Similar to the adult experience, the use of continuous-flow ventricular assist devices (VADs) has been increasing in the pediatric population. According to the PediMACS registry, continuous-flow VAD currently accounts for >60% of the durable device implantations in the U.S. Nonetheless, the continuous-flow VADs currently in use are designed for adults; this inevitably causes the patient-device size mismatch issue, especially when applied for small children. Pulsatile VADs, therefore, represent the only practical option for this group of patients despite the known risk profile of pulsatile VADs. To address such a frustrating reality, the National Heart, Lung, and Blood Institute (NHLBI) launched the Pediatric Circulatory Support Program in 2004, which is the predecessor of the so-called PumpKIN (Pump for Kids, Infants, and Neonates) program. The goal of this program was to develop mechanical circulatory support devices specifically designed for small children. As a result of extensive efforts of the multi-disciplinary team involving clinicians, scientists, manufactures, and federal agencies, the Infant Jarvik 2015, one of the original devices within the Pediatric Circulatory Support Program, has become the first continuous-flow VAD specifically designed for small children that obtained the Investigational Device Exemption (IDEs) from the U.S. Food and Drug Administration (FDA). This approval is a prerequisite to initiate a clinical trial (i.e., the PumpKIN trial). This article describes the history, current status, and future perspectives of this extremely challenging project, with a focus on the lessons we have learned over the decade.

/pdf/current-status-and-future-perspectives-of-the-pumpkin-trial-26an3bgsp6.pdf

Current status and future perspectives of the PumpKIN trial.

OBJECTIVES A second 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. Additionally, the data provided the opportunity to analyse patients of younger age and lower weight. 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 1 July 2019 were analysed. This report includes updates of patient characteristics, implant frequency, outcome (including mortality rates, transplants and recovery rates) as well as adverse events including neurological dysfunction, device malfunction, major infection and bleeding. RESULTS Twenty-nine hospitals contributed 398 registered implants in 353 patients (150 female, 203 male) to the registry. The most frequent aetiology of heart failure was any form of cardiomyopathy (61%), followed by congenital heart disease and myocarditis (16.4% and 16.1%, respectively). Competing outcomes analysis revealed that a total of 80% survived to transplant or recovery or are ongoing; at the 2-year follow-up examination, 20% died while on support. At 12 months, 46.7% received transplants, 8.7% were weaned from their device and 18.5% died. The 3-month adverse events rate was 1.69 per patient-year for device malfunction including pump exchange, 0.48 for major bleeding, 0.64 for major infection and 0.78 for neurological events. CONCLUSIONS The overall survival rate was 81.5% at 12 months following ventricular assist device implant. The comparison of survival rates of the early and later eras shows no significant difference. A focus on specific subgroups showed that survival was less in patients of younger age (<1 year of age) (P = 0.01) and lower weight (<20 kg) (P = 0.015). Transplant rates at 6 months continue to be low (33.2%) The fact that the EUROMACS registry is embedded within the European Association for Cardio-Thoracic Surgery Quality Improvement Programme offers opportunities to focus on improving outcomes.

/pdf/the-european-registry-for-patients-with-mechanical-4bg091tfwk.pdf

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

Mechanical circulatory support gained a significant value in the armamentarium of heart failure therapy because of the increased awareness of the prevalence of heart failure and the tremendous advances in the field of mechanical circulatory support during the last decades. Current device technologies already complement a heart transplant as the gold standard of treatment for patients with end-stage heart failure refractory to conservative medical therapy. This article reviews important aspects of mechanical circulatory support therapy and focuses on currently debated issues.

Current perspectives on mechanical circulatory support.

Background Nearly 1000 permanent ventricular assist devices (VADs) are implanted in patients with severe congestive heart failure in Germany each year. VADs are miniaturized centrifugal pumps that generate continuous blood flow; they are powered and controlled through a cable that passes through the skin. Para- corporeal systems are only rarely implanted, usually in children. Methods In this selective review of the literature, including guidelines and registry data, we discuss the indications, therapeutic effects, and complications of permanently implantable cardiac support systems. Results The optimal time for VAD implantation cannot be precisely defined. A comparative assessment of the various available systems is not possible, as no randomized trials have been performed on this topic. Registry data indicate that 69% to 81% of patients survive one year after VAD implantation, which is signifi- cantly better than the natural course of (conservatively treated) severe congestive heart failure. The distance patients are able to walk is 129 to 220 m longer at six months, depending on the system implanted. Scores on the EQ-5D health status questionnaire are 28 to 37 points better at six months. The potential severe compli- cations include infection, right-heart failure, hemorrhage, pump thrombosis, stroke, and death. Conclusion A VAD system can be implanted as an alternative to cardiac transplan- tation or as a bridging treatment until the patient can be listed for transplantation and receive the transplant. Because of the organ s , only a minority of VAD patients ever receive a transplant.

Permanent Implantable Cardiac Support Systems.

OBJECTIVES Publications on the paediatric Berlin Heart EXCOR ventricular assist device have revealed that low body weight 10 kg; n = 995) in different eras [era 1: January 2000-December 2012 (n = 1089) and era 2: January 2013-June 2017 (n = 743)]. RESULTS Overall survival in groups A and B significantly increased from era 1 to era 2 (group A 51% vs 65%, P < 0.001; group B 74% vs 78%, P = 0.001), whereas it remained stable in group C (78% vs 73%). In era 2, the survival of group B was not significantly different from group C. On the multivariable analysis of children weighing <5 kg, congenital heart disease, preoperative extracorporeal life support and biventricular support were independently associated with increased mortality in era 1 [hazard ratio 2.04 (95% confidence interval 1.18-3.53); 2.44 (1.36-4.37) and 1.93 (1.11-3.34), respectively] but not in era 2. CONCLUSIONS Paediatric EXCOR ventricular assist device therapy has significantly improved for patients weighing <10 kg. Withholding a ventricular assist device is not justified on the basis of the body weight alone.

Improvement of survival in low-weight children on the Berlin Heart EXCOR ventricular assist device support†.

Objectives With the scarcity of organs, a durable, reliable ventricular assist device (VAD) is required. The Berlin Heart EXCOR ® (BH) remains the most established VAD in the paediatric population. Implantable continuous flow (CF) VADs have been introduced to the paediatric field with encouraging early results. In this study, we compared the results of a newly introduced CF VAD (HeartWare VAD [HVAD] ® ) to results in a matched group of BH recipients. Methods The study included patients aged <16 years who received mechanical left VAD (LVAD) support between December 2005 and January 2016. The preimplant characteristics and postimplant outcomes of patients who received the HVAD were compared with those of a matched group who received the BH. Patients with congenital heart disease were excluded. Results Thirty patients were included in the study: 13 had received the HVAD and were matched with 17 patients who had received the BH LVAD. The only difference in preimplant characteristics was the need for higher inotropic support in the BH group. There was no difference in the need for right ventricular (RV) support (58.8% for BH vs 53.8% for HVAD, P  = 1.00) or in the incidence of cerebrovascular accidents (12.5% vs 7.7%, respectively, P  = 1.00), though the BH group showed prolonged mechanical ventilation (31.3% vs 0%, P  = 0.047). There were no deaths while on VAD support in either group. Patients with the HVAD showed a bimodal distribution for the primary end point (transplant/explant): All HVAD recipients who also required early RV support reached this end point within 30 days of receiving the implant. Conclusions Our early experience with the CF intracorporeal LVAD system (HVAD) indicates outcomes comparable to those with the well-established pulsatile flow paracorporeal LVAD (BH). The theoretical durability of the CF device, which might also allow for the possibility of hospital discharge and better quality of life, is yet to be proven.

/pdf/comparison-of-paracorporeal-and-continuous-flow-ventricular-48zvoi05jk.pdf

Comparison of paracorporeal and continuous flow ventricular assist devices in children: preliminary results.

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 recov...

/pdf/antithrombotic-therapy-in-pediatric-ventricular-assist-u2nc3mxrh4.pdf

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

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Comparison of paracorporeal and continuous flow ventricular assist devices in children: preliminary results.

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