Intermittend pneumatic venous thrombembolism (VTE) prophylaxis during neurosurgical procedures.

BACKGROUND: The management of perioperative venous thrombembolism (VTE) prophylaxis is highly variable between neurosurgical departments and general guidelines are missing. The main issue in debate are the dose and initiation time of pharmacologic VTE prevention to balance the risk of VTE-based morbidity and potentially life-threatening bleeding. Mechanical VTE prophylaxis with intermittend pneumatic compression (IPC), however, is established in only a few neurosurgical hospitals, and its efficacy has not yet been demonstrated. The objective of the present study was to analyze the risk of VTE before and after the implementation of IPC devices during elective neurosurgical procedures. METHODS: All elective surgeries performed at our neurosurgical department between 01/2018-08/2022 were investigated regarding the occurrence of VTE. The VTE risk and associated mortality were compared between groups: (1) only chemoprophylaxis (CHEMO; surgeries 01/2018-04/2020) and (2) IPC and chemoprophylaxis (IPC; surgeries 04/2020-08/2022). Furthermore, general patient and disease characteristics as well as duration of hospitalization were evaluated and compared to the VTE risk. RESULTS: VTE occurred after 38 elective procedures among > 12.000 surgeries. The number of VTEs significantly differed between groups with an incidence of 31/6663 (0.47%) in the CHEMO group and 7/6688 (0.1%) events in the IPC group. In both groups, patients with malignant brain tumors represented the largest proportion of patients, while VTEs in benign tumors occurred only in the CHEMO group. CONCLUSION: The use of combined mechanical and pharmacologic VTE prophylaxis can significantly reduce the risk of postoperative thromboembolism after neurosurgical procedures and, therefore, reduce mortality and morbidity.

Incidence of venous thromboembolism after cardiovascular surgery.

BACKGROUND: Among venous thromboembolism, pulmonary thromboembolism (PTE) is one of the most serious postoperative complications. Deep venous thrombosis (DVT) is the main cause. Considering the unknown prevalence of DVT and PTE in the postoperative period of cardiovascular surgery in Japan, we investigated the incidence in consecutive patients who underwent cardiovascular surgery. METHODS: A total of 225 patients who underwent cardiovascular surgery at four hospitals consented to participate in the study. We assessed DVT using lower extremity venous ultrasound preoperatively and postoperatively. Seven patients with preexisting DVT were excluded. Postoperative antithrombotic therapy was administered at the discretion of the attending physician at each institution. The postoperative intermittent pneumatic compression therapy followed the standard prophylaxis protocol at each institution. Patients were grouped into DVT and non-DVT cohorts for comparison. Continuous variables were expressed as means ± standard deviations and compared by the t-test. RESULTS: The analysis of lower extremity venous ultrasound images indicated that DVT developed in 16 of the 218 study patients (DVT, 7.3%). No patient had PTE. Procedure-related data revealed significantly higher total blood transfusion (DVT group: 61.2 ± 49.9 IU vs. non-DVT group: 27.7 ± 30.2 IU: p = 0.018, effect size = 1.048) in the DVT group. The multivariate logistic regression predictor of DVT based on preoperative, intraoperative, and postoperative factors was blood transfusion (p = 0.005, 95% confidence interval 1.010-1.059, odds ratio 1.034). CONCLUSIONS: The incidence of postoperatively developed DVT was 7.3% in this study.

Longitudinal assessment of health-related quality of life and clinical outcomes with at home advanced pneumatic compression treatment of lower extremity lymphedema.

OBJECTIVE: This prospective, longitudinal, pragmatic study describes at home treatment with a proprietary advanced pneumatic compression device (APCD) for patients with lower extremity lymphedema (LED). METHODS: Following institutiona review board approval, four participating Veterans Affairs centers enrolled LED patients from 2016 to 2022. The primary outcome measures were health-related quality of life (HR-QoL) questionnaires (lymphedema quality of life-leg and the generic SF-36v2) obtained at baseline and 12, 24, and 52 weeks. The secondary outcome measures were limb circumference, cellulitis events, skin quality, and compliance with APCD and other compression therapies. RESULTS: Because a portion of the trial was conducted during the coronavirus disease 2019 pandemic, 179 patients had 52 weeks of follow-up, and 143 had complete measurements at all time points. The baseline characteristics were a mean age of 66.9 ± 10.8 years, 91% were men, and the mean body mass index was 33.8 ± 6.9 kg/m2. LED was bilateral in 92.2% of the patients. Chronic venous insufficiency or phlebolymphedema was the most common etiology of LED (112 patients; 62.6%), followed by trauma or surgery (20 patients; 11.2%). Cancer treatment as a cause was low (4 patients; 2.3%). Patients were classified as having International Society for Lymphology (ISL) stage I (68.4%), II (27.6%), or III (4.1%). Of the primary outcome measures, significant improvements were observed in all lymphedema quality of life-leg domains of function, appearance, symptoms, and emotion and the overall score after 12 weeks of treatment (P < .0001) and through 52 weeks of follow-up. The SF-36v2 demonstrated significant improvement in three domains at 12 weeks and in the six domains of physical function, bodily pain, physical component (P < .0001), social functioning (P = .0181), role-physical (P < .0005), and mental health (P < .0334) at 52 weeks. An SF-36v2 score <40 indicates a substantial reduction in HR-QoL in LED patients compared with U.S. norms. Regarding the secondary outcome measures at 52 weeks, compared with baseline, the mean limb girth decreased by 1.4 cm (P < .0001). The maximal reduction in mean limb girth was 1.9 cm (6.0%) at 12 weeks in ISL stage II and III limbs. New episodes of cellulitis in patients with previous episodes (21.4% vs 6.1%, P = .001) were reduced. The 75% of patients with skin hyperpigmentation at baseline decreased to 40% (P < .01) at 52 weeks. At 52 weeks, compliance, defined as use for 5 to 7 days per week, was reported for the APCD by 72% and for elastic stockings by 74%. CONCLUSIONS: This longitudinal study of Veterans Affairs patients with LED demonstrated improved generic and disease-specific HR-QoL through 52 weeks with at home use of an APCD. Limb girth, cellulitis episodes, and skin discoloration were reduced, with excellent compliance.

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.

Procedure-Specific Thromboprophylaxis in Urological Surgeries: A Narrative Review.

PURPOSE: Postoperative pulmonary embolism is a leading cause of mortality in patients undergoing major urologic surgeries, presenting a complex challenge in balancing the risks of venous thromboembolism (VTE) and perioperative bleeding. This study examines the current evidence on thromboprophylaxis in urological procedures, focusing on procedure-specific considerations. METHODS: Literature on thromboprophylaxis in urological procedures was reviewed during the past decade. RESULTS: Various mechanical thromboprophylaxis methods, such as compression stockings, pneumatic compression devices, foot pumps, mobilization, and exercises, are available preventive measures. Additionally, unfractionated heparin (UFH) and low molecular weight heparin (LMWH) are commonly used pharmacological agents for VTE prevention, with the choice between mechanical, pharmacological, or combined approaches tailored to individual patient characteristics and surgical requirements. Patient risk stratification into low, medium, and highrisk categories based on age, BMI, and VTE history guides the selection of thromboprophylaxis strategies. Surgical procedures are categorized as oncological or non-oncological, with uro-oncological surgeries posing a higher VTE risk than non-oncological procedures. Consequently, a combination of pharmacological and mechanical prophylaxis is typically recommended for uro-oncological patients, while pharmacological prophylaxis is reserved for high-risk individuals undergoing non-oncological surgeries. Mechanical prophylaxis is advised for high-risk patients undergoing procedures with elevated VTE risk. CONCLUSION: This study summarized an optimal thromboprophylaxis protocol taking into account patient risk factors and the specific urological procedure.

Effects of intermittent pneumatic compression on the recovery of cardiovascular parameters after repeated sprint exercise.

PURPOSE: Intermittent pneumatic compression (IPC) applies gradual pressure to facilitate lymph and blood flow movement to reduce exercise-induced tissue fluid accumulation and plasma volume loss. This study aimed to evaluate the cardiovascular system response during the recovery with IPC compared with passive recovery (Sham). METHODS: Sixteen volunteers (7 females and 9 males) executed a cycling-based exhausting sprint interval exercise (8 × 20 s all out), followed by a 30-min IPC or Sham condition. Participants performed two trials in a randomised, counterbalanced, and crossover design. Several cardiovascular parameters (blood pressure, heart function, and peripheral vascular resistance) were recorded at baseline (5'), through the recovery protocol (30'), and afterwards (5'). RESULTS: The use of IPC during the recovery phase led to a faster recovery, stated in relative values to pre-exercise, in mean blood pressure (102.5 ± 19.3% vs. 92.7 ± 12.5%; P < 0.001), and cardiac output (139.8 ± 30.0% vs. 146.2 ± 40.2%; P < 0.05) in comparison to Sham condition. Furthermore, during the IPC-based recovery, there was a slower recovery in cardiac pressure change over time (92.5 ± 25.8% vs. 100.5 ± 48.9%; P < 0.05), and a faster return to pre-exercise values in the peripheral vascular resistance (75.2 ± 25.5% vs. 64.8 ± 17.4%; P < 0.001) compared to Sham. CONCLUSION: The application of IPC after high-intensity exercise promotes the recovery of the cardiovascular system, reducing cardiovascular strain. Future investigations should consider the effects on the sympathetic-parasympathetic balance, such as heart rate variability, to assess further bonds between the use of IPC and autonomous control.

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.

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.

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.