Running head: SYNTHESIS PAPER 1 Synthesis Paper Kristen Shiver University of South Florida 2 SYNTHESIS PAPER Abstract Deep vein thrombosis (DVT) is a serious complication that many hospitalized patients who are immobile are at risk for. Lung transplant patients are at high risk for deep vein thrombosis complications due to the postoperative immobile period and sensitivity of the new organ. The objective of this paper is to determine if the use of a sequential compression device during admission will reduce the risk of deep vein thrombosis and related complications in postoperative lung transplant patients. By using Google Scholar, PubMed, and CINAHL, three randomized controlled trials were found with the keywords of DVT prophylaxis, intermittent pneumatic compression, and DVT prophylaxis postoperatively. By utilizing the Agency for Healthcare Research and Quality one clinical practice guideline was found. All the studies evaluated showed positive outcomes for patients using some form of intermittent compression device. Each study displayed strong evidence that mechanical compression was both effective and perhaps safer than strictly pharmacological methods. The clinical practice guideline states that venous thromboembolism prophylaxis includes pneumatic compression devices placed before surgery and continued until patient is fully ambulatory as well anticoagulant therapy after surgery until discharge (ACOG, 2007). 3 SYNTHESIS PAPER Sequential Compression Device Use on DVT Prevention In the hospital, all non-ambulatory patients are a greater risk of developing deep vein thrombosis and subsequent complications, such as pulmonary embolism. According to an article by the CLOTS Trials Collaboration (2013), venous thromboembolism is one of the most important, potentially preventable, causes of death and morbidity in patients in hospital. To prevent deep vein thrombosis (DVT) complications, it is imperative to include some form of prophylaxis in the patient care plan. Sobiera-Teague et al. (2011) states that in patients not receiving thromboprophylaxis, the reported frequency of any venous thrombotic embolism (VTE) has ranged from 29% to 60%. In postoperative lung transplant patients, DVT prophylaxis is especially important because these patients are at an even greater risk of complications resulting from DVT, mainly pulmonary embolism, not just due to immobility but to the sensitivity of the transplanted organ and immunosuppression. Approximately 90% of symptomatic pulmonary emboli result from lower extremity deep vein thrombosis, thus demonstrating the critical use of prophylaxis for lung transplant patients (Colwell et al., 2005). To evaluate the prevention of DVT in this patient population a PICOT question was formed. In lung transplant patients, how does sequential compression device use compared to no sequential compression device use affect the development of deep vein thrombosis during current admission? Literature Search To conduct the search for appropriate evidence based literature, Google Scholar, PubMed, and CINHAL were used. Three randomized controlled trials were 4 SYNTHESIS PAPER found using the key words deep vein thrombosis, DVT prophylaxis, intermittent pneumatic compression, and DVT prophylaxis postoperatively. One clinical practice guideline was found using the Agency for Healthcare Research and Quality (AHRQ)(Table 1). Literature Review The guideline from the American College of Obstetricians and Gynecologist (ACOG) for prevention of DVT discussed the evidence-based recommendations for preventing DVT in surgical gynecological patients (2007). The guideline used various databases to conduct a literature search for relevant articles discussing the topic, and was reaffirmed in 2012 by utilizing a similar literature search for more current articles. The recommendations made by the guideline for moderate to highrisk patients include: Pneumatic compression devices placed before initiation of surgery and continued until the patient is fully ambulatory, unfractionated heparin (5,000 units) administered subcutaneously 2 hours before surgery and every 8 hours postoperatively and continued until discharge, and Low molecular weight heparin (dalteparin 5,000 antifactor-Xa units or enoxaparin 40 mg) administered subcutaneously, 12 hours before surgery and once daily postoperatively until discharge(ACOG, 2007). Though this guideline is referring to surgical gynecological patients specifically, it is relevant to the postoperative lung transplant patient population because both are surgical populations utilizing DVT prophylaxis. Sobiera-Teague et al. (2011) performed a randomized controlled trial about the use of a specific portable compression device called Venowave for prevention of SYNTHESIS PAPER 5 DVT in neurosurgical patients. The article discussed the process of randomly assigning 75 patients to receive Venowave devices and 75 patients to the control group. All were neurosurgical patients 18 or older and all standard measures taken to prevent DVT regardless. The outcome of the study was measured by confirming DVT presence or absence with venography and compression ultrasound. The results of the study showed a significant decrease in the incidence of DVT formation for the group of patients who received the Venowave device, for patients with the Venowave device the rate of VTE was 4.0% compared to 18.7% in the control group (P=0.008). The strengths of this source are that is a randomized controlled trial, displaying the highest level of evidence, and that the study uses both post surgical patients and non-surgical patients. A weakness of the article is that all patients received some form of prophylaxis, therefore there could be other factors influencing the success of the device. Colwell et al. (2005) conducted a randomized controlled trial about the use of mechanical compression device compared to low molecular weight heparin in the prevention of bleeding events and DVT. Patients who had a total hip arthroplasty were randomized to receive prophylaxis with a mobile compression device or low molecular weight heparin for ten days. The study consisted of 410 patients with 205 patients in the compression group and 209 in the heparin group. All patients were over 18 years of age and were scheduled for the procedure and had no history of venous thromboembolism or coagulation disorder. Definitions for major bleeding events and methods used to confirm these events and DVT events were discussed. The study showed a significantly higher instance of bleeding in the heparin group. SYNTHESIS PAPER 6 The rate of major bleeding events was 0% in the compression device group and 6% in the heparin group and the difference as significant (p=0.0004). There was no measurable difference between the two groups with regard to DVT prevalence. The study supported the use of mechanical compression versus heparin therapy as a form of prophylaxis in this patient population. A strength of the article is that is studying a specific post surgical patient population and is a randomized controlled trial. A weakness of the article is that there was little evidence specifically about DVT events versus bleeding events and that the mechanical compression group received a low dose aspirin as well. The final study conducted by the CLOTS Trials Collaboration (2013), assessed the effectiveness of intermittent pneumatic compression (IPC) to reduce the risk of DVT in patients who have had a stroke. This was a randomized controlled trial, taking place in hospitals where patients were randomized to either receive IPC or not on the day of admission. A technician who was masked to treatment allocation did a compression duplex ultrasound (CDU) of both legs at 7–10 days and, wherever practical, at 25–30 days after enrollment. The sample consisted of 2876 patients enrolled in 94 centers in the UK. The included patients were broadly representative of immobile stroke patients admitted to hospital and had a median age of 76 years. The results of the study supported the use of IPC by showing that the difference in the number of patients developing a DVT was 8.5% for patients receiving the ICP and 12.1% for patients who did not receive IPC with a significant difference of p=0.001. A strength of this article is that is a randomized controlled trial and discusses a immobile patient population. A weakness of this article is that 7 SYNTHESIS PAPER is not explicitly looking at the population under question and that medication use was not thoroughly discussed. Synthesis All of the research reviewed supports the use of intermittent pneumatic compression devices for the prevention of DVT and relating complications in postoperative patients (ACOG, 2007; CLOTS, 2013; Colwell et al., 2010; SobieraTeague et al., 2011). One study found that with the use of a portable pneumatic compression device the risk of venous thrombotic events were reduced by 79% when compared with no pneumatic compression device (Sobiera-Teague et al., 2011). Colwell et al. (2005) found that mechanical compression proved to be safer than heparin therapy in regards to major bleeding events after surgery. Finally the study conducted by the CLOTS Trials Collaboration (2013), further proves that universally intermittent pneumatic compression significantly decreases the incidence of DVT of hospitalized patients across healthcare systems by analyzing patients at multiple hospital locations and using the largest sample group. While the research does strongly support the use of intermittent compression devices, there are gaps in the research. For instance, assessing the use of mechanical compression solely, without any outside factors, is nearly impossible due to the nature of care in the hospital and multi-disciplinary approaches to care. Another area that was not discussed thoroughly in the literature was the effect of patient and provider compliance on DVT prevention outcomes. Both mechanical and pharmacological methods of prophylaxis success are dependent on patient 8 SYNTHESIS PAPER compliance and knowledge of treatment and all members of the care team correctly and consistently applying methods. Clinical Recommendations Venous thrombosis prophylaxis is a widely accepted and commonly implemented measure taken for many hospitalized patients, however there is not always a set policy to ensure that all necessary measures are taken. In order to ensure success consistent with the evidence based research, policies, procedures, and education need to be in place for all members of the healthcare team as well as patients. In relation to lung transplant patients, there should be a specific policy regarding the continued use of intermittent pneumatic compression devices, even with the use of pharmacological agents as well. The policy should specify that at all times the patient is not ambulating; intermittent pneumatic compression devices should be on the patient. Clinicians and managers will be responsible for educating members of their team about policies and correct use of the devices. Nurses will also need to include in their care plans use of the device as well as patient education about the device, the importance of use, and consistent monitoring of compliance. 9 SYNTHESIS PAPER References American College of Obstetricians and Gynecologists (ACOG). (2007). Prevention of deep vein thrombosis and pulmonary embolism. ACOG Practice Bulletin, 84. Retrieved from www.guideline.gov CLOTS (Clots in Legs Or Stockings after Stroke) Trials Collaboration. (2013). Effectiveness of intermittent pneumatic compression in reduction of risk of deep vein thrombosis in patients who have had a stroke (CLOTS 3): A multicentre randomised controlled trial. The Lancet, 382(9891), 516-524. doi: 10.1016/S0140-6736(13)61050-8 Colwell, C.W., Froimson, M. I., Mont, M.A., Ritter, M.A., Trousdale, R.T., Buehler, K.C., …Padgett, D.E. (2010). Thrombosis prevention after total hip arthroplasty: A prospective, randomized trial comparing a mobile compression device with low-molecular-weight heparin. The Journal of Bone and Joint Surgery, 92, 527535. doi: 10.2106/JBJS.I.0047 Sobiera-Teague, M., Hirsh, J., Yip, G., Gastaldo, F., Stokes, T., Sloane, D., …Eikelbloom, W. (2011). Randomized controlled trial of a new portable calf compression device (Venowave) for prevention of venous thrombosis in high-risk neurosurgical patients. Journal of Thrombosis and Haemostasis, 10, 229-235. doi: 10.1111/j.1538-7836.2011.04598.x 10 SYNTHESIS PAPER Table 1 Literature Review Reference Aims Sobiera-Teague, M., Hirsh, J., Yip, G., Gastaldo, F., Stokes, T., Sloane, D., …Eikelbloom, W. (2011). Randomized controlled trial of a new portable calf compression device (Venowave) for prevention of venous thrombosis in high-risk neurosurgical patients. Journal of Thrombosis and Haemostasis, 10, 229-235. doi: 10.1111/j.15387836.2011.04598. x Colwell, C.W., Froimson, M. I., Mont, M.A., Ritter, M.A., Trousdale, R.T., Buehler, K.C., …Padgett, D.E. (2010). Thrombosis prevention after total hip arthroplasty: A prospective, randomized trial comparing a mobile Sample To assess efficacy and tolerability of a portable intermittent compression device (Venowave) for the prevention of VTE in neurosurgical patients. Design and Measures A RCT comparing a specific IPC device with the control. Primary outcome was no DVT detected. To compare a new mobile compression device with low molecular weight heparin with regard to their safety and effectiveness fro the prevention of venous thromboembolic disease. A RCT with patients randomize d to receive either prophylaxi s or mobile compressi on for 10 days. 410 patients with 205 in compressio n group and 209 in heparin group. Outcomes / statistics 150 For patients with Neurosurgic the Venowave al patients. device the rate of VTE was 4.0% compared to 18.7% in the control group (P=0.008) The rate of major bleeding events was 0% in the compression device group and 6% in the heparin group and the difference as significant (p=0.0004). There was no measurable difference between the two groups with regard to DVT prevalence. 11 SYNTHESIS PAPER compression device with lowmolecular-weight heparin. The Journal of Bone and Joint Surgery, 92, 527535. doi: 10.2106/JBJS.I.00 47 CLOTS (Clots in Legs Or Stockings after Stroke) Trials Collaboration. (2013). Effectiveness of intermittent pneumatic compression in reduction of risk of deep vein thrombosis in patients who have had a stroke (CLOTS 3): A multicentre randomised controlled trial. The Lancet, 382(9891), 516524. doi: 10.1016/S01406736(13)61050-8 American College of Obstetricians and Gynecologists (ACOG). (2007). Prevention of deep vein thrombosis and pulmonary embolism. ACOG Practice Bulletin, To assess the effectiveness of IPC to reduce the risk of DVT in patients who have had a stroke. A RCT where patients were randomize d to either receive IPC or not on day of admission. 2876 immobile stroke patients were enrolled in 94 centers. The difference in the number of patients developing a DVT was 8.5% for patients receiving the ICP and 12.1% for patients who did not receive IPC with a significant difference of p=0.001. To aid practitioners in making decisions about appropriate obstetric and gynecologic care. To review the current literature on the use of thromboprophyla Handsearches of Published Literature (Primary Sources) Handsearches of Published Women undergoing gynecologi c surgery Effectiveness of thromboprophyla xis for preventing venous thromboembolis m Prophylacticrelated morbidity and mortality 12 SYNTHESIS PAPER 84. Retrieved from www.guideline.g ov xis in gynecology patients and to provide evidencebased recommendations to guide clinical decision making. Literature (Secondar y Sources) Searches of Electronic Databases