Cooling the forearm puncture site following transradial cardiac catheterization or percutaneous coronary intervention: the hemostatic 'Cryoband' pilot study.

Abstract

Background: The transradial approach in percutaneous coronary procedures has become the primary vascular access worldwide. Cryotherapy is frequently used to promote analgesia and vasoconstriction. This study aimed to evaluate the safety of forearm puncture site cooling using the novel hemostatic Cryoband protocol.

Methods: The proposed protocol modifies pneumatic wristband devices by incorporating a cooling plate of frozen gel on the forearm, situated beneath the air cuff. This is a pilot, prospective, single-arm study involving 100 patients. The primary endpoints were device success and time to hemostasis. The safety secondary endpoints included (a) hematomas [early discharge after transradial stenting of coronary arteries (EASY)] and bleeding (Bleeding Academic Research Consortium); (b) radial artery patency predischarge; (c) numerical rating scale for pain; and (d) frostbite burns.

Results: The study involved 106 procedures (84 for diagnosis and 22 for interventions) and demonstrated a 100% success rate for the device. The median time to hemostasis was 95 min (IQR: 90-110 min) for diagnostic procedures and 180 min (IQR: 160-210 min) for interventions. In-hospital outcomes indicated no hematomas exceeding EASY grade II, a 2% incidence of radial artery occlusion, a pain score of zero in 90% of cases, and no instances of frostbite burns. After a median follow-up of 9 days, no adverse clinical events were reported, and most patients (91.5%) did not experience bleeding.

Conclusion: Cooling the forearm puncture site with the novel Cryoband protocol was safe and effective. Further randomized studies are warranted to assess its potential clinical benefit over the standard technique.