TCT-997 Cooling of the Forearm Puncture Site After Transradial Cardiac Catheterization or Percutaneous Coronary Intervention: The Hemostatic “Cryoband” Pilot Study

Background: The transradial approach in percutaneous coronary procedures has become the main vascular access worldwide. Cryotherapy is commonly used in several medical conditions to promote analgesia and vasoconstriction. We aimed to access the safety of cooling the forearm puncture site through the novel hemostatic Cryoband protocol. Methods: The proposed protocol is a modification of any pneumatic wristband devices using a cooling plate of frozen gel on the forearm under the air cuff (Figure 1). This was a pilot, prospective, single-arm study involving 100 patients. The primary endpoints were device success and time to hemostasis. Safety secondary endpoints included 1) hematomas (EASY) and bleedings (BARC); 2) radial artery patency pre-discharge; 3) numerical rating scale of pain, and 4) frostbites burns. Results: The study comprised 106 procedures (84 for diagnosis and 22 for interventions) and showed 100% of device success and a median time to hemostasis of 95 min (Q1-Q3: 90-110 min) for diagnostic and 180 min (Q1-Q3: 160-210 min) for interventions. In-hospital outcomes revealed no occurrences of hematomas exceeding EASY grade II, 2% of radial artery occlusion, a pain score of zero in 90% of cases, and no instances of frostbite burns. Following a median 9-day follow-up, no adverse clinical events were reported, and most patients (91.5%) had no bleeding. Conclusions: Cooling the forearm puncture site with the novel Cryoband protocol was shown to be both safe and effective. Randomized studies will have to evaluate if local cryotherapy after transradial approach will improve clinical outcomes as compared with standard technique.