NHLBI-AATS Workshop: Identifying Collaborative Clinical Research Priorities in Lung Transplantation

Executive Summary

Purpose

The National Heart, Lung, and Blood Institute (NHLBI) and the American Association for Thoracic Surgery (AATS) co-sponsored a workshop to identify clinical research priorities in lung transplant research, with a particular focus on the time from recipient selection to one year post-transplant.

Currently, clinical outcomes following lung transplantation lag behind those achieved with transplantation of other solid organs. Despite this, lung transplantation is a relatively understudied area of research. Clinical management in lung transplantation is not well standardized in part due to lack of evidence-based treatments/management approaches.

The workshop included presentations in the areas of recipient selection, donor management, perioperative issues, and primary grant dysfunction, as well as discussion of the research gaps and priorities for lung transplantation research. The topic of chronic lung allograft dysfunction, although important, was outside the scope of this workshop. Workshop participants included thoracic surgery and pulmonary researchers, ethicists, patient advocacy group representatives, and representatives from federal agencies with a vested interest in lung transplant research. 

Recommendations

1. Identify donor or recipient interventions that improve survival as well as quality-of-life following lung transplantation.
   1. Develop novel therapies based on donor and/or recipient endotypes to prevent primary graft dysfunction.
   2. Assess outcomes in addition to mortality. Quality of life measures and surrogate endpoints should be utilized and validated for use in lung transplant clinical studies.
   3. Determine the optimal usage of extracorporeal lung support (ECLS) in decompensating patients on the lung transplant waitlist.
       
2. Develop improved donor and recipient assessment methods that can be used to better characterize donor-recipient interactions, expand the donor pool, and improve recipient outcomes.
   1. Establish protocols that standardize intraoperative assessments, enhance the collection and biobanking of accepted and rejected donor tissues, and promote quality data entry into transplant registries across treatment centers.
   2. Develop donor and recipient risk scores and best practice guidelines to assist with donor and recipient selection.
   3. Design structured interventions with organ procurement organizations (OPOs) and donor hospitals to increase the number of lungs donated after brain and circulatory death (DBD and DCD).
       
3. Evaluate surgical approaches and peri-operative clinical management strategies to optimize lung transplant recipient outcomes.
   1. Determine the impact of routine intraoperative ECLS compared to conventional mechanical ventilation and cardiopulmonary bypass techniques on lung transplant outcomes.
   2. Assess if certain types of lung transplant candidates may be best suited for a specific operative procedure such as single versus bilateral lung transplantation, specific incision type, or use of marginal donor lungs.
   3. Optimize peri-operative critical care of lung transplant recipients including routine use of lung protective ventilation.

NHLBI Contact

Lora Reineck, M.D., M.S.

Division of Lung Diseases, NHLBI

Lora.reineck@nih.gov (link sends e-mail)

Workshop Chair

• Michael Mulligan, MD – University of Washington

Non-Federal Workshop Participants

• Christian Bermudez, MD – University of Pennsylvania
• Kevin Chan, MD – University of Michigan
• Jason Christie, MD, MS – University of Pennsylvania
• Duane Davis Jr, MD – Florida Hospital
• Farhood Farjah, MD, MPH – University of Washington
• Jeffrey Goldstein – Lung Transplant Foundation
• Elisa Gordon, PhD, MPH – Northwestern University
• Cynthia Gries, MD – Florida Hospital
• Bartley Griffith, MD – University of Maryland
• Matthew Hartwig, MD – Duke University
• J.W. Awori Hayanga, MD, MPH – University of Pittsburgh
• Daniel Kreisel, MD, PhD – Washington University
• Pablo Sanchez, MD, PHD – University of Washington
• Jonathan Singer, MD – University of California San Francisco
• Laurie Snyder, MD – Duke University
• Lorraine Ware, MD – Vanderbilt University
• David Weill, MD – Weill Consulting Group
• Michael Weyant, MD – University of Colorado
• Timothy Whelan, MD – Medical University of South Carolina

Federal Workshop Participants

• Sean Agbor-Enoh, MD, PhD – NHLBI
• Neil Aggarwal, MD – NHLBI
• James Bowman III, MD – HRSA
• J. Matthew Craig, PhD – NHLBI
• James Kiley, PhD – NHLBI
• Jonah Odim, MD, PhD – NIAID
• Lora Reineck, MD, MS – NHLBI
• Mark Robien, MD – NIAID
• Hannah Valantine, MD – NHLBI
• Gail Weinmann, MD – NHLBI