Evaluation of a Novel Mechanical Venous Thromboembolism Compression Device in Trauma Patients: A Pilot Study.

BACKGROUND: Venous thromboembolism (VTE) is the fourth most common preventable hospital-acquired complication for hospitalized trauma patients. Mechanical prophylaxis, using sequential compression or intermittent pneumatic compression (IPC) devices, is recommended alongside pharmacologic prophylaxis for VTE prevention. However, compliance with device use is a barrier that reduces the effectiveness of mechanical prophylaxis. OBJECTIVE: This study aimed to determine whether using the Movement and Compressions (MAC) system compared with an IPC device impacts compliance with mechanical VTE prophylaxis in trauma patients. METHODS: This study used a before-and-after design with historical control at a Level II trauma center with a convenience sample of adult trauma patients admitted to the intensive care unit or acute care floor for at least 24 h. We trialed the MAC device for 2 weeks in November and December 2022 with prospective data collection. Data collection for the historical control group occurred retrospectively using patients from a point-in-time audit of IPC device compliance from August and September of 2022. RESULTS: A total of 51 patients met inclusion criteria, with 34 patients in the IPC group and 17 patients in the MAC group. The mean (SD) prophylaxis time was 17.2 h per day (4.0) in the MAC group and 7.5 h per day (8.8) in the IPC group, which was statistically significant (p < .001). CONCLUSION: Our findings suggest that the MAC device can improve compliance with mechanical prophylaxis.

Should intermittent pneumatic compression devices be standard therapy for the prevention of venous thromboembolic events in major surgery? Protocol for a randomised clinical trial (IMPOSTERS).

INTRODUCTION: Venous thromboembolism (VTE) is a recognised postsurgical risk. Current prevention methods involve low molecular weight heparin (LMWH), graduated compression stockings (GCS), and intermittent pneumatic compression devices (IPCDs). Australian guidelines, commonly adopted by surgeons, recommend LMWH with GCS and/or IPCDs. IPCDs pose clinical risks, increase care burden, are poorly tolerated, and are costly single-use plastic items. Utilising only LMWH and GCS, without IPCDs, could be more practical, patient-friendly, and cost-effective, with added environmental benefits. METHODS: This is a multicentre, prospective, two-arm randomised controlled non-inferiority trial at five New South Wales (NSW) hospitals, in Australia. We propose to randomise 4130 participants in a 1:1 ratio between arm A: LMWH+GCS+IPCDs (n=2065) or arm B: LMWH+GCS (n=2065). The primary outcome of interest is symptomatic VTE (deep vein thrombosis/pulmonary embolism) identified at the day 30 phone follow-up (FU), confirmed by ultrasound or imaging. Radiologists interpreting the lower-extremity ultrasonography will be blinded to intervention allocation. Secondary outcomes are quality of life at baseline, days 30 and 90 FU using the 5-level European Quality of Life Score, compliance and adverse events with IPCDs, GCS, and LMWH, as well as healthcare costs (from the perspective of the patient and the hospital), and all-cause mortality. The trial has 90% power to detect a 2% non-inferiority margin to detect a reduction rate of VTE from 4% to 2%. ETHICS AND DISSEMINATION: This study has been approved by the Hunter New England Human Research Ethics Committee (2022/ETH02276) protocol V.10, 13 July 2023. Study findings will be presented at local and national conferences and in scientific research journals. TRIAL REGISTRATION NUMBER: ANZCTR12622001527752.

Effectiveness of manual lymphatic drainage and intermittent pneumatic compression in lymphedema maintenance therapy.

Background: To compare the effectiveness of intermittent pneumatic compression (IPC) and/or manual lymphatic drainage (MLD) associated to compression stockings in the maintenance treatment of lymphedema. Patients and methods: Patients in the maintenance phase of lymphedema therapy with MLD and compression since more than a year with stable values for weight and circumferences of ankle and calf were asked to participate in a study: Compression had to be worn daily, (1) 4 weeks IPC+MLD, (2) 4 weeks MLD alone, (3) 4 Weeks IPC alone (Order 1 and 3 was randomized). At the beginning and after each 4 weeks, circumference measurements (by hand and by machine: BT600®, Bauerfeind) were documented, pain and discomfort were assessed, and quality-of-life questionnaires were completed. Results: Of 20 participants, 18 (14 female, 4 male), mean age 59.6 years (48-89) could be evaluated. 11 subjects had bilateral, 7 unilateral, 5 primary, 13 secondary lymphedema since 2-20 years (mean 7.7), the subjects had received MLD and compression for 2-14 years (mean 6.4), 1-3 times per week (mean 1.5). The BMI ranged between 21 and 47 (mean 33.7). No differences between any phases were found for: Calf and thigh volume, circumference of calf. Only the ankle circumference was significant less (-0.22 cm) when using "both" (IPC+MLD). Compared to before the study, quality of life was better in all three phases, but with a significantly higher improvement in the phases with IPC than in the phases without. Conclusions: There were no differences in objective measurement between MLD alone, IPC alone or both, excepting the minimal significant difference in ankle circumference after IPC+MLD. QOL favored IPC application. Considering the economic consequences of these results, a change of maintenance therapy with MLD weekly over years in favor of permanent care with IPC and few appointments of MLD per year should be considered and further investigated.

Feasibility study of percutaneous thoracic duct embolization with lower-limb intermittent pneumatic compression devices

PURPOSE: To demonstrate intranodal thoracic duct embolization (TDE) for treating chyle leaks following thoracic surgery and the feasibility of applying lower-limb intermittent pneumatic compression devices during TDE. METHODS: Between December 2017 and October 2020, 12 consecutive TDEs for post-operative chyle leaks were performed in 11 patients using intranodal lymphangiogram (IL) with an intermittent pneumatic compressive device applied to the lower limb. The procedure's duration, technical/clinical success, and complications were retrospectively evaluated. RESULTS: IL was successful at imaging the thoracic duct in all procedures (100%), and TDE had an intention- to-treat success rate of 92% (11/12). No related complications were observed during follow-up, which took place at a mean of 27 days. The time from the commencement of lymphangiogram until visualization of the thoracic duct was a mean of 21.6 min, and the mean overall procedure time was 87.3 min. CONCLUSION: This study supports IL-guided TDE as a safe and effective option to treat post-thoracic surgery chyle leaks. We revealed shorter lymphangiogram times compared with previously published studies, and we postulate that the application of intermittent lower-limb pneumatic compressive devices contributed toward this study's results by expediting the return of lymph from the lower limb. This study is the first to illustrate this approach in TDE and advocates for randomized controlled studies to further evaluate the influence of intermittent pneumatic compressive devices on the procedure.

Limb edema in critically ill patients: Comparing intermittent compression and elevation.

Intensive care unit (ICU) patients are at high risk for limb edema, which caused complications such as pain, joint contracture, limited range of motion and atrophy of the limbs. Thus, this study was conducted to compare ICU patients' upper limb edema between two groups with the intervention of limb elevation and intermittent pneumatic compression (IPC). In this quasi-experimental before and after study, 40 patients were recruited. One upper limb was randomly assigned to the upper limb elevation (ULE) group and the other one was assigned to the IPC group. The circumference of the wrist and the middle of the arm were compared between and within groups. Results showed that in both groups of IPC and ULE and all five sessions (unless the second session of ULE), participants' arm and wrist edema were reduced significantly after the interventions (arm: P < .01; wrist: P < .0001). The differences between the two groups of ULE and IPC in regards to limb edema reduction were not significant. Although there was no significant difference between IPC and ULE intervention in the removal of edema, ULE seems to be more feasible and practical, which should be assessed in future studies.

Discontinued Use of Outpatient Portable Intermittent Pneumatic Compression Devices May Be Safe for Venous Thromboembolism Prophylaxis in Primary Total Knee Arthroplasty Using Low-Dose Aspirin.

Venous thromboembolism (VTE) is a rare, but serious complication following total knee arthroplasty (TKA). Current VTE guidelines recommend pharmacologic agents with or without intermittent pneumatic compression devices (IPCDs). At our institution, both 81-mg aspirin (ASA) twice a day (BID) and portable IPCDs were previously prescribed to TKA patients at standard risk for VTE, but the IPCDs were discontinued and patients were treated with ASA alone going forward. The aim of this study is to determine if discontinued use of outpatient IPCDs is safe and does not increase the rate of VTE or any other related complications in patients following TKA. A retrospective review of 2,219 consecutive TKA cases was conducted, identifying patients with VTE, bleeding complications, infection, and mortality within 90 days postoperatively. Patients were divided into two cohorts. Patients in cohort one received outpatient IPCDs for a period of 14 days (control), while those in cohort two did not (ASA alone). All study patients received inpatient IPCDs and were maintained on 81-mg ASA BID for 28 days. A posthoc power analysis was performed using a noninferiority margin of 0.25 (α = 0.05; power = 80%), which showed that our sample size was fully powered for noninferiority for our reported deep vein thrombosis (DVT) rates, but not for pulmonary embolism (PE) rates. A total of 867 controls and 1,352 patients treated with ASA alone were identified. Only two control patients were diagnosed with a PE (0.23%), while one patient in the ASA alone group had DVT (0.07%). There was no statistical difference between these rates (p = 0.33). Furthermore, no differences were found in bleeding complications (p = 0.12), infection (p = 0.97), or 90-day mortality rates (p = 0.42) between both groups. The discontinued use of outpatient portable IPCDs is noninferior to outpatient IPCD use for DVT prophylaxis. Our findings suggest that this protocol change may be safe and does not increase the rate of VTE in standard risk patients undergoing TKA while using 81-mg ASA BID.

A randomized controlled trial of treatment with intermittent negative pressure for intermittent claudication.

OBJECTIVE: We investigated the effects of lower extremity intermittent negative pressure (INP) treatment for 1 hour two times daily for 12 weeks on the walking distance of patients with intermittent claudication (IC). METHODS: Patients with IC were randomized to treatment with -40 mm Hg INP (treatment group) or -10 mm Hg INP (sham control group). Pain-free walking distance (PWD) and maximal walking distance (MWD) on a treadmill, resting and postexercise ankle-brachial index, resting and postischemic blood flow (plethysmography), and quality of life (EQ-5D-5L and Vascuqol-6) were measured at baseline and after 12 weeks of treatment. RESULTS: A total of 72 patients were randomized, and 63 had data available for the intention-to-treat analyses. The between-group comparisons showed a significant change in the PWD, favoring the treatment group over the sham control group (estimated treatment effect, 50 m; 95% confidence interval [CI], 11-89; P = .014). The PWD had increased by 68 m (P < .001) in the treatment group and 18 m (P = .064) in the sham control group. No significant difference was found in the change in the MWD between the two groups (estimated treatment effect, 42 m; 95% CI, -14 to 97; P = .139). The MWD had increased by 62 m (P = .006) in the treatment group and 20 m (P = .265) in the sham control group. For patients with a baseline PWD of <200 m (n = 56), significant changes had occurred in both PWD and MWD between the two groups, favoring the treatment group (estimated treatment effect, 42 m; 95% CI, 2-83; P = .042; and estimated treatment effect, 62 m; 95% CI, 5-118; P = .032; respectively). Both overall and for the group of patients with a PWD <200 m, no significant differences were found in the changes in the resting and postexercise ankle-brachial index, resting and postischemic blood flow, or quality of life parameters between the two groups. CONCLUSIONS: Treatment with -40 mm Hg INP increased the PWD compared with sham treatment in patients with IC. For the patients with a baseline PWD of <200 m, an increase was found in both PWD and MWD compared with sham treatment.

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.

Haematological Effects of Intermittent Pneumatic Compression for Deep Vein Thrombosis Prophylaxis.

Intermittent pneumatic compression (IPC) is a widely used and recommended method to prevent deep vein thrombosis. While the haemodynamic effects of IPC are well understood, the objective of this systematic review was to analyse the evidence for additional haematological changes. Forty-eight studies were identified where the haematological effects of IPC were measured. The many differences between the studies prevented meta-analysis, but there was a significant amount of evidence that global fibrinolytic activity was increased by IPC, and that levels of D-dimer and tissue factor pathway inhibitor in the blood also increased. There was less consistent evidence for changes in tissue plasminogen activator, plasminogen activator inhibitor and other fibrinolytic parameters. The evidence for changes in pro-coagulant factors and many measures of platelet activation was weak, but there was evidence for increases in prostacyclin. There is sufficient evidence to conclude that IPC does produce haematological changes, but not enough data to clarify the detail of those changes or to determine if it is mediated more by direct compression of the blood vessels, or by the flow changes.

Circumferential tissue compression at the lower limb during walking, and its effect on discomfort, pain and tissue oxygenation: Application to soft exoskeleton design.

Soft exoskeletons apply compressive forces at the limbs via connection cuffs to actuate movement or stabilise joints. To avoid excessive mechanical loading, the interface with the wearer's body needs to be carefully designed. The purpose of this study was to establish the magnitude of circumferential compression at the lower limb during walking that causes discomfort/pain. It was hypothesized that the thresholds differ from those during standing. A cohort of 21 healthy participants were tested using two sizes of pneumatic cuffs, inflated at the thigh and calf in a tonic or phasic manner. The results showed lower inflation pressures triggering discomfort/pain at the thigh, with tonic compression, and wider pneumatic cuffs. The thresholds were lower during walking than standing still. Deep tissue oxygenation increased during phasic compression and decreased during tonic compression. According to the findings, circumferential compression by soft exoskeletons is preferably applied at anatomical sites with smaller volumes of soft tissue, using narrow connection cuffs and inflation pressures below 14 kPa.

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.

The Safety and Hemodynamic Effects of Pneumatic Sleeves in Patients with Severe Left Ventricular Dysfunction.

BACKGROUND: Pneumatic sleeves (PS) are often used during laparoscopic surgery and for prevention of deep vein thrombosis in patients who cannot receive anticoagulation treatment. There is very little information on the hemodynamic changes induced by PS and their effect on brain natriuretic peptide (BNP) in patients with severely reduced left ventricular ejection function (LVEF). OBJECTIVES: To determine the safety and hemodynamic changes induced by PS and their effects on brain natriuretic peptide (BNP). METHODS: This study comprised 14 patients classified as New York Heart Association (NYHA) II-III with severely reduced LVEF (< 40%). We activated the PS using two inflation pressures (50 or 80 mmHg, 7 patients in each group) at two cycles per minute for one hour. We measured echocardiography, hemodynamic parameters, and BNP levels in each patient prior to, during, and after the PS operation. RESULTS: The baseline LVEF did not change throughout the activation of PS (31 ± 10% vs. 33 ± 9%, P = 0.673). Following PS activation there was no significant difference in systolic or diastolic blood pressure, the pulse measurements, or central venous pressure. BNP levels did not change after PS activation (P = 0.074). CONCLUSIONS: The use of PS, with either low or high inflation pressures, is safe and has no detrimental effects on hemodynamic parameters or BNP levels in patients with severely reduced LVEF following clinical stabilization and optimal medical therapy.

Bowel perforation after pneumatic dilatation: Management with fully covered self-expandable metallic stent / Perforación colónica tras dilatación neumática: manejo con prótesis metálica autoexpandible totalmente recubierta

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Adjunctive Intermittent Pneumatic Compression for Venous Thromboprophylaxis.

BACKGROUND: Whether adjunctive intermittent pneumatic compression in critically ill patients receiving pharmacologic thromboprophylaxis would result in a lower incidence of deep-vein thrombosis than pharmacologic thromboprophylaxis alone is uncertain. METHODS: We randomly assigned patients who were considered adults according to the local standards at the participating sites (≥14, ≥16, or ≥18 years of age) within 48 hours after admission to an intensive care unit (ICU) to receive either intermittent pneumatic compression for at least 18 hours each day in addition to pharmacologic thromboprophylaxis with unfractionated or low-molecular-weight heparin (pneumatic compression group) or pharmacologic thromboprophylaxis alone (control group). The primary outcome was incident (i.e., new) proximal lower-limb deep-vein thrombosis, as detected on twice-weekly lower-limb ultrasonography after the third calendar day since randomization until ICU discharge, death, attainment of full mobility, or trial day 28, whichever occurred first. RESULTS: A total of 2003 patients underwent randomization - 991 were assigned to the pneumatic compression group and 1012 to the control group. Intermittent pneumatic compression was applied for a median of 22 hours (interquartile range, 21 to 23) daily for a median of 7 days (interquartile range, 4 to 13). The primary outcome occurred in 37 of 957 patients (3.9%) in the pneumatic compression group and in 41 of 985 patients (4.2%) in the control group (relative risk, 0.93; 95% confidence interval [CI], 0.60 to 1.44; P = 0.74). Venous thromboembolism (pulmonary embolism or any lower-limb deep-vein thrombosis) occurred in 103 of 991 patients (10.4%) in the pneumatic compression group and in 95 of 1012 patients (9.4%) in the control group (relative risk, 1.11; 95% CI, 0.85 to 1.44), and death from any cause at 90 days occurred in 258 of 990 patients (26.1%) and 270 of 1011 patients (26.7%), respectively (relative risk, 0.98; 95% CI, 0.84 to 1.13). CONCLUSIONS: Among critically ill patients who were receiving pharmacologic thromboprophylaxis, adjunctive intermittent pneumatic compression did not result in a significantly lower incidence of proximal lower-limb deep-vein thrombosis than pharmacologic thromboprophylaxis alone. (Funded by King Abdulaziz City for Science and Technology and King Abdullah International Medical Research Center; PREVENT ClinicalTrials.gov number, NCT02040103; Current Controlled Trials number, ISRCTN44653506.).

The staff and patient perspectives on compliance with mechanical prophylaxis for venous thromboembolism.

BACKGROUND: This study evaluated the accuracy of assessment and compliance with proper use of intermittent pneumatic compression (IPC) devices before and after implementation of education, accountability, and oversight measures for health care providers. METHODS: Prospective analysis of randomly selected, emergently hospitalized adult patients was performed (group 1). IPC use was observed by random visual inspections. These patients underwent independent venous thromboembolism (VTE) risk assessments by the admitting service and a VTE consult service. Mechanical prophylaxis orders were subsequently reviewed. Next, strategies to improve compliance were implemented. One year later, prospective analysis of a similar cohort (group 2) was performed, followed by surveys of staff and patients to identify barriers to compliance. RESULTS: In group 1, VTE risk assessments were accurate and IPC was appropriately ordered. Of patients who needed IPC, 24 had IPC correctly applied and 72 did not. In group 2, VTE risk assessments were accurate and IPC was appropriately ordered. Of patients who needed IPC, 26 had IPC correctly applied and 74 did not. Surveys revealed that most providers are aware of the indications, order appropriately, and make efforts to ensure application. Most nurses reported that orders were placed and that IPC was applied. Most patients claimed to have knowledge of VTE and IPC use, but half reported that they were not educated and complained of sleep interference. CONCLUSIONS: Even with implementation of strategies to improve compliance, most patients do not receive adequate mechanical prophylaxis. Health care providers appropriately order prophylactic measures but do not follow up to ensure application. Discomfort and lack of education of the patient were important barriers to prophylaxis.