Implantation of the Bonebridge BCI 602 after Mastoid Obliteration with S53P4 Bioactive Glass: A Safe Method of Treating Difficult Anatomical Conditions-Preliminary Results.

Bartłomiej Król,Katarzyna Beata Cywka,Piotr Henryk Skarżyński,Magdalena Beata Skarżyńska

doi:10.3390/life11050374

Abstract

This study presents the preliminary results of a new otosurgical method in patients after canal wall down (CWD) surgery; it involves the implantation of the Bonebridge BCI 602 implant after obliteration of the mastoid cavity with S53P4 bioactive glass. The study involved eight adult patients who had a history of chronic otitis media with cholesteatoma in one or both ears and who had had prior radical surgery. The mean follow-up period was 12 months, with routine follow-up visits according to the schedule. The analysis had two aspects: a surgical aspect in terms of healing, development of bacterial flora, the impact on the inner ear or labyrinth, recurrence of cholesteatoma, and possible postoperative complications (firstly, after obliteration of the mastoid cavity with S53P4 bioactive glass, then after implantation). The second was an audiological aspect which assessed audiometric results and the patient’s satisfaction based on questionnaires. During the follow-up period, we did not notice any serious postoperative complications. Studies demonstrated significantly improved hearing thresholds and speech recognition in quiet and noise using the Bonebridge BCI 602. Data collected after six months of use showed improved audiological thresholds and patient satisfaction. Based on the preliminary results, we believe that the proposed two-stage surgical method using bioactive glass S53P4 is a safe and effective way of implanting the Bonebridge BCI 602 in difficult anatomical conditions. This makes it possible to treat a larger group of patients with the device.

Highlights

Patients with chronic otitis media with cholesteatoma are often treated with surgery: preserving of the posterior wall of the ear canal, and in advanced stages of the disease, radical mastoidectomy [1,2,3].Despite the appreciably smaller number of recurrences of cholesteatoma with the canal wall down (CWD) technique [4], epidermis and cerumen accumulate in the postoperative cavity [5], which requires frequent follow-up visits
Our clinic has been carrying out mastoid obliteration procedures with S53P4 bioactive glass, and eight adult patients were selected from this group
Our observations show that when drilling in bioactive glass, special care needs to be taken because in all cases the S53P4 bioactive glass was harder than bone and it is not easy to correctly prepare the site for implantation

Summary

Introduction

Patients with chronic otitis media with cholesteatoma are often treated with surgery: preserving of the posterior wall of the ear canal ( called canal wall up, CWU), and in advanced stages of the disease, radical mastoidectomy (canal wall down, CWD) [1,2,3].Despite the appreciably smaller number of recurrences of cholesteatoma with the CWD technique [4], epidermis and cerumen accumulate in the postoperative cavity [5], which requires frequent follow-up visits. 100 years, the problem of obliteration of the mastoid cavity has been a challenge for generations of otosurgeons [9]. Some years of experience indicate that bioactive glass (S53P4) is a proper for reconstructing the posterior wall of the ear canal and obliterating the postoperative cavity [16,17]. The same was true for improvement on the Reverberation surgery; t = 5.55; p = 0.001. The only exception was the mean score on the Aversiveness subscale, 5.28; p = 0.001. The only exception was the mean score on the Aversiveness subscale, which which was similar before surgery (M = 27.73; SD = 17.63) to that obtained after surgery was similar before surgery (M = 27.73; SD = 17.63) to that obtained after surgery

Methods

Results

Discussion

Conclusion