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Pulmonary Artery Catheterization in Critically Ill Neonates

      The recent article by Yoshizato and Hagler in the April 1989 issue of the Proceedings (pages 387 to 391) raises several serious issues that are inapparent from a simple reading of the report. In nine critically ill neonates, pulmonary artery catheters were placed by using two-dimensional echocardiographic guidance. The purpose was to administer a pulmonary artery vasodilator, tolazoline (Priscoline), directly into the pulmonary artery. Of the nine patients, two (22%) died in the pericatheterization period. One death was attributed to respiratory failure and the second to renal failure in an infant with “minor” blood loss.
      The risk-to-benefit ratio of pulmonary flow catheters is currently an area of substantial controversy in adult medicine.
      • Mathay M
      • Robin E
      • Morin M
      • Winterbauer R
      A pulmonary artery catheter should be used in patients with respiratory failure.
      • Robin ED
      Defenders of the pulmonary artery catheter (letters to the editor and responses).
      Whatever the ultimate outcome of this controversy, investigators almost universally agree that (1) the balance between risks and benefits has not been established by an appropriate randomized clinical trial, (2) a considerable number of complications occur, and (3) some of these complications, such as right-sided myocardial injury, can be uncovered only by postmortem examination.
      • Rowley KM
      • Clubb KS
      • Walker Smith GJ
      • Cabin HS
      Right-sided infective endocarditis as a consequence of flow-directed pulmonary-artery catheterization: a clinicopathological study of 55 autopsied patients.
      I assume that these issues would be even more relevant in critically ill neonates. The use of pulmonary artery vasodilators in adults is also an unsettled issue.
      • Glanville AR
      • Burke CM
      • Theodore J
      • Robin ED
      Primary pulmonary hypertension: length of survival in patients referred for heart-lung transplantation.
      Again, the balance between risk and benefit has not been determined by an appropriate randomized clinical trial, nor do I believe that such a test has been used for administration of drugs through the pulmonary artery.
      In light of these issues, the article by Yoshizato and Hagler prompts the following legitimate questions: (1) Were autopsies performed on the infants who died? (2) What was the nature of the institutional review that approved the catheterization and the intra-pulmonary artery use of tolazoline? (3) What process was involved in obtaining informed consent from the parents? (4) Did this process include an explanation to the parents that the investigators themselves did not know the true risk-to-benefit ratio of the procedure being performed? (5) What were the parents told about the deaths of their children? (6) Were any of these issues raised during the peer review process of the manuscript?
      On the surface, it appears that an unproven instrument was used in a particularly vulnerable group of patients to give an unproven drug by an unproven route of administration.

      REFERENCES

        • Mathay M
        • Robin E
        • Morin M
        • Winterbauer R
        A pulmonary artery catheter should be used in patients with respiratory failure.
        in: Gitnick G Debates in Medicine. Vol 2. Year Book Medical Publishers, Chicago1989: 168-197
        • Robin ED
        Defenders of the pulmonary artery catheter (letters to the editor and responses).
        Chest. 1988; 93: 1059-1066
        • Rowley KM
        • Clubb KS
        • Walker Smith GJ
        • Cabin HS
        Right-sided infective endocarditis as a consequence of flow-directed pulmonary-artery catheterization: a clinicopathological study of 55 autopsied patients.
        N Engl J Med. 1984; 311: 1152-1156
        • Glanville AR
        • Burke CM
        • Theodore J
        • Robin ED
        Primary pulmonary hypertension: length of survival in patients referred for heart-lung transplantation.
        Chest. 1987; 91: 675-681

      Linked Article

      • Pulmonary Artery Catheterization in Critically Ill Neonates: Dr. Hagler replies
        Mayo Clinic ProceedingsVol. 64Issue 9
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          The letter from Professor Robin raises several questions relative to the placement of pulmonary artery catheters in critically ill neonates. In his letter, he questioned the risk-to-benefit ratio of pulmonary artery catheters as an area of substantial controversy in adult medicine. Indeed, the Food and Drug Administration (FDA) recently published the recommendations of a task force convened by the FDA in an effort to minimize the serious complications sometimes seen with use of central venous catheters.
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