A Clinical Trial of Venous Stent Placement for Post-thrombotic Syndrome: Current Status and Pandemic-related Changes

Patients with post-thrombotic syndrome (PTS) and iliac vein obstruction have lower extremity symptoms, activity limitation and impairment of health-related quality of life. Preliminary studies suggest that iliac vein stent placement, which eliminates venous outflow obstruction, may reduce the clinical severity of PTS. However, stent placement is associated with patient risk, inconvenience and cost. Therefore, the Chronic Venous Thrombosis – Relief with Adjunctive Catheter-directed Therapy (C-TRACT) trial was launched to rigorously assess the risk–benefit ratio of stent placement for the treatment of moderate or severe PTS. In the trial, patients in both treatment groups receive a high quality of multi-modality PTS care that includes medical, compressive, and ulcer therapies. Due to the COVID-19 pandemic, the trial protocol and practices were modified to enhance the study feasibility while preserving its ability to answer its primary question. This review summarises the current status of the trial and the potential impact of the pandemic-related adaptations to future venous clinical practice and research

Endovascular therapy for advanced post-thrombotic syndrome: Proceedings from a multidisciplinary consensus panel

Patients with advanced post-thrombotic syndrome (PTS) and chronic iliac vein obstruction suffer major physical limitations and impairment of health-related quality of life. Currently there is a lack of evidence-based treatment options for these patients. Early studies suggest that imaging-guided, catheter-based endovascular therapy can eliminate iliac vein obstruction and saphenous venous valvular reflux, resulting in reduced PTS severity; however, these observations have not been rigorously validated. A multidisciplinary expert panel meeting was convened to plan a multicenter randomized controlled clinical trial to evaluate endovascular therapy for the treatment of advanced PTS. This article summarizes the findings of the panel, and is expected to assist in developing a National Institutes of Health-sponsored clinical trial and other studies to improve the care of patients with advanced PTS

Very low energy diets prior to bariatric surgery may reduce postoperative morbidity: a systematic review and meta-analysis of randomized controlled trials

PurposeTo optimize patients prior to bariatric surgery, very low energy diets (VLEDs) are often employed for 2–4 weeks preoperatively. They are known to result in preoperative weight loss, decrease liver volume, and decrease surgeon-perceived operative difficulty. Their impact on postoperative morbidity has been less extensively studied. We performed a focused systematic review and meta-analysis with the aim of comparing preoperative VLEDs prior to bariatric surgery with controls in terms of overall postoperative morbidity.MethodsMEDLINE, Embase, and CENTRAL were searched from database inception to February 2023. Articles were eligible for inclusion if they were randomized controlled trials (RCTs) comparing postoperative morbidity in adult patients (i.e., over the age of 18) receiving a VLED with liquid formulation to those receiving a non-VLED control prior to elective bariatric surgery. Outcomes included overall 30-day postoperative morbidity and preoperative weight loss. An inverse variance meta-analysis was performed with GRADE assessment of the quality of evidence.ResultsAfter reviewing 2,525 citations, four RCTs with 294 patients receiving preoperative VLEDs with liquid formulation and 294 patients receiving a non-VLED control met inclusion. Patients receiving VLED experienced significantly more preoperative weight loss than patients receiving control (mean difference (MD) 3.38 kg, 95% confidence interval (CI) 1.06–5.70, p = 0.004, I2 = 95%). According to low certainty evidence, there was a non-significant reduction in 30-day postoperative morbidity in patients receiving VLED prior to bariatric surgery (risk ratio (RR) 0.67, 95%CI 0.39–1.17, p = 0.16, I2 = 0%).ConclusionThe impact of preoperative VLEDs on postoperative outcomes following bariatric surgery remains unclear. It is possible that VLEDs may contribute to decreased postoperative morbidity, but further larger prospective trials are required to investigate the signal identified in this study

Enhanced Recovery After Surgery (ERAS) protocols following emergency intra-abdominal surgery: A systematic review and meta-analysis protocol.

ObjectiveThe aim of this systematic review and meta-analysis is to evaluate whether the implementation of Enhanced Recovery After Surgery (ERAS) protocols for adult patients undergoing emergency intra-abdominal surgery decreases postoperative length of stay, postoperative morbidity, and mortality compared to conventional perioperative care.MethodsA systematic review and meta-analysis will be performed and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). It has been registered on the International Prospective Register for Systematic Reviews (PROSPERO; CRD42023391709). A comprehensive, electronic search strategy will be used to identify studies published and indexed in MEDLINE, EMBASE, Web of Science, CENTRAL, and Pubmed databases since their inception. Trial registries and references of included studies and pertinent previous systematic reviews will also be searched. Studies will be included if they are randomized controlled trials or cohort studies evaluating adult patients undergoing emergency intra-abdominal surgery and comparing ERAS or modified ERAS protocols to conventional perioperative care and report one of the following outcomes: postoperative length of stay, overall 30-day morbidity, 30-day mortality, 30-day infectious morbidity, prolonged postoperative ileus, return of bowel function, and 30-day readmissions. A meta-analysis will be performed using a random effects model for all comparative data using Cochrane Review Manager 5.3 (London, United Kingdom).DiscussionERAS protocols have become standard of care for patients undergoing elective surgery. Their use in the setting of emergency surgery is far less common. The aim of this systematic review and meta-analysis is to assess whether there are benefits in patient important outcomes with the implementation of ERAS protocols for patients undergoing emergency intra-abdominal surgery. Ultimately, we hope to promote their use and further large randomized controlled trials evaluating emergency surgery ERAS programs.Prospero registration numberCRD42023391709

Clinical pre-test probability adjusted versus age-adjusted D-dimer interpretation strategy for DVT diagnosis : A diagnostic individual patient data meta-analysis

Background: To increase the clinical usefulness of the D-dimer test in diagnosis of deep vein thrombosis (DVT), two strategies have been proposed: the age-adjusted, and the clinical pre-test probability (CPTP) adjusted interpretation. However, it is not known which of these strategies is superior. Objective: To conduct an individual patient data (IPD) meta-analysis that compares the sensitivity, specificity, negative predictive value (NPV), and utility (the proportion of all patients who have a negative D-dimer test) when the two strategies are used to interpret D-dimer results. Methods: Using an established IPD database, we conducted a meta-analysis to compare the two strategies. A bivariate random effects regression model was used to estimate and compare the pooled sensitivity and specificity simultaneously. The pooled NPV and utility of the two strategies was compared using a univariate random effects model. Results: Four studies were eligible for this analysis, with a total of 2554 patients. Overall prevalence of DVT was 12% with substantial heterogeneity between studies (P value <.001). Both strategies have high pooled NPVs (99.8%) with a difference of 0% (95% confidence interval [CI]: −0.1, 0.1). The difference between the pooled specificity of the CPTP-adjusted strategy (57.3%) and the age-adjusted strategy (54.7%) was 2.6% (95% CI: −7.7, 12.8). The CPTP-adjusted strategy (49.4%) has a marginally greater pooled utility compared with the age-adjusted approach (47.4%), with a pooled difference of 1.9% (95% CI: −0.1, 3.9). Conclusions: Both D-dimer interpretation strategies were associated with a high and similar NPV, and similar utility

A simplified decision rule to rule out deep vein thrombosis using clinical assessment and D-dimer

Background: Current clinical decision rules to exclude deep vein thrombosis (DVT) are underused partly because of their complexity. A simplified rule that can be easily applied would be more appealing to use in clinical practice. Methods: We used individual patient data from prospective diagnostic studies of patients suspected of DVT to develop a new clinical decision rule. The primary outcome was presence of DVT either at initial testing or during follow-up. DVT was considered safely excluded if the upper 95% confidence interval (CI) of DVT prevalence was <2%. Results: Four studies and 3368 patients were eligible for this analysis. Overall prevalence of DVT was 17%. In addition to D-dimer, two variables, calf swelling and DVT as the most likely diagnosis, are included in the new rule. Based on these two variables, two clinical pretest probability (CPTP) groups were defined; low (none of the two items present) and high (at least one of the items present). DVT can be safely excluded in patients with low CPTP with a D-dimer <500 ng/mL (prevalence = 0.1%; 95% CI, 0.0-0.8), low CPTP with a D-dimer between 500 ng/ml and 1000 ng/ml (prevalence = 0.3%; 95% CI, 0.0-1.7), and D-dimer <500 ng/ml in patients with high CPTP (prevalence = 0.3%; 95% CI, 0.0-1.0). Conclusions: The combination of D-dimer and Wells items resulted in a simple clinical decision rule with 3 items. The results suggest that the rule can safely exclude DVT. Prospective validation is required