RESUMO
PURPOSE: To analyze cardiovascular and cerebrovascular adverse events (ADRs) after intravitreal anti-vascular endothelial growth factor (VEGF; aflibercept, bevacizumab, brolucizumab, and ranibizumab) treatment. SUBJECTS: VigiBase, a World Health Organization (WHO) global safety report database DESIGN: Pharmacovigilance study METHODS: The individual-case-safety reports (ICSR) of cardiovascular and cerebrovascular ADRs after intravitreal anti-VEGF treatment were compared with those reported in the full database. From 2004 to 2023, 23,129 ADRs after intravitreal anti-VEGF therapy and 25,015,132 ADRs associated with any drug (full database). MAIN OUTCOME MEASURES: The reporting odds ratio (ROR) and information components (IC) were calculated, and the 95% lower credibility interval endpoint of the information component (IC025) was used for disproportionate Bayesian reporting. Inter-drug comparisons were performed using the ratio of odd ratio (rOR). RESULTS: Compared with the full database, anti-VEGFs were associated with an increased reporting of myocardial infarction (IC025 0.75; ROR: 1.78 [95% CI 1.70-1.86]), angina pectoris (IC025 0.53; ROR: 1.61 [95% CI 1.47-1.77]), arrythemias including atrial fibrillation, atrial flutter, ventricular fibrillation, supraventricular tachycardia (all IC025 >0, ROR>1), hypertension (IC025 2.22; ROR: 4.91 [95% CI 4.82-5.01]), and hypertensive crisis (IC025 1.97; ROR: 4.49 [95% CI 4.07-4.97]). Moreover, anti-VEGFs were associated with a higher reporting of cerebrovascular ADRs such as cerebral infarction (IC025 4.34; ROR: 23.19 [95% CI 22.10-24.34]), carotid artery stenosis (IC025 1.85; ROR: 5.24 [95% CI 3.98-6.89]), cerebral hemorrhage (IC025 2.29; ROR: 5.38 [95% CI 5.03-5.76]), and subarachnoid hemorrhage (IC025 1.98; ROR: 4.81 [95% CI 4.14-5.6]). Inter-drug comparison indicated that compared to ranibizumab, patients with aflibercept showed overall under-reporting of cardiovascular and cerebrovascular ADRs such as myocardial infarction (rOR 0.55 [95% CI 0.49-0.52]), atrial fibrillation (rOR 0.28 [95% CI 0.23-0.35]), cerebrovascular accident (rOR, 0.15 [95% CI 0.14-0.17]), and cerebral hemorrhage (rOR, 0.51 [95% CI 0.40-0.65]). CONCLUSIONS: In this pharmacovigilance case-noncase study, significantly increased reporting of cardiovascular and cerebrovascular ADRs were identified after intravitreal anti-VEGF treatment. While ranibizumab may exhibit superior systemic safety regarding its biological characteristics, it is crucial not to overlook the occurrence of cardiovascular and cerebrovascular ADRs considering its higher reporting rate than bevacizumab or aflibercept.
RESUMO
BACKGROUND: This study aimed to generate a Z score calculation model for coronary artery diameter of normal children and adolescents to be adopted as the standard calculation method with consensus in clinical practice. METHODS: This study was a retrospective, multicenter study that collected data from multiple institutions across South Korea. Data were analyzed to determine the model that best fit the relationship between the diameter of coronary arteries and independent demographic parameters. Linear, power, logarithmic, exponential, and square root polynomial models were tested for best fit. RESULTS: Data of 2,030 subjects were collected from 16 institutions. Separate calculation models for each sex were developed because the impact of demographic variables on the diameter of coronary arteries differs according to sex. The final model was the polynomial formula with an exponential relationship between the diameter of coronary arteries and body surface area using the DuBois formula. CONCLUSION: A new coronary artery diameter Z score model was developed and is anticipated to be applicable in clinical practice. The new model will help establish a consensus-based Z score model.
Assuntos
Vasos Coronários , Humanos , Feminino , Masculino , Estudos Retrospectivos , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/anatomia & histologia , Criança , Adolescente , República da Coreia , Pré-Escolar , Fatores Sexuais , Superfície Corporal , LactenteRESUMO
Ventricular septal defect (VSD) is a common congenital heart disease. However, consensus on the utility of echocardiography in predicting spontaneous closure (SC) of VSD remains lacking. This study aimed to identify and validate significant predictors of SC through a predictive scoring system. This retrospective study included medical records of 712 echocardiography instances performed on 304 patients diagnosed with VSD from 2016 to 2020 in their first year of life. A novel scoring system for predicting the SC of VSD was developed and validated using another dataset from different hospitals. Of the 304 patients, 215 (70.7%) had perimembranous (PM) VSDs and 89 had muscular (29.3%) VSDs. The median follow-up periods were 36.2 (interquartile range [IQR], 13-59) months and 13.7 9 (IQR, 5-37.4) days for PM and muscular VSDs, respectively. The overall SC rate during follow-up was 29.3%. Pulmonary hypertension (HTN), concomitant left ventricle (LV)-right atrium (RA) shunt, VSD size to aortic valve (AV) annulus size ratio, and left ventricular end-diastolic dimension (LVEDD) z-score were significant risk factors affecting SC of VSD. The "P-VSD" score, a new scoring system, demonstrated an area under the curve for predictability of 0.769. Pulmonary HTN, concomitant LV-RA shunt, LVEDD z-score, and VSD size-to-AV annulus size ratio at diagnosis were significantly associated with non-SC VSD after infancy. The P-VSD score can predict the SC of VSD in clinical settings and simplify the identification and appropriate management of high-risk patients.
RESUMO
Pulmonary arterial hypertension (PAH) is a severe medical condition characterized by elevated blood pressure in the pulmonary arteries. Nitric oxide (NO) is a gaseous signaling molecule with potent vasodilator effects; however, inhaled NO is limited in clinical practice because of the need for tracheal intubation and the toxicity of high NO concentrations. In this study, inhalable NO-releasing microspheres (NO inhalers) are fabricated to deliver nanomolar NO through a nebulizer. Two NO inhalers with distinct porous structures are prepared depending on the molecular weights of NO donors. It is confirmed that pore formation can be controlled by regulating the migration of water molecules from the external aqueous phase to the internal aqueous phase. Notably, open porous NO inhalers (OPNIs) can deliver NO deep into the lungs through a nebulizer. Furthermore, OPNIs exhibit vasodilatory and anti-inflammatory effects via sustained NO release. In conclusion, the findings suggest that OPNIs with highly porous structures have the potential to serve as tools for PAH treatment.
RESUMO
Two messenger RNA (mRNA) vaccines developed by Pfizer-BioNTech and Moderna are being rolled out. Despite the high volume of emerging evidence regarding adverse events (AEs) associated with the COVID-19 mRNA vaccines, previous studies have thus far been largely based on the comparison between vaccinated and unvaccinated control, possibly highlighting the AE risks with COVID-19 mRNA vaccination. Comparing the safety profile of mRNA vaccinated individuals with otherwise vaccinated individuals would enable a more relevant assessment for the safety of mRNA vaccination. We designed a comparative safety study between 18 755 and 27 895 individuals who reported to VigiBase for adverse events following immunization (AEFI) with mRNA COVID-19 and influenza vaccines, respectively, from January 1, 2020, to January 17, 2021. We employed disproportionality analysis to rapidly detect relevant safety signals and compared comparative risks of a diverse span of AEFIs for the vaccines. The safety profile of novel mRNA vaccines was divergent from that of influenza vaccines. The overall pattern suggested that systematic reactions like chill, myalgia, fatigue were more noticeable with the mRNA COVID-19 vaccine, while injection site reactogenicity events were more prevalent with the influenza vaccine. Compared to the influenza vaccine, mRNA COVID-19 vaccines demonstrated a significantly higher risk for a few manageable cardiovascular complications, such as hypertensive crisis (adjusted reporting odds ratio [ROR], 12.72; 95% confidence interval [CI], 2.47-65.54), and supraventricular tachycardia (adjusted ROR, 7.94; 95% CI, 2.62-24.00), but lower risk of neurological complications such as syncope, neuralgia, loss of consciousness, Guillain-Barre syndrome, gait disturbance, visual impairment, and dyskinesia. This study has not identified significant safety concerns regarding mRNA vaccination in real-world settings. The overall safety profile patterned a lower risk of serious AEFI following mRNA vaccines compared to influenza vaccines.
Assuntos
COVID-19 , Vacinas contra Influenza , Influenza Humana , Sistemas de Notificação de Reações Adversas a Medicamentos , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Humanos , Vacinas contra Influenza/efeitos adversos , Influenza Humana/prevenção & controle , Farmacovigilância , RNA Mensageiro/genética , Organização Mundial da Saúde , Vacinas de mRNARESUMO
AIMS: The clinical manifestation and outcomes of thrombosis with thrombocytopenia syndrome (TTS) after adenoviral COVID-19 vaccine administration are largely unknown due to the rare nature of the disease. We aimed to analyse the clinical presentation, treatment modalities, outcomes, and prognostic factors of adenoviral TTS, as well as identify predictors for mortality. METHODS AND RESULTS: PubMed, Scopus, Embase, and Web of Science databases were searched and the resulting articles were reviewed. A total of 6 case series and 13 case reports (64 patients) of TTS after ChAdOx1 nCoV-19 vaccination were included. We performed a pooled analysis and developed a novel scoring system to predict mortality. The overall mortality of TTS after ChAdOx1 nCoV-19 vaccination was 35.9% (23/64). In our analysis, age ≤60 years, platelet count <25 × 103/µL, fibrinogen <150 mg/dL, the presence of intracerebral haemorrhage (ICH), and the presence of cerebral venous thrombosis (CVT) were significantly associated with death and were selected as predictors for mortality (1 point each). We named this novel scoring system FAPIC (fibrinogen, age, platelet count, ICH, and CVT), and the C-statistic for the FAPIC score was 0.837 (95% CI 0.732-0.942). Expected mortality increased with each point increase in the FAPIC score, at 2.08, 6.66, 19.31, 44.54, 72.94, and 90.05% with FAPIC scores 0, 1, 2, 3, 4, and 5, respectively. The FAPIC scoring model was internally validated through cross-validation and bootstrapping, then externally validated on a panel of TTS patients after Ad26.COV2.S administration. CONCLUSIONS: Fibrinogen levels, age, platelet count, and the presence of ICH and CVT were significantly associated with mortality in patients with TTS, and the FAPIC score comprising these risk factors could predict mortality. The FAPIC score could be used in the clinical setting to recognize TTS patients at high risk of adverse outcomes and provide early intensive interventions including intravenous immunoglobulins and non-heparin anticoagulants.
Assuntos
COVID-19 , Trombocitopenia , Trombose , Vacinas contra COVID-19 , ChAdOx1 nCoV-19 , Humanos , Pessoa de Meia-Idade , SARS-CoV-2 , VacinaçãoRESUMO
Remdesivir has demonstrated clinical benefits in randomized placebo-controlled trials (RCTs) in patients with coronavirus disease 2019 (COVID-19)1-4 and was first approved for COVID-19 patients.5 However, whether remdesivir causes gastrointestinal adverse drug reaction (GI-ADRs) including hepatotoxicity is less clear.1-4,6 Therefore, we aimed to detect a diverse spectrum of GI-ADRs associated with remdesivir using VigiBase, the World Health Organization's international pharmacovigilance database of individual case safety reports.
Assuntos
Tratamento Farmacológico da COVID-19 , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Monofosfato de Adenosina/análogos & derivados , Sistemas de Notificação de Reações Adversas a Medicamentos , Alanina/análogos & derivados , Bases de Dados Factuais , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Humanos , Farmacovigilância , SARS-CoV-2 , Organização Mundial da SaúdeRESUMO
BACKGROUND: Device embolization is the most frequent procedural complication during transcatheter closure of congenital cardiac defects. Retrieval of an embolized device may often be complicated by failure to introduce the right atrial (RA) disk hub into the sheath or difficulty in securely grasping the hub pin of RA disk. We aimed to evaluate the efficiency and success rate of device retrieval using a novel double snare technique. METHODS: We reviewed retrieval procedures of embolized atrial septal defect (ASD) or left atrial appendage (LAA) occluder using double snare technique reported from five tertiary referral centers in Korea, Japan, and Uzbekistan. A total of 16 retrieval procedures in 15 patients were reported, including 14 patients who were planned for ASD device closure while 1 patient was planned for LA appendage occlusion. RESULTS: Retrieved devices included 15 ASD occluders from six different manufacturers and one Amplantzer cardiac plug. Success rate of retrieval procedure was 100% using the double snare technique. There were no complications related to device retrieval. Most (15/16, 93.8%) of these devices could be retrieved through their original delivery sheaths. In six patients for whom retrieval was unsuccessful with conventional single snare technique and switched to double snare technique, the retrieval time was shortened significantly (P = 0.004*) by using the double snare technique. CONCLUSIONS: The double snare technique enables effective retrieval of various embolized devices. It abolishes the need of changing the sheath to a larger one in most patients.
Assuntos
Apêndice Atrial/cirurgia , Remoção de Dispositivo/métodos , Comunicação Interatrial/cirurgia , Complicações Intraoperatórias , Dispositivo para Oclusão Septal/efeitos adversos , Adulto , Cateterismo Cardíaco/instrumentação , Feminino , Átrios do Coração/cirurgia , Humanos , Complicações Intraoperatórias/etiologia , Complicações Intraoperatórias/cirurgia , Japão , Masculino , Pessoa de Meia-Idade , Falha de Prótese , República da Coreia , Resultado do Tratamento , UzbequistãoAssuntos
COVID-19/epidemiologia , Síndrome de Linfonodos Mucocutâneos/epidemiologia , Síndrome de Linfonodos Mucocutâneos/terapia , Adolescente , COVID-19/prevenção & controle , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , República da Coreia/epidemiologia , Estudos Retrospectivos , Adulto JovemRESUMO
We report a fatal case of acute gastric dilatation in a 3-year old boy who presented with severe abdominal pain and massive gastric distension in the emergency room. On physical examination the patient was in shock due to acute abdomen and lower limb ischemia. Initial laboratory findings showed multi-organ failure with acute renal failure and pancreatitis. Abdominal computed tomography (CT) showed marked dilatation of the stomach resulting in compression of the abdominal aorta. The left kidney, spleen and pancreas were not visible on CT due to the necrotic changes. The patient was quickly stabilized by initial volume resuscitation, but suddenly deteriorated immediately after gastric decompression via nasogastric tube, and died from multi-organ failure 3 h after initial presentation.
Assuntos
Aorta Abdominal/diagnóstico por imagem , Doenças da Aorta/etiologia , Dilatação Gástrica/complicações , Doença Aguda , Doenças da Aorta/diagnóstico , Pré-Escolar , Constrição Patológica/diagnóstico , Constrição Patológica/etiologia , Diagnóstico Diferencial , Evolução Fatal , Dilatação Gástrica/diagnóstico , Humanos , Masculino , Radiografia Abdominal , Tomografia Computadorizada por Raios XRESUMO
The Liesegang pattern is a beautiful natural anisotropic patterning phenomenon observed in rocks and sandstones. This study reveals that the Liesegang pattern can induce nonlinear elasticity. Here, a Liesegang-patterned complex with biomineral-hydrogel repetitive layers is prepared. This Liesegang-patterned complex is obtained only when the biomineralization is performed under the supersaturated conditions. The Liesegang-patterned complex features a nonlinear elastic response, whereas a complex with a single biomineral shell shows a linear behavior, thus demonstrating that the Liesegang pattern is essential in achieving nonlinear elasticity. The stiff biomineral layers have buffered the concentrated energy on behalf of soft hydrogels, thereby exposing the hydrogel components to reduced stress and, in turn, enabling them to perform the elasticity continuously. Moreover, the nonlinear elastic Liesegang-patterned complex exhibits excellent stress relaxation to the external loading, which is the biomechanical characteristic of cartilage. This stress relaxation allows the bundle of fiber-type Liesegang-patterned complex to endure greater deformation.
RESUMO
BACKGROUND: Methimazole (MMI) and propylthiouracil (PTU) are commonly used for patients with thyrotoxicosis. Agranulocytosis and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is associated with high morbidity and mortality, requiring appropriate interventions. In this study, we compared adverse drug effects associated with MMI and PTU using a real-world large pharmacovigilance database. METHODS: We searched all Individual Case Safety Reports reported to be associated with MMI and PTU, from VigiBase between 1967 and June 2, 2021. We conducted disproportionality analysis (case/non-case analysis) to analyze the difference in reported adverse drug reactions (ADRs) between antithyroid drugs (case) and the entire database (non-cases). We further analyzed information for the cases of agranulocytosis and AAV. RESULTS: Among 11 632 cases of ADRs reported after MMI intake, agranulocytosis occurred in 1633 cases and AAV occurred in 41 cases. For 5055 cases of ADRs reported after PTU intake, agranulocytosis occurred in 459 cases and AAV occurred in 110 cases. Agranulocytosis occurred after a median of 28 days after PTU intake and 33 days after MMI intake. More than 95% of the agranulocytosis cases were classified as serious, but most of them (65.1% for PTU and 70.4% for MMI) were reported to have recovered after dechallenge actions; mostly drug withdrawal. AAV occurred after a median of 668 days after PTU intake, and 1162 days after MMI intake. CONCLUSIONS: This is a pharmacoepidemiological study investigating agranulocytosis and AAV caused by MMI and PTU. Through this research, we could provide more specific insights into a safe prescription of antithyroid drugs in a real-world setting.
Assuntos
Agranulocitose , Vasculite Associada a Anticorpo Anticitoplasma de Neutrófilos , Antitireóideos , Bases de Dados Factuais , Metimazol , Farmacovigilância , Propiltiouracila , Antitireóideos/efeitos adversos , Humanos , Agranulocitose/induzido quimicamente , Agranulocitose/epidemiologia , Propiltiouracila/efeitos adversos , Metimazol/efeitos adversos , Vasculite Associada a Anticorpo Anticitoplasma de Neutrófilos/induzido quimicamente , Feminino , Masculino , Pessoa de Meia-Idade , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Idoso , Organização Mundial da Saúde , Adulto Jovem , AdolescenteRESUMO
Introduction: The long-term effects of fenestration in patients with Fontan circulation remain unclear. We aim to evaluate the fenestration impact on early and late outcomes in patients with extracardiac Fontan (ECF) using a propensity score matching analysis. Methods: We performed an extensive retrospective multicenter clinical data review of the Korean Fontan registry and included 1,233 patients with surgical ECF (779 fenestrated, 454 non-fenestrated). Demographics, baseline, and follow-up data were collected and comprehensively analyzed. Patients were divided into two groups according to the baseline presence or absence of surgical fenestration. Subsequently, patients were sub-divided according to the fenestration status at the last follow-up. Propensity-score matching was performed to account for collected data between the 2 groups using a multistep approach. The primary outcomes were survival and freedom from Fontan failure (FFF). We also looked at postoperative hemodynamics, cardiopulmonary exercise test results, oxygen saturations, and functional status. Results: After propensity-score matching (454 matched pairs), there was no difference in survival or FFF between the 2 groups. However, ECF patients with baseline fenestration had significantly lower oxygen saturation (p = 0.001) and lower functional status (p < 0.001). Patients with fenestration had significantly longer bypass times, higher postoperative central venous pressure, higher postoperative left atrial pressure, and less prolonged pleural effusion in the early postoperative period. The propensity score matching according to the fenestration status at the last follow-up (148 matched pairs) showed that patients with a persistent fenestration had significantly lower oxygen saturation levels (p < 0.001). However there were no intergroup differences in the functional status, survival and FFF. Conclusions: Our results showed no long-term benefits of the Fenestration in terms of survival and FFF. Patients with persistent fenestration showed oxygen desaturation but no difference in exercise intolerance was shown between the 2 groups.
RESUMO
During the coronavirus disease 2019 (COVID-19) outbreak, the prevalence of obesity increased globally; this may be associated with hypertension incidence. However, investigations on the changes in the prevalence of hypertension among children and adolescents are limited. This cross-sectional study investigated the prevalence of hypertension among 1428 youths aged 10-18 years using data from the Korea National Health and Nutrition Examination Survey 2018-2020. We assessed the prevalence of hypertension according to sex, age, body mass index (BMI), and residential district. The prevalence of hypertension increased from 7.1% to 12.5% in all participants. In the sex-specific analysis, the prevalence was found to be increased in boys. In the age-specific analysis, the prevalence was found to be increased in youths aged 13-15 years. In the BMI-specific analysis, an increase in the prevalence was prominent in the normal BMI group. In the residential district-specific analysis, the prevalence of hypertension among youth increased in urban areas. Our results show that the prevalence of hypertension increased among Korean children and adolescents during the COVID-19 outbreak. These findings suggest the importance of close monitoring of hypertension among youth during the COVID-19 pandemic.
RESUMO
Thyroid hormone plays a vital role in regulating human metabolism. They affect the functions of major organs, such as the brain, liver, skeletal muscle, and heart. Hypothyroidism can lead to dilated cardiomyopathy and decreased heart function. In this report, we describe a case of a teenage boy who developed dilated cardiomyopathy due to hypothyroidism and was considered to undergo heart transplantation. Levothyroxine monotherapy was initiated but produced no improvement. Thereafter, a combination therapy of liothyronine and levothyroxine was administered, and heart function was gradually restored; he recovered completely after 6 months. Cardiac myocytes respond more specifically to liothyronine than to levothyroxine. Therefore, we suggest that liothyronine and levothyroxine combination therapy should be considered rather than levothyroxine monotherapy for hypothyroidism accompanied by heart disease.
RESUMO
Pulmonary arterial hypertension (PAH) related to an atrial septal defect (ASD) poses a challenge to transcatheter closure of an ASD (tcASD). We aimed to determine the predictors for remaining PAH (rPAH) post-tcASD. This retrospective study was conducted at a single tertiary university hospital. Adult patients with an ASD and PAH were divided into three groups according to pulmonary vascular resistance (PVR). Normalization of pulmonary atrial systolic pressure (PASP) was defined as an estimated right ventricular systolic pressure < 40 mmHg and was determined using transthoracic echocardiography. Among 119 patients, 80% showed PAH normalization post-tcASD. Normalization of PAH post-tcASD was observed in 100%, 56.2%, and 28.6% of patients in mild, moderate, and severe PVR groups, respectively. The patients' New York Heart Association functional class improved. Multivariate logistic regression analysis showed that age and high PVR were significant risk factors for rPAH. A receiving operator curve analysis showed a PASP cutoff value > 67.5 mmHg to be predictive of rPAH post-tcASD, with an area under the curve value of 0.944 (sensitivity, 0.922; specificity 0.933). Most patients, including moderate-to-severe PAH patients, improved hemodynamically and clinically with tcASD. Since patients with severe PAH are at a risk of rPAH, tcASD should be performed by selecting the patient carefully based on pre-procedure medication, a vasoreactivity test, and a balloon occlusion test.
RESUMO
Myriad lung diseases are life threatening and macrophages play a key role in both physiological and pathological processes. Macrophages have each pro-/anti-inflammatory phenotype, and each lung disease can be aggravated by over-polarized macrophage. Therefore, development of a method capable of mediating the macrophage phenotype is one of the solutions for lung disease treatment. For mediating the phenotype of macrophages, the pulmonary delivery system (PDS) is widely used due to its advantages, such as high efficiency and accessibility of the lungs. However, it has a low drug delivery efficiency ironically because of the perfect lung defense system consisting of the mucus layer and airway macrophages. In this study, zwitterion-functionalized poly(lactide-co-glycolide) (PLGA) inhalable microparticles (ZwPG) are synthesized to increase the efficiency of the PDS. The thin layer of zwitterions formed on PLGA surface has high nebulizing stability and show high anti-mucus adhesion and evasion of macrophages. As a reprogramming agent for macrophages, ZwPG containing dexamethasone (Dex) and pirfenidone (Pir) are treated to over-polarized M2 macrophages. As a result, a synergistic effect of Dex/Pir induces reprogramming of M2 macrophage to pro-inflammatory phenotypes.
Assuntos
Pneumopatias , Macrófagos , Humanos , Fenótipo , Pulmão , Nebulizadores e VaporizadoresRESUMO
We aimed to determine the feasibility, efficacy, success, and safety of intracardiac echocardiography (ICE) in transcatheter multiple atrial septal defect (ASD) closure. Of 185 patients with multiple ASDs who underwent transcatheter closure, 140 (76%) patients who weighed <30kg with a narrow distance between defects or in whom single device closure was anticipated were guided by ICE and 45 patients were guided by three-dimensional (3D) transesophageal echocardiography (TEE) with or without ICE. Patients in the ICE group were relatively younger and weighed less than those in the 3D TEE group (p < 0.0001). The ratio of the distance between defects >7 mm was high, and more cases required ≥2 devices in the 3D TEE group than those in the ICE group (p < 0.0001). All patients in the 3D TEE group and seven patients (5%) in the ICE group were operated on under general anesthesia (p < 0.0001). The fluoroscopic time was shorter in the ICE group (13.98 ± 6.24 min vs. 24.86 ± 16.47 min, p = 0.0005). No difference in the complete closure rate and complications was observed. ICE-guided transcatheter and 3D TEE were feasible, safe, and effective in successful multiple ASD device closures, especially for young children and patients at high risk under general anesthesia.
RESUMO
Importance: Infections are proposed to be triggering factors for Kawasaki disease (KD), although its etiological factors remain unknown. Recent reports have indicated a 4- to 6-week lag between SARS-CoV-2 infection and multisystem inflammatory syndrome in children with a similar presentation to that of KD. Objective: To investigate the temporal correlation between KD and viral infections, focusing on respiratory viruses. Design, Setting, and Participants: This cohort study was conducted among individuals aged 0 to 19 years diagnosed with KD between January 2010 and September 2020 from the Korean National Health Insurance Service. Data on infectious disease outbreaks from 2016 to 2019 were collected from the Korea Disease Control and Prevention Agency, Korean Influenza and Respiratory Virus Monitoring System, Korea Enteroviruses Surveillance System, and the Enteric Pathogens Active Surveillance Network in South Korea. Data were analyzed from December 2020 to October 2021. Main Outcomes and Measures: National databases for infectious diseases were used for a time-series analysis of the correlation between viral infections and KD. The temporal correlation between infectious disease outbreaks and KD outbreaks was evaluated using the Granger causality test (G-test), which is a useful tool to estimate correlations between 2 time series of diseases based on time lags. Results: Overall, 53â¯424 individuals with KD were identified, including 22â¯510 (42.1%) females and 30â¯914 (57.9%) males and 44â¯276 individuals (82.9%) younger than 5 years. Intravenous immunoglobulin-resistant KD was identified in 9042 individuals (16.9%), and coronary artery abnormalities were identified in 384 individuals (0.7%). Of 14 infectious diseases included in the analyses, rhinovirus infection outbreaks were identified as significantly correlated at 1 to 3 months before KD outbreaks in South Korea (r = 0.3; 1 month: P < .001; 2 months: P < .001; 3 months: P < .001). Outbreaks of respiratory syncytial virus infection were identified as significantly correlated with KD outbreaks by 2 months (r = 0.5; 2 months: P < .001). Additionally, varicella outbreaks were identified as significantly correlated at 2 and 3 months before KD outbreaks (r = 0.7; 2 months: P < .001; 3 months: P < .001). Conclusions and Relevance: In this cohort study with a time series analysis of children and youth in South Korea with KD, respiratory infections caused by rhinovirus and respiratory syncytial virus and varicella outbreaks were significantly correlated with KD at 1 to 3 months before KD outbreaks.