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Endoscopically Applied Biodegradable Stent in a Rabbit Model of Pediatric Tracheomalacia
Ji Suk Choi1, Jungirl Seok2,3, Min Rye Eom1
1Department of Otorhinolaryngology-Head and Neck Surgery, Biomedical Research Institute, Seoul National University Hospital, Seoul, Korea.
Insights
A novel polydioxanone (PDO) stent for pediatric tracheomalacia was tested in rabbits. The PDO stent demonstrated safety and significantly improved survival in a tracheomalacia model.
Area of Science:
- Biomaterials Science
- Pediatric Surgery
- Respiratory Medicine
Background:
- Tracheomalacia poses a significant risk to pediatric patients.
- Polydioxanone (PDO) stents offer a potential solution but require preclinical safety and efficacy evaluation.
- Animal models are crucial for assessing novel medical devices before human trials.
Purpose of the Study:
- To evaluate the safety and efficacy of a newly developed polydioxanone (PDO) stent in a rabbit model.
- To assess the biocompatibility and degradation profile of the PDO stent in normal rabbits.
- To determine the impact of PDO stent placement on survival rates in rabbits with induced tracheomalacia.
Main Methods:
- Twenty-nine New Zealand white rabbits were utilized for biocompatibility and tracheomalacia modeling.
- A tracheomalacia model was successfully created in 12 rabbits.
- PDO stents were endoscopically placed in eight rabbits with tracheomalacia and 13 normal rabbits.
Main Results:
- The PDO stent was safely placed and degraded within 10 weeks in normal rabbits, with reversible mucosal changes.
- In tracheomalacia models, PDO stent placement significantly increased survival duration from 1.0±0.8 days to 49.0±6.8 days (P=0.001).
- Accelerated degradation and granulation tissue formation were observed in the tracheomalacia model, leading to airway collapse and death in some cases.
Conclusions:
- A polydioxanone (PDO) stent and endoscopic placement system were successfully developed.
- The PDO stent exhibits a degradation time of approximately 10 weeks in normal rabbits, which is accelerated in a tracheomalacia model.
- PDO stent placement prolonged survival in rabbits with induced tracheomalacia, indicating therapeutic potential.
Objectives:
A polydioxanone (PDO) stent was developed to treat tracheomalacia in pediatric patients. However, its safety and efficacy need to be verified in animal studies before clinical trials in patients can be conducted. This study evaluated the safety and efficacy of a PDO stent in normal and tracheomalacia-model rabbits.
Methods:
In total, 29 New Zealand white rabbits were used: 13 for evaluating the biocompatibility of the PDO stent in normal rabbits and 16 for the creation of a tracheomalacia model. The tracheomalacia model was successfully established in 12 rabbits, and PDO stents were placed in eight of those rabbits.
Results:
The PDO stent was successfully positioned in the trachea of the normal rabbits using an endoscopic approach, and its degradation was observed 10 weeks later. The stent fragments did not induce distal airway obstruction or damage, and the mucosal changes that occurred after stent placement were reversed after degradation. The same procedure was performed on the tracheomalacia-model rabbits. The survival duration of the tracheomalacia rabbits with and without stents was 49.0±6.8 and 1.0±0.8 days, respectively. Thus, the PDO stent yielded a significant survival gain (P=0.001). In the tracheomalacia rabbits, stent degradation and granulation tissue were observed 7 weeks after placement, leading to airway collapse and death.
Conclusion:
We successfully developed a PDO stent and an endoscopic guide placement system. The degradation time of the stent was around 10 weeks in normal rabbits, and its degradation was accelerated in the tracheomalacia model. The mucosal changes associated with PDO stent placement were reversible. Placement of the PDO stent prolonged survival in tracheomalacia-model rabbits.
