Health technology assessment was first introduced to the Republic of Korea in 2006 by amending the Medical Services Act. The Committee of New Health Technology Assessment (CNHTA) is the ministerial committee that has the responsibility of reviewing the safety and effectiveness of new health technology. CNHTA review plays a gatekeeping role for new health technology in Korea, which can increase the burden on patients in Korea, either by out-of pocket payments or co-pays for National Health Insurance covered service. This kind of gatekeeping is a function of the healthcare system in many countries where no financial cap such as a fixed budget or diagnosis-related group payment is applied. However, it has been argued that gatekeeping works against industrial promotion policy. The one-stop service introduced in 2014 is a system similar to US parallel review between the US Food and Drug Administration and Centers for Medicare and Medicaid Services. This service provides a simultaneous process of regulatory review by the Ministry of Food and Drug Safety, identification of existing technology by the Health Insurance Review and Assessment Services, and new health technology assessment by the National Evidence-based Healthcare Collaborating Agency and the Ministry of Health and Welfare. This service is expected to reduce the total review process by 3 to12 months. A limited health technology appointment service was introduced in April 2014. This service designates orphan health technologies and health technologies for rare and incurable diseases and supports evidence development at designated hospitals. Several countries have similar systems: US Coverage with Evidence Development, Canadian Conditionally Funded Field Evaluation, UK Only in Research, and many others. The future direction of Health technology assessment should focus on the life cycle management of health technology. A consistent, continuous, and transformative mechanism to manage from the research and development of health technology to delisting obsolete technology to make room for new innovative technology is warranted.
Biomedical Technology* ; Budgets ; Centers for Medicare and Medicaid Services (U.S.) ; Child ; Child, Orphaned ; Delivery of Health Care ; Diagnosis-Related Groups ; Financial Management ; Gatekeeping ; Humans ; Insurance, Health ; Korea ; Life Cycle Stages ; National Health Programs ; Republic of Korea ; United States Food and Drug Administration

OBJECTIVES: The present study aimed at investigating the potential of using 18β-glycyrrhetinic acid against the cariogenic characteristics of Streptococcus mutans UA159. METHODS: The effects of 18β-glycyrrhetinic acid on biofilm formation and acid production were evaluated; the latter are indicators of cariogenicity of S. mutans. Biofilm architecture was also analyzed by scanning electron microscopy (SEM), and changes in gene expression related to biofilm formation were studied by quantitative RT-PCR. RESULTS: Treatment with 18β-glycyrrhetinic acid at a concentration of 20 µg/ml inhibited biofilm formation by 95% in the absence of sucrose and 60% in its presence, reduced acid production by 88.8%, and significantly suppressed the gene expression of comDE, gbpB, gtfC and vicR, which are thought to be involved in the virulence of S. mutans. CONCLUSIONS: These results suggest that 18β-glycyrrhetinic acid could be used as a complementary or alternative agent for preventing dental caries by interfering with the virulence properties of S. mutans without affecting the viability of the bacterial population.
Biofilms ; Dental Caries ; Gene Expression ; Microscopy, Electron, Scanning ; Streptococcus mutans ; Streptococcus ; Sucrose ; Virulence

Purpose: Drug-coated devices have been widely accepted as one of the most promising therapies for femoropopliteal artery revascularization. A recent meta-analysis showed increased mortality in patients treated with drug-coated devices. We sought to examine the association between mortality and drug-coated devices after the treatment of the femoropopliteal artery based on the Korea national administrative claims data. Methods: In the National Health Insurance Service database from August 2015 to December 2017, we identified patients with femoropopliteal artery revascularization using percutaneous transluminal angioplasty (PTA), bare metal stents (BMS), drug-coated balloon (DCB), or drug-eluting stents (DES). Kaplan-Meier methods were used to estimate the survival among devices, and log-rank tests were used to evaluate differences between groups. Adjusted hazard ratios (aHRs) were computed using the inverse probability of treatment weightings (IPTW). Results: There were 1,724 patients (mean age, 70.9 ± 10.7 years; male, 1,350 [78.3%]) included in the analysis. The median follow-up period was 552 days (interquartile range, 404–688 days). There was a difference in IPTW-adjusted mortality risk among device types (26.3% in PTA, 22.1% in BMS, 17.7% in DCB, and 17.8% in DES; P = 0.004). IPTW-adjusted Cox proportional hazard analysis showed that drug-coated devices were associated with decreased all-cause mortality risk (aHR, 0.70; 95% confidence interval, 0.58–0.86). Conclusion Our real-world analysis showed that there was no evidence of increased all-cause mortality after femoropopliteal artery revascularization with drug-coated devices compared with non-drug-coated devices.

Purpose: Drug-coated devices have been widely accepted as one of the most promising therapies for femoropopliteal artery revascularization. A recent meta-analysis showed increased mortality in patients treated with drug-coated devices. We sought to examine the association between mortality and drug-coated devices after the treatment of the femoropopliteal artery based on the Korea national administrative claims data. Methods: In the National Health Insurance Service database from August 2015 to December 2017, we identified patients with femoropopliteal artery revascularization using percutaneous transluminal angioplasty (PTA), bare metal stents (BMS), drug-coated balloon (DCB), or drug-eluting stents (DES). Kaplan-Meier methods were used to estimate the survival among devices, and log-rank tests were used to evaluate differences between groups. Adjusted hazard ratios (aHRs) were computed using the inverse probability of treatment weightings (IPTW). Results: There were 1,724 patients (mean age, 70.9 ± 10.7 years; male, 1,350 [78.3%]) included in the analysis. The median follow-up period was 552 days (interquartile range, 404–688 days). There was a difference in IPTW-adjusted mortality risk among device types (26.3% in PTA, 22.1% in BMS, 17.7% in DCB, and 17.8% in DES; P = 0.004). IPTW-adjusted Cox proportional hazard analysis showed that drug-coated devices were associated with decreased all-cause mortality risk (aHR, 0.70; 95% confidence interval, 0.58–0.86). Conclusion Our real-world analysis showed that there was no evidence of increased all-cause mortality after femoropopliteal artery revascularization with drug-coated devices compared with non-drug-coated devices.

PURPOSE: To evaluate the efficacy of catheter-directed thrombolysis in treating symptomatic deep venous thrombosis (DVT) in lower limbs. METHODS: Between Jan. 1999 and Dec. 2002, 29 consecutive patients with DVT had received thrombolytic therapy. The male: female ratio was 6: 23 and the mean age was 50.3+/-13.5 years. The mean duration of symptom was 9.9+/-22.1 days. Catheter-directed infusions of urokinase were administrated via ipsilateral popliteal veins and the angioplasty and stent placement performed after the thrombolytic procedure. The mean dosage of urokinase and duration of thrombolysis were 2, 435, 000+/-887, 000 units and mean duration of thrombolysis was 36.8+/-17.9 hours. Oral medication of warfarin continued at least six months or more. To evaluate the venous patency, duplex ultrasonography or CT venography were performed. RESULTS: Lysis was complete in 17 patients (58.6%, all acute DVT), partial in 11 (37.9%), with only one patient failing. Iliac vein stenosis had shown in 16 patient after thrombdysis. Which were treated with balloon angioplasty and stent insertion. As a postprocedural complication, vaginal bleeding occurred in two patients; one was treated with transfusion but the other stopped without treatment. CONCLUSION: Catheter-directed thrombolysis with urokinase is effective for the treatment of DVT in lower limbs. However further study will be reguired to evaluate the relationship between the incidence of postthrombotic syndrome and thrombolytic therapy alone.
Angioplasty ; Angioplasty, Balloon ; Constriction, Pathologic ; Female ; Humans ; Iliac Vein ; Incidence ; Lower Extremity ; Male ; Phlebography ; Popliteal Vein ; Postthrombotic Syndrome ; Stents ; Thrombolytic Therapy ; Ultrasonography ; Urokinase-Type Plasminogen Activator* ; Uterine Hemorrhage ; Venous Thrombosis* ; Warfarin

PURPOSE: Popliteal artery entrapment syndrome (PAES) is rare but major cause of non-atheromatous popliteal arterial insufficiency in young. Because of its rareness, it is often neglected or misdiagnosed as thrombosis or embolism. Consequently surgeons would lose the appropriate time of treatment. METHOD: We reviewed 11 cases of PAES from 1994 to 2002 regarding to clinical characteristics, image findings, management and their results. RESULT: Two of 11 patients had bilateral involvement. All patients were male and aged 12 to 45 year old (mean; 32.1). Intermittent claudication was presented as initial symptom in all. One had toe gangrene. Conventional arteriography (11 cases) was used as initial diagnostic method. CT (7 cases) and MR (4 cases) angiography were also used to make diagnosis. Type II PAES were most common in 7 limbs. 11 limbs of 10 patients underwent operation. One was managed conservatively because of advanced liver cirrhosis. Resection of medial head of gastrocnemius and popliteal arterial bypass were performed in 7 limbs. One myectomy with femoroposterotibial bypass, one femoropopliteal bypass without myectomy, and myectomy with patch angioplasty were performed. Postoperative complication occurred in two limbs. One had occlusion of graft, another had occluded segment of endarterectomised popliteal artery. Primary graft patency at 6 mo, 1 yr and 3 yr were 81% 81%, 81% respectively. CONCLUSION: In young patients with claudication who have localized lesion at popliteal artery, clinicians should pay attention to rule out PAES. Accurate diagnosis can be achieved by CT or MR angiography. Early surgical correction is recommended to minimize surgical procedure and reduce complication of the disease.
Angiography ; Angioplasty ; Diagnosis ; Embolism ; Extremities ; Gangrene ; Head ; Humans ; Intermittent Claudication ; Liver Cirrhosis ; Male ; Middle Aged ; Popliteal Artery* ; Postoperative Complications ; Thrombosis ; Toes ; Transplants