Objective To systematically evaluate the safety, efficacy, and economics of intracardiac echocardiography (ICE) versus transesophageal echocardiography (TEE) in left atrial appendage occlusion (LAAO). Methods PubMed, EMbase, The Cochrane Library, CBM, CNKI, VIP and WanFang Database were systematically searched to collect relevant studies on comparing ICE and TEE-guided LAAO from inception to June 15th, 2022. Two reviewers independently screened the literatures, extracted the data, and assessed the risk of bias of the included studies. Meta-analyses were performed using RevMan 5.3 and R 4.0.3. Retrospective cohort studies were excluded for sensitivity analysis. Subgroup analyses were performed based on the types of occluder and ICE catheter. Results A total of 14 studies with 6 599 patients were included. Meta-analyses showed no statistical differences in technical success rate, overall complications, device embolization, peri-device leakage, device-related thrombus, stroke, vascular complications, bleeding, operation time, fluoroscopy time, or contrast agent volume between the ICE and TEE-guided LAAO. The total in-room time (MD=–33.47 min, 95%CI –41.20 to –25.73, P<0.00001) and radiation dosage (MD=–170.20 mGy, 95%CI –309.79 to –30.62, P=0.02) were lower in the ICE group than those in the TEE group, whereas the incidence of pericardial effusion/tamponade was higher than the TEE group (RR=1.57, 95%CI 1.01 to 2.45, P=0.048). Except for pericardial effusion/tamponade, subgroup analyses and sensitivity analysis showed similar results. The analysis based on the cost data from the United States showed comparable or even lower total costs for ICE versus TEE, but comparative domestic cost studies were lacking. Conclusion Current evidence suggests that ICE-guided LAAO can reduce radiation dosage and total in-room time, and there is no statistical difference in the overall complication rate between the two groups. Owing to the limitations of sample size and quality of the included studies, the conclusion still needs to be verified by large sample size and high-quality randomized controlled trials.
ObjectiveTo systematically review the hemostatic effect of traditional Class Ⅲ hemostatic powder and aggregate absorbable hemostat in surgeries. MethodsThe PubMed, Embase, CENTRAL, CNKI, VIP and WanFang Data databases were electronically searched to collect controlled studies related to the objects from inception to September 18th, 2023. Two reviewers independently screened literature, extracted data and assessed the risk of bias of the included studies. Meta-analysis was then performed by using RevMan 5.3 software. ResultsA total of 7 randomized controlled trials, 5 cohort studies and 9 animal experiments were included. The results of analysis showed that the group with traditional Class Ⅲ hemostatic powder or aggregate absorbable hemostat had a higher hemostatic success rate and shorter hemostatic time than those with no hemostatic material in animal surgeries. And the group with aggregate absorbable hemostat had a higher 10min hemostatic success rate than those with traditional hemostatic measures. The application of traditional Class Ⅲ hemostatic powder in human cardiothoracic surgeries shortened the hemostatic time and reduced drainage after surgeries, but caused more blood loss during knee arthroplasties. Aggregate absorbable hemostat caused less blood loss than traditional hemostatic measures in human hip arthroplasties, and the 5min and 10min success rates of aggregate absorbable hemostat group were not worse than those of hemostatic gauze. ConclusionCurrent evidence shows that the hemostatic effect of both traditional Class Ⅲ hemostatic powder and aggregate absorbable hemostat are better than that of no hemostatic material in animal and human surgery, but the comparison between them and other hemostatic measures is not clear. Due to the limited quality and quantity of the included studies, more high quality studies are needed to verify the above conclusion.
ObjectiveTo systematically review the non-inferiority trials in the cardiovascular domain that utilize medical devices as interventions, and investigate its characteristics and threshold settings. MethodsThe PubMed, Embase, and CENTRAL databases were electronically searched to collect non-inferiority trials in the cardiovascular field involving medical devices from inception to July 26, 2023. Two reviewers independently screened literature and extracted data. The reported information included basic characteristics, features of non-inferiority trials, and threshold-setting features of the included studies. Data analysis was performed using Excel 2020 and R 4.2.1 software. ResultsA total of 214 studies were included, with 167 studies (78.0%) focusing on interventions related to coronary artery stents. The trials predominantly utilized a two-arm design (92.9%), with a prevalent use of non-inferiority absolute thresholds (96.7%) as the criteria for non-inferiority determination. In 150 studies (70.1%), non-inferiority thresholds were established based on estimated control group effect values, while 33 studies (15.4%) did not report the source of these values. The non-inferiority trial endpoint outcomes exhibited diversity, and there were substantial differences in threshold settings. The three most studied qualitative indicators were target lesion failure rates (2.1%-8.6%), target vessel failure rates (2.5%-19.6%), and major adverse cardiovascular events rates (2.1%-10.0%). Late lumen loss (0.1-0.4 mm) emerged as the most frequently studied quantitative indicator. After converting absolute non-inferiority thresholds for all indicators into relative thresholds, the range was 1.20-3.67. ConclusionSignificant variations in non-inferiority threshold settings are observed for identical endpoint outcomes across included studies, highlighting a lack of reporting on the rationale behind threshold settings.