Predictors of Bleeding in the Perioperative Anticoagulant Use for Surgery Evaluation Study.

Background In the PAUSE (Perioperative Anticoagulant Use for Surgery Evaluation) Study, a simple, standardized, perioperative interruption strategy was provided for patients with nonvalvular atrial fibrillation taking direct oral anticoagulants (DOACs). Our objective was to define the factors associated with perioperative bleeding. Methods and Results We analyzed bleeding as the composite of major and clinically relevant nonmajor bleeding. Putative predictors of bleeding, and preoperative DOAC level were prospectively collected during recruitment. We used stratified logistic regression models for analysis. All statistical analyses were performed in R version 3.6.0. There were 3007 patients requiring perioperative DOAC interruption. More than one third of the included patients underwent a high bleeding risk procedure. The 30-day rates of major and clinically relevant nonmajor bleeding were 3.02% in apixaban (n=1257), 2.84% in dabigatran (n=668), and 4.16% for rivaroxaban (n=1082). Multivariate analysis stratified by region found more bleeding for hypertension (odds ratio [OR], 1.79; 95% CI 1.07-2.99; P=0.027), and prior bleeding (OR, 1.71; 95% CI, 1.08-2.71; P=0.021). Surgical bleed risk classification (high- versus low-risk) as a predictor of bleeding was only significant in the univariate analysis. The prediction model for major and clinically relevant nonmajor bleeding had an area under the curve of 0.71, and the preoperative DOAC level did not improve the area under the curve of the model. Conclusions In patients treated with DOACs who required an elective surgery/procedure and were managed with standardized DOAC interruption and resumption, there we did not find reversible risk factors for bleeding, suggesting that adjustment of the PAUSE management protocol to mitigate against bleeding is not needed.

Clinical Validation of the Chinese Version of Patient Completed Caprini Risk Assessment Form.

To create and validate patient-completed Caprini risk score (CRS) tools for Chinese people. We revised Chinese patient-completed CRS form according to previously published studies. We prospectively recruited 70 internal medical patients and 70 surgical patients. The average age of these patients was 54.26 ± 15.29 years, 54.29% of them were male and 80% of them had education beyond high school. The study compared: (1) patient-completed CRS and physician-completed CRS; (2) the final value of physician-completed CRS (physician-completed CRS + body mass index) and CRS in the electronic medical record (EMR) system. Patient-completed CRS was 3.71 ± 3.63, patients spent 3.60 ± 1.24 minutes, 57.14% patients were at high-highest risk; physician-completed CRS was 3.84 ± 3.63, physicians spent 2.11 ± 1.13 minutes, 59.28% patients were at high-highest risk; the final value of physician-completed CRS was 4.12 ± 3.62, 63.58% patients were at high-highest risk; CRS value in the EMR system was 4.07 ± 3.58, 65% patients were at high-highest risk. There were strong positive correlations (P < .0001) between patient-completed CRS and physician-completed CRS (r = 0.978, κ = 0.76) and between the final value of physician-completed CRS and CRS in EMR (r = 0.994, κ = 0.97). This study successfully developed and validated a Chinese patient-completed CRS that we found can replace physician-completed CRS. This results in considerable time saving for physicians and this process should increase the percentage of patients having complete risk assessment when they are admitted to the hospital.

Completion of the Updated Caprini Risk Assessment Model (2013 Version).

The Caprini risk assessment model (RAM) has been validated in over 250 000 patients in more than 100 clinical trials worldwide. Ultimately, appropriate treatment options are dependent on precise completion of the Caprini RAM. As the numerical score increases, the clinical venous thromboembolism rate rises exponentially in every patient group where it has been properly tested. The 2013 Caprini RAM was completed by specially trained medical students via review of the presurgical assessment history, medical clearances, and medical consults. The Caprini RAM was completed for every participant both preoperatively and predischarge to ensure that any changes in the patient's postoperative course were captured by the tool. This process led to the development of completion guidelines to ensure consistency and accuracy of scoring. The 2013 Caprini scoring system provides a consistent, thorough, and efficacious method for risk stratification and selection of prophylaxis for the prevention of venous thrombosis.

Risk Assessment in Chinese Hospitalized Patients Comparing the Padua and Caprini Scoring Algorithms.

The current venous thromboembolism (VTE) guidelines recommend all patients to be assessed for the risk of VTE using risk assessment models (RAMs). The study was to evaluate the performance of the Caprini and Padua RAMs among Chinese hospitalized patients. We reviewed data from 189 patients with deep venous thrombosis (DVT) and 201 non-DVT patients. Deep venous thrombosis risk factors were obtained from all patients. The sensitivity and specificity of the Caprini and Padua scores for all patients were calculated. The receiver operating curve (ROC) and the area under the ROC curve (AUC) were used to evaluate the performance of each score. We documented that age, acute infection, prothrombin time (PT), D-dimer, erythrocyte sedimentation rate, blood platelets, and anticoagulation were significantly associated with the occurrence of DVT (P < .05). These results were true for all medical and surgical patients group (G1), as well as the analysis of medical versus surgical patients (G2). Finally, analysis of the scores in patients with and without cancer was also done (G3). The Caprini has a higher sensitivity but a lower specificity than the Padua (P < .05). Caprini has a better predictive ability for the first 2 groups (P < .05). We found Caprini and Padua scores have a similar predictive value for patients with cancer (P > .05), while Caprini has a higher predictive ability for no cancer patients in G3 than Padua (P < .05). For Chinese hospitalized patients, Caprini has a higher sensitivity but a lower specificity than Padua. Overall, Caprini RAM has a better predictive ability than Padua RAM.

Validation of a Patient-Completed Caprini Risk Assessment Tool for Spanish, Arabic, and Polish Speakers.

Targeted prophylaxis for venous thromboembolism (VTE) using the Caprini risk score (CRS) is effective reducing postoperative VTE. Despite its availability as preventive strategy, risk scoring remains underutilized. Critics to the CRS contend the time it takes to complete, and its limitation to English language. Aim is to create and validate patient-completed CRS tools for Spanish, Arabic, and Polish speakers. We translated the first patient-completed CRS to Spanish, Arabic, and Polish. We conducted a pilot study followed by the validation study. Using PASS version 11, we determined that a sample size of 37 achieved a power of 80%, to detect a difference of 0.1 between the null hypothesis correlation of 0.5 and the alternative hypothesis correlation of 0.7 using a 2-sided hypothesis test, significance level of .05. We tabulated and categorized scores using SPSS version 23 to estimate κ, linear correlation, and Bland Altman test. κ value >0.8 was defined as "almost perfect agreement." From 129 recruited patients, 50 (39%) spoke Spanish, 40 (31%) spoke Arabic, and 39 (30%) spoke Polish; average age 51 (16.69) years, 58 (45%) were men, with less than college education (67%). Mean (standard deviation) CRS was 5 (3.90), the majority (63%) above moderate VTE risk. We report excellent agreement comparing physician and patient results (κ = 0.93) and high correlation 0.97 ( P < .01) for the overall score. Bland Altman did not show trend for extreme values. We created and validated the first Spanish, Arabic, and Polish versions of the patient-completed CRS, with excellent correlation and agreement when compared to CRS-trained physician-completed form. Based on these results, the physician needs to calculate the body mass index. Completing the form was not time-consuming.

Validation of Venous Clinical Severity Score (VCSS) with other venous severity assessment tools from the American Venous Forum, National Venous Screening Program.

BACKGROUND: Several standard venous assessment tools have been used as independent determinants of venous disease severity, but correlation between these instruments as a global venous screening tool has not been tested. The scope of this study is to assess the validity of Venous Clinical Severity Scoring (VCSS) and its integration with other venous assessment tools as a global venous screening instrument. METHODS: The American Venous Forum (AVF), National Venous Screening Program (NVSP) data registry from 2007 to 2009 was queried for participants with complete datasets, including CEAP clinical staging, VCSS, modified Chronic Venous Insufficiency Quality of Life (CIVIQ) assessment, and venous ultrasound results. Statistical correlation trends were analyzed using Spearman's rank coefficient as related to VCSS. RESULTS: Five thousand eight hundred fourteen limbs in 2,907 participants were screened and included CEAP clinical stage C0: 26%; C1: 33%; C2: 24%; C3: 9%; C4: 7%; C5: 0.5%; C6: 0.2% (mean, 1.41 ± 1.22). VCSS mean score distribution (range, 0-3) for the entire cohort included: pain 1.01 ± 0.80, varicose veins 0.61 ± 0.84, edema 0.61 ± 0.81, pigmentation 0.15 ± 0.47, inflammation 0.07 ± 0.33, induration 0.04 ± 0.27, ulcer number 0.004 ± 0.081, ulcer size 0.007 ± 0.112, ulcer duration 0.007 ± 0.134, and compression 0.30 ± 0.81. Overall correlation between CEAP and VCSS was moderately strong (r(s) = 0.49; P < .0001), with highest correlation for attributes reflecting more advanced disease, including varicose vein (r(s) = 0.51; P < .0001), pigmentation (r(s) = 0.39; P < .0001), inflammation (r(s) = 0.28; P < .0001), induration (r(s) = 0.22; P < .0001), and edema (r(s) = 0.21; P < .0001). Based on the modified CIVIQ assessment, overall mean score for each general category included: Quality of Life (QoL)-Pain 6.04 ± 3.12 (range, 3-15), QoL-Functional 9.90 ± 5.32 (range, 5-25), and QoL-Social 5.41 ± 3.09 (range, 3-15). Overall correlation between CIVIQ and VCSS was moderately strong (r(s) = 0.43; P < .0001), with the highest correlation noted for pain (r(s) = 0.55; P < .0001) and edema (r(s) = 0.30; P < .0001). Based on screening venous ultrasound results, 38.1% of limbs had reflux and 1.5% obstruction in the femoral, saphenous, or popliteal vein segments. Correlation between overall venous ultrasound findings (reflux + obstruction) and VCSS was slightly positive (r(s) = 0.23; P < .0001) but was highest for varicose vein (r(s) = 0.32; P < .0001) and showed no correlation to swelling (r(s) = 0.06; P < .0001) and pain (r(s) = 0.003; P = .7947). CONCLUSIONS: While there is correlation between VCSS, CEAP, modified CIVIQ, and venous ultrasound findings, subgroup analysis indicates that this correlation is driven by different components of VCSS compared with the other venous assessment tools. This observation may reflect that VCSS has more global application in determining overall severity of venous disease, while at the same time highlighting the strengths of the other venous assessment tools.

Risk assessment as a guide to thrombosis prophylaxis.

PURPOSE OF REVIEW: This review discusses the current status of individual thrombosis risk assessment as an alternative to applying prophylaxis to broad groups in an attempt to simplify the process. Complete assessment is necessary in order to provide the proper type, duration, and intensity of prophylaxis, especially following discharge. RECENT FINDINGS: The concept of weighting risk factors to obtain a score has been used by some to guide prophylactic decisions for 20 years. This approach was thought to be intuitively correct despite not having been prospectively validated. During the past years, several studies have appeared linking the score to clinically relevant, imaging-proven venous thromboembolism events. In one study, 12.5% of patients with a score higher than 8 developed proven venous thromboembolism events within 60 days postoperatively. SUMMARY: The use of this score can suggest appropriate prophylaxis for surgical patients, especially those at high risk following hospital discharge.

Risk assessment as a guide for the prevention of the many faces of venous thromboembolism.

BACKGROUND: Approximately 900,000 cases of deep vein thrombosis and pulmonary embolism occur annually in the United States, and one-third lead to the patient's death. A variety of surgical factors contribute to Virchow's triad of venous stasis, vascular injury, and hypercoagulability, including intraoperative venous distension and microvascular endothelial damage. Patients also may have individual risk factors such as a history of thromboembolism, cancer, advanced age, or a genetic trait linked to hypercoagulation. This article discusses recent trends in the development and validation of venous thromboembolism risk scores, including the results of a large validation study. DATA SOURCES: A Medline literature search was performed to identify original studies. CONCLUSIONS: Venous thromboembolism risk scores have been developed for groups of patients based on a few broad risk categories, but a more accurate, individualized risk score can be obtained using a recently validated risk scoring system, which can be used to determine the type and length of prophylaxis to administer. Further studies are under way to refine this system.

Efficacy and safety of dabigatran etexilate for the prevention of venous thromboembolism following total hip or knee arthroplasty. A meta-analysis.

Dabigatran etexilate has been investigated in three phase III trials for the prevention of venous thromboembolism (VTE). Health technology assessment agencies increasingly require meta-analyses of all relevant evidence for an intervention, if appropriate. The objective of this study was to perform a meta-analysis of efficacy and safety data for the recommended dose of dabigatran etexilate, 220 mg once daily (od), for VTE prophylaxis after total knee arthroplasty (TKA) and total hip arthroplasty (THA), and discuss the appropriateness of combining the data. Risk ratios (RR) for VTE and bleed end-points were estimated using fixed and random effects meta-analysis. Analyses were performed combining RE-MODEL and RE-NOVATE, which compared dabigatran etexilate with enoxaparin 40 mg od after TKA and THA, respectively, and also including RE-MOBILIZE, which compared dabigatran etexilate with enoxaparin 30 mg twice daily after TKA. Tests for statistical heterogeneity were performed using the Chi-squared statistic. No significant differences were detected between dabigatran etexilate and enoxaparin in any of the end-points analysed, either in the two trial analysis (all p > 0.15), or when all three trials were combined ( all p > 0.30). RRs (random effects) for the composite end-point total VTE and all-cause mortality were 0.95 [95% confidence intervals 0.82 - 1.10] and 1.05 [0.87 - 1.26] in the two and three trial analyses, respectively. Meta-analysis of RE-MODEL and RE-NOVATE supported the conclusions of the individual trials that dabigatran etexilate is non-inferior to enoxaparin 40 mg od, with a similar safety profile. Meta-analysis of all three trials found no significant differences between treatments in any of the end-points analysed. Heterogeneity between the trials cannot be ruled out.

Venous thromboembolism following major orthopedic surgery: what is the risk after discharge?

Guidelines recommend thromboprophylaxis for at least 10 days to prevent venous thromboembolism in patients undergoing high-risk orthopedic surgery, such as total hip arthroplasty (THA) or total knee arthroplasty (TKA). Furthermore, the recently updated ACCP guidelines also recommend extending the duration of thromboprophylaxis for 28 to 35 days following THA or hip fracture surgery as the risk for venous thromboembolism persists for up to 3 months after surgery. Extended-duration thromboprophylaxis (up to 6 weeks) with low-molecular-weight heparin is significantly more effective in preventing venous thromboembolism in orthopedic surgery patients than the recommended practice of at least 10 days. Extended-duration thromboprophylaxis may require risk stratification to identify high-risk patients. Current risk-assessment models have limitations and are not specific to orthopedic surgery patients; therefore, improvements may facilitate the use of extended-duration thromboprophylaxis in high-risk patients, thereby reducing the burden of venous thromboembolism.

Economic burden of long-term complications of deep vein thrombosis after total hip replacement surgery in the United States.

BACKGROUND: Estimates of the cost of long-term complications of a primary deep vein thrombosis (DVT), including the post-thrombotic syndrome (PTS) and recurrent venous thromboembolism (VTE), may be relevant for resource allocation decisions. OBJECTIVE: The objective of this study was to provide US cost estimates of the long-term complications of a primary DVT, which occurs in approximately 5% to 20% (with adequate thromboprophylaxis) and 50% (in the absence of thromboprophylaxis) of total hip replacement surgeries (THRS). METHODS: A literature-based model was used to project the excess long-term complication costs of DVT following THRS. The model simulated the natural history of DVT complications using published estimates of the incidence and prognosis of PTS and recurrent VTE. Each complication was assigned a cost obtained by multiplying the amount of resources used in its management by the unit price of these resources. RESULTS: The annual per-patient cost of each complication was as follows: mild-to-moderate PTS, 839 dollars in the first year and 341 dollars in subsequent years; severe PTS, 3817 dollars in the first year and 1677 dollars in subsequent years; DVT, 3798 dollars; and pulmonary embolism, 6604 dollars. The average discounted lifetime cost of DVT complications was estimated to be 3069 dollars (95% interval 2091 dollars-4279 dollars). CONCLUSIONS: The long-term complications of a primary DVT represent a significant economic burden. Preventing a DVT could arguably lead to substantial savings in long-term DVT complications.