Regulatory Guideline Landscape NRP

Regulatory & Guideline Landscape for Normothermic and Hypothermic Perfusion: What’s Changing?

The utilization of perfusion related services is increasing in North America and around the world. Once an experimental therapy, extra-corporeal technology has become instrumental in open heart surgeries, life-saving respiratory and cardiac interventions, and organ preservation and transplantation. ECMO, formerly viewed as a “last resort” treatment, became widely accepted throughout the COVID-19 pandemic, and its utilization created an expanded modality to a variety of cardio-pulmonary conditions. Additionally, the rise of normothermic perfusion and hypothermic organ procurement techniques are offering a broader donor list that includes more hearts, kidneys, pancreases, lungs, and livers viable for transplant.

The Growth of the Perfusion Market

According to Mordor Intelligence, the perfusion market is currently valued at $1.31 billion dollars, and it’s slated to grow 4.58% by 2030 — reaching a value of $1.63 billion. The largest share of the market is in North America (nearly 35%), with transplant centers acquiring the majority of the revenue (nearly 70%). In relation to organ type, kidney preservation accounts for 37% of the market size, and in terms of technology, hypothermic perfusion accounts for over half the market share.

Top drivers for the growth include the increased demand for organ transplantation and the rise of hepatic, cardiovascular and respiratory diseases.

Increased Demand for Organ Transplantation

The New York Times reports that 170,000 transplants are performed around the world every year, but that number reflects only 10% of the need. 

The Association of Organ Procurement Associations (AOPO) says that the greatest demand is for kidneys. According to the World Health Organization, kidney disease is currently the ninth leading cause of death globally. In the US, out of 54,000 kidneys recovered in 2023, only 43,000 were ultimately transplanted. “This glaring discrepancy highlights organ non-utilization as a profound issue in our system,” the AOPO states. They cite concerns with organ quality and logistical challenges among the barriers to increased utilization. However, Transplantation reports that normothermic perfusion is making gains in preserving kidneys from donors after circulatory death (DCD), increasing the pool of viable organs.

Donate Life America reveals that around 4,000 individuals in the US are waiting for a heart transplant. While cold static storage only preserves a heart for six hours, a modified normothermic perfusion system can expand that window to up to 24 hours. This offers time for recipient travel and surgical preparation, decreasing the logistical barrier to surgery. Normothermic perfusion also increases the viability of hearts from DCD donors, which can add up to 300 more heart transplants annually.

Donate Life America says that around 9,000 Americans are on the liver transplant list every year, but the Health Resources and Services Administration reports that liver transplants reached a record high in 2023, largely thanks to the use of both Normothermic Regional Perfusion and Ex-Vivo Techniques.

The Rise of Cardiovascular and Respiratory Diseases

The rise of cardiovascular and respiratory diseases is also contributing to the growing use of extra-corporeal services. Over 30% of American men and women have high cholesterol, and one in three have hypertension. According to iData Research, 900,000 cardiac surgeries are performed in the US annually, requiring more perfusion support in the OR. Not only that, but ECMO provides life-saving intervention for cardiac arrest, with the potential to save 140,000 lives every year, according to The Advisory Board.

Respiratory diseases are also a major concern, especially since the COVID-19 pandemic. ECMO offers a lifeline for patients with severe respiratory conditions, especially ARDS, which affects 190,000 Americans annually. Additionally, ECMO can be used to relieve pressure on the lungs and allow for healing time or treatment for conditions such as the flu, pneumonia, severe asthma, sepsis, pulmonary hypertension, pulmonary contusion, and more. This modality also provides a bridge to organ donation and transplantation.

Meeting the Need for Perfusion

As the demand for certified extra-corporeal specialists increases, providers have to confront a shortage of perfusionists — an annual shortfall of 200-250 perfusionists per year. To fill the gap, SpecialtyCare is focused on education, training, and credentialing to increase the number of perfusionists in the industry. We currently employ 430 perfusionists nationwide, supporting more than 750,000 cardiac surgeries each year. 

As the number one provider of ECMO in the US, we deploy highly trained experts to hospitals and care centers around the country, and we assist with the development of in-house ECMO programs. Our Normothermic Regional Perfusion (NRP) teams are available 24 hours a day, 365 days a year, with a response time as little as 30 minutes.  NRP Specialists work in tandem with organ procurement organizations (OPO’s), transplant surgeons and hospitals in order to provide a service that determines the best fit and viability of each specific organ.

SpecialtyCare can help your hospital meet the growing demand for perfusion services. Contact us today to find out how we can support your organ transplants, cardiac surgeries, and respiratory interventions to increase positive outcomes for your patients.

Author

  • craigpetterson

    Craig M. Petterson, MPS, MBA, LCP, CCP, CRT is a Perfusionist and Normothermic Regional Perfusion Specialist currently serving as the Area Clinical Manager in Kansas City with Specialty Care.

    He holds advanced credentials including a Master of Perfusion Science (MPS) and an MBA, as well as Certification in Respiratory Care — He combines clinical expertise with leadership and management responsibilities, overseeing perfusion services and contributing to patient care, training, and research.  Craig has also aided the academic community as an Adjunct Assistant Professor at The University of Nebraska Medical Center as well as partaking in numerous publications and presentations at the regional and national level.

    Craig’s background exemplifies a blend of clinical and didactic specialization, business acumen, and leadership — positioning him as a key professional bridging the worlds of clinical care and organizational management in a medical setting.

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Reviewer

  • Specialtycare medical blog bg kirti patel joins specialtycare scaled

    Kirti P. Patel, MPS, MPH, CCP, LP, FAACP is the Region President of Cardiac Services and clinically active Perfusionist in SpecialtyCare’s West Region. He is a graduate of the Cardiovascular Perfusion Program from the Texas Heart Institute and University of Nebraska. He has over 25 years of experience as a perfusionist and is the author of more than 20 articles in the field. He is a past recipient of the Perfusionist of the Year award by his peers. Kirti serves on the executive board as Secretary on the American Society of ExtraCorporeal Technology and as a Chair for the Perfusion Licensure Committee for the Texas Medical Board. Kirti is also a Fellow in the American Academy of Cardiovascular Perfusion. Kirti is the founding father of the University of Texas McGovern Medical School Cardiovascular Perfusion Program in Houston, Texas where he served as a Program Director before joining SpecialtyCare.

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