• Title/Summary/Keyword: Adverse outcomes

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A novel fully covered metal stent for unresectable malignant distal biliary obstruction: results of a multicenter prospective study

  • Arata Sakai;Atsuhiro Masuda;Takaaki Eguchi;Keisuke Furumatsu;Takao Iemoto;Shiei Yoshida;Yoshihiro Okabe;Kodai Yamanaka;Ikuya Miki;Saori Kakuyama;Yosuke Yagi;Daisuke Shirasaka;Shinya Kohashi;Takashi Kobayashi;Hideyuki Shiomi;Yuzo Kodama
    • Clinical Endoscopy
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    • v.57 no.3
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    • pp.375-383
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    • 2024
  • Background/Aims: Endoscopic self-expandable metal stent (SEMS) placement is currently the standard technique for treating unresectable malignant distal biliary obstructions (MDBO). Therefore, covered SEMS with longer stent patency and fewer migrations are required. This study aimed to assess the clinical performance of a novel, fully covered SEMS for unresectable MDBO. Methods: This was a multicenter single-arm prospective study. The primary outcome was a non-obstruction rate at 6 months. The secondary outcomes were overall survival (OS), recurrent biliary obstruction (RBO), time to RBO (TRBO), technical and clinical success, and adverse events. Results: A total of 73 patients were enrolled in this study. The non-obstruction rate at 6 months was 61%. The median OS and TRBO were 233 and 216 days, respectively. The technical and clinical success rates were 100% and 97%, respectively. Furthermore, the rate of occurrence of RBO and adverse events was 49% and 21%, respectively. The length of bile duct stenosis (<2.2 cm) was the only significant risk factor for stent migration. Conclusions: The non-obstruction rate of a novel fully covered SEMS for MDBO is comparable to that reported earlier but shorter than expected. Short bile duct stenosis is a significant risk factor for stent migration.

Risk factors for recurrent stenosis after balloon dilation for benign hepaticojejunostomy anastomotic stricture

  • Takafumi Mie;Takashi Sasaki;Takeshi Okamoto;Tsuyoshi Takeda;Chinatsu Mori;Yuto Yamada;Takaaki Furukawa;Akiyoshi Kasuga;Masato Matsuyama;Masato Ozaka;Naoki Sasahira
    • Clinical Endoscopy
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    • v.57 no.2
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    • pp.253-262
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    • 2024
  • Background/Aims: Hepaticojejunostomy anastomotic stricture (HJAS) is a feared adverse event associated with hepatopancreatobiliary surgery. Although balloon dilation for benign HJAS during endoscopic retrograde cholangiopancreatography with balloon-assisted enteroscopy has been reported to be useful, the treatment strategy remains controversial. Therefore, we evaluated the outcomes and risk factors of recurrent stenosis after balloon dilation alone for benign HJAS. Methods: We retrospectively analyzed consecutive patients who underwent balloon-assisted enteroscopy-endoscopic retrograde cholangiopancreatography for benign HJAS at our institution between July 2014 and December 2020. Results: Forty-six patients were included, 16 of whom had recurrent HJAS after balloon dilation. The patency rates at 1 and 2 years after balloon dilation were 76.8% and 64.2%, respectively. Presence of a residual balloon notch during balloon dilation was an independent predictor of recurrence (hazard ratio, 2.80; 95% confidence interval, 1.01-7.78; p=0.048), whereas HJAS within postoperative 1 year tended to be associated with recurrence (hazard ratio, 2.43; 95% confidence interval, 0.85-6.89; p=0.096). The patency rates in patients without a residual balloon notch were 82.1% and 73.1% after 1 and 2 years, respectively. Conclusions: Balloon dilation alone may be a viable option for patients with benign HJAS without residual balloon notches on fluoroscopy.

COVID-19 Vaccination-Related Myocarditis: What We Learned From Our Experience and What We Need to Do in The Future

  • Jae-Hyeong Park;Kye Hun Kim
    • Korean Circulation Journal
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    • v.54 no.6
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    • pp.295-310
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    • 2024
  • Coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 has led to a global health crisis with substantial mortality and morbidity. To combat the COVID-19 pandemic, various vaccines have been developed, but unexpected serious adverse events including vaccine-induced thrombotic thrombocytopenia, carditis, and thromboembolic events have been reported and became a huddle for COVID-19 vaccination. Vaccine-related myocarditis (VRM) is a rare but significant adverse event associated primarily with mRNA vaccines. This review explores the incidence, risk factors, clinical presentation, pathogenesis, management strategies, and outcomes associated with VRM. The incidence of VRM is notably higher in male adolescents and young adults, especially after the second dose of mRNA vaccines. The pathogenesis appears to involve an immune-mediated process, but the precise mechanism remains mostly unknown so far. Most studies have suggested that VRM is mild and self-limiting, and responds well to conventional treatment. However, a recent nationwide study in Korea warns that severe cases, including fulminant myocarditis or death, are not uncommon in patients with COVID-19 VRM. The long-term cardiovascular consequences of VRM have not been well understood and warrant further investigation. This review also briefly addresses the critical balance between the substantial benefits of COVID-19 vaccination and the rare risks of VRM in the coming endemic era. It emphasizes the need for continued surveillance, research to understand the underlying mechanisms, and strategies to mitigate risk. Filling these knowledge gaps would be vital to refining vaccination recommendations and improving patient care in the evolving COVID-19 pandemic landscape.

Inter-Facility Transport on Extracorporeal Life Support: Clinical Outcomes and Comparative Analysis with In-house Patients

  • Hong, Tae Hee;Lee, Heemoon;Jung, Jae Jun;Cho, Yang Hyun;Sung, Kiick;Yang, Ji-Hyuk;Lee, Young-Tak;Cho, Su Hyun
    • Journal of Chest Surgery
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    • v.50 no.5
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    • pp.363-370
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    • 2017
  • Background: Extracorporeal life support (ECLS) is widely used in refractory heart or lung failure, and the demand for inter-facility transportation on ECLS is expanding. However, little is known about post-transportation outcomes, the clinical safety of such transportation, or the characteristics of the transported patients. Methods: This was a retrospective review of a 3-year, single-institution experience with inter-facility ECLS transport, as well as a comparative analysis of clinical outcomes with those of in-house patients. We also analyzed the risk factors for hospital mortality in the entire ECLS population using univariate and multivariate analyses to investigate the effects of transport. Results: All 44 patients were safely transported without adverse events. The average travel distance was 178.7 km, with an average travel time of 74.0 minutes. Early survival of the transported group seemed to be better than that of the in-house group, but the difference was not statistically significant (70.5% vs. 56.6%, p=0.096). The incidence of complications was similar between the 2 groups, except for critical limb ischemia, which was significantly more common in the transported group than in the in-house group (25.0% vs. 8.1%, p=0.017). After adjusting for confounders, being part of the transported group was not a predictor of early death (adjusted odds ratio, 0.689; p=0.397). Conclusion: Transportation of patients on ECLS is relatively safe, and the clinical outcomes of transported patients are comparable to those of in-house ECLS patients. Although matched studies are required, our study demonstrates that transporting patients on ECLS did not increase their risk of hospital mortality after adjustment for other factors.

Clinical Analysis of Traumatic Pancreatic Injury (개복 수술로 확인된 외상성 췌장 손상 환자에 대한 임상적 고찰)

  • HwangBo, Seon-Mi;Kwon, Young-Bong;Yun, Kyung-Jin;Kwon, Hyung-Jun;Chun, Jae-Min;Kim, Sang-Geol;Park, Jin-Young;Hwang, Yun-Jin;Yun, Young-Gook
    • Journal of Trauma and Injury
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    • v.24 no.2
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    • pp.68-74
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    • 2011
  • Purpose: Although pancreas injury is rare in abdominal trauma, it poses a challenge to the surgeon because its clinical features are not prominent and the presence of main duct injury cannot be easily identified by imaging studies. Furthermore, severe pancreas injuries require a distal pancreatectomy or a pancreaticoduodnectomy which are associated considerable morbidity and mortality. We reviewed the clinical features of and outcomes for patients with pancreas injury. Methods: For 10 years from Jan. 2001 to Dec. 2010, thirty-four patients were diagnosed as having pancreas injury by using an explo-laparotomy. Patients successfully treated by non-operative management were excluded. Patients were divided into early (n=18) and delayed surgery groups (n=11) based on an interval of 24hours between injury and surgery. The clinical features of and the outcomes for the patients in both groups were compared. Results: Males were more commonly injured (82.4% vs.17.6%). The mean age was 37.2 years. The injury mechanisms included vehicle accidents (62.9%, 22/34), assaults (20%, 7/34), and falls (11.4%, 3/34). The head and neck of the pancreas was most commonly injured, followed by the body and the tail (16, 12, and 6 cases).Of the 34 patients, 26 (76.5%) patients had accompanying injuries. Grade 1 and 2 occurred in 14 (5 and 9) patients, and grade 3, 4, and 5 occurred in 20 (16, 3, and 1) patients. The early and delayed surgery groups showed no difference in surgical outcomes. Two patients with grade 3 in the early surgery group died after surgery,one due to massive hemorrhage and the other due to septic shock. Of the five patients initially managed non-operatively, three developed peripancreatic necrosis and two developed pseudocyst. All five patients were successfully cured by surgery. Conclusion: All cases of pancreas injury in this study involved blunt injury, and accompanying injury to major vessels or the bowel was the major cause of mortality. Surgery delayed for longer than 24 hours after was not associated with adverse outcomes.

Protocol of a Nationwide Observational Study among Patients with Nontuberculous Mycobacterium Pulmonary Disease in South Korea (NTM-KOREA)

  • Kwak, Nakwon;Choi, Hongjo;Jeon, Doosoo;Jhun, Byung Woo;Jo, Kyung-Wook;Kang, Young Ae;Kwon, Yong-Soo;Lee, Myungsun;Mok, Jeongha;Shim, Tae-Sun;Shin, Hong-Joon;Whang, Jake;Yim, Jae-Joon
    • Tuberculosis and Respiratory Diseases
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    • v.83 no.2
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    • pp.141-146
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    • 2020
  • Background: The burden of nontuberculous mycobacterial (NTM) pulmonary disease (PD) is increasing globally. To understand the treatment outcomes and prognosis of NTM-PD, a unified registry is needed. In this project, we aim to construct a multicenter prospective observational cohort with NTM-PD in South Korea (NTM-KOREA). Methods: The primary objective of this study is to analyze treatment outcomes according to the species. In addition, recurrence rate, adverse events, the impact of each drug on treatment outcomes as well as the impact of characteristics of mycobacteriology will be analyzed. The inclusion criteria for the study are as follows: fulfilling the criteria for NTM-PD having one of the following etiologic organisms: Mycobacterium avium complex, M. abscessus subspecies abscessus, M. abscessus subspecies massiliense, or M. kansasii; receiving the first treatment for NTM-PD after enrollment; age >20 years; and consenting to participate in the study. Seven institutions will participate in patient enrollment and about 500 patients are expected to be enrolled. Participants will be recruited from 1 March 2020 until 19 March 2024 and will be observed through 19 March 2029. During the follow-up period, participants' clinical course will be tracked and their clinical data as well as NTM isolates will be collected. Conclusion: NTM-KOREA will be the first nationwide observational cohort for NTM-PD in South Korea. It will provide the information to optimize treatment modalities and will contribute to deeper understanding of the treatment outcomes and long-term prognosis of patients with NTM-PD in South Korea.

Reproductive outcomes of retransferring retained embryos in blastocyst transfer cycles

  • Yi, Hyun Jeong;Koo, Hwa Seon;Cha, Sun Hwa;Kim, Hye Ok;Park, Chan Woo;Song, In Ok
    • Clinical and Experimental Reproductive Medicine
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    • v.43 no.2
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    • pp.133-138
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    • 2016
  • Objective: To determine the incidence of embryo retention (ER) in the transfer catheter following embryo transfer (ET) in blastocyst transfer and investigate whether retransferring retained embryos has an impact on reproductive outcomes in patients undergoing in vitro fertilization-ET. Methods: We retrospectively analyzed the records of 1,131 blastocyst transfers, which comprised 223 single blastocyst transfer (SBT) and 908 double blastocyst transfer (DBT) cycles. Each SBT and DBT group was classified depending on whether ET was performed without retained embryos in the catheter during the first attempt (without-ER group) or whether any retained embryos were found following ET (ER group) for the purpose of comparing reproductive outcomes in a homogenous population. Results: The overall incidence of finding retained embryos was 2.8% (32/1,131). There were no retained embryos in SBT cycles. In DBT cycles, implantation rates (30.0% vs. 26.6%), positive ${\beta}-hCG$ rates (57.2% vs. 56.2%), clinical pregnancy rates (45.3% vs. 46.9%), and live birth rates (38.9% vs. 43.8%) were not significantly different between the without-ER and ER groups. There were no significant differences in the mean birth weight (g) $2,928.4{\pm}631.8$ vs. $2,948.7{\pm}497.8$ and the mean gestational age at birth ($269.3{\pm}17.2days$ vs. $264.2{\pm}25.7days$). A total of nine cases of congenital birth defects were found in this study population. Eight were observed in the without-ER group and one in the ER group. Conclusion: Our results suggest that retransfer of retained embryos does not have any adverse impact on reproductive outcomes in blastocyst transfer cycles. Furthermore, our results support finding that SBT might be advantageous for decreasing the incidence of retained embryos in catheters.

Pregnancy Rates and Outcomes of HIV-Infected Women in Korea

  • Choi, Heun;Kim, Moo Hyun;Lee, Se Ju;Kim, Eun Jin;Lee, Woonji;Jeong, Wooyong;Jung, In Young;Ahn, Jin Young;Jeong, Su Jin;Ku, Nam Su;Baek, Ji Hyeon;Choi, Young Hwa;Kim, Hyo Youl;Kim, June Myung;Choi, Jun Yong
    • Journal of Korean Medical Science
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    • v.33 no.47
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    • pp.296.1-296.7
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    • 2018
  • Background: Antepartum, intrapartum, and postpartum preventive measures with antiretroviral drugs, appropriate delivery methods, and discouraging breastfeeding significantly decrease the risk of mother-to-child transmission of human immunodeficiency virus (HIV) infection. Herein, we investigated the pregnancy outcomes in HIV-infected Korean women. Methods: We retrospectively reviewed medical records of childbearing-age HIV-infected women between January 2005 and June 2017 at four tertiary care hospitals in Korea. Results: Among a total of 95 HIV infected women of child-bearing age with 587.61 years of follow-up duration, 15 HIV-infected women experienced 21 pregnancies and delivered 16 infants. The pregnancy rate was 3.57 per 100 patient-years. Among the 21 pregnancies, five ended with an induced abortion, and 16 with childbirth including two preterm deliveries at 24 and 35 weeks of gestation, respectively. The two preterm infants had low birth weight and one of them died 10 days after delivery due to respiratory failure. Among the 14 full-term infants, one infant was small for gestational age. There were no HIV-infected infants. Conclusion: The pregnancy rate of HIV-infected women in Korea is lower than that of the general population. Although several adverse pregnancy outcomes were observed, mother-to-child transmission of HIV infection was successfully prevented with effective preventive measures.

Prognostic Factors in Patients Treated with DrugCoated Balloon Angioplasty for Symptomatic Peripheral Artery Disease

  • Sigala, Fragiska;Galyfos, George;Stavridis, Kyriakos;Tigkiropoulos, Konstantinos;Lazaridis, Ioannis;Karamanos, Dimitrios;Mpontinis, Vangelis;Melas, Nikolaos;Zournatzi, Ioulia;Filis, Konstantinos;Saratzis, Nikolaos
    • Vascular Specialist International
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    • v.34 no.4
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    • pp.94-102
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    • 2018
  • Purpose: Aim of this study is to report real-life experience on the treatment of peripheral artery disease (PAD) with a specific drug-coated balloon (DCB), and to evaluate potential prognostic factors for outcomes. Materials and Methods: This is a retrospective study reporting outcomes in patients with PAD who were treated with the Lutonix DCB during a four-year period. Major outcomes included: all-cause mortality, amputation, clinical improvement, wound healing and target lesion revascularization (TLR). Mean follow-up was $24.2{\pm}2.3$ months. Results: Overall, 149 patients (mean age: $68.6{\pm}8.3$ years; 113 males) were treated, either for intermittent claudication (IC) (n=86) or critical limb ischemia (CLI) (n=63). More than half the target lesions (n=206 in total) were located in the superficial femoral artery and 18.0% were below-the-knee lesions. CLI patients presented more frequently with infrapopliteal (P=0.002) or multilevel disease (P=0.0004). Overall, all-cause mortality during follow-up was 10.7%, amputation-free survival was 81.2% and TLR-free survival was 96.6%. CLI patients showed higher all-cause mortality (P=0.007) and total amputation (P=0.0001) rates as well as lower clinical improvement (P=0.0002), compared to IC patients. Coronary artery disease (CAD), gangrene and infrapopliteal disease were found to be predictors for death whereas CLI and gangrene were found to be predictors for amputation, during follow-up. Conclusion: PAD treatment with Lutonix DCBs seems to be an efficient and safe endovascular strategy yielding promising results. However, CAD, gangrene, CLI and infrapopliteal lesions were found to be independent predictors for adverse outcomes. Larger series are needed to identify additional prognostic factors.

C7 Fracture as a Complication of C7 Dome-Like Laminectomy : Impact on Clinical and Radiological Outcomes and Evaluation of the Risk Factors

  • Yang, Seung Heon;Kim, Chi Heon;Lee, Chang Hyun;Ko, Young San;Won, Youngil;Chung, Chun Kee
    • Journal of Korean Neurosurgical Society
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    • v.64 no.4
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    • pp.575-584
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    • 2021
  • Objective : Cervical expansive laminoplasty is an effective surgical method to address multilevel cervical spinal stenosis. During surgery, the spinous processes of C2 and C7 are usually preserved to keep the insertion points of the cervical musculature and nuchal ligament intact. In this regard, dome-like laminectomy (undercutting of C7 lamina) instead of laminoplasty is performed on C7 in selected cases. However, resection of the lamina can weaken the C7 lamina, and stress fractures may occur, but this complication has not been characterized in the literature. The objective of the present study was to investigate the incidence and risk factors for C7 laminar fracture after C7 dome-like laminectomy and its impact on clinical and radiological outcomes. Methods : Patients who underwent cervical open-door laminoplasty combined with C7 dome-like laminectomy (n=123) were classified according to the presence of C7 laminar fracture. Clinical parameters (neck/arm pain score and neck disability index) and radiologic parameters (C2-7 angle, C2-7 sagittal vertical axis, and C7-T1 angle) were compared between the groups preoperatively and at postoperatively at 3, 6, 12, and 24 months. Risk factors for complications were evaluated, and a formula estimating C7 fracture risk was suggested. Results : C7 lamina fracture occurred in 32/123 (26%) patients and occurred at the bilateral isthmus in 29 patients and at the spinolaminar junction in three patients. All fractures appeared on X-ray within 3 months postoperatively, but patients did not present any neurological deterioration. The fracture spontaneously healed in 27/32 (84%) patients at 1 year and in 29/32 (91%) at 2 years. During follow-up, clinical outcomes were not significantly different between the groups. However, patients with C7 fractures showed a more lordotic C2-7 angle and kyphotic C7-T1 angle than patients without C7 fractures. C7 fracture was significantly associated with the extent of bone removal. By incorporating significant factors, the probability of C7 laminar fracture could be assessed with the formula 'Risk score = 1.08 × depth (%) + 1.03 × length (%, of the posterior height of C7 vertebral body)', and a cut-off value of 167.9% demonstrated a sensitivity of 90.3% and a specificity of 65.1% (area under the curve, 0.81). Conclusion : C7 laminar fracture can occur after C7 dome-like laminectomy when a substantial amount of lamina is resected. Although C7 fractures may not cause deleterious clinical outcomes, they can lead to an unharmonized cervical curvature. The chance of C7 fracture should be discussed in the shared decision-making process.