Background/Aims: The Genoss DES™ is a novel, biodegradable, polymer-coated, sirolimus-eluting stent with a cobalt- chromium stent platform and thin strut. Although the safety and effectiveness of this stent have been previously investigated, real-world clinical outcomes data are lacking. Therefore, the aim of this prospective, multicenter trial was to evaluate the clinical safety and effectiveness of the Genoss DES™ in all-comer patients undergoing percutaneous coronary intervention. Methods: The Genoss DES registry is a prospective, single-arm, observational trial for evaluation of clinical outcomes after Genoss DES™ implantation in all-comer patients undergoing percutaneous coronary intervention from 17 sites in South Korea. The primary endpoint was a device-oriented composite outcome of cardiac death, target vessel-related myocardial infarction (MI), and clinically driven target lesion revascularization (TLR) at 12 months. Results: A total of 1,999 patients (66.4 ± 11.1 years of age; 72.8% male) were analyzed. At baseline, 62.8% and 36.7% of patients had hypertension and diabetes, respectively. The implanted stent number, diameter, and length per patient were 1.5 ± 0.8, 3.1 ± 0.5 mm, and 37.0 ± 25.0 mm, respectively. The primary endpoint occurred in 1.8% patients, with a cardiac death rate of 1.1%, target vessel-related MI rate of 0.2%, and clinically driven TLR rate of 0.8%. Conclusions In this real-world registry, the Genoss DES™ demonstrated excellent safety and effectiveness at 12 months among all-comer patients undergoing percutaneous coronary intervention. These findings suggest that the Genoss DES™ may be a viable treatment option for patients with coronary artery disease.

Bacillus Calmette-Guerin (BCG) vaccine is the only licensed vaccine for tuberculosis (TB) prevention. Previously, our group demonstrated the vaccine potential of Rv0351 and Rv3628 against Mycobacterium tuberculosis (Mtb) infection by directing Th1-biased CD4 + T cells coexpressing IFN-γ, TNF-α, and IL-2 in the lungs. Here, we assessed immunogenicity and vaccine potential of the combined Ags (Rv0351/Rv3628) formulated in different adjuvants as subunit booster in BCG-primed mice against hypervirulent clinical Mtb strain K (Mtb K). Compared to BCG-only or subunit-only vaccine, BCG prime and subunit boost regimen exhibited significantly enhanced Th1 response. Next, we evaluated the immunogenicity to the combined Ags when formulated with four different types of monophosphoryl lipid A (MPL)-based adjuvants: 1) dimethyldioctadecylammonium bromide (DDA), MPL, and trehalose dicorynomycolate (TDM) in liposome form (DMT), 2) MPL and Poly I:C in liposome form (MP), 3) MPL, Poly I:C, and QS21 in liposome form (MPQ), and 4) MPL and Poly I:C in squalene emulsion form (MPS). MPQ and MPS displayed greater adjuvancity in Th1 induction than DMT or MP did. Especially, BCG prime and subunit-MPS boost regimen significantly reduced the bacterial loads and pulmonary inflammation against Mtb K infection when compared to BCG-only vaccine at a chronic stage of TB disease. Collectively, our findings highlighted the importance of adjuvant components and formulation to induce the enhanced protection with an optimal Th1 response.

PURPOSE: Simple and reliable animal models of human diseases contribute to the understanding of disease pathogenesis as well as the development of therapeutic interventions. Although several murine models to mimic human asthma have been established, most of them require anesthesia, resulting in variability among test individuals, and do not mimic asthmatic responses accompanied by T-helper (Th) 17 and neutrophils. As dendritic cells (DCs) are known to play an important role in initiating and maintaining asthmatic inflammation, we developed an asthma model via adoptive transfer of allergen-loaded DCs.METHODS: Ovalbumin (OVA)-loaded bone marrow-derived DCs (BMDCs) (OVA-BMDCs) were injected intravenously 3 times into non-anesthetized C57BL/6 mice after intraperitoneal OVA-sensitization.RESULTS: OVA-BMDC-transferred mice developed severe asthmatic immune responses when compared with mice receiving conventional OVA challenge intranasally. Notably, remarkable increases in systemic immunoglobulin (Ig) E and IgG1 responses, Th2/Th17-associated cytokines (interleukin [IL]-5, IL-13 and IL-17), Th2/Th17-skewed T-cell responses, and cellular components, including eosinophils, neutrophils, and goblet cells, were observed in the lungs of OVA-BMDC-transferred mice. Moreover, the asthmatic immune responses and severity of inflammation were correlated with the number of OVA-BMDCs transferred, indicating that the disease severity and asthma type may be adjusted according to the experimental purpose by this method. Furthermore, this model exhibited less variation among the test individuals than the conventional model. In addition, this DCs-based asthma model was partially resistant to steroid treatment.CONCLUSIONS: A reliable murine model of asthma by intravenous (i.v.) transfer of OVA-BMDCs was successfully established without anesthesia. This model more accurately reflects heterogeneous human asthma, exhibiting a robust Th2/Th17-skewed response and eosinophilic/neutrophilic infiltration with good reproducibility and low variation among individuals. This model will be useful for understanding the pathogenesis of asthma and would serve as an alternative tool for immunological studies on the function of DCs, T-cell responses and new drugs.
Adoptive Transfer ; Anesthesia ; Animals ; Asthma ; Cytokines ; Dendritic Cells ; Eosinophils ; Goblet Cells ; Humans ; Immunoglobulin G ; Immunoglobulins ; Inflammation ; Interleukin-13 ; Lung ; Methods ; Mice ; Models, Animal ; Neutrophils ; Ovalbumin ; Ovum ; T-Lymphocytes

BACKGROUND AND OBJECTIVES: Recently, Genoss drug-eluting stent (DES)™ stent comprising cobalt-chromium platform with an ultrathin strut thickness, sirolimus, and an abluminal biodegradable polymer was developed. Owing to the lack of substantial evidence for the safety and efficacy of this stent, we report 12-month results of the Genoss DES™ stent.METHODS: We analyzed subjects who were eligible for a 12-month follow-up from the ongoing Genoss DES™ registry, which is a prospective, single-arm, observational, multicenter trial to investigate the clinical outcomes after the successful Genoss DES™ stent implantation among all-comers. The primary endpoint was a device-oriented composite outcome, defined as cardiac death, target vessel-related myocardial infarction, and target lesion revascularization at 12-month follow-up.RESULTS: Among 622 subjects, the mean age of subjects was 66.5±10.4 years, 70.6% were males, 67.5% had hypertension, and 38.3% had diabetes. The implanted stent number, diameter, and length per patient were 1.5±0.8, 3.1±0.4 mm, and 36.0±23.3 mm, respectively. At 12-month clinical follow-up, the primary endpoint occurred only in 4 (0.6%) subjects.CONCLUSIONS: The novel Genoss DES™ stent exhibited excellent safety and efficacy in real-world practice.
Death ; Drug-Eluting Stents ; Follow-Up Studies ; Humans ; Hypertension ; Male ; Multicenter Studies as Topic ; Myocardial Infarction ; Percutaneous Coronary Intervention ; Polymers ; Prospective Studies ; Registries ; Sirolimus ; Stents

BACKGROUND AND OBJECTIVES: Recently, Genoss drug-eluting stent (DES)™ stent comprising cobalt-chromium platform with an ultrathin strut thickness, sirolimus, and an abluminal biodegradable polymer was developed. Owing to the lack of substantial evidence for the safety and efficacy of this stent, we report 12-month results of the Genoss DES™ stent. METHODS: We analyzed subjects who were eligible for a 12-month follow-up from the ongoing Genoss DES™ registry, which is a prospective, single-arm, observational, multicenter trial to investigate the clinical outcomes after the successful Genoss DES™ stent implantation among all-comers. The primary endpoint was a device-oriented composite outcome, defined as cardiac death, target vessel-related myocardial infarction, and target lesion revascularization at 12-month follow-up. RESULTS: Among 622 subjects, the mean age of subjects was 66.5±10.4 years, 70.6% were males, 67.5% had hypertension, and 38.3% had diabetes. The implanted stent number, diameter, and length per patient were 1.5±0.8, 3.1±0.4 mm, and 36.0±23.3 mm, respectively. At 12-month clinical follow-up, the primary endpoint occurred only in 4 (0.6%) subjects. CONCLUSIONS The novel Genoss DES™ stent exhibited excellent safety and efficacy in real-world practice.

BACKGROUND: Growth factors play important roles in wound healing. However, the evidence for the effects of growth factors on post-thyroidectomy scars is limited. OBJECTIVE: We performed a prospective study to assess the preventive and therapeutic effect of a multi-growth factor (MGF)-containing cream on post-thyroidectomy scars. METHODS: Twenty-one patients with thyroidectomy scars applied MGF cream twice a day. We assessed the changes in erythema, pigmentation, skin elasticity, and skin hydration status using the erythema index, melanin index, cutometer, and corneometer, respectively. In addition, Vancouver scar scale (VSS) and patient satisfaction were assessed at 10 days after surgery (baseline), 2 weeks, 6 weeks, and 12 weeks after baseline. RESULTS: The mean total VSS scores were significantly lower at 6 weeks (3.24±1.51 vs. 1.91±1.38) and 12 weeks (3.24±1.51 vs. 1.71±1.59) compared to the baseline. The degree of pigmentation was significantly lower at 12 weeks compared to the baseline, and the skin elasticity, and the skin hydration status were significantly higher at 12 weeks compared to the baseline. Over 85% of the patients were satisfied with the use of MGF cream without any adverse effect. CONCLUSION: MGF cream might have additive or supportive effect for scar formation after thyroidectomy.
Cicatrix* ; Elasticity ; Erythema ; Humans ; Intercellular Signaling Peptides and Proteins ; Melanins ; Patient Satisfaction ; Pigmentation ; Prospective Studies ; Skin ; Skin Pigmentation ; Thyroidectomy ; Wound Healing

BACKGROUND/AIMS: Combination single-pill therapy can improve cost-effectiveness in a typical medical therapy. However, there is a little evidence about the efficacy and tolerability of combination single-pill antiplatelet therapy after percutaneous coronary intervention (PCI) with drug-eluting stents (DES). METHODS: From June to November 2012, in total, 142 patients who met the following criteria were enrolled: at least 18 years old; successful PCI with DES at least 3 months earlier; and regular medication of aspirin and clopidogrel with no side effects. After VerifyNow P2Y12 and aspirin assays, the combination single pill of aspirin and clopidogrel was given and laboratory tests were repeated 6 weeks later. RESULTS: At baseline, the incidence of aspirin resistance, defined as aspirin reaction unit (ARU) > or = 550, was 9.2%, that of clopidogrel resistance, defined as P2Y12 reaction unit (PRU) > or = 230, was 46.5%, and that of percent inhibition of PRU < 20% was 32.4%. At follow-up, the incidence of resistance by ARU value was 7.0%, 50.0% by PRU value, and 35.9% by percentage inhibition of PRU, respectively. The mean values of ARU (431.5 +/- 63.6 vs. 439.8 +/- 55.2; p = 0.216) and PRU (227.5 +/- 71.4 vs. 223.3 +/- 76.0; p = 0.350) were not significantly different before versus after antiplatelet-combination single-pill therapy. Five adverse events (3.5%) were observed during the study period. CONCLUSIONS: Combination single-pill antiplatelet therapy, which may reduce daily pill burden for patients after PCI with DES, demonstrated similar efficacy to separate dual-pill antiplatelet therapy.
Aged ; Antiplatyhelmintic Agents/*administration & dosage/adverse effects ; Aspirin/*administration & dosage/adverse effects ; Drug Combinations ; Drug Resistance ; *Drug-Eluting Stents ; Female ; Humans ; Intention to Treat Analysis ; Male ; Middle Aged ; Myocardial Ischemia/blood/diagnosis/*therapy ; Percutaneous Coronary Intervention/adverse effects/*instrumentation ; Platelet Function Tests ; Prospective Studies ; Tablets ; Ticlopidine/administration & dosage/adverse effects/*analogs & derivatives ; Time Factors ; Treatment Outcome

BACKGROUND AND OBJECTIVES: To evaluate the usefulness of fine needle aspiration (FNA) for thyroid nodule using the new Bethesda classification. SUBJECTS AND METHOD: Patient cytology data were reviewed by retrospective search of thyroid FNA. Cytologic diagnoses were classified as unsatisfactory, benign/negative for malignancy, indeterminate (ID), follicular neoplasm (FN), suspicious for malignancy (SM), and positive for malignancy (PM) according to the proposing of The National Cancer Institute. We analyzed the follow-up FNA diagnoses and the cytologic-histologic correlations. RESULTS: Of 1983 patients, 16.8% was classified as unsatisfactory, 73.6% as benign, 1.1% as ID, 0.4% as FN, 1.4% as SM, and 6.8% as PM. After the cytologic follow-up, the groups designated as unsatisafactory (80.2%) and ID (50%) mainly showed significant change in diagnosis. Two hundred fifty patients had surgical follow-up. Sensitivity, specificity, and accuracy, positive predictive values and negative predictive values for malignancy of thyroid were 87.6%, 97.2%, 91%, 98.3% and 81.2%, respectively. The cytologic-histologic diagnostic discrepancy rate was 13.6%. CONCLUSION: FNA for thyroid nodule using the new Bethesda classification was an accurate and sensitive method for the diagnosis of thyroid nodule, and can provide useful information for the management of thyroid nodule.
Biopsy, Fine-Needle ; Follow-Up Studies ; Humans ; National Cancer Institute (U.S.) ; Retrospective Studies ; Sensitivity and Specificity ; Thyroid Gland ; Thyroid Nodule

OBJECTIVE: The aims of this study were to present the newly developed pedicle guidance system for minimally invasive pedicle screw fixation under endoscopic visualization and to evaluate the feasibility, safety, and efficacy of this device. METHODS: The authors designed a special guidance device that allows a pedicle screw to be inserted with ease and accuracy under endoscopic visualization. The system consists of a bone biopsy needle (Jamshidi type needle), fiducial pins, a pushing trocar, retriever, specialized awls, and probes. After making an inch-long paramedian skin incision, the bone biopsy needle was percutaneously inserted into the pedicle, as in vertebroplasty, and the fiducial pin was inserted through the needle after removing the inner cannula. The fiducial pin was advanced into the vertebral body until the threaded distal end was positioned 1-2 cm away from the posterior bony structure. The biopsy needle was removed, leaving the fiducial pin in position. The operative wound was then dilated with a step dilator, a tubular retractor was introduced, and an endoscope was placed. Decompressive laminectomy and interbody fusion were then performed. A tubular retractor was repositioned in order to visualize the fiducial pins. A cannulated awl was used to create a hole over the fiducial pin. The pedicle trajectory was prepared using a cannulated probe, and a pedicle screw was inserted under fluoroscopic and endoscopic guidance. RESULT: Fifteen patients underwent surgery using this method. In all cases, the screws were safely inserted without misplacement. The overall operative time ranged from 180 min to 260 min (mean 219.3 min). There were no procedure related complications. CONCLUSION: This newly designed device proved to be practical, time saving, and useful for endoscope-assisted pedicle screw fixation.
Biopsy ; Catheters ; Endoscopes ; Endoscopy ; Humans ; Laminectomy ; Lumbar Vertebrae ; Needles ; Operative Time ; Skin ; Spinal Fusion ; Surgical Instruments ; Vertebroplasty

OBJECTIVES: Serial changes of focal ischemic lesions as seen on magnetic resonance (MR) images and triphenyltetrazolium chloride (TTC)-stained samples of transient middle cerebral artery occlusion in a rat model were evaluated to investigate the natural course of the lesions and the feasibility of the use of each method as a monitoring tool. METHODS: Transient middle cerebral artery occlusion (MCAO) was induced in fifteen adult female Sprague Dawley rats using the method of intraluminal vascular occlusion. Two hours after MCAO was induced, reperfusion was performed. Serial MR images were obtained and the volume of the brain infarct was estimated. For macroscopic and microscopic evaluation of the ischemic lesions, the ten animals were sacrificed at different times after MCAO. The rat brains were then removed and six coronal sections were made. Each section was incubated at 37 degrees C in 2% TTC solution for 15 minutes. RESULTS: Postischemic injury evaluations that were made periodically for eight weeks revealed that the lesion volume as determined from T2 maps had reached a peak on the second day after ischemic injury and the volume decreased afterwards for one week; by the fourth week, the lesion volume again increased to stabilize initial lesion development. There were considerable discrepancies between the infarct area of the samples determined by TTC staining and the in vivo infarct area estimated from the MR images, especially for late stages. CONCLUSION: T2 map MR images, with a careful consideration of the natural course of infarction development, can provide an adequate and noninvasive means to evaluate the degree of ischemic injury under diverse experimental circumstances.
Adult ; Animals ; Brain ; Female ; Humans ; Infarction ; Infarction, Middle Cerebral Artery ; Magnetic Resonance Spectroscopy ; Rats ; Rats, Sprague-Dawley ; Reperfusion ; Stroke ; Tetrazolium Salts