Efficacy and safety of pre-operative insertion of inferior vena cava filter in patients undergoing bariatric surgery: a systematic review.

Prophylactic placement of inferior vena cava (IVC) filters prior to performing bariatric surgery is an intervention of unclear safety and efficacy with disagreement between current practice guidelines. To better characterize the risk and benefit of IVC filter insertion prior to bariatric surgery based on the current evidence. A systematic review of the literature of patients with prophylactic IVC filter insertion prior to bariatric surgery was performed and 32 studies were identified for inclusion into the review, of which none were randomized controlled trials. Meta-analysis was performed including the high-quality included studies. Seven high quality studies reported thrombotic events in patients undergoing bariatric surgery who had an IVCF and a control group which allowed for meta-analysis. The pooled odds ratio of venous thrombotic events in the IVC filter population versus the group without IVC filters was 1.57 (95%CI 0.89, 2.76). Among high quality studies 5 reported major bleeding with a rate of 0.76% and 6 reported on IVC filter complications with a rate of 0.67%. Overall no significant reduction in the rate of venous thrombosis was found with prophylactic IVC filter insertion. Use of IVC filters for prophylaxis remains a concern given the lack of clear efficacy in this setting and a small but present complication risk.

Fibrin and Thrombin Sealants in Vascular and Cardiac Surgery: A Systematic Review and Meta-analysis.

OBJECTIVE: In vascular and cardiac surgery, the ability to maintain haemostasis and seal haemorrhagic tissues is key. Fibrin and thrombin based sealants were introduced as a means to prevent or halt bleeding during surgery. Whether fibrin and thrombin sealants affect surgical outcomes is poorly established. A systematic review and meta-analysis was performed to examine the impact of fibrin or thrombin sealants on patient outcomes in vascular and cardiac surgery. DATA SOURCES: Cochrane CENTRAL, Embase, and MEDLINE, as well as trial registries, conference abstracts, and reference lists of included articles were searched from inception to December 2019. REVIEW METHODS: Studies comparing the use of fibrin or thrombin sealant with either an active (other haemostatic methods) or standard surgical haemostatic control in vascular and cardiac surgery were searched for. The Cochrane risk of bias tool and the ROBINS-I tool (Risk Of Bias In Non-randomised Studies - of Interventions) were used to assess the risk of bias of the included randomised and non-randomised studies; quality of evidence was assessed by the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. Two reviewers screened studies, assessed risk of bias, and extracted data independently and in duplicate. Data from included trials were pooled using a random effects model. RESULTS: Twenty-one studies (n = 7 622 patients) were included: 13 randomised controlled trials (RCTs), five retrospective, and three prospective cohort studies. Meta-analysis of the RCTs showed a statistically significant decrease in the volume of blood lost (mean difference 120.7 mL, in favour of sealant use [95% confidence interval {CI} -150.6 - -90.7; p < .001], moderate quality). Time to haemostasis was also shown to be reduced in patients receiving sealant (mean difference -2.5 minutes [95% CI -4.0 - -1.1; p < .001], low quality). Post-operative blood transfusions, re-operation due to bleeding, and 30 day mortality were not significantly different for either RCTs or observational data. CONCLUSION: The use of fibrin and thrombin sealants confers a statistically significant but clinically small reduction in blood loss and time to haemostasis; it does not reduce blood transfusion. These Results may support selective rather than routine use of fibrin and thrombin sealants in vascular and cardiac surgery.

Advancing Digital Health Interventions as a Clinically Applied Science for Blood Pressure Reduction: A Systematic Review and Meta-analysis.

BACKGROUND: Behavioural counselling via internet- or mobile-based digital platforms is recommended for hypertension; however, outcome heterogeneity is problematic in trials of this digital intervention. Our objective was to assess how therapeutic outcome was optimized in digital trials for hypertension, according to key features of the intervention design and protocol. METHODS: We identified randomized controlled digital trials for systolic blood pressure (SBP) reduction in taskforce guideline and policy statements, systematic reviews, and meta-analyses published since 2010, by searching the EMBASE, Cochrane Library, psycINFO, and PubMed databases. This search was updated to January 2019. Trials included patients with elevated cardiovascular risk or cardiovascular disease. We classified digital trials by the number of components of the intervention, and whether the protocol was organized by an explicit model of behavioural change or counselling. The influence of these features was evaluated for treatment efficacy and heterogeneity of SBP outcomes. RESULTS: Seventeen trials met inclusion criteria: pooled n = 5780, 33% female, 93% taking antihypertensive medications. SBP reduction was -7.3 mm Hg for digital counselling (95% confidence interval: -7.0 to -7.5) vs -3.6 mm Hg for control (95% confidence interval: -3.4 to -3.9), P < 0.0001, with high-moderate heterogeneity (I2 = 67%). Trials with multiple behavioural intervention components and an organized theoretical framework of behaviour change or counselling demonstrated optimal SBP reduction with low-moderate heterogeneity (I2 = 49%). CONCLUSIONS: Digital health interventions optimize the efficacy of medical therapy for SBP reduction. There is opportunity to promote a disruptive change in clinical science that accompanies technological developments in digital health promotion.