Long-Term Results of the Linear Incision Technique With Tissue Reduction Versus Tissue Preservation for Inserting Bone-Anchored Hearing Implants: The Ongoing Optimization in Bone Implant Surgery.

OBJECTIVE: To compare the long-term outcomes of the linear incision technique with tissue reduction (LIT-TR) and the linear incision technique with tissue preservation (LIT-TP) for inserting bone-anchored hearing implants (BAHIs). STUDY DESIGN: Single-center retrospective cohort study. SETTING: Large general teaching hospital. PATIENTS: A total of 231 adult patients were included between August 2005 and October 2020, with a minimum follow-up time of 6 months. INTERVENTION: The test group received a BAHI using the LIT-TP (N = 147). The control group underwent surgery using the LIT-TR (N = 84). MAIN OUTCOME MEASURES: Soft tissue reactions, skin thickening, postoperative complications (e.g., wound dehiscence), and implant loss were compared between the test and control group. Furthermore, Cochlear Bone Anchored Solutions AB (Mölnlycke, Sweden) and Oticon Medical AB (Askim, Sweden) implants/abutments within the LIT-TP cohort were compared. Validated questionnaires were used to quantify patients' health-related quality of life (HRQoL). RESULTS: Significantly more cases with wound dehiscence and adverse soft tissue reactions (Holgers ≥2) were observed in the LIT-TR cohort (p < 0.001). However, the LIT-TP cohort showed significantly more cases with skin thickening (requiring treatment) within the first 2 years after implantation. There were no differences in implant loss rates, overall soft tissue reactions (Holgers >1), and overall HRQoL between the two patient groups. Significant improvement in the patients' HRQoL after implementation of a BAHI was found in both techniques. The Ponto Wide implant/abutment showed less frequent skin thickening (requiring treatment) and fewer soft tissue reactions compared with the BIA400 implant/abutment. CONCLUSION: This large-scale study demonstrates that the LIT-TP shows excellent long-term outcomes, including a low incidence of implant failure.

Health Economic Cost Analysis for Percutaneous Bone Conduction Devices: The Minimally Invasive Ponto Surgery Versus Linear Incision Technique with Tissue Preservation.

OBJECTIVES: To identify differences in mean cost per patient between the Minimally Invasive Ponto Surgery (MIPS) and the linear incision technique with tissue preservation (LITT-P). STUDY DESIGN: Health economic cost analysis. SETTING: The analysis was performed in a randomized multicenter controlled trial cohort. PATIENTS: Adult patients eligible for unilateral bone conduction device surgery. INTERVENTIONS: MIPS versus LITT-P surgery for bone conduction device implantation. MAIN OUTCOME MEASURES: Perioperative and postoperative costs were identified and compared. RESULTS: The difference in mean cost per patient between both techniques was €77.83 in favor of the MIPS after 22 months follow-up. The mean costs per patient were lower in the MIPS cohort for surgery (€145.68), outpatient visits (€24.27), systemic antibiotic therapy with amoxicillin/clavulanic acid (€0.30) or clindamycin (€0.40), abutment change (€0.36), and abutment removal (€0.18). The mean costs per patient were higher for implant and abutment set (€18.00), topical treatment with hydrocortison/oxytetracycline/polymyxine B (€0.43), systemic therapy with azithromycin (€0.09) or erythromycin (€1.15), local revision surgery (€1.45), elective explantation (€1.82), and implant extrusion (€70.42). Additional analysis of scenarios in which all patients were operated under general or local anesthesia or with recalculation when using current implant survival rates showed that differences in mean cost per patient were also in favor of the MIPS. CONCLUSION: The difference between the MIPS and the LITT-P in mean cost per patient was €77.83 in favor of the MIPS after 22 months of follow-up. The MIPS is an economically responsible technique and could be promising for the future.

The Minimally Invasive Star-Shaped Incision Technique and the Linear Incision Technique With Tissue Preservation for Percutaneous Bone Conduction Devices: A Retrospective Cohort Study.

Purpose: To compare intra- and postoperative outcomes between the standard linear incision technique with tissue preservation (LITT-P) and the minimally invasive star-shaped incision (SSI). Study Design: A retrospective cohort study. Methods: Primary outcomes evaluated operative time, implant survival, and intra-operative complications. A secondary outcome evaluated soft tissue tolerability assessed by the Holger's classification. Results: A total of 38 implants were placed (19 LITT-P; 19 SSI). The median and mean surgical duration for the LITT-P group was statistically shorter than the SSI group (p = 0.0001). No intra-operative complications were reported for both surgical approaches. Five implants were lost during postoperative follow-up: one in the LITT-P and four in the SSI cohort. Both cohorts showed favorable soft tissue tolerability. Less Holgers 1 and 2 and more Holgers 3 soft tissue reactions were observed after the LITT-P compared to the SSI. Conclusion: The novel SSI approach could be an alternative option based on the theoretical benefits and found favorable (and similar) soft tissue outcomes. Implant loss and surgical time are aspects to investigate regarding long-term durability and warrant further research.

Ex vivo Evaluation of a New Drill System for Placement of Percutaneous Bone Conduction Devices.

The procedure for installation of a percutaneous bone-conducting device has undergone significant improvements since its introduction 40 years ago. Today, the linear incision technique with tissue preservation (LITT-P) and the minimally invasive procedure (MIPS) are the most commonly used approaches. In both these techniques, a gradual increase of the osteotomy using a three-step drilling sequence is utilized, as this approach can allow a stepwise deepening and widening of the osteotomy in the mastoid and can prevent bone overheating. A new minimally invasive procedure (MONO) has been developed that allows an osteotomy to be performed and enables complete removal of the bone volume in one single drill step for a 4 mm implant using a novel parabolic twist drill. Here, the feasibility of the MONO procedure was qualitatively and quantitatively evaluated in terms of the dura response to drill trauma in comparison with the outcomes achieved with guide drills used for the LITT-P and MIPS techniques. Fresh frozen temporal bone from a human cadaver was subjected to penetration by three drills beyond the base of the mastoid bone to different depths. The sites were evaluated, and the damage to and possible penetration of the dura were determined. The results showed that for a drill depth exceeding mastoid bone thickness by not more than 1 mm, damage to the dura was limited or nonexistent, whereas for a drill depth exceeding bone thickness by 2 mm, damage increased, or the dura was penetrated. There was a trend toward more damage and penetration for both the round burr and MIPS guide drill compared with the MONO drill bit. From this experimental ex vivo study, it can be concluded that if the dura is encountered, the MONO system is not more inclined to penetrate the dura than the conventional LITT-P and MIPS systems.

Reliability of Postsurgical Soft Tissue Reaction Grading Scales for Bone-anchored Hearing Implants.

OBJECTIVE: This study aims to assess and compare the reliability of the Holgers, the IPS, and the Tullamore scales for skin tolerability assessment of postoperative bone-anchored hearing implant images. STUDY DESIGN: A survey study and retrospective review of percutaneous osseointegrated auditory implant images for scoring using three skin classification scales. SETTING: McGill University Health Center, Montreal, Quebec, Canada. PARTICIPANTS: Healthcare workers experienced and inexperienced with osseointegrated auditory implant skin classification scales. MAIN OUTCOME MEASURES: Participation involved completing: 1) survey questionnaires assessing experience with osseointegrated auditory implants and related skin reactions and 2) scoring postoperative osseointegrated auditory implant with surrounding skin images using the Holgers Classification, the IS (of the IPS) scale, and the Tullamore Classification. Participants were asked to rate 12 images of postoperative osseointegrated auditory implant and surrounding soft tissue. This process was repeated until participants scored all images using the three scales; each rater graded 36 images in total. The order in which scales were presented occurred at random. Intraclass correlation coefficients were calculated to assess reliability. RESULTS: Thirty-one participants were recruited to the study. Fourteen (45.2%) had experience with at least 1 osseointegrated auditory implant skin classification scale, while 17 (54.8%) did not have experience. The wide and overlapping 95% confidence intervals of the intraclass correlation coefficients results do not provide us with enough evidence to define a well-established degree and hierarchy of reliability when comparing the scales. Among experienced raters, all scales presented moderate to good reliability. CONCLUSIONS: The Holgers Classification, the IPS scale, and the Tullamore Classification all present moderate to good reliability when used by experienced raters to assess skin reactions following surgical implantation of an osseointegrated hearing device. As a result, clinicians should use these scales with a degree of caution. The findings of this study do not provide us with enough evidence to single out one of the scales as a standard to follow, but more extensive studies are required to assess the reliability of the scales.

Long-Term Outcomes of the Minimally Invasive Ponto Surgery vs. Linear Incision Technique With Soft Tissue Preservation for Installation of Percutaneous Bone Conduction Devices.

Objective: Comparing the surgical outcomes of the Minimally Invasive Ponto Surgery (MIPS) technique with the linear incision technique with soft tissue preservation (LITT-P) for bone conduction devices after a follow-up of 22 months. Methods: In this multicenter randomized controlled trial, there was the inclusion of 64 adult patients eligible for unilateral surgery. There was 1:1 randomization to the MIPS (test) or the LITT-P (control) group. The primary outcome was an (adverse) soft tissue reaction. Secondary outcomes were pain, loss of sensibility, soft tissue height/overgrowth, skin sagging, implant loss, Implant Stability Quotient measurements, cosmetic scores, and quality of life questionnaires. Results: Sixty-three subjects were analyzed in the intention-to-treat population. No differences were found in the presence of (adverse) soft tissue reactions during complete follow-up. Also, there were no differences in pain, wound dehiscence, skin level, soft tissue overgrowth, and overall quality of life. Loss of sensibility (until 3-month post-surgery), cosmetic scores, and skin sagging outcomes were better in the MIPS group. The Implant Stability Quotient was higher after the LITT-P for different abutment lengths at various points of follow-up. Implant extrusion was nonsignificantly higher after the MIPS (15.2%) compared with LITT-P (3.3%). Conclusion: The long-term results show favorable outcomes for both techniques. The MIPS is a promising technique with some benefits over the LITT-P. Concerns regarding nonsignificantly higher implant loss may be overcome with future developments and research. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT02438618.

Cochlear Implant Fixation Techniques: A Systematic Review of the Literature.

OBJECTIVE: Given the lack of consensus on fixation techniques of the cochlear implant, this review aims to create an up-to-date overview of intra- and postoperative complications, focusing on migration of the internal receiver/stimulator (R/S) device and the electrode array. DATA SOURCES: On June 29, 2020 we conducted a search in PubMed, Embase, Cochrane, Web of Science, and CINAHL. Keywords were "Cochlear implant," "complication," "migration," and synonyms. STUDY SELECTION: Studies were considered if: 1) the adult study population consisted of ≥ 10 patients, 2) the R/S device was fixated using the bony well or tight subperiostal pocket technique without bone-anchoring sutures or screws on the implant, and 3) migration of the R/S device or displacement of the electrode array were described as outcomes. DATA EXTRACTION: Study characteristics, interventions, follow-up, and outcomes were extracted. For critical appraisal, an adapted version of the Newcastle-Ottawa quality assessment scale for cohort studies was used. DATA SYNTHESIS: Seven studies were included (n = 430 patients). Migration of the R/S device was reported by three studies. Two studies applying the tight pocket technique reported migration rates ranging from 9.0 to 69.2%. One study using the bony bed technique reported migration of 100%, with an average of 2.5 mm. All studies lacked the required standard for comparability, assessment of outcome, and follow-up. CONCLUSIONS AND RELEVANCE: There is currently no evidence of a difference between the bony bed- and tight pocket fixation technique, regarding migration of the R/S device or the electrode array, in adult patients.

Inadequate Health Literacy in Patients with Arterial Vascular Disease.

OBJECTIVE: The aim was to identify the prevalence of inadequate health literacy in patients with arterial vascular disease. This was a cross sectional study. METHODS: Patients with arterial vascular disease visiting the outpatient clinic between January 5, 2015 and December 28, 2016, were randomly included and screened for inadequate health literacy with the Newest Vital Sign-Dutch (NVS-D), a validated health literacy assessment measure. A score of <4 out of six identified individuals with inadequate health literacy. Age, gender, highest education level, and reason for consultation were also registered. Data analysis was performed using Student's t-test or the Mann-Whitney U test and chi-square test. Logistic regression with backward elimination was applied to identify independent predictors. RESULTS: A total of 202 patients were included. The mean NVS-D score was 1.91 (SD ± 1.948, median 1). The prevalence of inadequate health literacy was 76.7%. A significantly higher prevalence of inadequate health literacy was found in patients ≥65 years (p < .001) and patients with a lower education level (p < .001). No significant difference was found between female/male patients (p = .056), nor between participants with peripheral arterial occlusive disease and abdominal aortic aneurysm (p = .116). Age (OR 1.060; 95% CI 1.017-1.104; p = .005) and education level (OR 0.164; 95% CI 0.078-0.346; p < .001) were identified as independent predictors of inadequate health literacy. CONCLUSION: This study shows a prevalence of inadequate health literacy of 76.7% in patients with arterial vascular disease, with a significantly higher prevalence in patients ≥ 65 years and patients with a lower education level. The high prevalence of inadequate health literacy should be considered when information is provided, and suggests the need to further investigate the best methods to convey medical information to this group of vulnerable patients.

Percutaneous bone-anchored hearing implant surgery: dermatome versus linear incision technique.

The objective of this historical cohort study is to identify if there are differences in soft tissue reactions and skin thickening between implantation of the percutaneous bone-anchored hearing implant (BAHI) using the dermatome or linear incision technique. All adult patients who received a BAHI between August 2005 and January 2013 were selected. One surgeon performed all procedures and only the dermatome and linear incision technique were used. A total of 132 patients/implants were included and significantly more patients with risk factors were seen in the linear incision cohort. A soft tissue reaction Holgers ≥1 was present in 18 patients (40.9 %) in the dermatome compared to 36 patients (40.9 %) in the linear incision group. A Holgers ≥2 was noticed in 9 (20.5 %) and 19 (21.6 %) patients, respectively. Skin thickening was described in 14 (31.8 %) and 11 patients (12.5 %) in, respectively, the dermatome and linear incision cohort, which was a significant difference (p = 0.001). Nevertheless, therapeutic interventions were effective. In conclusion, there was no significant difference in (adverse) soft tissue reactions; however, skin thickening was more present in the dermatome technique. In addition, significantly more patients with risk factors were allocated to the linear incision technique. Based on these results, the linear incision is advocated as preferred technique.

Percutaneous bone-anchored hearing implant surgery: inside or outside the line of incision?

The objective of this historical cohort study was to compare soft tissue reactions in adults after bone-anchored hearing implant (BAHI) surgery when the percutaneous implant is placed inside or outside the line of incision. All adult patients who received a percutaneous BAHI between 1 January 2010 and 31 January 2014 in our tertiary referral centre were identified. Patients were selected if operated by two surgeons, who perform the same standardised linear incision technique with one of them placing the implant outside the incision while the other prefers placement inside the line of incision. A total of 202 patients and 211 implants were included in the case analysis. The results showed the registration of a soft tissue reaction Holgers ≥1 in 47 implants (49.0 %) placed outside the incision compared to 70 implants (60.9 %) which were placed inside the line of incision. An adverse soft tissue reaction, Holgers ≥2, was noticed in 17 implants (17.7 %), respectively, 20 implants (17.4 %). No significant differences were found between the two groups for both the presence of soft tissue reactions Holgers ≥1 (p = 0.322) and a Holgers score ≥2 (p = 0.951). During the follow-up three implants were lost (1.4 %) and in 18 of 211 implants one or multiple revisions were performed (8.5 %). In conclusion, this study did not show any differences in the presence of postsurgical (adverse) soft tissue reactions between placement of the percutaneous BAHI inside or outside the line of incision.

[A former bodybuilder with a swelling on the forearm]. / Een oud-bodybuilder met een zwelling op de onderarm.

A 56-year-old man came to the general practitioner with a solitary compressible swelling on his left forearm, which enlarged during exercise. The patient reported a history of bodybuilding and he worked as a plasterer. Physical examination revealed primary varicose of the upper extremity, a rare localisation of a common vascular disease.