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

The Journal of Thoracic and Cardiovascular Surgery
Iki AdachiCharles D Fraser

Abstract

The Infant Jarvik 2015 is an implantable axial-flow ventricular assist device (VAD) that has undergone the major evolutionary design modifications to improve hemocompatibility. This study was conducted in anticipation of data submission to the US Food and Drug Administration to obtain Investigational Device Exemption approval. The VAD was implanted via a left thoracotomy in Barbado sheep (n = 10, 26 (19-34] kg). Anticoagulation was maintained with coumadin, with a target international normalized ratio of greater than the individual sheep's baseline values. The VAD was managed at the highest possible speed as clinically tolerable. Complete necropsy was performed at the end of the study. There were 2 early mortalities: tension pneumothorax (n = 1) and shower emboli of the fragmented myocardium (n = 1). The remaining 8 sheep (2 with 30-day and 6 with 60-day protocols) completed the anticipated study duration in excellent condition, with the 6 completing 60-day sheep showing appropriate weight gain during support. There were no signs of clinically significant hemolysis, with the final plasma-free hemoglobin of 2 (1-17) mg/dL. Necropsy showed old renal infarction in 7 sheep. Although thromboembolism can be the potential etiology, gi...Continue Reading

Citations

Mar 5, 2017·The Journal of Thoracic and Cardiovascular Surgery·Katsuhide Maeda
Mar 7, 2018·Artificial Organs·Dmitry TelyshevIgor Nesterenko
Mar 22, 2018·Current Opinion in Organ Transplantation·Martin SchweigerJennifer Conway
Nov 7, 2018·Artificial Organs·Arianna Di MolfettaAntonio Amodeo
Dec 7, 2018·Hematology·Lisa Baumann Kreuziger, M Patricia Massicotte
Apr 19, 2020·Current Opinion in Organ Transplantation·Zachary A SpigelIki Adachi
Feb 26, 2021·ASAIO Journal : a Peer-reviewed Journal of the American Society for Artificial Internal Organs·Chris H H ChanJohn F Fraser
Aug 19, 2021·The International Journal of Artificial Organs·Miriam WeisskopfNikola Cesarovic
Oct 19, 2019·The Journal of Thoracic and Cardiovascular Surgery·Iki Adachi
Nov 24, 2021·Current Opinion in Anaesthesiology·Catherine S ReidMatthias Siepe

❮ Previous
Next ❯

Related Concepts

Related Feeds

Artificial Heart & Ventricular Assist Devices

Total artificial hearts (TAH) and ventricular assist devices (VADs) provide cardiac support for patients with end-stage heart disease and have significantly improved the survival of these patients. Discover the latest research on Artificial Heart and Ventricular Assist Devices here.

Related Papers

ASAIO Journal : a Peer-reviewed Journal of the American Society for Artificial Internal Organs
John M ConnellGerson Rosenberg
The New England Journal of Medicine
Lindy H LandzaatDrew A Rosielle
ASAIO Journal : a Peer-reviewed Journal of the American Society for Artificial Internal Organs
Marc GibberB P Griffith
© 2022 Meta ULC. All rights reserved