The miniaturized pediatric continuous-flow device: Preclinical assessment in the chronic sheep model

Adachi, Iki; Bürki, Sarah; Horne, David; Costas, Gil; Spangler, Taylor; Jarvik, Robert; Teal, John; Baldwin, J. Timothy; Dasse, Kurt A.; Massicotte, M. Patricia; Conger, Jeff L.; Cohn, William E.; Fraser, Charles D.

doi:10.1016/j.jtcvs.2016.12.070

Cited by 28 publications

(35 citation statements)

References 15 publications

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“…In vitro hemolysis testing revealed that hemolysis was related to the shape of the pump blade tips and a critical speed over which hemolysis would occur .Therefore, the Infant Jarvik 2015 design was significantly modified, the in vitro test repetition revealed acceptable hemolysis, and the new version succeeded the preclinical testing . In vivo experiments performed by Adachi et al implanting the Infant Jarvik 2015 in ten sheep evidenced that six sheep survived for 2 months with the device implanted, two sheep survived for one month and two sheep experienced an early mortalities: one for pneumothorax and one for thromboembolism of fragmented myocardium. No sign of significant hemolysis was observed.…”

Section: Discussionmentioning

confidence: 99%

Is the New Infant Jarvik 2015 Suitable for Patients<8 kg? In Vitro Study Using a Hybrid Simulator

et al. 2018

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Our aim was to study the feasibility of implanting the Infant Jarvik 2015 in patients weighing less than 8 kg. The Infant Jarvik 2015 left ventricular assist device (LVAD) was tested in a hybrid simulator of the cardiovascular system reproducing specific patients’ hemodynamics for different patient weights (2–7 kg). For each weight, the sensitivity of the pump to different circulatory parameters (peripheral resistance, left ventricular elastance, right ventricular elastance, heart rate, and heart filling characteristics) has been tested repeating for each experiment a pump ramp (10 000–18 000 rpm). The increase in the pump speed causes a decrease (increase) in the left (right) atrial pressure, an increase (decrease) in the arterial systemic (pulmonary) pressure, an increase in the right ventricular pressure, a decrease (increase) in the left (right) ventricular volume, a decrease in the left ventricular cardiac output, an increase in the LVAD output and an increase in the right ventricular cardiac output (total cardiac output). Suction was observed for lower weight patients and for higher pump speed in the case of vasodilation, left ventricular recovery, bradycardia, right ventricular failure, and left ventricular hypertrophy. Backflow was observed in the case of left ventricular recovery at lower pump speed. In the hybrid simulator, the Infant Jarvik 2015 could be suitable for the implantation in patients lower than 8 kg because of the stability of the device respect to the cardio/circulatory changes (low frequency of suction and backflow) and because of the capability of the device to maintain adequate patient hemodynamics.

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Section: Discussionmentioning

confidence: 99%

Is the New Infant Jarvik 2015 Suitable for Patients<8 kg? In Vitro Study Using a Hybrid Simulator

et al. 2018

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“…The HeartWare MVAD is another device that initially showed promise, especially with its very small size, however, it is not yet available. Finally, the PumpKIN trial continues testing of the Jarvik 2015, a CF device which could support even the smallest of patients (71).…”

Section: Future Directionsmentioning

confidence: 99%

An overview of mechanical circulatory support in single-ventricle patients

et al. 2018

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The population of people with a single-ventricle is continually increasing due to improvements across the spectrum of medical care. Unfortunately, a proportion of these patients will develop heart failure.Often, for these patients, mechanical circulatory support (MCS) represents the only available treatment option. While single-ventricle patients currently represent a small proportion of the total number of patients who receive MCS, as the single-ventricle patient population increases, this number will increase as well.Outcomes for these complex single-ventricle patients who require MCS has begun to be evaluated. When considering the entire population, survival to hospital discharge is 30-50%, though this must be considered with the significant heterogeneity of the single-ventricle patient population. Patients with a single-ventricle have unique anatomy, mechanisms of failure, indications for MCS and the type of support utilized. This has made the interpretation and the generalizability of the limited available data difficult. It is likely that some subsets will have a significantly worse prognosis and others a better one. Unfortunately, with these limited data, indications of a favorable or poor outcome have not yet been elucidated. Though currently, a database has been constructed to address this issue. While the outcomes for these complex patients is unclear, at least in some situations, they are poor. However, significant advances may provide improvements going forward, including new devices, computer simulations and 3D printed models. The most important factor, however, will be the increased experience gained by the heart failure team to improve patient selection, timing, device and configuration selection and operative approach.

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“…The development of the Infant Jarvik 2015 may represent the breakthrough to this frustrating situation (5). This new pediatric-specific pump will be tested in the PumpKIN trial.…”

Section: Update On the Pumpkin Trialmentioning

confidence: 99%

“…The detail of the pre-clinical assessment has been published elsewhere (5 (5)]. The advantage of using Barbados sheep of this weight range is that this specific breed is already grown up and therefore there would be no much weight increase during the chronic state over 2 months.…”

Section: Pre-clinical Phasementioning

confidence: 99%

Current status and future perspectives of the PumpKIN trial

Adachi

2018

Transl Pediatr

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The miniaturized pediatric continuous-flow device: Preclinical assessment in the chronic sheep model

Abstract: This study has demonstrated that the Infant Jarvik 2015 VAD is capable of maintaining its functionality for an extended period of time with minimal hemolysis.

Cited by 28 publications

References 15 publications

Is the New Infant Jarvik 2015 Suitable for Patients<8 kg? In Vitro Study Using a Hybrid Simulator

Is the New Infant Jarvik 2015 Suitable for Patients<8 kg? In Vitro Study Using a Hybrid Simulator

An overview of mechanical circulatory support in single-ventricle patients

Current status and future perspectives of the PumpKIN trial

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