Author Affiliations: Vanderbilt University, Nashville, Tenn (Dr Bernard); National Heart, Lung, and Blood Institute, Bethesda, Md (Drs Sopko and Weinmann and Ms Webb); University of Minnesota, Minneapolis (Dr Cerra); Brigham and Women's Hospital, Boston, Mass (Dr Demling); University of Pennsylvania, Philadelphia (Dr Edmunds); University of California, Los Angeles (Dr Kaplan); Food and Drug Administration, Rockville, Md (Dr Kessler); National Institutes of Health, Bethesda (Dr Masur); University of Colorado, Denver (Dr Parsons); Washington University, St Louis, Mo (Dr Shure); Cleveland Clinic, Cleveland, Ohio (Dr Wiedemann); and Brown University, Providence, RI (Dr Williams). Workshop participants are listed at the end of this article.
Objective The efficacy and safety of the pulmonary artery catheter are under scrutiny
because of its association with increased morbidity and mortality in observational
studies. In response, the National Heart, Lung, and Blood Institute (NHLBI)
and the US Food and Drug Administration (FDA) conducted the Pulmonary Artery
Catheterization and Clinical Outcomes workshop in Alexandria, Va, on August
25 and 26, 1997, to develop recommendations regarding actions to improve pulmonary
artery catheter utility and safety.
Participants The NHLBI and FDA planning task force selected a workshop chairperson,
subcommittee chairs, and participants. Approximately 85 participants were
selected for their collective expertise in critical care, pulmonary medicine,
cardiovascular medicine and surgery, pediatrics, nursing, biostatistics, and
medical economics. The meeting was open to industry representatives and other
government and lay observers. This workshop was funded by the NHLBI and the
FDA's Division of Devices.
Evidence Published reports relating to the efficacy and safety of the pulmonary
artery catheter, especially consensus documents developed by professional
Consensus Process The planning task force disseminated materials, held teleconferences,
and developed draft position papers prior to the workshop. These were modified
during the workshop and thereafter in the course of several teleconferences,
and presented to the entire group for final modifications and approval.
Conclusions A need exists for collaborative education of physicians and nurses in
performing, obtaining, and interpreting information from the use of pulmonary
artery catheters. This effort should be led by professional societies, in
collaboration with federal agencies, with the purpose of developing and disseminating
standardized educational programs. Areas given high priority for clinical
trials were pulmonary artery catheter use in persistent/refractory congestive
heart failure, acute respiratory distress syndrome, severe sepsis and septic
shock, and low-risk coronary artery bypass graft surgery.
Bernard GR, Sopko G, Cerra F, et al. Pulmonary Artery Catheterization and Clinical Outcomes: National Heart, Lung, and Blood Institute and Food and Drug Administration Workshop Report. JAMA. 2000;283(19):2568–2572. doi:10.1001/jama.283.19.2568
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