Pump size of Berlin Heart EXCOR pediatric device influences clinical outcome in children

Miera, Oliver; Schmitt, Katharina; Delmo-Walter, Eva Maria; Ovroutski, Stanislav; Hetzer, Roland; Berger, Felix

doi:10.1016/j.healun.2014.03.007

Cited by 33 publications

(31 citation statements)

References 25 publications

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“…However, because of the lack of organ donors, especially in very small children, the use of ventricular assist device (VAD) is a validated therapy to bridge patients to the OHTx with a success rate up to 84% (Ibrahim et al, 2000; Reinhartz et al, 2003; Chang and McKenzie, 2005; Stiller et al, 2005; Hetzer et al, 2006; Gandhi et al, 2008; Brancaccio et al, 2010, 2013; Potapov et al, 2011; Almond et al, 2013; Miera et al, 2014; Kirklin, 2015; Mascio, 2015; Sandica et al, 2016). …”

Section: Introductionmentioning

confidence: 99%

“…Analyzing the infant population, only the Berlin Heart EXCOR (BHE; Berlin Heart, Berlin Heart AG, Berlin, Germany) is licensed as long term VAD to bridge children to OHTx (Ibrahim et al, 2000; Reinhartz et al, 2003; Chang and McKenzie, 2005; Stiller et al, 2005; Hetzer et al, 2006; Gandhi et al, 2008; Brancaccio et al, 2010, 2013; Potapov et al, 2011; Almond et al, 2013; Miera et al, 2014). The smallest patients are particularly demanding in terms of morbidity and mortality (Ibrahim et al, 2000; Reinhartz et al, 2003; Chang and McKenzie, 2005; Stiller et al, 2005; Hetzer et al, 2006; Gandhi et al, 2008; Brancaccio et al, 2010, 2013; Potapov et al, 2011; Almond et al, 2013; Miera et al, 2014) especially now that the LVAD staying is increasing over time.…”

Section: Introductionmentioning

confidence: 99%

“…The smallest patients are particularly demanding in terms of morbidity and mortality (Ibrahim et al, 2000; Reinhartz et al, 2003; Chang and McKenzie, 2005; Stiller et al, 2005; Hetzer et al, 2006; Gandhi et al, 2008; Brancaccio et al, 2010, 2013; Potapov et al, 2011; Almond et al, 2013; Miera et al, 2014) especially now that the LVAD staying is increasing over time. In particular, small body surface area, BHE size mismatch and younger age seems to be associated with an increased risk of thromboembolic complications (Almond et al, 2013; Miera et al, 2014). …”

Section: Introductionmentioning

confidence: 99%

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The Use of Berlin Heart EXCOR VAD in Children Less than 10 kg: A Single Center Experience

et al. 2016

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Objective: Despite the improvement in ventricular assist device (VAD) therapy in adults and in adolescents, in infant population only Berlin Heart EXCOR (BHE) is licensed as long term VAD to bridge children to Heart Transplantation (HTx). Particularly demanding in terms of morbidity and mortality are smallest patients namely the ones implanted in the first year of life or with a lower body surface area. This work aims at retrospective reviewing a single center experience in using BHE in children with a body weight under 10 kg.Methods: Data of all pediatric patients under 10 kg undergoing BHE implantation in our institution from March 2002 to March 2016 were retrospectively reviewed.Results: Of the 30 patients enrolled in the study, 53% were male, 87% were affected by a dilated cardiomyopathy with an average weight and age at the implantation of 6.75 ± 2.16 Kg and 11.57 ± 10.12 months, respectively. Three patients (10%) required a BIVAD implantation. After the implantation, 7 patients (23%) required re-intervention for bleeding and 9 patients (30%) experienced BHE cannulas infection. A total of 56 BHE pump were changed for thrombus formation (1.86 BHE pump for patient). The average duration of VAD support was 132.8 ± 94.4 days. Twenty patients (67%) were successfully transplanted and 10 patients (33%) died: 7 for major neurological complication and 3 for sepsis.Conclusion: Mechanical support in smaller children with end stage heart failure is an effective strategy for bridging patients to HTx. The need for BIVAD was relegated, in the last years, only to restrictive cardiomiopathy. Further efforts are required in small infants to improve anticoagulation strategy to reduce neurological events and BHE pump changes.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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The Use of Berlin Heart EXCOR VAD in Children Less than 10 kg: A Single Center Experience

et al. 2016

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“…The BHE consists of a para-corporeal, pneumatically driven, polyurethane blood pump (10, 15, 25, 30, 50, 60, and 80 ml) (17) with a multilayer flexible membrane separating blood from the air chamber. Silicon cannulae connect the blood pump to the patient, and tri-leaflet inflow and outflow valves prevent blood reflux.…”

Section: Mechanical Circulatory Support Typementioning

confidence: 99%

Mechanical Circulatory Support for Single Ventricle Failure

Griselli

Sinha

Jang

et al. 2018

Front. Cardiovasc. Med.

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Mechanical circulatory support (MCS) for failing single ventricle (SV) physiology is a complex and challenging problem, which has not yet been satisfactorily addressed. Advancements in surgical strategies and techniques along with intensive care management have substantially improved the outcomes of neonatal palliation for SV physiology, particularly for hypoplastic left heart syndrome (HLHS). This is associated with a steady increase in the number of SV patients who are susceptible to develop heart failure (HF) and would potentially require MCS at a certain stage in their palliation. We have reviewed the literature regarding the reported modalities of MCS use in the management of SV patients. This includes analysis of various devices and strategies used for failing circulation at distinct stages of the SV pathway: after neonatal palliation, after the superior cavo-pulmonary connection (SCPC), and after total cavo-pulmonary connection (TCPC).

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“…Extensive research regarding indication, timing, and management of MCS systems has been carried out with the aim of improving patient outcomes. However, experience in children is limited owing to device availability, especially in infants [6,7]. This is particularly true Abstract The Japanese organ transplant law was revised in July 2010 in order to enable children aged <15 years to donate organs.…”

Section: Introductionmentioning

confidence: 99%

Outcomes in children with advanced heart failure in Japan: importance of mechanical circulatory support

et al. 2015

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The Japanese organ transplant law was revised in July 2010 in order to enable children aged <15 years to donate organs. However, the waiting time for orthotopic heart transplantation (HTx) is as long as 636 days in children due to a shortage of organ donors. Ventricular assist devices (VADs) have been widely used as a bridge to transplantation in Western countries, whereas experience with VADs is limited in Japan due to a lack of device availability for small children. This study aimed to clarify the clinical profiles and outcomes of children with advanced heart failure in Japan and to investigate the importance of mechanical circulatory support (MCS), VADs, and extracorporeal membrane oxygenation (ECMO) in children. A retrospective chart review of patients with advanced heart failure who were eligible for HTx between January 2006 and May 2015 was performed at the Department of Pediatric Cardiology, Tokyo Woman's Medical University, Japan. Patients were divided into two groups based on need for MCS. Clinical data pre- and post-revision of the Japanese organ transplant law were compared. Preoperative clinical conditions were evaluated based on Interagency Registry for Mechanically Circulatory Support (INTERMACS) profiles. Twenty-two patients were included in the study, 12 of whom required MCS. VADs were implanted in nine patients and ECMO was needed in seven patients. Of the MCS group, 5 deaths occurred in patients with a preoperative INTERMACS profile-1. High total bilirubin was found to be associated with mortality by multivariate logistic regression analysis (OR 7.8, p = 0.02). Wait list mortality was 32 % and no difference in clinical profiles pre- and post-revision of the Japanese organ transplant law was observed. Approximately 55 % of pediatric patients with advanced heart failure required MCS support. Preoperative conditions such as INTERMACS profile-1 and high total bilirubin were associated with poor outcomes. The Japanese organ transplant law revision had no significant influence on patient profiles or outcomes.

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Pump size of Berlin Heart EXCOR pediatric device influences clinical outcome in children

Cited by 33 publications

References 25 publications

The Use of Berlin Heart EXCOR VAD in Children Less than 10 kg: A Single Center Experience

The Use of Berlin Heart EXCOR VAD in Children Less than 10 kg: A Single Center Experience

Mechanical Circulatory Support for Single Ventricle Failure

Outcomes in children with advanced heart failure in Japan: importance of mechanical circulatory support

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