Ex vivo Normothermic Perfusion in Heart Transplantation: A Review of the TransMedics^® Organ Care System

Abstract

Cardiac transplantation is the gold standard for treatment for select patients with end-stage heart failure, yet donor supply is limited. Ex vivo machine perfusion is an emerging technology capable of safely preserving organs and expanding the viable donor pool. The TransMedics^® Organ Care System™ is an investigational device which mimics physiologic conditions while maintaining the heart in a warm, beating state rather than cold storage. The use of Organ Care System allows increased opportunities for using organs from marginal donors, distant procurement sites, donation after cardiac death, and in recipients with complex anatomy. In the future, bioengineering technologies including use of mesenchymal stem cells, viral vector delivery of gene therapy, and alternate devices may further broaden the field of ex vivo machine perfusion.

Lay abstract

Cardiac transplantation is the gold standard for treatment for select patients with end-stage heart failure, but the supply of viable donor organs is limited. New technology known as machine perfusion is now capable of preserving donor hearts outside the body and can be used to assess the donor organ as well as allow transport over longer distances. The TransMedics^® Organ Care System is an investigational device that maintains the heart in a warm, beating state rather than transporting the heart on ice. The use of Organ Care System allows opportunities to assess viability in organs that may previously have been discarded, travel to distant sites to retrieve hearts, and provide more time to preserve the heart while preparing the recipient for surgery. In the future, it may also be possible to treat or improve the donor heart on the device prior to implantation.

Keywords:

• donation after cardiac death
• ex vivo normothermic perfusion
• heart transplantation
• Organ Care System

Financial & competing interests disclosure

J Kobashigawa is a member of the Clinical Events Committee of the TransMedics DCD Clinical Trial and has received a research grant from TransMedics and received honoraria for advisory board. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Company review disclosure

In addition to the peer-review process, with the author’s consent, the manufacturer of the product discussed in this article was given the opportunity to review the manuscript for factual accuracy. Changes were made by the author at their discretion and based on scientific or editorial merit only. The author maintained full control over the manuscript, including content, wording and conclusions.

Additional information

Funding

J Kobashigawa is a member of the Clinical Events Committee of the TransMedics DCD Clinical Trial and has received a research grant from TransMedics and received honoraria for advisory board. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.