E. Sandica

Bovine Jugular Veins versus Homografts in the Pulmonary Position: An Analysis across Two Centers and 711 Patients-Conventional Comparisons and Time Status Graphs as a New Approach.

BACKGROUND Various diseases and diversity in implantation ages, together with evolving diagnostic and therapeutic options, hinder comparative evaluations of long-term outcomes for valved conduits used for reconstruction of the right ventricular outflow tract (RVOT). We combined two common evaluation methods to optimally use information obtained by pooling the raw data from two high volume centers, each with very regular follow-up procedures, with the aim of analyzing durability differences between conventional homografts and bovine jugular veins. PATIENTS AND METHODS In the period 1985 to 2012, a total of 444 bovine jugular veins and 267 homografts were implanted, and 6,738 postoperative examinations took place. Evaluations included age-stratified Kaplan-Meier analyses, Cox regression models, and time status graphs, the third showing age-group stratified, time-related frequencies of intact, insufficient, stenotic, both insufficient and stenotic, and postinterventional conduits below the freedom from explantation curve. They take into account interventions, explantations, and the nonterminal character of echocardiographic findings. RESULTS The durability of intact bovine jugular veins in children and young adults is not inferior to that of homografts. Averaged over the first 12 years after implantation, the age groups < 25 years in fact showed advantages for bovine jugular vein recipients. The average fraction of patients younger than 25 years whose conduits were not explanted, postinterventional, stenotic, insufficient, or stenotic and insufficient was at least 10% higher in recipients of bovine jugular veins than in homograft recipients. CONCLUSION According to the time status graphs, the use of bovine jugular veins for RVOT in patients younger than 25 years appears to lead to superior results when compared with cryopreserved homografts.

Percutaneous closure of a gigantic patent ductus arteriosus (PDA) with pulmonary hypertension with an atrial septal defect occluder in a 35-year-old woman

Patent ductus arteriosus (PDA) is a common form of congenital heart defects (CHD); it counts for about 5–10 % of all CHD with an incidence of one in 2,500–5,000 live births [1]. In general, volume overload of the left atrium and left ventricle caused by the shunt and pulmonary vascular disease is clear indication for closure of the defect, whereas the risk of endocarditis and aneurysm formation of the PDA is under discussion. If untreated, a large PDA will regularly lead to pulmonary hypertension, heart failure and Eisenmenger syndrome [2]. PDA was the first example of congenital heart disease to be treated by transcatheter closure, and has now become an established form of treatment for the majority of patients with very few side effects. After the initial description in 1967 by Porstmann a large variety of different devices have been described (i.e., Rashkind device, Sideris buttoned device, various PDA coils, as well as specific PDA occluder devices such as the Amplatzer PDA-occluders [3]). Nowadays, percutaneous PDA closure has proved to be safe and effective with shortand long-term results comparable to surgical closure including those cases with mild and moderate pulmonary hypertension [2]. A common problem of all commercially available devices is the inability to close PDAs larger than 14 mm diameter based on manufacturer’s recommendations. Therefore, the majority of large PDAs are often closed surgically, although there are occasional case reports of very large PDAs closed with Amplatzer VSD or ASD Occluders [4, 5]. In the following report, we describe a case of successful transcatheter closure of an extremely large PDA measuring minimal 24 mm with an off-label use of a 24 mm Occlutech Figulla Flex ASD Occluder. A 35-year-old African woman (weight 77 kg, height 167 cm, BMI 27.6) was referred to our institution with an unknown heart disease for further evaluation. Clinically, she was in apparent heart failure (New York Heart Association III), transcutaneous oxygen saturation was 96 % and auscultation revealed a pronounced second heart sound and diastolic murmur. Her exercise performance measured by a 6-min walk test was 215 m only. The ECG revealed signs of right heart pressure load, and by echocardiography the estimated right ventricle pressure was 100 mmHg. This was caused by a very large PDA. It was noteworthy that the patient was human immunodeficiency virus positive. For further hemodynamic evaluation, the patient underwent a diagnostic catheterization. The PDA had a minimal diameter of 22 mm and an ampulla of 40 mm (see Fig. 1). The systemic arterial blood pressure was 115/66 mmHg (mean 85 mmHg) and the pulmonary arterial blood pressure 107/67 mmHg (mean 85 mmHg). The calculated pulmonary vascular resistance index (PVRI) was 12.6 Wood Units and the cardiac index (CI) 5.1 l/min/m. For further testing of the pulmonary vasoreagibility, the PDA was balloon occluded with a 30-mm sizing balloon. When the balloon was stabilized in the PDA, the minimal waist measured 24 mms. Thereafter, vasoreagibility of the M. Froehle (&) N. A. Haas C. Happel K. T. Laser Department for Congenital Heart Defects, Heart and Diabetes Center, North-Rhine Westphalia, Georgstrasse 11, 32545 Bad Oeynhausen, Germany e-mail: mfroehle@hdz-nrw.de

Antithrombotic therapy in pediatric ventricular assist devices: Multicenter survey of the European EXCOR Pediatric Investigator Group

Objectives: Mechanical circulatory support for pediatric heart failure patients with the Berlin Heart EXCOR ventricular assist system is the only approved and established bridging strategy for recovery or heart transplantation. In recent years, the burden of thromboembolic events has led to modifications of the recommended antithrombotic therapy. Therefore, we aimed to assess modifications of antithrombotic practice among the European EXCOR Pediatric Investigator Group members. Methods: We sent a questionnaire assessing seven aspects of antithrombotic therapy to 18 European hospitals using the EXCOR device for children. Returned questionnaires were analyzed and identified antithrombotic strategies were descriptively compared to “Edmonton protocol” recommendations developed for the US EXCOR pediatric approval study. Results: Analysis of 18 received surveys revealed substantial deviations from the Edmonton protocol, including earlier start of heparin therapy at 6–12 h postoperatively and in 50% of surveyed centers, monitoring of heparin effectiveness with aPTT assay, administering vitamin K antagonists before 12 months of age. About 39% of centers use higher international normalized ratio targets, and platelet inhibition is changed in 56% including the use of clopidogrel instead of dipyridamole. Significant inter-center variability with multiple deviations from the Edmonton protocol was discovered with only one center following the Edmonton protocol completely. Conclusion: Current antithrombotic practice among European EXCOR users representing the treatment of more than 600 pediatric patients has changed over time with a trend toward a more aggressive therapy. There is a need for systematic evidence-based evaluation and harmonization of developmentally adjusted antithrombotic management practices in prospective studies toward revised recommendations.

The European Registry for Patients with Mechanical Circulatory Support (EUROMACS): first EUROMACS Paediatric (Paedi-EUROMACS) report

OBJECTIVES EUROMACS is a registry of the European Association for Cardio-Thoracic Surgery (EACTS) whose purpose is to gather clinical data related to durable mechanical circulatory support for scientific purposes and to publish annual reports. Because the treatment of children with end-stage heart failure has several significantly different characteristics than the treatment of adults, data and outcomes of interventions are analysed in this dedicated paediatric report. METHODS Participating hospitals contributed pre-, peri- and long-term postoperative data on mechanical circulatory support implants to the registry. Data for all implants in paediatric patients (≤19 years of age) performed from 1 January 2000 to 31 December 2017 were analysed. This report includes updates of patient characteristics, implant frequency, outcome (including mortality rates, transplants and recovery rates) as well as adverse events. RESULTS Twenty-five hospitals contributed 237 registered implants in 210 patients (81 ♀, 129 ♂) to the registry. The most frequent diagnosis was any form of cardiomyopathy (71.4%) followed by congenital heart disease (18.6%). Overall mean support time on a device was 11.6 months (±16.5 standard deviation). A total of 173 children (82.4%) survived to transplant, recovery or are ongoing; 37 patients (17.6%) died while on support within the observed follow-up time. At 12 months 38% of patients received transplants, 7% were weaned from their device and 15% died. At 24 months, 51% of patients received transplants, 17% died while on support, 22% were on a device and 9% were explanted due to myocardial recovery. The adverse events rate per 100 patient-months was 0.2 for device malfunction, 0.05 for major bleeding, 0.06 for major infection and 0.03 for neurological events within the first 3 months after implantation. CONCLUSIONS The first paediatric EUROMACS report reveals a low transplant rate in European countries within the first 2 years of implantation compared to US data. The 1-year survival rate seems to be satisfactory. Device malfunction including pump chamber changes due to thrombosis was the most frequent adverse event.