The report is a product of the VA/HSR&D Evidence Synthesis Program.
Effectiveness of Intermittent Pneumatic Compression Devices for Venous Thromboembolism Prophylaxis
A recent report conducted by the Evidence-based Synthesis Program (ESP) has concluded that intermittent pneumatic compression devices (IPCDs) are appropriate for preventing venous thromboembolism (VTE) when used in accordance with current clinical guidelines. While the current evidence base to guide selection of a specific device or type of device is limited, the authors noted that practical criteria, including device flexibility, acceptability by nursing staff and patients, and the most frequently studied devices (e.g., the Kendall SCD™ and A-V Impulse System™), as well as cost, can help direct selection of appropriate IPCDs. Comparative effectiveness studies that evaluate clinical outcomes and usability and acceptability are urgently needed to address current gaps in the evidence.
This study was nominated by the VA National Surgery Office and Office of Nursing with the aim of evaluating IPCDs to inform best practice strategies, policy, and selection of devices for the VA Healthcare System. The report evaluated the comparative effectiveness of IPCDs in post-operative surgical and high-risk medical patients of high interest to the Veterans Health Administration (VHA). There is a major gap in the existing literature examining which specific populations will benefit from IPCD prophylaxis, and whether IPCDs vary importantly in VTE outcomes, adherence, and ease of use. This study addressed these gaps.
VTE, which encompasses deep vein thrombosis (DVT) and pulmonary embolism (PE), is a serious potential complication in hospitalized patients. In high-risk groups, such as post-operative surgical patients and acutely ill medical patients, it is a leading cause of morbidity and mortality. VTE prophylaxis is recommended for approximately 60% of high-risk surgical patients and for the 40% of hospitalized medical patients at risk for VTE.
Clinical practice guidelines generally recommend either pharmacological or mechanical VTE prophylaxis. Pharmacological options include anticoagulation (e.g., low molecular weight heparin [LMWH], new oral anticoagulants, or warfarin) and aspirin, but these may increase the risk of bleeding. Mechanical prophylaxis with IPCDs is recommended, particularly in populations at high risk of bleeding.
It is hypothesized that IPCDs prevent DVT formation through two mechanisms, namely, by decreasing venous stasis and activating fibrinolysis. These effects can be achieved by mechanical compression of the foot or calf alone, or by sequential compression of either the foot and calf, or the calf and thigh.
There are a wide variety of IPCDs currently available that differ in anatomical location of the sleeve garment, number and location of air bladders, patterns of compression cycles, and duration of inflation time and deflation time. Portable IPCDs offer the potential advantage of continued use while walking in the early post-operative period. By contrast, non-portable devices must be removed for walking. Some devices also include an hour meter that may facilitate adherence monitoring. Although some clinical guidelines recommend certain device features such as portability, in general, guidelines do not make recommendations for or against specific IPCDs or device categories. Therefore, it remains unclear which of these approaches works best for specific patient populations. Consequently, clinicians and health systems routinely struggle with IPCD selection.
Report conclusions are based on 18 randomized controlled trials (RCTs) and 3 observational studies in post-operative surgical and high-risk medical patients that evaluated the comparative effectiveness of IPCDs in reducing VTE events, all-cause mortality, major bleeding, or that rated ease of use or adherence. Most studies compared IPCDs with anticoagulation. Only 3 RCTs in high-risk surgical patients directly compared different IPCDs; there were no head-to-head comparisons in high-risk medical patients. IPCDs were comparable to anticoagulation for major clinical outcomes, but confidence intervals were typically wide and clinically important differences could not be excluded. IPCDs may decrease the risk of major bleeding compared to anticoagulation, and when used in combination with LMWH, may decrease the risk of VTE. Subgroup analyses did not show significant differences by device location or mode of inflation. The current evidence base to guide selection of a specific device or type of device is limited. Until comparative effectiveness studies are conducted to address this gap in evidence, clinicians and policymakers should consider practical features of the currently available devices.
Pavon JM, Williams JW Jr., Adam SS, Razouki ZA, McDuffie JR, Lachiewicz PF, Kosinski AS, Beadles CA, Ortel TL, Nagi A. Evidence Report: Effectiveness of Intermittent Pneumatic Compression Devices for Venous Thromboembolism Prophylaxis in High-Risk Surgical and Medical Patients. VA ESP Project #09-009; 2015.
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