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.
LITT-P has a significantly higher rate of skin thickening and LITT-R has a significantly higher proportion of adverse soft tissue reactions. Nevertheless, combined with the advantages of LITT-P described in other studies, this can be advocated as the preferred technique.
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.
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, followup, 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 ¼ 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.
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.
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