A multicenter study of the HeartWare ventricular assist device in small children

Miera, Oliver; Kirk, Richard; Buchholz, Holger; Schmitt, Katharina; VanderPluym, Christina; Rebeyka, Ivan M.; Wrightson, Neil; Berger, Felix; Griselli, Massimo; Conway, Jennifer

doi:10.1016/j.healun.2016.01.019

Cited by 77 publications

(41 citation statements)

References 9 publications

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“…Debate is ongoing with respect to how young and how small an HVAD recipient can be. Anecdotal experience with the HVAD suggests that children with a body surface area as low as 0.6 m 2 may be candidates for HVAD support 35. This is consistent with our experience.…”

Section: Current Challengessupporting

confidence: 90%

“…He has been supported well (>600 days of ongoing support) without any neurologic events. These anecdotal experiences clearly demonstrate the potential feasibility of continuous-flow VAD support even in small children 20,30,31,35,37…”

Section: Current Challengesmentioning

confidence: 71%

“…A caveat remains in that the smaller the LV, the lower the tolerance for technical imperfections. Miera et al35 recently published their experience with the use of HVAD in small children with a body surface area of ≤1.0 m 2 . In this multicenter retrospective study, four patients (33%) out of 12, excluding one who died early postoperatively, experienced pump thrombosis.…”

Section: Current Challengesmentioning

confidence: 99%

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Pediatric ventricular assist devices: current challenges and future prospects

Bürki¹,

Adachi²

2017

VHRM

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The field of mechanical circulatory support has made great strides in the preceding 2 decades. Although pediatric mechanical circulatory support has lagged behind that of adults, the gap between them is expected to close soon. The only device currently approved by the US Food and Drug Administration for use in children is the Berlin Heart EXCOR ventricular assist device (VAD). The prospective Berlin Heart Investigational Device Exemption Trial demonstrated good outcomes, such as bridge to transplantation or recovery, in ~90% of children supported with this device. However, a high incidence of hemorrhagic and thrombotic complications was also noted. As a result, pediatric centers have just started implanting adult intracorporeal continuous-flow devices in children. This paradigm shift has opened a new era in pediatric mechanical circulatory support. Whereas children on VAD were previously managed exclusively in hospital, therapeutic options such as outpatient management and even destination therapy have been becoming a reality. With continued miniaturization and technological refinements, devices currently in development will broaden the range of options available to children. The HeartMate 3 and HeartWare MVAD are two such compact VADs, which are anticipated to have great potential for pediatric use. Additionally, a pediatric-specific continuous-flow VAD, the newly redesigned Jarvik Infant 2015, is currently undergoing preclinical testing and is expected to undergo a randomized clinical trial in the near future. This review aims to discuss the challenges posed by the use of intracorporeal adult continuous-flow devices in children, as well as to provide our perspective on the future prospects of the field of pediatric VADs.

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Section: Current Challengessupporting

confidence: 90%

Section: Current Challengesmentioning

confidence: 71%

Section: Current Challengesmentioning

confidence: 99%

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Pediatric ventricular assist devices: current challenges and future prospects

Bürki¹,

Adachi²

2017

VHRM

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“…15 However, in his series of 13 younger patients (3.7–10.5 years) <1 m 2 with 61% primary diagnosis of cardiomyopathy/myocarditis, the group had 23% early bleeding and 15% late bleeding events (38% total) along with two (15%) patients with thromboembolic neurologic events and four with (31%) pump thrombosis. 16 Peng et al . 17 series of 12 patients were 3.7–17 years, three < 5 years, all but one of whom had cardiomyopathy.…”

Section: Discussionmentioning

confidence: 99%

Antithrombotic Therapy in a Prospective Trial of a Pediatric Ventricular Assist Device

2016

ASAIO Journal

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Efficacious ventricular assist device (VAD) support in pediatric patients depends on successful antithrombotic management. The experience with antithrombotic management for the EXCOR Pediatric VAD Investigational Device Exemption (IDE) study is described. All 68 children in North America enrolled in the IDE study from May 9, 2007 to December 10, 2010 are included. The Edmonton Anticoagulation and Platelet Inhibition Protocol was provided for management guidance. Monitoring parameters, drug dosing, targeted serious adverse events, and pump changes were reviewed. Major bleeding occurred in 43% of all subjects with most events occurring within 14 days of implantation. Bleeding events were probably/definitely related in 24% to antithrombotic management. Neurologic events occurred in 28% of subjects and were probably/definitely related in 9% to antithrombotic therapy intensity. Most neurologic events occurred between 4 and 30 days postimplantation and sporadically thereafter. Pump change occurred in 56% of subjects. Use of an antithrombotic protocol for enrolled subjects was possible in this multicenter study. Incidence of significant bleeding and thromboembolic events was acceptable when balanced against life-saving benefits of VADs. Further studies are needed to optimize the antithrombotic management of this patient population.

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“…In particular, there has been a concern regarding an elevated risk of device-related complications such as pump thrombosis in small children. The recent multi-institutional study (4) involving four pediatric centers focusing on continuous-flow VAD support in children with a BSA of <1.0 m 2 reported a 31% (4 patients out of 13) incidence of pump thrombosis. The fundamental issue stems from the fact that a pump designed for adult hearts is used in small children (i.e., patient-device size mismatch).…”

Section: Introductionmentioning

confidence: 99%

Current status and future perspectives of the PumpKIN trial

Adachi

2018

Transl Pediatr

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A multicenter study of the HeartWare ventricular assist device in small children

Cited by 77 publications

References 9 publications

Pediatric ventricular assist devices: current challenges and future prospects

Pediatric ventricular assist devices: current challenges and future prospects

Antithrombotic Therapy in a Prospective Trial of a Pediatric Ventricular Assist Device

Current status and future perspectives of the PumpKIN trial

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