Randomized study for a novel elbow joint fixation device on postoperative complications in patients undergoing percutaneous coronary diagnostic or therapeutic procedures through the brachial artery

Abstract

Abstract Brachial artery access for coronary diagnostic or therapeutic procedures is associated with a greater risk of vascular complications. To determine whether 3D printing of a novel elbow joint fixation device could reduce postoperative complications after percutaneous coronary diagnostic or therapeutic procedures through the brachial artery. Patients who underwent percutaneous coronary diagnostic or therapeutic procedures by brachial access were randomly assigned to receive either a 3D-printed elbow joint fixation device (brace group) or traditional compression (control group) from March 2023 to December 2023. The severity of puncture site-related discomfort at 24 h postsurgery was significantly lower in the brace group (P = 0.014). Similarly, the upper arm calibration rate at 24 h postsurgery was significantly lower in the brace group [0.024 (0.019–0.046) vs. 0.077 (0.038–0.103), P < 0.001], as was the forearm calibration rate [0.026 (0.024–0.049) vs. 0.050 (0.023–0.091), P = 0.007]. The brace group had a significantly lower area of subcutaneous hemorrhage at 24 h postsurgery [0.255 (0–1.00) vs. 1 (0.25–1.75) cm2]. In patients who underwent percutaneous coronary diagnostic or therapeutic procedures by brachial access after manual compression hemostasis, the novel elbow joint fixation device was effective at reducing puncture site-related discomfort, alleviating the degree of swelling, and minimizing the subcutaneous bleeding area. Additionally, no significant complications were observed. Trial registration: China Clinical Trial Registration on 01/03/2023 (ChiCTR2300068791).

Keywords

• Novel elbow joint fixation device
• Brachial artery
• Percutaneous coronary diagnostic
• Therapeutic procedures
• 3D printing