How deep are the radial and ulnar arteries

Patent hemostasis with Vasoband versus TR Band

detailed description

Introduction: TRA is increasingly used worldwide because of its proven benefits of TRA, reducing complications, reducing costs, and increasing patient comfort at the access site (1) The common structural consequence of TRA is occlusion of the radial artery (RAO). It occurs in 2-10% of patients undergoing TRA (2). Various pharmacological as well as non-pharmacological practices have been associated with RAO. Maintaining a hardware profile that is smaller than the inner diameter of the radial artery has been associated with better radial artery patency rates according to the procedure (3). Use of unfractionated heparin and other administered parenteral anticoagulants during the procedure has also been associated with a reduction in RAO, with a dose-dependent effect with better reduction at higher doses of heparin (4,5). One of the most effective measures to reduce RAO is to avoid flow arrest in the radial artery during hemostatic compression (6). This technique is called & quot; patented hemostasis & quot; designated. It has been shown to clearly and significantly reduce the incidence of RAO. In patients with radial arteries of small diameter, as well as low blood pressure, the ability to achieve and It has been observed that the maintenance of patent hemostasis is lower than that of the other co-dominance of forearm artery circulation are the radial and ulnar arteries It has been shown that the interdependence and compression of the ipsilateral ulnar artery increases the flow as well as the maximum flow velocity in the arteria radialis (7). Ipsilateral compression of the ulnar artery during hemostatic compression of a punctured radial artery has been shown to be considerable and significantly reduce the incidence of RAO compared to the patented hemostasis ( 8). Randomized and observational records using this previously published technique have used two devices to achieve radial and ulnar compression, with difficult ergonomics leading to frequent dislocation of ulnar compression during hemostasis Process of the radial artery. The researchers intend to investigate the comparative effectiveness of the first dedicated dual compression device for achieving patented hemostasis compared to the currently popular radial artery compression device. Patients and Methods: Patients referred for diagnostic cardiac catheterization with TRA are screened. Written informed consent is included in the study. A transradial heart Catheterization is performed using the standard technique described below. Catheterization technique: After sterile preparation and local anesthetic infiltration 5 French hydrophilic The introducer sheath is inserted into the radial artery using the standard puncture technique (9). Once the introducer is in the radial artery lumen, 200 µg nitroglycerin, 2.5 mg verapamil, and 5000 IU unfractionated heparin are administered intra-arterially.5 French or lower profile hardware is used to facilitate the procedure at the operator's discretion. Once the procedure is complete, the patient is randomized to: Group 1, which includes patients receiving hemostatic compression using the current Standard of Care TR tape (Terumo Corporation, Japan). The tape is applied according to the instructions for use with optimal pressure to achieve complete hemostasis. Group 2 consists of patients receiving a vaso-band (VasoInnovations, Inc, USA), used as directed, with the ulnar balloon inflated for the first 60 minutes of hemostatic compression of the radial artery, inflating the radial balloon to obtain full hemostasis after the cover is removed. Primary point of the study: patency of the radial artery 0-15 minutes after application of the radial artery, hemostatic compression of the artery. Monitoring of patency: The patency of the radial artery is monitored immediately after the tape is applied. In both groups, the Barbeau test is reversed and the patency is assessed again 15 minutes later tape application, 30 minutes after tape application, 60 minutes after tape application, as and after removing the band after 120 minutes. If a longer duration of pressure with the tape is required in both groups in order to achieve hemostasis, the bands are applied for a longer duration and the appropriateness of the hemostasis is scored every 15 minutes after 120 minutes and the band is removed as soon as sufficient hemostasis is achieved has been. Radial patency is assessed 60 minutes after removal of the band. Basic demographic and procedural data, pharmacological data and detailed data are collected on each patient. Statistical Analysis Plan: Categorical variables are expressed as proportions and differences between the two groups are assessed using the chi-square test or Pearson's test Variables are assessed for normality of distribution and expressed as the mean and standard deviation for normally distributed variables and median and interquartile range for those with no normal distribution. Parametric tests are used to compare the differences between the two groups for normally distributed numeric variables and nonparametric tests are used in variables with an abnormal distribution. If necessary, a multivariable analysis is performed using a forward selection binary logistic regression for categorically dependent variables and linear regression for numeric variables. Obtained operational characteristics-derived c-statistics are used to assess the stability of the model. Calculation of the sample size: Based on the available literature using the current standard care standard TR-Band, Patent Hemostasis defined as patency of the radial artery during hemostatic compression after 15 minutes in compression is achievable in 75% of patients undergoing TRA . The only published randomized study of prophylactic ipsilateral compression of the ulnar artery during the radial artery hemostatic compression showed that 15 minutes later a patented 96% hemostasis was achieved on the start of compression. Using this data using a chi-square model, a sample size of 250 to 300 patients, evenly divided between two groups, will be required to achieve 90% performance with an alpha editor of 0.05. With a crossover rate of 10%, a sample is taken into account. A size of 200 patients is required. An interim analysis is performed after randomizing 200 patients. If the event rates are low, the sample size is increased to 350 patients. .