Pediatric and adolescent bone-anchored implant. Skin changes and complications

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Pediatric and adolescent bone-anchored

implant. Skin changes and complications

Implant zakotwiczony w kości u dzieci i młodzieży.

Zmiany skórne i powikłania

Amit Wolfovitz, Ariel Grobman, Hillary A. Snapp, Fred F. Telischi

Department of Otolaryngology – Head and Neck Surgery, University of Miami, Miller School of Medicine, Miami, Floryda, USA

Article history: Received: 01.03.2021 Accepted: 10.03.2021 Published: 21.03.2021

ABSTRACT: Objective: To assess the contributing factors for development of skin changes and local complications in the pediatric and adolescent population who underwent bone-anchored implantation (BAI).

Methods: Retrospective chart review of pediatric and adolescent patients (age 0–17 years) who underwent BAI for mixed hearing loss, conductive hearing loss, and single-sided deafness, at a tertiary care academic center. Demographic, clinical, implant type and surgical variables were collected and analyzed to identify their contribution to the development of skin changes and local complications.

Results: Thirty-nine BAI surgeries were performed in 28 subjects during the review period. The mean age of implantation was 10.5 ± 3.4 years (5–16 years). Skin changes and local complications occurred in 61.5% (24/39) of BAIs performed. In total, 75% (18/24) were attributed to local complications, and 25% (6/24) to skin changes. Revision surgery was required in 41.0% (16/39) of cases. The mean age upon revision with either skin changes or local complications, local complications alone, and skin changes alone was 14.6 ± 3.3 years (7.25–19), 13.4 ± 4.0 years (7.3–17), and 16.1 ± 1.2 years (13.8–17) respec- tively with no difference between the groups. Among implants with skin changes and local complications the abutment survival was found to be 33.3% at 6.75 years following implantation. No significant difference of demographic and clinical factors was noted when looking at cases with and without skin changes and local complications. Higher rates of skin changes and local complications were noted in two-stage techniques, non-linear incision and the use of absorbable sutures.

Conclusion: Fewer skin changes/local complications were observed with linear incision/punch technique, single stage, and non- -absorbable skin sutures. Abutment survival with skin changes and local complications plateaus at 6.75 years following implantation. The potential need for revision surgery and longer abutment replacement during puberty, presumably when scalp soft tissue thickens, should be considered prior to initial implantation of younger children, with information given to their care givers.

KEYWORDS: adolescent, bone-anchored implant, local complications, skin changes

STRESZCZENIE: Cel: Ocena czynników przyczyniających się do rozwoju zmian skórnych i powikłań miejscowych w populacji dzieci i młodzieży poddawanych zabiegom wszczepiania implantów słuchowych zakotwiczonych w kości (BAI).

Metody: Retrospektywny przegląd dokumentacji pacjentów pediatrycznych i pacjentów w okresie dojrzewania (wiek 0–17 lat) poddanych zabiegowi BAI w związku z niedosłuchem mieszanym, niedosłuchem przewodzeniowym i jednostronną głucho- tą w ośrodku akademickim trzeciego stopnia referencyjności. Zebrano dane demograficzne, dane kliniczne, informacje nt.

rodzaju implantu oraz zmienne związane z zabiegiem operacyjnym, które następnie poddano analizie pod kątem związku z powstawaniem zmian skórnych i powikłań miejscowych.

Wyniki: W badanym okresie wykonano 39 zabiegów BAI u 28 pacjentów. Średni wiek w momencie implantacji wynosił 10,5 ± 3,4 lat (5–16 lat). Do wystąpienia zmian skórnych i powikłań miejscowych doszło w przypadku 61,5% (24/39) zabiegów BAI.

Ogółem, powikłania miejscowe odpowiadały za 75% (18/24) przypadków, zaś zmiany skórne za 25% (6/24). Operacja rewizyjna była wymagana w 41,0% (16/39) przypadków. Średnia wieku w momencie operacji rewizyjnej w związku ze zmianami skórny- mi lub powikłaniami miejscowymi, samymi powikłaniami miejscowymi i samymi zmianami skórnymi wynosiła odpowiednio:

14,6 ± 3,3 lat (7,25–19), 13,4 ± 4,0 lat (7,3–17) i 16,1 ± 1,2 lat (13,8–17), bez różnic między grupami. Dla implantów związanych z wy- stąpieniem zmian skórnych i powikłań miejscowych przeżywalność łączników po okresie 6,75 lat od implantacji wyniosła 33,3%.

Nie stwierdzono istotnych różnic w zakresie czynników demograficznych i klinicznych między pacjentami, u których doszło do wystąpienia zmian skórnych i powikłań miejscowych a pacjentami, u których zmiany i powikłania nie wystąpiły. Wyższe odsetki zmian skórnych i powikłań miejscowych odnotowano dla zabiegów wykonywanych z wykorzystaniem: technik dwuetapowych, nacięć nieliniowych i szwów wchłanialnych.

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excluded if they did not have a minimum of 6 months postoperative follow-up, if they had a transcutaneous BAI system (i.e Baha attract system, Cochlear Corp; Sophono system, Medtronic), or in cases of temporal bone trauma or metabolic disease that might change the integrity of the implant.

Surgical technique

The incisional technique for patients undergoing BAI included either dermatome, linear incision or punch incision [10–12]. Subcutane- ous soft tissue reduction was used in some of the cases according to soft tissue thickness and surgical approach. Abutment exposure was performed via punch incision or through a standard skin incision. The surgical approach for abutment placement in our cohort was originally performed in two stages for all patients and was later modified to single stage, in line with modern surgical trends [13].

The abutment size was determined according to the implant’s ma- nufacturer guidelines with skin thickness measurement that were made using a 22-gauge needle inserted perpendicularly through the skin prior to local anesthetic injection. A sleeper implant was used in some of the pediatric cases (when skull thickness or bone quality were suspected to be inadequate, hence decreasing the chances for normal osseointegration). A combination of absorbable and non- -absorbable sutures were used to close subcutaneous and skin incision followed by Adaptic™ or Xeroform™ gauze placed underneath the healing cap to prevent post-operative hematoma.

Variables

Primary outcome measures included post-operative documented skin changes and local complications. Local complications were defined according to the Holgers grading system [9], which includes skin inflammation and/or infection that occurred at least 3 months after the surgery (grade 0 – no skin reaction, grade 1 – redness and slight swelling, grade 2 – redness moist tissue and moderate swelling, grade 3 – redness moist tissue and moderate swelling and tissue granulation, and grade 4 – profound infection resulting in removal of the implant) whereas skin changes were categorized as skin overgrowth over the abutment, development of hypertrophic scar, or keloid without local inflammation and/or infection, that do not fit to any of the criteria listed in Holgers grading system. Other post-operative variables included osseointegration of abutment, failures of osseointegration resulting in loss of fixture or removal of fixture, or removal of abutment due to chronic/irresolvable skin complications. Demographic and clinical data were collected on all patients including age, gender, ethnicity, etiology, surgical indication, laterality, and Body Mass Index (BMI). For the purposes of this review BMI was categorized either as

ABBREVIATIONS

BAI – Bone-anchored implants BMI – Body Mass Index SD – standard deviation

INTRODUCTION

Bone-anchored implants (BAI) are US FDA-approved for the treatment of single-side deafness, conductive hearing loss, and mixed hearing loss in adults and children > 5 years of age [1–2]. Additional- ly, BAIs may serve as percutaneous fixation of an artificial auricular prosthesis in cases of severe auricular deformity (congenital/acqu- ired microtia, or anotia) (Fig. 1A.) [3–4]. Over time, new technology and surgical techniques have evolved in order to minimize surgical site skin and soft tissue reactions, and improve osseo-integration and stability of the implants [5–7]. Specifically, longer abutments with and without hydroxyapatite coating have been introduced in an attempt to improve soft tissue integration [8], while incision techniques, have become increasingly less invasive [6]. Despite published reports related to BAI skin complications, data are lacking regarding the use of newer and longer abutments in conjunction with minimally invasive techniques. Moreover, literature is usually focused on the local complications alone (commonly categorized according to Holgers grading system [9]). Nevertheless, quite often other skin changes are encountered that do not fit into this classic grading system, such as skin overgrowth over the abutment, development of hypertrophic scar, or keloid which interrupt the proper use of BAI. The objective of the present study was to review factors contributing to the development of skin changes and local complications in pediatric and adolescent population who have undergo- ne BAI and to discuss the natural history of cases with skin changes and local complications.

MATERIALS AND METHODS

Design and subjects

University of Miami Institutional Review Board (IRB) approval was obtained (University of Miami #20161215) and a retrospective chart review was performed to identify all pediatric patients (ages 0–17 years) who underwent surgical procedure for BAI between January 2010 and December 2016 (using Current Procedural Ter- minology [CPT] search: 69710, 69711, 69714, 69715, 69717, 69718, L8690, L8691, L8692, L8693, 69399, 69799, L8699). Surgical indi- cations included BAI for auricular prosthesis, conductive hearing loss, mixed hearing loss, and single-sided deafness. Subjects were

Wniosek: W przypadkach technik jednoetapowych, prowadzonych z użyciem nacięć liniowych/wycięć z zastosowaniem pun- cha i z wykorzystaniem szwów niewchłanialnych, obserwowano mniejszy odsetek zmian skórnych/powikłań miejscowych.

Czas przeżycia łącznika w przypadkach zmian skórnych i powikłań miejscowych sięga 6,75 lat od implantacji. Przed pierw- szym wszczepieniem implantu u młodszych dzieci należy rozważyć ewentualną potrzebę wykonania operacji rewizyjnej i wymiany łącznika na dłuższy w okresie dojrzewania, prawdopodobnie w czasie, gdy tkanka miękka skóry głowy ulegnie zgrubieniu. O ewentualności tej należy poinformować opiekunów dziecka.

SŁOWA KLUCZOWE: implant zakotwiczony w kości, młodzież, powikłania miejscowe, zmiany skórne

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normal [<25] or overweight [>25]). Surgical data collected included surgical approach, need for tissue debulking, implant fixture and abutment sizes, dural exposure, abutment exposure method (via incision vs. separated skin punch), number of surgical stages, use of back-up (i.e. sleeper) implant, and type of suture used.

Data was processed in Microsoft Excel (Microsoft®, Redmond, WA).

Cases were stratified first into groups with or without either skin changes or local complications, in order to identify factors that might contribute to their development.

Statistical analysis

Descriptive statistics are used to report demographic (e.g. age and gender) data. Quantitative data is presented as mean, standard deviation (SD) and range (minimum and maximum); qualitative data is presented as frequencies and percentages. The Shapiro- -Wilk test was employed in order to assess the normality of the data

distribution. Student’s T-test was used to compare age, and Fishe- r’s exact test was used to compare various demographic and surgical parameters of the groups with and without either skin changes or local complications. P values <0.05 were considered statistically significant. The Kaplan-Meier curve was constructed in order to assess the abutment’s survival rate (i.e. abutments which were not replaced with longer and/or hydroxyapatite-coated ones) with and without either skin changes or local complications. SPSS 24.0 software (SPSS Inc., Chicago, IL) was used for statistical analysis.

RESULTS

Twenty-eight children meeting inclusion criteria underwent unilateral or bilateral BAI surgery during the study period, i.e. from Ja- nuary 2010 to December 2016. A total of 39 implants were identified for retrospective analysis. The subjects ranged in age from 5 to 16 years of age with a mean age at time of implantation of 10.5

± 3.4 years. There were 16 (57.1%) females and 12 (42.9%) males, nine Fig. 1. (A) Bone-anchored implant for conductive/mixed hearing loss (white arrow) and two implants for auricular reconstruction (black arrows); (B) skin overgrowth without local

inflammation/infection; (C) osseointegration failure.

Tab. I. Demographic and clinical characteristics for 28 identified implants (N = 39) recipients.

Characteristics: value

Age upon implantation 10.5 ± 3.4 years (5–16)

Gender Male: 12; Female: 16

Side Right: 9; Left: 11; Bilateral: 8

Ethnicity Black: 3; White: 6; Hispanic: 19

BMI normal (≤24.9): 22; over-weight/obese (>25.0): 6

Etiology Microtia/atresia: 15; CHARGE association: 5; Other: 8

Indication Conductive/mixed hearing loss (C/MHL): 21; single side deafness: 5; auricular reconstruction (AR): 1; combined C/MHL & AR: 1

A B C

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A Kaplan-Mayer curve was constructed in order to assess the abutment’s survival rate with either skin changes or local complications or without. Among implants with either skin changes or local complications the abutment survival rate was found to be 33.3% (8/24) at 6.75 years following implantation. The mean age of implantation of these abutments was 8.9 ± 3.8 years (5.75–16). There was no significant difference in demographic, clinical, or surgical factors between cases with either skin changes or local complications who underwent abutment replacement compared to cases with either skin changes or local complications who did not undergo abutment replacement. No further abutment change was needed later than 6.75 years following implantation (Fig. 3.).

No significant differences in demographic and clinical factors (age, gender, ethnicity, etiology, surgical indication, laterality, and Body Mass Index) were noted between subjects when looking at cases with local complications alone (18/39 cases, 46.2%), as described by Holgers [9] classification. As far as surgical factors are concer- ned, two-stage technique and the use of absorbable sutures were significantly more common in the local complications alone group (18/39, Tab. III.).

In cases with either skin changes or local complications (24/39;

61.5%), no differences were noted in demographic or clinical factors (age, gender, ethnicity, etiology, surgical indication, laterality, and Body Mass Index) between cases with vs. without either skin changes or local complications. When looking at surgical factors, dermatome approach, the use of non-linear incision, two-stage technique, and the use of absorbable sutures were significantly more common in cases who had either skin changes or local complications (Tab. III.).

(32.1%) right ears and 11 (39.3%) left ears, and eight (28.6%) underwent bilateral implantations. Demographic and clinical data are summa- rized in Tab. I. Skin changes and local complications in combination occurred in 24/39 cases (61.5%, Tab. II., Fig. 1.). There were no cases of combined skin changes and local complications. Skin changes alone occurred in 6/39 cases (15.4%), skin overgrowth accounted for 4/6 cases and hypertrophic scar/keloid for 2/6 cases. Local complications were reported in 18/39 cases (46.2%). In local complications alone, 7/18 were classified as Holgers 1, 8/18 Holgers 2, and 3/18 Holgers 3, and none as Holgers 4. Failure of osseointegration occurred in 6/39 (15.4%). All of the failed cases had local complications defined according to Holgers grading system: 1 cases of grade 1, 3 cases of grade 2, and 2 cases of grade 3. The mean age of implanted cases who had implant failure was 9.8 ± 3.9 years (6–16).

Revision surgery was required in 16/39 cases (41.0%, Tab. II.). In all subjects requiring revision, a history of either skin changes or local complications was identified. Among the revised cases, longer abutment replacement accounted for 13/16 cases (seven cases had an increment of one size in their newly installed abutments’ length while another six cases had two sizes increment). Among the 13 replaced abutments eight were converted into longer hydroxyapatite-coated abutments which were not available upon their original implant surgery and five were converted into a longer not hydroxyapatite-coated abutment. Abutment replacement for local complications accounted for 8/13 cases, whereas for skin changes 5/13 cases (Tab. II.). The mean age of patients undergoing revision surgery for either skin changes or local complications was 14.6 ± 3.3 years (7.3–19), for local complications alone (10/16) 13.4 ± 4.0 years (7.3–19), for skin changes alone (6/16) 16.1 ± 1.2 years (13.8–17). There was no statistical difference between the groups (Fig. 2.).

Fig. 2. Mean age of implantation and revision.

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a crucial component of the BAI system, and result in inability to use the BAI as indicated. The use of the sound processor might be significantly impaired due to difficulty with its connection to the implant. Also, provided BAI systems rely on transmission of signal through vibratory output, these complications may result in attenuation or distortion of the signal.

Out of 16 revision surgeries that were performed for skin changes and local complications, 13/39 (33.3%) were done for replacement for longer abutments (either coated or non-coated with hydroxyapatite) a comparable value to previous studies [14]. Eight of the replaced abutments were of cases who had local complications and five had skin changes. When revision occurred due to local complication alone, the majority of revisions required two sizes increment in their abutment’s length, and hydroxyapatite- -coated abutment (which was readily available by the time of the revision surgery), whereas when revision occurred due to skin

DISCUSSION

Previously reported complication rates in children following BAI vary in the literature from 2.4% to 44% [14]. However, these reports focused solely on skin reactions categorized as a Holgers [9] classification ≥2. The present study demonstrated Holgers classification of ≥2 in 28.2% of the cases (11/39). Our study expanded on these reports combining Holgers classification [9] with skin changes such as skin overgrowth, scar hypertrophy, and keloid development.

Under this expanded classification, we found the complication rate to increase to 61.5% in children and adolescents (24/39).

Demographic and clinical factors (age at implantation, gender, ethnicity, etiology, surgical indication, laterality, and Body Mass Index) were not associated with a higher rate of either local complications alone or together with skin changes in the present study.

Previous studies demonstrated ethnic disparity in skin complications in adults post BAI [1].

When assessing the surgical factors, significantly fewer skin changes and local complications were demonstrated with non-dermatome technique (i.e. Linear incision or skin punch) approach. Strij- bos et al. found no association between the approach and the rate of soft tissue reaction in adults, though demonstrating more skin thickening with dermatome approach [10]. Additionally, significantly fewer local complications and significantly less either skin changes or local complications were seen with single-stage technique and avoiding the use of absorbable skin sutures.

Skin changes around the abutment, such as skin overgrowth and scar hypertrophy are not considered part of Holgers classification system, the most accepted system for grading local complication and inflammation post BAI surgery [9]. These distinct changes were observed in 15.4% of our cohort. While they are not local complications mandating immediate treatment (either conse- rvative or surgical) these skin changes may affect the abutment,

Tab. II. Skin changes and local complications, revision cases, and osseointegration failure.

Characteristic N (%) Revision

n (%) Replacement to longer abutment

upon revision n(%) Osseointegration

Failure (Fig. 1C.) n(%) Skin changes (6/39; 15.4%):

Skin overgrowth (Fig. 1B.) 4 (10.3%) 4 (10.3%) 3 (7.7%) [1HA] 0

Hypertrophic scar 2 (5.1%) 2 (5.2%) 2 (5.1%) 0

Local complications (18/39; 46.2%):

Holgers 1 7 (18.0%) 4 (10.3%) 3 (7.7%) [3HA] 1

Holgers 2 8 (20.5%) 3 (7.7%) 2 (5.1%) [2HA] 3 (7,7%)

Holgers 3 3 (7.7%) 3 (7.7%) 3 (7.7%) [2HA] 2 (5,1%)

Holgers 4 0 0 0 0

HA – Hydroxyapatite-coated abutment

0,0%

25,0%

50,0%

75,0%

100,0%

0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 5 5.5 6 6.5 7 7.5 8 8.5 9 9.5 10 YEARS POST IMPLANTATION

Either skin changes or local complications (n=24; 61.5%) No skin changes or local complications (n=15; 38.5%)

Fig. 3. Abutment’s survival rate with either skin changes or local complications vs. without skin changes or local complications.

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Limitations of this study include the relatively small number of cases and the retrospective nature of this study. Additionally, our institu- te is a tertiary referral center dealing with more complicated cases hence posing possible selection bias. The authors would also want to point at a relatively large amount of factors that were assessed, potentially increasing the chance of type 1 error, hence statistical significance should be evaluated with caution and the main empha- sis should be on the descriptive portion of statistics.

CONCLUSION

Fewer skin changes and local complications were seen with linear incision/punch technique, single stage, and non-absorbable skin sutures. The abutment survival with skin changes and local complications plateaus at 6.75 years following implantation. The potential need for revision surgery and longer abutment due to increased age and growth of scalp soft tissue thickness, should be considered prior to initial implantation of younger children, with information given to their caregivers.

FUNDING

Department of Otolaryngology – Head and Neck Surgery, Univer- sity of Miami, Miller School of Medicine, Miami, Florida.

changes alone the majority of the cases had only one size increment in their abutment’s length and non-coated abutment. It is worth mentioning though that most of the revisions due to skin changes in our cohort occurred prior to hydroxyapatite-coated abutment availability. Though there was no difference in the age of revision surgery between cases with skin changes alone (6/39, 16.1 ± 1.2 years [13.8–17]), local complications alone (10/39;

13.4 ± 4.0 years [7.3–17]), or either skin changes or local complications (16/39; 14.6 ± 3.3 years [7.3–19], Fig. 2.), the mean age of all these groups suggests the need to revise abutment as children go through puberty (defined as ages 8–13 years for females and 9–14 years for males) with associated scalp and soft tissue changes [15, 16]. As Fig. 3. demonstrates, only 33.3% of abutments in cases with skin changes and local complications

“survived” from the original surgery, 6.75 years following initial implantation (compared to 100% of abutments in cases without either skin changes or local complications).

Of interest, no additional abutment replacements were required following this replacement, most probably related to skin maturi- ty and overcoming the skin changes seen during puberty. Six implants (15.4%) in our series failed to osseointegrate, a comparable value to several previous studies [14, 17, 18]. Though higher than reported with new implant systems, this rate may be attributed to the heterogeneity of the implants used in the present study with different impact stability [14, 17, 18].

Tab. III. Factors affecting skin changes (SC) and local complication (LC).

Factor assessed With LC only

n = 18 Without LC

n = 21 P-value

(test performed)

Demographic and clinical NS

Surgical

Number of stages Single: 4; Two: 12 § Single: 12; Two: 7 § 0.04*

(Fisher’s exact)

Type of skin sutures Absorbable: 10;

Non-absorbable: 5 § Absorbable: 4;

Non-absorbable: 13 § 0.03*

(Fisher’s exact)

With either SC or LC

n = 24 Without SC/LC

n = 15 P-value

(test performed)

Demographic and clinical NS

Surgical approach Dermatome 11 Dermatome 1 0.013*

(Fisher’s exact)

Linear or punch incision: 9;

Non-linear incision: 11 § Linear or punch incision: 14;

Non-linear incision: 1 <0.01*

(Fisher’s exact)

Number of stages Single: 5; Two: 15 § Single: 11; Two: 4 <0.01*

(Fisher’s exact)

Type of skin sutures Absorbable: 12;

Non-absorbable: 5 § Absorbable: 2;

Non-absorbable: 13 <0.01*

(Fisher’s exact)

* Statistically significant (p < 0.05); § - data is missing for some of the cases

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Word count: 3201 Tables: 3 Figures: 3 References: 18 Access the article online: DOI: 10.5604/01.3001.0014.7908 Table of content: https://otorhinolaryngologypl.com/issue/13697

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Corresponding author: Amit Wolfovitz MD; Department of Otolaryngology – Head and Neck Surgery, University of Miami, Miller School of Medicine; 1200 NW 14^th Street, 5^th Floor, Miami, FL 33136, USA; Phone: +305 2436466; E-mail: Amit.wolfovitz@gmail.com

Cite this article as: Wolfovitz A., Grobman A., Snapp H.A., Telischi F.F.: Pediatric and adolescent bone- anchored implant. Skin changes and complications; Pol Otorhino Rev 2021; 10 (1): 1-8

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