Extended Post Discharge Prophylaxis for Venous Thromboembolism Prevention After Bariatric Surgery.

PURPOSE: The utility of routine post-discharge VTE prophylaxis after bariatric surgery remains a matter of debate. While inpatient chemical prophylaxis decreases the risk of fatal pulmonary embolism, most thromboembolic events occur after discharge and carry high morbidity and mortality. To address this risk, apixaban was introduced as extended prophylaxis for 30 days after surgery. MATERIALS AND METHODS: The study ranges between 1/2014 and 7/2022. Apixaban was incorporated as routine extended prophylaxis protocol in 05/2017 and is dosed at 2.5 mg BID for 30 days. There were two study groups: those who received apixaban on discharge (n = 1443; 60%) and those who did not (n = 953; 40%). Patients with concern for postoperative bleeding (hypotension, unexplained tachycardia with hematocrit drop > 6%, hematocrit drop > 9%), or on preoperative anticoagulant/antiplatelet therapy (except aspirin), were not discharged on apixaban. Post-discharge VTE, readmission, transfusion, and reoperation rates were compared between groups. RESULTS: There were 2396 consecutive primary bariatric operations: sleeve gastrectomy (1949; 81%), Roux-en-Y gastric bypass (419; 18%), and duodenal switch (28; 1%). There were no post-discharge VTEs in patients treated with apixaban vs. five (0.5%) VTEs in patients who did not receive treatment; p = 0.02. There was a higher incidence in post-discharge bleeding events in the apixaban group (0.5 vs 0.3%; p = 0.75), mostly requiring readmission for monitoring without intervention or transfusion. In the apixaban group, one patient underwent EGD for bleeding while another required blood transfusion; there were no reoperations for bleeding. CONCLUSION: There were no post-discharge VTEs in patients who received apixaban. Treatment was associated with a higher risk of self-resolving bleeding events. This study adds to the increasing body of evidence supporting the benefit of routine, extended oral chemoprophylaxis after bariatric surgery.

Extended postoperative venous thromboembolism prophylaxis after bariatric surgery: a comparison of existing risk-stratification tools and 5-year MBSAQIP analysis.

BACKGROUND: Venous thromboembolism (VTE) is a leading cause of 30-day mortality after metabolic and bariatric surgery (MBS). Multiple predictive tools exist for VTE risk assessment and extended VTE chemoprophylaxis determination. OBJECTIVE: To review existing risk-stratification tools and compare their predictive abilities. SETTING: MBSAQIP database. METHODS: Retrospective analysis of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database was performed (2015-2019) for primary minimally invasive MBS cases. VTE clinical factors and risk-assessment tools were evaluated: body mass index threshold of 50 kg/m2, Caprini risk-assessment model, and 3 bariatric-specific tools: the Cleveland Clinic VTE risk tool, the Michigan Bariatric Surgery Collaborative tool, and BariClot. MBS patients were deemed high risk based on criteria from each tool and further assessed for sensitivity, specificity, and positive predictive value. RESULTS: Overall, 709,304 patients were identified with a .37% VTE rate. Bariatric-specific tools included multiple predictors: procedure, age, race, gender, operative time, length of stay, heart failure, and dyspnea at rest; operative time was the only variable common to all. The body mass index cutoff and Caprini risk-assessment model had higher sensitivity but lower specificity when compared with the Michigan Bariatric Surgery Collaborative and BariClot tools. While the sensitivity of the tools varied widely and was overall low, the Cleveland Clinic tool had the highest sensitivity. The bariatric-specific tools would have recommended extended prophylaxis for 1.1%-15.6% of patients. CONCLUSIONS: Existing MBS VTE risk-assessment tools differ widely for inclusion variables, high-risk definition, and predictive performance. Further research and registry inclusion of all significant risk factors are needed to determine the optimal risk-stratified approach for predicting VTE events and determining the need for extended prophylaxis.

Venous Thromboembolism in Surgically Treated Esophageal Cancer Patients: A Provincial Population-Based Study.

Objective Venous thromboembolism (VTE) is a major cause of morbidity and mortality in surgical patients. Surgery for esophageal cancer carries a high risk of VTE. This study identifies the risk factors and associated mortality of thrombotic complications among patients undergoing esophageal cancer surgery. Methods All patients in the province of Ontario undergoing esophageal cancer surgery from 2007 to 2017 were identified. Logistic regression identified VTE risk factors at 90 days and 1 year postoperatively. A flexible parametric survival analysis compared mortality and survival up to 5 years after surgery for patients with and without a postoperative VTE. Results Overall 9,876 patients with esophageal cancer were identified; 2,536 (25.7%) underwent surgery. VTE incidence at 90 days and 1 year postoperatively were 4.1 and 6.3%, respectively. Patient factors including age, sex, performance status, and comorbidities were not associated with VTE risk. VTE risk peaked at 1 month after surgery, with a subsequent decline, plateauing after 6 months. Adenocarcinoma was strongly associated with VTE risk compared with squamous cell carcinoma (SCC) (odds ratio [OR] 2.53, 95% confidence interval [CI] 1.38-4.63, p = 0.003). VTE risk decreased with adjuvant chemotherapy (OR = 0.58, 95% CI 0.36-0.94, p = 0.028). Postoperative VTE was associated with decreased survival at 1 and 5 years (hazard ratio = 1.57, 95% CI 1.23-2.00, p < 0.001). Conclusion Esophageal cancer patients with postoperative VTE have worse long-term survival compared with those without thrombotic complications. Adenocarcinoma carries a higher VTE risk compared with SCC. Strategies to reduce VTE risk should be considered to reduce the negative impacts on survival conferred by thrombotic events.

Evaluation of the Clinical Impact of Thromboprophylaxis in Patients With COVID-19 Following Hospital Discharge.

BACKGROUND: Data are limited regarding the incidence of thromboembolism post-hospital discharge among COVID-19 patients. Guidelines addressing the role of extended thromboprophylaxis for COVID-19 patients are limited and conflicting. OBJECTIVE: The purpose of this study was to evaluate the incidence of post-discharge thromboembolic and bleeding events and the role of thromboprophylaxis among COVID-19 patients. METHODS: A retrospective analysis was conducted of hospitalized patients with symptomatic COVID-19 infection who were discharged from a University of Colorado Health (UCHealth) hospital between March 1, 2020, and October 31, 2020. The primary outcome was objectively confirmed thromboembolism within 35 days post-discharge. The main secondary outcome was the incidence of bleeding events within 35 days post-discharge. Outcomes were compared between those who received extended prophylaxis and those who did not. RESULTS: A total of 1171 patients met the study criteria. A total of 13 (1.1%) of patients had a documented thromboembolic event and 10 (0.9%) patients had a documented bleeding event within 35 days post-discharge. None of the 132 patients who received extended prophylaxis had a thromboembolic event compared to 13 of 1039 who did not receive extended prophylaxis (0 and 1.3%, respectively; P = .383). The incidence of bleeding was higher among patients who received extended prophylaxis compared to those who did not (3.0% vs 0.6%, P = .019). CONCLUSIONS AND RELEVANCE: These results suggest that post-discharge extended prophylaxis may be beneficial for select COVID-19 patients, while carefully weighing the risk of bleeding. Application of our findings may assist institutions in development of thromboprophylaxis protocols for discharged COVID-19 patients.

Surgery and the Subtype of Inflammatory Bowel Disease Impact the Risk of Venous Thromboembolism After Hospital Discharge.

BACKGROUND: Surgery for inflammatory bowel disease (IBD) is associated with an increased risk of venous thromboembolism (VTE) during hospitalization. It is unclear whether this association persists after hospital discharge. AIMS: We assessed the association between surgery and VTE following hospital discharge in IBD. METHODS: We conducted a population-based cohort study between 2002 and 2016 in Ontario, Canada. Adults with IBD hospitalized for ≥ 72 h who underwent an intra-abdominal surgery were compared to hospitalized, nonsurgical IBD patients. Multivariable Cox proportional hazard models were used to compare VTE risk within 12 months of discharge. RESULTS: A total of 80,445 hospital discharges were analyzed: 60% Crohn's disease (CD) and 40% ulcerative colitis (UC). The median time to VTE was three times longer for nonsurgical patients with CD and 1.6 times longer for nonsurgical patients with UC. Compared with nonsurgical patients, surgery for CD was associated with a lower cumulative risk of VTE in the 2 weeks after discharge and persisted through to 12 months after discharge (adjusted HR 0.24; 95% CI 0.15-0.40). In contrast, urgent surgery for UC was associated with an increased risk of VTE. The increased risk was greatest at 2 weeks after discharge (aHR, 1.80; 95% CI 1.26-2.57) and declined progressively over the course of 12 months. CONCLUSIONS: Surgery was associated with a greater risk of VTE after hospital discharge in UC but not CD. In patients with UC who have undergone urgent surgery, healthcare providers should consider an extended period of prophylaxis after hospital discharge.

Venous Thromboembolism in COVID-19: Towards an Ideal Approach to Thromboprophylaxis, Screening, and Treatment.

PURPOSE OF REVIEW: Novel coronavirus disease 2019 (COVID-19) has been associated with an increased risk of arterial and venous thromboembolic (VTE) diseases. However, there is a limited amount of data regarding the prevention and management of VTE in severe hospitalized COVID-19 patients. RECENT FINDINGS: In this article, we review currently available clinical data, and mechanisms for COVID-associated coagulopathy, and propose algorithms for screening, prevention (including extended-duration prophylaxis), and treatment of these patients. Although these recommendations are subject to change given rapidly evolving data, we provide a framework that can guide clinicians in managing thrombotic complications in this challenging condition.

Extended Venous Thromboembolism Prophylaxis in Medically Ill Patients: An NATF Anticoagulation Action Initiative.

Hospitalized patients with acute medical illnesses are at risk for venous thromboembolism (VTE) during and after a hospital stay. Risk factors include physical immobilization and underlying pathophysiologic processes that activate the coagulation pathway and are still present after discharge. Strategies for optimal pharmacologic VTE thromboprophylaxis are evolving, and recommendations for VTE prophylaxis can be further refined to protect high-risk patients after hospital discharge. An early study of extended VTE prophylaxis with a parenteral agent in medically ill patients yielded inconclusive results with regard to efficacy and bleeding. In the Acute Medically Ill VTE Prevention with Extended Duration Betrixaban (APEX) trial, extended use of betrixaban halved symptomatic VTE, decreased hospital readmission, and reduced stroke and major adverse cardiovascular events compared with standard enoxaparin prophylaxis. Based on findings from APEX, the Food and Drug Administration approved betrixaban in 2017 for extended VTE prophylaxis in acute medically ill patients. In the Reducing Post-Discharge Venous Thrombo-Embolism Risk (MARINER) study, extended use of rivaroxaban halved symptomatic VTE in high-risk medical patients compared with placebo. In 2019, rivaroxaban was approved for extended thromboprophylaxis in high-risk medical patients, thus making available a new strategy for in-hospital and post-discharge VTE prevention. To address the critical unmet need for VTE prophylaxis in medically ill patients at the time of hospital discharge, the North American Thrombosis Forum (NATF) is launching the Anticoagulation Action Initiative, a comprehensive consensus document that provides practical guidance and straightforward, patient-centered recommendations for VTE prevention during hospitalization and after discharge.

Thrombophilia prevalence in patients seeking laparoscopic sleeve gastrectomy: extended chemoprophylaxis may decrease portal vein thrombosis rate.

BACKGROUND: Portomesenteric vein thrombosis (PMVT) may occur after laparoscopic sleeve gastrectomy (LSG). Previous studies have shown that PMVT patients may have undiagnosed thrombophilia. We recently changed our practice to check thrombophilia panel in every LSG patient preoperatively. OBJECTIVES: To estimate the thrombophilia prevalence in patients seeking LSG, and determine if extended chemoprophylaxis post LSG reduces PMVT. SETTINGS: University hospital. METHODS: Thrombophilia panels were drawn on every patient seeking LSG after July 2018 at 2 high-volume accredited bariatric surgery centers. A positive panel included factor VIII >150%; protein C <70%; protein S <55%; antithrombin III <83%; and activated protein C resistance <2.13. Patients with a positive panel were discharged on extended chemoprophylaxis. PMVT rates and bleeding occurrences were recorded for LSG patients from August 2018 to March 2019 and were compared with a historic cohort of LSG performed from January 2014 to July 2018. RESULTS: One thousand seventy-five patients seeking LSG had thrombophilia panel checked preoperatively. The cohort was 83% female; mean age and body mass index were 39.2 years and 43 kg/m2, respectively. Of the cohort, 52.4% (563/1075) had positive thrombophilia panel, including factor VIII elevation (91.5%), antithrombin III deficiency (6.0%), protein S deficiency (1.1%), protein C deficiency (.9%), and activated protein C resistance (.5%). Between January 2014 and July 2018, 13 PMVT were diagnosed among 4228 LSG (.3%) and there were 17 bleeding occurrences (.4%). After August 2018, one PMVT was diagnosed among 745 LSG (.1%) and there were 5 bleeding occurrences (.6%). CONCLUSIONS: The estimated thrombophilia prevalence in patients seeking LSG is 52.4%. The majority (91.5%) of these patients have factor VIII elevation. Extended prophylaxis may decrease PMVT postLSG.

Perioperative venous thromboembolism prophylaxis in prostate cancer surgery.

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.

Extended venous thromboembolism prophylaxis after abdominopelvic cancer surgery: a retrospective review.

Objective: Extended prophylaxis against venous thromboembolism (vte) after abdominal or pelvic cancer surgery with low molecular weight heparin (lmwh) is recommended by multiple guidelines. The primary objective of the present study was to assess adherence to that guideline recommendation at tertiary care centres within Hamilton Health Sciences (hhs). Methods: Given that an estimated 70% of the study population would be expected to receive extended prophylaxis, a sample size of 105 patients was calculated. Patients who had undergone abdominal or pelvic surgery for cancer from March 2012 to December 2015 were identified, and data were collected from electronic health records. The primary outcome was prescription of extended vte prophylaxis. Results: Of 105 patients, only 3 received extended vte prophylaxis. Those 3 patients had serous carcinoma of the uterus, transitional cell carcinoma of the bladder, and cecal cancer. Of the 3 patients, 2 were followed by the thrombosis service while in hospital; none of the other 102 patients received any form of extended vte prophylaxis. Conclusions: Based on multiple randomized controlled trials, guidelines suggest lmwh prophylaxis for up to 4 weeks after major abdominal or pelvic cancer surgery. Despite those recommendations, postoperative extended vte prophylaxis is not commonly prescribed at hhs facilities. Next steps will include identification of barriers and an examination of how those barriers could be addressed. Failure to use prophylaxis is not consistent with evidence-based guidelines and is placing patients at risk of vte.

Risk factors for post-discharge venous thromboembolism in patients undergoing colorectal resection: a NSQIP analysis.

BACKGROUND: Extended thromboprophylaxis after abdominal and pelvic cancer surgery to prevent venous thromboembolic events (VTE) is recommended but adherence is sub-optimal. Identifying patients at highest risk for post-discharge events may allow for selective extended thromboprophylaxis. The aim of our study was to identify the different risk factors of venous thromboembolism for in-hospital and post-discharge events. METHODS: The American College of Surgeons-National Surgical Quality Improvement Program (ACS-NSQIP) 2012-2016 database was queried for all patients having colorectal resection. Primary outcome was postoperative VTE occurrence within 30 days. A multinomial logistic regression was performed to identify in-hospital and post-discharge predictors of VTE, adjusting for potential confounders. RESULTS: Out of 260,258 patients, 5381 (2.1%) developed VTE. A total of 3442 (1.3%) were diagnosed during the initial hospital stay and 1929 (0.8%) post-discharge. Risk factors for in-hospital and post-discharge VTE were different as patients with an in-hospital event were more likely to be older, male, known for preoperative steroid use, have poor functional status, significant weight loss, preoperative sepsis, prolonged operative time, undergoing an emergency operation. In the post-discharge setting, steroid use, poor functional status, preoperative sepsis, and postoperative complications remained significant. Postoperative complications were the strongest predictor of in-hospital and post-discharge VTE. Patients with inflammatory bowel disease had a higher risk of VTE than patients with malignancy for both in-patient and post-discharge events. CONCLUSIONS: Patients at high-risk for post-discharge events have different characteristics than those who develop VTE in-hospital. Identifying this specific subset of patients at highest risk for post-discharge VTE may allow for the selective use of prolonged thromboprophylaxis.

Tolerability of up to 200 days of prophylaxis with valganciclovir oral solution and/or film-coated tablets in pediatric kidney transplant recipients at risk of cytomegalovirus disease.

This multicenter, open-label study evaluated the tolerability of extended prophylaxis with valganciclovir in pediatric kidney transplant recipients at risk of CMV disease. Fifty-six patients aged 4 months to 16 years received once-daily valganciclovir oral solution and/or tablets, dosed by BSA and renal function, for up to 200 days. The most common AEs on treatment were upper respiratory tract infection (33.9%), urinary tract infection (33.9%), diarrhea (32.1%), leukopenia (25.0%), neutropenia (23.2%), and headache (21.4%). There were fewer AEs during days 101-228 vs days 1-100. Twenty-seven patients (48.2%) had treatment-related AEs during valganciclovir treatment, most commonly leukopenia (21.4%), neutropenia (19.6%), anemia (7.1%), and tremor (5.4%). Treatment-related serious AEs were reported for nine patients (16.1%) and six withdrew due to AEs. Viremia was centrally confirmed in 10 patients; there was no confirmed CMV disease. One patient tested positive for a resistance mutation (UL97 L595F). Biopsy-proven acute rejection occurred in six patients (10.7%), but no graft loss or deaths occurred. In conclusion, up to 200 days of valganciclovir prophylaxis in pediatric kidney allograft recipients showed a safety profile consistent with that established in adult transplant patients.

Comparison of postoperative venous thromboembolism incidence in gastrointestinal and gynecologic solid tumors.

INTRODUCTION: Studies have shown the benefit of 28days of extended postoperative venous thromboembolism (VTE) prophylaxis for patients undergoing major cancer surgery in the abdomen or pelvis. We retrospectively evaluated the VTE incidence at the University of Kansas Hospital between gynecologic (GYN) cancer patients, who receive extended prophylaxis, and gastrointestinal (GI) cancer patients, who do not. METHODS: Patients were evaluated between January of 2010 and December of 2013, and VTE data for eligible patients were collected for 30 and 90days postoperatively. RESULTS: The study population composed of 190 GYN and 204 GI patients. Colon and endometrial cancers were the most common diagnoses. For GYN and GI patients respectively, VTE occurred in 4.2% and 5.4% at 30days (p=0.584) and 7.4% and 7.8% at 90days (p=0.514). One VTE-related death occurred in the GI group. GI patients underwent more open surgeries, 77.9% versus 66.3% (p=0.010) and had longer postoperative hospital stay, median of 7 versus 4days (p<0.0001). Out of all cancer patients combined, 40% versus 17.9% had stage IV disease and 10.2% versus 0.9% had open surgery in the VTE and non-VTE groups, respectively. CONCLUSIONS: There were no significant differences in overall VTE incidence between the two patient groups at 30 and 90days postoperatively. A majority of VTEs occurred in stage IV patients and patients who underwent open surgeries regardless of diagnosis.

Cytomegalovirus disease is associated with higher all-cause mortality after lung transplantation despite extended antiviral prophylaxis.

BACKGROUND: The duration of anticytomegalovirus (CMV) prophylaxis after lung transplantation (LT) varies among transplant centers. METHODS: A retrospective review of CMV donor-seropositive/recipient-seronegative (D+/R-) and CMV recipient-seropositive (R+) LT patients between January 2005 and September 2012 was performed. Starting January 2007, valganciclovir prophylaxis was given for at least 12 months (often lifelong) for CMV D+/R- and extended from three to six months for R+ LT patients. Risks of CMV infection and CMV disease, and mortality after LT, were assessed. RESULTS: A total of 88 LT patients were studied, including 32 CMV D+/R-, and 56 R+ patients. During the follow-up period, 11 (12.5%) patients had asymptomatic CMV infection, and nine (10.3%) developed CMV disease. CMV disease (HR, 4.189; 95% CI: 1.672-10.495; p = 0.002) and CMV infection and disease (HR, 3.775; 95% CI: 1.729-8.240; p = 0.001) were significant risk factors for mortality. Overall, no significant difference was observed in rates of CMV infection or disease among LT recipients who received shorter vs. extended CMV prophylaxis. CONCLUSIONS: Despite extended prophylaxis, LT patients remain at risk of CMV infection and disease. CMV remains associated with increased mortality after transplantation.

Effectiveness and safety of expanded perioperative thromboprophylaxis in complex gynecologic surgery.

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 thromboses (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.