Dataset Information

Microbiome on the Bone-Anchored Hearing System: A Prospective Study.

ABSTRACT: 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.

SUBMITTER: Calon TGA

PROVIDER: S-EPMC6498861 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Microbiome on the Bone-Anchored Hearing System: A Prospective Study.

Calon Tim G A TGA Trobos Margarita M Johansson Martin L ML van Tongeren Joost J van der Lugt-Degen Malieka M Janssen A M L AML Savelkoul Paul H M PHM Stokroos Robert J RJ Budding Andries E AE

Frontiers in microbiology 20190426

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 ...[more]

PMID: 31105654

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Project description:OBJECTIVE:To study the effect of implanting the percutaneous bone-anchored hearing system (BAHS) itself and inflammation of the peri-abutment skin warrant clarification. In this study, we aimed to acquire further insight into the immune responses related to BAHS surgery and peri-implant skin inflammation. MATERIALS AND METHODS:During surgery and 12 weeks post-implantation, skin biopsies were obtained. If applicable, additional biopsies were taken during cases of inflammation. The mRNA expression of IL-1?, IL-6, IL-8, TNF?, IL-17, IL-10, TGF-ß, MIP-1?, MMP-9, TIMP-1, COL1?1, VEGF-A, FGF-2 TLR-2, and TLR-4 was quantified using qRT-PCR. RESULTS:Thirty-five patients agreed to the surgery and 12-week biopsy. Twenty-two patients had mRNA of sufficient quality for analysis. Ten were fitted with a BAHS using the minimally invasive Ponto surgery technique. Twelve were fitted with a BAHS using the linear incision technique with soft-tissue preservation. Five biopsies were obtained during episodes of inflammation. The post-implantation mRNA expression of IL-1? (P = .002), IL-8 (P = .003), MMP9 (P = .005), TIMP-1 (P = .002), and COL1?1 (P < .001) was significantly up-regulated. IL-6 (P = .009) and FGF-2 (P = .004) mRNA expression was significantly down-regulated after implantation. Within patients, no difference between post-implantation mRNA expression (at 12 weeks) and when inflammation was observed. Between patients, the expression of IL-1? (P = .015) and IL-17 (P = .02) was higher during cases of inflammation compared with patients who had no inflammation at 12-week follow-up. CONCLUSIONS:As part of a randomized, prospective, clinical trial, the present study reports the molecular profile of selected cytokines in the soft tissue around BAHS. Within the limit of this study, the results showed that 12 weeks after BAHS implantation the gene expression of some inflammatory cytokines (IL-8 and IL-1?) is still relatively high compared with the baseline, steady-state, expression. The up-regulation of anabolic (COL1?1) and tissue-remodeling (MMP-9 and TIMP1) genes indicates an ongoing remodeling process after 12 weeks of implantation. The results suggest that IL-1?, IL-17, and TNF-? may be interesting markers associated with inflammation.

Project description:BackgroundBone-anchored hearing systems (BAHSs) are widely used for hearing rehabilitation and are indicated in cases of conductive and mixed hearing loss and in single-sided deafness. The Ponto system, that is one available option, has been on the market since 2009.Objective of reviewThe aim of this study is to systematically review the literature reporting on the Ponto system, with regard to audiological and surgical outcomes and patient's quality-of-life scores.Type of reviewA systematic literature search was performed in the PubMed database 2009-July 2019.Search strategySearch term: ((osseointegrated hearing aid) OR (bone conduction implant) OR (bone anchored hearing) OR BAHA OR BAHS OR BAHI). Pre-defined inclusion and exclusion criteria were applied.Evaluation methodEnglish-language articles reporting original clinical data (audiological, surgical or quality-of-life outcomes) on the Ponto system were included. Articles reporting on Ponto and another BAHS system where the results on Ponto constituted less than 50% of the patient population or including only results on testband or softband devices were excluded.ResultsAudiological outcomes were discussed in 20 publications. Improvement against the unaided thresholds was demonstrated. The functional improvement was on average 33.9 dB. The effective gain or remaining air-bone gap was on average 6.7 dB. All evaluated data showed aided speech reception thresholds significantly below normal speech level. Twenty-seven publications reported surgical and follow-up data for the Ponto system. Implant survival was 97.7%, adverse skin reactions (Holgers ≥ 2) were 5% across visits and 15% across patients. No complications were life-threatening, causing permanent disability/damage or requiring a hospitalisation. Five studies reported quality of life using the Glasgow benefit inventory, 98% reported an improvement when analysing the score on an individual level.ConclusionsThe outcomes of this systematic review confirm that percutaneous systems provide consistent audiological benefits and improved quality of life for patients. Further, the review demonstrates that the percutaneous systems are safe, with relatively low complication rates. Skin-related complications are the most common complication type and are experienced by approximately one patient out of seven, or in less than one of 20 follow-up visits.

Project description:PURPOSE:In this prospective clinical pilot study, abutments with different topologies (machined versus polished) were compared with respect to the clinical outcome and the microbiological profile. Furthermore, three different sampling methods (retrieval of abutment, collection of peri-abutment exudate using paper-points, and a small peri-abutment soft-tissue biopsy) were evaluated for the identification and quantification of colonising bacteria. METHODS:Twelve patients, seven with machined abutment and five with polished abutment, were included in the analysis. Three different sampling procedures were employed for the identification and quantification of colonising bacteria from baseline up to 12 months, using quantitative culturing. Clinical outcome measures (Holgers score, hygiene, pain, numbness and implant stability) were investigated. RESULTS:The clinical parameters, and total viable bacteria per abutment or in tissue biopsies did not differ significantly between the polished and machined abutments. The total CFU/mm2 abutment and CFU/peri-abutment fluid space of anaerobes, aerobes and staphylococci were significantly higher for the polished abutment. Anaerobic bacteria were detected in the tissue biopsies before BAHS implantation. Anaerobes and Staphylococcus spp. were detected in all three compartments after BAHS installation. For most patients (10/12), the same staphylococcal species were found in at least two of the three compartments at the same time-point. The common skin coloniser Staphylococcus epidermidis was identified in all patients but one (11/12), whereas the pathogen Staphylococcus aureus was isolated in five of the patients. Several associations between clinical and microbiological parameters were found. CONCLUSIONS:There was no difference in the clinical outcome with the use of polished versus machined abutment at 3 and 12 months after implantation. The present pilot trial largely confirmed a suitable study design, sampling and analytical methodology to determine the effects of modified BAHS abutment properties. LEVEL OF EVIDENCE:2. Controlled prospective comparative study.

Project description:PurposeTo investigate the molecular activities in different compartments around the bone-anchored hearing system (BAHS) with either electropolished or machined abutments and to correlate these activities with clinical and microbiological findings.Materials and methodsTwelve patients received machined or electropolished abutments after implant installation of BAHS. Peri-abutment fluid and tissue were collected from baseline to 12 months. Gene expression of cytokines and factors related to tissue healing and inflammation, regeneration and remodelling, as well as bacterial recognition were determined using quantitative-polymerase chain reaction (qPCR). The clinical status was evaluated using the Holgers scoring system, and bacterial colonisation was investigated by culturing.ResultsThe gene expression of inflammatory cytokines (IL-8, IL-1β, and IL-10) and bacteria-related Toll-like receptors (2 and 4) was higher in the peri-abutment fluid than at baseline and in the peri-abutment tissue at 3 and 12 months. Conversely, the expression of genes related to tissue regeneration (Coll1a1 and FOXO1) was higher in the tissue samples than in the peri-abutment fluid at 3 and 12 months. Electropolished abutments triggered higher expression of inflammatory cytokines (IL-8 and IL-1β) (in peri-abutment fluid) and regeneration factor FOXO1 (in peri-abutment tissue) than machined abutments. Several cytokine genes in the peri-abutment fluid correlated positively with the detection of aerobes, anaerobes and Staphylococcus species, as well as with high Holger scores.ConclusionThis study provides unprecedented molecular information on the biological processes of BAHS. Despite being apparently healed, the peri-abutment fluid harbours prolonged inflammatory activity in conjunction with the presence of different bacterial species. An electropolished abutment surface appears to be associated with stronger proinflammatory activity than that with a machined surface. The analysis of the peri-abutment fluid deserves further verification as a non-invasive sampling and diagnostic procedure of BAHS.

Project description:ObjectivesThe purpose of this study was to evaluate the benefits of bilateral implantation for bone-anchored hearing system (BAHS) users in terms of spatial resolution abilities and auditory memory for speech.DesignThis is a prospective, single-center, comparative, single-blinded study where the listeners served as their own control. Twenty-four experienced bone-anchored users with a bilateral conductive or mixed hearing loss participated in the study. After fitting the listeners unilaterally and bilaterally with BAHS sound processor(s) (Ponto 3 SuperPower), spatial resolution was estimated by measuring the minimum audible angle (MAA) to achieve an 80% correct response via a two-alternative-forced choice task (right-left discrimination of noise bursts) in two conditions: both sound processors active (bilateral condition) and only one sound processor active (unilateral condition). In addition, a memory recall test, the Sentence-final Word Identification and Recall (SWIR) test was performed with five lists of seven sentences for each of the two conditions (unilateral and bilateral). Self-reported performance in everyday life with the listener's own sound processors was also evaluated via a questionnaire (the abbreviated version of the Speech, Spatial and Qualities of Hearing scale).ResultsThe MAA to discriminate noise bursts improved significantly from 75.04° in the unilateral condition to 3.61° in the bilateral condition ( p < 0.0001). The average improvement in performance was 54.28°. The SWIR test results showed that the listeners could recall, on average, 55.03% of the last words in a list of seven sentences in the unilateral condition and 57.23% in the bilateral condition. While the main effect of condition was not significant, there was a significant interaction between condition and repetition (list), revealing a significantly higher recall performance in the bilateral condition than in the unilateral condition for the second repetition/list out of five (10.2% difference; p = 0.022). Self-reported performance with bilateral BAHS obtained via the Speech, Spatial and Qualities of Hearing scale questionnaire was, on average, 4.4 for speech, 3.7 for spatial, and 5.1 for qualities of hearing. There was no correlation between self-reported performance in everyday life and bilateral performance in the MAA test, while significant correlations were obtained between self-reported performance and recall performance in the SWIR test.ConclusionsThese results showed a large benefit in spatial resolution for users with symmetric BC thresholds when being fitted with two BAHS, although their self-reported performance with bilateral BAHS in everyday life was rather low. In addition, there was no overall benefit of bilateral fitting on memory for speech, despite observing a benefit in one out of five repetitions of the SWIR test. Performance in the SWIR test was correlated with the users' self-reported performance in everyday life, such that users with higher recall ability reported to achieve better performance in real life. These findings highlight the advantages of bilateral fitting on spatial resolution, although bilaterally fitted BAHS users continue to experience some difficulties in their daily lives, especially when locating sounds, judging distance and movement. More research is needed to support a higher penetration of bilateral BAHS treatment for bilateral conductive and mixed hearing losses.

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 ?m 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.

Dataset Information

Microbiome on the Bone-Anchored Hearing System: A Prospective Study.

Publications

Microbiome on the Bone-Anchored Hearing System: A Prospective Study.

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