Background and Objectives: The Fractional Flow Reserve and Intravascular UltrasoundGuided Intervention Strategy for Clinical Outcomes in Patients with Intermediate Stenosis (FLAVOUR) trial demonstrated non-inferiority of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) compared with intravascular ultrasound (IVUS)-guided PCI. We sought to investigate the cost-effectiveness of FFR-guided PCI compared to IVUS-guided PCI in Korea. Methods: A 2-part cost-effectiveness model, composed of a short-term decision tree model and a long-term Markov model, was developed for patients who underwent PCI to treat intermediate stenosis (40% to 70% stenosis by visual estimation on coronary angiography).The lifetime healthcare costs and quality-adjusted life-years (QALYs) were estimated from the healthcare system perspective. Transition probabilities were mainly referred from the FLAVOUR trial, and healthcare costs were mainly obtained through analysis of Korean National Health Insurance claims data. Health utilities were mainly obtained from the Seattle Angina Questionnaire responses of FLAVOUR trial participants mapped to EQ-5D. Results: From the Korean healthcare system perspective, the base-case analysis showed that FFR-guided PCI was 2,451 U.S. dollar lower in lifetime healthcare costs and 0.178 higher in QALYs compared to IVUS-guided PCI. FFR-guided PCI remained more likely to be cost-effective over a wide range of willingness-to-pay thresholds in the probabilistic sensitivity analysis. Conclusions Based on the results from the FLAVOUR trial, FFR-guided PCI is projected to decrease lifetime healthcare costs and increase QALYs compared with IVUS-guided PCI in intermediate coronary lesion, and it is a dominant strategy in Korea.

Background and Objectives: The Fractional Flow Reserve and Intravascular UltrasoundGuided Intervention Strategy for Clinical Outcomes in Patients with Intermediate Stenosis (FLAVOUR) trial demonstrated non-inferiority of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) compared with intravascular ultrasound (IVUS)-guided PCI. We sought to investigate the cost-effectiveness of FFR-guided PCI compared to IVUS-guided PCI in Korea. Methods: A 2-part cost-effectiveness model, composed of a short-term decision tree model and a long-term Markov model, was developed for patients who underwent PCI to treat intermediate stenosis (40% to 70% stenosis by visual estimation on coronary angiography).The lifetime healthcare costs and quality-adjusted life-years (QALYs) were estimated from the healthcare system perspective. Transition probabilities were mainly referred from the FLAVOUR trial, and healthcare costs were mainly obtained through analysis of Korean National Health Insurance claims data. Health utilities were mainly obtained from the Seattle Angina Questionnaire responses of FLAVOUR trial participants mapped to EQ-5D. Results: From the Korean healthcare system perspective, the base-case analysis showed that FFR-guided PCI was 2,451 U.S. dollar lower in lifetime healthcare costs and 0.178 higher in QALYs compared to IVUS-guided PCI. FFR-guided PCI remained more likely to be cost-effective over a wide range of willingness-to-pay thresholds in the probabilistic sensitivity analysis. Conclusions Based on the results from the FLAVOUR trial, FFR-guided PCI is projected to decrease lifetime healthcare costs and increase QALYs compared with IVUS-guided PCI in intermediate coronary lesion, and it is a dominant strategy in Korea.

Background and Objectives: The Fractional Flow Reserve and Intravascular UltrasoundGuided Intervention Strategy for Clinical Outcomes in Patients with Intermediate Stenosis (FLAVOUR) trial demonstrated non-inferiority of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) compared with intravascular ultrasound (IVUS)-guided PCI. We sought to investigate the cost-effectiveness of FFR-guided PCI compared to IVUS-guided PCI in Korea. Methods: A 2-part cost-effectiveness model, composed of a short-term decision tree model and a long-term Markov model, was developed for patients who underwent PCI to treat intermediate stenosis (40% to 70% stenosis by visual estimation on coronary angiography).The lifetime healthcare costs and quality-adjusted life-years (QALYs) were estimated from the healthcare system perspective. Transition probabilities were mainly referred from the FLAVOUR trial, and healthcare costs were mainly obtained through analysis of Korean National Health Insurance claims data. Health utilities were mainly obtained from the Seattle Angina Questionnaire responses of FLAVOUR trial participants mapped to EQ-5D. Results: From the Korean healthcare system perspective, the base-case analysis showed that FFR-guided PCI was 2,451 U.S. dollar lower in lifetime healthcare costs and 0.178 higher in QALYs compared to IVUS-guided PCI. FFR-guided PCI remained more likely to be cost-effective over a wide range of willingness-to-pay thresholds in the probabilistic sensitivity analysis. Conclusions Based on the results from the FLAVOUR trial, FFR-guided PCI is projected to decrease lifetime healthcare costs and increase QALYs compared with IVUS-guided PCI in intermediate coronary lesion, and it is a dominant strategy in Korea.

Background and Objectives: The Fractional Flow Reserve and Intravascular UltrasoundGuided Intervention Strategy for Clinical Outcomes in Patients with Intermediate Stenosis (FLAVOUR) trial demonstrated non-inferiority of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) compared with intravascular ultrasound (IVUS)-guided PCI. We sought to investigate the cost-effectiveness of FFR-guided PCI compared to IVUS-guided PCI in Korea. Methods: A 2-part cost-effectiveness model, composed of a short-term decision tree model and a long-term Markov model, was developed for patients who underwent PCI to treat intermediate stenosis (40% to 70% stenosis by visual estimation on coronary angiography).The lifetime healthcare costs and quality-adjusted life-years (QALYs) were estimated from the healthcare system perspective. Transition probabilities were mainly referred from the FLAVOUR trial, and healthcare costs were mainly obtained through analysis of Korean National Health Insurance claims data. Health utilities were mainly obtained from the Seattle Angina Questionnaire responses of FLAVOUR trial participants mapped to EQ-5D. Results: From the Korean healthcare system perspective, the base-case analysis showed that FFR-guided PCI was 2,451 U.S. dollar lower in lifetime healthcare costs and 0.178 higher in QALYs compared to IVUS-guided PCI. FFR-guided PCI remained more likely to be cost-effective over a wide range of willingness-to-pay thresholds in the probabilistic sensitivity analysis. Conclusions Based on the results from the FLAVOUR trial, FFR-guided PCI is projected to decrease lifetime healthcare costs and increase QALYs compared with IVUS-guided PCI in intermediate coronary lesion, and it is a dominant strategy in Korea.

The final analysis of the phase 3 Targeted Investigational Treatment Analysis of Novel Anti-androgen (TITAN) trial showed improvement in overall survival (OS) and other efficacy endpoints with apalutamide plus androgen deprivation therapy (ADT) versus ADT alone in patients with metastatic castration-sensitive prostate cancer (mCSPC). As ethnicity and regional differences may affect treatment outcomes in advanced prostate cancer, a post hoc final analysis was conducted to assess the efficacy and safety of apalutamide in the Asian subpopulation. Event-driven endpoints were OS, and time from randomization to initiation of castration resistance, prostate-specific antigen (PSA) progression, and second progression-free survival (PFS2) on first subsequent therapy or death. Efficacy endpoints were assessed using the Kaplan-Meier method and Cox proportional-hazards models without formal statistical testing and adjustment for multiplicity. Participating Asian patients received once-daily apalutamide 240 mg ( n = 111) or placebo ( n = 110) plus ADT. After a median follow-up of 42.5 months and despite crossover of 47 placebo recipients to open-label apalutamide, apalutamide reduced the risk of death by 32% (hazard ratio [HR]: 0.68; 95% confidence interval [CI]: 0.42-1.13), risk of castration resistance by 69% (HR: 0.31; 95% CI: 0.21-0.46), PSA progression by 79% (HR: 0.21; 95% CI: 0.13-0.35) and PFS2 by 24% (HR: 0.76; 95% CI: 0.44-1.29) relative to placebo. The outcomes were comparable between subgroups with low- and high-volume disease at baseline. No new safety issues were identified. Apalutamide provides valuable clinical benefits to Asian patients with mCSPC, with an efficacy and safety profile consistent with that in the overall patient population.
Male ; Humans ; Prostatic Neoplasms/pathology* ; Androgen Antagonists/therapeutic use* ; Prostate-Specific Antigen ; Castration ; Prostatic Neoplasms, Castration-Resistant/drug therapy*

PURPOSE: To evaluate the first results of surgical treatment using newly developed magnetically controlled growing rods (MCGR) for early onset scoliosis (EOS). MATERIALS AND METHODS: From January 2013 to January 2017, 5 patients, who underwent surgical treatment with MCGR for EOS and were followed for more than one year, were analyzed retrospectively. The demographic and radiology data, including age at surgery, diagnosis, number of lengthening, Cobb angle, T1–S1 length, T1–T12 length, and complications, were analyzed. RESULTS: The mean age of the patients was 6.0±2.7 years old. The subjects were 3 males and 2 females: 2 with neuromuscular scoliosis, 1 with syndromic scoliosis, 1 with idiopathic scoliosis, and 1 with congenital scoliosis. The mean number of lengthening was 9.8±2.9 times and the follow-up was 21.6±5.7 months. The Cobb angle improved from 82.0°±28.5° to 48.3°±28.8° at the last follow-up. The T1–S1 length increased from 283.1±72.7 mm to 342.6±86.3 mm at the last follow-up. The T1–T12 length increased from 163.1±50.5 mm to 202.3±65.5 mm at the last follow-up. One screw loosening complication was encountered and there were no neurological complications. CONCLUSION: The treatment using MCGR for EOS is effective and useful.
Diagnosis ; Female ; Follow-Up Studies ; Humans ; Male ; Retrospective Studies ; Scoliosis*

Amyloid fibril formation has been implicated in the pathogenesis of neurodegenerative diseases. Fibrillation generates numerous conformers. Presumably, the conformers may possess specific biological properties, thus providing a biochemical framework for strains of prions. However, the precise relationship between various fibril conformers and their pathogenic functions has not been determined because of limited accessibility to adequate amounts of fibrils from tissue samples. α-Synuclein is one such protein, and it has been implicated in Parkinson disease. Using a technique known as protein misfolding cyclic amplification, originally developed for amplifying prions, we established a procedure through which the amplification of α-synuclein fibrils is possible. With a trace amount of seeds, we succeeded in amplifying α-synuclein fibrils. The replication of the seeds was faithful in terms of conformation even after multiple rounds of cyclic amplification. Moreover, two transgenic mouse strains each representing a distinct synucleinopathy were used to investigate different conformers by using this technique. The amplified α-synuclein fibrils derived from the tissue extracts of these two strains led to the production of two different fibril conformers with distinct proteinase K digestion profiles. Together, our results demonstrated that a trace amount of α-synuclein fibrils in tissue extracts could be amplified with their conformations conserved. This procedure should be useful in amplifying α-synuclein fibrils from the brains and body fluids of patients afflicted with synucleinopathies and may serve as a potential diagnostic tool for Parkinson disease and other synucleinopathies.
Amyloid ; Animals ; Body Fluids ; Brain ; Digestion ; Endopeptidase K ; Humans ; Mice ; Mice, Transgenic ; Neurodegenerative Diseases ; Parkinson Disease ; Prions ; Tissue Extracts

STUDY DESIGN: Retrospective study. OBJECTIVES: To evaluate the outcomes of dual growing rod treatment over a follow-up period of at least 2 years in patients with progressive pediatric spinal deformity. SUMMARY OF LITERATURE REVIEW: The dual growing rod treatment is safe and effective in curve correction and maintenance in patients with progressive pediatric spinal deformity. MATERIALS AND METHODS: Between 2009 to 2017, 14 patients who underwent dual growing rod treatment were followed up for more than 2 years. We analyzed their demographic and radiologic data, including age at surgery, sex, diagnosis, instrumented levels, number of total operations, number of lengthening procedures, interval of lengthening, Cobb angle, thoracic kyphosis angle, lumbar lordosis angle, T1-S1 length, and complications. RESULTS: The mean age of the patients was 11.0±2.9 years old. There were 10 male and 4 female patients, including 8 cases of neuromuscular scoliosis, 3 cases of idiopathic scoliosis, 2 cases of spondyloepiphyseal dysplasia, and 1 case of congenital scoliosis. The mean follow-up period was 42.4±14.0 months. The total number of operations was 6.6±2.6. The average number of lengthening procedures was 4.3±2.3 at an interval of 6.9±2.1 months. The Cobb angle improved from 60.4°±27.9° to 33.5°±19.7° after the initial treatment and 29.1°±16.4° after the last follow-up or final fusion. The T1-S1 length increased from 328.2±57.5 mm to 388.0±64.9 mm after the initial treatment and 424.9±64.4 mm after the last follow-up or final spinal fusion. The average growth rate was 11.5 mm/year. Six patients experienced 11 complications, of which 4 were Implant-related, and 7 were Infections. CONCLUSIONS: The dual growing rod technique is an effective and relatively safe treatment in patients with progressive pediatric spinal deformity.
Animals ; Congenital Abnormalities* ; Diagnosis ; Female ; Follow-Up Studies ; Humans ; Kyphosis ; Lordosis ; Male ; Osteochondrodysplasias ; Retrospective Studies ; Scoliosis ; Spinal Fusion

Male osteoporosis is known to progress slowly and is less severe compared to female osteoporosis, and the incidence of lumbar compression fracture is considerably lower in male population. Hypogonadism which can develop from various causes including hypopituitarism is a common cause for secondary male osteoporosis. Hypopituitarism as a late complication of severe form of hemorrhagic fever with renal syndrome (HFRS) is known to occur occasionally but its clinical symptoms rarely appear. A 75-year-old male patient who had recovered from HFRS 13 years ago was admitted due to severe low back pain. He presented with gradually developed symptoms of hypogonadism and hypothyroidism resulting from hypopituitarism. MRI revealed collapsed pituitary gland and empty sella. This case presents with a male patient with multiple lumbar compression fractures due to severe osteoporosis secondary to hypogonadism, which resulted from hypopituitarism as a late complication of HFRS.
Aged ; Female ; Fever ; Fractures, Compression ; Hemorrhagic Fever with Renal Syndrome ; Humans ; Hypogonadism ; Hypopituitarism ; Hypothyroidism ; Incidence ; Low Back Pain ; Male ; Osteoporosis ; Pituitary Gland

OBJECTIVE: To assess the feasibility and clinical efficacy of laparoscopic myomectomy (LM). METHODS: We analyzed retrospectively the data for 110 LM preformed at Kangbuk Samsung Hospital between July 2003 and July 2006. We reviewed their clinical charts and the operative and anesthetic records, and analyzed data on the patients' age, parity, previous operative history, preoperative indication, the diameter of the largest myoma, operating time, number of the removed myoma, hospital stay, change of the hemoglobin concentration from preoperative to postoperative day 1, concomitant procedures, histopathological reports, and complications. RESULTS: The mean age of the patients was 35.7+/-5.8 years, the mean parity was 0.8+/-0.9, and 26 (23%) patients had a previous operative history. The most common operative indication was a palpable abdominal mass (46 patients, 41.9%), followed by chronic pelvic pain (32 patients, 29.0%), abnormal uterine bleeding (24 patients, 21.8%), urinary frequency (7 patients, 6.4%), and infertility (1 patient, 0.9%). The mean operating time was 82.9+/-30.8 minutes, and the mean diameter of the largest myoma was 7.1+/-2.3 cm. The heaviest of the removed myoma weighed 795 gm. The mean change of the hemoglobin concentration was 2.2+/-1.1 g/dL, and the mean hospital stay was 3.5+/-1.4 days. Postoperatively, transfusions were done 10% (11 cases) of patients, and 2 cases of paralytic ileus and a case of subcutaneous emphysema were noted. Conversion rate to laparotomy was 0.9% (1 case). CONCLUSION: LM for various sized myomas can be performed successfully and effectively by decreasing laparoconversion, if the surgical team and the laparoscopic surgeon are experienced and enhanced equipment is available.
Female ; Humans ; Infertility ; Intestinal Pseudo-Obstruction ; Laparotomy ; Length of Stay ; Myoma* ; Parity ; Pelvic Pain ; Retrospective Studies ; Subcutaneous Emphysema ; Uterine Hemorrhage