ISHLT Response to OPTN Promote Efficiency of Lung Donor Testing

Published 24 September 2024

• Advanced Lung Failure & Transplantation
• OPTN Comment
• Pulmonology

The International Society for Heart and Lung Transplantation (ISHLT) appreciates the opportunity to provide feedback on the “Promote Efficiency of Lung Donor Testing” OPTN public comment. This proposal aims to enhance the efficiency and effectiveness of lung donor testing, which is critical for improving organ allocation and transplant outcomes. The policy effectively considers the constraints of resource-limited settings while balancing necessary requirements with operational feasibility. Previous guidance, such as the “Donor Heart and Lung Procurement: A Consensus Statement” (PMID: 32503726), has provided a solid foundation for organ testing standards, and this policy builds upon those standards to further improve outcomes.

ISHLT supports this policy and offers the following feedback for consideration:

Balance of Requirement and Feasibility

1. The proposed lung testing requirements generally provides a good balance between theinformation needed by transplant programs and what OPOs can reasonably provide. However, thefrequency of required ABGs may still pose challenges for OPOs with limited resources, potentiallyincreasing their workload.
2. We suggest adjusting the ABG frequency requirements or offering a pathway for OPOs to justifydeviations when resources are limited, possibly reducing the burden on small centers.Additionally, the policy should clarify that consistent ABG sampling should occur only whenventilator settings are stable for 30 minutes to ensure reliable results.

Testing and Guidance

1. CT Scans: While making the CT scans conditional ("if performed") is understandable, werecommend making CT scans mandatory. A CT scan provides critical data about donor lungquality, and transplant centers may hesitate to accept an organ without it. If a CT scan cannot beperformed due to technical or logistical reasons, the OPO should document the rationale. This willensure transparency and maintain trust between OPOs and transplant centers.
   
2. Bronchoscopies: Similarly, while the proposal recommends that bronchoscopies remainconditional ("if performed"), for consistency we recommend making bronchoscopies mandatory,especially because the guidance language states, “Every attempt should be made to obtain abronchoscopy…”. Although smaller hospitals may not have the capability to performbronchoscopies, the availability of portable / disposable bronchoscopy equipment may mitigatethis. As recommended for CT scans above, when a bronchoscopy is not performed, OPOs shouldbe required to document why, ensuring that this step is evaluated.
   
3. Fungal and Bacterial Cultures: We support the inclusion of fungal and bacterial cultures in theguidance rather than policy as appropriate, as these results are not immediately available andnecessary for offer organ acceptance but provide useful information for post-lung transplant care.
4. Chest measurements: Chest measurements and lung sizing are critical for pediatric and small adult recipients but are currently listed under guidance. We suggest moving chest measurements into the policy to ensure consistent reporting across OPOs.
5. Finally, ISHLT questions the value of having separate policy and guidance language, particularly because the guidance language is in a separate location in the OPTN website that is not easily located. There is overlap between the two components and, as the policy language includes items that are not mandatory (i.e. includes both “must” and “should” direction), it is not clear why the language that is currently in the guidance document could not be moved to the policy document for clarity and accessibility.

Operational Feasibility

Most OPOs should be able to provide the proposed testing results for ABGs, chest x-rays, and echocardiograms. However, smaller OPOs may still face difficulties in meeting these demands. Therefore, we recommend standardizing training and resources to avoid creating disparities between larger and smaller organizations.

Use of NHLBI ARDS Network Formula

We agree with the use of the NHLBI ARDS network formula for calculating IBW. This formula is widely accepted and provides consistency across evaluation and fairness in organ assessments. Special consideration should be given to pediatric donors as the ARDS formula may not be appropriate for this population.

Patient and Family Support

Engaging patients and donor families is crucial for building trust and understanding. Clear communication about the benefits of these changes, such as improving lung transplant outcomes and efficiency, may help gain support.
Efficiency Challenges and Solutions

While the policy addresses many challenges, the increased workload for OPOs and transplant centers due to the national allocation system remains a concern. Improving the efficiency of donor testing through technology, such as better data integration and automated processes, could alleviate some of these burdens. Additionally, implementing pilot programs to test new approaches or technologies can provide valuable insight into improving efficiency while informing policies.

Training and Education

1. Providing comprehensive training for OPO staff on updated requirements and best practices will improve compliance and organ utilization. The training should be widely accessible to ensure consistent standards across all OPOs.
2. In addition to providing training modules, there should be feedback mechanisms for OPOs to report challenges or suggest improvements to ensure that the policy adapts as needed.