Publications by authors named "Miera O"

Objectives: Restrictive cardiomyopathy is rare and is generally associated with worse clinical outcomes compared to other cardiomyopathies. Ventricular assist device (VAD) support for these children is seldom applied and often hampered by the surgical difficulties.

Methods: All paediatric (<19 years) patients with a restricted cardiomyopathy supported by a VAD from the EUROMACS database were included and compared to patients with a dilated cardiomyopathy (retrospective database analyses).

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Objectives: The use of ventricular assist devices (VADs) in children is increasing. However, absolute numbers in individual centres and countries remain small. Collaborative efforts such as the Paedi-European Registry for Patients with Mechanical Circulatory Support (EUROMACS) are therefore essential for combining international experience with paediatric VADs.

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Aims: Heart transplantation is a well-established treatment for end-stage heart failure in paediatric patients, demonstrating excellent long-term outcomes.

Methods: This retrospective study analyses 35 years of data on 244 paediatric recipients (<18 years) at a single institution from 1986 to 2022. The analysis explores changes in diagnoses, survival, waiting times and mechanical circulatory support (MCS) over three decades (1991-2000, 2001-2010 and 2011-2020).

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Objectives: Myocardial recovery in children supported by a durable left ventricular assist device is a rare, but highly desirable outcome because it could potentially eliminate the need for a cardiac transplant and the lifelong need for immunosuppressant therapy and the risk of complications. However, experience with this specific outcome is extremely limited.

Methods: All patients < 19 years old supported by a durable left ventricular assist device from the European Registry for Patients with Mechanical Circulatory Support database were included.

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The withdrawal of HVAD in 2021 created a concern for the pediatric population. The alternative implantable centrifugal blood pump HeartMate 3 has since been used more frequently in children. This paper analyses the outcome of children on LVAD support provided with an HVAD or HM3.

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Article Synopsis
  • - The study analyzed data from the EUROMACS database focusing on children under 19 years old who were supported by ventricular assist devices (VAD) and assessed the impact of having an implantable cardioverter-defibrillator (ICD) at the time of VAD placement.
  • - Out of 303 patients, only 7% had an ICD, and the analysis revealed that while 77% of these children were eventually transplanted, there was no significant difference in overall survival rates between those with an ICD and those without.
  • - The presence of an ICD did not confer a survival advantage in pediatric patients on VAD support, indicating that the benefit of this device in this context may be limited.
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Background: The number of single ventricle patients undergoing Fontan palliation and surviving to adulthood worldwide has steadily increased in recent years. Nevertheless, the Fontan circulation is destined to fail. Ultimately, heart transplantation (HTx) remains the definitive treatment option.

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Objectives: The Berlin Heart EXCOR (BHE) offers circulatory support across all paediatric ages. Clinically, the necessary care and the outcomes differ in various age groups. The EUROMACS database was used to study age- and size-related outcomes for this specific device.

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Riociguat, a soluble guanylate cyclase stimulator, is approved for treatment of adults with pulmonary arterial hypertension (PAH). The safety, tolerability, and pharmacokinetics (PK) of oral riociguat in a pediatric population with PAH was assessed in PATENT-CHILD (NCT02562235), a multicenter, single-arm, 24-week, open-label, Phase 3 study. Patients aged 6-17 years in World Health Organization functional class (WHO-FC) I-III treated with stable endothelin receptor antagonists and/or prostacyclin analogs received riociguat equivalent to 0.

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Article Synopsis
  • The use of ECLS/ECMO for cardiac and circulatory failure has risen significantly, with about 3,000 implantations each year in Germany, highlighting a need for standardized guidelines.
  • The German Society for Thoracic and Cardiovascular Surgery announced the development of S3 guidelines in July 2015, involving collaboration from multiple scientific societies and patient representatives.
  • Published in February 2021, the guidelines provide evidence-based recommendations on initiation, management, and aftercare of ECLS/ECMO therapy, addressing both clinical practices and economic considerations.
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Article Synopsis
  • Pediatric ventricular assist devices (VADs) face significant risks of complications like stroke and bleeding, which are leading causes of death and disability in these patients.
  • Recent developments in antithrombotic strategies, especially with drugs like bivalirudin, have shown promise in reducing neurologic events, particularly for smaller pediatric VADs.
  • The report aims to highlight current antithrombotic regimens linked to low complication rates and share 10 key lessons learned from 20 years of experience in managing pediatric VADs, focusing on methods to minimize clotting and bleeding risks beyond just the medication used.
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Objectives: Ventricular assist device support as a bridge to transplant or recovery is a well-established therapy in children on the cardiac transplant waiting list. The goal of this study was to investigate the incidence of and the associated factors for cerebrovascular accidents in paediatric patients supported by a Berlin Heart EXCOR.

Methods: All patients <19 years of age supported by a Berlin Heart EXCOR between January 2011 and January 2021 from the European Registry for Patients with Mechanical Circulatory Support were included.

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Left ventricular assist-device (LVAD) implantation is a life-saving therapy for patients with advanced heart failure (HF). With chronic unloading and circulatory support, LVAD-supported hearts often show significant reverse remodeling at the structural, cellular and molecular level. However, translation of these changes into meaningful cardiac recovery allowing LVAD explant is lagging.

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Objectives: A third paediatric report has been generated from the European Registry for Patients with Mechanical Circulatory Support (EUROMACS). The purpose of EUROMACS, which is operated by the European Association for Cardio-Thoracic Surgery, is to gather data related to durable mechanical circulatory support for scientific purposes and to publish reports with respect to the course of mechanical circulatory support therapy. Since the first report issued, efforts to increase compliance and participation have been extended.

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Aims Worldwide applications of extracorporeal circulation for mechanical support in cardiac and circulatory failure, which are referred to as extracorporeal life support (ECLS) or veno-arterial extracorporeal membrane oxygenation (va-ECMO), have dramatically increased over the past decade. In spite of the expanding use and the immense medical as well as socio-economic impact of this therapeutic approach, there has been a lack of interdisciplinary recommendations considering the best available evidence for ECLS treatment. Methods and Results In a multiprofessional, interdisciplinary scientific effort of all scientific societies involved in the treatment of patients with acute cardiac and circulatory failure, the first evidence- and expert consensus-based guideline (level S3) on ECLS/ECMO therapy was developed in a structured approach under regulations of the AWMF (Association of the Scientific Medical Societies in Germany) and under use of GRADE (Grading of Recommendations Assessment, Development and Evaluation) criteria.

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In Germany, a remarkable increase regarding the usage of extracorporeal membrane oxygenation (ECMO) and extracorporeal life support (ECLS) systems has been observed in recent years with approximately 3000 ECLS/ECMO implantations annually since 2015. Despite the widespread use of ECLS/ECMO, evidence-based recommendations or guidelines are still lacking regarding indications, contraindications, limitations and management of ECMO/ECLS patients. Therefore in 2015, the German Society of Thoracic and Cardiovascular Surgery (GSTCVS) registered the multidisciplinary S3 guideline "Use of extracorporeal circulation (ECLS/ECMO) for cardiac and circulatory failure" to develop evidence-based recommendations for ECMO/ECLS systems according to the requirements of the Association of the Scientific Medical Societies in Germany (AWMF).

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In Germany, a remarkable increase regarding the usage of extracorporeal membrane oxygenation (ECMO) and extracorporeal life support (ECLS) systems has been observed in recent years with approximately 3000 ECLS/ECMO implantations annually since 2015. Despite the widespread use of ECLS/ECMO, evidence-based recommendations or guidelines are still lacking regarding indications, contraindications, limitations and management of ECMO/ECLS patients. Therefore in 2015, the German Society of Thoracic and Cardiovascular Surgery (GSTCVS) registered the multidisciplinary S3 guideline "Use of extracorporeal circulation (ECLS/ECMO) for cardiac and circulatory failure" to develop evidence-based recommendations for ECMO/ECLS systems according to the requirements of the Association of the Scientific Medical Societies in Germany (AWMF).

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Article Synopsis
  • Acute kidney injury (AKI) is a common issue after neonatal aortic arch repair, with a study comparing two methods: deep hypothermic circulatory arrest (DHCA) and moderate hypothermia with distal aortic perfusion (MHDP).
  • In a total of 125 neonates studied, 54.4% experienced AKI, predominantly stage 1, but higher stages were more frequent in those who underwent DHCA than MHDP.
  • The findings suggest that while mild AKI is common, MHDP is linked to lower rates of moderate and severe AKI, with early mortality rates not showing a significant difference between the two methods.
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Article Synopsis
  • The study focuses on adults with congenital heart disease (ACHD), who often suffer from heart failure (HF) due to past surgeries and require better treatment data to improve their care.
  • Researchers will collect data from a multi-country register, the ARTORIA-R, identifying ACHD patients listed for heart transplantation from 1989-2020, using both retrospective and prospective methods.
  • The goal is to track outcomes like clinical worsening, death on the waiting list, and overall mortality after transplantation to enhance understanding and management of advanced heart failure in this population.
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Background: Ventricular assist devices (VAD) are increasingly used in patients with end-stage heart failure due to acquired heart disease. Limited data exists on the use and outcome of this technology in children.

Methods: All children (<18 years of age) with VAD support included in the German National Register for Congenital Heart Defects were identified and data on demographics, underlying cardiac defect, previous surgery, associated conditions, type of procedure, complications and outcome were collected.

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