Prospective 5 year outcomes of different implant designs and surgical techniques in 68 patients with bone anchored hearing implants.
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ABSTRACT:
SUBMITTER: Vijverberg MA
PROVIDER: S-EPMC10087793 | biostudies-literature | 2023 Jan
REPOSITORIES: biostudies-literature
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Prospective 5 year outcomes of different implant designs and surgical techniques in 68 patients with bone anchored hearing implants.
Vijverberg Maarten A MA Caspers Coosje J I CJI Kruyt Ivo J IJ Mylanus Emmanuel A M EAM Hol Myrthe K S MKS
Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery 20220917 1
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Project description:BackgroundThe aim of this study is to investigate the clinical effectiveness of Ponto in Korea, a recently released percutaneous bone-anchored hearing implant.Methods16 patients with single-sided deafness (SSD) and mixed or conductive hearing loss who underwent Ponto implantation from December 2018 to September 2020 were enrolled in the study. Puretone audiometry, the Korean version of the Hearing in Noise Test (K-HINT), sound localization test (SLT), and Pupillometry were performed pre- and three months post-operation. Standardized questionnaires, the Hearing Handicap Inventory for the Elderly (HHIE) and Speech, Spatial and Qualities of Hearing Scale (SSQ), were administered.ResultsThe mean age of subjects was 55.5 (range, 48-67) years. Four males and 12 females participated in the study. The mean puretone average was 73.17 dB hearing level (HL) before surgery and significantly improved to 36.72 dB HL three months after surgery. The mean word recognition score improved from 26.0% to 90.75% after implantation. In the case of K-HINT, there was a significant difference in summation (Z = -2.250, P = 0.024) and head shadow effects (Z = -3.103, P = 0.002). There was no significant difference in root mean square error degree (RMSE) and hemifield identification scores for SLT testing. Pupillometry was performed to measure listening effort and the results revealed that the degree of pupillary dilatation decreased under the condition of quiet, 0 dB signal to noise ratio (SNR) and 3 dB SNR. The total score for HHIE decreased significantly (Z = -3.130, P = 0.002) while the SSQ score increased significantly (Z = -2.216, P = 0.027).ConclusionsThe Ponto bone-anchored hearing system showed significant clinical benefit in Korean patients with conductive and mixed hearing loss and SSD.
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Project description:ObjectiveDescribe the feasibility and safety of completing bone-anchored hearing implants via the minimally invasive punch technique in the in-office setting.Study designThis single-institution case series included 20 patients who underwent in-office bone-anchored hearing implant placement under local anesthesia from 2018 to 2021.SettingVeterans Affairs Northern California Healthcare System.MethodsFollowing completion of the case series, patients were retrospectively surveyed regarding their satisfaction with this approach via a modified SSQ-8 (Surgical Satisfaction Questionnaire) to fit our purposes.ResultsA total of 23 implants were completed in the in-office setting on 20 patients. Intra- and postoperative complication rates, including skin changes, irritation, infection, and poor wound healing, were similar to or better than currently published complication rates in the literature. In addition, patients reported overwhelmingly positive responses on the SSQ-8, almost universally stating that they were "very satisfied" with their clinic experience.ConclusionThis case series suggests that it is feasible and safe to complete this procedure in the clinic under local anesthesia, but further prospective studies are needed to evaluate this in a more generalized population.
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Project description:Osseointegrated implants inserted in the temporal bone are a vital component of bone-anchored hearing systems (BAHS). Despite low implant failure levels, early loading protocols and simplified procedures necessitate the application of implants which promote bone formation, bone bonding and biomechanical stability. Here, screw-shaped, commercially pure titanium implants were selectively laser ablated within the thread valley using an Nd:YAG laser to produce a microtopography with a superimposed nanotexture and a thickened surface oxide layer. State-of-the-art machined implants served as controls. After eight weeks' implantation in rabbit tibiae, resonance frequency analysis (RFA) values increased from insertion to retrieval for both implant types, while removal torque (RTQ) measurements showed 153% higher biomechanical anchorage of the laser-modified implants. Comparably high bone area (BA) and bone-implant contact (BIC) were recorded for both implant types but with distinctly different failure patterns following biomechanical testing. Fracture lines appeared within the bone ~30-50 μm from the laser-modified surface, while separation occurred at the bone-implant interface for the machined surface. Strong correlations were found between RTQ and BIC and between RFA at retrieval and BA. In the endosteal threads, where all the bone had formed de novo, the extracellular matrix composition, the mineralised bone area and osteocyte densities were comparable for the two types of implant. Using resin cast etching, osteocyte canaliculi were observed directly approaching the laser-modified implant surface. Transmission electron microscopy showed canaliculi in close proximity to the laser-modified surface, in addition to a highly ordered arrangement of collagen fibrils aligned parallel to the implant surface contour. It is concluded that the physico-chemical surface properties of laser-modified surfaces (thicker oxide, micro- and nanoscale texture) promote bone bonding which may be of benefit in situations where large demands are imposed on biomechanically stable interfaces, such as in early loading and in compromised conditions.
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Project description:ObjectiveTo compare 6-months outcomes of the modified minimally invasive Ponto surgery (m-MIPS) to both the linear incision technique with soft tissue preservation (LIT-TP), and original MIPS (o-MIPS) for inserting bone-anchored hearing implants (BAHIs).Study designExploratory pilot study with one test group and two historical control groups.SettingTertiary referral center.PatientsIn the test group, 24 patients (25 implants) were prospectively included. Each control group comprised 25 patients (25 implants) who participated in previously conducted clinical trials.InterventionsThe test group received a BAHI using m-MIPS. The two control groups underwent surgery using the LIT-TP and o-MIPS, respectively.Main outcome measuresImplant survival, implant stability, and surgery-related variables were compared between the test and control groups. Soft tissue status, skin sensibility, and subjective numbness were compared between m-MIPS and LIT-TP only.ResultsImplant survival was comparable between m-MIPS and LIT-TP, whereas implant stability measurements were slightly lower for m-MIPS. M-MIPS resulted in comparable adverse skin reactions and skin sensibility, significantly reduced surgical time and slightly improved subjective numbness, compared with LIT-TP. Between m-MIPS and o-MIPS, no statistically significant differences in implant survival, implant stability and surgical time were observed.ConclusionsA trend toward lower implant loss rates after m-MIPS was observed, when compared with o-MIPS. M-MIPS seems to be a good alternative to LIT-TP for inserting BAHIs, since most clinical outcomes were either comparable or slightly better for m-MIPS. Upon deciding on which technique to use, larger studies on implant survival should be performed. Furthermore, other aspects such as costs, training aspects and surgical experience should be evaluated.
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Project description: Not available
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Project description:BackgroundSince the introduction of bone-anchored hearing aids (BAHAs) in the 1980s, the practices of surgeons who implant these hearing aids have become varied; different indications and surgical techniques are utilized depending on the surgeon and institution. The objective of the current study is to describe the clinical and surgical practices of otolaryngologists in Canada who perform pediatric BAHA operations.MethodsA detailed practice questionnaire was devised and sent to all members of the Canadian Society of Otolaryngology-Head and Neck Surgery. Those who performed pediatric BAHA surgeries were asked to participate.ResultsTwelve responses were received (response rate of 80%). All of the respondents identified congenital aural atresia to be an indication for pediatric BAHAs. Other indications were chronic otitis externa or media with hearing loss (92%), allergic reactions to conventional hearing aids (75%), congenital fixation or anomaly of ossicular chain (67%), and unilateral deafness (25%). Minor complications, such as skin reactions, were reported in 25% of cases, while major complications were very rare. There was great variability with regards to surgical techinque and post-operative management. The extent of financial support for the BAHA hardware and device also varied between provinces, and even within the same province.ConclusionThere is a lack of general consensus regarding pediatric BAHA surgeries in Canada. With such a small community of otolaryngologists performing this procedure, we are hopeful that this survey can serve as an impetus for a national collaboration to establish a set of general management principles and inspire multi-site research ventures.
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Project description:The bone-anchored hearing system (BAHS) has evolved to a common treatment option for various types of hearing revalidation. The BAHS consists of an implant in the skull that breeches the skin. Soft tissue reactions are a common complication associated with BAHS and are generally poorly understood. This study aims to investigate the influence of BAHS and associated skin reactions around the implant. A total of 45 patients were prospectively followed from implantation up to at least 1 year. Swabs were obtained at baseline, 12 weeks follow-up and during cases of inflammation (Holgers score ≥2). The microbiota was assessed using IS-proTM, a bacterial profiling method based on the interspace region between the 16S-23S rRNA genes. Detection of operational taxonomic units, the Shannon Diversity Index, sample similarity analyses and Partial Least Squares Discriminant Analysis (PLS-DA) were employed. Staphylococcus epidermidis, Streptococcus pneumoniae/mitis, Propionibacterium acnes, Staphylococcus capitis, Staphylococcus hominis, Bifidobacterium longum, Haemophilus parainfluenzae, Lactobacillus rhamnosus, Bordetella spp., Streptococcus sanguinis, Peptostreptococcus anaerobius, Staphylococcus aureus, Lactococcus lactis, Enterobacter cloacae, and Citrobacter koseri were the most commonly found bacterial species. S. pneumoniae/mitis was significantly more often observed after implantation, whereas P. acnes was significantly less observed after implantation compared with baseline. The relative abundance of S. epidermidis (17%) and S. aureus (19.4%) was the highest for the group of patients with inflammation. The Shannon Diversity Index was significantly increased after implantation compared with pre-surgical swabs for Firmicutes, Actinobacteria, Fusobacteria, Verrucomicrobia (FAFV), but not for other phyla. When combining all phyla, there was no significant increase in the Shannon Diversity Index. The diversity index was similar post-surgically for patients experiencing inflammation and for patients without inflammation. With a supervised classifier (PLS-DA), patients prone to inflammation could be identified at baseline with an accuracy of 91.7%. In addition, PLS-DA could classify post-surgical abutments as non-inflamed or inflamed with an accuracy of 97.7%. This study shows the potential of using IS-proTM to describe and quantify the microbiota associated with the percutaneous BAHS. Furthermore, the results indicate the possibility of an early identification of patients susceptible to adverse skin reaction following implantation. Both S. aureus and S. epidermidis should be considered as relevant bacteria for BAHS-associated inflammation.
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Project description:Titanium implants are frequently applied to the bone in orthopedic and trauma surgery. Although these biomaterials are characterized by excellent implant survivorship and clinical outcomes, there are almost no data available on the initial protein layer binding to the implant surface in situ. This study aims to investigate the composition of the initial protein layer on endoprosthetic surfaces as a key initiating step in osseointegration. In patients qualified for total hip arthroplasty, the implants are inserted into the femoral canal, fixed and subsequently explanted after 2 and 5 min. The proteins adsorbed to the surface (the implant proteome) are analyzed by liquid chromatography-tandem mass spectrometry (LC-MS/MS). A statistical analysis of the proteins' alteration with longer incubation times reveals a slight change in their abundance according to the Vroman effect. The pathways involved in the extracellular matrix organization of bone, sterile inflammation and the beginning of an immunogenic response governed by neutrophils are significantly enriched based on the analysis of the implant proteome. Those are generally not changed with longer incubation times. In summary, proteins relevant for osseointegration are already adsorbed within 2 min in situ. A deeper understanding of the in situ protein-implant interactions in patients may contribute to optimizing implant surfaces in orthopedic and trauma surgery.
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