1.Safety and Effectiveness of Passeo-18 Lux Drug-Coated Balloon Catheter in Infrainguinal Endovascular Revascularization in the Korean Population:A Multicenter Post-Market Surveillance Study
Tae Won CHOI ; Je Hwan WON ; Hwan Jun JAE ; Yong Sun JEON ; Sang Woo PARK ; Gi-Young KO ; Nam Yeol YIM ; Jong Yun WON ; Chang Won KIM ; Jinoo KIM
Korean Journal of Radiology 2024;25(6):565-574
Objective:
To evaluate the safety and clinical outcomes of the Passeo-18 Lux drug-coated balloon (DCB) in endovascular revascularization procedures under real-world conditions in a Korean population with atherosclerotic disease of the infrainguinal arteries, including below-the-knee (BTK) arteries.
Materials and Methods:
Eight institutions in the Republic of Korea participated in this prospective, multicenter, single-arm, post-market surveillance study. Two hundred patients with Rutherford class 2–5 peripheral arterial disease and infrainguinal lesions suitable for endovascular treatment were competitively enrolled. Data were collected at baseline, the time of intervention, discharge, and 1-, 6-, 12-, and 24-month follow-up visits. The primary safety endpoint was freedom from major adverse events (MAE) within 6 months (except when limiting the time frame for procedure- or device-related mortality to within 30 days), and the primary effectiveness endpoint was freedom from clinically driven target lesion revascularization (CDTLR) within 12 months after the procedure.
Results:
A total of 197 patients with 332 target lesions were analyzed. Two-thirds of the patients had diabetes mellitus, and 41.6% had chronic limb-threatening ischemia. The median target lesion length was 100 mm (interquartile range: 56–133 mm).Of the target lesions, 35.2% were occlusions, and 14.8% were located in the BTK arteries. Rate of freedom from MAE was 97.9% at 6 months, and the rate of freedom from CD-TLR was 95.0% and 92.2% at 12 and 24 months, respectively. Subgroup analysis of 43 patients and 49 target lesions involving the BTK arteries showed rate of freedom from MAE of 92.8% at 6 months and rates of freedom from CD-TLR of 88.8% and 84.4% at 12 and 24 months, respectively.
Conclusion
The results of the present study, including the BTK subgroup analysis, showed outcomes comparable to those of other DCB studies, confirming the safety and effectiveness of Passeo-18 Lux DCB in the Korean population.
2.The Profile of Early Sedation Depth and Clinical Outcomes of Mechanically Ventilated Patients in Korea
Dong-gon HYUN ; Jee Hwan AHN ; Ha-Yeong GIL ; Chung Mo NAM ; Choa YUN ; Jae-Myeong LEE ; Jae Hun KIM ; Dong-Hyun LEE ; Ki Hoon KIM ; Dong Jung KIM ; Sang-Min LEE ; Ho-Geol RYU ; Suk-Kyung HONG ; Jae-Bum KIM ; Eun Young CHOI ; JongHyun BAEK ; Jeoungmin KIM ; Eun Jin KIM ; Tae Yun PARK ; Je Hyeong KIM ; Sunghoon PARK ; Chi-Min PARK ; Won Jai JUNG ; Nak-Jun CHOI ; Hang-Jea JANG ; Su Hwan LEE ; Young Seok LEE ; Gee Young SUH ; Woo-Sung CHOI ; Keu Sung LEE ; Hyung Won KIM ; Young-Gi MIN ; Seok Jeong LEE ; Chae-Man LIM
Journal of Korean Medical Science 2023;38(19):e141-
Background:
Current international guidelines recommend against deep sedation as it is associated with worse outcomes in the intensive care unit (ICU). However, in Korea the prevalence of deep sedation and its impact on patients in the ICU are not well known.
Methods:
From April 2020 to July 2021, a multicenter, prospective, longitudinal, noninterventional cohort study was performed in 20 Korean ICUs. Sedation depth extent was divided into light and deep using a mean Richmond Agitation–Sedation Scale value within the first 48 hours. Propensity score matching was used to balance covariables; the outcomes were compared between the two groups.
Results:
Overall, 631 patients (418 [66.2%] and 213 [33.8%] in the deep and light sedation groups, respectively) were included. Mortality rates were 14.1% and 8.4% in the deep and light sedation groups (P = 0.039), respectively. Kaplan-Meier estimates showed that time to extubation (P < 0.001), ICU length of stay (P = 0.005), and death P = 0.041) differed between the groups. After adjusting for confounders, early deep sedation was only associated with delayed time to extubation (hazard ratio [HR], 0.66; 95% confidence inter val [CI], 0.55– 0.80; P < 0.001). In the matched cohort, deep sedation remained significantly associated with delayed time to extubation (HR, 0.68; 95% 0.56–0.83; P < 0.001) but was not associated with ICU length of stay (HR, 0.94; 95% CI, 0.79–1.13; P = 0.500) and in-hospital mortality (HR, 1.19; 95% CI, 0.65–2.17; P = 0.582).
Conclusion
In many Korean ICUs, early deep sedation was highly prevalent in mechanically ventilated patients and was associated with delayed extubation, but not prolonged ICU stay or in-hospital death.
3.Removal of Squamous Cell Carcinoma Caused by Burn Scars and Concurrent Scar Revision Surgery:Case Report
Jun Sik KIM ; Jae Bong SHIN ; Nam Gyun KIM ; Gi Cheol DO ; Min Hyung KIM ; Tae Ho KIM ; Kyung Suk LEE
Journal of Korean Burn Society 2023;26(2):58-61
Even long after the initial burn injury, skin complications and inflammatory disorders resulting from burn scars remain significant challenges for patients. This is especially concerning when these complications evolve into cancer. Therefore, We have reported a case in which issues stemming from burn scar contractures and squamous cell carcinoma were simultaneously addressed, resulting in enhanced aesthetic and functional outcomes for the patient
4.Conservative Treatment of Chemical Burns with Glacial Acetic Acid: Case Report
Jun Sik KIM ; Jae Bong SHIN ; Nam Gyun KIM ; Gi Cheol DO ; Min Hyung KIM ; Tae Ho KIM ; Kyung Suk LEE
Journal of Korean Burn Society 2023;26(2):44-47
Glacial acetic acid is a highly dangerous chemical that, in recent years, has been linked to multiple adverse drug reactions in patients. Despite warnings, improper dilution of concentrated glacial acetic acid has led to severe burns and related morbidities. Therefore, We have reported a case where toes were injured due to chemical burns from glacial acetic acid, but they were successfully healed through long time conservative treatment.
5.Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation Targeting Restitution Parameter-Guided Catheter Ablation: CUVIA-REGAB Prospective Randomized Study
Young CHOI ; Byounghyun LIM ; Song-Yi YANG ; So-Hyun YANG ; Oh-Seok KWON ; Daehoon KIM ; Yun Gi KIM ; Je-Wook PARK ; Hee Tae YU ; Tae-Hoon KIM ; Pil-Sung YANG ; Jae-Sun UHM ; Jamin SHIM ; Sung Hwan KIM ; Jung-Hoon SUNG ; Jong-il CHOI ; Boyoung JOUNG ; Moon-Hyoung LEE ; Young-Hoon KIM ; Yong-Seog OH ; Hui-Nam PAK ; For the CUVIA-REGAB Investigators
Korean Circulation Journal 2022;52(9):699-711
Background and Objectives:
We investigated whether extra-pulmonary vein (PV) ablation targeting a high maximal slope of the action potential duration restitution curve (Smax) improves the rhythm outcome of persistent atrial fibrillation (PeAF) ablation.
Methods:
In this open-label, multi-center, randomized, and controlled trial, 178 PeAF patients were randomized with 1:1 ratio to computational modeling-guided virtual Smax ablation (V-Smax) or empirical ablation (E-ABL) groups. Smax maps were generated by computational modeling based on atrial substrate maps acquired during clinical procedures in sinus rhythm. Smax maps were generated during the clinical PV isolation (PVI). The V-Smax group underwent an additional extra-PV ablation after PVI targeting the virtual high Smax sites.
Results:
After a mean follow-up period of 12.3±5.2 months, the clinical recurrence rates (25.6% vs. 23.9% in the V-Smax and the E-ABL group, p=0.880) or recurrence appearing as atrial tachycardia (11.1% vs. 5.7%, p=0.169) did not differ between the 2 groups. The postablation cardioversion rate was higher in the V-Smax group than E-ABL group (14.4% vs. 5.7%, p=0.027). Among antiarrhythmic drug-free patients (n=129), the AF freedom rate was 78.7% in the V-Smax group and 80.9% in the E-ABL group (p=0.776). The total procedure time was longer in the V-Smax group (p=0.008), but no significant difference was found in the major complication rates (p=0.497) between the groups.
Conclusions
Unlike a dominant frequency ablation, the computational modeling-guided V-Smax ablation did not improve the rhythm outcome of the PeAF ablation and had a longer procedure time.
6.Two Cases of Oculopharyngeal Muscular Dystrophy in Brothers with Ptosis and Eye Movement Disorder
Seulki BANG ; Sanghyu NAM ; Jin San LEE ; Sung-Hye PARK ; Min Seok KANG ; Tae Gi KIM ; Kyung Hyun JIN
Journal of the Korean Ophthalmological Society 2020;61(5):575-581
Purpose:
To report two cases of early onset oculopharyngeal muscular dystrophy, which were suspected to be chronic progressive external ophthalmoplegia.Case summary: Case 1, a 15-year-old male and Case 2, a 13-year-old male brother, visited the clinic with persistent diplopia 6 years prior. The older brother’s best-corrected visual acuity was 0.6 in both eyes and showed an exodeviation of 25 prism diopters. Bilateral ptosis was observed with ocular muscle movement limitations in all directions, and bilateral macular edema was found on fundus examinations. The younger brother had a best-corrected visual acuity of 1.0 in both eyes and showed exodeviation of 45 prism diopters. Bilateral ptosis and ocular muscle movement limitations were also observed. Both patients were suspected to have chronic progressive external ophthalmoplegia and were referred to a neurologist for a neurological examination and muscle biopsy. The muscle biopsies showed that both patients were diagnosed with oculopharyngeal muscular dystrophy.
Conclusions
It is important, initially, to report a case of early onset oculopharyngeal muscular dystrophy that has eyelid and eye movement symptoms, but no other typical symptoms.
7.Unilateral versus Bilateral Groin Puncture for Atrial Fibrillation Ablation: Multi-Center Prospective Randomized Study
Hee Tae YU ; Dong Geum SHIN ; Jaemin SHIM ; Gi Byoung NAM ; Won Woo YOO ; Ji Hyun LEE ; Tae Hoon KIM ; Jae Sun UHM ; Boyoung JOUNG ; Moon Hyoung LEE ; Young Hoon KIM ; Hui Nam PAK
Yonsei Medical Journal 2019;60(4):360-367
PURPOSE: Catheter ablation for atrial fibrillation (AF) requires heavy anticoagulation and uncomfortable post-procedural hemostasis. We compared patient satisfaction with and the safety of unilateral groin (UG) puncture-single trans-septal (ST) ablation with conventional bilateral groin (BG) puncture-double trans-septal (DT) ablation in paroxysmal AF patients. MATERIALS AND METHODS: We enrolled 222 patients with paroxysmal AF (59.4±10.7 years old) who were randomized in a 2:1 manner into UG-ST ablation (n=148) and BG-DT ablation (n=74) groups. If circumferential pulmonary vein isolation could not be achieved after three attempts of touch-up ablation in the UG-ST group, the patient was crossed over to BG-DT by performing a left groin puncture. RESULTS: Ten patients in the UG-ST group (6.8%) required crossover to the BG-DT approach. There were no significant differences in procedure time (p=0.144) and major complications rate (p>0.999) between the UG-ST and BG-DT groups. Access site pain (p=0.014), back pain (p=0.023), and total pain (p=0.015) scores were significantly lower for the UG-ST than BG-DT group as assessed by the Visual Analog Scale. Over 20.2±8.7 months of follow up, there was no difference in AF recurrence free-survival rates between the two groups (Log rank, p=0.984). CONCLUSION: UG-ST AF ablation is feasible and safe, and was found to significantly reduce post-procedural hemostasis-related discomfort, compared to the conventional DT approach, in patients with paroxysmal AF.
Atrial Fibrillation
;
Back Pain
;
Catheter Ablation
;
Follow-Up Studies
;
Groin
;
Hemostasis
;
Humans
;
Patient Satisfaction
;
Prospective Studies
;
Pulmonary Veins
;
Punctures
;
Recurrence
;
Visual Analog Scale
8.Oral Glucose Tolerance Testing Allows Better Prediction of Diabetes in Women with a History of Gestational Diabetes Mellitus
Tae Jung OH ; Yeong Gi KIM ; Sunyoung KANG ; Joon Ho MOON ; Soo Heon KWAK ; Sung Hee CHOI ; Soo LIM ; Kyong Soo PARK ; Hak C JANG ; Joon Seok HONG ; Nam H CHO
Diabetes & Metabolism Journal 2019;43(3):342-349
BACKGROUND: We aimed to identify the postpartum metabolic factors that were associated with the development of diabetes in women with a history of gestational diabetes mellitus (GDM). In addition, we examined the role of the oral glucose tolerance test (OGTT) in the prediction of future diabetes. METHODS: We conducted a prospective study of 179 subjects who previously had GDM but did not have diabetes at 2 months postpartum. The initial postpartum examination including a 75-g OGTT and the frequently sampled intravenous glucose tolerance test (FSIVGTT) was performed 12 months after delivery, and annual follow-up visits were made thereafter. RESULTS: The insulinogenic index (IGI30) obtained from the OGTT was significantly correlated with the acute insulin response to glucose (AIRg) obtained from the FSIVGTT. The disposition indices obtained from the OGTT and FSIVGTT were also significantly correlated. Women who progressed to diabetes had a lower insulin secretory capacity including IGI30, AIRg, and disposition indices obtained from the FSIVGTT and OGTT compared with those who did not. However, the insulin sensitivity indices obtained from the OGTT and FSIVGTT did not differ between the two groups. Multivariate logistic regression analysis showed that the 2-hour glucose and disposition index obtained from the FSIVGTT were significant postpartum metabolic risk factors for the development of diabetes. CONCLUSION: We identified a crucial role of β-cell dysfunction in the development of diabetes in Korean women with previous GDM. The 2-hour glucose result from the OGTT is an independent predictor of future diabetes. Therefore, the OGTT is crucial for better prediction of future diabetes in Korean women with previous GDM.
Diabetes Mellitus, Type 2
;
Diabetes, Gestational
;
Female
;
Follow-Up Studies
;
Glucose
;
Glucose Tolerance Test
;
Humans
;
Insulin
;
Insulin Resistance
;
Logistic Models
;
Postpartum Period
;
Pregnancy
;
Prospective Studies
;
Risk Factors
9.Invasive Aspergillosis Associated Bacterial Infection in the Nasal Septum After Sphenoid Sinus Surgery.
Hyun Gi SOHN ; Min Ho YOON ; Tae Eun KIM ; Nam Kyung YEO
Korean Journal of Otolaryngology - Head and Neck Surgery 2018;61(10):541-545
Nasal septal infection can result from progression of a fungal infection from the adjacent sinuses. Nasal septal fungal abscesses complicating nasal trauma, surgical procedures, sinus, and dental infections have previously been reported in a small number of cases. Adequate management involves early diagnosis, prompt empiric antifungal therapy, and surgical debridement in order to prevent the development of life-threatening complications. We report a rare case of nasal septum necrosis from Aspergillus infection in a 79-year-old man with diabetes mellitus and chronic renal failure following endoscopic sphenoid sinus surgery due to an isolated sphenoid fungal ball.
Abscess
;
Aged
;
Aspergillosis*
;
Aspergillus
;
Bacterial Infections*
;
Debridement
;
Diabetes Mellitus
;
Early Diagnosis
;
Humans
;
Kidney Failure, Chronic
;
Nasal Septum*
;
Necrosis
;
Sphenoid Sinus*
10.Long-circulating and target-specific distributions of cyanine 5.5-labeled hyaluronic acid nanoparticles in mouse organs during 28 days after a single administration
Tae Sik YUN ; Chunmei LIN ; Jung Min YON ; Seul Gi PARK ; Lee Wha GWON ; Jong Geol LEE ; In Jeoung BAEK ; Sang Seop NAHM ; Beom Jun LEE ; Young Won YUN ; Sang Yoon NAM
Korean Journal of Veterinary Research 2018;58(4):183-192
Although hyaluronic acid (HA) has been developed as a nanoparticle (NP; 320–400 nm) for a drug delivery system, the tissue targeting efficacy and the pharmacokinetics of HA-NPs are not yet fully understood. After a dose of 5 mg/kg of cyanine 5.5-labeled HA-NPs or HA-polymers was intravenously administrated into mice, the fluorescence was measured from 0.5 h to 28 days. The HA-NPs fluorescence was generally stronger than that of HA-polymers, which was maintained at a high level over 7 days in vivo, after which it gradually decreased. Upon ex vivo imaging, liver, spleen, kidney, lung, testis and sublingual gland fluorescences were much higher than that of other organs. The fluorescence of HA-NPs in the liver, spleen and kidney was highest at 30 min, where it was generally maintained until 4 h, while it drastically decreased at 1 day. However, the fluorescence in the liver and spleen increased sharply at 7 days relative to 3 days, then decreased drastically at 14 days. Conversely, the fluorescence of HA-polymers in the lymph node was higher than that of HA-NPs. The results presented herein may have important clinical implications regarding the safety of as self-assembled HA-NPs, which can be widely used in biomedical applications.

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