Hemostasis control after femoral percutaneous approach: A systematic review and meta-analysis
Reich R, Helal L, Mantovani VM, Rabelo-Silva ER
International journal of nursing studies. 2022;137:104364
BACKGROUND Hemostasis control after percutaneous endovascular procedures through the femoral approach remains challenging for catheterization laboratory nurses, given method variability. OBJECTIVE To summarize the available evidence on vascular devices efficacy dedicated to hemostasis control compared to the extrinsic compression after percutaneous procedures in the femoral vein or artery. METHODS A systematic review with meta-analysis of randomized clinical trials was conducted. We compared different hemostasis methods in adult patients who underwent diagnostic and/or therapeutic procedures through femoral access. The databases searched were PubMed, Embase, CINAHL and Cochrane CENTRAL, and updated on 03/2022. The outcomes included hematoma, pseudoaneurysm, bleeding, minor and major vascular complication, time to hemostasis, device failure, and manual compression repetition. The risk of bias was assessed using the Cochrane Risk of Bias Tool 1.0. Pooled effect sizes on continuous, categorical and proportion variables were estimated with the random effects model. The continuous variables were summarized as the difference between means weighted by the inverse of variance (WMD), and the categorical ones by the summary of relative risks (RR), estimated by the DerSimonian and Laird method. The Freeman-Tukey method was used to estimate the summary effect of proportions. RESULTS Fifty articles were included in the systematic review. When compared to extrinsic compression, vascular closure devices resulted in a relative risk reduction (RRR) for hematoma: RR 0.82 [95%CI 0.72 to 0.94] and in shorter time to hemostasis WMD -15.06 min [95%CI -17.56 to -12.56]; no association was observed between interventions with vascular closure devices and extrinsic compression for pseudoaneurysm, bleeding, minor and major vascular complications. Compared to extrinsic compression, sealant or gel type devices were compatible with a RRR for hematoma: RR 0.73 [95%CI 0.59 to 0.90]; and metal clip or staple type devices for pseudoaneurysm: RR 0.48 [95%CI 0.25 to 0.90]; and major vascular complication: RR 0.33 [95%CI 0.17 to 0.64]. For each 100 observations, the device failure rate for metal clip or staple was 3.28% [95%CI 1.69 to 6.27]; for suture 6.84% [95%CI 4.93 to 9.41]; for collagen 3.15% [95%CI 2.24 to 4.41]; and for sealant or gel 7.22% [95% CI 5.49 to 9.45]. CONCLUSIONS Vascular closure devices performed better in hemostasis control. The certainty of the evidence was rated as very low to moderate. REGISTRATION PROSPERO CRD42019140794.
Two HEmostasis Methods After TransradIal Catheterization: THEMATIC Randomized Clinical Trial
Dos Santos SM, Wainstein RV, Valle FH, Correa CL, Aliti GB, Ruschel KB, Goncalves SC, Wainstein MV, Rabelo-Silva ER
The Journal of cardiovascular nursing. 2020
OBJECTIVE The aim of this study was to compare the effect of 2 hemostasis devices on the incidence of radial artery occlusion (RAO) after transradial cardiac catheterization. BACKGROUND Radial artery occlusion is the most prevalent ischemic complication after radial artery catheterization. There is still no predictive pattern of vessel patency assessment, and the comparative effectiveness of different hemostasis techniques has yet to be established. METHODS This study used a randomized clinical trial of adult patients undergoing transradial cardiac catheterization. Participants were randomized into an intervention group (hemostasis with the TR Band device) and a control group (hemostasis with a conventional pressure dressing). The primary end point was the incidence of RAO (at discharge and at 30 days post catheterization). RESULTS Among the 600 patients included (301 in the intervention group and 299 controls), immediate RAO occurred in 24 (8%) in the TR Band group and 19 (6%) in the pressure-dressing group; at 30 days, RAO was present in 5 patients (5%) in the TR Band group and 7 (6%) in the pressure-dressing group. On multivariate analysis, peripheral vascular disease was the only independent predictor of RAO at discharge and at 30 days. CONCLUSIONS The incidence of RAO was similar in patients who received hemostasis with a TR Band versus a pressure dressing after transradial cardiac catheterization.