Thromboprophylaxis in gynecologic cancer surgery: Is extended prophylaxis with low molecular weight heparin justified? (original) (raw)
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Gynecologic Oncology, 2013
► Venous thromboembolism rates within 30 days of surgery were significantly reduced in gynecologic cancer patients receiving extended duration prophylaxis. ► The decrease in venous thromboembolism rates was not sustained at 90 days following surgery. ► Additional study is needed to further reduce long-term venous thromboembolism rates in women with gynecologic malignancies. a b s t r a c t Objective. To compare the incidence of venous thromboembolism (VTE) before and after the implementation of standardized extended duration prophylaxis guidelines in women undergoing laparotomy for gynecologic cancer.
Cost-effectiveness of combination thromboembolism prophylaxis in gynecologic oncology surgery
Gynecologic Oncology, 2004
This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology The use of external pneumatic compression (EPC) for 5 days, with or without low molecular weight heparin (LMWH), as prophylactic therapy for deep vein thrombosis (DVT) in gynaecologic oncology surgery. LMWH (enoxaparin) was administered at a dose of 40 mg/day for 5 days. Type of intervention Primary prevention. Economic study type Cost-effectiveness analysis. Study population The study population comprised three hypothetical cohorts of women undergoing gynaecologic surgery. There was a 35-year-old cohort with Stage IB cervix cancer, a 55-year-old cohort with Stage IA endometrial cancer, and a 65-yearold cohort with Stage IIIC ovarian cancer. Setting The setting was a hospital. The economic study was carried out in the USA.
Effectiveness and safety of expanded perioperative thromboprophylaxis in complex gynecologic surgery
Gynecologic Oncology, 2015
Objective-To determine the effectiveness and safety of an expanded perioperative venous thromboembolism (VTE) prophylaxis strategy in women undergoing complex gynecologic surgery. Methods-We performed a cohort study of 527 patients undergoing major surgery at a single institution over a thirty-month interval during which the gynecologic oncology service implemented an expanded approach to VTE prophylaxis. We compared rates of VTE pre-and post-intervention as well as bleeding and infectious complications. Results-Prior to the intervention, there were 23 VTE events in 345 patients (rate of 6.67%): 8 deep vein thrombosis (DVTs) and 15 pulmonary emboli (PEs). Post intervention, there were 5 VTE events in 182 patients (2.7%): 3 DVTs and 2 PEs (RR=0.4 p=0.056). Time-to-event analysis showed a significantly higher incidence of VTE events in the pre-intervention time frame compared to the post-intervention period (p = 0.049). There were no significant differences in bleeding or infection complications between groups. Conclusions-Implementation of a perioperative VTE prophylaxis protocol was safe, feasible and resulted in a clinically significant reduction in symptomatic VTE. Preoperative single-dose unfractionated heparin for all patients, combined with two weeks of thromboprophylaxis in gynecologic cancer patients, may decrease VTE events without increasing bleeding or infection.
Thrombosis Research, 2016
Purpose To describe a patient and procedure specific approach to selecting Venous thromboembolism (VTE) prophylaxis for men who undergo radical prostatectomy. Methods We performed a literature search and narrative review of VTE after radical prostatectomy. We describe the current paradigm of perioperative thromboprophylaxis and underlying rationale. Relevant findings from the European Association of Urology thromboprophylaxis guidelines are interpreted and summarized. Results The use of extended post-operative thromboprophylaxis for patients who undergo radical prostatectomy is appropriate when the risk of symptomatic VTE outweighs the risk of major bleeding. Patient and procedure factors impact VTE risk. Patient risk can be stratified as low, moderate or high based on 4 factors; age > 75, BMI > 35, VTE in a first degree relative, and personal history of VTE. Procedure risk of VTE and bleeding can be stratified by modality of surgery (open, laparoscopic, robotic) and extent of pelvic lymphadenectomy. Using these factors, patients at the lowest risk for VTE will have an expected incidence of VTE of 0.4-0.8% and those at highest risk from 1.5 to 15.7%. Incidence of major bleeding ranges from 0.4 to 1.4%. These ranges emphasize the need to consider the net benefit for each specific patient. Use of mechanical prophylaxis is supported by weaker evidence but has fewer harms and is likely reasonable for most patients. Conclusion Many patients who undergo radical prostatectomy will benefit from extended post-operative thromboprophylaxis. Risk of thrombosis is likely higher with open approach and extended lymph node dissection. The net benefit of treatment should be considered using patient-and procedure-specific criteria. When the net benefit is negligible or possibly harmful no pharmacological thromboprophylaxis should be used.
Systematic Reviews
Background Venous thromboembolism (VTE) is a common postoperative complication associated with significant morbidity and mortality. The use of prophylactic heparin postoperatively reduces this risk, and the use of extended duration prophylaxis is becoming increasingly common. Malignancy and pelvic surgery both independently further increase the risk of postoperative VTE and patients undergoing major pelvic surgery for malignancy are at particularly high risk of VTE. However, the optimum duration of prophylaxis specifically in this population currently remains unclear. Methods We will conduct a systematic review of literature in accordance with the Cochrane Handbook for Systematic Reviews of Interventions (Higgins JPT, Green S. Cochrane Handbook for Systematic Reviews of Interventions version 5.1.0.,2011) to evaluate current evidence of the effectiveness and safety of inpatient versus extended VTE prophylaxis with heparin (all forms) following major pelvic surgery for malignancy. We ...
JAMA Network Open
IMPORTANCE Current guidelines recommend a 28-day course of enoxaparin for thromboprophylaxis after surgery for gynecologic cancer. The high cost of this medication and the low adherence rates observed in prior studies provide an opportunity to benefit patients by demonstrating the safety of a more cost-effective, easier to use thromboprophylactic. OBJECTIVE To investigate the safety and efficacy of an oral treatment alternative for thromboprophylaxis in postoperative patients with gynecologic cancer. DESIGN, SETTING, AND PARTICIPANTS This was a patient-based, multicenter, open-label, blinded, end point, randomized clinical trial conducted May 2015 to March 2019 in outpatient and inpatient gynecologic oncology settings. Women undergoing surgery for suspected or confirmed gynecologic cancer were approached for recruitment. The trial compared rates of major bleeding and clinically relevant nonmajor bleeding events during a 90-day follow-up period in patients taking apixaban or enoxaparin for postoperative thromboprophylaxis using a modified intent-to-treat analysis. Data analysis was performed from October to December 2019. INTERVENTIONS Women were randomized to 28 days of apixaban (2.5 mg orally twice daily) or enoxaparin (40 mg subcutaneously daily). MAIN OUTCOMES AND MEASURES The primary outcome was major bleeding and clinically relevant nonmajor bleeding events. Secondary outcomes included incidence of venous thromboembolic events, adverse events, medication adherence, participant quality of life, and medication satisfaction. RESULTS Of 500 women recruited for the study, 400 were enrolled and randomized (median age, 58.0 years; range, 18.0-89.0 years); 204 received apixaban and 196 received enoxaparin. Treatment groups did not differ in terms of race/ethnicity, cancer stage, or surgery modality (open vs robotic). There were no statistically significant differences between the apixaban and enoxaparin groups in terms of rates of major bleeding events (1 patient [0.5%] vs 1 patient [0.5%]; odds ratio [OR], 1.04; 95% CI, 0.07-16.76; P > .99), clinically relevant nonmajor bleeding events (12 patients [5.4%] vs 19 patients [9.7%]; OR, 1.88; 95% CI, 0.87-4.1; P = .11), venous thromboembolic events (2 patients [1.0%] vs 3 patients [1.5%]; OR, 1.57; 95% CI, 0.26-9.50; P = .68), adverse events, medication adherence, or quality of life between the groups. Participant satisfaction was significantly greater in the apixaban group with regard to ease of taking the medication (186 patients [98.9%] vs 110 (continued) Key Points Question Is there an efficacious and safe oral treatment for thromboprophylaxis in postoperative patients with suspected gynecologic malignant neoplasms? Findings This multicenter randomized clinical trial included 400 women randomized to either oral apixaban or subcutaneous enoxaparin. There were no differences between groups for rates of major bleeding (0.5% vs 0.5%), clinically relevant nonmajor bleeding (5.4% vs 9.7%), and venous thromboembolic events (1.0% vs 1.5%); although adherence rates did not differ, patients in the apixaban group reported increased ease and decreased pain associated with taking the medication. Meaning These findings suggest that oral apixaban may offer a safe alternative to subcutaneous enoxaparin that is easier and less painful for patients to take.
Annals of Oncology, 2010
Background: The purpose of the present study was to evaluate whether early postoperative D-dimer levels and certain pre-, intra-, and postoperative parameters can be used to predict venous thromboembolism (VTE) in gynecologic cancer patients. Materials and methods: We prospectively evaluated 267 gynecologic cancer patients who underwent surgery at our institution. The plasma D-dimer level was measured serially before the operation and on certain postoperative days. After the operation, primary screening for VTE was undertaken by meticulous examination for clinical signs and elevation of the plasma D-dimer level. Seventy-five patients underwent multidetector row computed tomography and were subjected to further investigations. Results: VTE was detected in 21 of the 75 patients. There were significant differences in the D-dimer value between VTE-positive and VTE-negative patients on postoperative days 3, 5, and 7. The optimal cutoff value for the postoperative D-dimer level was determined as 5 lg/ml on day 3. Logistic regression multivariate analysis revealed that high D-dimer values on postoperative day 3, the use of recombinant human erythropoietin (rHuEPO), and non-O blood group were independent risk factors for postoperative VTE. Conclusion: High plasma D-dimer level on postoperative day 3, the use of rHuEPO, and non-O blood group were independent risk factors for postoperative VTE.
Venous Thromboembolic Events in Minimally Invasive Gynecologic Surgery
Journal of Minimally Invasive Gynecology, 2013
The rate of venous thromboembolic events (VTEs) including deep venous thrombosis and pulmonary embolism among women undergoing gynecologic surgery is high, particularly for women with a gynecologic malignancy. Current guidelines recommend VTE thrombopropylaxis in the immediate postoperative period for patients undergoing open surgery. However, the VTE prophylaxis recommendations for women undergoing minimally invasive gynecologic surgery are not as well established. The risk of VTEs in patients undergoing minimally invasive surgery appears to be low based on retrospective analyses. To date, there are no established guidelines that specifically provide a standard of care for patients undergoing minimally invasive gynecologic surgery for benign or malignant disease.