Coarctation of the Aorta

The purpose of this study is to evaluate the effectiveness and mechanism of action of Losartan in the treatment of coarctation of aorta.

The purpose of this two-way cohort study was to explore whether an integrated prenatal and postnatal treatment model for neonates with critical congenital heart disease (CCHD) could be effective in avoiding preoperative morbidities, creating an ideal timing for surgery, thereby reducing postoperative in-hospital mortality, and improving surgical prognosis compared with the traditional model of care. In addition, in neonates with CCHD associated with the right cardiac system, the investigators aim to further investigate whether early postnatal cardiac surgery has the potential advantage of obtaining a time window for myocardial regeneration and thus improving myocardial remodeling. The aim of this study is to improve the diagnostic and therapeutic capacity of critical congenital heart disease and to promote the integrated prenatal-postnatal treatment model for clinical use. This will ultimately improve the quality of healthcare services for patients with cardiovascular diseases and lay the foundation for exploring guidelines for the treatment of cardiovascular diseases suitable for China's national conditions. The project will be jointly implemented by Beijing Anzhen Hospital , Capital Pediatric Research Institute, and 307 PLA General Hospital. Starting from January 1, 2022, the hospitals will continue to collect hospitalized cases of newborns with CCHD. The integrated prenatal and postnatal model is defined as a definitive diagnosis of CCHD in the fetal period (22-26 weeks), documentation of intrauterine transfer in our obstetrics department, subsequent initiation of an intrapartum or postpartum surgical plan after multidisciplinary consultation, and transfer to the pediatric heart center at the first hour of life, where the child is treated with either postpartum immediate or elective surgery, depending on patient status. For neonates who meet the indications for emergency surgery, surgery is performed immediately after birth. For neonates with non-emergency surgical indications, surgery is performed after birth adjustment to optimal status. The traditional model was defined as postpartum transfer via an outside hospital with routine interventions. The investigators then evaluate surgical prognosis and myocardial regenerative capacity to compare the effects of the two treatment models. This project will validate the advantages of an integrated prenatal and postnatal model over traditional models through real-world research and will improve prognosis in neonates with CCHD.

The aortic arch with a common origin of the innominate and left carotid artery (CILCA) prevalence in the general population is 13.6%. Its reputation as a benign anatomical variant has been ultimately shattered by further studies that identified the CILCA arch as a potential marker for thoracic aortic disease (TAD) The aim of this work is to report the CT anatomical characteristics of the aortic arch in subjects with or without aneurysms requiring treatment, in 5 major European cardiovascular centers.

This study is a single center retrospective and prospective observational study to evaluate the clinical results of patients who received revascularization of the aorta and peripheral artery at asan medical center. Data will be collected on approximately 6,000 subjects in asan medical center. Individuals will be followed up at 1, 6, and 12 months, 3, 5years up to 10 years by telephone call or hospital visit. Data collected during all follow-up visits will include a composite of major adverse limb events, or death from any cause.

The proposed Investigational Device Exemption (IDE) is to assess the safety and preliminary effectiveness of the simplified hybrid frozen elephant trunk repair technique Branched Stented Anastamosis Frozen Elephant Trunk Repair (B-SAFER) which involves a physician modified endovascular stentgraft to treat the proximal aorta in subjects with aortic disease involving multiple segments. The study will also evaluate the device functionality when using this operative technique for device implantation including multiple components.

Children living with chronic health conditions face a higher risk of developing cardiovascular diseases than their peers, largely due to the accelerated aging of the heart and blood vessels. Although experts recognize this elevated risk and recommend close monitoring and early intervention, the underlying mechanisms driving this phenomenon remain poorly understood. At present, no effective interventions specifically target its root causes. Recent research shows that both large blood vessels (such as the carotid artery) and small vessels (such as those in the retina) can display early signs of damage decades before clinically apparent heart or vascular disease emerges. This accelerated vascular aging can result from multiple factors - including disease-related processes such as persistent inflammation and metabolic disturbances, treatment-related effects such as chemotherapy or long-term steroid use, and lifestyle changes associated with chronic illness, such as reduced physical activity and altered eating habits. However, it is still unclear how these factors influence the development and progression of vascular changes in children as they grow. Importantly, these changes can be monitored through non-invasive methods, offering a unique opportunity to study at-risk patients many years before overt cardiovascular disease develops. Identifying these early changes may enable us to detect and track individuals at heightened risk well in advance of clinical disease. This study aims to deepen our understanding of the causes of increased cardiovascular risk in children with chronic conditions and to lay the groundwork for earlier, more targeted prevention strategies.

The primary objective of this open label exploratory study is to evaluate the effect of CR to improve autonomic cardiovascular regulation in participants with symptoms of stress, anxiety, or insomnia. The secondary objective is to evaluate the effect of CR on a variety of self-reported symptom inventories. Tertiary objectives are to explore the impact of selected medications on outcomes associated with use of CR, the effect size in subgroups of participants who also report specific co-morbid symptoms or conditions of interest, and any unexpected challenges or barriers for working with the same. The latter includes those with TBI, PTSD, hypertension, hot flashes, chronic pain, or prior stroke. Methods: This will be a single site, open label, pilot clinical trial, enrolling people aged 11 or older, who have self-reported symptoms of stress, anxiety, or insomnia, and meet a threshold score on self-reported inventories. Up to 200 participants will be enrolled. Participants will receive between 4 and 12 sessions of audible tones echoing current brainwave activity (CR). Participants will continue their other current care throughout the study. There will be pre- and post-intervention data collection of physiological outcomes (BP, HR, and measures of autonomic cardiovascular regulation assessed by heart rate variability and baroreflex sensitivity), which will also serve as the primary outcome. Secondary outcomes to be collected include symptom inventories for insomnia (Insomnia Severity Index, ISI; depression (Center for Epidemiological Studies- Depression Scale, CES-D), anxiety (Generalized Anxiety Disorder-7, GAD-7), and stress (Perceived Stress Scale, PSS). Other tertiary measures include traumatic stress (PTSD Checklist for civilians, PCL-C, or military, PCL-M), and overall quality of life (QOLS). Participants who also self-report having specific co-morbid symptoms or conditions of interest may complete additional condition-specific outcome measures. All measures will be collected at an enrollment visit (V1), and the intervention will begin 0-14 days thereafter. Mean contrasts will be used to compare the changes in measures of autonomic cardiovascular regulation from V1 to V3, the primary outcome, as well as for secondary and appropriate tertiary outcomes. Linear mixed models, which can accommodate within-subject correlations due to repeated assessments over time, will be used to generate point estimates for effect size along with 95% confidence intervals.

The so-called "bovine" aortic arch (BAA) is characterized by the presence of a common origin of the innominate and left carotid artery, or, less frequently, by the origin of the left carotid directly from the innominate artery (i.e. type 2 BAA). In the present protocol, for brevity and according to the STROBE guidelines the investigators employed the acronym CILCA (common origin of the innominate and left carotid artery) arch, previously employed in publications of our group. The CILCA is the second more common arch configuration, and its prevalence in the general population is 13.6%, with relevant differences among ethnic groups. However, the real prevalence of the CILCA is likely underestimated, because its presence is largely unreported due to the presumed clinical irrelevance of this anatomical variant. In fact, the peculiar anatomical features associated with the CILCA mandate specific management strategies and preoperative planning in both surgical and endovascular procedures involving the aortic arch, including type A aortic dissection repair and carotid stenting. There is increasing evidence in the literature that the CILCA represents a potential determinant of the onset of thoracic aortic disease. Notably, it is associated with a 1.4-fold increased risk of developing aortic aneurysms or dissections, and this entails a relevant prevalence of this anatomical variant among patients requiring thoracic endovascular aortic repair (TEVAR). In fact, the CILCA presents a consistent and peculiar anatomical pattern compared with standard arch configuration, which provides relevant information for TEVAR planning, and may have prognostic implications. This registry aims to provide insights on the pathogenic mechanisms that expose subjects with CILCA arch to the increased risk of postoperative complications. So, the CILCA arch registry will capture clinical data and medical images of subjects with CILCA arch treated by surgical or endovascular (TEVAR) means. Technical and specific aims: * Development of automatic segmentation of medical images for the assessment of geometric features by machine learning * Assessment of a simplified method for the calculation of the "displacement forces" in proximal landing zones for TEVAR Primary Endpoint: Identification of peculiar anatomical characteristics in patients with CILCA arch, before\\after treatment of aortic pathologies (including both TEVAR and Open Repair). Secondary Endpoint: Identification of anatomical risk factors for the postoperative clinical outcomes. REGISTRY DESIGN International Multicenter and Observational clinical registry. Enrollment will include 500 patients with CILCA arch, treated with TEVAR or open repair. All patients will be followed up for 5 years, and their' clinical pathway and treatment strategy will be at discretion of the operator following current guidelines for thoracic aortic disease. FOLLOW-UP PERIOD Postoperatively, patients will be followed-up for 5 years. This includes every medical check-up performed according to clinical practice (including telephone contacts) to obtain information regarding medical history, cardiovascular drugs use, hospitalizations, and adverse events, at 30 days, at 12 months, and yearly after. Repeated imaging (i.e. CT scan or magnetic resonance imaging) will be obtained according to current guidelines, or medical need. STATISTICAL ANALYSIS All patients who are successfully registered will be included in the analysis. Being this an observational registry aiming to investigate the postoperative outcomes of patients with CILCA, the investigators proceeded without a formal power analysis. The number of patients scheduled to be enrolled (i.e. 500) was deemed adequate to provide robust evidence for future statistical analyses. The study will be performed according to "good clinical practice ". The collection of personal, procedural and clinical data of patients must take place into the electronic CRF. Only the investigators and the personnel registered on the "Site Personnel Signature Log" will be granted access to the eCRF. .

Our study has the intention of analysing the clinical and echocardiographic characteristics of infants with prenatal and neonatal diagnosis of suspected CoAo, transferred at birth to the O.U. of Cardiology and Paediatric Cardiac Surgery at the Policlinico di Sant' Orsola in order to identify reliable predictors of CoAo, in particular reliable in presence of the ductus arteriosus of Botallo. It is an observational study: patients participating in the study will not undergo to any procedures outside the normal clinical practice; likewise, the clinical variables that will be collected for study are those that are commonly collected by the physician in daily clinical practice. This study therefore involves the observation of current clinical practice without the application of any kind of 'intervention'.The primary objective of the study is: to identify the clinical and/or echocardiographic features predictive of the development of Aortic Coarctation through the creation of a data collection with which to census all patients with a diagnosis of suspected or overt Aortic Coarctation, admitted from 01/01/2007 to 31/12/2026 at the Paediatric Cardiology and Cardiac Surgery Centre of the Policlinico di Sant'Orsola, Bologna.

A minimum of 100 subjects will be enrolled. Follow-up will occur immediately after the initial implant procedure, at subsequent re-dilation procedures, annually, and at any additional standard of care follow-up visits (determined by the implanting physician) through 5 years post-implant. Data collected at each follow-up will be used in analysis. This study will monitor key data points related to the device and procedure.