External stenting: A reliable technique to relieve airway obstruction in small children

Ando, Motomi; Nagase, Yuzo; Hasegawa, Hisaya; Takahashi, Yukihiro

doi:10.1016/j.jtcvs.2016.12.041

Cited by 33 publications

(24 citation statements)

References 27 publications

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“…Various forms of external splinting have been attempted for severe tracheobronchomalacia refractory to traditional supportive treatment . As early as 1968, ribs were used to externally splint the trachea .…”

Section: Discussionmentioning

confidence: 99%

“…In the late 1970s through the 1980s, Filler and colleagues used a silicone elastomer (Silastic) reinforced polypropylene mesh (Marlex) splint, which was applied externally to the airways with mixed results . More recently, groups in Germany and Japan described techniques to treat pediatric tracheobronchomalacia via external airway stabilization using polytetrafluoroethylene (PTFE) prostheses . Specifically, Ando et al reported 98 patients undergoing 127 external PTFE airway stents at a mean age of 7.2 months .…”

Section: Discussionmentioning

confidence: 99%

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3D‐printed, externally‐implanted, bioresorbable airway splints for severe tracheobronchomalacia

et al. 2019

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Objective To report the clinical safety and efficacy of 3D-printed, patient-specific, bioresorbable airway splints in a cohort of critically ill children with severe tracheobronchomalacia. Methods From 2012–2018, 15 subjects received 29 splints on their trachea, right and/or left mainstem bronchi. The median age at implantation was eight months (range, 3–25 months). Nine children were female. Five subjects had a history of ECMO (extra-corporeal membrane oxygenation), and eleven required continuous sedation, six of which required paralytics to maintain adequate ventilation. Thirteen were chronically hospitalized, unable to be discharged, and seven were hospitalized their entire lives. At the time of splint implantation, one subject required ECMO, one required positive airway pressure, and 13 subjects were tracheostomy and ventilator dependent, requiring a median positive end-expiratory pressure (PEEP) of 14 cmH2O (range, 6–20 cmH20). Outcomes collected included level of respiratory support, disposition, and splint-related complications. Results At the time of discharge from our institution, at a median of 28 days’ post-implantation (range, 10–56 days), the subject on ECMO was weaned from extracorporeal support, and the subjects who were ventilated via tracheostomy had a median change in PEEP (discharge – baseline) of −2.5 cmH2O (range, −15 to 2 cmH2O, p=0.022). At median follow-up of 8.5 months (range, 0.3–77 months), all but one of the 12 surviving subjects lives at home. Of the 11 survivors who were tracheostomy dependent pre-op, one is decannulated, one uses a speaking valve, six use a ventilator exclusively at night, and three remain ventilator dependent. Conclusion This case series demonstrates the initial clinical efficacy of the 3D-printed bioresorbable airway splint device in a cohort of critically ill children with severe tracheobronchomalacia.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

3D‐printed, externally‐implanted, bioresorbable airway splints for severe tracheobronchomalacia

et al. 2019

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“…In order to be effective, the splint must have sufficient radial strength to prevent airway collapse, degrade over a clinically appropriate time period into innocuous products, and be easy to affix to the tracheal wall. External splints and fixation plates from nondegradable materials such as polytetrafluoroethylene and polyetherketoneketone, as well as degradable materials including polycaprolactone, polydioxanone, and (D,L‐lactide‐co‐glycolide), have been reported in both preclinical and human use. However, there remains a need to develop splints with modifiable mechanical properties and degradation profiles.…”

Section: Introductionmentioning

confidence: 99%

“…External splints and fixation plates from nondegradable materials such as polytetrafluoroethylene 10 and polyetherketoneketone, 11 as well as degradable materials including polycaprolactone, 12,13 polydioxanone, 14,15 and (D,L-lactide-co-glycolide), [16][17][18][19] have been reported in both preclinical and human use. However, there remains a need to develop splints with modifiable mechanical properties and degradation profiles.…”

Section: Introductionmentioning

confidence: 99%

Preclinical assessment of resorbable silk splints for the treatment of pediatric tracheomalacia

et al. 2018

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Objective Tracheomalacia is characterized by weakness of the tracheal wall resulting in dynamic airway collapse during respiration; severe cases often require surgical intervention. Off‐label external splinting with degradable implants has been reported in humans; however, there remains a need to develop splints with tunable mechanical properties and degradation profiles for the pediatric population. The objective of this pilot study is to assess the safety and efficacy of silk fibroin‐based splints in a clinically relevant preclinical model of tracheomalacia. Methods Silk splints were evaluated in a surgically induced model of severe tracheomalacia in N = 3 New Zealand white rabbits for 17, 24, and 31 days. An image‐based assay was developed to quantify the dynamic change in airway area during spontaneous respiration, and histopathology was used to study the surrounding tissue response. Results The average change in area in the native trachea was 23% during spontaneous respiration; surgically induced tracheomalacia resulted in a significant increase to 86% (P < 0.001). The average change in airway area after splint placement was reduced at all terminal time points (17, 24, and 31 days postimplantation), indicating a clinical improvement, and was not statistically different than the native trachea. Histopathology showed a localized inflammatory reaction characterized by neutrophils, eosinophils, and mononuclear cells, with early signs suggestive of fibrosis at the splint and tissue interface. Conclusion This pilot study indicates that silk fibroin splints are well tolerated and efficacious in a rabbit model of severe tracheomalacia, with marked reduction in airway collapse following implantation and good tolerability over the studied time course. Level of Evidence NA Laryngoscope, 129:2189–2194, 2019

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“…It is out of these situations that the frontiers of medicine and surgery are advanced. Ando and their colleagues' large case series of external airway stenting for airway obstruction in small children is an example of this process at work (1). This group's contribution highlights three important aspects of innovative procedures in high-risk situations: modification of established techniques; acceptance of a learning curve and weathering the complications that arise during the process.…”

mentioning

confidence: 99%

The price of innovation: a primer on high risk, high reward surgery

2017

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External stenting: A reliable technique to relieve airway obstruction in small children

Abstract: External stenting is a reliable method to relieve airway compression for small children, allowing an age-proportional growth of the airway.

Cited by 33 publications

References 27 publications

3D‐printed, externally‐implanted, bioresorbable airway splints for severe tracheobronchomalacia

3D‐printed, externally‐implanted, bioresorbable airway splints for severe tracheobronchomalacia

Preclinical assessment of resorbable silk splints for the treatment of pediatric tracheomalacia

The price of innovation: a primer on high risk, high reward surgery

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