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Randomized study for a novel elbow joint fixation device on postoperative complications in patients undergoing
Yue Zhang1,2, Mengting Yang3, Qianlan Tao4
1Chengdu Medical College, Chengdu, Sichuan, China.
Insights
A novel 3D-printed elbow fixation device significantly reduced complications and discomfort after brachial artery access for coronary procedures. This innovative brace offers a safer alternative to traditional compression, improving patient outcomes.
Area of Science:
- Cardiovascular Interventions
- Medical Device Innovation
- 3D Printing in Medicine
Background:
- Brachial artery access for coronary procedures carries a risk of vascular complications.
- Minimizing post-procedural complications is crucial for patient recovery and safety.
Purpose of the Study:
- To evaluate the efficacy of a novel 3D-printed elbow joint fixation device in reducing postoperative complications.
- To compare the outcomes of using the 3D-printed device versus traditional compression after brachial artery access.
Main Methods:
- A randomized controlled trial involving patients undergoing percutaneous coronary procedures via brachial artery access.
- Patients were assigned to either a 3D-printed elbow fixation device group or a traditional compression group.
- Outcomes including puncture site discomfort, calibration rates, and subcutaneous hemorrhage were assessed 24 hours post-surgery.
Main Results:
- The 3D-printed device group showed significantly lower puncture site-related discomfort (P=0.014).
- Reduced upper arm (P<0.001) and forearm (P=0.007) calibration rates were observed in the device group.
- The device group also exhibited a significantly smaller area of subcutaneous hemorrhage (P<0.001).
Conclusions:
- The novel 3D-printed elbow joint fixation device effectively reduces post-procedural discomfort, swelling, and bleeding after brachial artery access.
- The device is a safe and effective alternative to traditional compression methods.
- No significant complications were reported in the device group.
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).
