Intermittent pneumatic compression therapy as a preventive measure for venous thromboembolism after total hip arthroplasty: A systematic review

TL;DR

Intermittent pneumatic compression (IPC) therapy helps prevent blood clots after hip replacement surgery, especially when combined with medication.

Contribution

This systematic review evaluates IPC's effectiveness in preventing VTE after THA, emphasizing its combination with pharmacological agents.

Findings

IPC combined with pharmaceutical agents is most effective in reducing VTE risk after THA.

IPC alone is better than no prevention but less effective than combined IPC and anticoagulants.

IPC is a key part of comprehensive VTE prevention strategies in THA.

Abstract

Venous thromboembolism (VTE) is a significant and avoidable complication that may occur after total hip arthroplasty (THA). Various mechanical and chemical prophylactic measures may mitigate this elevated risk of death and functional impairment. Consequently, early prevention of VTE is essential via the identification of related risk factors.

A search was performed using the databases of PubMed, ScienceDirect, PEDro, and Cochrane Library to get papers from 2004 to 2024 in accordance with PRISMA guidelines. Only randomized controlled trials (RCTs) published in English that included at least one group undergoing intermittent pneumatic compression (IPC) treatment as a prophylactic intervention after total hip arthroplasty (THA) were included. This systematic review has been registered in PROSPERO. The quality evaluation of the included studies was conducted using the PEDro scale and the Cochrane risk of bias instrument.

We selected 12 studies from a total of 733 based on predetermined criteria. A total of 2,352 patients of both genders underwent total hip arthroplasty, comprising 1,294 patients in the experimental group and 1,058 patients in the control group across the included studies. The results indicate that the combination of IPC and pharmaceutical agents was the most effective treatment for reducing VTE risk in patients who underwent THA.

IPC therapy is very effective in avoiding VTE, particularly when used in combination with pharmacological therapies after THA surgery. The best ways to lower the risk of VTE are to use both IPC and anticoagulants together. However, IPC alone may lower the risk of VTE compared to not using any prevention at all. In general, IPC is a crucial component of comprehensive VTE prevention strategies in THA.

Figures

PRISMA flow chart of the study.

Cochrane risk of bias of all included studies.

Full text

Introduction

Hip arthroplasty is the most common surgical intervention for addressing hip joint disorders, which includes hemiarthroplasty and total hip arthroplasty (THA). Total hip arthroplasty yields superior results for patient functionality and quality of life, as well as improved clinical outcomes [1]. THA involves replacing both articular surfaces of the hip with prosthetic implants, which consist of the acetabular component, the femoral component, and the bearing surfaces fitted into their natural positions with or without cement [2]. Annually, more than 1 million hip replacement procedures are conducted worldwide [3]. Despite the global success of THA surgery, it is associated with systemic and procedure-specific complications like venous thromboembolism (VTE), hematoma formation, nerve injury, fracture, postoperative dislocation, deep infection, wound, heterotopic ossification, and other arthroplasty-related issues [4,5]. Among these problems, VTE is a prominent and serious concern in individuals who have undergone THA. It includes deep vein thrombosis (DVT) and pulmonary embolism (PE), primarily resulting from endothelial damage, a hypercoagulable condition, and venous stasis [6,7]. Additional potential risk factors for the development of in-hospital VTE encompass advanced age (>70 years), female sex, obesity, diabetes mellitus, cardiovascular illness, revision surgery, cement fixation, hemorrhage, and a prior history of VTE [8].

The prevalence of VTE following THA ranges from 40% to 80%, with a median occurrence of 0.6% (DVT approximately 0.24% and PE around 0.41%), potentially up to 2.5% in revision THA [9]. Thus, the timely prevention of VTE with recommended prophylaxis is essential to prevent additional complications, such as post-thrombotic syndrome and pulmonary embolism [7,10,11]. Various approaches exist for the treatment of VTE, with the most prevalent being chemical prophylaxis, which encompasses the use of various anticoagulants, and mechanical prophylaxis, which involves the application of devices such as graduated compression stockings, elastic stockings, and foot pumps [12,13]. Chemical prophylaxis is linked to bleeding and wound complications, while mechanical prophylaxis is devoid of such side effects [13]. Conversely, numerous research studies and guidelines indicate that the synergistic effect of both mechanical and chemical prophylaxis is more advantageous than the use of either method alone [14,15].

The intermittent pneumatic compression (IPC) device features an inflatable sleeve encircling the calf or foot, which is linked to an electrical pneumatic pump that inflates the sleeve with air. This exerts external pressure on the leg or foot, compressing the deep vein, enhancing blood circulation, and reducing the formation of blood clots, hence diminishing the risk of VTE [13,16]. Researchers conducted numerous clinical studies to evaluate the effectiveness of IPC devices as a safe and preferable approach for mitigating VTE following major orthopedic surgeries. Despite being a non-invasive therapy, researchers have not thoroughly studied the effectiveness of IPC as a stand-alone or supplemental intervention for the prevention of VTE in patients with THA. The aim of this systematic study was to assess the efficacy of IPC in mitigating the risk of VTE in patients undergoing THA. This evaluation may assist clinicians in enhancing postoperative care and could offer a safer, non-pharmacological alternative to anticoagulants for IPC therapy.

Methods

This research adheres to the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) criteria and presents the required information appropriately [17]. This systematic review has been registered in PROSPERO under registration number CRD42024553081.

Search strategy

Electronic databases including PubMed, Web of Science, Science Direct, Cochrane Library, and PEDro, were collectively searched to assess evidence regarding IPC for the prevention of VTE in patients with post-THA, restricting the search to studies published in English from 2004 to 31 August 2024. Boolean terms were used with keywords like “total hip arthroplasty,” “intermittent pneumatic compression,” “mobile compression device,” “post-surgical complications,” “venous thromboembolism,” “deep vein thrombosis,” and “pulmonary embolism,” as seen in Table 1.

Table 1: Search strategy with keywords.

Eligibility criteria

The studies were chosen according to predetermined selection criteria based on PICO (participants, intervention, comparison, outcomes) as shown in Table 2. This analysis encompassed papers from both male and female patients, aged 40–80 years, who underwent THA. The treatments included IPC devices either alone or in conjunction with anticoagulants, whereas the outcome measurements encompassed Duplex or Doppler ultrasonography, CT angiography, girth measurement, NPRS scale/VAS, and bleeding evaluation. This review excluded studies including preoperative patients receiving just pharmaceutical therapy as an intervention, as well as randomized controlled trial designs published in languages other than English.

Table 2: Eligibility criteria based on PICO format.

Selection process

Two independent researchers performed a literature review employing pre-established research criteria. Subsequent to the removal of duplicate articles from the chosen studies, the researchers implemented a screening procedure by assessing the abstract and title of each study article prior to a comprehensive examination of the full text. Twelve articles that satisfied the review’s inclusion criteria were subsequently incorporated.

Data extraction process

After analyzing the selected articles, data extraction process was completed using a Microsoft Excel spreadsheet. The accompanying data were extracted from each included research: ‘first author name,’ ‘age of study participants,’ ‘participants in experimental and control groups,’ ‘intervention,’ ‘outcome measures and study conclusion.’ No author was consulted throughout the data extraction process.

Methodological quality

Two independent evaluators appraised the study quality using the ‘Pedro scale’ and the ‘Cochrane risk of bias instrument’. The PEDro assessment scale has 11 points, with a maximum attainable score of 10 points. The final score calculation excludes the first variable, which denotes the qualifying conditions. Every answer receives a score of either 1 or 0. A score ranging from 0 to 3 indicates “poor quality,” 4–5 signifies “fair,” 6–8 represents “good,” and > 9 defines “excellent” [18]. The “Cochrane risk of bias tool” assesses study quality by inquiring about random allocation, used treatments, unexamined outcomes, randomly assigned outcomes, and other biases present in published research. Three categories for the study were established based on these inquiries: low, medium, and high-risk bias [19].

Results

Study selection

A PRISMA flowchart illustrates the process of research selection. Utilizing several data search engines, we identified a total of 733 articles. Upon eliminating the duplicates, 431 articles remained. Seventeen articles were eliminated based on the title and abstract. A total of 264 (S1 Text) papers were evaluated based on full text/open access, and ultimately, 12 studies [6,7,10,20–28] were included into this systematic review, as seen in Fig 1. The PRISMA checklist is used to ensure transparent and comprehensive reporting of systematic reviews (S2 Text).

PRISMA flow chart of the study.

Methodological quality

PEDro scale.

The PEDro scale was used to evaluate the quality of the included studies. Two investigators computed the PEDro score for all included studies manually. Ten papers [6,10,20,21,23–28] in this review are classified as ‘good’ quality, whereas two articles [7,22] are deemed of fair quality, as shown in Table 3.

Table 3: Studies quality assessment based on the PEDro score.

Cochrane risk of bias

The Cochrane risk of bias tool was used to assess the quality of the research, as seen in Fig 2. The publications were classified into three risk categories: low, medium, and high. Of the 12 trials, 10 [6,10,20,21,23–28] demonstrate a minimal risk of bias regarding allocation concealment. Regarding participant blinding and outcome assessment blinding, almost every research exhibits a significant risk of bias. Regarding random sequence generation, eight studies [6,10,20,23,24,26–28] were included, whereas concerning incomplete outcome data, all 12 studies [6,7,10,20–28] shown a minimal risk of bias. In all papers examined, the author did not acknowledge any kind of reporting bias or other biases. Consequently, there was an ambiguous risk bias concerning two variables: inadequate data outcomes and reporting bias.

Cochrane risk of bias of all included studies.

Study and population characteristics

The data presented in Table 4 illustrates a notable consistency in the study and participant characteristics among the articles reviewed. All studies included were randomized controlled trials conducted in Korea [7] with additional trials carried out in India [10], Switzerland [6], China [22,29], Germany [25,26], the USA [23], Australia [27], Nepal [28], Japan [21], and Israel [20]. This analysis included 2,356 patients undergoing total hip arthroplasty, with 1,298 assigned to the experimental group and 1,058 to the control group. The prevalent outcome measures identified in the 12 articles analysed include duplex ultrasound, colour doppler ultrasound, pulmonary CT angiography, girth measurement, NPRS scale, pain visual analog scale, and bleeding assessment [6,7,10,20–28].

Table 4: Study and population characteristic.

Study intervention

Each study featured in this systematic review [6,7,10,20–28] incorporates at least one group where IPC is utilized as an intervention. The intervention group included 206 [26] participants in the IPC alone category, 617 [6,7,10,23,28] in the IPC with aspirin category, 348 [6,21,22] in the IPC with graduated stockings category, 342 [20,24–26] in the IPC with LMWH category, 168 in the IPC with enoxaparin category, and 167 in the IPC with rivaroxaban category [27].

While all intervention groups incorporated IPC, there was significant variability in the usage time, frequency, pressure, inflation-deflation duration, and overall treatment length. The treatment duration across all studies ranges from postoperative day 1 to postoperative day 16. Four studies suggest a usage duration for IPC between 6 and 8 hours daily [22–24,26]. Conversely, Eisele R et al [26] indicates a usage duration ranging from 2 to 10 hours daily. Paudel S et.al and Paudel S [10,28] support the implementation of IPC continuously throughout the day until mobilization occurs. Kwak HS et.al and Silbersack Y et.al [7,25] in their trial, indicate a continuous application of IPC whereas Wang D et.al, Liqun W et.al and Khalafallah A et.al [22,24,27] suggest continuous application ranges between 18–48 hours, and Carnevale PV et.al [6] recommends a 30-minute application period. The inflation pressure settings for the cuff vary between 45 and 100 mmHg.

Two studies recommended a pressure setting of 45 mmHg [22,26], while two others suggested a pressure of 52 mmHg [25,26] for distal cuff inflation. One study established a pressure of 50 mmHg [23], and another aimed for a pressure setting of 100 mmHg [6]. Six studies [6,7,22,23,25,26] implemented a treatment duration of 10 days, while two studies (8,24) utilized IPC until the 4th post-operative day. Additionally, two studies [23,26] suggested a treatment duration exceeding 10 days, one study [20] applied IPC for 5 days, and another study [21] applied IPC for 2 days.

Discussion

This systematic review aimed to examine the efficacy and reliability of IPC devices used as a safer treatment option for VTE risk reduction after THA surgery. Twelve randomized controlled trials were considered in this review and examined according to predetermined inclusion criteria to derive a clear result. The PEDro scale and the Cochrane risk of bias tool facilitated the quality evaluation of the included studies. This review had 2,356 participants of both sexes, aged 40–80 years. A total of 1,298 patients comprised the experimental group, whereas 1,058 patients constituted the control group. All patients underwent IPC as an intervention, either singularly or in conjunction with pharmacological treatments, to avert VTE following total hip arthroplasty. Moreover, the majority of research contrasted IPC with anticoagulation concerning significant clinical outcomes and encapsulated the principal findings derived from this comparison [6,7,10,20,21,23–28].

The primary outcome of this review was VTE, which was analysed individually in each article to assess the efficacy of IPC according to the available data. Among the 12 articles reviewed, Woo-Lam Jo et al. [11] endorsed the application of duplex ultrasound as an outcome measure for DVT detection which is also supported in other 4 articles [7,21,23,26]. In contrast, H. Al-Thani et.al and Wong Lin et.al [30,31] presented evidence supporting the use of colour doppler ultrasonography supported by other 7 articles [10,20,22,24,25,27,28]. Both AAOS (American Academy of Orthopedic Surgeons) and ACCP (American College of Chest Physicians) recommend doppler or duplex ultrasonography for the screening of VTE post-operatively and during the time of discharge [32,33]. The studies conducted by Hogg K et al. [34] and Albrecht MH et al. [35] provided justification for the widespread application of CT angiography in the detection of PE which is also in line with other five studies [7,10,25,27,28]. Six investigations [6,21,22,24,27,28] evaluated the risk of bleeding taken into account as a baseline risk of VTE reoccurrence, which was further elaborated in an another study by Nopp. S et al [36].

As a mechanical preventative measure, IPC helps lower venous congestion and stasis by squeezing the lower limb. It also helps lower pro-coagulant and thrombolysis. The guidelines of AAOS and ACCP, which support the use of either mechanical or chemical prophylaxis, or both, recommend IPC as an effective modality to significantly reduce the risk of VTE [32,33,37]. Nevertheless, the characteristics of IPC devices exhibit significant diversity across various studies and may demonstrate divergent effects depending on use duration, frequency, and compression pressure. Three research [22,23,26] recommend 6–8 hours of intermittent pneumatic compression (IPC) treatment over a duration of 10 days, while two additional studies [7,25] advocate for continuous IPC administration for the whole 10-day period. Two studies [10,28] use intermittent pneumatic compression (IPC) continuously throughout the day until the patient mobilizes on the fourth postoperative day. Carnevale PV et.al [6] in their study administered IPC for 30 minutes, twice day, for a duration of 10 days. Khalafallah A et.al [27] indicated that a 24-hour use of IPC, with pharmaceutical prophylaxis, successfully reduced VTE risk without elevating bleeding risk. Liqun W et. al [24] compared 6 hours of IPC use with 18 hours, indicating that 6 hours is more beneficial. Ben-galim P et. al [20] employs WizAir-DVT IPC devices alongside standard IPC devices for a duration of 5 days, concluding that WizAir-DVT IPC devices provide enhanced patient movement and prompt hospital release. Our results corroborate the ACCP’s guideline that all THA patients should get thromboprophylaxis using IPC, pharmacological medications, or a combination of both, for a duration of 10–14 days, extending up to 35 days [32].

Among 12 investigations, five studies [6,7,10,23,28] use IPC in conjunction with aspirin, four studies [20,24–26] utilize IPC with LMWH, and two studies [21,27] include alternative anticoagulants such as enoxaparin and rivaroxaban alongside IPC. In three included RCT trials [6,21,22], the author sought to evaluate the outcomes of graded compression stockings (GCS) as standard treatment with intermittent pneumatic compression (IPC) and found that IPC combined with GCS significantly reduces venous thromboembolism (VTE) compared to traditional GCS therapy alone.

This review included 12 studies that recommended IPC as a thromboprophylaxis to reduce bleeding and VTE risk. Previous studies by Zareba P. et al. [14] and Kakkos S. et al. [38] supported the clinical findings of these studies, suggesting that IPC, compared with other interventions, has decreased the risk of VTE and bleeding complications, and that a combination of IPC and medications was more effective than medications alone.

Strength and limitations of the study

This systematic review consolidates data from multiple trials, providing a thorough assessment of the efficacy of IPC while improving the generalizability of the findings by reducing bias through quality evaluation. This study supports the practical application of IPC in post-THA care by demonstrating that it serves as a non-invasive, clinically significant alternative or complement to pharmacological prophylaxis, particularly for patients at elevated risk of VTE or those unable to get anticoagulant therapy. This comprehensive review has various limitations, notably a significant variation in IPC frequency, dosage, and session, which obstructs the determination of a specific IPC protocol for patients who underwent THA. Our review is confined to articles published in English, exclusively comprising RCT trials from 2004 to 2024. Although pulmonary embolism is frequently reported in venous thromboembolism patients and associated with a significant mortality risk, the research included in this systematic review failed to offer adequate information regarding its clinical effects. The absence of comprehensive randomized studies in this domain underscores the necessity for further research.

Clinical implication

This systematic review consolidates data from multiple studies, providing a thorough analysis of the efficacy of IPC while improving the generalizability of the findings by reducing bias through quality assessment. This study illustrates the efficacy of IPC as a non-invasive, clinically relevant alternative or complement to pharmacological prophylaxis in post-THA management, especially for patients predisposed to VTE or contraindicated for anticoagulant therapy.

Conclusion

The systematic review highlights the potential advantages of IPC treatment in avoiding VTE after THA. IPC therapy appears to be a useful preventive approach based on the available data, especially when combined with pharmaceutical treatments. The most effective preventive measures to reduce the risk of VTE include combinations of IPC and anticoagulants, even though IPC alone can reduce the incidence of VTE when compared to no prophylaxis. In general, IPC continues to be an important part of comprehensive VTE prevention strategies in THA, with possibilities for improvements in clinical protocols and personalized care methods.

Supporting information

S1 TextList of included and excluded studies.(DOCX)

S2 TextPRISMA _ Checklist.(DOCX)