Cranial Remodeling

Number: 0379

Policy

1. Aetna considers cranial remodeling bands (or helmets) as medically necessary orthoses for treatment of moderate-to-severe positional head deformities associated with premature birth, restrictive intra-uterine positioning, cervical abnormalities, birth trauma, torticollis (shortening of the sternocleidomastoid muscle) and sleeping positions in children when banding is initiated at 3 to 12 months of age and the following conditions are met:

   1. A 2-month trial of conservative therapy consisting of re-positioning the child's head such that the child lies opposite to the preferred position, has failed to improve the deformity and is judged to be unlikely to do so, and

   2. One of the following must be met:

      1. Anthropometric data (measurements used to evaluate abnormal head shape by measuring the distance in mm from one pre-designated point on the face or skull to another, comparing the right and left sides) verifies that a moderate-to-severe plagiocephaly is documented by a physician experienced in such measurement.  (Note: These measurements are generally obtained by the orthotist fitting the band or helmet).  The most significant measurements used in this initial evaluation are skull base asymmetry, cranial vault asymmetry, orbitotragial depth, and cephalic index.

         DIAGRAM:

         

         A difference of asymmetry greater than 6 mm between anthropometric measurements (see diagram above) in any of the anthropometric data in the first column of the following table warrants coverage of a trial of orthotic banding to correct the craniofacial deformity:

         Table: Anthropometric Data Measurements and Measures

         Anthropometric Data	Measurement	Measures
         Cranial base (sn-t on same side)	from right and left subnasal point (sn) to tragus (t)	measures maxillary depth or right and left morphological face height
         Cranial vault (fz R-euL, fz L-euR)	from frontozygomaticus point (fz) on one side of face to euryon (eu)	measures cranial vault asymmetry
         Orbitotragial depth (ex-t, R, L)	from exocanthion point (ex) to tragus (t)	measures orbito-tragion depth (exocanthion)

      2. For brachycephaly evaluation, a cephalic index of 2 standard deviations (SDs) below mean (head narrow for its length) or 2 SDs above mean (head wide for its length) warrants coverage of a trial of orthotic banding to correct the craniofacial deformity in a child after 4 months of age and before 12 months of age.  (Note: These measurements are generally obtained by the orthotist fitting the band or helmet).

         Table: Brachycephaly Evaluation - Measurements and Measures

         Brachycephaly Evaluation Data	Measurement	Measures
         Head width (eu - eu)	from euryon (eu) on one side of head to euryon (eu) on the other side	measures greatest transverse diameter or maximal head width
         Head length (g-op)	from glabella point (g) to opisthocranion (op)	measures maximal head depth or length

          

         Cephalic index = Head width (eu - eu) x 100 
                                            Head length (g - op) 

         Cephalic index equal to head width eu minus eu multiplied by 100 divided by head length g minus op

         Table: Cephalic Index for Male and Female and their age

         Sex	Age	-2 SD	-1 SD	Mean	+1 SD	+2 SD
         Male	16 days to 6 months	63.7	68.7	73.7	78.7	83.7
         Male	6 to 12 months	64.8	71.4	78.0	84.6	91.2
         Female	16 days to 6 months	63.9	68.6	73.3	78.0	82.7
         Female	6 to 12 months	69.5	74.0	78.5	83.0	87.5

          

      3. Infants who develop significant plagiocephaly secondary to a constant head position required for long-term hyperalimentation who do not respond to simple changing of the catheter location allowing the head to be re-positioned.
      4. Members with excess frontal bossing secondary to sagittal synostosis
      5. Premature infants with dolichocephalic head shape who have developed a mis-shapen head secondary to sustained head position.

      A second cranial remodeling band or helmet is considered medically necessary for children who met the aforementioned criteria at the initiation of therapy if the asymmetry has not resolved or significantly improved after 2 to 4 months such that the severity of head deformity indicates another orthosis and the orthosis becomes ill-fitting after attempts to adjust and leaves little or no room for new growth. A second orthosis may be medically necessary to prevent regression of head shape in very young infants (8 months or younger) who met the aforementioned criteria at the initiation of therapy, who have outgrown the initial orthosis, and have not developed midline head control, rolling, or sitting. Note: remodeling bands (or helmets) are contraindicated and considered not medically necessary after 2 years of age).

2. Aetna considers the use of a cranial remodeling band (or helmet) cosmetic for persons not meeting the afore-mentioned criteria. 

3. Aetna considers use of a cranial remodeling band (or helmet) medically necessary for infants with synostotic plagiocephaly to correct continued asymmetry following surgery (i.e., a trial of conservative therapy is not needed when the cranial remodeling band is used following surgery for synostotic plagiocephaly). 

   Aetna considers the use of a cranial remodeling band or helmet without surgery to correct asymmetry in infants with synostotic plagiocephaly as experimental and investigational; craniosynostosis that is not surgically corrected is a contraindication to use of cranial remodeling bands or helmets.
   
   Aetna considers pre-operative molding helmet therapy for the treatment of sagittal craniosynostosis experimental and investigational because the effectiveness of this approach has not been established.

4. Aetna considers the use of sleep positioning wrap for the treatment of infants with positional head shape deformities experimental and investigational because its effectiveness has not been established.

5. Aetna considers intra-operative indocyanine green angiography to evaluate scalp perfusion during cranial vault remodeling in infants experimental and investigational because the effectiveness of this approach has not been established.

6. Aetna considers distraction osteogenesis medically necessary for syndromic craniosynostosis -- Apert, Crouzon, and Pfeiffer syndromes (see CPB 0549 - Distraction Osteogenesis for Craniofacial Defects).

Note: Aetna considers cranial removeling helmets and bands contraindicated and not medically necessary in unshunted or uncontrolled hydrocephalus..

Background

Plagiocephaly (an asymmetrical head shape) is most often the result of an infant spending extended periods of time on their back, typically during sleep.  Plagiocephaly can also occur as a feature of other disorders (e.g., craniofacial disorders, torticollis, cervical anomalies) and is categorized as either positional or synostotic (premature union of cranial sutures).  Although 1 in 300 infants exhibit variable degrees of plagiocephaly, true sutural synostosis, which interferes with cranium development and may cause increased intra-cranial pressure, occurs in only 0.4 to 1 per 1,000 live births.

Positional plagiocephaly is treated conservatively and many cases do not require any treatment as the condition may resolve spontaneously when the infant begins to sit up.  When the deformity is moderate or severe and a trial of re-positioning the infant has failed, a pediatric neurologist, neurosurgeon or other appropriate specialist in craniofacial deformities may prescribe a cranial remodeling band to remodel the misshapen head. 

Cranial orthotics are designed to improve plagiocephaly without synostosis or deformational plagiocephaly, which is a condition found in infants whose heads show an asymmetrical flattening caused by uneven external pressures on the skull. There are two types of cranial orthotics: cranial bands and soft-shell helmets.

The headband or helmet is custom made and custom fitted to the infant’s head and is designed to actively guide the growth of the skull to a more normal shape. Orthotic management of plagiocephaly without synostosis is usually initiated between three and 18 months of age and continues for an average of four to six months. Both helmets and cranial bands are recommended to be worn 23 hours per day with an hour off for exercises and skin care. 

Examples of brands of cranial remodeling bands and helmets include the DOC BAND^®, Gillette Children's Craniocap, and the STARband^™ Cranial Headband.  Average treatment time with the cranial remodeling band or helmet is 4.5 months.

A systematic evidence review of cranial orthosis treatment for infant deformational plagiocephaly prepared for the UK National Health Services (NHS QIS, 2007) found no randomized controlled trials assessing the effectiveness of cranial orthoses for the treatment of deformational plagiocephaly were identified.  The assessment stated that no evidence-based conclusions can be reached on the effectiveness of cranial orthoses due to the limited methodological quality of the available trials.  "Further research in the form of a randomised controlled trial is needed to determine the true effectiveness of cranial orthoses."

While infants with positional plagiocephaly may be treated with head positioning and/or helmeting, the standard treatment for synostotic plagiocephaly (asymmetrical head caused by premature closure of the cranial sutures) is surgery.  There is some evidence suggesting that a cranial remodeling band (or helmet) may improve outcomes following surgery to treat synostotic plagiocephaly.  Seymour-Dempsey et al (2002) retrospectively reviewed the results of surgery alone (n = 6) versus surgery and post-operative banding (n = 15) in treating children diagnosed with sagittal synostosis.  The investigators reported that correction toward a normal cephalic index was seen in the banded group throughout the course of treatment, while this trend was not present in the non-banded group.

Cranial rmodeling bands and helmets are contraindicated in infants older than 24 months. The skulls of these children have finished growing and no longer have the pliability and plasticity necessary to create a change in shape.

In a randomized controlled trial, Hutchison et al (2010) examined the effectiveness of the Safe T Sleep positioning wrap in infants with positional head shape deformities. A total of 126 infants presenting to a plagiocephaly clinic were randomized to either positioning strategies or to positioning plus the use of a Safe T Sleep^™ positioning wrap.  Head shape was measured using a digital photographic technique, and neck function was assessed.  They were followed-up at home 3, 6 and 12 months later.  There was no difference in head shape outcomes for the 2 treatment groups after 12 months of follow-up, with 42 % of infants having head shapes in the normal range by that time; 80 % of children showed good improvement.  Those that had poor improvement were more likely to have both plagiocephaly and brachycephaly and to have presented later to clinic.  The authors concluded that most infants improved over the 12-month study period, although the use of a sleep positioning wrap did not increase the rate of improvement.

Larsen (2004) stated that a second orthosis is rarely required but could be used in very severe head deformations, unusual circumstances (illness-negated use or if the child has serious health and/or positioning issues), or unusually high expectations of the family.  The author noted that criteria for determining a second orthosis include the following:

• Despite every effort, the orthosis becomes ill-fitting or leaves little or no room for new growth;
• If age and severity indicate another orthosis and parents are willing to continue; and
• If prescribed for use as a continued post-operative adjunct or for preventative measures.

The American Academy of Orthotists and Prosthetists' draft consensus statement on "Orthotic management of deformational plagiocephaly (AAOP, 2004) stated that "very young infants who have not developed midline head control, rolling, or sitting, may require a second orthosis to prevent regression of the head shape".  The AAOP stated that a second orthosis is rarely required but may be used in cases of increased severity, extenuating circumstance (infant with multiple health issues), or a very young infant (less than 3 months).  Criteria for use of a second orthosis include ill-fitting orthosis after multiple attempts to adjust, age/severity indicators with a willingness to continue by the family, post-operative adjunct/ preventative measures.  The guideline also noted that termination of the orthotic treatment program is recommended, without weaning, when head shape falls within normal limits.  If unresolved torticollis exists or if sleeping patterns are poor (same side as flatness), use is continued for an additional 2 to 4 weeks.  Furthermore, unshunted or uncontrolled hydrocephalus as well as craniosynostosis are contraindications for cranial remolding orthosis.

Chan and colleagues (2013) noted that craniosynostosis results in characteristic skull deformations.  Correction of craniosynostosis has traditionally involved an open cranial vault remodeling (CVR) procedure.  A technique recently developed endoscope-assisted craniectomy (EAC) repair in conjunction with a post-operative molding helmet to guide cranial growth.  Few studies compared these 2 approaches to the treatment of the various forms of craniosynostosis.  These investigators presented a single institution's experience with open CVR and EAC.  This study was a retrospective review of 57 patients who underwent craniosynostosis repair by either the endoscope-assisted or open techniques; and compared operating room times, blood loss, volume of transfused blood, length of hospital stay, and overall costs.  The endoscopic technique was performed on younger children (4.7 months versus 10.6 months, p = 0.001), has shorter operating room times (2 hours 13 minutes versus 5 hours 42 minutes, p = 0.001), lower estimated blood loss (74.4 ml versus 280.2 ml, p = 0.001), less transfused blood (90.6 ml versus 226.9 ml), shorter hospital stays (1.2 days versus 4.9 days, p = 0.001), and decreased cost ($24,404 versus $42,744, p = 0.008) relative to the traditional open approach.  The authors concluded that issues with the endoscope-assisted procedure primarily concerned the post-operative helmet regimen, specifically patient compliance (17.1 % non-compliance rate) and minor skin breakdown (5.7 %).  The endoscope-assisted repair with post-operative helmet molding therapy was a cost-effective procedure with less operative risk and minimal post-operative morbidity.  This was a valuable treatment option in younger patients with compliant care-givers.

Vogel and associates (2014) stated that the surgical management of infants with sagittal synostosis has traditionally relied on open CVR techniques; however, minimally invasive technologies, including EAC repair followed by helmet therapy (HT, EAC+HT), is increasingly used to treat various forms of craniosynostosis during the 1st year of life.  These researchers determined the costs associated with EAC+HT in comparison with those for CVR.  They performed a retrospective case-control analysis of 21 children who had undergone CVR and 21 who had undergone EAC+HT.  Eligibility criteria included an age less than 1 year and at least 1 year of clinical follow-up data.  Financial and clinical records were reviewed for data related to length of hospital stay and transfusion rates as well as costs associated with physician, hospital, and outpatient clinic visits.  The average age of patients who underwent CVR was 6.8 months compared with 3.1 months for those who underwent EAC+HT.  Patients who underwent EAC+HT most often required the use of 2 helmets (76.5 %), infrequently required a 3ird helmet (13.3 %), and averaged 1.8 clinic visits in the first 90 days after surgery.  Endoscope-assisted craniectomy plus HT was associated with shorter hospital stays (mean of 1.10 versus 4.67 days for CVR, p < 0.0001), a decreased rate of blood transfusions (9.5 % versus 100 % for CVR, p < 0.0001), and a decreased operative time (81.1 versus 165.8 minutes for CVR, p < 0.0001).  The overall cost of EAC+HT, accounting for hospital charges, professional and helmet fees, and clinic visits, was also lower than that of CVR ($37,255.99 versus $56,990.46, respectively, p < 0.0001).  The authors concluded that EAC+HT were a less costly surgical option for patients than CVR.  Furthermore, EAC+HT were associated with a lower utilization of peri-operative resources.  The authors stated that these findings suggested that EAC+HT for infants with sagittal synostosis may be a cost-effective 1st-line surgical option.

Hinchcliff et al (2013) stated that the current treatment of craniosynostosis is open surgical excision of the prematurely fused suture and CVR.  Due to the change in skull morphology and the increase in volume, some tension on the skin flaps is noted with closure.  Although complete wound breakdown is rare, it can be a devastating complication.  These researchers presented their experience with the use of the SPY imaging system (Lifecell Corporation, Branchburg, NJ) to visualize and record blood flow within the flaps of a 1-year old patient with anterior plagiocephaly.  The authors concluded that intra-operative indocyanine green angiography has the potential to be a significant advantage in such cases, providing a safe and objective method to assess intra-operative scalp perfusion, allowing the surgeon to take additional measures to ameliorate any ischemic problems.

Xia et al (2008) reported on a systematic evidence review to compare molding helmet therapy with head repositioning therapy for infants with deformational plagiocephaly. The Cochrane Library and MEDLINE were searched using reported terms. Electronic searches were conducted of ISI Web of Science, Science Direct. Journals@Ovid and conference proceedings were screened. Studies that compared molding helmet therapy with head repositioning therapy for otherwise healthy infants with deformational plagiocephaly with or without torticollis were eligible for inclusion. Infants had to have received no prior treatment. Reasons for exclusion of identified studies included insufficient information about recruitment of samples and methods used to measure outcomes. The review assessed treatment success. Included studies compared molding with repositioning with and without physiotherapy or neck stretching. In most studies, the duration of treatment ranged from three to five months. All infants were under 12 months when treatment started; in most studies treatment started at five to eight months. Two reviewers independently selected studies. Seven cohort studies were included (n = 881). The number of children in each treatment group ranged from 10 to 176. Five prospective, one retrospective and one study with a prospective repositioning group and a retrospective molding group were included. All studies included consecutive infants. Flaws included allocation based on physician or patient preference, cross-over from repositioning to molding, inadequate details of co-interventions, lack of reporting of masked outcome assessment, molding offered to older or more severely affected infants and a high drop-out rate.  Five studies with comparable data reported that success rates were higher in infants treated with molding compared to repositioning therapy. Of the other two studies, the average treatment time for reposition was much greater than the duration of molding time and the other did not use the same anatomical landmarks to assess outcomes in both groups. The only study (n=335) for which the author felt able to calculate the magnitude to treatment effect reported that treatment success was significantly more common in the molding compared to the repositioning group; RR 1.3 (95 % confidence interval (CI): 1.2 to 1.4); NNT 5 (95 % CI: 4 to 7). Reasons for exclusion of other studies included inadequate data or information about treatments, significant measurement bias and recruitment only of children who failed repositioning. The authors concluded that there was considerable evidence that molding therapy may be more effective at reducing skull asymmetry than repositioning therapy in infants with deformational plagiocephaly. However, studies were potentially biased and more research was required. 

A critique of this systemic review stated that Xia et al’s conclusions that there was considerable evidence appeared inconsistent with the subsequent statement about potential biases in the included studies and a more cautious initial statement would appear to have been more appropriate (CRD, 2009).

Taylor et al (2015) reported long-term aesthetic outcomes with fronto-orbital advancement and CVR in treating unicoronal synostosis over a 35-year period.  These investigators performed a retrospective review on patients with isolated unicoronal synostosis from 1977 to 2012.  Demographic, pre-operative phenotypic, and long-term aesthetic outcomes data were analyzed with chi-squared and Fisher's exact test for categorical data and Wilcoxon rank-sum and Kruskal-Wallis rank for continuous data.  A total of 238 patients were treated; 207 met inclusion criteria.  None underwent secondary intervention for intracranial pressure.  At definitive intervention, there were 96 (55 %) Whitaker class I patients, 11 (6 %) class II, 62 (35 %) class III, and 6 (3 %) class IV.  Nasal root deviation and occipital bossing each conferred an increased risk of Whitaker class III/IV [odds ratios (OR), 4.4 (1.4 to 13.9), p = 0.011; OR, 2.6 (1.0 to 6.8), p = 0.049].  Patients who underwent bilateral CVR with extended unilateral bandeau were less likely Whitaker class III/IV at latest follow-up compared with those undergoing strictly unilateral procedures [OR, 0.2 (0.1 to 0.7), p = 0.011].  Over-correction resulted in decreased risk of temporal hollowing [OR, 0.3 (0.1 to 1.0), p = 0.05].  Patients with 5 years or more of follow-up were more likely to develop supraorbital retrusion [OR, 7.2 (2.2 to 23.4), p = 0.001] and temporal hollowing [OR, 3.7 (1.5 to 9.6), p = 0.006] and have Whitaker class III/IV outcomes [OR, 4.9 (1.8 to 12.8), p = 0.001].  The authors concluded that traditional fronto-orbital advancement and CVR appears to mitigate risk of intracranial pressure but may lead to aesthetic shortcomings as patients mature, namely fronto-orbital retrusion and temporal hollowing.

Van Wijk et al (2014) reported on the results of the first randomized controlled trial of helmet therapy in infants with positional skull deformation. The trial determined the effectiveness of helmet therapy for positional skull deformation compared with the natural course of the condition in infants aged 5-6 months. The investigators performed a pragmatic, single blinded, randomized controlled trial (HEADS, HElmet therapy Assessment in Deformed Skulls) nested in a prospective cohort study in 29 pediatric physiotherapy practices; helmet therapy was administered at four specialized centers. Study participants were 84 infants aged 5 to 6 months with moderate to severe skull deformation, who were born after 36 weeks of gestation and had no muscular torticollis, craniosynostosis, or dysmorphic features. Participants were randomly assigned to helmet therapy (n = 42) or to natural course of the condition (n=42) according to a randomization plan with blocks of eight. Six months of helmet therapy compared with the natural course of skull deformation. In both trial arms parents were asked to avoid any (additional) treatment for the skull deformation. The primary outcome was change in skull shape from baseline to 24 months of age assessed using plagiocephalometry (anthropometric measurement instrument). Change scores for plagiocephaly (oblique diameter difference index) and brachycephaly (cranioproportional index) were each included in an analysis of covariance, using baseline values as the covariate. Secondary outcomes were ear deviation, facial asymmetry, occipital lift, and motor development in the infant, quality of life (infant and parent measures), and parental satisfaction and anxiety. Baseline measurements were performed in infants aged between 5 and 6 months, with follow-up measurements at 8, 12, and 24 months. Primary outcome assessment at 24 months was blinded. The change score for both plagiocephaly and brachycephaly was equal between the helmet therapy and natural course groups, with a mean difference of -0.2 (95 % CI:-1.6 to 1.2, p = 0.80) and 0.2 (-1.7 to 2.2, p = 0.81), respectively. Full recovery was achieved in 10 of 39 (26 %) participants in the helmet therapy group and 9 of 40 (23 %) participants in the natural course group (odds ratio 1.2, 95 % CI:0.4 to 3.3, p = 0.74).  All parents reported one or more side effects.  The investigators concluded, based on the equal effectiveness of helmet therapy and skull deformation following its natural course, high prevalence of side effects, and high costs associated with helmet therapy, we discourage the use of a helmet as a standard treatment for healthy infants with moderate to severe skull deformation.

An UpToDate review on “Overview of craniosynostosis” (Buchanan and Hollier, 2015) states that “In most cases, positional plagiocephaly can be treated by change in positioning.  A custom-fitted helmet designed to relieve pressure on the flattened side is often used in severe cases (which are rare).  However, a single-blind trial has found no difference in outcomes, including change in skull shape (plagiocephaly or brachycephaly) and full recovery, at two years of age in 84 infants with moderate to severe positional skull deformation who were randomly assigned to helmet therapy or to no therapy (natural course of the condition).  In addition, a number of adverse effects were reported with helmet use, including skin irritation and parental difficulty in cuddling the infant.  The trial had several limitations, including the 21 percent participation rate and exclusion of the most severe cases of positional flattening.  Until further larger randomized trials that include patients with more severe positional plagiocephaly/brachycephaly are performed, we will continue to suggest helmet therapy for patients with severe or recalcitrant positional flattening”.

Utria and colleagues (2016) noted that due to the changing properties of the infant skull, there is still no clear consensus on the ideal time to surgically intervene in cases of non-syndromic craniosynostosis (NSC).  These investigators shed light on how patient age at the time of surgery may affect surgical outcomes and the subsequent need for reoperation.  They performed a retrospective cohort review for patients with NSC who underwent primary cranial vault remodeling between 1990 and 2013.  Patients' demographic and clinical characteristics and surgical interventions were recorded.  Post-operative outcomes were assessed by assigning each procedure to a Whitaker category.  Multi-variate logistic regression analysis was performed to determine the relationship between age at surgery and need for minor (Whitaker I or II) versus major (Whitaker III or IV) re-operation.  Odds ratios for Whitaker category by age at surgery were assigned.  A total of 413 unique patients underwent cranial vault remodeling procedures for NSC during the study period.  Multi-variate logistic regression demonstrated increased odds of requiring major surgical revisions (Whitaker III or IV) in patients younger than 6 months of age (OR 2.49, 95 % CI: 1.05 to 5.93), and increased odds of requiring minimal surgical revisions (Whitaker I or II) in patients older than 6 months of age (OR 2.72, 95 % CI: 1.16 to 6.41).  The authors concluded that timing, as a proxy for the changing properties of the infant skull, is an important factor to consider when planning vault reconstruction in NSC.  They stated that the data presented in this study demonstrated that patients operated on before 6 months of age had increased odds of requiring major surgical revisions.

Subgaleal Drain Placement After Primary Cranioplasty in Craniosynostosis:

Tong and associates (2015) stated that there is no published data addressing the use of post-operative subgaleal drains in patients undergoing primary cranioplasty for craniosynostosis.  These investigators conducted a retrospective chart review in this population of patients, comparing outcomes of those who received post-operative drains with those who did not.  They hypothesized that the subgaleal drains can significantly reduce post-operative facial edema and decrease the length of hospital stay.  These researchers conducted a retrospective chart review of all patients undergoing primary cranioplasty for craniosynostosis with subgaleal drain placement (May 2010 to March 2012).  A comparison group without drain placement was matched appropriately to establish a comparison of outcomes.  The authors examined if subgaleal drainage led to improvement in post-operative facial edema, reduced length of hospital stay, post-operative changes in hematocrit (Hct), and complication rates.  Of the 50 patients in this cohort, 25 patients had received subgaleal drains.  The mean length of stay was 2.4 versus 3.5 days for the respective drained and un-drained cohorts (p = 0.03).  There was no significant difference in the mean decline in Hct between drained and un-drained patients, with the mean Hct drop of 4.8 % versus 5.0 %, respectively (p = 0.83).  Post-operative seroma formation developed in 3 un-drained patients (17 %) versus none in the drained cohort (0 %).  Although subjective, drained patients were observed to achieve quicker resolution of facial swelling and earlier recovery of eye opening.  The authors concluded that there is clinical benefit in subgaleal drain placement as earlier resolution of post-operative facial edema and a significantly shortened length of hospital stay was found among the drained cohort.  They stated that future studies warrant prospective clinical trials to establish the safety and effectiveness of using subgaleal drains in cranial remodeling procedures of craniosynostosis.

Distraction Osteogenesis for Surgical Treatment of Craniosynostosis:

Mundinger and colleagues (2016) stated that distraction osteogenesis has been proposed as an alternative to cranial remodeling surgery for craniosynostosis, but technique descriptions and outcome analyses are limited to small case series.  These researchers summarized operative characteristics and outcomes of distraction osteogenesis and presented data comparing distraction osteogenesis to cranial remodeling surgery.  They performed a systematic review of the literature; descriptive analysis, operative technical data, outcomes, or post-operative complications of distraction osteogenesis for craniosynostosis were included.  A total of 1,325 citations were reviewed, yielding 53 articles and 880 children who underwent distraction osteogenesis for craniosynostosis.  Distraction plates were used in 754 patients (86 %), whereas springs were used for the remaining 126 patients (14 %).  Standard and spring distraction osteogenesis was reported to successfully treat the primary condition 98 % of the time.  Suboptimal results were reported in 11 patients (1.3 %), and minor complications were reported in 19.5 % of cases (n = 172).  Major complications were rare, occurring in 3.5 % of cases (n = 31), and included 2 reported deaths.  Absolute operative times and blood loss were marginally greater for cranial remodeling surgery cases, but the differences were not statistically significant.  The authors concluded that distraction osteogenesis is an effective cranial vault remodeling technique for treating craniosynostosis.  No statistical differences were found with respect to operative time, blood loss, need for transfusion, or intensive care unit resources compared with cranial remodeling surgery.  Moreover, they stated that outcome studies with longer follow-up periods specifically investigating cost, relapse, and reoperation rates are needed to effectively compare this treatment modality as an alternative to cranial remodeling surgery.  (Level of Evidence = 4)

Pre-Operative Molding Helmet Therapy for the Treatment of Sagittal Craniosynostosis:

The above policy is based on the following references: