An Extended Role of Continuous Flow Device in Pediatric Mechanical Circulatory Support

Peng, Ed; Kirk, Richard; Wrightson, Neil; Duong, Phuoc; Ferguson, Lee P.; Griselli, Massimo; Butt, Tanveer; O’Sullivan, John; MacGowan, Guy A.; Crossland, David; Schueler, Stephan; Hasan, Asif

doi:10.1016/j.athoracsur.2016.02.013

Cited by 25 publications

(19 citation statements)

References 20 publications

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“…Although not without risk, pediatric VAD support is successful in bridging children, primarily noninfants with DCM, to HT . Because much of the risk of adverse events and mortality is early after VAD placement and largely reflective of the severity of illness prior to VAD placement, once on successful VAD support most children are neither “too sick” nor unable to wait extended durations for transplantation . The most attractive group in which to apply a time‐limited status 1A window are outpatients, well supported by continuous‐flow, intracorporeal VADs (eg, Heartmate II/III, Heartware HVAD).…”

Section: Discussionmentioning

confidence: 99%

Impact of the 2016 revision of US Pediatric Heart Allocation Policy on waitlist characteristics and outcomes

Magnetta

Godown

West

et al. 2019

American Journal of Transplantation

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US Pediatric Heart Allocation Policy was recently revised, deprioritizing candidates with cardiomyopathy while maintaining status 1A eligibility for congenital heart disease (CHD) candidates on “high‐dose” inotropes. We compared waitlist characteristics and mortality around this change. Status 1A listings decreased (70% to 56%, P < .001) and CHD representation increased among status 1A listings (48% vs 64%, P < .001). Waitlist mortality overall (subdistribution hazard ratio [SHR] 0.96, P = .63) and among status 1A candidates (SHR 1.16, P = .14) were unchanged. CHD waitlist mortality trended better (SHR 0.82, P = .06) but was unchanged for CHD candidates listed status 1A (SHR 0.92, P = .47). Status 1A listing exceptions increased 2‐ to 3‐fold among hypertrophic and restrictive cardiomyopathy candidates and 13.5‐fold among dilated cardiomyopathy (DCM) candidates. Hypertrophic (SHR 6.25, P = .004) and restrictive (SHR 3.87, P = .03) cardiomyopathy candidates without status 1A exception had increased waitlist mortality, but those with DCM did not (SHR 1.26, P = .32). Ventricular assist device (VAD) use increased only among DCM candidates ≥1 years old (26% vs 38%, P < .001). Current allocation policy has increased CHD status 1A representation but has not improved their waitlist mortality. Excessive DCM status 1A listing exceptions and continued status 1A prioritization of children on stable VADs potentially diminish the intended benefits of policy revision.

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Section: Discussionmentioning

confidence: 99%

Impact of the 2016 revision of US Pediatric Heart Allocation Policy on waitlist characteristics and outcomes

Magnetta

Godown

West

et al. 2019

American Journal of Transplantation

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“…16 Peng et al . 17 series of 12 patients were 3.7–17 years, three < 5 years, all but one of whom had cardiomyopathy. Anticoagulation was begun 24 hours after implantation and only when surgical bleeding was <1 ml/kg/hour for three consecutive hours.…”

Section: Discussionmentioning

confidence: 99%

“…Two patients experienced device thrombosis but no neurologic events, two patients required mediastinal reexploration for bleeding and clot removal, and two patients developed ischemic bowel, with one death. 17 The mechanical features and intrathoracic placement of the HVAD are potentially advantageous in terms of reducing thromboembolic complications. However, the Berlin patients reported in this paper included a broad range of patient sizes and a larger proportion of both congenital cardiac disease and infectious diagnoses, which may impact SAEs and outcomes.…”

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 a recent multi-institutional study, we have demonstrated the feasibility of discharging majority of children on HVAD support, who may then go on to resume regular activities 33. However, recent studies (including the PediMACS registry data) show that about half of the patients supported by continuous-flow VADs are still managed in hospital 34–36. As the experience with continuous-flow VAD in children advances, the home discharge rate will steadily increase.…”

Section: Current Challengesmentioning

confidence: 99%

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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An Extended Role of Continuous Flow Device in Pediatric Mechanical Circulatory Support

Cited by 25 publications

References 20 publications

Impact of the 2016 revision of US Pediatric Heart Allocation Policy on waitlist characteristics and outcomes

Impact of the 2016 revision of US Pediatric Heart Allocation Policy on waitlist characteristics and outcomes

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

Pediatric ventricular assist devices: current challenges and future prospects

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