Efficacy and safety of a patent hemostatic device (PHD) with quantitative pressure for radial artery hemostasis: a first-in-human feasibility study

Abstract Objectives: Hemostatic devices are commonly used after coronary angiography (CAG) or percutaneous coronary intervention (PCI) via the transradial approach. However, radial artery occlusion (RAO) and bleeding still occur due to uncertainties regarding the hemostatic pressure. The aim of this study is to evaluate the safety and feasibility of a patent hemostatic device (PHD) with individualized hemostatic pressure settings to mitigate the risks of RAO and bleeding. Methods: A single-center, prospective, feasibility study was conducted in patients undergoing CAG/PCI. Adults recruited from Peking University First Hospital received the PHD. RAO, bleeding, hematoma, compression time, self-reported syndromes (pain, numbness, and swelling), and other access complications were measured. Results: PHD was attempted in 11 participants with a mean age of 59.0±10.8 years, of whom 90.9% were male. The average hemostatic pressure after CAG/PCI was 141.8±19.5 mm Hg with a compression time of 210.0±72.3 minutes. None of the participants exhibited RAO. Three participants had errhysis, and one participant suffered minor bleeding. In total, 72.7% (8 of 11) participants achieved successful hemostasis within 3 hours. No moderate or severe pain, numbness, or swelling were observed. Conclusions: This study shows the feasibility of the novel PHD for radial hemostasis in a small cohort of patients. Considering the potential benefits, particularly the prevention of RAO, a larger sample size is needed to evaluate the long-term safety and efficacy of the PHD.