Fondaparinux Significantly Reduces Postoperative Venous Thromboembolism After Body Contouring Procedures Without an Increase in Bleeding Complications

2019 ◽  
Vol 39 (11) ◽  
pp. 1214-1221 ◽  
Author(s):  
Deniz Sarhaddi ◽  
Kyle Xu ◽  
Alex Wisbeck ◽  
Olivier Deigni ◽  
Sumesh Kaswan ◽  
...  

Abstract Background It is well established that abdominoplasty confers a uniquely high risk of venous thromboembolism (VTE) complications. However, chemoprophylaxis is not routinely utilized due to the risk of bleeding complications. Fondaparinux, a factor Xa inhibitor FDA approved in 2001 for postoperative VTE prophylaxis, has emerged as a safe option for preventing VTE complications after high-risk surgeries. Objectives The goal of this study was to examine the effectiveness and safety of fondaparinux for VTE chemoprophylaxis in patients undergoing abdominoplasty. Methods This is a single-center retrospective chart review from January 2008 to December 2014 of 492 patients who underwent abdominoplasty with or without an additional body procedure. Prior to 2011, no VTE chemoprophylaxis was utilized (n = 233). In 2011, the routine employment of postoperative chemoprophylaxis with fondaparinux was implemented (n = 259). Patient demographics and 2005 Caprini scores were evaluated. Primary outcomes included postoperative VTE and bleeding complications. Results There were no statistical differences in patient demographics or median Caprini score. The treatment group demonstrated a statistically significant reduction in the rate of VTE compared with the nontreatment group (0% vs 2.1%, respectively, P = 0.02). There was no statistically significant difference in the rate of hematoma requiring reoperation between the nontreatment and treatment groups (1.7% vs 2.3%, P = 0.76) or blood loss requiring transfusion (0% vs 0.8%, P = 0.5). Conclusions Fondaparinux for VTE chemoprophylaxis after abdominoplasty is efficacious in decreasing the risk of VTE in this susceptible patient population without increasing the risk of postoperative bleeding complications. Level of Evidence: 3

Author(s):  
Vasileios Vasilakis ◽  
Bill G Kortesis ◽  
Gaurav Bharti ◽  
Matthew H Isakson ◽  
Joseph P Hunstad

Abstract Background Reducing the incidence of venous thromboembolism (VTE) following abdominal body contouring surgery remains a top priority for patient safety. There is a lack of consensus regarding the optimal chemoprophylactic agent for postoperative VTE prophylaxis, and the role of oral anticoagulants warrants further investigation. Objectives The aim of this multisurgeon, single-institution study was to determine the safety and efficacy of a 7-day postoperative rivaroxaban regimen for VTE prophylaxis in abdominal body contouring surgery. Methods A retrospective chart review was performed of all patients who underwent abdominoplasty, circumferential body lift, fleur-de-lis panniculectomy, or circumferential fleur-de-lis panniculectomy at our surgical center from August 2014 to November 2019. A 7-day postoperative course of once-daily 10 mg rivaroxaban, starting on postoperative day 1, was administered to every patient unless there was a contraindication. The 2 primary endpoints were the incidence of VTE and bleeding events. Results A total of 600 patients were included in the study. There were no deaths. There were 4 (0.7%) incidents of VTE events: 2 (0.3%) patients suffered pulmonary embolus and 2 (0.3%) patients suffered a lower-extremity deep venous thrombosis. A total of 13 (2.2%) patients suffered complications related to bleeding. Of these, operative intervention for control and evacuation was required in 7 (1.2%) patients. Conclusions A 7-day postoperative course of once-daily rivaroxaban for VTE risk reduction in abdominal body contouring surgery is associated with a low incidence of VTE events and a low risk of bleeding complications. Level of Evidence: 4


2018 ◽  
Vol 26 (2) ◽  
pp. 86-90
Author(s):  
RAUL CARNEIRO LINS ◽  
EPITÁCIO LEITE ROLIM FILHO ◽  
FERNANDO DE SANTA CRUZ OLIVEIRA ◽  
SAULO MONTEIRO DOS SANTOS ◽  
TALE LUCAS VIEIRA ROLIM ◽  
...  

ABSTRACT Objectives: To evaluate the effectiveness of aspirin as prophylaxis for deep venous thrombosis (DVT) in patients undergoing total hip arthroplasty (THA), and to analyze the incidence of bleeding during the post-operative period. Methods: This prospective study carried out in 2017 consisted of 37 patients indicated for THA with high risk for DVT. Immediately after the procedure, aspirin, elastic compression socks and early deambulation were initiated. Doppler ultrasound was performed in the legs 6 days and 6 weeks post-procedure to rule out venous thromboembolism. Hematometric variables and clinical criteria were used to detect bleeding. Results: The incidence of VTE (venous thromboembolism) 6 days post-procedure was 21.6%. By 6 weeks post-procedure, it dropped to 8.1%, (p = 0.102). Only 2.7% were diagnosed with VTE, 6 days and also 6 weeks post-procedure. Within the immediate postoperative period, hemoglobin was lower (p < 0.001), in contrast to 6 weeks after surgery, when it returned to baseline levels. Conclusion: Aspirin was an effective chemical prophylaxis for venous thromboembolism in high-risk patients who underwent THA. There was no clinical record of postoperative bleeding and hematometric levels suggested that there was no chronic bleeding. Level of Evidence II; Prospective study.


Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 2080-2080
Author(s):  
Addie A Hill ◽  
Poy P Theprungsirikul ◽  
Maureen T Quigley ◽  
Mary E Menduni ◽  
Thadeus L Trus ◽  
...  

Abstract Background: Patients undergoing bariatric surgery are at increased risk for symptomatic venous thromboembolism (VTE). Although the incidence of clinical VTE is lower than in other general and orthopedic surgical procedures, pulmonary embolism is an independent predictor of death after gastric bypass surgery. The optimal strategy for postoperative thrombophylaxis in bariatric surgery has yet to be elucidated. In 2010 our institution proposed a guideline for postoperative thrombophylaxis for bariatric surgery based on risk stratification. Patients were considered high risk if they had history of VTE or a BMI >/= 60 kg/m2 or if they had two or more of the following: age > 50, BMI >/= 50 kg/m2, male sex, recent history of smoking, obstructive sleep apnea, varicose veins, or hormone therapy within 30 days. All patients undergoing bariatric surgery received enoxaparin 40 mg SC twice daily in addition to mechanical thrombophylaxis including venodynes and compression stockings during the hospital stay. Prophylactic IVC filter insertion was not recommended. High-risk patients received an extended course of anticoagulation for 10 days after discharge. Methods: We retrospectively reviewed the medical charts of 692 patients who underwent bariatric surgery at Dartmouth-Hitchcock Medical Center from 2009 to 2014. We analyzed the incidence of VTE and bleeding complications under two different institutional thrombophylaxis protocols: an earlier protocol of VTE prophylaxis based on surgeon's preference (n = 62) and our subsequent protocol based on risk stratification (n = 630). Results: Prior to implementing our protocol the incidence of VTE and bleeding complications in patients who underwent bariatric surgery was 1.6% (1 in 62) for each. After 2010, with the implementation of extended VTE prophylaxis for high-risk patients, the incidence of postoperative VTE was 0% (0 in 630) and the incidence of postoperative bleeding was 2.7% (17 in 630). Of 17 patients who developed postoperative bleeding, 14 (82%) developed bleeding before postoperative day 3 during the hospitalization and 3 (18%) experienced delayed bleeding after hospital discharge. Of 3 patients with delayed bleeding, only 1 was on the extended thrombophylaxis protocol. Severe bleeding, defined as the need for packed red blood cell transfusions or re-operation, occurred in 1.6% (10 in 630). Conclusion: Our study demonstrates that a protocol based on risk stratification is effective at reducing the risk of symptomatic VTE in patients undergoing bariatric surgery. Although the incidence of all postoperative bleeding appears to have increased slightly after implementation of the protocol, the incidence of severe bleeding appears unchanged. As most of the post-operative bleeding events occurred during the hospitalization period, extending the length of pharmacologic thromboprophylaxis was not associated with an increase in bleeding. This study is limited by its retrospective design and the small number of patients studied prior to implementing the extended VTE prophylaxis protocol. Nevertheless, the findings are promising with respect to VTE risk reduction after bariatric surgery and suggest that prospective evaluation of the thromboprophylaxis protocol is in order. Disclosures No relevant conflicts of interest to declare.


Author(s):  
Alex Tang ◽  
Stephen G. Zak ◽  
Daniel Waren ◽  
Richard Iorio ◽  
James D. Slover ◽  
...  

AbstractVenous thromboembolism (VTE) events are rare, but serious complications of total joint replacement affect patients and health care systems due to the morbidity, mortality, and associated cost of its complications. There is currently no established universal standard of care for prophylaxis against VTE in patients undergoing revision total knee arthroplasty (rTKA). The aim of this study was to determine whether a protocol of 81-mg aspirin (ASA) bis in die (BID) is safe and/or sufficient in preventing VTE in patients undergoing rTKAs versus 325-mg ASA BID. In 2017, our institution adopted a new protocol for VTE prophylaxis for arthroplasty patients. Patients initially received 325-mg ASA BID for 1 month and then changed to a lower dose of 81-mg BID. A retrospective review from 2011 to 2019 was conducted identifying 1,438 consecutive rTKA patients and 90-day postoperative outcomes including VTE, gastrointestinal, and wound bleeding complications, acute periprosthetic joint infection, and mortality. In the 74 months prior to protocol implementation, 1,003 rTKAs were performed and nine VTE cases were diagnosed (0.90%). After 26 months of the protocol change, 435 rTKAs were performed with one VTE case identified (0.23%). There was no significant difference in rates or odds in postoperative pulmonary embolism (PE; p = 0.27), DVT (p = 0.35), and total VTE rates (p = 0.16) among patients using either protocol. There were also no differences in bleeding complications (p = 0.15) or infection rate (p = 0.36). No mortalities were observed. In the conclusion, 81-mg ASA BID is noninferior to 325-mg ASA BID in maintaining low rates of VTE and may be safe for use in patients undergoing rTKA.


2020 ◽  
Vol 41 (Supplement_1) ◽  
pp. S93-S93
Author(s):  
Brian McKinzie ◽  
Rabia Nizamani ◽  
Samuel W Jones ◽  
Felicia N Williams

Abstract Introduction Burn injured patients are at high risk of thromboembolic complications. Morbid obesity further increases risk for thromboembolic complications. Recent evidence supports the use of anti-Xa guided enoxaparin dosing for the prevention of venous thromboembolism (VTE) in high risk populations. Our objective was to evaluate the efficacy of enoxaparin 40mg twice daily in achieving prophylactic plasma anti-Xa levels in obese burn patients. Methods A retrospective chart review of an ABA-verified burn center from November 2018 until September 2019 identified patients who were either ≥100 kilograms (kg) or had a body mass index (BMI) ≥ 30 kg/m2 and were initiated on enoxaparin 40 mg twice daily for VTE prophylaxis. Patients were included if they were at least 18 years of age and received at least three sequential doses of enoxaparin with appropriately timed peak plasma anti-Xa levels to monitor efficacy. Patient demographics were analyzed, as well as body weight, BMI, and total body surface area (TBSA) burn. Statistical analysis was performed with student’s t-test for continuous data and Fischer’s exact test for categorical data. Results During the study period, 148 patients were screened with 44 patients included for analysis. Forty-one percent of the patients evaluated did not reach target peak plasma anti-Xa levels (0.2–0.5 IU/mL) on enoxaparin 40 mg twice daily. Patients who did not meet prophylactic target levels were more likely to be male (p&lt; 0.05) and have an increased body weight (129 +/- 24 kg versus 112 +/- 17 kg, p&lt; 0.05). Eleven out of 18 patients received dosage adjustments with subsequent anti-Xa levels available for follow-up assessment, of which an additional four patients required further dosage adjustment to meet goal peak plasma levels. Conclusions Current utilization of a fixed 40 mg twice daily regimen of enoxaparin for VTE prophylaxis is inadequate to meet target prophylactic peak plasma anti-Xa levels in the obese burn patient population. Dose adjusting enoxaparin to target peak plasma anti-Xa levels to reduce VTE rates in obese burn patients should be further evaluated. Applicability of Research to Practice This study demonstrates the need for more accurate dosing and evaluation of our dosing practices for VTE prevention. It also demonstrates the importance of having a Burn dedicated pharmacist in facilitating appropriate care.


Author(s):  
Basant Kumar Pathak ◽  
P Harikrishnan ◽  
Manish Manrai

Introduction: Venous Thromboembolism (VTE) is a major cause of morbidity and mortality in patients admitted to healthcare facilities. This can be prevented by giving thromboprophylaxis to patients after assessing the risk for VTE. This however is not being routinely done leading to underuse of thromboprophylaxis due to inadequate practice of risk assessment. Aim: To conduct an audit of VTE prophylaxis in Intensive Care Unit (ICU) based on Padua score and International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) Risk Assessment Model (VTE RAM). Materials and Methods: This was a cross-sectional observational study and the data was collected from medical records of patients retrospectively who were admitted to medical ICU between October 2019 and December 2019. Based on medical records risk assessment was done using the Padua score and IMPROVE VTE RAM. The prophylaxis given to patients was scrutinised for appropriateness based on American Society of Haematology (ASH) guidelines. The two validated scores Padua score and IMPROVE VTE RAM were compared with each other for any significant difference in the risk assessment made using Chi-square test and p-value <0.05 were considered significant. Results: Out of the 176 patients risk assessment was not done in any patient. On calculating the Padua score, 149 patients (84.66%) were in high risk for VTE (Padua Score ≥4) and amongst them only 76 (51%) patients received thromboprophylaxis. On calculating the IMPROVE VTE RAM score, 137 patients (77.84%) were in moderate or high risk for VTE requiring prophylaxis and amongst them only 76 (55.47%) patients received thromboprophylaxis. The accuracy of clinician’s judgement without risk assessment was 58.52% (95% CI: 65.80%-51.24%) and 64.20% (95% CI: 71.28%-57.12%) as compared to risk assessment by Padua score and IMPROVE VTE RAM, respectively. There was no significant difference between IMPROVE VTE RAM and Padua score with respect to risk assessment for VTE (p-value of 0.10). Conclusion: The practice of VTE prophylaxis is grossly inadequate and there is a requirement to sensitise the healthcare providers about the importance of risk assessment for VTE.


2010 ◽  
Vol 103 (02) ◽  
pp. 312-317 ◽  
Author(s):  
Karen Fiumara ◽  
Chiara Piovella ◽  
Shelley Hurwitz ◽  
Gregory Piazza ◽  
Clyde Niles ◽  
...  

SummaryVenous thromboembolism (VTE) prophylaxis in high-risk patients is frequently underutilised. We previously devised a one-screen computer alert program that identified hospitalised patients at high risk for VTE who were not receiving prophylaxis and advised their physicians to prescribe prophylaxis. While this strategy reduced the 90-day incidence of symptomatic VTE by 41%, the majority of electronic alerts were ignored. We have now developed a serial three-screen alert computer program designed to educate physicians who initially declined to order prophylaxis after a single screen alert. Of a total cohort of 880, the responsible physicians for 425 patients received a single electronic alert, whereas 455 who declined prophylaxis after the first screen received the second and third screens of the novel three-screen alert. Our enhanced serial three-screen alert program generated VTE prophylaxis orders for 58.4% of the 455 patients whose physicians initially declined to order prophylaxis following the one-screen alert. There was no significant difference in symptomatic 90-day VTE rates between the two cohorts (2.8% for the one-screen vs. 2.2% for the three-screen, p=0.55). We conclude that our three-screen computer alert program can markedly increase prophylaxis among physicians who decline an initial single screen alert.


2020 ◽  
pp. 089719002092981
Author(s):  
Raghad Saadi ◽  
Kimberly Brandt ◽  
Robert Madlinger ◽  
Steven F. Nerenberg

Background: Traumatic brain injury (TBI) is an independent risk factor for venous thromboembolism (VTE). Prophylaxis (PPX) beyond 48 hours increases VTE risk 3- to 4-fold. Pharmacologic VTE PPX initiation is controversial due to potential bleeding complications. Objective: To evaluate VTE PPX in patients with TBI for practice variation, efficacy, and safety. Methods: Retrospective review from January 2013 to September 2016 in adults admitted to the intensive care unit with moderate to severe TBI. Demographics, time to stable computerized tomography scan, time to PPX initiation, PPX regimen, and incidences of VTE and adverse effects were collected. Data were analyzed via descriptive statistics, analysis of variance, and linear regression models. Results: Of 96 patients included, 14.6% did not receive VTE PPX (G1), 7.3% initiated therapy within 0 to 24 hours (G2), 14.6% after 24 to 48 hours (G3), and 63.5% after 48 hours (G4). VTE occurred in 0% of G1 and G2, 28.6% of G3, and 8.2% of G4 patients ( P = .038). Of 9 VTE cases, 8 received medical and 1 received trauma PPX dosing ( P = .44). There were 3 major bleeds ( P = .79) and 19 minor bleeds ( P = .042). Of 14 fatalities, 42.9% were in G1, 0% in G2, 14.2% in G3, and 42.9% in G4 ( P = .009). Conclusion: The majority of patients received delayed PPX, with no correlation between VTE incidence and PPX regimen. There was a significant difference in VTE incidence stratified by time to PPX. Further studies are required to determine optimal timing of PPX. Higher mortality rate was correlated with the lack of PPX. Increased minor bleeds occurred with earlier PPX initiation.


2019 ◽  
Vol 40 (9) ◽  
pp. 989-995 ◽  
Author(s):  
Vasileios Vasilakis ◽  
Gabriel M Klein ◽  
Michael Trostler ◽  
Muntazim Mukit ◽  
Jocellie E Marquez ◽  
...  

Abstract Background Venous thromboembolism (VTE) chemoprophylaxis warrants an individualized, risk-stratified approach, and constitutes a relatively controversial topic in plastic surgery. Objectives The aim of this study was to determine the safety of a 7-day postoperative enoxaparin regimen for VTE prophylaxis compared with a single preoperative dose of heparin in abdominal body contouring surgery. Methods This single-institution pre-post study investigated the safety of a 7-day enoxaparin postoperative regimen in abdominal body contouring procedures performed by a single surgeon from 2007 to 2018. Four procedures were included: traditional panniculectomy, abdominoplasty, fleur-de-lis panniculectomy, and body contouring liposuction. Group I patients received a single dose of 5000 U subcutaneous heparin in the preoperative period, and no postoperative chemical prophylaxis was administered. Group II patients received 40 mg subcutaneous enoxaparin in the immediate preoperative period, then once daily for 7 days postoperatively. Results A total of 195 patients were included in the study, 66 in Group I and 129 in Group II. The groups demonstrated statistically similar VTE risk profiles, based on the 2005 Caprini risk-assessment model. There were no statistically significant differences in the 2 primary outcomes: postoperative bleeding and VTE events. Group I patients had higher reoperation rates (22.7% vs 10.1%, P = 0.029), which was secondary to higher rates of revision procedures. Conclusions A 7-day postoperative course of once-daily enoxaparin for VTE risk reduction in abdominal body contouring surgery does not significantly increase the risk of bleeding. Implementation of this regimen for postdischarge chemoprophylaxis, when indicated following individualized risk stratification, is appropriate. Level of Evidence: 4


Author(s):  
Taras M. Domanskyy ◽  
Artur V. Gabriyelyan ◽  
Oleg V. Beregovoy ◽  
Stanislav I. Filianin ◽  
Svitlana S. Moshta

Background. Patients with dual antiplatelet therapy have high risk of perioperative bleeding. In this article we evaluated the risk of bleeding in patients whose antiplatelet therapy had not been canceled before coronary artery bypass grafting (CABG). The aim. To investigate and evaluate the risk of intra- and postoperative bleeding in patients who underwent CABG during antiplatelet therapy. Materials and methods. In the study, 47 case reports of patients with coronary heart disease who underwent CABG were evaluated. The patients were divided into 2 groups. The first group included 26 patients who discontinued antiplatelet therapy less than 5 days before the operation. The second group included 21 patients who discontinued antiplatelet therapy more than 5 days before the operation. Stratification of the risk of bleeding was performed using HAS-BLED Score for Major Bleeding Risk online calculator. Results and discussion. The major bleeding risk was 5.1 ± 1.4% and 4.4 ± 1.6% in the first and in the second group, respectively. In spite of higher risk of bleeding in the first group, there was no significant difference in intra- and postoperative bleeding complications. Conclusions. Candidates for surgical intervention who receive dual antiplatelet therapy have high risk of intra- and postoperative bleeding complications. In urgent cases when timely discontinuation of dual antiplatelet therapy is impossible and there is urgent need in the intervention, the latter must be performed. For patients who were prepared for CABG and discontinued dual antiplatelet therapy less than 5 days before the operation, sufficient volume of blood for transfusion must be provided.


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