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Prominent Premaxilla in Bilateral Cleft Lip: A Blinded Expert-Panel Assessment of Orthopedic Response and Final Aesthetic Outcomes
Tanikawa, Daniela Y S; Chong, David K; Fisher, David M; Flores, Roberto L; Meazzini, Maria Costanza; Shetye, Pradip R; Figueroa, Álvaro A
BACKGROUND:A prominent premaxilla in bilateral cleft lip presents significant orthopedic and surgical challenges. Although presurgical infant orthopedics (PSIO) is widely used, evidence linking orthopedic response to clinically meaningful outcomes remains limited. This study evaluated orthopedic response, need for lip adhesion, and final aesthetic outcomes using blinded expert-panel assessments. METHODS:Fifty consecutive bilateral cleft patients treated with PSIO were reviewed, including 25 treated with nasal elevator and lip taping (NE) and 25 treated with Presurgical Lip-Alveolus-Nose Approximation (PLANA). Twenty-seven patients with prominent premaxilla underwent blinded assessment of orthopedic response by 3 cleft surgeons and 3 orthodontists. Final aesthetic outcomes were evaluated in a separate blinded assessment of 50 postoperative cases, mixing patients with and without prominent premaxilla to minimize recognition bias. RESULTS:The prevalence of prominent premaxilla was similar between groups (60.0% versus 48.0%; P=0.571). Lip adhesion was required more frequently in NE-treated than PLANA-treated patients (46.7% versus 8.3%; P=0.043). Patients treated with PLANA demonstrated superior orthopedic outcomes for premaxillary position, columellar length, and overall PSIO response (all P<0.001). Patients with prominent premaxilla achieved final nasal, lip, and overall nasolabial appearance ratings comparable to those without prominent premaxilla (all P>0.05). Evaluators showed poor ability to identify initially prominent premaxilla based on final appearance alone. Overall PSIO response correlated with final nasolabial appearance (ρ=0.48, P=0.024). CONCLUSIONS:Although a prominent premaxilla represents a more challenging initial deformity, it did not predict inferior final appearance. Better orthopedic response was associated with more favorable final aesthetic outcomes, supporting the clinical relevance of effective presurgical orthopedic correction.
PMID: 42690915
ISSN: 1536-3732
CID: 6071904
Comparative Analysis of Presurgical Lip, Alveolus, and Nose Approximation and Nasoalveolar Molding in Infants With Bilateral Cleft Lip
Singer, Andrea J; Rivera, Lucas R Perez; Staffenberg, David A; Flores, Roberto L; Shetye, Pradip R
Presurgical lip, alveolus, and nose approximation (PLANA) is a form of presurgical infant orthopedics designed to reduce cleft severity without an intraoral molding plate. This study compared nasolabial outcomes and the burden of care in patients with a bilateral cleft treated with PLANA in relation to nasoalveolar molding (NAM). A single-institution retrospective review was conducted of all patients with bilateral cleft lip treated with NAM (2016-2019) or PLANA (2023-2025). Clinical data were collected, including treatment timing, number of visits, and number of unscheduled appointments. Anthropometric measurements for nasolabial angle (NLA), columella length, pronasale to subnasale distance, and alar base width at initiation and completion of therapy were collected. Paired-samples t tests were used for intragroup changes, and independent-samples t tests were used for intergroup comparisons. Across 24 patients (11 PLANA and 13 NAM), the PLANA cohort required fewer visits (6 versus 17, P<0.05) and unscheduled appointments (0 versus 1, P=0.01). Treatment initiation occurred earlier in the PLANA group (11 versus 35 d, P<0.05), as did the insertion of the nasal appliance or stent (19 versus 72 d, P<0.05). Primary surgery was performed earlier in the PLANA group (107 versus 150 d, P<0.05). Both groups exhibited improvements in NLA, columella length, and the pronasale-to-subnasale difference, with no intergroup differences. The PLANA group exhibited greater improvement in alar base width (3.3 versus 0.4 mm, P=0.01). Patients treated with PLANA exhibit favorable nasolabial outcomes, as well as reduced treatment durations, scheduled visits, unscheduled appointments, and overall burden of care.
PMID: 42607152
ISSN: 1536-3732
CID: 6071418
Presurgical Lip, Alveolus, and Nose Approximation Versus Nasoalveolar Molding: Cleft Severity and Anthropometric Outcomes
Perez Rivera, Lucas R; Ricke, Chloe; Flores, Roberto L; Shetye, Pradip R
Nasoalveolar molding (NAM) is an established form of presurgical infant orthopedics (PSIO), whereas presurgical lip, alveolus, and nose approximation (PLANA) is a novel approach. This study compared presurgical outcomes between infants with a unilateral cleft lip treated with PLANA and NAM using an objective method for assessment of cleft severity and PSIO outcomes. A single-institution retrospective review was conducted of all patients treated with NAM (2017-2019) and PLANA (2023-2025). Anthropometric measurements including columellar angle, nostril width ratio, and lateral subnasale displacement were collected at the initiation and completion of therapy, and predefined thresholds were used to classify patients by cleft severity (mild, moderate, severe, and very severe) and outcome (poor, good, and excellent). A total of 64 patients were identified, including 36 patients treated with NAM and 28 treated with PLANA. At baseline, the 2 cohorts exhibited similar distributions in cleft severity categories. At the completion of therapy, statistically significant differences were observed between NAM (27.8% mild, 52.8% moderate, 16.7% severe, and 2.8% very severe) and PLANA (67.9% mild, 28.6% moderate, 3.6% severe, 0.0% very severe). This translated to significant differences in PSIO outcomes between NAM (11.1% excellent, 55.6% good, and 33.3% poor) and PLANA (60.7% excellent, 35.7% good, and 3.6% poor). Numerically, the 2 cohorts were statistically similar at baseline, but after PSIO the PLANA cohort displayed more favorable anthropometrics and larger improvements in all 3 parameters. Using an objective method for evaluating cleft severity, patients treated with PLANA exhibited superior morphologic outcomes in comparison to NAM.
PMID: 42544928
ISSN: 1536-3732
CID: 6070790
An Institutional Comparative Cost Analysis Between Nasoalveolar Molding and Presurgical Lip, Alveolus, and Nose Approximation
Perez Rivera, Lucas R; Kantar, Rami S; Rrushi, Vitorela; Staffenberg, David A; Flores, Roberto L; Shetye, Pradip R
Presurgical lip, alveolus, and nose approximation (PLANA) is a novel presurgical infant orthopedics approach that has demonstrated early favorable nasolabial outcomes. However, its associated costs have not been evaluated. This study compared treatment costs between PLANA and nasoalveolar molding (NAM). A single-institution retrospective review of patients treated with NAM (2018-2019) and PLANA (2024-2025) was conducted. Patients were grouped by unilateral or bilateral involvement, and the average number of visits per cohort was calculated. Publicly available standardized payment values from the Centers for Medicare & Medicaid Services were used to approximate the costs of physician services and facility resources. Total costs were calculated from the sum of the costs for physician services, facilities, and medical supplies. Seventy-four patients were included, including 40 treated with NAM (unilateral 30 and bilateral 10), and 34 treated with PLANA (unilateral 24 and bilateral 10). For patients with a unilateral cleft, the average cost of NAM was $4362.37 (services: $1893.67, facilities: $2160.50, and supplies: $308.20), whereas the average cost of PLANA was $2791.94 (services: $752.61, facilities: $830.96, and supplies: $1208.37). Across patients with a bilateral cleft, the average cost of NAM was $4980.01 (services: $2178.93, facilities: $2492.88, and supplies: $308.20), whereas the average cost of PLANA was $3100.76 (services: $895.24, facilities: $997.15, and supplies: $1208.37). The cost of NAM is largely driven by physician services and facility expenses, whereas the cost of PLANA is primarily driven by medical supplies, offset by a reduced number of visits. These findings may inform cleft centers in their selection of presurgical orthopedic interventions and guide the development of standardized payment criteria.
PMID: 42546168
ISSN: 1536-3732
CID: 6070799
A Systematic Review of Pain Control Protocols in Alveolar Bone Grafting
Perez Rivera, Lucas R; Herold, Benjamin; Pullmann, Dominika; Juneja, Ankit; Narayanan, Anandhini; Ricke, Chloe; Kantar, Rami S; Shertzer, Alon; Flores, Roberto L
ObjectiveTo systematically evaluate donor site pain control interventions for iliac crest-based secondary alveolar bone grafting (ABG).DesignSystematic review in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines.SettingOriginal scientific investigations.Patients, ParticipantsPatients undergoing iliac crest-based secondary ABG.InterventionsDonor site analgesics and minimally invasive harvest techniques.Main Outcome Measure(s)Pain scores, opioid consumption, length of stay, ambulation variables, complications, and pain assessment scales used.Results33 studies met the inclusion criteria, encompassing 1925 patients. The most frequently studied methods for donor site pain control were analgesic infusion pumps or catheters (8, 24.2%), local bupivacaine (8, 24.2%), local liposomal bupivacaine (5, 15.2%), transversus abdominis plane blocks (4, 12.1%), and bupivacaine-soaked sponges (4, 12.1%). Most studies evaluated pain scores (21, 63.6%), opioid consumption (17, 51.5%), and length of stay (17, 51.5%). The most used pain assessment scales were generic numeric (1-10) pain rating scales (9, 27.3%), the Visual Analog Scale (9, 27.3%), and the Wong-Baker FACES Scale (3, 9.1%). Use of locally administered liposomal bupivacaine was associated with improved donor site pain scores, reduced opioid consumption, and shorter length of stay. Alternative interventions exhibited variable efficacy.ConclusionsAcross the available evidence, despite notable variations in bone graft harvest techniques, intraoperative medication dosages, and pain assessment methods, locally administered liposomal bupivacaine was associated with favorable donor site pain control. The significant heterogeneity in the documentation of postoperative pain highlights the need for standardized pain assessment protocols to reliably assess the relative efficacy of donor site pain control strategies for secondary ABG.
PMID: 42563223
ISSN: 1545-1569
CID: 6070856
Does American Cleft Palate Craniofacial Association Cleft Team Accreditation Address Cleft Burden? A National Analysis
Pullmann, Dominika; Groysman, Leya; Kantar, Rami; Rivera, Lucas Perez; Flores, Roberto L
National efforts promoting high-quality cleft care rely on accreditation by the American Cleft Palate-Craniofacial Association (ACPA), though accreditation does not account for regional disease burden. Using U.S. natality and global health datasets (2014-2021), cleft incidence, prevalence, and disability-adjusted life years (DALYs) were compared with trends in ACPA accreditation. While births and cleft incidence declined nationally, accreditation expanded substantially. Conversely, prevalence and DALYs rose regionally without corresponding increases in accredited centers. Several states demonstrated discordant trends between burden and access. These findings suggest misalignment between accredited cleft care availability and evolving geographic disease burden, underscoring the need for data-driven resource planning.
PMID: 42340253
ISSN: 1545-1569
CID: 6055752
Caregiver Experiences With Infant PLANA Therapy for Cleft Lip and/or Palate: A Cross-Sectional Survey Study
Ricke, Chloe; Perez Rivera, Lucas R; Staffenberg, David A; Flores, Roberto L; Shetye, Pradip R
ObjectiveTo evaluate caregiver experiences with presurgical lip, alveolus, and nose approximation (PLANA) therapy, including adherence, burden, support, and perceived effectiveness in infants with cleft lip and/or palate.DesignCross-sectional survey study using an anonymous, voluntary questionnaire administered via Research Electronic Data Capture. Descriptive statistics were used to summarize responses, and qualitative responses were analyzed for common themes.SettingSingle tertiary care academic institution.Patients, ParticipantsCaregivers of infants with cleft lip and/or palate undergoing PLANA therapy were identified through institutional records. Of 48 eligible caregivers, 23 unique responses were included.InterventionsPLANA therapy utilizing the NoseAlign device with concurrent lip taping, applied at home with periodic clinical follow-up.Main Outcome Measure(s)Caregiver-reported adherence, training satisfaction, infant tolerance, caregiver burden, perceived support, and perceived effectiveness.ResultsCaregivers reported high satisfaction with training (73.9% very satisfied) and high adherence, with 87.0% reporting consistent use and 100% reporting daily wear. Most reported no feeding interference (86.4%) and good infant tolerance (73.9% comfortable or very comfortable). Caregiver burden was low, with 60.9% reporting minimal impact on daily routines and 78.3% reporting confidence in application. Perceived support from the medical team was uniformly high (100%). Overall, 90.9% were satisfied with outcomes, and 95.7% would recommend PLANA therapy.ConclusionsPLANA therapy demonstrates high caregiver satisfaction, strong adherence, and favorable perceived outcomes. Its simplified design may reduce caregiver burden while maintaining effectiveness. Further studies are needed to evaluate long-term outcomes and cost-effectiveness.
PMID: 42360073
ISSN: 1545-1569
CID: 6056452
An Analysis of Predictors of Early Morbidity and Mortality in Infants with Robin Sequence
Lisk, Rebecca C; Perez, Lucas R; Kantar, Rami S; Flores, Roberto L
ObjectiveTo assess the incidence of Robin Sequence in the United States and evaluate predictors of early morbidity and mortality.DesignRetrospective cohort study.SettingEpic Cosmos database.Patients, ParticipantsPatients with Robin Sequence diagnosed within the first year of life from January 2015 to December 2024.InterventionsVariables including prenatal drug exposure (PDE), prematurity, intrauterine growth restriction (IUGR), concomitant airway diagnoses, genetic syndromes, and anomalies of the cardiopulmonary, gastrointestinal, or central nervous system (CNS) were captured.Main Outcome Measure(s)Incidence across a 10-year period and associations with admission to the neonatal intensive care unit (NICU) and length of stay (LOS), 30-day readmission and ED visit, and one-year mortality through a multivariate logistic regression.Results3863 patients were identified, for an incidence of 1 in 3713 live births. NICU admission was significantly associated with PDE, prematurity, IUGR, tracheomalacia, laryngomalacia, cleft palate, and presence of a cardiopulmonary or CNS anomaly. NICU LOS was associated with prematurity, bronchomalacia, and the presence of a gastrointestinal anomaly. 30-day readmission was associated with PDE, prematurity, tracheomalacia, laryngomalacia, cleft palate, cardiopulmonary anomalies, and CNS anomalies. 30-day ED visit was associated with prematurity, tracheomalacia, cleft palate, cardiopulmonary anomalies, and CNS anomalies. One-year mortality was associated with prematurity, IUGR, cardiopulmonary anomalies, and CNS anomalies.ConclusionsSignificant associations were identified between morbidity and mortality and perinatal factors, concomitant airway diagnoses, and the presence of cardiopulmonary and CNS anomalies. These findings underscore the importance of an early comprehensive evaluation for patients with Robin Sequence.
PMID: 42294976
ISSN: 1545-1569
CID: 6049422
Adverse Outcomes After Mandibular Distraction Osteogenesis in Robin Sequence
Perez Rivera, Lucas R; Lisk, Rebecca C; Kantar, Rami S; Flores, Roberto L
Mandibular distraction osteogenesis (MDO) is a common procedure used to correct upper airway obstruction in patients with Robin sequence. However, analysis of predictors of adverse outcomes after MDO has relied on small single-institution cohorts. This retrospective cohort study leveraged the Epic Cosmos multicenter database to evaluate predictors of morbidity and mortality in patients with Robin sequence undergoing MDO from January 2015 to December 2024. A multivariable logistic regression was used to evaluate associations between perinatal factors, airway anomalies, genetic syndromes, and congenital anomalies affecting the cardiopulmonary, gastrointestinal and central nervous system (CNS), and postoperative outcomes including 1-year mortality, tracheostomy, intensive care unit (ICU) admission within 30 days, 30-day hospital readmission, 30-day emergency department visit, ICU length of stay (LOS), and overall hospital LOS. Across a total of 685 patients, CNS anomalies were statistically significantly associated with 1-year mortality; cardiopulmonary anomalies and bronchomalacia were predictive of tracheostomy; tracheal stenosis was associated with ICU admission; CNS anomalies were associated with 30-day emergency department visit; and no variables were significantly associated with 30-day readmission. Age at surgery was inversely associated with longer ICU LOS and overall LOS, whereas prematurity, prenatal drug exposure, gastroesophageal reflux, and CNS anomalies were associated with longer overall LOS. These results highlight the burden of comorbidities of the airway, cardiopulmonary system, and central nervous system for patients with Robin sequence undergoing MDO and can inform surgeons on the likelihood of adverse events based on the diagnostic characteristics of the patient.
PMID: 42228516
ISSN: 1536-3732
CID: 6043742
Socioeconomic Disparities in the Integrated Plastic Surgery Match
Perez Rivera, Lucas R; Flores, Roberto L; Weichman, Katie E
PMID: 42154476
ISSN: 1529-4242
CID: 6037992