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Accepted Manuscript: 10.1016/j.joms.2015.12.016
Accepted Manuscript: 10.1016/j.joms.2015.12.016
Accepted Manuscript: 10.1016/j.joms.2015.12.016
PII: S0278-2391(16)00008-2
DOI: 10.1016/j.joms.2015.12.016
Reference: YJOMS 57076
Please cite this article as: Dentino KM, Marrinan EM, Brustowicz K, Mulliken JB, Padwa BL, Pharyngeal
Flap is Effective Treatment for Post Maxillary Advancement Velopharyngeal Insufficiency in Patients
with Repaired Cleft Lip and Palate, Journal of Oral and Maxillofacial Surgery (2016), doi: 10.1016/
j.joms.2015.12.016.
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Kelley M. Dentino, D.M.D.;1 Eileen M. Marrinan, M.S., M.P.H.;2 Katherine Brustowicz;3 John
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B. Mulliken, M.D.;4 Bonnie L. Padwa, D.M.D., M.D. 5
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Address correspondence and reprint requests:
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Dr. Bonnie L. Padwa, DMD, MD
Department of Plastic and Oral Surgery
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Boston Children’s Hospital
300 Longwood Avenue, Boston, MA 02115
Phone: 617-355-6259
Fax: 617-738-1657
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E-mail: Bonnie.Padwa@childrens.harvard.edu
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Clinical Research Fellow, Harvard Medical School, Department of Plastic and Oral Surgery,
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Boston, MA
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Professor of Surgery, Harvard Medical School; Department of Plastic & Oral Surgery, Boston
Children’s Hospital, Boston, MA
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ABSTRACT
Purpose: Patients with repaired cleft lip and/or palate (CL/P) can develop velopharyngeal
insufficiency after Le Fort I maxillary advancement. The aim of this study was to evaluate
speech outcomes in patients who required a pharyngeal flap after Le Fort I maxillary
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advancement.
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Patients and Methods: Retrospective cohort study of all patients with repaired CL/P who
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velopharyngeal insufficiency (VPI). Subjects were included if they had outcome measures
documented at three time points: 1) pre-Le Fort I (baseline), 2) post-Le Fort I, and 3) post-
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pharyngeal flap. Outcome measures including speech characteristics (resonance, nasal emission,
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intra-oral pressure) and velopharyngeal function were evaluated on perceptual assessment by a
speech pathologist specializing in cleft care. Velopharyngeal closure was assessed with multi-
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statistics were summarized and continuous data expressed as mean ± standard deviation.
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Repeated measures ANOVA and paired samples t-test were used to measure changes in speech
outcome variables between time-points. All p-values were two-tailed and considered significant
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Results: There were 23 patients for analysis: 13 females (56.5%) and 10 males (43.5%). Two
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patients (9%) with cleft palate (CP) only; 9 (39%) with unilateral cleft lip and palate (CLP); and
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12 (52%) with bilateral CLP. Follow-up evaluations performed on average 12 months post-
decreased hypernasality, reduced nasal emission, and increased intra-oral pressure for consonant
production. Patients with repaired CL/P who had VPI after Le Fort I maxillary advancement
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surgery (p<0.001).
Conclusions: The superiorly-based pharyngeal flap is highly successful in correcting VPI after
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Introduction
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Children with cleft lip and/or palate (CL/P) can exhibit restricted maxillary growth
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following repair; either as an unwanted consequence of surgical intervention or part of an
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intrinsic abnormality of skeletal growth.1 Regardless of etiology, approximately 25-40% of
patients2 with repaired CL/P will require Le Fort I osteotomy and maxillary advancement after
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completion of facial growth.3 Although this procedure corrects skeletal malocclusion and
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improves nasolabial appearance, it also alters palatal position, increases pharyngeal volume, and
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advancement. However, patients who have had a palatoplasty are at a disadvantage because the
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short, scarred velum may be unable to accommodate to an increase in pharyngeal size.8,9 The
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reported incidence of velopharyngeal insufficiency (VPI) in patients with CL/P after maxillary
advancement varies widely, ranging from 0-84%.2,4,5,7 McComb and colleagues reported an
incidence of 23% in our unit and showed that patients with a short soft palate or increased
pharyngeal depth are at greatest risk for developing VPI after Le Fort I osteotomy, regardless of
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the extent of sagittal maxillary advancement.2 Several other studies have documented that there
Surgical correction of VPI can be achieved through a number of techniques including pharyngeal
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flap, sphincter pharyngoplasty, double-opposing Z-palatoplasty, and palatal muscular
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retropositioning.16 We favor a superiorly-based “tailored” pharyngeal flap.9 Pre-operative
nasopharyngoscopy and/or videofluoroscopy allow the surgeon to adjust the dimensions of the
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flap according to the valve closure pattern and width of the pharynx. Success rates in these
patients have been reported between 78-98% with a very low incidence of complications.6,9,17,18
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No studies have evaluated whether the superiorly-based flap is similarly effective for correcting
VPI in patients with CL/P who required maxillary advancement. The aim of this study is to
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investigate speech outcomes in patients with repaired CL/P who had a pharyngeal flap for VPI
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The purpose of this study was to evaluate speech outcomes in patients who required a pharyngeal
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flap after Le Fort I maxillary advancement. The investigators hypothesize that a superiorly based
insufficiency in patients with repaired CL/P. The specific aims of the study were: 1) measure
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speech and velopharyngeal function before and after maxillary advancement and 2) compare to
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Methods
Study design
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To address the research purpose, the investigators designed and implemented a retrospective
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cohort study of patients with repaired CL/P who had VPI following Le Fort I maxillary
advancement and were treated with a pharyngeal flap. This study was approved by the
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Institutional Review Board of the Committee on Clinical Investigation at Boston Children’s
Hospital and all research activities were conducted in accordance with the Declaration of
Helsinki.
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Subjects
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The study population was composed of all patients with repaired CL/P who had VPI after
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maxillary advancement and required a pharyngeal flap between 2008 and 2013. To be included
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in the study patients had to have speech evaluations at three time points: 1) prior to Le Fort I
(baseline), 2) post-Le Fort I, and 3) post-pharyngeal flap. Patients were excluded if they had
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insufficient records.
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Descriptive data were collected from the medical record including date of birth, gender, cleft side
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and severity, syndromic diagnosis, surgical history, and post-operative course. Speech
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closure, at three time points: 1) prior to Le Fort I (baseline), 2) post-Le Fort I, and 3) post-
pharyngeal flap.
Procedures
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All patients underwent a tailored, superiorly-based pharyngeal flap. Two patients with VPI
required post-Le Fort I osteotomy take-down of an existing flap that had previously been
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performed at another institution and a new flap. One surgeon (JBM) performed the pharyngeal
flap in all patients. The width of the flap (narrow, medium, wide, very wide) was tailored based
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the amount of lateral pharyngeal wall motion at the level of closure observed on pre-operative
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multi-view videofluoroscopy and the width of the nasopharynx. If the tonsils or adenoids were
performed at least 8 weeks prior to the pharyngeal flap. There were 2 patients who had an
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Speech pathologists specializing in cleft care performed perceptual evaluations of speech and
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velopharyngeal function. Speech was scored using the Pittsburgh Weighted Values for Speech
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correctable variables (Table 1): resonance (0-6, normal to severely hypernasal), visible and
audible nasal emission (0-4, absent to turbulent), and intraoral pressure for the production of
consonants (0-3, adequate to reduced). Patients were also asked whether their resonance posed a
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personal or social problem.20 Articulation errors and voice quality were assessed, but not
calculated in the final weighted score of speech outcomes, as they are not corrected by an
operation. The speech pathologist provided an overall diagnosis of velopharyngeal function as:
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Velopharyngeal function and valve closure patterns were further assessed by nasopharyngoscopy
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single otolaryngologist specializing in cleft care. The results of multi-view videofluoroscopy
were reviewed by a speech pathologist and the plastic surgeon (JBM). The data were recorded
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for velopharyngeal touch closure (consistent, intermittent, none), gap size (pinhole, small,
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moderate, large) and defect pattern (coronal, sagittal, circular). The presence of a Passavant ridge
or large adenoids contributing to closure was noted and the size and position of the tonsils was
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also documented. Lateral pharyngeal wall motion was recorded as the percentage of closure by
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medial movement toward the midline as determined by the vomer21,22 Palatal length was judged
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to be short, normal, or long relative to pharyngeal depth during full velar elevation by the speech
second operation was recommended. Time to most recent follow-up was documented and
symptoms, and need for secondary operation or revision (tonsillectomy, adenoidectomy, flap
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Variables
The primary predictor variables were classified as demographic variables, anatomic variables,
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and surgical variables. Demographic predictor variables included: age, gender, cleft type, and
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syndromic diagnosis. Anatomic predictor variables were evaluated prior to pharyngeal flap and
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(yes/no), velopharyngeal touch closure (consistent, intermittent, none), gap size (pinhole, small,
moderate, large), defect pattern (coronal, sagittal, circular), and lateral pharyngeal wall
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movement (poor, fair, good, excellent). Surgical predictor variables included presence of
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velopharyngeal insufficiency prior to maxillary advancement (yes/no) and pharyngeal flap width
The primary outcome variable was velopharyngeal function following maxillary advancement,
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as determined by the speech pathologist (Table 2). Secondary outcome variables included
Pittsburgh Scale scores and speech characteristics of resonance, nasal emission, and intraoral
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Statistical Analysis
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De-identified data were collected in Excel (Microsoft, Redmond, WA) and analyzed using SPSS
PC Version 19.0 (IBM SPSS Inc., Chicago, IL). Patient characteristics and descriptive statistics
were summarized and continuous data were expressed as a mean ± standard deviation. A paired t
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test compared pre and post-operative speech scores and we used a non-parametric Wilcoxon
signed rank test to compare pre- and post-operative Pittsburgh Scale scores. Bivariate non-
parametric analyses were used to identify relationships between predictor and outcome variables;
those with significance of p<0.15 were selected for inclusion in the regression analysis. A
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repeated measures ANOVA was used to measure changes in each speech outcome variable
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between all time-points while controlling for effect modifiers and covariates. All p-values were
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Results
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Subjects
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There were 64 patients with repaired CL/P who had a Le Fort I maxillary advancement (mean
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advancement 8mm + 2.2 mm [range 5-12 mm]) between 2008 and 2013, all by the senior author
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(BLP). Twenty-six patients (40.6%) had VPI after Le Fort I, including 20 patients who were
known to have borderline VPI prior to maxillary advancement and 2 patients who had a
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pharyngeal flap in place at the time of the procedure. Three subjects were excluded because of
insufficient records, leaving 23 patients for analysis: 13 females (56.5%) and 10 males (43.5%).
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Two patients (9%) had CP only; 9 (39%) had unilateral CLP; and 12 (52%) had bilateral CLP.
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Three of the subjects (13%) had a syndromic diagnosis: popliteal pterygium (n=1), Opitz G/BBB
(n=1), and Marshall (n=1). The mean age at Le Fort I osteotomy and maxillary advancement was
17.9 + 0.48 years and the mean age at pharyngeal flap was 19.2 + 0.56 years. The mean time
between Le Fort I and pharyngeal flap was 1.3 + .52 years (range 6 – 52 months).
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The mean scored speech variables and velopharyngeal function prior to Le Fort I osteotomy are
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shown in Tables 3 and 4. At baseline, Pittsburgh Scale scores varied from 0-11 (median=2). A
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majority of patients (n=17, 74%) were diagnosed as borderline sufficient/insufficient at baseline,
the others had normal velopharyngeal function (n=3) or gross VPI (n=3). Speech was typically
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characterized by intermittent-to-mild hypernasality (n=10, 45%) and/or visible nasal emission
(n=17, 77%). There were no patients with moderate to severe hypernasality or audible nasal
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emission and only 1 patient (5%) reported a social concern related to speech. Of 21 patients
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demonstrating articulatory errors, only 2 patients exhibited compensatory patterns related to VPI;
in 5 patients; all others demonstrated at least touch closure, often with intermittent leakage or
mild bubbling of secretions through a pinhole size defect (n=14). Average lateral wall movement
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towards the midline was 51+ 20%. Of note, most patients had a short palate (n=15), and 3
patients had a moderate to large adenoidal pad contributing to closure: 1 with no VPI (Pittsburgh
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Scale score=0) and 2 with borderline sufficiency (Pittsburgh scale scores=1,2). Six patients had a
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large Passavant ridge contributing to closure, 3 with borderline sufficiency (Pittsburgh Scale
scores 1-2) and 3 with borderline insufficiency (Pittsburgh Scale scores 3-6).
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Following maxillary advancement, all 23 patients were diagnosed with borderline to gross VPI
demonstrating a significant deterioration from baseline (p<0.001) (Table 4). Patients had speech
evaluation an average of 5.8 months following Le Fort I advancement. The increase in VPI and
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hypernasal resonance, increased nasal emission, weak intraoral pressure for consonants, and
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higher Pittsburgh Scale scores (median 6, range: 2-14) (Table 3).
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The speech characteristics that became worse following Le Fort I osteotomy included hypernasal
resonance (83%), nasal emission (73%), and inadequate pressure for oral consonants (57%). Six
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patients demonstrated compensatory articulation errors related to VPI.
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Nasopharyngoscopy and/or videofluoroscopy were performed to estimate lateral pharyngeal wall
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movement and level of velopharyngeal closure. Only 1 patient had consistent touch closure
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centrally, but still had air escape through a bilateral defect due to inadequate pharyngeal wall
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motion. Two patients had intermittent closure, with inconsistent air escape through a small or
moderate circular gap; 18 patients (78%) had obvious VPI, including 15 who had a small-to-
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large persistent central gap, 2 who had a widely open valve, and 1 patient with an existing
pharyngeal flap had open lateral ports with minimal pharyngeal wall movement. There were 11
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patients who were noted to have a prominent Passavant ridge near the level of closure. The mean
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Following the pharyngeal flap, the median time to post-operative assessment of speech and
velopharyngeal function was 5 months (range: 2-58). All patients had sufficient or borderline
sufficient velopharyngeal closure following pharyngeal flap (Table 4), representing a statistically
significant improvement (p<0.001) that was unchanged when controlling for effect modifiers
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and covariates (Table 5). Follow-up evaluations performed on average 12 months post-
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operatively also demonstrated a statistically significant improvement for all variables (Table 6),
including decreased hypernasality, reduced nasal emission, and increased intra-oral pressure for
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consonant production (Table 3), that was unchanged when controlling for covariates (Table 5).
The average Pittsburgh Scale score was also effectively corrected, with scores ranging from 0-3.
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Two patients had clinically insignificant findings: 1 had inconsistent mild hypernasality and 1
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had inconsistent visible nasal emission. There were 2 patients who had inconsistent hyponasal
resonance, however, they did not report any social concerns or difficulty with speech and were
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The mean time to most recent follow up was 2.1 years (range: 3 mo-10 years). There were no
patients who required a flap augmentation for persistent or relapsing VPI and none of the
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patients required a flap revision or take-down. Five patients reported sleep disordered breathing
apnea.
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Discussion
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The purpose of this study was to evaluate speech outcomes in patients who required a pharyngeal
flap after Le Fort I maxillary advancement. The investigators hypothesize that a superiorly based
insufficiency in patients with repaired CL/P. The specific aims of the study were to: 1) measure
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speech and velopharyngeal function before and after maxillary advancement and 2) compare to
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outcomes after pharyngeal flap.
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This study documents a superiorly-based pharyngeal flap to be effective treatment for patients
with CL/P who have VPI after Le Fort I maxillary advancement. Hyponasal speech indicates
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some degree of obstruction after pharyngeal flap;23 this was documented in 13% of our cohort,
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although in all cases it was minor and not bothersome to the patients. Overall, there were no
major complications requiring a second intervention, and 100% of the patients reported a
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satisfactory speech outcome - a measure that is arguably the most critical gauge of success.20
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We selected for a sample of patients who had persistent changes in velopharyngeal function
following Le Fort I osteotomy, and in whom we were able to quantify and objectively measure
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closure at baseline, with elements of mild hypernasal resonance, visible nasal emission, and
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and maxillary advancement are common, variable, and often they are transient.24,25 Among
individuals with CL/P, the implications of a change in speech are not trivial: Broder and Strauss
showed that patients with CL/P and speech difficulties are more vulnerable to psychosocial
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Previous studies have mentioned the benefits of pharyngeal flap following maxillary
advancement,5,7,28 but without quantifying outcomes. Similar successful outcomes have been
documented for non-syndromic CL/P patients who require pharyngeal flap for VPI after
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palatoplasty in childhood. Sullivan et al9 reported a 97% success rate and significant
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improvements (p<0.0001) in all outcome measures using the same technique.
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There are important anatomic and physiological differences between young patients who develop
VPI after primary palatal closure and adult patients who develop VPI as a consequence of
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sagittal advancement of the velar musculature.8,21,29-37 In childhood, deficient palatal length or
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insufficient palatal elevation may be masked by large adenoids.36-39 With growth, adenoidal
of the velopharyngeal port rotates to a more vertical position.21,34-37,40,41 A repaired palate is less
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able to accommodate these changes because of inadequate velar stretch42 and poorly formed
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velar eminence.43 As a result, contact with the pharyngeal wall occurs at a more posterior part of
the uvula compared to normal.8,29,36,44,45 While many adults with repaired CL/P can achieve
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functional borderline or touch closure, there may be subclinical defects such as a pinhole gap,
It has been suggested that adult patients may be predisposed to forming a prominent Passavant
ridge following Le Fort I advancement.47-50 There is speculation that this occurs because of
stretched muscle fibers that insert on the posterior pharyngeal wall.51,52 The function of a
Passavant ridge remains controversial. It is unclear whether the ridge develops following Le Fort
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I osteotomy or is only more obvious having previously been hidden below the level of closure
when viewed on nasopharyngoscopy. In our sample, the number of patients with a Passavant
ridge nearly doubled after Le Fort I (n=6 at baseline, and n=11 post-Le Fort I). Whatever the
anatomic basis of the ridge, it may be possible to take advantage of its position when locating the
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flap.16,47,53,54
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The strengths of this study include a single protocol with one surgeon performing the primary
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cleft repair and pharyngeal flap and a second surgeon doing the Le Fort I osteotomy. However,
there was more than one speech pathologist that evaluated these patients at all time points. The
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perceptual evaluations of speech and velopharyngeal function are objective measures that have
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some inherent subjectivity and it is possible that this introduced some bias into the data. This
study has several other weaknesses including its retrospective nature and relatively small sample
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size.
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In conclusion, a pharyngeal flap, tailored to lateral pharyngeal wall movement and pharyngeal
width, is an effective treatment for post-Le Fort I osteotomy VPI in patients with repaired CL/P.
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The risks are minimal and velopharyngeal gap defects can be corrected in patients with variable
velopharyngeal anatomy.
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Resonance
0 = Normal
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1 = Mildly hyponasal
2 = Mixed hyponasal/hypernasal
3 = Inconsistent mildly hypernasal
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4 = Consistent mildly hypernasal
5 = Moderately hypernasal
6 = Severely hypernasal
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Nasal emission
0 = Absent
1 = Visible by mirror exam
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2 = Audible
3 = Turbulent
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Intraoral pressure for consonant production
0= Adequate
1 = Inconsistently reduced
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2= Consistently reduced
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1) Sufficient
• normal-hyponasal resonance, absence of visible nasal emission, adequate intraoral pressure, no
personal/social problems
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• Pittsburgh Scale score = 0 (Sufficient)
2) Borderline sufficient
• inconsistent mildly hypernasal resonanace, visible nasal emission, adequate intraoral pressure,
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no personal/social problems
• Pittsburgh Scale score = 1-2 (Borderline sufficient)
3) Borderline insufficient
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• consistent hypernasal resonance, audible or turbulent nasal emission, inconsistent reduced
intraoral pressure, personal or social problem
• Pittsburgh Scale score = 3-6 (Borderline insufficient)
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4) Insufficient
• moderate or severely hypernasal resonance, audible or turbulent nasal emission, reduced
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intraoral pressure, personal/social problem
• Pittsburgh Scale score <7 = Insufficient
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Table 3. Scored Speech Variables for All Time Points. Expressed as mean + SD.
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Nasal Emission 0.98 ± 0.75 2.56 ± 1.21 0.77 ± 0.56
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Intraoral 0.16 ± 0.37 0.80 ± 0.41 0.00 ± 0.00
Pressure
Pittsburgh Scale 2.77 ± 2.84 7.13 ± 3.42 1.82 ± 1.17
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score
VPI 1.27 ± 0.94 2.83 ± 0.39 0.25 ± 0.27
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Borderline insufficient 30% 30% 0%
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Insufficient 13% 70% 0%
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Table 5. Bivariate correlations between predictor and outcome variables. Data given as p
values with significant values starred.
Outcome Variables
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Age 0.157 0.150 0.034* 0.014* 0.064
Predictor Variables
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Demographic
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Syndromic
Diagnosis 0.584 0.999 0.716 0.097 0.211
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Passavant
Ridge 0.199 0.221 0.375 0.835 0.409
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Touch
Anatomic Predictor Variables
Defect
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Lateral Wall
Movement 0.041* 0.683 0.599 0.685 0.515
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Palatal
Length 0.418 0.999 0.510 0.548 0.157
Sagittal
Variables
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Pharyngeal
Flap Width 0.022* 0.488 0.383 0.936 0.721
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Table 6. Improvement in All Outcome Variables after Pharyngeal Flap. Data given as p
values.
VPI <0.001
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Pittsburgh Scale Scores 0.001
Resonance 0.008
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Nasal Emission 0.003
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Intraoral Pressure <0.001
*Repeated measures ANOVA, adjusted for covariates age, gender, cleft type, pharyngeal flap width and
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lateral pharyngeal wall movement.
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