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Background: It is hypothesized that, for patients with hearing loss, surgically placing an implant/abutment combination whilst leaving the subcutaneous tissues intact will improve cosmetic and clinical results, increase quality of life (QoL) for the patient, and reduce medical costs. Here, incremental costs and consequences associated with soft tissue preservation surgery with a hydroxyapatite (HA)-coated abutment (test) were compared with the conventional approach, soft tissue reduction surgery with an all-titanium abutment (control). Methods: A cost-consequence analysis was performed based on data gathered over a period of 3 years in an open randomized (1:1) controlled trial (RCT) running in four European countries (The Netherlands, Spain, France, and Sweden). Subjects with conductive or mixed hearing loss or single-sided sensorineural deafness were included. Results: During the first year, in the Netherlands (NL), France (FR), and Spain (ES) a net cost saving was achieved in favor of the test intervention because of a lower cost associated with surgery time and adverse event treatments [NL 86 (CI -50.33; 219.20), FR 134 (CI -3.63; 261.30), ES 178 (CI 34.12; 97.48)]. In Sweden (SE), the HA-coated abutment was more expensive than the conventional abutment, which neutralized the cost savings and led to a negative cost (SE -29 CI -160.27; 97.48) of the new treatment modality. After 3 years, the mean cost saving reduced to 17 (CI -191.80; 213.30) in the Netherlands, in Spain to 84.50 (CI -117.90; 289.50), and in France to 80 (CI -99.40; 248.50). The mean additional cost in Sweden increased to -116 (CI -326.90; 68.10). The consequences in terms of the subjective audiological benefit and Health-related quality of life (HRQoL) were comparable between treatments. A trend was identified for favorable results in the test group for some consequences and statistical significance is achieved for the cosmetic outcome as assessed by the clinician. Conclusions: From this multinational cost-consequence analysis it can be discerned that health care systems can achieve a cost saving during the first year that regresses after 3 years, by implementing soft tissue preservation surgery with a HA-coated abutment in comparison to the conventional treatment. The cosmetic results are better. (sponsored by Cochlear Bone Anchored Solutions AB; Clinical and health economic evaluation with a new Baha® abutment design combined with a minimally invasive surgical technique, ClinicalTrials.gov NCT01796236).
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Background: Soft tissue preservation using a hydroxyapatite-coated abutment in bone conduction hearing implant surgery may lead to improved clinical outcomes over the short (1 year) and long term (3 years). Methods: In this open multi-center, randomized (1:1), controlled clinical trial, subjects with conductive, mixed hearing loss or single-sided sensorineural deafness were randomly assigned to receive the conventional intervention, a titanium abutment with soft tissue reduction surgery (control), or a new intervention, a hydroxyapatite-coated abutment with soft tissue preservation surgery (test). The primary efficacy outcome was the combined endpoint of numbness, pain, peri-abutment dermatitis, and soft tissue thickening/overgrowth after 1 and 3 years. Results: The Intention-to-treat (ITT) population consisted of 52 control subjects and 51 test subjects. The difference between the groups after 1 year of follow-up as measured by the primary efficacy outcome was not statistically significant (p = 0.12) in the ITT population (n = 103), but did reach statistical significance (p = 0.03) in the per-protocol (PP) population (n = 96). It showed an advantage for the test group, with over twice as many subjects (29%) without these medical events during the first year compared to the control group (13%). After 3 years, the difference between the two groups had declined and did not reach statistical significance (24 vs. 10%, ITT p = 0.45). Secondary outcome measures which showed a statistical significant difference during the first year, such as surgical time (15 vs. 25 minutes, p < 0.0001), numbness (90 vs. 69% of subjects experienced no numbness at 1 year, p < 0.01), neuropathic pain at 3 months (p = 0.0087) and the overall opinion of the esthetic outcome (observer POSAS scale at 3 months, p < 0.01) were favorable for the test group. More soft tissue thickening/overgrowth was observed at 3 weeks for the test group (p = 0.016). Similar results were achieved for the long term follow up. Conclusions: Soft tissue preservation with a hydroxyapatite-coated abutment leads to a reduction in the combined occurrence of complications over the first year which is not statistically significant in the ITT population but is in the PP population. This effect decreased for the long-term study follow up of 3 years and did also not reach statistical significance.
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OBJECTIVE: In this study, three-dimensional Fourier transformation constructive interference in steady state (3DFT-CISS) magnetic resonance imaging was used to quantify the distance between the vertical part of the posterior semicircular canal and the posterior fossa as a measure of the endolymphatic sac and duct in patients with Menière's disease. Differences in this distance between affected and unaffected ears, as well as differences between unilaterally and bilaterally affected patients, were studied and compared with a control group. Also, possible correlations between the measured distance and the duration and severity of symptoms, patient age, and average hearing loss were investigated in the group of patients with Menière's disease. STUDY DESIGN: Retrospective clinical study. SETTING: Tertiary referral center (University Hospital) as part of a large, diagnostic research project on Menière's disease. PATIENTS: Of the 111 patients with Menière's disease initially included, 90 patients underwent 3DFT-CISS MRI. Eighty-six of these patients were analyzed in this MRI study. Fifty-six patients had unilateral Menière's disease, and 30 patients had bilateral Menière's disease (116 affected and 56 unaffected ears). Sixty-two ears in patients without Menière's disease were studied as controls. INTERVENTION: The distance between the vertical part of the posterior semicircular canal and the posterior fossa was determined by 3DFT-CISS MRI. MAIN OUTCOME MEASURES: Contiguous axial 3DFT-CISS MRI slices of 0.7 to 1.0 mm were made by a radiologist according to a strict protocol. Measurements of the distance between the vertical part of the posterior semicircular canal and the posterior fossa were taken by two professionals-a radiologist and an otolaryngologist-using a ruler and the original scan. RESULTS: A significantly smaller distance (2.9 mm) between the vertical part of the posterior semicircular canal and the posterior fossa as visualized on MRI scans was found in the ears of patients with Menière's disease than in the ears of patients in the control group (3.8 mm, p < 0.001). In both uni- and bilaterally affected patients (n = 56 and n = 30, respectively), no significant difference between ears was found (p = 0.44 and p = 0.19, respectively). In bilaterally affected patients, however, this distance (3.2 mm) was significantly greater than the distance in unilaterally affected patients (2.7 mm, p = 0.004). There was no relationship between the MRI-visualized distance between the vertical part of the posterior semicircular canal and the posterior fossa and the duration of disease, average hearing loss, or severity of symptoms in uni- and bilaterally affected patients. CONCLUSION: The difference in MRI-visualized distances between the vertical part of the posterior semicircular canal and the posterior fossa of uni- and bilaterally affected patients strongly suggests that unilateral and bilateral hearing loss are two different entities in patients with Menière's disease. The size of the endolymphatic sac seems not to be the only factor in the pathogenesis of Menière's disease. That the MRI-visualized distance between the vertical part of the posterior semicircular canal and the posterior fossa does not have any relationship to the duration of the disease or to patient age indicates that this distance is a congenital feature.
