XVIVO Heart Assist Transport™
CAUTION:
The XVIVO Heart Technology is not regulatory approved on any market and its safety and efficacy has not been established. The XVIVO Heart Technology is not commercially available.
With the aim to change the paradigm of heart preservation
XVIVO’s technology for non-ischemic heart preservation (NIHP) uses cold, oxygenated perfusion. The technology is currently under clinical trials in Australia/New Zealand, Europe and the US to investigate if it can significantly extend the period the heart can be preserved outside the body and potentially improve outcomes after transportation. This would mean that more hearts can be used with a reduced risk of complications. Simultaneously, with prolonged preservation time, the complicated logistics of heart transplantation can be facilitated.
Multiple clinical studies are ongoing.
Oxygen in heart transplantation
The technology preserves the resting heart during transportation using hypthermic, oxygenated perfusion with solutions specifically tailored for the heart.
CAUTION:
The XVIVO Heart Technology is not regulatory approved on any market and its safety and efficacy has not been established. The XVIVO Heart Technology is not commercially available.
Currently under clinical trials to investigate potential key benefits
Increased utilization
– extended criteria donors
Improved outcomes
– fewer complications
Extended preservation
– better logistics, longer travel distance, optimized matching
Extended transportation times
An investigator initiated clinical trial investigating extended transportation times
The donor heart ischemic time is one of the most important factors influencing transplant outcomes. With static cold storage, the optimal donor heart ischemia time is less than 3 hours [1].
Results from an investigator driven clinical trial in Australia and New Zealand are published in The Journal of Heart and Lung Transplantation. The study suggests that donor hearts that were previously considered unsuitable due to long distances may be transplanted with a 100% survival rate at 30 days when using XVIVO’s heart technology, even with the extended transportation times, reaching up to 8 hours and 47 minutes[2].
1. P. Tang et al. Determining optimal donor heart ischemic times in adult cardiac transplantation. J Card Surg. 2022;37:2042-2050.
2. Mc.Giffin et al. Hypothermic oxygenated perfusion (HOPE) safely and effectively extends acceptable donor heart preservation times – results of the Australian and New Zealand trial. J. Heart Lung Transplant 2023 Oct 31:S1053-2498(23)02110-1. doi: 10.1016/j.healun.2023.10.02.
XVIVO Heart Assist Transport™
Supported by 20+ years of pre-clinical research and development.
- Portability: compact design with an integrated battery, suitable for standard aircraft and transport vehicles.
- Temperature control: equipped with an insulated container and cooling unit, maintaining a constant 8°C.
- Continuous oxygenation: features a cylinder with a carbogen gas mix (95% oxygen and 5% carbon dioxide) and a regulator for consistent oxygenation during perfusion.
- User-friendly operation: intuitive interface and software with guided instructions for an enhanced clinician experience.
- Automated perfusion: once perfusion is established, there’s no need to adjust pressure, flow, or temperature.
The heart technology includes a preservation device, pre-assembled set, and a tailor-made solution.
CAUTION:
The XVIVO Heart Technology is not regulatory approved on any market and its safety and efficacy has not been established. The XVIVO Heart Technology is not commercially available.
XVIVO Heart Assist Transport™ Perfusion Set
Pre-assembled perfusion set with a plug-and-play design.
CAUTION:
The XVIVO Heart Technology is not regulatory approved on any market and its safety and efficacy has not been established. The XVIVO Heart Technology is not commercially available.
XVIVO Heart Solution™ and XVIVO Heart Solution Supplement™
A tailor-made perfusion solution combined with a proprietary supplement designed specifically for donor heart preservation.
CAUTION:
The XVIVO Heart Technology is not regulatory approved on any market and its safety and efficacy has not been established. The XVIVO Heart Technology is not commercially available.
NIHP2019. Non-ischemic Preservation of the Donor Heart in Heart Transplantation – a Randomized, Controlled, Multicenter Trial.
Registered with clinicaltrials.gov, NCT03991923.
PRESERVE Heart Study. A Prospective, Multi-center, Single-Arm, Open-Label Study of Hearts Transplanted After Non-Ischemic Heart PRESERVation From Extended Donors.
Registered with clinicaltrials.gov, NCT05881278.
Qin G, et al. Intact endothelial and contractile function of coronary artery after 8 hours of heart preservation. Scand Cardiovasc J. 2016 Oct-Dec;50(5-6):362-366.
Qin G, et al. Intact coronary and myocardial functions after 24 hours of non-ischemic heart preservation. Scand Cardiovasc J. 2020 Feb;54(1):59-65.
Critchley W, et al. Non-ischemic Heart Preservation via Hypothermic Cardioplegic Perfusion Induces Immunodepletion of Donor Hearts Resulting in Diminished Graft Infiltration Following Transplantation. Front Immunol. 2020 Jul 28;11:1621.
Steen S, et al. Safe orthotopic transplantation of hearts harvested 24 hours after brain death and preserved for 24 hours. Scand Cardiovasc J. 2016 May 3; 50(3): 193–200.
Hoe S. et al. Donor heart ischemic time can be extended beyond 9 hours using hypothermic machine perfusion in sheep. J. Heart Lung Transplant 2023.
Nilsson J et al. A nonrandomized open-label phase 2 trial of nonischemic heart preservation for human heart transplantation. Nat Commun. 2020 Jun 12;11(1):2976. doi: 10.1038/s41467-020- 16782-9. PMID: 32532991; PMCID: PMC7293246
Kaye D et al. Favorable Impact of Hypothermic Machine Perfusion (HMP) on Early Renal Outcomes in Patients Undergoing Heart Transplantation Using Prolonged (6-8 Hour) Donor Hearts. J. Heart Lung Transplant / 2023 / doi: 10.1016/j.healun.2023.02.1702
Emmanuel S et al.Initial Australian Experience with the XVIVO Non-Ischaemic Hypothermic Perfusion Device for Heart Preservation. J. Heart Lung Transplant / 2023 / 10.1016. j.healun.2023.02.133