Prophylaxis of venous thromboembolism in general surgery in Spain. Analysis of a national survey. / Profilaxis del tromboembolismo venoso en cirugía general en España. Análisis de una encuesta nacional.

INTRODUCTION: Venous thromboembolism (VTE) represents a serious postoperative complication that can be prevented by adequate thromboprophylaxis. Surveys provide relevant information about clinician's attitudes and preferences regarding VTE prophylaxis. METHODS: Transversal, descriptive study based on a survey sent to general surgeons members of the Spanish Association of Surgeons (AEC), that included 31 questions regarding postoperative VTE and its prevention, as well as three clinical scenarios. RESULTS: 530 surgeons, 21.8% of the 2,429 invited by electronic mail to participate, completed the survey. Most of the answering clinicians work on in big teaching hospitals, and 28.5% are residents. VTE represents a serious problem for 28% of participants. Although 81% consider that their knowledge on the prevention of postoperative VTE is adequate, a similar percentage recognizes the need for further education. The vast majority (98.7%) use low molecular weight heparins, which are considered the most effective and safe modality, followed by mechanical methods. The Caprini risk assessment score is used by 81% of surgeons, who usually start pharmacological prophylaxis preoperatively. However, there are remarkable differences in the dosing of heparins, timing of initiation, and duration, especially in non-oncologic surgical patients. CONCLUSIONS: Most Spanish surgeons are interested in the prevention of postoperative VTE. Overall, the level of knowledge on thromboprophylaxis is adequate. However, our results indicate that there is a need for better education on relevant practical aspects of prophylaxis that could be achieved by incorporating recommendations from recent guidelines to local hospital-based protocols.

Economic benefit of a novel dual-mode ambulatory compression device for treatment of chronic venous leg ulcers in a randomized clinical trial.

BACKGROUND: Limb compression is a key component of protocols used to heal venous leg ulcers (VLUs). A novel ambulatory pneumatic compression device was tested in comparison with multilayered bandage (MLB) compression systems for the treatment of VLUs in a prospective randomized clinical trial. METHODS: Patients with VLUs measuring 1.5 to 50 cm2 with duration of 1 to 24 months were randomized to treatment with a pneumatic compression device, the ACTitouch adaptive compression therapy (ACT) system (Tactile Medical, Minneapolis, Minn), or MLB. The ACT group patients were seen in the clinic at weeks 1, 2, 4, 6, 9, 12, and 16 or until wounds healed; the MLB group was seen weekly for bandage and dressing changes for 16 weeks or until wounds healed. All other aspects of VLU care were standardized between the two groups. The primary study objective was to compare the VLU percentage area reduction at 16 weeks in the ACT group compared with the MLB group. RESULTS: There were 56 patients randomized to treatment with ACT (n = 26) or MLB (n = 30). In the ACT group, five patients exited because of skin or wound problems related to the ACT device and five withdrew because of the inconvenience of using the device. Therefore, the trial was halted before full randomization so improvements to the ACT device could be made. Data collected on 42 patients who were able to tolerate treatment for the 16-week study period (per protocol group) showed that both groups experienced similar rates of wound healing. In the per protocol population, the percentage area size reduction was greater for the ACT group compared with the MLB group (83.8% vs 70.5%, respectively), whereas no significant differences were noted in the percentage of wounds that healed by 16 weeks (60.0% vs 63.0%, respectively). CONCLUSIONS: In this truncated clinical trial, a novel dual-mode ambulatory compression device, when tolerated, achieved wound healing results similar to those with MLB for chronic VLUs. The device requires modifications to improve the patient's comfort and ease of use. However, this mode of therapy appears to have promise for improving the cost-effectiveness of treatment for chronic VLUs.

Superior Clinical, Quality of Life, Functional, and Health Economic Outcomes with Pneumatic Compression Therapy for Lymphedema.

BACKGROUND: Pneumatic compression therapy is one of several options for the management of lymphedema. The lack of clarity around clinical outcomes, quality of life, cost of care, and its proper application, as a function of lymphedema complexity, limit its use in clinical practice. This is compounded by difficulties associated with insurance approval and uncertainty about the role of this modality in the treatment algorithm. The purpose of this study is to elucidate the healthcare economics and value of pneumatic compression therapy for lymphedema. METHODS: All patients who underwent treatment for lymphedema at a single institution were followed prospectively over a 2-year period. Patient demographics, comorbidities, treatment modality, and treatment efficacy were determined. Direct costs over the 2-year period, inclusive of hospitalization and device costs, SF-36 quality of life, and leg lymphedema complexity score (LLCS), were measured. RESULTS: A total of 128 patients were enrolled over a period of 3 years for a total of 232 extremities treated for secondary lymphedema. Pneumatic compression therapy was utilized for all patients and led to a 28% decrease in absolute limb volume (P < 0.001), decrease in body mass index (BMI) (P < 0.001), significant improvement in SF-36 quality of life in 7 out of 8 domains (P < 0.001), and a significant improvement in LLCS (P < 0.001) at 1 year. A subsequent decrease in hospitalization for lymphedema-associated complications saved over $3,200 per patient per year. CONCLUSIONS: Pneumatic compression therapy leads to improved clinical outcomes, quality of life, and functional status for clinically significant lymphedema. Significant per capita direct cost savings, a beneficial impact on pay for performance measures, and a reduction in lymphedema-related complications suggest that earlier adoption of this treatment modality may offer a superior value proposition to patients, physicians, hospitals, and the healthcare system.

A comparative cost-effectiveness analysis of mechanical and pharmacological VTE prophylaxis after lower limb arthroplasty in Australia.

BACKGROUND: Venous thromboembolism (VTE) is a complication following surgery. Low-molecular-weight heparin (LMWH) or direct oral anticoagulants (DOACs) are efficacious but come with inherent bleeding risk. Mechanical prophylaxis, such as intermittent pneumatic compression (IPC), does not induce bleeding but may be difficult to implement beyond the immediate post-operative period. This study compared the cost and quality-adjusted life years (QALYs) saved of commonly used VTE prophylaxis regimens after lower limb arthroplasty. METHODS: A previously published cost-utility model considering major efficacy and safety endpoints was updated to estimate the 1-year cost-effectiveness of different VTE prophylaxis regimens. The VTE strategies assessed included apixaban, dabigatran, rivaroxaban, LMWH, IPC, IPC + LMWH and IPC + apixaban. Efficacy data were derived from studies in PubMed, and cost data came from the 2017 Australian AR-DRG and PBS pricing schemes. RESULTS: Costs for VTE prophylaxis including treatment of its associated complications over the first year after surgery ranged from AUD $644 (IPC) to AUD $956 (rivaroxaban). Across 500 simulations, IPC was the cheapest measure in 73% of simulations. In 97% of simulations, a DOAC was associated with the highest resulting QALYs. Compared to IPC, apixaban was cost-effective in 76.4% of simulations and apixaban + IPC in 87.8% of simulations. For VTE events avoided, the DOACs and IPC were on par. LMWH and LMWH + IPC were negatively dominated. CONCLUSIONS: Apixaban, IPC or a sequential/simultaneous combination of both is currently the most cost-effective VTE prophylaxis regimens. The choice between them is best guided by the relative VTE and bleeding risks of individual patients.

Health and economic benefits of advanced pneumatic compression devices in patients with phlebolymphedema.

OBJECTIVE: Phlebolymphedema (chronic venous insufficiency-related lymphedema) is a common and costly condition. Nevertheless, there is a dearth of evidence comparing phlebolymphedema therapeutic interventions. This study sought to examine the medical resource utilization and phlebolymphedema-related cost associated with Flexitouch (FLX; Tactile Medical, Minneapolis, Minn) advanced pneumatic compression devices (APCDs) relative to conservative therapy (CONS) alone, simple pneumatic compression devices (SPCDs), and other APCDs in a representative U.S. population of phlebolymphedema patients. METHODS: This was a longitudinal matched case-control analysis of deidentified private insurance claims. The study used administrative claims data from Blue Health Intelligence for the complete years 2012 through 2016. Patients were continuously enrolled for at least 18 months, diagnosed with phlebolymphedema, and received at least one claim for CONS either alone or in addition to pneumatic compression (SPCDs or APCDs). The main outcomes included direct phlebolymphedema- and sequelae-related medical resource utilization and costs. RESULTS: After case matching, the study included 86 patients on CONS (87 on FLX), 34 on SPCDs (23 on FLX), and 69 on other APCDs (67 on FLX). Compared with CONS, FLX was associated with 69% lower per patient per year total phlebolymphedema- and sequelae-related costs net of any pneumatic compression device-related costs ($3839 vs $12,253; P = .001). This was driven by 59% fewer mean annual hospitalizations (0.13 vs 0.32; P < .001) corresponding to 82% lower inpatient costs and 55% lower outpatient hospital costs. FLX was also associated with 52% lower outpatient physical therapy and occupational therapy costs and 56% lower other outpatient-related costs. Compared with SPCDs, FLX was associated with 85% lower total costs ($1153 vs $7449; P = .008) driven by 93% lower inpatient costs ($297 vs $4215; P = .002), 84% lower outpatient hospital costs ($368 vs $2347; P = .020), and 85% lower other outpatient-related costs ($353 vs $2313; P = .023). Compared with APCDs, FLX was associated with 53% lower total costs ($3973 vs $8436; P = .032) because of lower outpatient costs and lower rates of cellulitis (22.4% vs 44.9% of patients; P = .02). CONCLUSIONS: This analysis indicates significant benefits attributable to FLX compared with alternative compression therapies that can help reduce the notable economic burden of phlebolymphedema.

US budget impact of increased payer adoption of the Flexitouch advanced pneumatic compression device in lymphedema patients with advanced chronic venous insufficiency and multiple infections.

AIMS: To assess the budget impact to a US commercial health plan of providing access to the Flexitouch (FLX) advanced pneumatic compression device (Tactile Medical) to lymphedema (LE) patients with either comorbid chronic venous insufficiency (CVI) or frequent infections. METHODS: Budget impact was calculated over 2 years for a hypothetical US payer with 10-million commercial members. Model inputs were derived from published sources and from a case-matched analysis of Blue Health Intelligence (BHI) claims data for the years 2012-2016. To calculate the budget impact, the Status Quo budget (i.e. total cost for LE and sequelae-related medical treatment) was compared to the budget under each of three Alternate Payer Policy scenarios which assumed that a sub-set of patients was redistributed from their initial treatment groups to a group that received FLX. Model outputs included cumulative payer costs, net budget impact, and breakeven point. Sensitivity analyses were performed to assess the impact of model inputs on results. RESULTS: Increasing access to FLX yielded a favorable budget impact in every scenario. For LE patients with comorbid CVI, the three alternate scenarios resulted in cumulative 2-year budget impacts of -$52,841, -$173,317, and -$375,601, respectively. For LE patients with comorbid frequent infections, the three alternate scenarios resulted in cumulative 2-year budget impacts of -$192,729, -$259,339, and -$613,179, respectively. LIMITATIONS: Use of claims data assumes accurate coding and does not allow one to control for disease severity or treatment adherence. Also, the distribution of patients between treatment arms was determined using claims data from a specific payer organization, and could differ for health plans with different coverage policies. CONCLUSIONS: While previous studies have illustrated cost savings with adoption of FLX, US commercial health plans may also achieve tangible cost savings by expanding access to FLX for LE patients with comorbid CVI and multiple infections.

The Cutaneous, Net Clinical, and Health Economic Benefits of Advanced Pneumatic Compression Devices in Patients With Lymphedema.

IMPORTANCE: The prevalence and clinical burden of lymphedema is known to be increasing. Nevertheless, evidence-based comparative effectiveness data regarding lymphedema therapeutic interventions have been poor. OBJECTIVE: To examine the impact of an advanced pneumatic compression device (APCD) on cutaneous and other clinical outcomes and health economic costs in a representative privately insured population of lymphedema patients. DESIGN, SETTING, AND PARTICIPANTS: Retrospective analysis of a deidentified private insurance database from 2007 through 2013, and multivariate regression analysis comparing outcomes for the 12 months before and after APCD purchase, adjusting for baseline patient characteristics. Patients with lymphedema who received an APCD who were commercially insured and Medicare managed care enrollees from a large, national US managed care health insurer. The study population was evaluated as cancer-related and non-cancer-related lymphedema cohorts. INTERVENTION: Receipt of an APCD. MAIN OUTCOMES AND MEASURES: Rates of cellulitis, use of lymphedema-related manual therapy, outpatient hospital visits, and inpatient hospitalizations. Lymphedema-related direct costs were measured for home health care, hospital outpatient care, office visits, emergency department use, and inpatient care. RESULTS: The study sample included 718 patients (374 in the cancer cohort and 344 in the noncancer cohort). In both cohorts, use of an APCD was associated with similar reductions in adjusted rates of cellulitis episodes (from 21.1% to 4.5% in the cancer cohort and 28.8% to 7.3% in the noncancer cohort; P < .001 for both), lymphedema-related manual therapy (from 35.6% to 24.9%in the cancer cohort and 32.3% to 21.2% in the noncancer cohort; P < .001 for both), and outpatient visits (from 58.6% to 41.4% in the cancer cohort and 52.6% to 31.4% in the noncancer cohort; P < .001 for both). Among the cancer cohort, total lymphedema-related costs per patient, excluding medical equipment costs, were reduced by 37% (from $2597 to $1642, P = .002). The corresponding decline in costs for the noncancer cohort was 36% (from $2937 to $1883, P = .007). CONCLUSIONS AND RELEVANCE: The study found an association between significant reductions in episodes of cellulitis (cancer vs noncancer cohorts) and outpatient care and costs of APCD acquisition within a 1-year time frame in patients with both cancer-related and non-cancer-related lymphedema.

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.

Effect of intermittent pneumatic compression on disability, living circumstances, quality of life, and hospital costs after stroke: secondary analyses from CLOTS 3, a randomised trial.

BACKGROUND: The results of the CLOTS 3 trial showed that intermittent pneumatic compression (IPC) reduced the risk of deep vein thrombosis and improved survival in immobile patients with stroke. IPC is now being widely used in stroke units. Here we describe the disability, living circumstances, quality of life, and hospital costs of patients in CLOTS 3. METHODS: In CLOTS 3, a parallel group trial in 94 UK hospitals, immobile patients with stroke from days 0 to 3 of admission were assigned with a computer-generated allocation sequence in a 1:1 ratio to IPC or no IPC through a central randomisation system. We followed up patients at about 6 months with postal or telephone questionnaire to assess the secondary endpoints: disability (Oxford Handicap Scale [OHS]), living circumstances, health-related quality of life (EQ5D-3L), and hospital costs (based on use of IPC and length of hospital stay). Patients and carers who completed the postal questionnaires were not masked to treatment allocation, but telephone follow-up in non-responders was masked. All analyses were by intention to treat. This trial is registered, number ISRCTN93529999. FINDINGS: Between Dec 8, 2008, and Sept 6, 2012, we enrolled 2876 patients, with 1438 in each group. Despite the previously reported reduction in the risk of proximal deep vein thrombosis at 30 days (primary endpoint), there were no significant differences in disability (OHS 0-2 vs 3-6, adjusted odds ratio [OR] 0·98, 95% CI 0·80 to 1·19, p=0·83; adjusted ordinal analysis common OR 0·97, 95% CI 0·86 to 1·11), living circumstances (institutional care vs not; adjusted OR 1·11, 95% CI 0·89 to 1·37; p=0·358), or health-related quality of life (median utility value 0·26, IQR -0·07 to 0·66 with IPC, and 0·27, -0·06 to 0·64, with no IPC; p=0·952). The estimated cost of IPC was £64·10 per patient (SD 28·3). The direct costs of preventing a deep vein thrombosis and death were £1282 (95% CI 785 to 3077) and £2756 (1346 to not estimable), respectively, with IPC. Hospital costs increased by £451 with IPC compared with no IPC because of a longer stay in hospital (mean 44·5 days [SD 37·6] vs 42·8 days [37·2]; mean difference 1·8 days, 95% CI -1·0 to 4·5). By 6 months, despite an increase in survival (IPC 152·5 days [SD 60·6] vs no IPC 148·1 days [64·3]; mean difference 4·5 days, 95% CI -0·2 to 9·1), there was a non-significant increase in quality-adjusted survival associated with IPC (IPC 27·6 days [SD 40·6] vs no IPC 26·7 days [39·6]; mean difference 0·9 days, 95% CI -2·1 to 3·9). INTERPRETATION: IPC is inexpensive, prevents deep vein thrombosis, improves survival but not functional outcomes, and does not lead to a significant gain in quality-adjusted survival. When deciding whether to treat patients with IPC, clinicians need to take into account all these potential effects. FUNDING: National Institute of Health Research Health Technology Assessment Programme, Chief Scientist Office of Scottish Government, and Covidien.

Effectiveness of 'in-cast' pneumatic intermittent pedal compression for the pre-operative management of closed ankle fractures: a clinical audit.

BACKGROUND: Timing of surgery for ankle fractures is largely dependent on the condition of the surrounding soft-tissues. This study aimed to determine the clinical effectiveness of a pre-operative in-cast artero-venous (AV) impulse device in the management of closed ankle fractures requiring surgery. METHODS: A consecutive series of 64 closed ankle fractures were managed using the AV impulse system prior to surgery. Patients were compared to 73 consecutive closed ankle fractures managed surgically in the same unit immediately prior to the implementation of the AV impulse device study. Outcomes measured were time to surgery, length of hospital stay and surgical site infections. RESULTS: Median length of time to surgery, hospital stay duration and surgical site infections were all significantly reduced in the study group as compared to the control group. CONCLUSIONS: In-cast intermittent AV compression foot pumps in the pre-operative management of closed ankle fractures were associated with earlier surgery, earlier discharge and reduced complications.

Sequential compression biomechanical device versus primary amputation in patients with critical limb ischemia.

INTRODUCTION: Patients with critical limb ischemia (CLI), who are unsuitable for intervention, face the consequence of primary amputation. Sequential compression biomechanical device (SCBD) therapy provides a limb salvage option for these patients. OBJECTIVES: To assess the outcome of SCBD in patients with severe CLI who are unsuitable for revascularization. Primary end points were limb salvage and 30-day mortality. METHODS: From 2005 to 2012, 189 patients with severe CLI were not suitable for revascularization. In all, 171 joined the SCBD program. We match controlled 75 primary amputations. RESULTS: All patients were Rutherford category 4 or higher. Sustained clinical improvement was 68% at 1 year. Mean toe pressure increased from 19.9 to 35.42 mm Hg, P < .0001. Mean popliteal flow increased from 35.44 to 55.91 cm/sec, P < .0001. The 30-day mortality was 0.6%. Limb salvage was 94% at 5 years. Freedom from major adverse clinical events was 62.5%. All-cause survival was 69%. Median cost of managing a primary amputation patient is €29,815 compared to €3,985 for SCBD. We treated 171 patients with artassist at a cost of €681,965. However, primary amputation for 75 patients cost €2,236,125. CONCLUSION: The SCBD therapy is a cost-effective and clinically effective solution in patients with CLI having no option of revascularization. It provides adequate limb salvage while providing relief of rest pain without any intervention.

Does intermittent pneumatic compression reduce the risk of post stroke deep vein thrombosis? The CLOTS 3 trial: statistical analysis plan.

BACKGROUND: Venous thromboembolism (VTE) is a common and important complication of stroke. The CLOTS 3 trial aims to determine whether, compared with best medical care, best medical care plus intermittent pneumatic compression (IPC) in immobile stroke patients reduces the risk of proximal deep vein thrombosis (DVT). METHODS/DESIGN: The CLOTS 3 trial is a multicenter, parallel group trial with centralized randomization (minimization) to ensure allocation concealment. The protocol has been published (Trials 2012, 13:26) and is available in full at: http://www.clotstrial.com. Between December 2008 and September 2012, 105 centers in the UK recruited 2,876 immobile stroke patients within the first 3 days of their hospital admission. Patients were allocated to best medical care or best medical care plus IPC. Ultrasonographers performed a compression Doppler ultrasound scan to detect DVT in each treatment group at 7 to 10 days and 25 to 30 days. The primary outcome cluster includes symptomatic or asymptomatic DVT in the popliteal or femoral veins detected on either scan. Patients will be followed up by postal or telephone questionnaire at 6 months from randomization to detect later symptomatic DVT and pulmonary embolism (PE), and to measure functional outcome (Oxford Handicap Scale) and quality of life (EQ-5D-3L). The ultrasonographers performing the scans are blinded to treatment allocation, whereas the patients and caregivers are not. The trial has more than 90% power to detect a 4% absolute difference (12% versus 8%) in risk of the primary outcome and includes a health economic analysis.Follow-up will be completed in April 2013 and the results reported in May 2013. In this update, we describe the statistical analysis plan. TRIAL REGISTRATION: ISRCTN: ISRCTN93529999.

Does intermittent pneumatic compression reduce the risk of post stroke deep vein thrombosis? The CLOTS 3 trial: study protocol for a randomized controlled trial.

BACKGROUND: Approximately 80,000 patients each year are admitted to U.K. hospitals with an acute stroke and are immobile. At least 10% will develop a proximal deep vein thrombosis in the first month and 1.5% a pulmonary embolus. Although hydration, antiplatelet treatment and early mobilisation may reduce the risk of deep vein thrombosis, there are currently no preventive strategies which have been clearly shown to be both effective and safe. Anticoagulation increases the risks of bleeding and compression stockings are ineffective. Systematic reviews of small randomized trials of intermittent pneumatic compression have shown that this reduces the risk of deep vein thrombosis in patients undergoing surgery, but that there are few data concerning its use after stroke. The CLOTS trial 3 aims to determine whether, compared with best medical care, best medical care plus intermittent pneumatic compression in immobile stroke patients reduces the risk of proximal deep vein thrombosis. METHODS/DESIGN: CLOTS Trial 3 is a parallel group multicentre trial; with centralized randomisation (minimisation) to ensure allocation concealment. Over 80 centres in the U.K. will recruit 2800 immobile stroke patients within the first 3 days of their hospital admission. Patients will be allocated to best medical care or best medical care plus intermittent pneumatic compression. Ultrasonographers will perform a Compression Duplex Ultrasound Scan to detect deep vein thrombosis in each treatment group at about 7-10 days and 25-30 days. The primary outcome cluster includes symptomatic or asymptomatic deep vein thrombosis in the popliteal or femoral veins detected on either scan. Patients are then followed up by postal or telephone questionnaire at 6 months from randomisation to detect later symptomatic deep vein thrombosis and pulmonary emboli and to establish their functional outcome (Oxford handicap scale) and quality of life (EQ5D-3 L). The ultrasonographers performing the scans are blinded to treatment allocation, whereas the patients and caregivers are not. The trial has 90% power to detect a 4% absolute difference in risk of the primary outcome and includes a health economic analysis. DISCUSSION: The trial started recruitment in Dec 2008 and will complete recruitment during 2012. It will report results in 2013. TRIAL REGISTRATION NUMBER: ISRCTN: ISRCTN93529999.

Sequential compression biomechanical device in patients with critical limb ischemia and nonreconstructible peripheral vascular disease.

OBJECTIVES: Critical limb ischemia (CLI) patients who are unsuitable for intervention face the dire prospect of primary amputation. Sequential compression biomechanical device (SCBD) therapy provides a limb salvage option for these patients. This study assessed the outcome of SCBD in severe CLI patients who otherwise would face an amputation. Primary end points were limb salvage and 30-day mortality. Secondary end points were hemodynamic outcomes (increase in popliteal artery flow and toe pressure), ulcer healing, quality-adjusted time without symptoms of disease or toxicity of treatment (Q-TwiST), and cost-effectiveness. METHODS: From 2004 to 2009, we assessed 4538 patients with peripheral vascular disease (PVD). Of these, 707 had CLI, 518 underwent intervention, and 189 were not suitable for any intervention. A total of 171 patients joined the SCBD program for 3 months. RESULTS: All patients were Rutherford category ≥4. Median follow-up was 13 months. Mean toe pressure increased from 39.9 to 55.42 mm Hg, with a mean difference in toe pressure of 15.49 mm Hg (P = .0001). Mean popliteal flow increased from 35.44 to 55.91 cm/s, with mean difference in popliteal flow of 20.47 cm/s (P < .0001). Mortality at 30 days was 0.6%. Median amputation-free survival was 18 months. Limb salvage at 3.5 years was 94%. Freedom from major adverse clinical events (MACE) at 4.5 years was 62.5%. We treated 171 patients with SCBD at a cost of €681,948, with an estimated median per-patient cost of treatment with SCBD of €3988. CONCLUSION: SCBD therapy is a cost-effective and clinically efficacious solution in CLI patients with no option of revascularization. It provides adequate limb salvage and ameliorated amputation-free survival while providing relief of rest pain without any intervention.

Fundas de compresión neumática intermitente / Intermitent pneumatic compression hosiery

La utilización de sistemas de compresión gradual, como terapéutica asociada para el control de las patologías tromboembólicas, está comúnmente extendida (medias compresivas graduales, vendaje con vendas de crêpe…), aunque incrementa las cargas de trabajo para el profesional de enfermería, y su indicación son limitadas en pacientes de alto riesgo. Se ha generalizado la necesidad de utilizar dispositivos mecánicos, ampliamente reconocida por un nivel de evidencia razonable, para el control de la enfermedad tromboembólica venosa en aquellos enfermos con alto riesgo de sangrado en los que no es posible, o bien cuando está limitado el uso de fármacos para controlar dicha complicación en el paciente encamado. La compresión neumática intermitente (CNI) está integrada en buena parte de recomendaciones y guías de práctica clínica de asociaciones científicas y entidades especializadas como la American College of Chest Physicians (ACCP), y National Institute for Health and Clinical Excellence (NICE), entre otras. Por ello, queremos mostrar la sencillez de manejo de un dispositivo altamente eficaz en la prevención enfermedad tromboembólica venosa (ETEV), y cómo puede reducir las cargas de trabajo del personal de enfermería, a la vez que nos garantiza cuidados de alta calidad(AU)

The use of gradual compression systems (gradual compression hosiery, bandages composed of crepe strips,…) as therapeutic measures associated with the control of thromboembolic pathologies is a rather extensive common practice although their use increases the work load generated for nursing professionals; while at the same time, they have some indications to bear in mind and limited efficiency for use on high risk patients. The need to utilize mechanical devices has become a generally accepted practice, widely recognized as having a reasonable effectiveness level, to control thromboembolic vascular diseases on those bedridden patients who have a high risk of bleeding on whom the use of drugs to control this complication is not possible, or is limited. Intermitent pneumatic compression is integrated in the majority of recommendations and clinical practice guides published by scientific associations and specialized agencies such as the American College of Chest Physicians (ACCP), National Institute for Health and Clinical Excellence (NICE), among others. Therefore, the authors want to demonstrate the easy handling of a highly effective device to help prevent venous thromboembolic disease, and how it is possible to reduce the workload for nursing personnel while at the same time guarantee high quality care(AU)

An economic evaluation of venous thromboembolism prophylaxis strategies in critically ill trauma patients at risk of bleeding.

BACKGROUND: Critically ill trauma patients with severe injuries are at high risk for venous thromboembolism (VTE) and bleeding simultaneously. Currently, the optimal VTE prophylaxis strategy is unknown for trauma patients with a contraindication to pharmacological prophylaxis because of a risk of bleeding. METHODS AND FINDINGS: Using decision analysis, we estimated the cost effectiveness of three VTE prophylaxis strategies-pneumatic compression devices (PCDs) and expectant management alone, serial Doppler ultrasound (SDU) screening, and prophylactic insertion of a vena cava filter (VCF) -- in trauma patients admitted to an intensive care unit (ICU) with severe injuries who were believed to have a contraindication to pharmacological prophylaxis for up to two weeks because of a risk of major bleeding. Data on the probability of deep vein thrombosis (DVT) and pulmonary embolism (PE), and on the effectiveness of the prophylactic strategies, were taken from observational and randomized controlled studies. The probabilities of in-hospital death, ICU and hospital discharge rates, and resource use were taken from a population-based cohort of trauma patients with severe injuries (injury severity scores >12) admitted to the ICU of a regional trauma centre. The incidence of DVT at 12 weeks was similar for the PCD (14.9%) and SDU (15.0%) strategies, but higher for the VCF (25.7%) strategy. Conversely, the incidence of PE at 12 weeks was highest in the PCD strategy (2.9%), followed by the SDU (1.5%) and VCF (0.3%) strategies. Expected mortality and quality-adjusted life years were nearly identical for all three management strategies. Expected health care costs at 12 weeks were Can$55,831 for the PCD strategy, Can$55,334 for the SDU screening strategy, and Can$57,377 for the VCF strategy, with similar trends noted over a lifetime analysis. CONCLUSIONS: The attributable mortality due to PE in trauma patients with severe injuries is low relative to other causes of mortality. Prophylactic placement of VCF in patients at high risk of VTE who cannot receive pharmacological prophylaxis is expensive and associated with an increased risk of DVT. Compared to the other strategies, SDU screening was associated with better clinical outcomes and lower costs.

Cost benefit of intermittent pneumatic compression for venous thromboembolism prophylaxis in general surgery.

AIM: In moderate to high-risk general surgical patients, the cost effectiveness of mechanical prophylaxis for venous thromboembolism (VTE) is uncertain. Therefore, we determined the costs and savings of intermittent pneumatic compression (IPC) plus graduated compression stockings (GCS). METHODS: Postoperative VTE events in the absence of prophylaxis, efficacy of prophylaxis and costs of prophylaxis have been obtained from the English literature and Medicare 2004 reimbursement schedule. RESULTS: In 1000 moderate to high risk general surgical patients, in the absence of prophylaxis, the cost of investigating and treating 72 patients with clinical suspicion of DVT and 32 with PE is calculated to be $263,779. This corresponds to a cost of $263 per surgical patient. The cost of IPC combined with TED stockings in 1000 similar patients would be $66 760, and the cost of diagnosis and treatment of the reduced numbers (69% reduction) of clinical VTE is $ 83,574 making a total of $150 344. This means a saving of $133,435 ($263,779 - $150,344) per 1000 patients. This corresponds to a saving of $113 per surgical patient. Sensitivity analysis demonstrates that despite variation in costs or efficacy for IPC plus GCS, marked savings persist. CONCLUSIONS: Prophylaxis with IPC not only prevents VTE but also saves money.

Nonoperative active management of critical limb ischemia: initial experience using a sequential compression biomechanical device for limb salvage.

Critical limb ischemia (CLI) patients are at high risk of primary amputation. Using a sequential compression biomechanical device (SCBD) represents a nonoperative option in threatened limbs. We aimed to determine the outcome of using SCBD in amputation-bound nonreconstructable CLI patients regarding limb salvage and 90-day mortality. Thirty-five patients with 39 critically ischemic limbs (rest pain = 12, tissue loss = 27) presented over 24 months. Thirty patients had nonreconstructable arterial outflow vessels, and five were inoperable owing to severe comorbidity scores. All were Rutherford classification 4 or 5 with multilevel disease. All underwent a 12-week treatment protocol and received the best medical treatment. The mean follow-up was 10 months (SD +/- 6 months). There were four amputations, with an 18-month cumulative limb salvage rate of 88% (standard error [SE] +/- 7.62%). Ninety-day mortality was zero. Mean toe pressures increased from 38.2 to 67 mm Hg (SD +/- 33.7, 95% confidence interval [CI] 55-79). Popliteal artery flow velocity increased from 45 to 47.9 cm/s (95% CI 35.9-59.7). Cumulative survival at 12 months was 81.2% (SE +/- 11.1) for SCBD, compared with 69.2% in the control group (SE +/- 12.8%) (p = .4, hazards ratio = 0.58, 95% CI 0.15-2.32). The mean total cost of primary amputation per patient is euro29,815 ($44,000) in comparison with euro13,900 ($20,515) for SCBD patients. SCBD enhances limb salvage and reduces length of hospital stay, nonoperatively, in patients with nonreconstructable vessels.

Thromboembolic prophylaxis with intermittent pneumatic compression devices in trauma patients: a false sense of security?

PURPOSE: Intermittent pneumatic compression devices provide a safe and attractive means of venous thromboembolism prophylaxis. We hypothesized that intermittent pneumatic compression devices were inadequate prophylaxis secondary to noncompliance. METHODS: This was a prospective double-blind study evaluating compliance with intermittent pneumatic compression devices in nonambulatory adult trauma patients. Compliance was evaluated for the first 3 days of admission. The study consisted of two 3-month stages (before and after hospital personnel education on the importance of venous thromboembolism prophylaxis). FINDINGS: During the first stage, device compliance was 85%, 59%, and 74% in the intensive care unit, surgical ward, and overall, respectively. Following hospital personnel education, device compliance was 82%, 65%, and 77% in the intensive care unit, surgical ward, and overall, respectively. There was no significant difference in compliance between the 2 stages. CONCLUSIONS: With inadequate compliance and the cost attributed with intermittent pneumatic compression devices, other means of venous thromboembolism prophylaxis should be considered first, specifically low-molecular-weight heparin if not contraindicated.