Importance of Intermittent Pneumatic Compression for Medical and Surgical Patients

1. The Need For Intermittent Pneumatic Compression Among Medical And Surgical Patients Joseph A. Caprini, M.D., M.S., FACS, RVT,DFSVS Senior Clinician Educator University of Chicago Pritzker School of Medicine Chicago, IL Emeritus Physician Evanston Northwestern Healthcare, Evanston, IL

2. Endothelial Damage From Venodilatation Rutherford’s Textbook of Vascular Surgery, Fourth Edition (WB Saunders Co., Phila. 1995) Figure 134-4(B), page 1793. 

3. Effectiveness of intermittent pneumatic compression in reduction of deep vein thrombosis in patients who have had a stroke (CLOTS 3): a multicenter randomized controlled trialThe CLOTS (Clots in Legs Or sTockings after Stroke) Trial Collaboration* • This study involved 2876 immobile stroke patients who were randomized to receive either IPC or no IPC during hospitalization. • Proximal DVT occurred in 122 patients (8.5%) who received IPC and 174 (12.1%) who received no IPC; an absolute reduction of 3.6%(OR 0.65 95% CI0.51-0.84; p=0.001). • Skin breaks occurred in 44 patients who received IPC (3.0%) and 20 (1.0%) who received no IPC. • Deaths occurred within 30 days of the treatment period in156 (11.0%) allocated IPC and 89 (13.0%) allocated no IPC (p=0.057) • IPC is an effective method of reducing DVT risk and possibly improving survival in a wide variety of patients who are immobile following stroke • Subsequent analysis concluded that IPC prevents deep vein thrombosis, improves survival but not functional outcomes, and • does not lead to a significant gain in quality-adjusted survival* Lancet 2013: 382: 516-524. *Lancet Neurol 2014; 13: 1186–92

4. Venous Thromboembolism Effect of Intermittent Pneumatic Compression (IPC) (11 studies: General Surgery) X2 test: p<0.001 Odds ratio: 3.77 95%CI 2.73 to 5.20 26.0% 74% reduction in DVT incidence 6.8%

5. IPC and DVT Prevention: Combined ModalitiesA Meta-Analysis in Postoperative Patients • A total of 2270 patients were included in 15 eligible studies • 1125 in the IPC group • 1145 in the no prophylaxis group • IPC devices reduced the risk of DVT by 60% (relative risk 0.40; 95% CI 0.29, 0.56; P<0.001) • The authors suggest that further randomized trials are warranted to test the utility of: • IPC in hospitalized medical patients • Combination pharmacological-IPC prophylaxis in both medical and surgical patients Urbanakova J, et al. J Thromb Haemost. 2005;94:1-5.

6. Odds reduction =25.8% (95% CI : 49.7; -9.5) 7 p = 0.14 6 5 % of VTE 6.1% 4 4.6% 62/1021 3 47/1027 2 1 0 Fondaparinux Dalteparin Primary efficacy analysis VTE reduction with fondaparinux Agnelli G et al. B J Surg 2005; in press

7. Safety outcomes for treatment period Fondaparinux Dalteparin p value As treated patients n = 1433 n = 1425 n (%) n (%) Major bleeding 0.12 49 (3.4%) 34 (2.4%) 0.34 Minor bleeding 31 (2.2%) 23 (1.6%) 0.40 Death 15 (1.0%) 20 (1.4%) Agnelli G et al. B J Surg 2005; in press

8. APOLLO – primary endpoint Odds reduction = -69.8% (95 %CI : -87.3; -27.9%) p = 0.004 9 8 7 6 22/418 % of VTE incidence up to day 10 5 4 5.3% 3 7/424 2 1.7% 1 0 Fondaparinux Placebo (IPC) • Secondary endpoints: fondaparinux showed superiority over placebo (IPC) for trend in the right direction Turpie AG et al. ISTH 2005: P1046

9. Fondaparinux Placebo Secondary endpoints DVT incidence on qualifying assessment (primary efficacy population) p = 0.007 10 p = 0.037 IPC 8 Distal only DVTnot analysed 5 6 3.8 % 4 1.7 1.7 1.4 2 0.2 0 Any Proximal Distal only DVT Turpie AG et al. ISTH 2005: P1046

10. Secondary endpoints • Symptomatic VTE incidence up to day 10 Randomised population Turpie AG et al. ISTH 2005: P1046

11. Bleeding • Adjudicated major bleeding events during treatment period As treated population Turpie AG et al. ISTH 2005: P1046

12. The Rate Of Bleeding Complications After Pharmacological DVT Prophylaxis Leonardi MJ, et al. Arch Surg. 2006;141:790-9. *Bleeding incidence not trivial 33 RCTs in 33,000 patients 5.5 4.0 3.4 3.3 Complications (%) 2.6 2.0 1.9 1.8 1.0 0.8 0.7 NA

13. CHEST Consensus Guidelines 2012 *Estimated baseline risk in the absence of pharmacologic or mechanical prophylaxis Gould, MK et al; CHEST 2012; 141(2)(Suppl):e227S–e277S

14. A Prospective, Randomized Trial Comparing a Mobile Compression Device with Low-Molecular-Weight Heparin Patients were treated for 10 days and duplex scans used for screening. The IPC use averaged 20 hrs. daily which included at-home use. Colwell, CW et al: J Bone Joint Surg Am. 2010;92:527-35

15. A Prospective, Randomized Trial Comparing a Mobile Compression Device with Low-Molecular-Weight Heparin • This study demonstrated that the portable compression device was safer than LMWH with respect to major bleeding after total hip arthroplasty. • Major bleeding occurred in 6%(eleven) of the patients in the heparin group and in none of the patients in the compression group (p = 0.0004). • Equivalency not established • A study to demonstrate equivalency, noninferiority, or superiority in efficacy would require a minimum of 1480 patients per group due to the low VTE rate using LMWH. Colwell, CW et al: J Bone Joint Surg Am. 2010;92:527-35

16. Conclusions • The shortcomings of GCS in practice limit its effectiveness for thrombosis prophylaxis • IPC is effective in reducing DVT in stroke patients and may improve overall survival • The use of IPC alone is appropriate for many surgical patients with caprini scores less than 5 since the risk of VTE is less than the risk of bleeding using anticoagulation • Combined IPC and pharmacologic methods appropriate for the highest-risk patients • Home compression is a new untapped resource for ongoing thrombosis prophylaxis

17. The End