We have concentrated research efforts to improve the procurement and preservation phases of the organ transplantation process by developing a system to provide controlled, hypothermic delivery of an oxygenated, nutrient solution to the donor organ in a manner that can be easily inserted into the current procurement process.

For over 10 years, OTS has been conducting pre-clinical research experiments in donor organ preservation technologies studying:

• The comparison of static, cold storage with machine perfusion using the OTS LifeCradle® measuring viability markers. These markers include
  • oxygen consumption,
  • sub-cellular metabolism,
  • cell death during the preservation period
  • cardiac function post orthotopic transplantation in animal model
  • overall organ integrity^1-9,16
• techniques for cooling and maintaining temperature control of the perfusion solution and organ during the preservation period⁹
• distribution of myocardial perfusion at various flow rates to
  • maximize delivery of oxygen and substrates to the myocardium while
  • washing away harmful metabolites and
  • minimizing edema¹⁰
• methods of oxygenating the perfusion solutions¹¹ and
• various perfusion solutions while evaluating
  • buffering capacity,
  • substrate utilization and
  • electrolyte balance.^4,12-14

Both swine and canine models have been used for studying preservation techniques during 4-24 hours of donor heart preservation prior to orthotopic transplantation in a recipient animal. ^{2, 3, 5, 6, 11, 15} Techniques have been developed to measure tissue levels of metabolites from extremely small biopsies to help determine the viability of the preserved organ prior to transplantation. ^{8, 9} Research studies also have been carried out in Langendorff preps with rat hearts and adult swine cadaveric hearts to evaluate various perfusion solutions.^{4, 12, 14, 15}

Recent studies presented at the 2009 International Society of Heart & Lung Transplantation in Paris with discarded human hearts using the LifeCradle® in the real donor operating room setting have verified the ease of use in the current procurement process. Twelve-hour preservation periods with these discarded human hearts in the LifeCradle® have shown that the hearts are still consuming oxygen and the tissue lactate levels are significantly lower than in the cold, static storage controls at the end of the preservation periods.¹⁹ These results are consistent with the findings in the earlier animal transplant studies.

Going beyond the heart, OTS and our research collaborators have conducted studies that include the perfusion and preservation of livers, kidneys, and lungs to define the organ specific requirements to extent viability and resuscitate organs currently discarded. These studies are helping to define perfusion pressure and flow parameters, temperature range, and perfusion solution components to best preserve these organs for transplantation.

Research and clinical prototype devices and solutions are being developed and studies are being conducted in both pre-clinical and clinical phases.

OTS has collaborated with OPOs, surgeons and research scientists from major academic medical centers and institutes across the nation, as well as in Australia and Europe. These research collaborators have helped define the specifications for the OTS LifeCradle® device that will soon be entering clinical trials for donor heart preservation. They also have designed studies and prototype devices that are undergoing clinical trials in other targeted organ transplant arenas.

These OTS collaborators have presented their research results at national and international peer group conferences and symposia and through publications in peer reviewed journals.