Pneumatic Compression Devices Research Articles

Patient Centered Outcomes of a Lymphedema Pump in Patients with Symptomatic Lower Extremity Edema

Phlebolymphedema is a challenging condition to manage, with limited options for effective treatment. For patients, this may be debilitating and lead to infection, loss of independence and affect quality of life (QOL). This study aims to evaluate patient-reported outcomes of an advanced pneumatic compression device (APCD) in the treatment of lower extremity phlebolymphedema. Patients with diagnosis of lower extremity phlebolymphedema at an acute care facility within the New York City Health and Hospitals Cooperation treated with the Flexitouch (FLX; Tactile Systems Technology, Inc, Minneapolis, Minnesota) APCD from December 2021 to March 2023 were evaluated. Patient-perceived subjective outcomes were assessed via a short questionnaire, with subsequent analysis using Chi-squared test. Primary endpoints were subjective improvements in 1) swelling, 2) pain, and 3) ease of use of device as surrogates for patient satisfaction. Secondary endpoint was subjective patient-reported compliance, obtained by investigating 1) if patients were trained to use device, and 2) if patients were using the device. A total of 52 participants were included in this study, consisting of 30.8% male and 69.2% female patients with a mean age of 71.7 years. While selection criteria did not exclude unilateral disease or alternative etiologies, we note that the entire study population had been diagnosed with bilateral lower extremity lymphedema in the setting of chronic venous insufficiency. Other patient characteristics including race, comorbidities and smoking status were documented in Table 1. Table 2 demonstrates the results of Chi-squared analysis. This study noted significant patient-perceived improvement in swelling and pain (91.4% with P < 0.00001; 85.7% with P = 0.00002 respectively) as well as patient-reported ease of use of the FLX device (85.7% with P = 0.00002). Additional secondary findings included a majority of patients reporting being trained on how to use FLX and also maintaining compliance with the device (69.2% with P = 0.005; 67.3% with P = 0.012 respectively). FLX APCD use has been found to demonstrate desirable patient-reported outcomes as a general trend. The participants in this study noted statistically significant subjective improvement in swelling and pain, ease of use of device as well as adherence to training and compliance with device. FLX appears to be positively received by patients, and the authors recommend its consideration for management of bilateral lower extremity phlebolymphedema.

New non-drug technologies for lymphedema associated with breast cancer: a review

INTRODUCTION. Breast Cancer-Related Lymphedema (BCRL) is the most common complication after radical treatment of breast cancer (BC). Currently, there are no molecular therapeutic targets whose pharmacologic action could prevent edema, making it necessary to study the efficacy of non-pharmacologic techniques. AIM. To study the effectiveness of non-medication technologies in BCRL to develop recommendations for practical application based on the analysis of systematic reviews and meta-analyses of randomized controlled trials (RCTs). MATERIALS AND METHODS. The search was conducted in the Physiotherapy Evidence-Based Database (PEDro, 2002–2024) using the keywords: “lymphedema”, “upper limbs”, “breast cancer”. A total of 203 sources were selected as of March 2024. RESULTS AND DISCUSSION. Numerous studies have found that the use of early postoperative physical exercise with a gradual expansion of the load in patients at risk of developing BCRL is a safe and effective method of rehabilitation. The effectiveness of early preventive use of manual lymphatic drainage (MLD) in 4 RCTs was studied in a Cochrane review. However, the clinical effectiveness of early prophylactic use of MLD to prevent BCRL remains insufficiently proven. In contrast, prophylactic use of compression sleeves has been shown to reduce and delay the onset of arm lymphedema in women at high risk of developing BCRL during the first year after breast cancer surgery. Studies have also confirmed the effectiveness of an early Prospective Surveillance Model using bioimpedance spectroscopy for early detection and immediate treatment of BCRL. It has been proven that in order to reduce the volume of a limb with BCRL, it is necessary to prescribe an intensive phase of complex decongestive therapy (CDT) for at least 3 weeks. Studies have also proven the effectiveness of using a standard or improved intermittent pneumatic compression device in the rehabilitation phases, including at home. CONCLUSION. To reduce the risk of development and progression of BCRL, modern exercise therapy techniques should be used to increase physical activity in order to control body weight, and educational techniques for self-massage and self-application of compression bandages should be actively used. The “golden” standard for conservative treatment of BCRL remains CDT, which is based on MLD. At the same time, the wider use and development of new methods of hardware lymphatic drainage that imitate MLD, which is a highly resourceful and costly method of treatment for BCRL, is justified. To confirm the clinical effectiveness of improved hardware pneumocompression, additional RCTs assessing long-term treatment results are required.

Timeframe for lymphedema therapy for head and neck cancer survivors.

e13535 Background: More than 90% of head and neck cancer (HNC) survivors experience secondary head and neck lymphedema. Prompt identification and treatment are essential given the progressive nature of lymphedema and potential complications. Usual care includes complete decongestive therapy performed by a lymphedema therapist followed by lifelong home self-care. The ability to participate in lymphedema therapy (LT) is deleteriously impacted by numerous barriers. We are conducting a phase 3 multisite randomized trial involving HNC survivors with treatment-naïve lymphedema which compares usual lymphedema care to the use of an advanced pneumatic compression device (APCD). For patients treated on the usual care arm, data pertaining to LT delivery was collected prospectively. Herein we report the preliminary analysis from this dataset. Methods: Eligible patients were age ≥18 years, had pathologically confirmed HNC, completed curative intent cancer therapy with no evidence of active cancer, were diagnosed with internal or external head and neck lymphedema with at least one core lymphedema associated symptom and had not previously received treatment for lymphedema. Participants were randomized to either usual care with complete decongestive therapy directed by a lymphedema therapist followed by home self-care or daily self-directed use of APCD. Anatomic measurements and patient reported outcome measures were obtained at 2-, 4- and 6-month endpoints. The intervention phase lasted 6 months and therapy records were received for analysis. Key outcome measures included the time from referral to LT evaluation consultation, time from LT evaluation to treatment session and time from referral to treatment session. Results: At the time of this analysis, 87 participants randomized to usual care arm were eligible for inclusion in this assessment. Of the 87 patients, we were unable to document completion of LT consultation or therapy for 39 patients. Among the 48 participants who were referred for LT and received therapy, 72% were male and 28% were female, with 91% identifying as white, 7% as black, and 2% as other. The average age was 62. The mean time from referral by a health care provider to initial lymphedema consultation was 19.6 (σ 18.1) days. Of note, there was a wide-ranging timeframe from referral to LT treatment, varying from 0 to 93 days. The mean time from consultation to treatment was 1.7 days (σ 5.1) and referral to treatment was 21.3 (σ 17.8). Conclusions: A key finding of this study is the high rate (45%) of those referred for LT were not documented to complete a therapy consultation or to receive therapy. Of those patients who receive therapy, consultation and treatment were delay significantly in a high percentage of patients. These finding highlight the need for additional investigation into barriers to timely implementation of LT for head and neck cancer survivors. Guidelines and standards of care should be developed to guide practitioners. Clinical trial information: NCT04797390 .

A Multi-center Cross-Sectional Assessment of Healthcare Professionals' Knowledge, Attitudes, and Practices Toward Thromboprophylaxis.

Background Venous thromboembolism (VTE) is a potentially avoidable condition that affects hospitalized patients. Risk stratification and preventative strategies have substantial evidence supporting their use, but reasons hinder widespread adoption, compliance, and success, explaining the continuation of VTE. Thromboprophylaxis consists of several measures that are frequently adopted to avoid the complications of VTE. The study evaluated knowledge, attitude, and practice towardusing thromboprophylaxis by health professionals. Methods This multi-center cross-sectional study was carried out on health professionals involved in patient care working in various secondary and tertiary hospitals in the study region between October 2023 and February 2024. A previously published questionnaire was sent in the form of an online survey to the study participants. Fifteen, ten, and ninequestions evaluated the participants' knowledge, attitude, and practice of thromboprophylaxis, respectively. The study followed the checklist for reporting results of the Internet E-survey (CHERRIES) guidelines. Frequency and percentages were calculated. Bi-variable and multi-variable logistic regression were carried out and presented as crude and adjusted odds ratios with corresponding 95% confidence intervals. AP-value of <0.05 was considered significant. Results Of the 219 participants, 115 (52.5%) and 104 (47.5%) were males and females. More than 50.7%were in the age group of >30 years, and the majority of the participants possessed a bachelor's (104 (47.5%)) degree. One hundred seventy-six (80.4%)of the study participants were working in government hospitals, and the majority (112 (51.1%)) were nurses. One hundred sixty-two (74% (67.63-79.65)), 175 (79.9% (73.98-85.01)) and 211 (96.3% (92.93)) had satisfactory knowledge, a positive attitude, and good practice regarding thromboprophylaxis, respectively. Regarding the facility characteristics, 196 (89.5%), 150 (68.5%), and 164 (74.9%) respondents agreed with the availability of a VTE prevention policy, VTE prevention consultants, and the availability of anticoagulants. Eighty (36.5%)participants responded with a 'not availability' of pneumatic compression devices. Of the 15 knowledge questions, the majority (124 (56.6%)) participants faulted the false statements regarding 'patients of DVT being symptomatic' and 119 (54.3%) on the statement that helping patients 'out of bed activity does not prevent VTE'. On multi-variable analysis, participants who were aware of having a VTE prevention policy and availability of anticoagulants were more knowledgeable with adjusted odds ratios of 5.39 (1.88-15.39) and 2.52 (1.12-5.63) respectively. Every practice domain received >90% approval ratings. Conclusions The study concludes that an overall satisfactory knowledge and positive attitude regarding thromboprophylaxis exists among the participants. The study proposes more training sessions on VTE prevention and orientation of health professionals on the availability of VTE policy guidelines and facility availability of resources for thromboprophylaxis.

Head and neck cancer survivors’ perception of lymphedema care.

e24046 Background: Secondary lymphedema and fibrosis occurs in more than 90% of HNC survivors. Given the progressive nature of lymphedema, prompt identification and treatment are essential. Treatment of HNC related lymphedema is fraught by numerous barriers. Advanced pneumatic compression devices (APCD) may address critical barriers. We conducted a phase 3 randomized multi-site trial in HNC survivors with treatment naïve lymphedema comparing usual care to APCD. Here in we report a qualitative analysis of participants treatment experience. Methods: Semi-structured interviews were audio recorded and transcribed after participants completed the 6th-month visit (N = 14 usual care, N = 23 APCD). Questions addressed treatment experience, perceptions of care, barriers, and facilitators. A hierarchical coding system was developed and refined using the interview guide and preliminary review of the transcripts. Transcripts were coded by experienced qualitative researchers. The coded transcripts were analyzed using an iterative inductive-deductive approach and based on our theoretical framework. Results: Participants were 65% male, 35% female and identified as 92% white, 5% black, and 5% Hispanic. The average age was 62 with a range of 32-82. We identified two distinct and one common set of barriers and facilitators. For usual care, health system (care coordination, logistics) and therapist factors (perceived skills and demeanor) were important while device characteristics (fit, comfort) were important for the APCD. Cognitive affective factors (self-efficacy, knowledge, outcome expectations, frustration) were similar for both therapies and interacted with the device/system characteristics. Conclusions: We identified distinct treatment barriers and facilitators for usual lymphedema care and treatment with APCD. Barriers identified in this study highlight practice changing opportunities to address system issues and develop interventions to enhance care and quality of life. Utilization of both treatment strategies may allow tailoring of treatments thus optimizing outcomes. Clinical trial information: NCT04797390 .

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

ObjectiveThis prospective, longitudinal, pragmatic study describes at home treatment with a proprietary advanced pneumatic compression device (APCD) for patients with lower extremity lymphedema (LED). MethodsFollowing 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. ResultsBecause 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%. ConclusionsThis 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.

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. 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. 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 24h. 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. 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 17.2h per day (4.0) in the MAC group and 7.5h per day (8.8) in the IPC group, which was statistically significant (p < .001). Our findings suggest that the MAC device can improve compliance with mechanical prophylaxis.

Incidence and risk factors of venous thromboembolism in neurosurgical patients after implementing a screening protocol; a retrospective cohort study of a tertiary center

Introduction: Venous thromboembolism (VTE) is a common complication in neurosurgical procedures both before and after surgery. Objective: To examine the incidence of venous thromboembolism (VTE) in neurosurgical patients before surgery and in the postoperative period after implementing a VTE prophylaxis protocol. We also aimed to determine VTE risk factors. Methods: We conducted a retrospective cohort study examining 200 patients admitted to the hospital for cranial and spine neurosurgical procedures between January 2020 and October 2021. All patients were screened for VTE using a protocol combining measurement of D-dimer level and venous duplex ultrasonography. Patients who screened negative for VTE were evaluated for VTE risk using the Caprini risk assessment model; those with Caprini score ≥3 (indicating moderate-to-high risk) received VTE prophylaxis using intermittent pneumatic compression devices. Results: Preoperative screening demonstrated DVT in seven of 200 patients (3.5%). All DVTs were asymptomatic and proximal in location. Univariate logistic regression showed that stroke, neurodegenerative disease, and confinement to bed for more than 72 hours were significant predictors of preoperative DVT. Among the patients without DVT on preoperative screening, 179 (93%) had a Caprini score ≥3; intermittent pneumatic compression was used for prophylaxis in 173 of these (96.6%). Incidence of postoperative VTE was 2.6% (5/193). Extended length of hospital stay, postoperative hydrocephalus, and infection were significant risk factors for VTE. Conclusion: Preoperative VTE screening using D-dimer level and V-DUS and implementation of VTE prophylaxis using IPC can reduce the incidence of VTE and VTE-related mortality in neurosurgical patients.

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)

IntroductionVenous 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...

Trends in pneumatic compression devices and their impact on patient outcomes: a review

Pneumatic compression devices have seen a remarkable evolution in recent years with innovative designs and applications. This review explores the trends in pneumatic compression devices and their impact on patient outcomes. Pneumatic compression devices are widely used in various medical contexts, such as wound care, lymphedema management, and venous thromboembolism prevention. This review summarizes the findings of recent studies that investigate the effectiveness of these devices in improving patient outcomes. We discuss the evolving technology, clinical applications, and evidence of their impact on parameters like wound healing, edema reduction, and venous thromboembolism prevention. Through an analysis of the current literature, we aim to provide valuable insights for healthcare practitioners, policymakers, and researchers, emphasizing the significance of pneumatic compression devices in modern patient care.

The effectiveness of pneumatic compression devices in preventing venous thromboembolism in patients undergoing elective spine surgeries

Objectives: Venous thromboembolic events are devastating complications that may arise following spine surgery with rates ranging from 0% to 14% in the literature. Orthopedic procedures increase the risk of thromboembolic events, and diagnosis is often challenging due to the varying presentations. Most research on venous thromboembolism (VTE) and international standards emphasizes that prevention such as mechanical prophylaxis is more crucial than therapy. This study aimed to assess the effectiveness of pneumatic compressive devices in preventing VTE in spinal surgery patients. Methods: This retrospective cohort study assessed the outcomes of mechanical prophylaxis in the form of pneumatic devices in 547 patients at our institution over five years from 2016 to 2021. Above-knee pneumatic compression stockings were applied before, during, and after surgery with patient outcomes being recorded. Results: Data was collected from 547 patients, who underwent elective spinal surgery at our center between January 2016 and January 2021. The mean age was 47.27 years (±20.84), and most patients were male (63.1%). Most patients were classified as having a low risk (35.6%) or mild risk (43.5%) of VTE determined by the Caprini score. Following spinal surgery, only one patient in our cohort experienced post-operative VTE (0.18%). Conclusion: Pneumatic compression effectively prevents VTE in patients undergoing elective spine surgery. Although pharmacologic prophylaxis has traditionally been used to prevent VTE, pneumatic compressive devices represent an alternative or supplementary approach to reduce the risk of VTE further.

Precision nursing and intermittent pneumatic compression significantly reduce perioperative deep vein thrombosis in post-surgical ovarian cancer patients.

This study investigated the efficacy of precision nursing combined with intermittent pneumatic compression (IPC) devices in preventing perioperative deep vein thrombosis (DVT) in patients with ovarian cancer. A retrospective analysis was conducted on 136 ovarian cancer surgery patients at Xi'an People's Hospital from February 2019 to April 2023. The patients were divided into two groups: 71 patients received precision nursing with IPC intervention (study group), while the remaining received standard nursing care (control group). Key variables analyzed included operation duration, intraoperative blood loss, postoperative blood transfusion requirements, changes in limb circumference, and variations in coagulation parameters activated partial thromboplastin time (APTT), D-Dimer (D-D), Fibrinogen (FIB), and Prothrombin Time (PT) before and after surgery. The incidence of DVT was recorded in both groups to determine risk factors for deep vein thrombosis. No significant differences were observed between the groups regarding operation duration, intraoperative blood loss, and postoperative blood transfusion rates (P > 0.05). Post-intervention, significant improvements were noted in the study group, with reduced FIB and D-D levels and increased PT and APTT levels compared to the control group (P < 0.05). Furthermore, the study group exhibited a significantly smaller post-intervention difference in limb circumference and a lower incidence of DVT (P=0.003). Precision nursing combined with IPC, pre-intervention D-D < 498.5, and FIGO stages III+IV were identified as independent factors against DVT development. Precision nursing paired with an IPC device significantly reduces the risk of perioperative DVT in ovarian cancer patients compared to conventional care.

Characteristics and Effects of Intermittent Pneumatic Compression Devices Interventions to Prevent Venous Thromboembolism in Critical Care Patients: A Systematic Review of Randomized Controlled Trials

Characteristics and Effects of Intermittent Pneumatic Compression Devices Interventions to Prevent Venous Thromboembolism in Critical Care Patients: A Systematic Review of Randomized Controlled Trials

Comparison of different intervention methods to reduce the incidence of venous thromboembolism: study protocol for a cluster-randomized, crossover trial

BackgroundVenous thromboembolism (VTE) remains a priority challenge among orthopedic trauma patients. It is crucial to further improve the prophylaxis against VTE in routine orthopedic treatment. This study aims to compare the efficacy of two low molecular weight heparin (LMWH) regimens and additional intermittent pneumatic compression in preventing VTE among orthopedic trauma patients.Methods and analysisThis is a cluster-randomized crossover clinical study conducted in four hospitals in Shanghai from December 2019 to December 2023. The unit of randomization is orthopedic wards, and each ward will define a cluster. All clusters will implement four diverse intervention measures and one control measure in a given random sequence. Perioperative orthopedic trauma patients aged ≥ 18 years with stable vital signs, Caprini score > 2, and no contraindication of anticoagulation or intermittent pneumatic compression (IPC) devices will be eligible. The sample size will be determined to be 2590, considering cluster effect, period effect, and interactions. We will generally use the intention-to-treat (ITT) at the subject level for each outcome. For the primary outcome of the study, the incidence of VTE will be presented as risk ratio and 95% CIs. Generalized estimating equation (GEE) will be deployed to compare differences and adjust cluster effect, period effect, and interaction among interventions and periods if applicable.DiscussionVTE is a complication that cannot be underestimated after major orthopedic surgery. Early identification, early assessment, and early prevention can significantly reduce the incidence of VTE. Most guidelines recommend both medical and physical prevention, and we hope to demonstrate how they would affect the incidence among perioperative orthopedic patients. We want to explore if there is a difference between the two types of LWMH with or without an IPC device to provide more evidence for future guidelines and prevent more patients from the threat of VTE.Ethics and disseminationThe study received approval from the IRB of the coordinating center and all participating hospitals. Findings will be disseminated through peer-reviewed publications and conference presentations.Trial registrationChiCTR1900027659. Registered on 17 November 2019

Impact of text reminders on pneumatic compression device (PCD) compliance in patients with breast cancer-related lymphedema

PurposeDo cell phone text reminders impact the rate of compliance with pneumatic compression device (PCD) therapy among women with breast cancer-related lymphedema (BCRL)?MethodsA prospective, randomized, 2-group feasibility study conducted at 2 centers. Participants were adult females (≥18 years old) with unilateral BCRL who had the capability of receiving reminder text messages. All participants underwent PCD therapy. Participants were randomized 1:1 to control (no text messages) or test group (received text message reminders if the PCD had not been used for 2 consecutive days). The rate of compliance between treatment groups was the main outcome measure. Secondary outcome measures were changes in arm girth, quality of life (QOL), and symptom severity.ResultsTwenty-nine participants were enrolled and randomized, 25 were available for follow-up at 60 days (14 test, 11 control). Overall, 52.2% (12/23) of all participants were completely compliant, an additional 43.5% (10/23) were partially compliant, and 1 patient (4.3%) was noncompliant. The test and control groups did not differ in device compliance. In the pooled population, weight, BMI, and arm girth were improved. Overall disease-specific QOL and symptom severity were improved. Regression analysis showed benefits were greater among participants with higher rates of compliance.ConclusionsAutomated text reminders did not improve compliance in patients with BCRL as compliance rates were already high in this patient population. Improvements in weight, BMI, arm girth, disease-specific quality of life, and symptom severity measures were observed regardless of the treatment assignment. Full compliance resulted in greater functional and QOL benefits.Trial registrationThe study was registered at www.clinicaltrials.gov (NCT04432727) on June 16, 2020.

Conventional versus facilitated hemostatic dressings after radial artery puncture: a systematic review and meta-analysis

Abstract In the last thirty years, transradial access (TRA) became the gold standard access site for minimal invasive coronary diagnostics and therapy. Though the complication rate is relatively low, TRA is frequently iterated, therefore the slightest improvement could be utmost beneficial for a big proportion of cardiology patients. In recent few years, facilitated hemostatic dressings with the utilisation of chitosan and potassium ferrate molecules were introduced into the clinical practice to improve postprocedural hemostasis. The available evidence suggests that the novel dressings are decreasing complication numbers, but currently no coherent meta-analysis is available on the subject. We hypothesised that better clinical outcomes can be expected with the novel facilitated hemostatic dressings in terms of radial artery occlusion, radial artery damage, time to hemostasis and hematoma events compared to conventional mechanical compression devices. A systematic search was performed in Medline, Central Web of Science, Scopus and Embase on 13th January, 2023. Randomised controlled trials comparing chitosan and potassium-ferrate covered dressings to pneumatic or screwable mechanical compression devices. Observational studies, trials not reporting outcomes or containing scientifically unproven devices were excluded. The RoB 2 tool was used for risk of bias assessment, which was low across the included studies. As primary endpoint, radial artery occlusion (RAO) was determined, the secondary endpoints were hematoma events, time to hemostasis and radial artery damage (dissection, pseudoaneurysm). Raw data from the selected studies were pooled using a random effects model with the Mantel-Haenszel method and the Hartung-Knapp adjustment. Statistical heterogeneity across trials was assessed by means of Cochrane Q test, and the I2 values. Data of a total of 3524 patients were collected from 7 randomised controlled trials. Concerning the primary endpoint, RAO, a 0.70 relative risk (RR) was found (p=0.028, confidence interval (CI): 0.52-0.95) in favour of the facilitated hemostatic devices. In the chitosan subgroup a lower tendency of RAO in the facilitated group (RR: 0.66 p=0.059 CI: 0.42-1.03) was found. In the potassium ferrate subgroup no significant difference was observed between the devices (RR: 0.93 p=0.819 CI: 0.27-3.20). Low grade (EASY I/II) hematoma events were not significantly different between the two examined groups (RR: 0.76 p=0.268 CI: 0.43-1.32). Time to hemostasis was 95.8 (mean difference, p≺0.001 CI: 46.8-144.9) minutes shorter in the facilitated devices group from 5 studies containing 2132 patient’s data. This meta-analysis includes the largest number of patients for facilitated hemostatic dressings to date. These devices lower the incidence of RAO by 30% compared to mechanical compression devices with the additional advantage of reduced compression times. More randomised controlled clinical trials are needed in the subject.

Prevention of venous thromboembolism in acute spontaneous intracerebral haemorrhage: A survey of opinion

IntroductionPeople immobilized following acute spontaneous intracerebral haemorrhage (ICH) are at risk of venous thromboembolism (VTE) but the role of short-term prophylactic anticoagulation remains uncertain. We surveyed UK clinical practice and opinion regarding preventing VTE after ICH. Patients and methodsAn online survey was sent to stroke healthcare professionals within the United Kingdom and Ireland via a professional society (British and Irish Association of Stroke Physicians (BIASP)). ResultsOne hundred and twenty-three staff members responded to the survey, of whom 80% were consultant stroke physicians. All responders except one considered the issue to be important or extremely important, but only 5 (4%) were “extremely certain” and 51 (41%) “fairly certain” regarding the optimal treatment approach. Intermittent pneumatic compression (IPC) devices alone were the most used method (in 60%) followed by IPC devices and switching to low molecular weight heparin (LMWH) (in 30%). We identified high levels of uncertainty regarding the role of anticoagulation, and its optimal timing; uncertainty was greater in lobar compared to deep ICH. Most respondents (93%) consider a randomised controlled trial investigating the role of pharmacological VTE prophylaxis after acute ICH as important and would consider participation. Discussion and conclusionThe optimal method for the prevention of VTE in non-traumatic ICH patients remains an area of clinical uncertainty. Clinical trials assessing short-term anticoagulation in patients after acute ICH would be beneficial in providing evidence to resolve this clinical dilemma.

Coverage News You Can Use: Pneumatic Compression Devices and Surgical Dressings.

Coverage News You Can Use: Pneumatic Compression Devices and Surgical Dressings.

The Wound Express System, A Potential Treatment for Patients with Ulcers and Non-Operable Arterial Disease: A Pilot Safety Study

Background: Intermittent pneumatic compression (IPC) devices apply intermittent compression to the thigh, which is thought to facilitate wound healing by improving wound perfusion in patients with chronic limb-threatening ischemia and no option for revascularization. Wound Express is an IPC device but its safety and efficacy are currently unclear. In this study, we aimed to determine the safety of the Wound Express IPC system in this high-risk cohort.Methods: This was a prospective, non-controlled, non-randomized pilot safety study. In total, 19 patients were screened for inclusion and 10 were recruited. IPC was applied for 2 hours per day for 12 weeks. The primary endpoint was any treatment-related adverse event in the first 3 months. Secondary endpoints included pain using the visual analogue scale, limb status assessed using the Wound, Ischemia, Foot Infection (WIFi) score and quality of life using the Vascular Quality of Life Questionnaire (VASUQOL) score.Results: Of the 10 patients who were enrolled, eight completed the 12-week course. There were no treatment-related adverse events. One patient died from coronavirus disease 19-related disease and two withdrew for reasons unrelated to treatment. Median pain scores were reduced from 6 to 0, while median VASUQOL increased from 10 to 16.5. WIFi scores were reduced in three out of eight of participants (37.5%).Conclusion: Wound Express appears to be safe and may decrease pain, improve wound healing and improve quality of life for chronic limb-threatening ischemia patients. Adequately powered, prospectively randomized trials of the Wound Express system to assess its efficacy and safety are warranted.

An Evidenced-Based Review of the Prevention of Venous Thromboembolism in Traumatic Patients with Intermittent Pneumatic Compression Devices.

To search, evaluate, and summarize the best evidence of intermittent pneumatic compression devices to prevent venous thromboembolism in trauma patients. Evidence retrieval was conducted from top to bottom according to the "6S" evidence model, including guidelines, clinical decision making, evidence summary, expert consensus, and systematic reviews. The retrieval time limit was from the establishment of the database to August 31, 2022. Two researchers independently evaluated the quality of the literature, extracted evidence, and summarized evidence. A total of 140 studies were obtained in the literature retrieval, and 50 studies were obtained after rechecking and reading the title and abstract. After combining the inclusion and exclusion criteria, 19 studies were finally included. Among them, there were 12 guidelines, 1 clinical decision making, 1 evidence summary, 1 expert consensus, and 4 systematic reviews. The 27 best pieces of evidence were summarized from the four dimensions of pretreatment evaluation, contraindications and applicable conditions, treatment strategies, training, and patient education. This study summarized the evidence of using an intermittent pneumatic compression device to prevent venous thromboembolism in trauma patients and provided the basis for scientific and effective standardized management of mechanical thromboembolism prevention. When applying evidence, it is necessary to combine clinical practice and patient wishes and select evidence pertinent to improving the effectiveness of intermittent pneumatic compression devices in preventing venous thromboembolism. In addition, compliance with the clinical application of IPC is relatively low, so we should start from two aspects before the application of evidence. We should not only increase the number of IPCs but also strengthen the training of VTE prevention knowledge and practical skills of medical staff to provide good health education for patients and their families to improve compliance with the clinical application of IPC.