12-month effect of middle ear pressure therapy with the EFET01 device for intractable definite Meniere's disease and delayed endolymphatic hydrops after certification by the public health insurance system in Japan.

BACKGROUND: Middle ear pressure therapy (MEPT) is effective for intractable vertigo in patients with definite Meniere's disease (MD) and treatment-refractory delayed endolymphatic hydrops (DEH). Four-month MEPT with the EFET01®, an MEPT device developed in Japan and covered by national health insurance since September 2018, has shown efficacy. However, efficacy and safety after 12 months of treatment, which is appropriate for determining the therapeutic effect of MEPT devices, is unclear. OBJECTIVES: Examine the therapeutic effect of 12-month MEPT using the ETET01®. MATERIAL AND METHODS: Patients underwent MEPT using the EFET01® from September 2018 to July 2021. Thirty-three patients followed for >12 months were enrolled in this retrospective study. Clinical data were evaluated in the first and second 6-month treatment periods. Data from the second 6-month period were compared with data from an MEPT study using a different device. RESULTS: MEPT with the EFET01® significantly improved vertigo in the first period, with further improvement in the second period. The efficacy and safety were comparable to MEPT with other devices. CONCLUSIONS: MEPT with the EFET01® is effective for intractable vertigo in patients with definite MD and DEH, and 12-month follow-up is recommended. SIGNIFICANCE: The efficacy of 12-month MEPT with the EFET01® was demonstrated.

Efficiency of a novel middle ear pressure device for intractable definite Meniere's disease and delayed endolymphatic hydrops after certification by the public health insurance system in Japan.

BACKGROUND: Middle ear pressure therapy (MEPT) is effective in treating intractable vertigo in patients with definite Meniere's disease (MD) and delayed endolymphatic hydrops (DEH) refractory to conservative treatment. A novel middle ear pressure device, the EFET01®, which requires no transtympanic ventilation tubes, was developed in Japan, approved by the Japanese Ministry of Health, Labour and Welfare, and has been used under Japanese national health insurance since September 2018. OBJECTIVES: To examine short-term therapeutic effect of MEPT using the ETET01® compared with previous clinical trial results. METHODS: Patients selected according to Japan Society for Equilibrium Research (JSER) guidelines underwent MEPT using the EFET01 from September 2018 to July 2021, and 44 patients were enrolled in this retrospective study. Clinical data analysed at 4 months after the start of MEPT were compared with those of the previous clinical trial for the EFET01. RESULTS: MEPT using the EFET01 showed the same therapeutic efficacy as that of the previous clinical trial, i.e. improvement in the intensity and frequency of vertigo with no effect on hearing, even under JSER guidelines for proper use of MEPT. CONCLUSION: MEPT using the EFET01 provided an effective treatment option for intractable vertigo in patients with definite MD and DEH.

Factors Related to Participation in Health Examinations for Japanese National Health Insurance: NIPPON DATA2010.

BACKGROUND: This study investigated relationships among socioeconomic factors and participation in health examinations for Japanese National Health Insurance (NHI) using a representative Japanese population. METHODS: We used the linkage database of NIPPON DATA2010 and Comprehensive Survey of Living Conditions 2010. Participants with NHI aged 40-74 years were included in the analysis. Prevalence ratios (PRs) for participation in health examinations in the past year were set as an outcome. Participant characteristics, including sex, age, socioeconomic factors (educational attainment, employment, equivalent household expenditure [EHE], house ownership, and marital status), laboratory measures, and lifestyle were included in an age-stratified modified Poisson regression analysis to examine relationships. RESULTS: The number of study participants was 812, and 564 (69.5%) participated in health examinations in the past year. Among those aged 40-64 years, there was no significant PR for socioeconomic factors. Among those aged 65-74 years, high (≥13 years) educational attainment (adjusted PR, 1.22; 95% confidence interval [CI], 1.05-1.41) and house ownership (PR 1.40; 95% CI, 1.11-1.77) were positively associated with participation, while high (4th quartile) EHE (PR 0.84; 95% CI, 0.73-0.97) was negatively associated. CONCLUSION: These results suggest that high educational attainment, house ownership, and low EHE were positive factors for participation in health examinations among those aged 65-74 years.

Cost-Benefit Performance Simulation of Robot-Assisted Thoracic Surgery As Required for Financial Viability under the 2016 Revised Reimbursement Paradigm of the Japanese National Health Insurance System.

PURPOSE: To discuss the cost-benefit performance (CBP) and establish a medical fee system for robotic-assisted thoracic surgery (RATS) under the Japanese National Health Insurance System (JNHIS), which is a system not yet firmly established. METHODS: All management steps for RATS are identical, such as preoperative and postoperative management. This study examines the CBP based on medical fees of RATS under the JNHIS introduced in 2016. RESULTS: Robotic-assisted laparoscopic prostatectomy (RALP) and robotic-assisted partial nephrectomy (RAPN) now receive insurance reimbursement under the category of use of support devices for endoscopic surgery ($5420 and $3485, respectively). If the same standard amount were to be applied to RATS, institutions would need to perform at least 150 or 300 procedures thoracic operation per year to show a positive CBP ($317 per procedure as same of RALP and $130 per procedure as same of RAPN, respectively). CONCLUSION: Robotic surgery in some areas receives insurance reimbursement for its "supportive" use for endoscopic surgery as for RALP and RAPN. However, at present, it is necessary to perform da Vinci Surgical System Si (dVSi) surgery at least 150-300 times in a year in a given institution to prevent a deficit in income.