Using a PowerPoint presentation, summarize the current evidence on the effectiveness of sequential compression devices in preventing deep vein thrombosis.

Date: May, 2024

EBP Question: What is the current evidence-based practice regarding SCD use in managing VTE?

Article Number

Author and Date

Evidence Type

Sample, Sample Size, Setting

Findings That Help Answer the EBP Question

Observable Measures

Limitations

Evidence Level, Quality

1.

Arabi, Y. M., Hameed, F., Burns, K. E. A., Mehta, S., Alsolamy, S. J., Alshahrani, M. S., Mandourah, Y., Almekhlafi, G. A., Almaani, M., Bshabshe, A. A., Finfer, S., Arshad, Z., Khalid, I., Mehta, Y., Gaur, A., Hawa, H., Buscher, H., Lababidi, H., Aithan, A. A.,….Al-Dawood, A. (2019). Adjunctive intermittent pneumatic compression for venous thromboprophylaxis.  The New England Journal of Medicine, 380, 1305-1315. https://doi.org/10.1056/NEJMoa1816150

Randomized controlled trial (RCT).

2003 patients were randomized — 991 were assigned to the pneumatic compression group and 1012 to the control group. IPC was applied for a median of 22 hours daily for a median of 7 days. The trials were conducted in 20 sites in Saudi Arabia, Canada, Australia, and India.

Incident proximal DVT occurred in 37 of 957 patients (3.9%) in the pneumatic compression group and in 41 of 985 patients (4.2%) in the control group (relative risk, 0.93; 95% confidence interval [CI], 0.60 to 1.44; P=0.74).

The percentage of patients who had prevalent proximal DVT did not differ significantly between the pneumatic compression group and the control group (3.4% [34 of 991 patients] vs. 2.7% [27 of 1012 patients]; relative risk, 1.29; 95% CI, 0.78 to 2.12).

-The percentage of patients who had any lower-limb DVTs also did not differ significantly between the pneumatic compression group and the control group (9.6% [95 of 991 patients] vs. 8.4% [85 of 1012 patients]; relative risk, 1.14; 95% CI, 0.86 to 1.51).

-Pulmonary embolism occurred in 8 of 991 patients (0.8%) in the pneumatic compression group and in 10 of 1012 patients (1.0%) in the control group (relative risk, 0.82; 95% CI, 0.32 to 2.06).

-A composite outcome of venous thromboembolism that included pulmonary embolism or all prevalent and incident lower-limb deep-vein thromboses occurred in 103 of 991 patients (10.4%) in the pneumatic compression group and in 95 of 1012 patients (9.4%) in the control group (relative risk, 1.11; 95% CI, 0.85 to 1.44).

-The death rates from any cause (assessed at ICU discharge, 28 days, hospital discharge, and 90 days) did not differ significantly between the two trial groups. The composite outcome of lower-limb deep-vein thrombosis, pulmonary embolism, or death from any cause at 28 days occurred in 231 of 990 patients (23.3%) in the pneumatic compression group and in 243 of 1011 patients (24.0%) in the control group (relative risk, 0.97; 95% CI, 0.83 to 1.14).

The percentages of patients who had lower-limb skin injury or ischemia did not differ significantly between the pneumatic compression group and the control group

Evaluate whether adjunctive intermittent pneumatic compression in critically ill patients receiving pharmacologic thromboprophylaxis with unfractionated heparin or low-molecular-weight heparin would result in a lower incidence of proximal lower-limb deep-vein thrombosis than pharmacologic thromboprophylaxis alone.

-The incidence of the primary outcome in the control group was lower than expected, which reduced the power of the trial; consequently, the results do not rule out the possibility of a clinically important treatment effect (a benefit of as much as 40% or a harm of as much as 44%).

-The inability to blind patients, caregivers, and ultrasonographers of the trial-group could have introduced biases.

I, A

2.

Dhakal, P., Shrotriya, S., Sharma, M., Al-Janadi, A., Wang, L., & Rayamajhi, S. (2017). Do sequential compression devices prevent venous thromboembolism in hospital inpatients? Blood, 130(Supplement 1), 2084. https://doi.org/10.1182/blood.V130.Suppl_1.2084.2084

RCT

39,265 patients. 20,220 had SCD for VTE prophylaxis, 2,397 had anticoagulants (AC), 5,719 had BOTH, and 10,929 had NONE of the measures.

0.6% (n=246) of the patients developed VTE during their hospital stay: 50 in the SCD group, 40 in AC, 126 in BOTH, and 20 in the NONE group.

-Among patients in the SCD group, 0.2% developed VTE; 0.1% developed VTE in the NONE group. VTE developed in 1.6% of cases in the AC group and 2.2% in BOTH group.

- The odds of developing VTE decreased with SCD compared to NONE (OR 0.26; 95% CI 0.18-0.38).

Determine if SCD prevents VTE in medically ill hospitalized patients

Undetermined- abstract only

Abstract

3.

Dhakal, P., Wang, L., Gardiner, J., Shrotriya, S., Sharma, M., & Rayamajhi, S. (2019). Effectiveness of sequential compression devices in preventing venous thromboembolism in medically ill hospitalized patients: A retrospective cohort study. Turkish Journal of Hematology, 36(3), 193–198. https://doi.org/10.4274/tjh.galenos.2019.2018.0413

Retrospective cohort.

30,824 adult patients admitted to a teaching hospital from April 2015 to March 2016 were included.

-67 patients (0.22%) developed VTE during their hospital stays, with deep vein thrombosis (DVT) in 55 cases and pulmonary embolism (PE) in 12.

-VTE was seen in 47 out of 20,018 patients on SCDs (41 DVT, 6 PE) and 20 out of 10,819 patients without SCDs (14 DVT, 6 PE).

-Risk-adjusted analysis showed no significant difference in VTE incidence in the SCD group compared to NONE (odds ratio 0.99, 95% confidence interval 0.57-1.73, p=0.74).

-Compared to the NONE group, SCDs are not associated with decreased VTE incidence during hospital stay.

To evaluate the effectiveness of sequential compression devices (SCDs) for venous thromboembolism (VTE) prevention in medically ill hospitalized patients.

-Excluded of

high-risk patients who received anticoagulants with or without

SCDs may have led to a poor representation of all hospitalized medical patients.

-The compliance and appropriate use of

the SCDs could not be verified in all cases. This may have limited the effectiveness of the intervention.

III, B

4.

Duval, C., Sirois, C., Savoie-White, F. H., Tardif, P. A., Bérubé, M., Turgeon, A. F., Cook, D. J., Lauzier, F., & Moore, L. (2022). Effect of intermittent pneumatic compression in addition to pharmacologic prophylaxis for thromboprophylaxis in hospitalized adult patients: A Systematic review and meta-analysis. Critical Care Explorations, 4(10), e0769. https://doi.org/10.1097/CCE.0000000000000769

Systematic review and meta-analysis.

17 RCTs of 8,796 participants.

Adjunctive IPC was associated with a decreased risk of VTE (15 trials, RR = 0.53; 95% CI [0.35-0.81]) and DVT (14 trials, RR = 0.52; 95% CI [0.33-0.81]) but not PE (seven trials, RR = 0.73; 95% CI [0.32-1.68]).

Evaluate the efficacy of adding IPC to pharmacologic prophylaxis to prevent VTE in hospitalized adults.

-Results indicate low-quality evidence underpinning the additional use of IPC to pharmacological thromboprophylaxis to prevent VTE and DVT.

I, C

5.

Fernando, S. M., Tran, A., Cheng, W., Sadeghirad, B., Arabi, Y. M., Cook, D. J., Møller, M. H., Mehta, S., Fowler, R. A., Burns, K. E., Wells, P. S., Carrier, M., Crowther, M. A., Scales, D. C., English, S. W., Kyeremanteng, K., Kanji, S., Kho, M. E., & Rochwerg, B. (2022). VTE prophylaxis in critically ill adults: A systematic review and network meta-analysis. Chest, 161(2), 418-428. https://doi.org/10.1016/j.chest.2021.08.050

Systematic review and meta-analysis.

13 RCTs (9,619 patients).

- LMWH reduced the incidence of DVT (OR, 0.59 [95% credible interval [CrI], 0.33-0.90], high certainty)

- Unfractionated heparin (UFH) may reduce the incidence of DVT (OR, 0.82 [95% CrI, 0.47-1.37]; low certainty).

- LMWH probably reduces DVT compared with UFH (OR, 0.72 [95% CrI, 0.46-0.98]; moderate certainty).

- Compressive devices may reduce the risk of DVT compared with control treatments; however, this is based on low-certainty evidence (OR, 0.85 [95% CrI, 0.50-1.50]). Combination therapy showed unclear effects on DVT compared with either therapy alone (very low certainty).

-Compare the efficacy and safety of LMWH, UFH, mechanical compressive devices (SCD and iPC), a combination of pharmacologic and mechanical compressive devices, and control node (a composite of either no prophylaxis, placebo, or graduated compression stockings for prevention of VTE in critically ill adults.

-Evaluate the comparative efficacy of any pharmacologic therapy, mechanical compression devices, a combination of pharmacologic and mechanical compressive devices, and control treatment.

Abstract only

Abstract

6.

Guo, P. C., Li, N., Zhong, H. M., & Zhao, G. F. (2022). Clinical effectiveness of a pneumatic compression device combined with low-molecular-weight heparin for the prevention of deep vein thrombosis in trauma patients: A single-center retrospective cohort study. World Journal of Emergency Medicine, 13(3), 189–195. https://doi.org/10.5847/wjem.j.1920-8642.2022.040

Retrospective cohort study

-252 patients (n=126- the control group; patients on LMWH, (n=126- observation group; LMWH+PCD) with mild craniocerebral injury and clavicular fractures between January 2016 and February 2020 in an academic medical center in China.

-The incidence of DVT in the observation group was significantly lower than in the control group (5.6% vs. 15.1%, χ2=4.605, p<0.05).

-The postoperative visual analog scores (VAS) of the two groups were lower than those before surgery (p<0.05). -Improved coagulation function of the observation group (p<0.05).

-The postoperative risk of DVT in patients who received LMWH alone was 1.764 times that of patients who received LMWH+PCD (p<0.05).

Investigate the clinical effectiveness of a pneumatic compression device (PCD) combined with LMWH to prevent and treat DVT in trauma patients.

-Small sample size

-Single site study

- Short study time

II, B

7.

Ibrahim, M., Ahmed, A., Mohamed, W. Y., & El-Sayed Abu Abduo, S. (2015). Effect of compression devices on preventing deep vein thrombosis among adult trauma patients: A systematic review. Dimensions of Critical Care Nursing 34(5), 289-300. https://doi.org/ 10.1097/DCC.0000000000000127

Systematic review.

Five randomized controlled trials were included, with 1072 patients between 1990 and 2014 in the United States (4 trials) and Canada (1 trial).

- SCDs significantly reduced the incidence of DVT in trauma patients. -Also, foot pumps were more effective in reducing the incidence of DVT compared with sequential compression devices.

Review the effect of compression devices in preventing DVT among adult trauma patients.

-A small number of trials makes findings less representative of the population and decreases the power to show the statistically significant observed rate difference.

-Poor randomization and control of some of the included studies, lack of uniformity in methods in DVT screening, and heterogeneity could have the findings.

II, B

8.

Kakkos, S. K., Nicolaides, A. N., & Caprini, J. A. (2020). Interpretation of the PREVENT study findings on the adjunctive role of intermittent pneumatic compression to prevent venous thromboembolism. Annals of Translational Medicine, 8(11). https://doi.org/10.21037/atm.2020.01.68

Editorial review of a systematic review of RCTs

22 trials with 9,137 participants, comprising 15 RCTs (7,762 patients).

- Symptomatic PE occurred equally frequently with intermittent pneumatic compression (IPC) and combined modalities (with anticoagulation).

- DVT occurred in 4.1% with IPC-only use and 2.19% in combined modalities (OR 0.52).

-However, combined therapy increases the risk of any bleeding compared to the use of IPC alone (0.66% vs. 4.0% with combined modalities OR 5.04).

-The findings for major bleeding were similar (OR 6.81).

-There was no difference in the incidence of DVT between subgroups, such as orthopedic vs. non-orthopedic patients (P=0.16).

-Combined modalities reduced the incidence of symptomatic PE (1.20% vs. 2.92% for pharmacological prophylaxis alone, OR 0.39).

-Comparison of single vs. combined modalities in preventing venous thromboembolism (VTE).

In PREVENT, 16,053 patients were assessed for eligibility, but only 2003 (about 12%) underwent randomization.

The concurrent use of an antiplatelet (rivaroxaban) in about 40% of PREVENT trial patients may have reduced the study's power.

-Use of a variety of IPC devices of variable proof of clinical effectiveness may have reduced further the true effect size of IPC.

II, C

9.

Pavon, J. M., Adam, S. S., Razouki, Z. A., McDuffie, J. R., Lachiewicz, P. F., Kosinski, A. S., Beadles, C. A., Ortel, T. L., Nagi, A., & Williams, J. W. (2016). Effectiveness of intermittent pneumatic compression devices for venous thromboembolism prophylaxis in high-risk surgical patients: A systematic review. Journal of Arthroplasty, 31(2), 524-532. https://doi.org/10.1016/j.arth.2015.09.043

Systematic review of RCTs and observational studies.

14 RCTs (2633 subjects) and 3 observational studies (1724 subjects); most were conducted in joint arthroplasty patients.

IPC devices were comparable to anticoagulation for major clinical outcomes (VTE: risk ratio, 1.39; 95% confidence interval, 0.73-2.64). Limited data suggest that concurrent use of anticoagulation with IPCD may lower VTE risk compared with anticoagulation alone and that IPCD, compared with anticoagulation, may lower major bleeding risk.

Analyze the comparative effectiveness of IPC devices for selected outcomes (mortality, VTE, symptomatic or asymptomatic deep vein thrombosis, major bleeding, ease of use, and adherence) in postoperative surgical patients.

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I, B

10.

Wang, Y., Huang, D., Wang, M., & Liang, Z. (2020). Can intermittent pneumatic compression reduce the incidence of venous thrombosis in critically ill patients: A systematic review and meta-analysis. Clinical and Applied Thrombosis/Hemostasis, 26. https://doi.org/10.1177/1076029620913942

Systematic review and meta-analysis.

10 studies (6 RCTs and 4 observational studies), including 4759 patients.

- VTE incidence decreased in the IPC group compared with no thromboprophylaxis group (RR 0.35, CI 0.18-0.68, P = .002)

- Lower VTE incidence in the IPC group than in the graduated compression stockings (GCS) group (RR: 0.47, CI: 0.24-0.91, P = .03).

-There were no significant differences between using IPC and low-molecular-weight heparin (LMWH) for VTE incidence (RR: 1.26, CI: 0.72-2.22, P = .41), but LMWH showed significantly more bleeding events.

-IPC as an adjunctive treatment did not further reduce VTE incidence (RR: 0.55, CI: 0.24-1.27, P = .16).

-IPC can reduce the incidence of VTE for critically ill patients, which is better than GCS and LMWH, but it has no significant advantage as an adjunct therapy for thromboprophylaxis.

- Validate the efficacy of IPC to prevent VTE in critically ill patients.

-The duration of IPC use varies in the included studies, and patients' disease and coagulation status may have affected the incidence of VTE.

-Some studies only screened patients with suspected PE, so the incidence of PE may be biased, thus affecting the effectiveness of IPC assessment.

-The meta-analysis included both RCTs and observational studies. Observational studies are very prone to bias, which may have affected the study results.

- However, overall, the included trials were considered moderate to high quality.

I, A