Analyzing complications of minimally invasive pediatric cochlear implantation: A review of 248 implantations




Abstract


Purpose


This study aims to report the postoperative complications and management of cochlear implantation in pediatric patients at our institution. All procedures were carried out by a single surgeon utilizing minimally invasive techniques. The impact of past surgical history of tympanostomy tubes was also reviewed to access association with postoperative complications.


Materials and methods


All children receiving cochlear implants at our institution between April 2003 and October 2014 were reviewed. Complications were grouped into “major” and “minor” depending on degree of management and “immediate,” “early,” and “delayed” depending on time of presentation.


Results


In our series, 248 cochlear implants were placed into 141 children. The mean age at time of surgery was 4.8 years. The overall complication rate per ear was 16.5%, 5.2% being major and 11.3% being minor complications. Complications arose in the first 30 days following surgery in 8.4% of patients, with acute otitis media being the most common. A history of tympanostomy tubes did not impact complication rate. Excluding device failures, major complication rate was 2.4%. Hematoma was not encountered, and delayed seroma occurred in one patient.


Conclusion


Minimally invasive cochlear implantation carries a low complication rate. The most common major complication was intrinsic device failure, and the most common minor complication was acute otitis media. Past medical history of chronic otitis media with tympanostomy tube placement prior to cochlear implantation did not have a statistically significant impact on postoperative complication rates. Given the rarity of hematomas and seromas, pressure dressings appear to be unnecessary with this approach.



Introduction


Cochlear implantation (CI) is a well-established surgical intervention for the treatment of patients with sensorineural hearing loss (SNHL) . The prevalence of SNHL ranges from 1.0–1.7 cases per 1000 live births . While the benefits of unilateral versus bilateral implantation are debated, at our institution bilateral implants have become the preferred modality in children deemed appropriate candidates . CI provides the most benefit when carried out early in development, preferably around the age of 12 months .


The objective of this study is to examine the incidence of postoperative complications in pediatric patients receiving minimally invasive CI. Demographics, etiologies, and surgical techniques will be reported and analyzed to determine the relationship between these factors and surgical complications.





Methods



Population


All research was approved by the University of Mississippi institutional review board. Between April 2003 and October 2014, 156 children of varying demographics and SNHL etiologies underwent placement of 248 cochlear implants at our institution. Patients receiving traditional larger incision surgery or reimplantations of devices placed at other institutions were excluded. All operations were performed by a single attending surgeon (JDC) and resident assistant. Patients receiving bilateral implantation were classified as two distinct ears.



Surgical technique


A minimally invasive approach similar to that outlined by O’Donoghue was utilized . Monitoring leads for the Medtronic NIM Response® (Medtronic, Inc., Minneapolis, MN) are placed into the orbicularis oris and oculi muscles bilaterally. A small amount of hair is shaved behind each ear over implantation site. A four cm vertical incision site is marked posterior to the postauricular sulcus and infiltrated with local anesthetic with epinephrine. Templates are used to mark the position of the external processor and internal receiver. In cases of bilateral simultaneous implantation, the entire head is prepped preoperatively.


An incision is made and carried to level of the mastoid periosteum. A posteriorly based rectangular periosteal flap, essential for complete periosteal closure, is designed and elevated. A pocket to accommodate the receiver is elevated and a small recess is drilled into the skull for placement. A limited mastoidectomy is performed in the usual fashion. Since it was released the senior author has used the Visao® drill (Medtronic, Inc., Jacksonville, FL) with curved burs for the facial recess and cochleostomy ( Fig. 1 ). These burs have a non-rotating shaft that virtually eliminates the risk of heat transfer to the nerve and the curve allows easier middle ear visualization. The round window niche is then drilled and the scala tympani is entered through the round window or a separate cochleostomy. Overlying skin is retracted, and tie down sutures are secured at the hub of the implant ( Fig. 2 ). The facial recess and mastoid are then packed with gelfoam soaked in ofloxacin. An intraoperative x-ray is gathered to assure adequate electrode positioning. Glasscock® (Oto-Med, Inc., Lake Havasu City, AZ) ear dressings are used instead of pressure dressings. Generally, the patient is discharged the same day if the child is over 12 months and there are no other medical conditions that would warrant admission .




Fig. 1


Drill. Example of drill entry into for the facial recess and cochleostomy (Figure 1). These curved burs have a non-rotating shaft that minimizes heat transfer and provides maximal visualization.



Fig. 2


Retractors. Placement of retractors for easily visualization of cochlear implant hub.



Complication classification


Similar to the classification scheme offered in recent literature, postoperative complications were classified as either major or minor depending on extent of management . Minor complications were those that could be managed with outpatient therapy. Major complications were those considered to result in serious, potentially life-threatening conditions, such as those requiring intravenous (IV) antibiotics, or those requiring major surgical revision such as explantation or reimplantation. In cases of acute otitis media (AOM), which may or may not be related to the CI procedure, a post-operative timeframe of 30 days was set as the cutoff criteria to being attributed to a surgical complication. Additionally, complications were grouped according to time of presentation. Complications presenting within the first week were classified as immediate post-operative complications, those presenting from one week to 30 days early complications, and those presenting after 30 days delayed complications.



Tympanostomy tubes


Past surgical history was reviewed for tympanostomy tube placement. The patients were grouped accordingly to evaluate associations between tympanostomy tubes and post-operative complications of CI.





Methods



Population


All research was approved by the University of Mississippi institutional review board. Between April 2003 and October 2014, 156 children of varying demographics and SNHL etiologies underwent placement of 248 cochlear implants at our institution. Patients receiving traditional larger incision surgery or reimplantations of devices placed at other institutions were excluded. All operations were performed by a single attending surgeon (JDC) and resident assistant. Patients receiving bilateral implantation were classified as two distinct ears.



Surgical technique


A minimally invasive approach similar to that outlined by O’Donoghue was utilized . Monitoring leads for the Medtronic NIM Response® (Medtronic, Inc., Minneapolis, MN) are placed into the orbicularis oris and oculi muscles bilaterally. A small amount of hair is shaved behind each ear over implantation site. A four cm vertical incision site is marked posterior to the postauricular sulcus and infiltrated with local anesthetic with epinephrine. Templates are used to mark the position of the external processor and internal receiver. In cases of bilateral simultaneous implantation, the entire head is prepped preoperatively.


An incision is made and carried to level of the mastoid periosteum. A posteriorly based rectangular periosteal flap, essential for complete periosteal closure, is designed and elevated. A pocket to accommodate the receiver is elevated and a small recess is drilled into the skull for placement. A limited mastoidectomy is performed in the usual fashion. Since it was released the senior author has used the Visao® drill (Medtronic, Inc., Jacksonville, FL) with curved burs for the facial recess and cochleostomy ( Fig. 1 ). These burs have a non-rotating shaft that virtually eliminates the risk of heat transfer to the nerve and the curve allows easier middle ear visualization. The round window niche is then drilled and the scala tympani is entered through the round window or a separate cochleostomy. Overlying skin is retracted, and tie down sutures are secured at the hub of the implant ( Fig. 2 ). The facial recess and mastoid are then packed with gelfoam soaked in ofloxacin. An intraoperative x-ray is gathered to assure adequate electrode positioning. Glasscock® (Oto-Med, Inc., Lake Havasu City, AZ) ear dressings are used instead of pressure dressings. Generally, the patient is discharged the same day if the child is over 12 months and there are no other medical conditions that would warrant admission .




Fig. 1


Drill. Example of drill entry into for the facial recess and cochleostomy (Figure 1). These curved burs have a non-rotating shaft that minimizes heat transfer and provides maximal visualization.



Fig. 2


Retractors. Placement of retractors for easily visualization of cochlear implant hub.



Complication classification


Similar to the classification scheme offered in recent literature, postoperative complications were classified as either major or minor depending on extent of management . Minor complications were those that could be managed with outpatient therapy. Major complications were those considered to result in serious, potentially life-threatening conditions, such as those requiring intravenous (IV) antibiotics, or those requiring major surgical revision such as explantation or reimplantation. In cases of acute otitis media (AOM), which may or may not be related to the CI procedure, a post-operative timeframe of 30 days was set as the cutoff criteria to being attributed to a surgical complication. Additionally, complications were grouped according to time of presentation. Complications presenting within the first week were classified as immediate post-operative complications, those presenting from one week to 30 days early complications, and those presenting after 30 days delayed complications.



Tympanostomy tubes


Past surgical history was reviewed for tympanostomy tube placement. The patients were grouped accordingly to evaluate associations between tympanostomy tubes and post-operative complications of CI.





Results


A breakdown of demographics, SNHL etiology, and implant placement can be found in Tables 1 and 2 . One-hundred-eighty-four of the 248 cases were placed as part of bilateral approach, the remaining 64 were unilateral only. Of the bilateral implant cases, 82 were placed as part of a bilateral sequential implantation requiring two separate surgeries, and the remaining 102 were placed simultaneously in 51 surgical operations. Implants were placed in 141 right and 107 left ears. Cochlear Nucleus® devices accounted for the vast majority, 233 (94.0%) of the implantations. Thirteen (5.2%) of the implants were Med-el® and four (1.6%) were Advanced Bionics®. Overall, the 248 implants were evenly distributed among males and females. Ages ranged from 3 months and 14 days in a post-meningitic child to 18 years 8 months, with a mean age of 4 years and 9 months at time of surgery. Mean time of follow-up was 3.9 years. SNHL etiology is broken down by patient in Table 2 .



Table 1

Patient demographics and clinical characteristics by implant.




















































































Implants Placed (n = 248) # %
Sex of Patients
Males 124 50.0%
Females 124 50.0%
Bilateral 184 74.2%
Bilateral Simultaneous 102 41.1%
Bilateral Sequential 82 33.1%
Unilateral 64 25.8%
Placement
Right Ear 141 56.9%
Left Ear 107 43.1%
Brand of Implant
Cochlear 231 93.15%
Med-el 13 5.24%
Advanced Bionics 4 1.61%
Average Age at Time of Implantation 4 years 9 months
Oldest Age at Time of Implantation 18 years 8 months
Youngest Age at Time of Implantation 3 months 14 days
Average Time of Implant Follow-Up 3 years 11 months
Median Time of Implant Follow-Up 3 years 8 months

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Aug 23, 2017 | Posted by in OTOLARYNGOLOGY | Comments Off on Analyzing complications of minimally invasive pediatric cochlear implantation: A review of 248 implantations

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