Short‐term results from seventy‐six patients receiving a bone‐anchored hearing implant installed with a novel minimally invasive surgery technique

Johansson, Martina; Stokroos, Robert J.; Banga, Rupan; Hol, Myrthe K. S.; Mylanus, Emmanuel A. M.; Jones, H. Savage; Tysome, James R.; Vannucchi, Paola; Hof, Janny R.; Brunings, Jan Wouter; Tongeren, Joost van; Lutgert, R. W.; Banerjee, A.; Windfuhr, Jochen P.; Caruso, Antonio; Giannuzzi, Anna Lisa; Bordin, Silvana; Hanif, J; Schart-Morén, Nadine; Singam, Shyam; Jonhede, Sofia; Holmberg, Marcus; Cremers, C.W.R.J.; Hultcrantz, Malou

doi:10.1111/coa.12803

Cited by 33 publications

(48 citation statements)

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“…The implants were installed using the minimally invasive Ponto surgery (MIPS) technique. Here, the drilling and installation is performed through a biopsy incision, eliminating the need for a linear incision and exposure of the bone bed [ 22 , 23 ]. In brief, the main steps of the MIPS technique are: (1) the site for implant is estimated at 50–55 mm from the ear canal and skin thickness is determined prior to application of local or general anaesthetics; (2) a 5-mm punch biopsy is used for making a circular incision; (3) the cannula is inserted in the circular incision; (4) step-wise drilling is performed through the cannula; (5) the cannula is removed and the implant installed and, finally, (6) a soft healing cap is attached to the abutment and a suitable dressing is applied.…”

Section: Methodsmentioning

confidence: 99%

The clinical outcome and microbiological profile of bone-anchored hearing systems (BAHS) with different abutment topographies: a prospective pilot study

Trobos

Johansson

Jonhede³

et al. 2018

Eur Arch Otorhinolaryngol

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PurposeIn 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.MethodsTwelve 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.ResultsThe 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.ConclusionsThere 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 evidence2. Controlled prospective comparative study.Electronic supplementary materialThe online version of this article (10.1007/s00405-018-4946-z) contains supplementary material, which is available to authorized users.

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Section: Methodsmentioning

confidence: 99%

The clinical outcome and microbiological profile of bone-anchored hearing systems (BAHS) with different abutment topographies: a prospective pilot study

Trobos

Johansson

Jonhede³

et al. 2018

Eur Arch Otorhinolaryngol

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“…19,20 Surgical techniques included the linear incision technique with soft-tissue preservation 6,21 or the MIPS technique. 6,22 An elaborate description is provided in the protocol publication. 6 Briefly, in the control group, the linear incision technique with soft tissue preservation was performed.…”

Section: Methodsmentioning

confidence: 99%

Cytokine expression profile in the bone‐anchored hearing system: 12‐week results from a prospective randomized, controlled study

Calon

Tongeren

Omar

et al. 2018

Clin Implant Dent Rel Res

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ObjectiveTo 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 MethodsDuring 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‐1β, IL‐6, IL‐8, TNFα, IL‐17, IL‐10, TGF‐ß, MIP‐1α, MMP‐9, TIMP‐1, COL1α1, VEGF‐A, FGF‐2 TLR‐2, and TLR‐4 was quantified using qRT‐PCR.ResultsThirty‐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‐1β (P = .002), IL‐8 (P = .003), MMP9 (P = .005), TIMP‐1 (P = .002), and COL1α1 (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‐1β (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.ConclusionsAs 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‐1β) is still relatively high compared with the baseline, steady‐state, expression. The up‐regulation of anabolic (COL1α1) and tissue‐remodeling (MMP‐9 and TIMP1) genes indicates an ongoing remodeling process after 12 weeks of implantation. The results suggest that IL‐1β, IL‐17, and TNF‐α may be interesting markers associated with inflammation.

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“…Until now, a standardized method and tools to perform the punch technique for BAHS have been lacking. Recently, the Minimally Invasive Ponto Surgery (MIPS) technique was introduced by Oticon Medical AB (Askim, Sweden) to address this problem ( 18 , 19 ). This surgical procedure is a punch-only technique performed with a specially designed surgical kit.…”

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confidence: 99%

Minimally Invasive Ponto Surgery Versus the Linear Incision Technique With Soft Tissue Preservation for Bone Conduction Hearing Implants: A Multicenter Randomized Controlled Trial

Calon

Johansson

Bruijn

et al. 2018

Otology &Amp; Neurotology

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Objective:To compare the surgical outcomes of the Minimally Invasive Ponto Surgery (MIPS) technique with those of the linear incision technique with soft-tissue preservation for bone-anchored hearing systems (BAHS).Design:Sponsor-initiated multicenter, open, randomized, controlled clinical trial.Setting:Maastricht University Medical Centre, Ziekenhuisgroep Twente and Medisch Centrum Leeuwarden, all situated in The Netherlands.Participants:Sixty-four adult patients eligible for unilateral BAHS surgery.Interventions Single-stage BAHS surgery with 1:1 randomization to the linear incision technique with soft-tissue preservation (control) or the MIPS (test) group.Primary and Secondary Outcome Measurements:Primary objective: compare the incidence of inflammation (Holgers Index ≥ 2) during 12 weeks’ follow-up after surgery. Secondary objectives: skin dehiscence, pain scores, loss of sensibility around the implant, soft-tissue overgrowth, skin sagging, implant extrusion, cosmetic results, surgical time, wound healing and Implant Stability Quotient measurements.Results:Sixty-three subjects were analyzed in the intention-to-treat population. No significant difference was found for the incidence of inflammation between groups. Loss of skin sensibility, cosmetic outcomes, skin sagging, and surgical time were significantly better in the test group. No statistically significant differences were found for dehiscence, pain, and soft-tissue overgrowth. A nonsignificant difference in extrusion was found for the test group. The Implant Stability Quotient was statistically influenced by the surgical technique, abutment length, and time.Conclusion:No significant differences between the MIPS and the linear incision techniques were observed regarding skin inflammation. MIPS results in a statistically significant reduction in the loss of skin sensibility, less skin sagging, improved cosmetic results, and reduced surgical time. Although nonsignificant, the implant extrusion rate warrants further research.

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Short‐term results from seventy‐six patients receiving a bone‐anchored hearing implant installed with a novel minimally invasive surgery technique

Cited by 33 publications

References 11 publications

The clinical outcome and microbiological profile of bone-anchored hearing systems (BAHS) with different abutment topographies: a prospective pilot study

The clinical outcome and microbiological profile of bone-anchored hearing systems (BAHS) with different abutment topographies: a prospective pilot study

Cytokine expression profile in the bone‐anchored hearing system: 12‐week results from a prospective randomized, controlled study

Minimally Invasive Ponto Surgery Versus the Linear Incision Technique With Soft Tissue Preservation for Bone Conduction Hearing Implants: A Multicenter Randomized Controlled Trial

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