Q&A: Shaping the future of lung transplantation with technology

Key takeaways:

• Temperature and inflation pressure pose challenges in transporting and preserving donor lungs.
• A lung preservation system that manages these variables recently received FDA clearance.

In the transplantation world, technology has played a major role in advancing the way donor organs are transported and preserved.

One advancement in lung transplant preservation that recently received FDA 510(k) clearance is the BAROguard system (Paragonix Technologies), which is designed to keep lungs at optimal temperatures and inflation pressures during transport, according to a press release.

Knowing that fluctuations in lung pressure can occur with changes in ambient pressure, the release highlights that BAROguard’s ability to manage lung pressure will be especially helpful when lungs are transported by aircraft.

Healio spoke with Lisa Anderson, PhD, CEO, president and co-founder of Paragonix Technologies, to learn more about this preservation system, challenges in transporting lungs and how the new technology benefits both patients and clinicians.

Healio: What have been some challenges in transporting organs, specifically lungs?

Anderson: Donor organs, particularly lungs, are sensitive to storage conditions as they travel from a donor to the intended recipient. Traditionally, donor lungs are stored in a cooler filled with ice, a simple practice that has been used for decades. The ice is intended to cool the lungs down to preserve them during travel. However, by placing donor lungs within a closed container full of ice, a preservation environment is created in which lung temperatures drop to freezing temperatures and below the range agreed upon by the preeminent professional lung transplant society. This exposes the lungs to higher risk for freezing injury at the cellular level.

Lungs are unique compared with other donor organs as oxygen can be used directly by the organ during preservation. As such and per industry standard, donor lungs are inflated with air during packaging in preparation for travel to the recipient. The inflation pressure during the transportation and preservation between the donor and recipient varies due to surgical and environmental factors. Both overinflation and underinflation can increase the risk for injury to lungs, which has been established in the field of respiratory medicine. The challenge thus evolves — not only do you need to monitor and maintain the temperature of the lungs, but now you must standardize for air pressure as well. It’s a complex series of factors typically overlooked but has the potential to significantly influence posttransplant complications.

The BAROguard Donor Lung Preservation System is our solution to these challenges. We have coupled our thermal Paragonix technology with a one-of-a-kind active airway pressure management system that enables surgeons to maintain lungs at desired conditions. Both temperature and airway pressure data are transmitted to transplant teams in real time, allowing everybody full visibility of the lungs’ thermal and airway pressure conditions until they have reached the destined recipient.

Healio: How could temperature and airway pressure changes outside of clinically recommended ranges during transport negatively impact a lung donation?

Anderson: Variability in lung temperatures and airway pressure can increase the risk for injury to the donor lungs. Near-freezing temperatures can harm the cell tissue and have been correlated to posttransplant lung function, whereas warm temperatures can speed up tissue death. High airway pressures may increase the risk for pressure-related injury (ie, barotrauma), whereas low airway pressures may increase the risk for lung collapse (ie, atelectasis).

These issues combined can reduce the quality and viability of the donor lungs, potentially raising the risk for complications after surgery. The BAROguard system was invented to address these issues by keeping the lungs within an optimal temperature and airway pressure range, ensuring that the donated lungs arrive at the recipient hospital in a controlled manner.

Healio: How has the process of organ transplantation changed/evolved over recent years?

Anderson: New technologies have been revolutionizing the process of organ transplantation over recent years. It’s become a renaissance of much-needed innovation, of which I am so proud to partake. Transplant centers and companies alike are striving to find new methods to extend the time and distance an organ can travel to expand the donor pool and offer more options to the thousands of patients on the organ waiting list.

As we look ahead to the future of organ transplantation, I’m excited to witness the role that technology and innovation will play in advancing the efficiency and success of transplants and, ultimately, improving patient care. Thoughtful organ preservation technology has already been correlated to impact postsurgical complications and to ensure that organs arrive at their destination safely. We look forward to continuing to help shape this future.

Healio: How will the BAROguard system positively impact both patients and clinicians?

Anderson: BAROguard is designed to benefit both patients and clinicians involved in organ transplantation. It represents a significant improvement from the standard of care, addressing the risks of lung transportation in a way never before seen with full-fledged airway pressure management, temperature monitoring, GPS location tracking and additional support features intended to streamline the clinical experience. We hope that the use of BAROguard will translate into fewer posttransplant complications and smoother recoveries, ultimately enhancing the chances of successful patient outcomes.

Reference:

• Paragonix Technologies receives FDA clearance for BAROguard donor lung preservation system. https://www.paragonixtechnologies.com/news/paragonix-technologies-receives-fda-clearance-for-baroguard-tm-donor-lung-preservation-system. Published Aug. 24, 2023. Accessed Oct. 24, 2023.