Steen Solution™

Steen Solution™

For reliable objective ex vivo assessment of "marginal" and rejected lungs

STEEN Solution™ is a buffered extracellular solution optimally designed to perfuse the isolated donor lung during ex-vivo lung perfusion. STEEN Solution™ includes human serum albumin to provide an optimal colloid osmotic pressure and dextran 40 to coat and protect the endothelium from excessive leucocyte interaction. STEEN Solution™ is intended for assessment of isolated lungs after removal from the donor body for eventual transplantation into a recipient.

Maintains stability of isolated lungs ex-vivo

STEEN Solution™ is designed to facilitate prolonged evaluation and promote stability of isolated lungs ex vivo. The STEEN Solution™ perfusate and circuitry can maintain stable lung function, without edema formation, for up to 10 hours at 37 °C 7, 12, 18-22.

Ex-vivo assessment with STEEN Solution™ can expand your donor lung pool

About four of every five lungs offered for transplantation are currently rejected by present selection criteria1,2. Rejected lungs from marginal and extended donors have been successfully used for transplantation for almost two decades and the concept has now become routine practice 3,4,5,16-18. The number of transplants of lungs perfused ex vivo is now well above 400 and the number is increasing with the clinical EVLP programs being established world-wide.

 

Testing lung viability – A glimpse into the future

With EVLP, the perfusion circuit of the lung mimics in-vivo conditions; the ventilated lung is perfused with deoxygenated STEEN Solution™, with or without red blood cells, and the critical parameters of gaseous exchange, pulmonary vascular resistance and other key variables under normothermic conditions are monitored. Variables such as pressures, flow rate, dynamic compliance, and small airway resistance are frequently used as markers of organ status.

The STEEN Solution™ perfusate and XPS™ ex-vivo machine perfusion methodology permit:

  • A more refined functional ex-vivo evaluation of accept/reject criteria
  • Normothermic functional evaluation without edema formation
  • Permits more rational allocation and use of the limited pool of donor lungs offered for transplantation

Steen Solution™ Contains

  • Human Serum Albumin – provides normal oncotic pressure preventing edema formation.
  • Dextran 40 – a mild scavenger which coats and protects endothelium from subsequent excessive platelet/leucocyte interaction.14, 15
  • Extra-cellular electrolyte composition (low K+) – avoids vascular spasm under normothermic conditions.

In clinical use

The lungs are enclosed in the transparent container, Organ Chamber™, to maintain humidity.

The pulmonary artery of the closed circuit is connected to a pump, oxygenator and heat and gas exchanger so that the perfusate – STEEN Solution™ (with or without red blood cells) – assumes physiological temperature and partial gas pressures. A leucocyte filter is connected before the inflow to prevent leucocyte-induced tissue injury.

Since the lungs are generally cold before perfusion, initial flow rates must be very low, gradually increasing as the temperature increases. The flow should never exceed 4 l/min. Careful ventilation is begun as the temperature of the perfusate outflow reaches 32 °C.

Functional assessment can begin when the circuit has reached the steady state described above, monitoring arterial and venous blood gases, end-tidal carbon dioxide and a range of hemodynamic parameters.

To Order: REF 19004; 500 mL bottle
Content: 1 bottle contain 500 ml STEEN Solution™
Packaging: PETG bottle
Storage: Store dark at +2 to + 8oC in an upright position. Use only unopened and undamaged packages.
Shelf life: At least three months from date of shipment.
Intended Use: STEEN Solution™ is intended for assessment of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.
Properties: Sterile
Bacterial Endotoxins EU/ml <0.25
Osmolality (mOsm/kg) 275 – 315
pH 7.1 – 7.7

*Humanitarian Device. Authorized by Federal law in the USA for use in flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the ex-vivo function of the lungs can be reassessed for transplantation. The effectiveness of this device for this use has not been demonstrated.

References

  1. Ware LB et al. Lancet 2002, 360:619-20
  2. Pierre AF et al. J Thorac Cardiovasc Surg. 2002, 123;3:421-8
  3. Kron I et al. Ann Surg. 1993;217:518-24
  4. Sundaresan S et al. J. Thorac Cardiovasc Surg. 1995, 109:1075-80
  5. Shumway S et al. Ann Thorac Surg. 1994,57:92-5
  6. Steen S et al. Lancet 2001, 357:825-829
  7. Steen S et al. Ann Thorac Surg. 2003,76:244-52
  8. Cypel M, et al. J Heart LungTransplant 2008;27(12):1319-1325
  9. Cypel M, Rubacha M, Yeung J, et. al. Am J Transplantation 2009;9:1-8
  10. Steen S, Ingemansson R, Eriksson L, et. al. Ann Thorac Surg 2007;83:2191–5
  11. Ingemansson, R et al. Ann Thorac Surg 2009;87(1):255-260
  12. Neyrinck A et al. J Heart Lung Transplant 2004,23;173 (abstr)
  13. Wierup P et al. Ann Thorac Surg. 2006, 81:460-6
  14. Menger MD et al. Transplant Proceed. 1995, 27;5:2863-65
  15. Hoffman H et al. Z. Hertz-Thorax-Gefässschir 1997, 11:108-14
  16. Zych B et al, British J of Transplantation, 2010; 4 (3), 10-16
  17. Cypel M, et al. J Thorac Cardiovasc Surg. 2012 Nov; 144(5):1200-6
  18. Koike T et al. J Heart Lung Transplant. 2011 Dec;30 (12):1312-9
  19. Munshi L, et al. Lancet Respir Med. 2013 Jun;1(4):318-28
  20. Machuca T N, et al.  Surg Clin North Am. 2013 Dec;93(6):1373-94
  21. Sanchez P G, et al.  J Heart Lung Transpl. 2012, 31: 339-348.
  22. Aigner C, et al.  Am. J Transplant. 2012; 12; 1839-1847
  23. Carrel A, et al. Science. 1935; 81:621
  24. Cypel M, Keshavjee S.  Curr Opin Organ Transplant. 2016 Jun;21(3):329-35
  25. Sanchez PG, Mackowick KM, Kon ZN,  Curr Opin Organ Transplant. 2016 Jun;21(3):258-66.
  26. Wallinder A, et al,  J Heart Lung Transplant. 2016 Nov;35(11):1303-1310.
  27. Yeung J C, et al, Lancet Respir Med. 2017 Feb;5(2):119-124
  28. Andreasson AS, et al,  Eur J Cardiothorac Surg. 2017 Mar 1;51(3):577-586
  29. Slama A, et al,  J Heart Lung Transplant. 2017 Jul;36(7):744-753
  30. Martens A, et al, Transpl Int. 2017 Oct;30(10):1002-1010
  31. Hashimoto K, et al, J Heart Lung Transplant. 2017 Jun 21. pii: S1053-2498(17)31870-3
  32. Hsin M K, et al, Ann Surg. 2018 Jan;267(1):196-197.