Hypothermic Machine Perfusion: Improving the Organ Transplant Process and Hospital Operations

943

Transplantable organs are in chronic shortage in the U.S., and there continues to be a woeful imbalance between donor organ supply and demand. One hundred five thousand eight hundred individuals are on the nation’s transplant waiting list today, and a new patient is added every 10 minutes. Seventeen people die every day because they did not receive a life-saving organ in time, often because the donor organ’s journey to the patient put the organ quality at risk.

It is common for the organ to be shipped in a decades-old, low-tech preservation modality: chilled on ice and stored in a cooler—otherwise known as static cold storage (SCS).

Hospitals are looking for better ways to preserve and transport organs for transplant to mitigate this risk. Hypothermic machine perfusion (HMP) is a promising solution that has rapidly gained broad adoption in the US and worldwide.

With the help of HMP technology, hospital leadership and administrators significantly improve the delicate environment of its transplant program: streamlining hospital operations surrounding transplants, providing more transplants per year, and improving patient outcomes.

Weighing the Costs and Patient Benefits of Static Cold Storage vs. Cold Perfusion

There are three FDA-approved methods for portable organ preservation: static cold storage, HMP, and normothermic machine perfusion (NMP). While static cold storage relies entirely on a passive system of maintaining near-freezing temperatures to slow tissue degradation, both HMP and NMP employ active preservation – a method that pumps fluids through the organ to keep it in a life-like state. While HMP and NMP preserve healthy tissue for longer, NMP maintains the donor organ at body temperature, and HMP gently circulates a cool preservation solution that keeps the organ in a moderate hypothermic state just above 32 degrees Celsius.

These three methods come with very different costs, advantages, and drawbacks.

Static cold storage (the cool box filled with ice) has been the traditional approach for transporting donor organs. It is low-cost and requires essentially no training to implement. Among the several limitations of static cold storage, a key drawback is that only organs that meet strict criteria of age, condition, and type of death are accepted for this preservation modality, and these organs are not typically matched to waiting-list patients who are incredibly sick. Additionally, in the case of a kidney, the organ must be removed from the donor within 30 minutes of death and transported to the recipient’s hospital within 18-24 hours. If the organ has been in transit beyond this window, the surgeon will likely reject it upon arrival.

In practice, organ transplantation is considered time-sensitive and often conducted as an emergency-like procedure, putting added strain on hospital resources. When a viable donor organ is accepted for transplant, the intended organ recipient, surgeon, and support staff are often rushed to the operating room to minimize the time the organ has been in transit. This becomes more urgent when a donor organ is transported via static cold storage. With this method, organs commonly suffer inevitable damage through ischemia, another limitation of SCS which causes it to be considered inferior in many circumstances.

By comparison, hypothermic and normothermic preservation are observed to help increase the quality and quantity of donor organs for transplantation. However, HMP and NMP each have unique logistical and handling requirements.

For example, while each modality requires operator training, NMP devices employ a complex technological system to keep the organ at body temperature, control contamination/infection risk, biological waste management and require significant advanced training. In contrast, HMP devices are typically considered less complex and more user-friendly. Organs preserved via HMP are pumped with a chilled, nutrient-rich, oxygenated solution that does not contain blood or blood products. The cooling source for the preservation solution is an integrated ice-filled chamber that, while simple in its design, is robust and effective in maintaining the prescribed hypothermic temperature for 18-24 hours. Another essential comparison between HMP and NMP is if a NMP machine stops working during donor organ preservation, there is no fail-safe. Comparatively, if a hypothermic system fails,  it automatically reverts to static cold storage mode, preserving the donor organ in a protective hypothermic environment during transit. HMP for kidneys has also demonstrated successful ex-vivo preservation of donor organs for up to 48-72 hours.

Investing in HMP to Improve Hospital Operations

When considering a new organ preservation technology, hospital administrators will likely want to evaluate a full range of financial implications of adoption. Typically, expensive and complex new technologies, however promising, are only practical for some hospital operating budgets. Alternatively, low-cost solutions are often associated with mediocre performance, causing operational disruptions and wasting time and money. Moderately priced and easy to use, today’s HMP technologies strike a middle ground. HMP has become a standard of care for preserving and transporting many categories of donor kidneys in transplant programs worldwide.

By keeping organs safely preserved longer, HMP gives hospital administrators hours of flexibility when scheduling transplants and strategizing staffing within the hospital. In many transplant programs that have adopted HMP, operations are performed more like routine scheduled surgery vs. emergency-like procedures. In transplant centers with HMP, scheduling surgeries during regular daytime hours supports better outcomes as surgeons and their staff, patients, and their families prepare and perform under more optimal conditions.

HMP also allows hospitals to accept organs from expanded criteria donors that otherwise are not deemed acceptable. Instead of turning down organs otherwise considered as too ‘marginal’ due to factors of donor age, prior medical or lifestyle conditions, and circumstances of death, clinical data has demonstrated that a broad scope of expanded criteria organs can be transplanted with successful outcomes when HMP is utilized. HMP creates flexibility and maximizes hospital finances and resources while allowing a significant increase in life-saving transplants for waiting list patients.

In addition, patients who receive organs transported via HMP tend to need less time to recover in the hospital, experience fewer complications and remissions, and allow their new organ to remain functional for longer compared to patients with organs transported by static cold storage. Using technology that enables patients to recover faster and require fewer hospital visits post-transplant, hospitals can accelerate patient turnover, thereby improving profitability by freeing up beds and reducing complications that cost tens of thousands of dollars per patient.

Cause and Effect

The productivity benefits and improved clinical outcomes enabled by HMP far outweigh the moderate costs associated with purchasing technology and training staff to use it. As there are several organ preservation technologies on the market, administrators interested in exploring options should verify clinical benefits that are clearly defined and bring sustainable value to the hospital’s organ transplant operations. Many companies claim their product offering will improve patient outcomes. Still, many administrators will require concrete examples and evidence that prove claimed technological performance and the provider’s capability to deliver essential support. Less diligence could result in poorer performance and results than the transplant administrator’s technology.

Organ preservation technologies are advancing like never before in the history of transplantation. Adopting the right new technology for your hospital can provide not only financial and patient outcome benefits but downstream improvements, including improved staff organization, reduced stress, and better utilization of facility resources. In particular, the adoption and routine use of HMP technology can help achieve an important goal;  providing more patients with a better opportunity to receive the transplant they and their loved ones have been hoping for, and in so doing, delivering a second chance at life.

Author: David Kravitz, CEO and Founder of Organ Recovery Systems