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.

A systematic review of venous thromboembolism mechanical prophylaxis devices during surgery.

PURPOSE: Hospitalisation and surgery are major risk factors for venous thromboembolism (VTE). Intermittent pneumatic compression (IPC) and graduated compression stockings (GCS) are common mechanical prophylaxis devices used to prevent VTE. This review compares the safety and efficacy of IPC and GCS used singularly and in combination for surgical patients. METHODS: Ovid Medline and Pubmed were searched in a systematic review of the literature, and relevant articles were assessed against eligibility criteria for inclusion along PRISMA guidelines. RESULTS: This review is a narrative description and critical analysis of available evidence. Fourteen articles were included in this review after meeting the criteria. Results of seven studies comparing the efficacy of IPC versus GCS had high heterogeneity but overall suggested IPC was superior to GCS. A further seven studies compared the combination of IPC and GCS versus GCS alone, the results of which suggest that combination mechanical prophylaxis may be superior to GCS alone in high-risk patients. No studies compared combination therapy to IPC alone. IPC appeared to have a superior safety profile, although it had a worse compliance rate and the quality of evidence was poor. The addition of pharmacological prophylaxis may make mechanical prophylaxis superfluous in the post-operative setting. CONCLUSION: IPC may be superior to GCS when used as a single prophylactic device. A combination of IPC and GCS may be more efficacious than GCS alone for high-risk patients. Further high-quality research is needed focusing on clinical relevance, safety and comparing combination mechanical prophylaxis to IPC alone, particularly in high-risk surgical settings when pharmacological prophylaxis is contraindicated.

Application Areas of Intermittent Pneumatic Compression in the Prevention of Deep Vein Thrombosis During Dixon Surgery: A Randomized, Controlled Trial.

PURPOSE: Deep vein thrombosis (DVT) is common in the lithotomy position after laparoscopic surgery. Intermittent pneumatic compression (IPC) plays an important role in DVT prevention. However, few studies have compared the different compression areas of IPC application. It was hypothesized that the location of the compression sleeves could have an impact on the effects of thromboprophylaxis. METHODS: In this randomized, controlled trial performed from August 2020 to March 2021, 164 patients scheduled to undergo laparoscopic Dixon surgery were randomly assigned to one of four groups, based on the bilateral placement of compression sleeves during surgery: feet, calves, thighs, or control (no IPC). Both lower extremities were monitored for DVT on days 1 and 7 after surgery, using ultrasonographic assessment of mean blood velocity, blood flow volume, and diameter of the common femoral veins. Thrombosis-related hematologic analysis was performed. FINDINGS: On day 1 after surgery, IPC of the feet or calves was associated with a reduced prevalence of DVT compared with controls (both: P = 0.024; OR = 0.09; 95% CI, 0.01-0.72), while IPC of the thighs had no significant benefit (P = 0.781; OR = 0.86; 95% CI, 0.29-2.55). The prevalence of DVT in the left extremity was lower with IPC of the feet and calves compared with controls (both, P = 0.048). The mean blood velocity in the common femoral vein was significantly increased after surgery with IPC of the left and right feet (P = 0.006 and 0.007, respectively) and calves (P = 0.011 and P = 0.026, respectively) compared with controls. Similarly, the volume of blood flow in the left common femoral vein was greater with IPC of the feet and calves (P = 0.03 and 0.027, respectively). However, on day 7 after surgery, the between-group differences in the prevalences of DVT and hematologic indicators of thrombosis were not significant. IMPLICATIONS: On day 1 after surgery, IPC application at the feet or calves facilitated venous return and, hence, reduced the prevalence of DVT, especially in the left extremities. However, there were no significant differences in the prevalences of DVT or thrombosis-related hematologic indicators among the four groups on the day 7 after surgery. Chinese Clinical Trial Registration identifier: ChiCTR2000035325.

A Prospective Preliminary Study Examining the Physiological Impact of Pneumatic Compression Dosing in the Treatment of Lower Extremity Lymphedema.

Background: Optimal frequency and duration of pneumatic compression device (PCD) therapy for lymphedema is undetermined. This prospective, randomized preliminary study evaluated the impact of different PCD dosing protocols on physiological and patient-reported outcomes (PROs) to estimate treatment effects, assess the responsiveness of various measurement techniques, and identify endpoints for a definitive PCD dosing trial. Methods and Results: Twenty-one patients with lower extremity lymphedema were randomized into three groups for treatment with the Flexitouch advanced PCD: (A) once per day for 1 hour, 12 consecutive days; (B) twice per day in 1-hour treatments, 5 consecutive days; or (C) twice per day in 2-hour treatments, 5 consecutive days. Outcomes measured were changes in limb volume (LV), tissue fluid, tissue tone, and PROs. Those in group A experienced mean (standard deviation) LV reductions of 109 (58) mL (p = 0.003) on day 1 and of 97 (86) mL (p = 0.024) on day 5. Group A also showed possible single-treatment decreases in extracellular fluid volume by bioimpedance spectroscopy (BIS) on day 5. There were no consistent changes in groups B and C. Long-term assessment of LV and BIS showed no clear change. Tonometry, ultrasound, local tissue water, and PROs showed wide variation among participants. Conclusions: LV measurements showed potential benefit for 1-hour daily PCD treatment. A definitive dosing trial should include LV, BIS, and PROs in a comparison of 1- and 2-hour daily treatment protocols conducted over a study period of 4 weeks. These data may inform appropriate outcome measures for other intervention studies in lymphedema.

Compression therapy in peripheral artery disease: a literature review.

OBJECTIVE: Our objective is to examine the pathophysiology of oedema in the ischaemic and post-revascularised limb, compare compression stockings to pneumatic compression devices, and summarise compression regimens in patients with severe peripheral artery disease (PAD) without revascularisation, after revascularisation, and in mixed arterial and venous disease. METHOD: A scoping literature review of the aforementioned topics was carried out using PubMed. RESULTS: Compression therapy has been shown to increase blood flow and aid in wound healing through a variety of mechanisms. Several studies suggest that intermittent pneumatic compression (IPC) devices can be used to treat critical limb ischaemia in patients without surgical options. Additionally, compression stockings may have a role in preventing oedema after peripheral artery bypass surgery, thereby diminishing pain and reducing the risk of surgical wound dehiscence. CONCLUSION: Oedema may occur in the ischaemic limb after revascularisation surgery, as well as in combination with venous disease. Clinicians should not fear using compression therapy in PAD.

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.

The FACT : Use of a novel intermittent pneumatic compression device to promote pre-surgery arm vein dilation in patients with chronic renal failure.

BACKGROUND: Arteriovenous fistula (AVF) creation and maturation for hemodialysis is globally a topic of importance given the poor results and high costs associated with renal care. Successful AVF (surgical or endovascular) creation requires appropriate superficial veins and quality arteries. Many procedures fail due to initial small veins with limited blood flow capacity and distensibility. Intermittent pneumatic compression has previously shown success in trials to increase superficial veins in patients with end stage renal disease post AVF. The objective of this study is to investigate the role of an intermittent pneumatic device, the Fist Assist®, to dilate cephalic arm veins in patients with advanced chronic kidney disease (CKD) prior to AVF placement. METHODS: Three centers enrolled subjects from June 2019 through July 2021. Baseline Doppler measurements of the cephalic vein in standard locations the forearm and upper arm with and without a blood pressure cuff were recorded. Patients were instructed and used Fist Assist® on their non-dominant arm for up to 4 h daily for 90 days. At approximately 3 months, Doppler measurements were repeated. The primary endpoint was cephalic vein enlargement with secondary endpoints based on percentage of veins approaching 2.5 mm in the forearm and 3.5 mm in the upper arm. RESULTS: Thirty-seven subjects with CKD (mean eGFR 13.8 mL/min) were enrolled and completed the trial. Paired-difference t-tests (one tail) for aggregate data showed significant venous dilation of the cephalic vein in both the forearm and upper arm after use with the Fist Assist® (p < 0.05). Mean differences in the forearm veins were approximately 0.6 and 1.1 mm in the upper arm cephalic vein after Fist Assist® application. There were no major complications reported by any subject during the trial. CONCLUSIONS: Fist Assist® use in patients with CKD is effective to enhance vein dilation. Forearm and upper arm cephalic veins increased on average 0.6 and 1.1 mm respectively after Fist Assist® application. This is the first trial to evaluate the effect of intermittent, focal pneumatic compression on pre-surgery vein diameter in patients with advanced CKD before AVF creation.

Effect of pneumatic compression device and stocking use on symptoms and quality of life in women with lipedema: A proof-in-principle randomized trial.

OBJECTIVE: Does short-term use of pneumatic compression devices (PCD) and off-the-shelf compression alleviate symptoms and improve quality of life in women with lipedema and secondary lipolymphedema? METHODS: Prospective, randomized controlled, industry-sponsored, proof-in-principle study comparing PCD plus conservative care (PCD+CC) to CC alone (control). Adult females with bilateral lipedema and secondary lymphedema were randomized to PCD+CC or CC. Outcome measures were lower limb and truncal circumferential measurements, bioimpedance, and quality-of-life, symptom, and pain intensity questionnaires. RESULTS: Both groups experienced improvements in leg circumference and bioimpedance with more improvement in the PCD+CC group than the CC group. Pain scores of the SF-36 survey and numerical rating scales were improved in the PCD+CC group. Wong-Baker Faces scores showed trends toward improvement in both groups. CONCLUSIONS: This proof-in-principle study supports conservative management with graduated compression and with or without PCD for improvement in leg circumference, bioimpedance measurements, and pain in patients with lipedema.

Addition of Intermittent Pneumatic Compression to Conventional Treatment Improves Volume Reduction Before Lymphatic Surgery for Lower Limb Lymphedema: A Pilot Study.

This study assesses the impact of an advanced intermittent pneumatic compression device (IPC - Lympha Press® Optimal Plus) when added to Complete Decongestive Therapy (CDT) compared to CDT alone on volume reduction of limbs with lymphedema. The goal is to maximally reduce edema in preparation for microsurgery. Fifty subjects scheduled for Multiple Lymphatic-Venous Anastomosis (MLVA) were randomly (sequentially) assigned to experimental or control group: 25 (21 females and 4 males) in the experimental IPC group and 25 (20 females and 5 males) in the control group. The two groups were similar in age, sex distribution, and type of lymphedema. Results indicate the IPC group reported greater volume loss than the control group (p= 0.00137) comparing final vs. initial limb volume. The average percentage edema volume loss achieved with added IPC was two times greater (11.7%) than in the control group (5.0%). When differences in treatment duration were accounted for, the IPC group achieved consistently greater proportional volume loss (12.83% vs 6.30%) than conservative therapy alone. In our pilot study, IPC added to CDT resulted in greater proportional volume loss and provides better preparation for MLVA surgery.

Comparison of intermittent pneumatic compression device and compression stockings for workers with leg edema and pain after prolonged standing: a prospective crossover clinical trial.

BACKGROUND: During prolonged standing, insufficient calf muscle pumping accompanies venous stasis and hypertension in the lower legs, resulting in valve dysfunction, venous wall problems, and sub-sequent inflammation. Compression therapy, which includes medical compression stockings (MCS) and mechanical intermittent pneumatic compression (IPC), is one of the most effective therapeutic interventions for treating chronic venous diseases. This study aimed to compare the therapeutic effect among resting, IPC and MCS alone, and IPC with MCS in long-standing workers (> 8 h daily). METHODS: This crossover trial was conducted with 39 participants with complaints of leg edema and pain whose work involved standing for more than 8 h daily. Four treatment protocols were established for each visit as follows: protocol A (not wear MCS during work and rest without IPC after work), protocol B (wear MCS during work and rest without IPC after work), protocol C (not wear MCS during work and treat with IPC after work), and protocol D (wear MCS during work and treat with IPC after work). The primary outcome was the visual analogue scale (VAS) score for leg pain. The secondary outcomes were leg volume (mL), circumference (cm), extracellular fluid/total body fluid (ECF/TBF), and extracellular water/total body water (ECW/TBW) through bioelectrical impedance analysis. Outcomes were assessed before work (T0), after work (T1), and 60 min after intervention (T2). RESULTS: All four protocols had significantly increased leg pain after work (T0-1) but improved 60 min after intervention (T1-2), particularly protocol C (decreased VAS by 1.9). When leg swelling was compared at T0 and T1, protocols A and C showed significant increases in leg volume and circumference, indicating significant work-induced edema, whereas protocols B and D showed no change or even a decrease. After interventions, leg volume and circumference significantly decreased in protocols A and C, although protocols B and C did not show significant improvement. The ECF/TBF and ECW/TBW of all protocols decreased after interventions. CONCLUSIONS: Leg pain and edema after prolonged standing (T1-T2) in adults were safely and effectively improved by both IPC alone and IPC with MCS. Although the use of MCS during the workday did not show improvement in leg pain immediately after work (T0-T1), both MCS with resting and MCS with IPC decreased leg pain at T1-T2 and prevented leg edema at T0-T1. TRIAL REGISTRATION: This trial protocol was registered at the Clinical Research Information Service (KCT0005383, the date of first registration: 08/09/2020).

Patient-reported barriers and facilitators for intermittent pneumatic compression device use on the antepartum unit.

OBJECTIVE: To examine patient barriers to intermittent pneumatic compression (IPC) device compliance during antepartum hospital admissions. METHODS: This was a prospective survey study of a diverse group of pregnant patients who were admitted to the antepartum floor in a quaternary care hospital from June 2019 through March 2021. Patients receiving pharmacotherapy for venous thromboembolism prophylactic or therapeutic indications were excluded. The primary outcome was patient reported barriers to use of IPC during antepartum hospital admission. Responses were summarized using descriptive statistics. RESULTS: A total of 40 patients were surveyed. All participants correctly identified the purpose of IPC. When asked regarding IPC importance, 7.5% reported not important, 40% reported somewhat important but not a priority, 5% important only on the first day they were given, and 47.5% reported important whenever the patient was in bed. The most bothersome characteristics of IPC use identified by the respondents on a Likert scale from 1 to 5 were sweating, made the legs too hot, restricted movement, and inconvenience and time spent putting on and taking off the IPC. Making the device wireless/cordless (77.5%), using a lighter weight or cooler material for the cuffs (55%), and better availability of nurses to assist with putting on, taking off, and troubleshooting the IPC (17.5%) were identified by patients as ways to increase compliance with IPC. CONCLUSIONS: This survey identified several modifiable barriers to the use of IPC on the antepartum floor.

Efficacy of intermittent compression devices for thromboembolic prophylaxis in major abdominal surgery: a systematic review and meta-analysis.

BACKGROUND: The benefits of mechanical prophylaxis for the prevention of venous thromboembolism (VTE) in abdominal and pelvic surgery are uncertain, with different guidelines stating that graduated compression stockings (GCS) and intermittent pneumatic compression devices (IPCDs) can be used either alone or in combination. To review the efficacy of IPCDs in preventing VTE following abdominal and pelvic surgery. METHODS: A systematic review was conducted, identifying relevant literature reporting clinical trials conducted in abdominopelvic surgery, comparing the effect of IPCDs alone or in combination with no prophylaxis, GCS and chemical prophylaxis. The review identified studies reported from 1966 to 2022 in Medline, Embase, PubMed and Cochrane databases for randomized controlled trials. RESULTS: Thirteen RCTs involving 1914 participants were identified. IPCDs were superior to placebo (OR VTE 0.39; 95% CI 0.20-0.76) but not superior to other forms of prophylaxis (OR 0.83; 95% CI 0.30-2.27) or to GCS alone (OR 0.9; 95% CI 0.24-3.36). The addition of IPCDs to GCS compared with GCS alone was beneficial (OR 0.45; 95% CI 0.23-0.91) as was the addition of IPCDs to standard perioperative chemoprophylaxis (OR 0.25; 95% CI 0.09-0.74). The overall quality and reliability of trials were low, with high risk of bias. CONCLUSIONS: IPCDs are more effective than placebo in reducing VTE rates but are not more effective than other forms of thrombo-prophylaxis (chemical or mechanical) following abdominal and pelvic surgery. There is poor quality evidence to suggest that they might have a role as additional prophylaxis when combined with GCS and chemical prophylaxis.

Multiple blood flow surges during intermittent pneumatic compression: The origins and their implications.

Intermittent pneumatic compression (IPC) therapy has been used to enhance peripheral blood flow for prevention and rehabilitation of ischemic-related vascular diseases. A novel phenomenon has been reported that multiple blood flow surges appeared in the skin blood flow signal during each compression, but its mechanism has not been fully revealed. This study aimed to gain insights into the origins of these blood flow surges through experiment and biomechanical modeling methods. Foot skin blood flow (SBF) signals of 13 healthy adults (23.8 ± 0.5 yr old, 7 males) and air cuff pressure signals were recorded during IPC. Lumped parameter modeling and wavelet analysis were adopted to investigate the multiple blood flow surges (named as Peak1, Peak2 and Peak3). The results of the simulated Peak1 and Peak2 were in good agreements with the experiment results, suggesting that IPC could enhance foot SBF not only by deflation, but also by inflation. Statistical analysis demonstrated that high frequency compression with more frequent occurrence of Peak1 and Peak2 lead to significantly higher (Friedman test, p < 0.001) time-averaged SBF enhancement than the traditional mode. In addition, wavelet analysis showed that the major frequency component of the Peak3 (0.059 Hz) was within the range of the vascular myogenic activity, suggesting a vascular regulation process triggered by intravascular pressure changes. Our study provide new insights into the mechanism of how IPC enhance foot SBF.