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Comments Regarding The Prevent TrialJ A Caprini MDAlfonso Tafur MD Arabi YM, AlHameed F, Burns KEA, et al. Adjunctive intermittent pneumatic compression for venous thromboprophylaxis. N Engl J Med. DOI: 10.1056/NEJMoa1816150Ultrasonographers may scan the distal leg veins at their discretion (see below 8)Screening for distal DVT not done because of the debated clinical relevance and the fact that it is challenging for the sonographers (repeated below 8,9)Compression devices used included the flowtron and Kendall SCD express which are proven products.DVT 2600 from South Korea, Synkro IPC from the United Kingdom, triple play from the United States, and swell cure from India are all devices that have not been subjected to the scrutiny of the two main products and their efficacy is suspect. I have tested the triple play and was not impressed. THIS IS THE MOST IMPORTANT POSSIBILITY THAT EXPLAINS THE LACK OF EFFICACY OF THE COMBINATION OF IPC AND ANTICOAGULATIONIn addition, we do not know what percentage of patients used each of these devices. I’ve seen a lot of patients in ICU who were allowed to get up in the chair and am I to understand that they all had these devices on for 22 hrs. per day?The sensitivity analysis is weak due to the low n.Specific details regarding the criteria used for some of the exclusion criteria such as what is severe arterial disease and if there is a bulky dressing on one leg or burns what about compression and ultrasound on the other leg?Here are the exclusion criteria which creates many questionsInability or contraindication to applying intermittent pneumatic compression to both legs or to obtain adequate ultrasound of the lower extremities What is meant by vein ligation and amputationBurns in the lower extremities, lacerations, active skin infection, large dressings at the site of intermittent pneumatic compression placement or in the thighs that prevent adequate ultrasounds Acute ischemia in the lower extremitiesAmputated foot or leg on one or two sidesCompartment syndrome Severe peripheral arterial disease Vein ligation, gangrene, recent vein grafts, and draining incisionsBone fracture in lower extremities Arterial line in the dorsalis pedis artery The appendix does not explain the details of these exclusions and how they were universally dealt with in the 20 centers.I highlight these exclusions because of the disparity between 16,053 patients seen and the study including only 2003 patients so these conclusions do not seem generalizable to the overall trauma.The lack of a standard scanning protocol is reflected by this statement in the paper-“Examination of the distal leg veins (peroneal, posterior tibial, anterior tibial, and muscular veins) was performed according to local hospital practices.” This highlights the problem of lack of standardization of this screening technique across the 20 centersWhile there is controversy about small distal clots, multiple thrombosed calf veins may have a totally different outcome and may need treatment.It is an ICAVAL requirement that the entire leg is scanned to be a US accredited center.In summary, I have been interested in mechanical methods since 1975, have the first study of the SCD in general surgery published in 1983. I was a member of the APOLLO trial which was the general surgery ?trial with a venographic endpoint using IPC. In addition, I have been part of several Cochrane analysis regarding mechanical methods. Enclosed are my thoughts regarding the recent PREVENT trial showing no difference in VTE adding IPC to anticoagulants in trauma patients. I am sure there will be debate about my observations but that is what Sedona is all about. I fully realize that there is little proof that IPC prevents PE but it is assumed since it prevents DVT. While that is a separate question this study with all its shortcomings study again demonstrates no effect on PE from the combination.?One bright note regarding the trial is the initial screening which revealed the following results:?"Prevalent deep-vein?thromboses were detected in 34 patients in the?pneumatic compression group and in 27 patients?in the control group during trial days 1 to 3, and?these patients were excluded from the analysis?of the primary outcome."?These results indicate the?value of early screening for VTE in trauma patients and I feel this should done according to the Caprini score results and maybe D-Dimer. That would make for a very?interesting future study. We know that in hip fracture?patients with a score of 12 or above, a high incidence of DVT was observed; they recommend routine screening with these high scores prior to surgery. ................
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