which recommends transcatheter thrombolysis with local anticoagulation and endovascular mechanical thrombectomy. Of the 25 patients selected for study inclusion, 12 had undergone emergency surgical exploration (group 1) and 13 had undergone the initial catheter-directed thrombolysis (group 2). Data extracted from each patient's records for statistical analyses included method of diagnosis, symptoms, etiology and risk factors, thrombus location, initial management, morbidity, mortality, duration and total cost of hospitalization (in Renminbi, RMB), secondary operation, total length of bowel resection, duration of and findings in follow-up, and death/survival. RESULTS: The two treatment groups showed similar rates of morbidity, 30-d mortality, and 1-year survival, as well as similar demographic characteristics, etiology or risk factors, computed tomography characteristics, symptoms, findings of blood testing at admission, complications, secondary operations, and follow-up outcomes. In contrast, the patients who received the initial non-operative treatment of transcatheter thrombolysis had significantly shorter durations of admission to symptom elimination (group 1: 18.25 ± 7.69 d vs group 2: 7.23 ± 2.42 d) and hospital stay (43.00 ± 13.77 d vs 20.46 ± 6.59 d), and early enteral or oral nutrition restoration (20.50 ± 5.13 d vs 8.92 ± 1.89 d), as well as significantly less total length of bowel resection (170.83 ± 61.27 cm vs 29.23 ± 50.24 cm) and lower total cost (200020.4 ± 91505.62 RMB vs 72785.6 ± 21828.16 RMB) (P < 0.05 for all). Statistical analyses suggested that initial transcatheter thrombolysis is correlated with quicker resolution of the thrombus, earlier improvement of symptoms, stimulation of collateral vessel development, reversal of intestinal ischemia, receipt of localizing bowel resection to prevent short bowel syndrome, shorter hospitalization, and lower overall cost of treatment. CONCLUSION: For ASMVT patients with circumscribed peritonitis, early diagnosis is key to survival, and non-operative transcatheter thrombolysis is feasible and effective as an initial treatment.

Cost-effectiveness of rivaroxaban compared with enoxaparin plus a vitamin K antagonist for the treatment of venous thromboembolism.

BACKGROUND: Venous thromboembolism (VTE), comprised of deep vein thrombosis (DVT) and pulmonary embolism (PE), is commonly treated with a low-molecular-weight heparin such as enoxaparin plus a vitamin K antagonist (VKA) to prevent recurrence. Administration of enoxaparin + VKA is hampered by complexities of laboratory monitoring and frequent dose adjustments. Rivaroxaban, an orally administered anticoagulant, has been compared with enoxaparin + VKA in the EINSTEIN trials. The objective was to evaluate the cost-effectiveness of rivaroxaban compared with enoxaparin + VKA as anticoagulation treatment for acute, symptomatic, objectively-confirmed DVT or PE. METHODS: A Markov model was built to evaluate the costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios associated with rivaroxaban compared to enoxaparin + VKA in adult patients treated for acute DVT or PE. All patients entered the model in the 'on-treatment' state upon commencement of oral rivaroxaban or enoxaparin + VKA for 3, 6, or 12 months. Transition probabilities were obtained from the EINSTEIN trials during treatment and published literature after treatment. A 3-month cycle length, US payer perspective ($2012), 5-year time horizon and a 3% annual discount rate were used. RESULTS: Treatment with rivaroxaban cost $2,448 per-patient less and was associated with 0.0058 more QALYs compared with enoxaparin + VKA, making it a dominant economic strategy. Upon one-way sensitivity analysis, the model's results were sensitive to the reduction in index VTE hospitalization length-of-stay associated with rivaroxaban compared with enoxaparin + VKA. At a willingness-to-pay threshold of $50,000/QALY, probabilistic sensitivity analysis showed rivaroxaban to be cost-effective compared with enoxaparin + VKA approximately 76% of the time. LIMITATIONS: The model did not account for the benefits associated with an oral and minimally invasive administration of rivaroxaban. 'Real-world' applicability is limited because data from the EINSTEIN trials were used in the model. Also, resource utilization and costs were based on the US healthcare system. CONCLUSION: Rivaroxaban is a cost-effective option for anticoagulation treatment of acute VTE patients.

The incidence and mortality of thromboembolic events in lumbar spine surgery.

STUDY DESIGN: Retrospective database analysis. OBJECTIVE: A population-based database was analyzed to identify the incidence, risk factors, and mortality associated with thromboembolic events after lumbar spine surgery. SUMMARY OF BACKGROUND DATA: Pulmonary embolism (PE) and deep vein thrombosis (DVT) are potential complications that may occur after orthopedic procedures. The incidence of these complications is not well characterized after lumbar spine surgery. METHODS: Data from the Nationwide Inpatient Sample was obtained from 2002-2009. Patients undergoing lumbar decompression (LD), or lumbar fusion (LF) for degenerative conditions were identified. Acute PE and DVT incidences and mortality rates were calculated. Comorbidities were calculated using a modified Charlson Comorbidity Index. Statistical analysis was performed using the Student t test for discrete variables and χ test for categorical data. Logistic regression was used to identify independent predictors of thromboembolic events. A P value of less than or equal to 0.0005 was used to denote statistical significance. RESULTS: A total 578,457 LDs and LFs were identified from 2002-2009. DVT incidences were 2.4 and 4.3 per 1000 cases in the LD and LF groups, respectively. PE incidences were 1.0 and 2.6 per 1000 cases in the LD and LF groups, respectively. Patients who had undergone LF with thromboembolic events were younger, had fewer comorbidities, and incurred greater costs than patients who had undergone LD. Statistically significant predictors of DVT were pulmonary circulation disorders, coagulopathy, fluid/electrolyte disorders, anemia, obesity, teaching hospital status, and larger hospitals. Predictors for the development of PE were pulmonary circulation disorders, fluid/electrolyte disorders, anemia, black ethnicity and teaching hospital status. CONCLUSION: Patients undergoing LD or LF are at inherent risk of thromboembolic events. DVT and PE are more common after LF procedures. Preoperative pulmonary circulation disorders, fluid/electrolyte disorders, deficiency anemia, and teaching hospital status were significant risk factors for developing both DVT and PE. Preventive measures in patients at risk may decrease the incidence of thromboembolic events. LEVEL OF EVIDENCE: 4.

Comprehensive assessment of prophylactic preoperative inferior vena cava filters for major spinal reconstruction in adults.

STUDY DESIGN: A retrospective data analysis. OBJECTIVE: To report a comprehensive assessment of preoperative prophylactic inferior vena cava (IVC) filter placement in spine surgery. SUMMARY OF BACKGROUND DATA: Venous thromboembolism (VTE) is a serious complication after major spinal reconstructive surgery in adults. Specifically, pulmonary embolism (PE) can result in significant morbidity and mortality, and it has been reported in up to 13% of patients. Prophylactic IVC filter placement was initiated for all "high-risk" spinal surgery patients after a pilot study demonstrated decreased VTE-related morbidity and mortality. METHODS: After institutional review board approval, the medical records of all patients receiving an IVC filter at a single institution from 2000 to 2007 were reviewed. Age, sex, surgical approach, postoperative deep vein thrombosis (DVT), postoperative superficial thrombus, presence of pulmonary or paradoxical embolus, mortality, and IVC filter complications were all evaluated. Indications for IVC filter placement included history of DVT or PE, malignancy, hypercoagulability, prolonged immobilization, staged procedures of longer than 5 segment levels, combined anterior-posterior approaches, iliocaval manipulation during exposure, and anesthetic time of more than 8 hours. Descriptive statistics were used for the analysis of patient characteristics. Nonparametric frequency statistics (odds ratios [OR], χ) were used for analysis of main outcomes. RESULTS: A total of 219 patients (150 women, 69 men) with a mean age of 58.8 (range, 17-86) years, were analyzed. There were 2 complications from IVC filter placement (66 Greenfield filters; 157 retrievable filters). The incidence of lower extremity DVT was 18.7% (41/219) in 36 patients. PE incidence was 3.7% (8/219 patients), and the paradoxical embolus rate was 0.5% (1 patient). Prophylactic IVC filter use reduced the odds of developing a pulmonary embolus (OR = 3.7, P < 0.05) compared with population controls. Patients receiving Greenfield filters had significantly higher VTE incidence than those receiving retrievable filters (OR = 2.8, P = 0.008). Anesthesia duration of more than 8 hours significantly increases VTE incidence (P = 0.029). No statistical significance (P < 0.05) was noted with combined anterior-posterior approach (118 patients) versus posterior-only approach (101 patients) and the incidence of DVT (24/118, 20.3% for former; 17/101, 16.8% for latter). There were a total of 14 deaths; none related to PE or paradoxical embolism during an 8-year period. Mean and median follow-up was 2.8 and 2.4 years, respectively, with 126 achieving 2 or more years of follow-up. CONCLUSION: VTE-related morbidity and mortality have heightened the awareness within the spine community to the perioperative management of patients undergoing major spinal reconstruction. Prophylactic IVC filter placement significantly lowers VTE-related events, including PE development, than population controls.