Pulmonary artery catheterization and clinical outcomes - National Heart, Lung, and Blood Institute and Food and Drug Administration workshop report

Objective The efficacy and safety of the pulmonary artery catheter are unde r scrutiny because of its association with increased morbidity and mortalit y in observational studies. In response, the National Heart, Lung, and Bloo d Institute (NHLBI) and the US Food and Drug Administration (FDA) conducted the Pulmonary Artery Catheterization and Clinical Outcomes workshop in Ale xandria, Va, on August 25 and 26, 1997, to develop recommendations regardin g actions to improve pulmonary artery catheter utility and safety. Participants The NHLBI and FDA planning task force selected a workshop chai rperson, subcommittee chairs, and participants. Approximately 85 participan ts were selected for their collective expertise in critical care, pulmonary medicine, cardiovascular medicine and surgery, pediatrics, nursing, biosta tistics,and medical economics. The meeting was open to industry representat ives and other government and lay observers. This workshop was funded by th e NHLBI an the FDA's Division of Devices. Evidence Published reports relating to the efficacy and safety of the pulmo nary artery catheter, especially consensus documents developed by professio nal societies. Consensus Process The planning task force disseminated materials, held tele conferences, and developed draft position papers prior to the workshop. The se were modified during the workshop and thereafter in the course of severa l teleconferences, and presented to the entire group for final modification s and approval. Conclusions A need exists for collaborative education of physicians and nur ses in performing, obtaining, and interpreting information from the use of pulmonary artery catheters. This effort should be led by professional socie ties, in collaboration with federal agencies, with the purpose of developin g and disseminating standardized educational programs. Areas given high pri ority for clinical trials were pulmonary artery catheter use in persistent/ refractory congestive heart failure, acute respiratory distress syndrome, s evere sepsis and septic shock, and low-risk coronary artery bypass graft su rgery.