Effects of saline submersion at body temperature on airway supportive devices including a novel nasopharyngeal device produced using 3D-printing.

PURPOSE: This study investigated dimension changes of various nasopharyngeal airways, including a novel self-supporting device, after saline submersion at body temperature to simulate in-vivo use. Dimension changes over time may reduce efficacy during long-term use and require sizing adjustments or limits on duration of use. MATERIALS AND METHODS: Cuffless Covidien endotracheal tubes, pediatric Rusch fixed flange polyvinyl chloride nasal airway tubes, pediatric Rusch Robertazzi style Mediprene nasal airway tubes, and novel silicone elastomer self-supporting nasopharyngeal airways were fully submerged in 0.9 % normal saline solution incubated at 37 degrees Celsius for 15 days. All devices had tube length and wall thickness measured after 0, 1, 2, 3, 4, 5, 10, and 15 days. The 95 % confidence intervals of tube dimensions at each date were compared with the 95 % confidence intervals at day 0. RESULTS: The Covidien ET tube, Rusch PVC NPA, and ssNPA tube lengths and wall thicknesses did not change significantly over 15 days. The Rusch Mediprene NPAs had a statistically significant increase in length starting at day 1 and wall thickness at day 2. CONCLUSIONS: The novel ssNPA did not expand in the in-vitro environment, supporting its safety for extended use. The PVC NPA and ET tube dimensions also remained stable. However, the Rusch Mediprene NPAs had significant length expansion after 1 day of submersion, indicating a considerable risk of expansion during extended use with potential implications for patient care. Silicone and PVC NPA dimensions remained stable when saturated, indicating these materials may be more appropriate for extended use.

Incorporating a Three-Dimensional Printed Airway into a Pediatric Flexible Bronchoscopy Curriculum.

Background: Although hands-on simulation plays a valuable role in procedural training, there are limited tools available to teach pediatric flexible bronchoscopy (PFB). Fellowship programs rely on patient encounters, with inherent risk, or high-cost virtual reality simulators that may not be widely available and create education inequalities. Objective: Our objective was to study the educational value and transferability of a novel, low-cost, three-dimensional-printed pediatric airway model (3D-AM) for PFB training. Our central hypothesis was that the 3D-AM would have high educational value and would be easily transferrable to learners at different teaching hospitals. Methods: The 3D-AM was designed to teach technical bronchoscopy skills, airway anatomy, airway pathology, and bronchoalveolar lavage (BAL). The curriculum was offered to incoming fellows in pediatric pulmonology, pediatric surgery, and pediatric critical care across three different teaching institutions. After course completion, each participant assessed the simulation model(s) with a 5-point Likert scale across six domains: physical attributes, realism of experience, ability to perform tasks, value, relevance, and global impression. The expert instructors assessed the learners' competency using a modified version of the Bronchoscopy Skills and Tasks Assessment Tool. Results: A total of 14 incoming fellows participated in the course. The mean scores for the 3D-AM across all six domains and across the three institutions was between 4 and 5, suggesting that learners generally had a favorable impression and a similar experience across different institutions. All learners "agreed" or "strongly agreed" that the course was a valuable use of their time, helped teach technical skills and airway anatomy, and would be useful for extra training during fellowship. Most of the learners correctly identified anatomy, bronchomalacia, and performed a BAL. Wall trauma was observed in 36% of learners. Conclusion: The utility, low cost, and transferability of this model may create opportunities for PFB training across different institutions despite resource limitations in the United States and abroad.

Webbed Neck Deformity Reconstruction in Patients with Turner Syndrome: Technical Considerations in Treating Congenital Pterygium Colli.

Importance: Present an excellent outcome for a rare pterygium colli reconstruction. Objective: Establish techniques that have yielded a successful aesthetic and functional outcome for a patient with pterygium colli in a procedure that lacks consensus. Design, Setting, and Participants: Surgical pearls-description of considerations for a successful reconstruction. An academic practice. Pediatric patient with Turner's syndrome who underwent neck and auricular reconstruction.

Comparison of Caregiver- and Child-Reported Quality of Life in Children With Sleep-Disordered Breathing.

OBJECTIVE: Caregivers frequently report poor quality of life (QOL) in children with sleep-disordered breathing (SDB). Our objective is to assess the correlation between caregiver- and child-reported QOL in children with mild SDB and identify factors associated with differences between caregiver and child report. STUDY DESIGN: Analysis of baseline data from a multi-institutional randomized trial SETTING: Pediatric Adenotonsillectomy Trial for Snoring, where children with mild SDB (obstructive apnea-hypopnea index <3) were randomized to observation or adenotonsillectomy. METHODS: The Pediatric Quality of Life Inventory (PedsQL) assessed baseline global QOL in participating children 5 to 12 years old and their caregivers. Caregiver and child scores were compared. Multivariable regression assessed whether clinical factors were associated with differences between caregiver and child report. RESULTS: PedsQL scores were available for 309 families (mean child age, 7.0 years). The mean caregiver-reported PedsQL score was higher at 75.2 (indicating better QOL) than the mean child-reported score of 67.9 (P < .001). The agreement between caregiver and child total PedsQL scores was poor, with intraclass correlation coefficients of 0.03 (95% CI, -0.09 to 0.15) for children 5 to 7 years old and 0.21 (95% CI, 0.03-0.38) for children 8 to 12 years old. Higher child age and health literacy were associated with closer agreement between caregiver and child report. CONCLUSION: Caregiver- and child-reported global QOL in children with SDB was weakly correlated, more so for young children. In pediatric SDB, child-perceived QOL may be poorer than that reported by caregivers. Further research is needed to assess whether similar trends exist for disease-specific QOL metrics.

Development of a High-Fidelity, 3D Printed Otoplasty Surgical Simulator.

IMPORTANCE: Prominotia has functional and esthetic impact for the child and family and proficiency in otoplasty requires experiential rehearsal. OBJECTIVES: To design and validate an anatomically accurate, 3D printed prominotia simulator for rehearsal of otoplasties. METHODS: A 3D prominotia model was designed from a computed tomographic (CT) scan and edited in 3-matic software. Negative molds were 3D printed and filled with silicone. Expert surgeons performed an otoplasty procedure on these simulators and provided Likert-based feedback. RESULTS: Six expert surgeons with a mean of 14.3 years of practice evaluated physical qualities, realism, performance, and value of the simulator. The simulator was rated on a scale of 1 (no value) to 5 (great value) and scored 3.83 as a training tool, 3.83 as a competency evaluation tool, and 4 as a rehearsal tool. CONCLUSIONS: Expert validation rated the otoplasty simulator highly in physical qualities, realism, performance, and value. With minor modifications, this model demonstrates valuable educational potential.

A Validated 3D Printed Laryngeal Suturing Simulator for Endoscopic Laryngeal Cleft Repair.

OBJECTIVES: Endoscopic laryngeal cleft repair (ELCR) with endolaryngeal suturing is an advanced surgical skill. This study objective was to assess the validity of 3-dimensionally (3D) printed laryngeal suturing simulator for ELCR. STUDY DESIGN: Development and validation of a simulator for ELCR. METHODS: An ELCR model was developed using 3D printed and readily available materials. Participants were surveyed before and after a simulation session using five-point Likert scale questions. Performance data was assessed using blinded expert video review and rated using a novel objective structured assessment of technical skills (OSATS) for endoscopic laryngeal suturing. RESULTS: Twenty-one participants ranging from residents to attendings completed the simulation session. Survey respondents reported on a five-point Likert scale that the model was "easy to use" and "quite realistic" (both mean of 4). Confidence improved significantly in 86% of participants (p < 0.01). Overall OSATS scores (out of a total of 55) showed a median improvement in technical skills of 11.7 points (p = 0.004). OSATS demonstrated good intra-rater (κ = 0.689 and 0.677) and moderate inter-rater (κ = 0.573) reliability. Completion times improved from the first to the last suture by a median time of 512 to 350 s (decrease of 202 s, p = 0.002). Participants with no prior ELCR experience improved more than those with in vivo experience. CONCLUSION: This study demonstrates the validity of a simulator utilizing 3D printed larynges for ELCR. A novel OSATS for endoscopic laryngeal suturing was successfully implemented. Confidence, technical skills, and completion times improved with the use of the model across a variety of participants. Laryngoscope, 133:785-791, 2023.

A national pediatric otolaryngology fellowship virtual dissection course using 3D printed simulators.

OBJECTIVE: Our objective was to create and evaluate a novel virtual platform dissection course to complement pediatric otolaryngology fellowship training in the setting of the COVID-19 pandemic. METHODS: A four-station, four-simulator virtual course was delivered to pediatric otolaryngology fellows virtually using teleconferencing software. The four stations consisted of microtia ear carving, airway graft carving, cleft lip repair, and cleft palate repair. Fellows were asked to complete pre- and post-course surveys to evaluate their procedural confidence, expertise, and attitudes towards the course structure. RESULTS: Statistical analysis of pre-course survey data showed fellows agreed that simulators should play an important part in surgical training (4.59 (0.62)); would like more options for training with simulators (4.31 (0.88)); and would like the option of saving their simulators for later reference (4.41 (0.85)). Fellows found the surgical simulators used in the course to be valuable as potential training tools (3.96 (0.96)), as competency or evaluation tools (3.91 (0.98)), and as rehearsal tools (4.06 (0.93)). Analysis showed a statistically significant improvement in overall surgical confidence in performing all four procedures. CONCLUSION: This virtual surgical dissection course demonstrates 3D printed surgical simulators can be utilized to teach fellows advanced surgical techniques in a low-risk, virtual environment. Virtual platforms are a viable, highly-rated option for surgical training in the setting of restricted in-person meetings and as a mechanism to increase access for fellows by reducing costs and travel requirements during unrestricted periods.

Novel treatment for hypotonic airway obstruction and severe obstructive sleep apnea using a nasopharyngeal airway device with 3D printing innovation.

STUDY OBJECTIVES: Pediatric obstructive sleep apnea impacts child and familial well-being. Airway management in patients with hypotonic pharyngeal conditions is complex. Some patients may benefit from continuous positive airway pressure or bilevel positive airway pressure, others may require further invasive measures for treatment. There is critical need for treatment alternatives for patients with pharyngeal hypotonia. METHODS: This is a retrospective case series. Collaboratively with patients, families, biomedical engineers, and medical professionals, a long-term nasopharyngeal airway (NPA) was created to bypass upper airway obstruction. Two patients used a safety pin and tape attachment, and two patients used a novel 3D-printed, self-supporting nasal securement. All 4 patients had polysomnography before and during NPA use. Paired 1-tailed t-tests were conducted to compare apnea-hypopnea index, hypopnea index, obstructive index, and oxygen nadir. RESULTS: Compared to baseline polysomnography, repeat polysomnography with the NPA in place demonstrated statistically significant improvement for apnea-hypopnea index (75.8 ± 36.6 events/h to 8.9 ± 2.9 events/h, P = .03), hypopnea index (45.4 ± 25.8 events/h to 7.7 ± 3.2 events/h, P = .04), and oxygen saturation nadir (60.3 ± 13.0% to 79.3 ± 8.7%, P = .01). The NPA had been used for over 1 year in 3 of the 4 children. Those using the safety pin and tape did report skin irritation due to adhesive required to keep device in place. CONCLUSIONS: Current management of severe upper airway obstruction and obstructive sleep apnea in hypotonic pharyngeal conditions requires a team-based approach to care. A long-term NPA device may be an alternative or temporizing option to continuous positive airway pressure, upper airway surgery, or tracheostomy in children with pharyngeal hypotonia and severe obstructive sleep apnea. Larger studies of this approach are underway to assess efficacy in a range of obstructive sleep apnea severity in this population. CITATION: Powell AR, Srinivasan S, Helman JL, et al. Novel treatment for hypotonic airway obstruction and severe obstructive sleep apnea using a nasopharyngeal airway device with 3D printing innovation. J Clin Sleep Med. 2022;18(10):2497-2502.

Neurobehavioral morbidity of pediatric mild sleep-disordered breathing and obstructive sleep apnea.

STUDY OBJECTIVES: Obstructive sleep apnea is associated with neurobehavioral dysfunction, but the relationship between disease severity as measured by the apnea-hypopnea index and neurobehavioral morbidity is unclear. The objective of our study is to compare the neurobehavioral morbidity of mild sleep-disordered breathing versus obstructive sleep apnea. METHODS: Children 3-12 years old recruited for mild sleep-disordered breathing (snoring with obstructive apnea-hypopnea index < 3) into the Pediatric Adenotonsillectomy Trial for Snoring were compared to children 5-9 years old recruited for obstructive sleep apnea (obstructive apnea-hypopnea 2-30) into the Childhood Adenotonsillectomy Trial. Baseline demographic, polysomnographic, and neurobehavioral outcomes were compared using univariable and multivariable analysis. RESULTS: The sample included 453 participants with obstructive sleep apnea (median obstructive apnea-hypopnea index 5.7) and 459 participants with mild sleep-disordered breathing (median obstructive apnea-hypopnea index 0.5). By polysomnography, participants with obstructive sleep apnea had poorer sleep efficiency and more arousals. Children with mild sleep-disordered breathing had more abnormal executive function scores (adjusted odds ratio 1.96, 95% CI 1.30-2.94) compared to children with obstructive sleep apnea. There were also elevated Conners scores for inattention (adjusted odds ratio 3.16, CI 1.98-5.02) and hyperactivity (adjusted odds ratio 2.82, CI 1.83-4.34) in children recruited for mild sleep-disordered breathing. CONCLUSIONS: Abnormal executive function, inattention, and hyperactivity were more common in symptomatic children recruited into a trial for mild sleep-disordered breathing compared to children recruited into a trial for obstructive sleep apnea. Young, snoring children with only minimally elevated apnea-hypopnea levels may still be at risk for deficits in executive function and attention. TRIAL REGISTRATION: Pediatric Adenotonsillectomy for Snoring (PATS), NCT02562040; Childhood Adenotonsillectomy Trial (CHAT), NCT00560859.

Integrated microtia and aural atresia management.

Objectives: To present recommendations for the coordinated evaluation and management of the hearing and reconstructive needs of patients with microtia and aural atresia. Methods: A national working group of 9 experts on microtia and atresia evaluated a working document on the evaluation and treatment of patients. Treatment options for auricular reconstruction and hearing habilitation were reviewed and integrated into a coordinated care timeline. Results: Recommendations were created for children with microtia and atresia, including diagnostic considerations, surgical and non-surgical options for hearing management and auricular reconstruction, and the treatment timeline for each option. These recommendations are based on the collective opinion of the group and are intended for otolaryngologists, audiologists, plastic surgeons, anaplastologists, and any provider caring for a patient with microtia and ear canal atresia. Close communication between atresia/hearing reconstruction surgeon and microtia repair surgeon is strongly recommended.

A Longitudinal Comparison of Telemedicine Versus In-Person Otolaryngology Clinic Efficiency and Patient Satisfaction During COVID-19.

OBJECTIVES: Telemedicine was increasingly adopted in otolaryngology as a result of the COVID-19 pandemic, but how it compares to in-person visits over the longitudinal course of the pandemic has not been characterized. This study compares telemedicine visits to in-person visits on measures of clinical efficiency and patient satisfaction. METHODS: We examined all in-person and telemedicine encounters that occurred during the 13-month period from April 1, 2020 to April 30, 2021 at a pediatric otolaryngology clinic associated with a large tertiary care children's hospital. We compared patient demographics, primary encounter diagnoses, completions, cancellations, no-shows, cycle time, and patient satisfaction. RESULTS: A total of 19 541 (90.5%) in-person visits and 2051 (9.5%) telemedicine visits were scheduled over the study period. There was no difference in patient age or gender between the visit types. There was a difference in race (75% White or Caucasian for in-person and 73% for telemedicine, P = .007) and average travel distance (53.3 miles for in-person vs 71.0 for telemedicine, P = .000). The most common primary diagnosis was Eustachian tube dysfunction for in-person visits (11.8%) and sleep disordered breathing for telemedicine visits (13.7%). Completion rate was greater for telemedicine visits (52.4% in-person vs 62.5% telemedicine). Cancellations were greater for in-person visits (42.6% in-person vs 24.2% telemedicine), but no-shows were greater for telemedicine (5.0% in-person vs 13.3% telemedicine, all P = .000). Average cycle time was shorter for telemedicine visits (56.5 minutes in-person vs 47.6 minutes telemedicine, P = .000). Patient satisfaction with provider interactions and overall care experience was high for both visit types. CONCLUSIONS: Telemedicine was utilized more during months of heightened COVID-19 cases, with higher completion rates, fewer cancellations, shorter cycle times, saved travel distance, and comparable patient satisfaction to in-person visits. Telemedicine has the potential to remain an efficient mode of care delivery in the post-pandemic era.

Early preclinical evaluation of a novel, computer aided designed, 3D printed, bioresorbable posterior cricoid scaffold.

OBJECTIVES: The posterior cricoid split with rib graft is a procedure that elegantly corrects pediatric posterior glottic stenosis and subglottic stenosis. Currently, the procedure requires harvesting of rib cartilage which leaves room for optimization. With use of three dimensional printing technology, our objective was to design a device that would negate the need for costal cartilage harvesting in this procedure. METHODS: An optimized, novel polycaprolactone scaffold was designed using computer aided design software and three dimensional printing. A pilot proof of concept study was conducted with implantation of the device in three porcine animal subjects. Device was evaluated by post-procedural clinical course, endoscopic exams, post-mortem exam, and histological evaluation. RESULTS: A series of variably sized scaffolds were created. The scaffolds showed structural integrity and successfully expanded the cricoid cartilage in the porcine model study. Post-operative endoscopy and clinical exams demonstrated no signs of implant instability or failure. Gross and histologic exams showed successful mucosalization over the scaffold and cartilage ingrowth by six weeks. CONCLUSION: This porcine animal pilot study demonstrated early success of a computer-aided designed, 3D printed, bioresorbable PCL posterior graft scaffold. The scaffolds eliminate the need for costal cartilage harvesting and had excellent surgical usability. The scaffolds functioned as designed, offering proof of concept and grounds for further evaluation to expand on this small pilot study with larger animal studies and continued design refinement.

Addressing the Pandemic Training Deficiency: Filling the Void with Simulation in Facial Reconstruction.

OBJECTIVE/HYPOTHESIS: To assess the use of a three-dimensional (3D) printed, multilayer facial flap model for use in trainee education as an alternative method of teaching surgical techniques of facial reconstruction. STUDY DESIGN: Cohort study. METHODS: A 3D printed facial flap simulator was designed from a computed tomography scan and manufactured out of silicone for low-cost, high-fidelity simulation. This simulator was tested by a group of Otolaryngology-Head and Neck Surgery trainees at a single institution. The simulator group was compared to a control group who completed an exercise on a traditional paper facial flap exercise. Both groups underwent didactic lectures prior to completing their respective exercises. Pre- and post-exercise Likert scale surveys measuring experience, understanding, effectiveness, and realism were completed by both groups. Central tendency, variability, and confidence intervals were measured to evaluate the outcomes. RESULTS: Trainees completing the facial flap simulator reported a statistically significant (p < 0.05) improvement in overall expertise in facial flap procedures, design of facial flaps, and excision of standing cutaneous deformities. No statistically significant improvement was seen in the control group. CONCLUSIONS: Trainees found the facial flap simulator to be an effective and useful training tool with a high level of realism in surgical education of facial reconstruction. Surgical simulators can serve as an adjunct to trainee education, especially during extraordinary times such as the novel coronavirus disease 2019 pandemic, which significantly impacted surgical training. LEVEL OF EVIDENCE: NA Laryngoscope, 131:E2444-E2448, 2021.

Adoption of Telemedicine for Multidisciplinary Care in Pediatric Otolaryngology.

OBJECTIVE: The COVID-19 pandemic has introduced a period of social isolation that has challenged the ability of providers to uphold in-person patient care. Although commonplace in pediatric otolaryngology, multidisciplinary clinics pose a unique challenge during this time due to increased infection risk from multiple patient-provider interactions. Guidance on the application of telemedicine for multidisciplinary clinics in pediatric otolaryngology is limited. METHODS: We provide comprehensive guidance on best practices for conducting telemedicine visits for a number of multidisciplinary otolaryngology clinics using our experiences at a single tertiary care children's hospital. A review of literature to support the adoption of telemedicine in multidisciplinary pediatric otolaryngology is also incorporated. RESULTS: Telemedicine was successfully adopted for 7 multidisciplinary pediatric clinics with a variety of specialists: aerodigestive disorders, congenital hearing loss, microtia/aural atresia, orofacial clefting, sleep disorders, tracheostomy care, and velopharyngeal dysfunction. CONCLUSIONS: Telemedicine is feasible for a variety of multidisciplinary clinics and its optimization is critical for providing care to complex pediatric otolaryngology patients during the COVID-19 pandemic and beyond.

Development of a novel mandibular distraction osteogenesis simulator using Computer Aided Design and 3D printing.

INTRODUCTION: Micrognathia, a component of Robin Sequence, can cause glossoptosis, failure of palatal fusion, and critical obstruction of the airway. Mandibular distraction osteogenesis (MDO) is at times offered to anteriorly translate the mandible and tongue, relieving airway obstruction. MDO is an intricate reconstructive procedure that may be ideal for teaching using a high-fidelity educational simulator, allowing early hands-on experience in a zero-risk environment. OBJECTIVES: To design a novel, low-cost, high-fidelity neonatal MDO simulator that can be used for trainee education and refinement of surgical technique. METHODS: A novel MDO simulator was developed using additive manufacturing techniques. Three experts in MDO surgery completed a 20-item survey, rating the simulator's physical attributes, the realism of experience, the simulator's value, its relevance to practice and the surgeon's ability to perform tasks on a 4-point Likert scale. RESULTS: Computer Aided Design (CAD) and 3D printing allowed for the production of a realistic surgical simulator that emulates important aspects of MDO surgery. This preliminary evaluation indicated adequate means across the five domains relevant to the simulator's fidelity and usability (M = 3.33 to 3.75) out of a maximum of 4 points. Lowest rated items were consistent with expert comments allowing future refinement on subsequent iterations. Consumable material costs per model were $9.39 USD. CONCLUSIONS: The MDO model demonstrated adequate fidelity and holds promise as a skill-development tool for surgeons in training. Further studies are planned to determine its utility as a training and assessment tool.

Multi-institutional Comparison of Temporal Bone Models: A Collaboration of the AAO-HNSF 3D-Printed Temporal Bone Working Group.

OBJECTIVE: The American Academy of Otolaryngology-Head and Neck Surgery Foundation's (AAO-HNSF's) 3D-Printed Temporal Bone Working Group was formed with the goal of sharing information and experience relating to the development of 3D-printed temporal bone models. The group conducted a multi-institutional study to directly compare several recently developed models. STUDY DESIGN: Expert opinion survey. SETTING: Temporal bone laboratory. METHODS: The working group convened in 2018. The various methods in which 3D virtual models had been created and printed in physical form were then shared and recorded. This allowed for comparison of the advantages, disadvantages, and costs of each method. In addition, a drilling event was held during the October 2018 AAO-HNSF Annual Meeting. Each model was drilled and evaluated by attending-level working group members using an 15-question Likert scale questionnaire. The models were graded on anatomic accuracy as well as their suitability as a simulation of both cadaveric and operative temporal bone drilling. RESULTS: The models produced for this study demonstrate significant anatomic detail and a likeness to human cadaver specimens for drilling and dissection. Models printed in standard resin material with a stereolithography printer scored highest in the evaluation, though the margin of difference was negligible in several categories. CONCLUSION: Simulated 3D temporal bones created through a number of printing methods have potential benefit in surgical training, preoperative simulation for challenging otologic cases, and the standardized testing of temporal bone surgical skills.

Preclinical assessment of clinically streamlined, 3D-printed, biocompatible single- and two-stage tissue scaffolds for ear reconstruction.

Auricular reconstruction is a technically demanding procedure requiring significant surgical expertise, as the current gold standard involves hand carving of the costal cartilage into an auricular framework and re-implantation of the tissue. 3D-printing presents a powerful tool that can reduce technical demands associated with the procedure. Our group compared clinical, radiological, histological, and biomechanical outcomes in single- and two-stage 3D-printed auricular tissue scaffolds in an athymic rodent model. Briefly, an external anatomic envelope of a human auricle was created using DICOM computed tomography (CT) images and modified in design to create a two-stage, lock-in-key base and elevating platform. Single- and two-stage scaffolds were 3D-printed by laser sintering poly-L-caprolactone (PCL) then implanted subcutaneously in five athymic rats each. Rats were monitored for ulcer formation, site infection, and scaffold distortion weekly, and scaffolds were explanted at 8 weeks with analysis using microCT and histologic staining. Nonlinear finite element analysis was performed to determine areas of high strain in relation to ulcer formation. Scaffolds demonstrated precise anatomic appearance and maintenance of integrity of both anterior and posterior auricular surfaces and scaffold projection, with no statistically significant differences in complications noted between the single- and two-staged implantation. While minor superficial ulcers occurred most commonly at the lateral and superior helix coincident with finite element predictions of high skin strains, evidence of robust tissue ingrowth and angiogenesis was visible grossly and histologically. This promising preclinical small animal model supports future initiatives for making clinically viable options for an ear tissue scaffold.

Hybrid Three-Dimensional-Printed Ear Tissue Scaffold With Autologous Cartilage Mitigates Soft Tissue Complications.

OBJECTIVES/HYPOTHESIS: To analyze the use of highly translatable three-dimensional (3D)-printed auricular scaffolds with and without novel cartilage tissue inserts in a rodent model. STUDY DESIGN: Preclinical rodent animal model. METHODS: This prospective study assessed a single-stage 3D-printed auricular bioscaffold with or without porcine cartilage tissue inserts in an athymic rodent model. Digital Imaging and Communications in Medicine computed tomography images of a human auricle were segmented to create an external anatomic envelope filled with orthogonally interconnected spherical pores. Scaffolds with and without tissue inset sites were 3D printed by laser sintering bioresorbable polycaprolactone, then implanted subcutaneously in five rats for each group. RESULTS: Ten athymic rats were studied to a goal of 24 weeks postoperatively. Precise anatomic similarity and scaffold integrity were maintained in both scaffold conditions throughout experimentation with grossly visible tissue ingrowth and angiogenesis upon explantation. Cartilage-seeded scaffolds had relatively lower rates of nonsurgical site complications compared to unseeded scaffolds with relatively increased surgical site ulceration, though neither met statistical significance. Histology revealed robust soft tissue infiltration and vascularization in both seeded and unseeded scaffolds, and demonstrated impressive maintenance of viable cartilage in cartilage-seeded scaffolds. Radiology confirmed soft tissue infiltration in all scaffolds, and biomechanical modeling suggested amelioration of stress in scaffolds implanted with cartilage. CONCLUSIONS: A hybrid approach incorporating cartilage insets into 3D-printed bioscaffolds suggests enhanced clinical and histological outcomes. These data demonstrate the potential to integrate point-of-care tissue engineering techniques into 3D printing to generate alternatives to current reconstructive surgery techniques and avoid the demands of traditional tissue engineering. LEVEL OF EVIDENCE: NA Laryngoscope, 131:1008-1015, 2021.

Delivery system can vary ventilatory parameters across multiple patients from a single source of mechanical ventilation.

BACKGROUND: Current limitations in the supply of ventilators during the Covid19 pandemic have limited respiratory support for patients with respiratory failure. Split ventilation allows a single ventilator to be used for more than one patient but is not practicable due to requirements for matched patient settings, risks of cross-contamination, harmful interference between patients and the inability to individualize ventilator support parameters. We hypothesized that a system could be developed to circumvent these limitations. METHODS AND FINDINGS: A novel delivery system was developed to allow individualized peak inspiratory pressure settings and PEEP using a pressure regulatory valve, developed de novo, and an inline PEEP 'booster'. One-way valves, filters, monitoring ports and wye splitters were assembled in-line to complete the system and achieve the design targets. This system was then tested to see if previously described limitations could be addressed. The system was investigated in mechanical and animal trials (ultimately with a pig and sheep concurrently ventilated from the same ventilator). The system demonstrated the ability to provide ventilation across clinically relevant scenarios including circuit occlusion, unmatched physiology, and a surgical procedure, while allowing significantly different pressures to be safely delivered to each animal for individualized support. CONCLUSIONS: In settings of limited ventilator availability, systems can be developed to allow increased delivery of ventilator support to patients. This enables more rapid deployment of ventilator capacity under constraints of time, space and financial cost. These systems can be smaller, lighter, more readily stored and more rapidly deployable than ventilators. However, optimizing ventilator support for patients with individualized ventilation parameters will still be dependent upon ease of use and the availability of medical personnel.