Contemporary Prevalence of Oral Clefts in the US: Geographic and Socioeconomic Considerations.

Background: Socio-economic status, living environments, and race have been implicated in the development of different congenital abnormalities. As orofacial clefting is the most common anomaly affecting the face, an understanding of its prevalence in the United States and its relationship with different determinants of health is paramount. Therefore, the purpose of this study is to determine the modern prevalence of oral-facial clefting in the United States and its association with different social determinants of health. Methods: Utilizing Epic Cosmos, data from approximately 180 US institutions were queried. Patients born between November 2012 and November 2022 were included. Eight orofacial clefting (OC) cohorts were identified. The Social Vulnerability Index (SVI) was used to assess social determinants of health. Results: Of the 15,697,366 patients identified, 31,216 were diagnosed with OC, resulting in a prevalence of 19.9 (95% CI: 19.7-20.1) per 10,000 live births. OC prevalence was highest among Asian (27.5 CI: 26.2-28.8) and Native American (32.8 CI: 30.4-35.2) patients and lowest among Black patients (12.96 CI: 12.5-13.4). Male and Hispanic patients exhibited higher OC prevalence than female and non-Hispanic patients. No significant differences were found among metropolitan (20.23/10,000), micropolitan (20.18/10,000), and rural populations (20.02/10,000). SVI data demonstrated that OC prevalence was positively associated with the percentage of the population below the poverty line and negatively associated with the proportion of minority language speakers. Conclusions: This study examined the largest US cohort of OC patients to date to define contemporary US prevalence, reporting a marginally higher rate than previous estimates. Multiple social determinants of health were found to be associated with OC prevalence, underscoring the importance of holistic prenatal care. These data may inform clinicians about screening and counseling of expectant families based on socio-economic factors and direct future research as it identifies potential risk factors and provides prevalence data, both of which are useful in addressing common questions related to screening and counseling.

Same-day Discharge for Cleft Palate Repair: A Single-Surgeon Retrospective Analysis.

OBJECTIVE: To evaluate the safety of same-day discharge for patients undergoing primary cleft palate repair. DESIGN: Single-surgeon retrospective review. SETTING: Tertiary care institution. PATIENTS/PARTICIPANTS: 40 consecutive patients that underwent primary cleft palate repair by a single surgeon from September 2018 to June 2023. INTERVENTIONS: Same-day discharge versus overnight admission after primary palatoplasty. MAIN OUTCOME MEASURES: 30-day readmission, reoperation, wound and all-cause complication rate and 1-year fistula incidence. RESULTS: Of 40 total cases, 20 patients were discharged on the same calendar day and 20 patients were admitted for overnight stay following primary cleft palate repair. In the same-day discharge group, readmission incidence was 10%(n = 2), wound complication incidence was 5%(n = 1), and postoperative complication incidence was 15%(n = 3). In comparison, patients admitted overnight had a readmission incidence of 5%(n = 1, P = 1.00), wound complication incidence of 10%(n = 2, P = 1.00), and postoperative complications of 20%(n = 4, P = 1.00) No patients had 30-day reoperations or fistulas at 1 year. A higher proportion of admitted patients held a preoperative diagnosis of unilateral cleft palate and alveolus (Veau 3) as compared to patients discharged on the same day (P = .019). During the postoperative hospital course, admitted patients received significantly more oxycodone at median of 2 doses (IQR 1.00-3.75) and acetaminophen at a median of 4 doses (IQR 3.00-5.00) than patients with same-day discharge with a median of 1 dose (IQR 0.00 -1.00, P < .001). CONCLUSIONS: In a low-risk patient population, same-day discharge following primary cleft palate repair may be safely undertaken and result in similar short-term outcomes and 1-year fistula incidence as patients admitted for overnight stay.

Association of Commonly Prescribed Antepartum Medications and Incidence of Orofacial Clefting.

BACKGROUND: Pharmacologic agents are often used in the antepartum period, however, studies on their effect on fetal development are limited. Thus, this study aims to examine the effect of commonly prescribed antepartum medications on the development of orofacial clefting. METHODS: Utilizing EPIC Cosmos deidentified data from approximately 180 US institutions was queried. Patients born between January 1, 2013, to January 1, 2023, were included. Eight OC cohorts were identified. Gestational medication use was identified by medications prescribed, provider-administered, or reported use by mothers. Medications used in at least 1 in 10,000 pregnancies were included in this analysis. RESULTS: A total of 12 098 newborns with available maternal pharmacologic data were born with any type of orofacial clefting. Prevalence for all oral clefts, any cleft palate, and any cleft lip were 20.56, 18.10, and 10.60 per 10 000 individuals, respectively. Notable significant exposures include most anticonvulsants, such as lamotrigine (OR1.33, CI 1.10-1.62), and topiramate (OR1.35, CI 1.13-1.62), as well as nearly all SSRIs/SNRIs, including fluoxetine (OR1.34, CI 1.19-1.51), sertraline (OR1.25, CI 1.16-1.34), and citalopram (OR1.28, CI 1.11-1.47). Corticosteroids were also correlated including dexamethasone (OR1.19, CI 1.12-1.27), and betamethasone (OR1.64, CI 1.55-1.73), as were antibiotics, including amoxicillin (OR1.22, CI 1.14-1.30), doxycycline (OR1.29, CI 1.10-1.52), and nitrofuran derivatives (OR1.10, CI 1.03-1.17). CONCLUSION: New associations between commonly prescribed antepartum medications and orofacial clefting were found. These findings should be confirmed as causality is not assessed in this report. Practitioners should be aware of the potential increased risk associated with these medications.

Virtual Reality Simulation of Airway Management Post-Cleft Palate Surgery: A Model for Sustainable and Equitable Education.

BACKGROUND: The effectiveness of virtual-reality (VR) simulation-based training in cleft surgery has not been tested. The purpose of this study was to evaluate learners' acceptance of VR simulation in airway management of a pediatric patient post-cleft palate repair. METHODS: This VR simulation was developed through collaboration between BioDigital and Smile Train. 26 medical students from a single institution completed 10 min of standardized VR training and 5 min of standardized discussion about airway management post-cleft palate repair. They spent 4-8 min in the VR simulation with guidance from a cleft surgery expert. Participants completed pre- and post-surveys evaluating confidence in using VR as an educational tool, understanding of airway management, and opinions on VR in surgical education. Satisfaction was evaluated using a modified Student Evaluation of Educational Quality questionnaire and scored on a 5-point Likert scale. Wilcoxon signed-rank tests were performed to evaluate responses. RESULTS: There was a significant increase in respondents' confidence using VR as an educational tool and understanding of airway management post-cleft palate repair after the simulation (P < .001). Respondents' opinions on incorporating VR in surgical education started high and did not change significantly post-simulation. Participants were satisfied with VR-based simulation and reported it was stimulating (4.31 ± 0.88), increased interest (3.77 ± 1.21), enhanced learning (4.12 ± 1.05), was clear (4.15 ± 0.97), was effective in teaching (4.08 ± 0.81), and would recommend the simulation (4.2 ± 1.04). CONCLUSION: VR-based simulation can significantly increase learners' confidence and skills in airway management post-cleft palate repair. Learners find VR to be effective and recommend its incorporation in surgical education.

Direct inkjet writing type 1 bovine collagen/ß-tricalcium phosphate scaffolds for bone regeneration.

Bone tissue has the capacity to regenerate under healthy conditions, but complex cases like critically sized defects hinder natural bone regeneration, necessitating surgery, and use of a grafting material for rehabilitation. The field of bone tissue engineering (BTE) has pioneered ways to address such issues utilizing different biomaterials to create a platform for cell migration and tissue formation, leading to improved bone reconstruction. One such approach involves 3D-printed patient-specific scaffolds designed to aid in regeneration of boney defects. This study aimed to develop and characterize 3D printed scaffolds composed of type I collagen augmented with ß-tricalcium phosphate (COL/ß-TCP). A custom-built direct inkjet write (DIW) printer was used to fabricate ß-TCP, COL, and COL/ß-TCP scaffolds using synthesized colloidal gels. After chemical crosslinking, the scaffolds were lyophilized and subjected to several characterization techniques, including light microscopy, scanning electron microscopy, and x-ray diffraction to evaluate morphological and chemical properties. In vitro evaluation was performed using human osteoprogenitor cells to assess cytotoxicity and proliferative capacity of the different scaffold types. Characterization results confirmed the presence of ß-TCP in the 3D printed COL/ß-TCP scaffolds, which exhibited crystals that were attributed to ß-TCP due to the presence of calcium and phosphorus, detected through energy dispersive x-ray spectroscopy. In vitro studies showed that the COL/ß-TCP scaffolds yielded more favorable results in terms of cell viability and proliferation compared to ß-TCP and COL scaffolds. The novel COL/ß-TCP scaffold constructs hold promise for improving BTE applications and may offer a superior environment for bone regeneration compared with conventional COL and ß-TCP scaffolds.

Abbe Flap Division Before Two Weeks' Time: Harmful or Advantageous?

INTRODUCTION: The Abbe flap is a standard intervention to treat upper lip deformities in patients with bilateral cleft lip. This two-stage procedure requires a 2 to 3-week period in which the superior and inferior lips remain connected. This study evaluates the safety of Abbe flap division and inset prior to 14 days' time. MATERIALS AND METHODS: A single institution, 8-year review of all patients with a bilateral cleft lip who underwent Abbe flap reconstruction was performed. Patients were classified into two groups: those whom division was performed 14 days or later and those with division earlier than 14 days. RESULTS: A total of 26 patients were identified. Patients who underwent Abbe flap division in less than 14 days (n = 10) demonstrated an average time to division of 9.7 days (range 7-13 days) with no evidence of flap loss, wound breakdown or infection. Patients who underwent Abbe flap division within 14 days or more (n = 16) demonstrated an average time to division of 15 days with four minor complications and no flap loss. CONCLUSION: Dividing the Abbe flap after the first postoperative week appears to be safe and without additional risk to flap loss or wound breakdown. A shorter time to Abbe flap division may decrease the burden of care on patients and their caregivers.

The Burden of Care of Nasoalveolar Molding: An Institutional Experience.

Nasoalveolar molding (NAM) is an early presurgical intervention to facilitate primary cleft lip repair by reducing cleft severity and improving labial and nasal form. However, it continues to be associated with the burden of care that influences access and completion of therapy. The authors, therefore, aim to determine the burden of care of NAM therapy for families seeking treatment at a high-volume urban cleft center. A retrospective study of all patients undergoing primary cleft repair between 2012 and 2020 was performed. Patients were grouped based on whether or not NAM therapy was offered. Variables including physical, psychosocial, and financial factors were assessed. Two hundred and thirty patients underwent primary cleft repair between 2012 and 2020. Of these, 176 patients were indicated for NAM, with 4% discontinuing, and 54 patients did not undergo NAM. The 169 patients who completed NAM had a mean duration of treatment of 13.6±8.8 wks consisting of 15±6 scheduled NAM adjustment visits and 1±1 unscheduled visit made urgently to assess caregiver concerns. The mean travel distance was 28.6±37.1 miles. Eighty-four percent of caregivers were married, and 16% did not have English as a primary language. Though 57% had private insurance, 43% of patients received charity support for their treatment. NAM is a finite presurgical intervention that requires caregivers to participate in patient care for approximately three months of their early life. The decision to pursue NAM should be considered alongside the burden of care for caregivers to complete treatment.

Defining the Treatment Gap in Nasoalveolar Molding: Factors Affecting the Utilization of NAM in an Urban Cleft Center.

BACKGROUND: Many cleft centers incorporate NasoAlveolar Molding (NAM) into their presurgical treatment protocols. However, there are limited data on eligible patients who do not receive or complete NAM. This study characterizes the demographics associated with non-utilization or completion of NAM. METHODS: A single-institution retrospective review was performed of all patients with cleft lip and alveolus undergoing primary unilateral and bilateral cleft lip repair from 2012-2020. Patients were grouped based on utilization or non-utilization of NAM. Demographic and treatment data were collected, including documented reasons for not pursuing or completing NAM. RESULTS: Of 230 eligible patients, 61 patients (27%) did not undergo or complete NAM (no-NAM). In this group, 37 (60.7%) received no presurgical intervention, 12 (19.7%) received presurgical nostril retainers, 3 (4.9%) received lip taping, 1 (1.6%) received a combination of taping/nostril retainers, and 8 (13.1%) discontinued NAM. The most common reasons for not receiving NAM were sufficiently aligned cleft alveolus (21.3%), medical complexity (16.4%), late presentation (16.4%), and alveolar notching (18%). Compared to the NAM group, the no-NAM group had significantly lower rates of prenatal cleft diagnosis/consult, and significantly higher proportion of non-married and non-English speaking caregivers. Multivariable analysis controlling for insurance type, primary language, prenatal consult, marital status, and age at first appointment found that age at first appointment is the only statistically significant predictor of NAM utilization (P < .001). CONCLUSIONS: Common reasons for non-utilization of NAM include well-aligned cleft alveolus, medical complexity, and late presentation. Early presentation is an important modifiable factor affecting rates of NAM utilization.

Anatomical Study of Domain Rescue of Palatal Length in Patients With a Wide Cleft Palate: Buccal Flap Reconstruction in Primary Palatoplasty.

BACKGROUND: This study characterizes the potential loss of velar length in patients with a wide cleft and rescue of this loss of domain by local flap reconstruction, providing anatomic evidence in support of primary lengthening of the soft palate during palatoplasty. METHODS: A retrospective review was conducted of all patients with a cleft palate at least 10mm in width, who underwent primary palatoplasty with a buccal flap prior to 18 months of age over a 2-year period. All patients underwent primary palatoplasty with horizontal transection of the nasal mucosa, which was performed after nasal mucosa repair, but prior to muscular reconstruction. The resulting palatal lengthening was measured and the mucosal defect was reconstructed with a buccal flap. RESULTS: Of the 22 patients included, 3 (13.6%) had a history of Pierre Robin sequence, and 5 (22.7%) had an associated syndrome. No patients had a Veau I cleft, 7 (31.8%) had a Veau II, 12 (54.5%) had a Veau III, and 3 had (13.6%) a Veau IV cleft. All patients had a right buccal flap during primary palatoplasty. The mean cleft width at the posterior nasal spine was 10.6 ± 2.82mm, and mean lengthening of the velum after horizontal transection of the nasal mucosa closure was 10.5 ± 2.23mm. There were 2 (9.1%) fistulas, 1 (4.5%) wound dehiscence, 1 (4.5%) 30-day readmission, and no bleeding complications. CONCLUSIONS: Patients with a wide cleft palate have a potential loss of 1cm velar length. The buccal flap can rescue the loss of domain in palatal length, and potentially improve palatal excursion.

Internet-based Digital Simulation for Cleft Surgery Education: A 10-year Assessment of Demographics, Usage, and Future Directions.

Background: In October 2012, an open-access, multimedia digital cleft simulator was released. Its purpose was to address global disparities in cleft surgery education, providing an easily accessible surgical atlas for trainees globally. The simulator platform includes a three-dimensional surgical simulation of cleft care procedures, intraoperative videos, and voiceover. This report aims to assess the simulator's demographics and usage in its tenth year since inception. Finally, we also aim to understand the traction of virtual reality in cleft surgical education. Methods: Usage data of the simulator over 10 years were retrospectively collected and analyzed. Data parameters included the number of users, sessions, countries reached, and content access. An electronic survey was emailed to registered users to assess the benefits of the simulator. Results: The total number of new and active simulator users reached 7687 and 12,042. The simulator was accessed an average of 172.9.0 ± 197.5 times per month. Low- to middle-income regions accounted for 43% of these sessions. The mean session duration was 11.4 ± 6.3 minutes, yielding a total screen time of 3022 hours. A total of 331 individuals responded to the survey, of whom 80.8% found the simulator to be very useful or extremely useful. Of those involved in education, 45.0% implemented the simulator as a teaching tool. Conclusions: Global utilization of the simulator has been sustained after 10 years from inception with an increased presence in low- to middle-income nations. Future similar surgical simulators may provide sustainable training platforms to surgeons in low- and high-resource areas.

LeFort I Horizontal Osteotomy: Defining the Feasibility of the "High Osteotomy".

OBJECTIVE: To define "high osteotomy" and determine the feasibility of performing this procedure. DESIGN: Single institution, retrospective review. SETTING: Academic tertiary referral hospital. PATIENTS, PARTICIPANTS: 34 skeletally mature, nonsyndromic patients with unilateral CLP who underwent Le Fort I osteotomy between 2013 and 2020. Patients with cone-beam computed tomography (CBCT) scans completed both pre- (T1) and post-operatively (T2) were included. Patients with bilateral clefts and rhinoplasty prior to post-operative imaging were excluded. INTERVENTIONS: Single jaw one-piece Le Fort I advancement surgery. MAIN OUTCOME MEASURES: Measurements of the superior ala and inferior turbinates were taken from the post-operative CBCT. RESULTS: The sample included 26 males and 8 females, 12 right- and 22 left-sided clefts. The inferior turbinates are above the superior alar crease at a rate of 73.53% and 76.48% on the cleft and non-cleft sides, respectively. One (2.9%) osteotomy cut was above the level of the cleft superior alar crease, and no cuts were above the level of the non-cleft superior ala. On average, the superior ala was 2.63 mm below the inferior turbinates. The average vertical distances from the superior alar crease and the inferior turbinates to the base of the non-cleft side pyriform aperture were 12.17 mm (95% CI 4.00-20.34) and 14.80 mm (95% CI 4.61-24.98), respectively. To complete a "high osteotomy," with 95% confidence, the cut should be 20.36 mm from the base of the pyriform aperture. CONCLUSIONS: A "high" osteotomy is not consistently possible due to the relationship between the superior alar crease and the inferior turbinate.

A novel treatment of pediatric bilateral condylar fractures with lateral dislocation of the temporomandibular joint (TMJ) using transfacial pinning.

A 3-year-old patient sustained a tripartite mandibular fracture, including bilateral condylar fractures with lateral dislocation of the left condyle and symphyseal fracture. Staged lower jaw reconstruction with closed reduction of the laterally dislocated condyle, transfacial pinning between the mandibular angles, MMF using circummandibular wiring and intermaxillary fixation screws was performed.

Three-Dimensional Printing Bioceramic Scaffolds Using Direct-Ink-Writing for Craniomaxillofacial Bone Regeneration.

Defects characterized as large osseous voids in bone, in certain circumstances, are difficult to treat, requiring extensive treatments which lead to an increased financial burden, pain, and prolonged hospital stays. Grafts exist to aid in bone tissue regeneration (BTR), among which ceramic-based grafts have become increasingly popular due to their biocompatibility and resorbability. BTR using bioceramic materials such as ß-tricalcium phosphate has seen tremendous progress and has been extensively used in the fabrication of biomimetic scaffolds through the three-dimensional printing (3DP) workflow. 3DP has hence revolutionized BTR by offering unparalleled potential for the creation of complex, patient, and anatomic location-specific structures. More importantly, it has enabled the production of biomimetic scaffolds with porous structures that mimic the natural extracellular matrix while allowing for cell growth-a critical factor in determining the overall success of the BTR modality. While the concept of 3DP bioceramic bone tissue scaffolds for human applications is nascent, numerous studies have highlighted its potential in restoring both form and function of critically sized defects in a wide variety of translational models. In this review, we summarize these recent advancements and present a review of the engineering principles and methodologies that are vital for using 3DP technology for craniomaxillofacial reconstructive applications. Moreover, we highlight future advances in the field of dynamic 3D printed constructs via shape-memory effect, and comment on pharmacological manipulation and bioactive molecules required to treat a wider range of boney defects.

"The Effects of Gingivoperiosteoplasty and Cleft Palate Repair on Facial Growth."

PURPOSE: Gingivoperiosteoplasty (GPP) can avoid secondary alveolar bone graft in up to 60% of patients. The effects of GPP on maxillary growth are a concern. However, palatoplasty can also negatively impact facial growth. This study quantifies the isolated effects of GPP and cleft palate repair on maxillary growth at the age of mixed dentition. METHODS: A single institution, retrospective study of all patients undergoing primary reconstruction for unilateral cleft lip and alveolus (CLA) or cleft lip and palate (CLP) was performed. Study patients had lateral cephalograms at age of mixed dentition. Patients were stratified into four groups: CLA with GPP (CLA+GPP), CLA without GPP (CLA-GPP), CLP with GPP (CLP+GPP), and CLP without GPP (CLP-GPP). Cephalometric measurements included: sella-nasion-point A (SNA), sella-nasion-point B (SNB), and A point-nasion-B point (ANB). Landmarks were compared between patient groups and to Eurocleft Center D data. RESULTS: 110 patients met inclusion criteria: 7 CLA-GPP, 16 CLA+GPP, 24 CLP-GPP, and 63 CLP+GPP patients. There were no significant differences in SNA, SNB, and ANB between CLA+GPP and CLA-GPP, or between CLP+GPP and CLP-GPP groups. In patients who did not receive GPP, SNA was significantly lower in patients with a cleft palate compared to patients with an intact palate (p < 0.05). There were no significant differences in SNA or SNB of CLP-GPP or CLP+GPP groups when compared to Eurocleft data. CONCLUSION: When controlling for the effects of cleft palate repair, GPP does not appear to negatively affect midface growth at the age of mixed dentition.

Characterizing Cleft Rhinoplasty Across Skeletal Maturity: A Systematic Review of Terminology and Surgical Techniques.

OBJECTIVE: The purpose of this study is to assess cleft rhinoplasty terminology across phases of growth.Design/Setting: A systematic review was performed on cleft rhinoplasty publications over 20 years.Interventions: Studies were categorized by age at surgical intervention: infant (<1 year); immature (1 to 14 years); mature (>15 years).Main Outcome Measures: Collected data included terminology used and surgical techniques. RESULTS: The 288 studies included demonstrated a wide range of terminology. In the infant group, 51/54 studies used the term "primary." In the immature group, 7/18 studies used the term "primary," 3/18 used "secondary." In the mature group, 2/33 studies used the term "primary," 16/33 used "secondary," 2/33 used "definitive," 5/33 used terms such as "mature," "adult," and "late," and 8/33 did not use terminology.Surgical technique assessment demonstrated: cleft rhinoplasty at infancy used nostril rim or no nasal incision, immature rhinoplasty used closed and open rhinoplasty incisions; and mature rhinoplasty used a majority of open rhinoplasty. Infant and immature cleft rhinoplasty incorporated septal harvest or spur removal in <10% of cases, whereas these procedures were common in mature rhinoplasty. No studies in infants or immature patients used osteotomies or septal grafts, common techniques in mature rhinoplasty. CONCLUSIONS: Current terminology for cleft rhinoplasty is varied and inconsistently applied across stages of facial development. However, cleft rhinoplasty performed at infancy, childhood, and facial maturity are surgically distinct procedures. The authors recommend the terminology "infant," "immature," and "mature" cleft rhinoplasty to accurately describe this procedure within the context of skeletal growth.

Clinical Outcomes of Bilateral Cleft Lip and Palate Repair with Nasoalveolar Molding and Gingivoperiosteoplasty to Facial Maturity.

BACKGROUND: The long-term effects of nasoalveolar molding (NAM) on patients with bilateral cleft lip and palate (BCLP) are unknown. The authors report clinical outcomes of facially mature patients with complete BCLP who underwent NAM and gingivoperiosteoplasty (GPP). METHODS: A single-institution retrospective study of nonsyndromic patients with complete BCLP who underwent NAM between 1991 and 2000 was performed. All study patients were followed to skeletal maturity, at which time a lateral cephalogram was obtained. The total number of cleft operations and cephalometric measures was compared with a previously published external cohort of patients with complete and incomplete BCLP in which a minority (16.7%) underwent presurgical orthopedics before cleft lip repair without GPP. RESULTS: Twenty-four patients with BCLP comprised the study cohort. All patients underwent GPP, 13 (54.2%) underwent alveolar bone graft, and nine (37.5%) required speech surgery. The median number of operations per patient was five (interquartile range, two), compared with eight (interquartile range, three) in the external cohort ( P < 0.001). Average age at the time of lateral cephalogram was 18.64 years (1.92). There was no significant difference between our cohort and the external cohort with respect to sella-nasion-point A angle (SNA) [73 degrees (6 degrees) versus 75 degrees (11 degrees); P = 0.186] or sella-nasion-point B angle (SNA) [78 degrees (6 degrees) versus 74 degrees (9 degrees); P = 0.574]. Median ANB (SNA - SNB) was -3 degrees (5 degrees) compared with -1 degree (7 degrees; P = 0.024). Twenty patients (83.3%) underwent orthognathic surgery. CONCLUSION: Patients with BCLP who underwent NAM and GPP had significantly fewer total cleft operations and mixed midface growth outcomes at facial maturity compared with patients who did not undergo this treatment protocol. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

The Reality of Commercial Payer-Negotiated Rates in Cleft Lip and Palate Repair.

BACKGROUND: Commercial payer-negotiated rates for cleft lip and palate surgery have not been evaluated on a national scale. The aim of this study was to characterize commercial rates for cleft care, both in terms of nationwide variation and in relation to Medicaid rates. METHODS: A cross-sectional analysis was performed of 2021 hospital pricing data from Turquoise Health, a data service platform that aggregates hospital price disclosures. The data were queried by CPT code to identify 20 cleft surgical services. Within- and across-hospital ratios were calculated per CPT code to quantify commercial rate variation. Generalized linear models were used to assess the relationship between median commercial rate and facility-level variables and between commercial and Medicaid rates. RESULTS: There were 80,710 unique commercial rates from 792 hospitals. Within-hospital ratios for commercial rates ranged from 2.0 to 2.9 and across-hospital ratios ranged from 5.4 to 13.7. Median commercial rates per facility were higher than Medicaid rates for primary cleft lip and palate repair ($5492.20 versus $1739.00), secondary cleft lip and palate repair ($5429.10 versus $1917.00), and cleft rhinoplasty ($6001.00 versus $1917.00; P < 0.001). Lower commercial rates were associated with hospitals that were smaller ( P < 0.001), safety-net ( P < 0.001), and nonprofit ( P < 0.001). Medicaid rate was positively associated with commercial rate ( P < 0.001). CONCLUSIONS: Commercial rates for cleft surgical care demonstrated marked variation within and across hospitals, and were lower for small, safety-net, or nonprofit hospitals. Lower Medicaid rates were not associated with higher commercial rates, suggesting that hospitals did not use cost-shifting to compensate for budget shortfalls resulting from poor Medicaid reimbursement.

National Undervaluation of Cleft Surgical Services: Evidence from a Comparative Analysis of 50,450 Cases.

BACKGROUND: Relative value units (RVUs) are broadly used for billing and physician compensation; however, the accuracy of RVU assignments has not been scientifically evaluated for craniofacial surgery. The authors hypothesize that unbalanced RVU allocation creates inappropriate disparities in value among procedures performed by cleft and craniofacial surgeons. METHODS: The National Surgical Quality Improvement Program Pediatric database was queried to identify all cleft and craniofacial surgery cases performed by plastic surgeons from 2012 to 2019 based on CPT code. Microsurgical cases and CPT codes with a case count of fewer than 10 were excluded. Efficiency was defined as total RVUs divided by total operative time (ie, RVUs/hour). Mean efficiency per CPT code was ranked and compared by quartile using t tests. RESULTS: The sample consisted of 69 CPT codes with 50,450 cases. In the top quartile, most CPT codes were craniofacial procedures including frontofacial procedures (23.53%) and craniectomies for craniosynostosis or bony lesions (35.29%) (mean, 15.65 ± 4.22 RVUs/hour). The lowest quartile was composed mainly of CPT codes for cleft procedures including operations for velopharyngeal insufficiency (17.65%), cleft palate repair (23.53%), and cleft septoplasty (5.88%) (mean, 7.39 ± 0.98 RVUs/hour; P < 0.001). It was 2.5 times more efficient for a cleft and craniofacial surgeon to perform a local skin flap (15.18 RVUs/hour) than a secondary palatal lengthening for cleft palate (6.09 RVUs/hour). CONCLUSIONS: The current RVU allocation to cleft and craniofacial procedures creates arbitrary disparities in physician efficiency, with cleft procedures disproportionately negatively affected. RVU assignments should be reevaluated to avoid disincentivizing cleft surgical care.

Engineering 3D Printed Bioceramic Scaffolds to Reconstruct Critical-Sized Calvaria Defects in a Skeletally Immature Pig Model.

BACKGROUND: Three-dimensional printed bioceramic scaffolds composed of 100% ß-tricalcium phosphate augmented with dipyridamole (3DPBC-DIPY) can regenerate bone across critically sized defects in skeletally mature and immature animal models. Before human application, safe and effective bone formation should be demonstrated in a large translational animal model. This study evaluated the ability of 3DPBC-DIPY scaffolds to restore critically sized calvarial defects in a skeletally immature, growing minipig. METHODS: Unilateral calvarial defects (~1.4 cm) were created in 6-week-old Göttingen minipigs ( n = 12). Four defects were filled with a 1000 µm 3DPBC-DIPY scaffold with a cap (a solid barrier on the ectocortical side of the scaffold to prevent soft-tissue infiltration), four defects were filled with a 1000 µm 3DPBC-DIPY scaffold without a cap, and four defects served as negative controls (no scaffold). Animals were euthanized 12 weeks postoperatively. Calvariae were subjected to micro-computed tomography, 3D reconstruction with volumetric analysis, qualitative histologic analysis, and nanoindentation. RESULTS: Scaffold-induced bone growth was statistically greater than in negative controls ( P ≤ 0.001), and the scaffolds with caps produced significantly more bone generation compared with the scaffolds without caps ( P ≤ 0.001). Histologic analysis revealed woven and lamellar bone with haversian canals throughout the regenerated bone. Cranial sutures were observed to be patent, and there was no evidence of ectopic bone formation or excess inflammatory response. Reduced elastic modulus and hardness of scaffold-regenerated bone were found to be statistically equivalent to native bone ( P = 0.148 for reduced elastic modulus of scaffolds with and without caps and P = 0.228 and P = 0.902 for hardness of scaffolds with and without caps, respectively). CONCLUSION: 3DPBC-DIPY scaffolds have the capacity to regenerate bone across critically sized calvarial defects in a skeletally immature translational pig model. CLINICAL RELEVANCE STATEMENT: This study assessed the bone generative capacity of 3D-printed bioceramic scaffolds composed of 100% ß-tricalcium phosphate and augmented with dipyridamole placed within critical-sized calvarial defects in a growing porcine model.

"Septoplasty" Performed at Primary Cleft Rhinoplasty: A Systematic Review of Techniques and Call for Accurate Terminology.

OBJECTIVE: Primary cleft nasal repair can include septal reconstruction. We hypothesize that primary cleft septoplasty and adult septoplasty have fundamental differences that render these procedures as distinct surgical entities. DESIGN: Systematic review of the PubMed, Cochrane, and Embase databases performed on pediatric cleft and general adult septoplasty techniques through December 2021. (PROSPERO ID CRD42022295763). MAIN OUTCOME MEASURES: Collected data included information on septal dissection, septal detachment, and management of the bony and cartilaginous septum. RESULTS: Twenty-eight pediatric cleft septoplasty and 229 adult septoplasty studies were included. Dissection in primary cleft septoplasty was limited to the anterocaudal septum, while secondary cleft septoplasty and adult septoplasty techniques entailed wide exposures of the cartilaginous septum with or without exposure of the perpendicular plate of the ethmoid. In primary cleft septoplasty, detachment of the septum was mostly limited to the nasal spine and anterior base of the cartilaginous septum, while secondary cleft septoplasty and adult septoplasty included detachment from the vomer, and ethmoid. In the few reports of cartilage excision during primary cleft septoplasty, removal was limited to the anterior inferior border of the septum, while secondary cleft septoplasty and adult septoplasty included excision of the cartilaginous and bony septum. CONCLUSION: Primary cleft septoplasty is distinct from septoplasty performed on facially mature patients. More specifically, septal dissection and detachment are limited to the anterior caudal area during primary lip repair, with rare removal of cartilage or bone. Given these differences, the authors suggest the term "septal reset" to describe septoplasty performed during primary cleft nasal repair.