FDA sets a date to review XVIVO's lung perfusion system
The FDA sets a date to consider Humanitarian Device Exemption for XVIVO's perfusion system for preserving donor lungs. Sweden-based XVIVO Perfusion landed a date with the FDA to review Humanitarian Device Exemption for its XVIVO Perfusion System for preserving donor lungs. XVIVO will meet on March 20 with the FDA's Gastroenterology &Urology Devices Panel to review data on the device, which provides continuous perfusion of otherwise unacceptable lung tissue, allowing clinicians to reevaluate the organs for transplantation. News Well, Humanitarian Device Exemption (HDE), Regulatory/Clearance, Food &Drug Administration (FDA), Organ Transplantread more
TransMedics said today that it won pre-market approval from the FDA for its OCD Lung transplant system, which is designed to keep donated human lungs in near-living condition until transplantation. The March 22 approval covers standard double-lung transplantation procedures, Andover, Mass.-based TransMedics said. The federal safety watchdog granted the PMA based on data from the 316-patient Inspire trial, the results from which were published this week in The Lancet Respiratory Medicine, comparing OCS lung with the standard of care – cold flush and storage. Inspire met its primary outcome – a composite of ...
CONCLUSION: The literature strongly supports a specific infusion rate1-7 (2.5 mg/kg/h) for bivalirudin anticoagulation during extracorporeal circulation. Clinicians must consider the loss of clotting factors and the administration of blood products while adjusting the bivalirudin infusion during bypass. We have now elected to maintain an infusion rate of ≥0.5 mg/kg/h for bivalirudin anticoagulation at our center, based on institutional experience, though consideration for a higher infusion rate for an added margin of safety should be considered. It is imperative to have a well-developed protocol for the management of th...
Adult heart transplantation from Donation After Circulatory Determined Death (DCD) donors is now established in four heart transplant centers across the globe. The protocols for acceptable donation withdrawal ischaemia time, DWIT (period from withdrawal of life supportive therapy (WLST) to onset of heart perfusion) vary from 30 minutes to 4 hours. If the 30-minute guideline is adhered to many donors will not meet criteria within this short ischaemic period, resulting in the loss of some donor hearts that may have been acceptable for transplantation.
Standard heart preservation, before transplantation, consists of cold ischemic storage of the heart. Clinical studies have shown that the morbidity and mortality risk increases with an extension of the allograft ischemic time. Pre-clinical studies have demonstrated that a new preservation technology of donor hearts, using an ex-vivo non-ischemic heart perfusion system (NIHP), can be safely applied 24 hours in pigs. However, until now this state-of-the-art technique has never been used on humans.
The clinical use of ex vivo lung perfusion (EVLP) allows for the assessment of donor lung viability prior to transplantation, and has helped to expand the donor pool. The EVLP perfusate offers a unique opportunity to assess biological processes in the donor lung. Neutrophil extracellular traps (NETs) have been described as a product of NETosis, an innate neutrophil-mediated immune response. NETs have been implicated in acute lung injury and have been shown to be pathogenic in primary graft dysfunction.
Neurological complications are the major causes of death in patients on ECMO. Near-infrared spectroscopy (NIRS) is used as a noninvasive method of surveillance for cerebral perfusion. Cerebral oxygen saturation monitoring by NIRS may predict neurological injury in ECMO patients
Regulatory T cells (Tregs) can be expanded and cryopreserved, making them a viable therapeutic option in lung transplantation (LTx). Tregs may potently control alloreactive conventional T cells (Tcon) if they interact with antigen-presenting cells (APCs) prior to, rather than with, Tcon. Normothermic ex vivo lung perfusion (EVLP) provides the opportunity for graft therapy prior to LTx. We aimed to determine feasibility, engraftment potential and effects of recipient-derived Tregs delivered during EVLP.
The impact of pre-transplant renal function on heart transplant (HTx) outcomes may be different between those with optimized perfusion with LVAD and those without prior LVAD. The purpose of this study was to investigate the association between pre-transplant estimated glomerular filtration rate (eGFR) and HTx survival in LVAD and non-LVAD cohorts, to determine whether there should be different eligibility criteria for degree of renal dysfunction prior to HTx.
Portable ex vivo lung perfusion (EVLP) is an alternative to cold static storage for graft preservation in lung transplantation. In the clinical INSPIRE trial, lung preservation with the organ care system (OCS) resulted in reduced rates of early PGD. Here, we investigate mechanisms of improved preservation in the OCS focusing on immunological changes in a porcine lung transplant model.
The ability to confidently identify which extended criteria donor lungs can be successfully reconditioned via ex-vivo lung perfusion (EVLP) and will function well post transplant is essential. IL-1 β is a promising early perfusate marker shown to differentiate between 1-year post-Tx survival and mortality with high precision in EVLP recipients (p=0.005, AUC=0.93). However, the typical EVLP assessment time before a decision on transplant suitability has to be made is as short as two-four hours . For any biomarker technology to have real clinical relevance it has to be highly accurate and able to deliver a result availa...