1.
Comparison of a new slender 6 french sheath with a standard 5 french sheath for transradial coronary angiography and intervention: a randomized multicenter trial the RAP and BEAT (Radial Artery Patency and Bleeding, Efficacy, Adverse evenT) Trial
Aminian A, Saito S, Takahashi A, Bernat I, Jobe RL, Kajiya T, Gilchrist IC, Louvard Y, Kiemeneij F, Van Royen N, et al
Eurointervention : Journal of Europcr in Collaboration With the Working Group on Interventional Cardiology of the European Society of Cardiology. 2017;13((5):):e549-e556
Abstract
AIMS: The 6 French(Fr) Glidesheath Slender (GSS6Fr, Terumo, Japan) is a recently developed thin-walled radial sheath with an outer diameter (OD) that is smaller than the OD of standard 6Fr sheaths. The effect of this introducer sheath on radial artery occlusion (RAO) is unknown. METHODS AND RESULTS We conducted a randomized, multicenter, non-inferiority trial comparing the GSS6Fr against the standard 5Fr Glidesheath (GS5Fr, Terumo, Japan) in patients undergoing TR coronary angiography and/or intervention. Patients in each group were subsequently randomized to undergo patent hemostasis or the institutional hemostasis protocol. The primary endpoint was the occurrence of RAO at discharge. A total of 1926 patients were randomized in 12 centers. The incidence of RAO was 3.47% with GSS6Fr compared with 1.74% with GS5Fr (risk difference 1.73%, 95% CI 0.51-2.95%; Pnon inferiority=0.150). Patients randomized to patent hemostasis had similar rate of RAO compared with institutional hemostasis (2.61% vs 2.61%, P=1). There was no difference with regard to all secondary end-points, including vascular access-site complication, local bleeding and spasm. CONCLUSIONS In this large multicenter randomized trial, the GSS6Fr was associated with a low event rate for the primary end-point (RAO) although non-inferiority to the GS5Fr was not met, due to a lower than expected rate of RAO in the GS5Fr group. As compared to institutional hemostasis, the use of patent hemostasis was not associated with a reduced rate of RAO.
2.
Application of cryoprecipitate as a hematostatic glue
Shiono N, Koyama N, Watanabe Y, Tokuhiro K, Suzuki N, Fujii T, Ozawa T, Sakuragawa H, Ohsawa H, Iwashita Y, et al
Journal of Cardiovascular Surgery. 1998;39((5):):609-12.
Abstract
BACKGROUND The effectiveness of cryoprecipitate, harvested from a patient's own fresh frozen plasma, for use in cardiac surgery as a hematostatic glue was studied in 32 randomized elective adult cardiac surgery patients from January 1993 to July 1994. MATERIALS AND METHODS Patients from the Toho Sakura Hospital were randomly allocated to two groups: Group 1 (n=11) received conventional fibrin glue presently available in our institution; while Group 2 (n=21) received autologous cryoprecipitate as a hematostatic glue. Surgical procedures broken down by group were as follows: Group 1: 4 CABG, 5 valvular surgeries and 2 other. Group 2: 11 CABG, 6 valvular surgery, 4 other. We preserved the patient's own blood and stored pure red cell and fresh frozen plasma (FFP). Cryoprecipitate was prepared from the FFP and preserved until required. RESULTS Cryoprecipitate had a 5-fold increase in fibrinogen activity (1190+/-311 mg/dl vs 238+/-34 mg/dl p<0.001), a 10-fold increase in factor VIII activity (362+/-219% vs 34+/-11%, p=0.001), and 4.5-fold increase in factor XIII activity (538+/-213% vs 119+/-50%, p<0.001), compared to serum. The amount of bleeding postoperatively was slightly lower in the cryoprecipitate glue group compared to the conventional glue group, but this was not significantly different. CONCLUSIONS We conclude that autologous samples of human cryoprecipitate prepared from a patient's own FFP had a strong hematostatic effect compared to conventional fibrin glue and was a very valuable hematostatic agent during cardiac surgery.