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• W2064943909 abstract "The recent article by Gore et al1Gore J.H. Goldberg R.J. Spodick D.H. Alpert J.S. Dalen J.E. A community-wide assessment of the use of pulmonary artery catheters in patients with acute myocardial infarction.Chest. 1987; 92: 721-727Crossref PubMed Scopus (295) Google Scholar on pulmonary artery (PA) catheterization in patients with complicated myocardial infarction concluded that a prospective trial of the use of the PA catheter in critically ill patients was required. However, the content of an accompanying editorial by Robin2Robin E.D. Death by pulmonary artery flow-directed catheter (editorial).Chest. 1987; 92: 727-731Crossref PubMed Google Scholar reflected a more stringent interpretation of the data than was expressed by Gore and colleagues. Not unexpectedly, subsequent letters to the editor were, in part, critical of the process that Dr. Robin utilized when expressing his opinions on PA catheterization in both the scientific and lay press. In this communication, it is our purpose to review some of the arguments regarding PA catheterization by analyzing, in part, the process a clinician utilizes in evaluating any diagnostic test.3Guyatt G.H. Tugwell P.X. Feeny D.H. Haynes R.B. Drummond M. A framework for clinical evaluation of diagnostic technologies.Can Med Assoc J. 1986; 134: 587-594PubMed Google Scholar As critical care practitioners, it might be argued that we are unable to present a completely unbiased view of the pertinent issues. Since the art of medicine remains a significant component of any physician's diagnostic and therapeutic decision-making process, this concern may have foundation. Nonetheless, we both have previously encouraged dialog about the nature and quality of information obtained with PA catheterization,4Raper R. Sibbald W.J. Misled by the wedge? The Swan Ganz catheter and left ventricular preload..Chest. 1986; 89: 427-434Abstract Full Text Full Text PDF PubMed Scopus (183) Google Scholar,5Sprung C.L. The pulmonary artery catheter—methodology and clinical applications. Aspen, Baltimore1983Google Scholar and the potential complications of this invasive procedure.6Sprung C.L. Marcial E.H. Garcia A.A. Sequeira R.F. Pozen R.G. Prophylactic use of lidocaine to prevent advanced ventricular arrhythmias during pulmonary artery catheterization—A prospective, double-bind study.Am J Med. 1983; 75: 906-910Abstract Full Text PDF PubMed Scopus (21) Google Scholar In the retrospective study by Gore et al, patients undergoing PA catheterization following complicated myocardial infarction had a greater mortality rate than non-catheterized patients. At the very least, this study should once again remind the clinician of the need to assess critically the indications for PA catheterization in each patient considered for this procedure. Before accepting Dr. Robins call for a moratorium on PA catheterization, however, methodologic concerns of the study by Gore et al must be appreciated. Notwithstanding difficulties inherent in any retrospective study, particularly one undertaken over a period of time where therapy of complicated myocardial infarction was clearly undergoing significant change, Gore et al failed to clearly state the definitions utilized for congestive heart failure, hypotension and shock. Although mortality in the study by Gore et al remained greater in patients undergoing PA catheterization following multivariate analysis to adjust for infarct size, the lack of data concerning associated illness severity, the prior health status and hemodynamic profiles of the study population, colors the validity, and therefore, the interpretation of the results. Information detailing the impact of changes in therapy which followed PA catheterization was not reported. The potential for significant differences in practice performance in the 16 participating hospitals, which could have significantly altered the results,7Knaus W.A. Draper E.A. Wagner D.P. Zimmerman J.E. An evaluation of outcome from intensive care in major medical centres.Ann Intern Med. 1986; 104: 410-418Crossref PubMed Scopus (1010) Google Scholar was not sufficiently discussed. Thus, the data from Gore et al do not support any proposal2Robin E.D. Death by pulmonary artery flow-directed catheter (editorial).Chest. 1987; 92: 727-731Crossref PubMed Google Scholar for an immediate change in the clinical approach to monitoring critically ill patients with PA catheters. The need to establish diagnostic accuracy and to concurrently identify indications for use of the PA catheter in critically ill patients7Knaus W.A. Draper E.A. Wagner D.P. Zimmerman J.E. An evaluation of outcome from intensive care in major medical centres.Ann Intern Med. 1986; 104: 410-418Crossref PubMed Scopus (1010) Google Scholar has been the subject of many reviews.8Davies M.J. Cronin K.D. Domaingue C.M. Pulmonary artery catheterization. An assessment of risks and benefits in 220 surgical patients.Anaesth Intensive Care. 1982; 10: 9-14PubMed Google Scholar, 9Goldenheim P.D. Kazemi H. Cardiopulmonary monitoring of critically ill patients.N Engl J Med. 1984; 311: 776-780Crossref PubMed Scopus (56) Google Scholar, 10Sharkey S.W. Beyond the wedge: Clinical physiology and the Swan-Ganz catheter.Am J Med. 1987; 83: 111-118Abstract Full Text PDF PubMed Scopus (57) Google Scholar, 11Civetta J.M. Invasive catheterization.in: Shoemaker W.C. Thompson W.L. Critical care—state of the art. Vol 1. 1: Soc Crit Care Med, Fullerton, California.1980: B1-B47Google Scholar The pulmonary artery occlusion pressure and the thermodilution cardiac output have been demonstrated to correlate well with both the left ventricular end-diastolic pressure and left atrial pressure4Raper R. Sibbald W.J. Misled by the wedge? The Swan Ganz catheter and left ventricular preload..Chest. 1986; 89: 427-434Abstract Full Text Full Text PDF PubMed Scopus (183) Google Scholar and the cardiac output by the Fick and green-dye techniques,12Levett J.M. Replogle R.L. Thermodilution cardiac output: A critical analysis and review of the literature.J Surg Res. 1979; 27: 392-404Abstract Full Text PDF PubMed Scopus (197) Google Scholar respectively. With careful attention to technique,4Raper R. Sibbald W.J. Misled by the wedge? The Swan Ganz catheter and left ventricular preload..Chest. 1986; 89: 427-434Abstract Full Text Full Text PDF PubMed Scopus (183) Google Scholar,5Sprung C.L. The pulmonary artery catheter—methodology and clinical applications. Aspen, Baltimore1983Google Scholar the PA catheter, therefore, accurately measures indices of cardiovascular performance not previously available. Yet, there remain important clinical links that are crucial when using PA catheters in the critically ill. The catheter must be placed in the “proper patient,” it must be inserted and managed correctly, and the monitored data base must be interpreted and acted upon in an appropriate fashion. Exclusive of an ability to improve an understanding of disease, one question a clinician must pose when evaluating any diagnostic procedure is whether the procedure will improve patient care, and thereby, outcome.3Guyatt G.H. Tugwell P.X. Feeny D.H. Haynes R.B. Drummond M. A framework for clinical evaluation of diagnostic technologies.Can Med Assoc J. 1986; 134: 587-594PubMed Google Scholar To minimize misunderstanding and controversy, appreciation of some of the terms applied to PA catheterization, indeed to any diagnostic procedure, is essential.13Lowrance W.W. Of acceptable risk: Science and the determination of safety. William Kaufman, Inc, Los Altos, California1976Google Scholar Risk is a measure of the probability and severity of adverse effects; safety is the degree to which risks are judged to be acceptable. Efficacy is a measure of the probability and intensity of favorable effects; benefit is the degree to which efficacies are judged desirable.13Lowrance W.W. Of acceptable risk: Science and the determination of safety. William Kaufman, Inc, Los Altos, California1976Google Scholar Therefore, risks and efficacies are objective measurable facts, whereas safety and benefits are subjective value judgments. A distinction between factual and value-laden matters should be recognized and respected candidly. Discussion of the influence of PA catheterization on patient care and outcome necessitates discussion of the risks and efficacies of this diagnostic procedure. Risks result from complications of catheter insertion and use, inappropriate treatment based on information obtained following catheterization, financial costs and increased morbidity or mortality as a direct result of catheterization. There are risks to PA catheterization, although they are typically infrequent and not usually life-threatening.14Sprung C.L. Complications of pulmonary artery catheterization.in: Sprung C.L. The pulmonary artery catheter—Methodology and clinical applications. Aspen, Baltimore1983: 73-101Google Scholar,15Gill J.B. Cairns J.A. Prospective study of pulmonary artery balloon flotation catheter insertions.J Intensive Care Med. 1988; 3: 121-128Crossref Scopus (8) Google Scholar Efficacies include establishing a correct diagnosis, treating the patient with the appropriate therapy, decreasing morbidity, and primarily improving survival. What is the therapeutic impact, or how often might clinicians change therapy based upon information available only with PA catheterization? Forrester et al16Forrester J.S. Diamond G.A. Swan H.J.C. Correlative classification of clinical and hemodynamic function after acute myocardial infarction.Am J Cardiol. 1977; 39: 137-145Abstract Full Text PDF PubMed Scopus (297) Google Scholar demonstrated that clinicians could predict, with 90 percent confidence levels, the pulmonary artery occlusion pressure and the cardiac index in patients with acute myocardial infarction. In contrast, Connors et al17Connors A.F. McCaffree E.R. Gray D.A. Evaluation of right heart catheterization in the critically-ill patients without acute myocardial infarction.N Engl J Med. 1983; 308: 263-267Crossref PubMed Scopus (273) Google Scholar reported that these parameters could not be clinically defined in critically ill patients without acute myocardial infarction, data which have been substantiated by other investigators.18Fein A.M. Goldberg S.K. Walkenstein M.D. Dershaw B. Braitman L. Lippman M.L. Is pulmonary artery catheterization necessary for the diagnosis of pulmonary edema?.Am Rev Respir Dis. 1984; 129: 1006-1009PubMed Google Scholar In the study by Connors et al, therapy was changed in approximately 50 percent of patients with the information obtained by PA catheterization. Hence, we conclude that PA catheterization does provide the clinician with information not easily recognized by clinical examination in a large proportion of critically ill patients.17Connors A.F. McCaffree E.R. Gray D.A. Evaluation of right heart catheterization in the critically-ill patients without acute myocardial infarction.N Engl J Med. 1983; 308: 263-267Crossref PubMed Scopus (273) Google Scholar,18Fein A.M. Goldberg S.K. Walkenstein M.D. Dershaw B. Braitman L. Lippman M.L. Is pulmonary artery catheterization necessary for the diagnosis of pulmonary edema?.Am Rev Respir Dis. 1984; 129: 1006-1009PubMed Google Scholar Such information must also be considered clinically relevant since mortality rate in some groups of critically ill patients has been correlated with data which are available only with PA catheterization.18Fein A.M. Goldberg S.K. Walkenstein M.D. Dershaw B. Braitman L. Lippman M.L. Is pulmonary artery catheterization necessary for the diagnosis of pulmonary edema?.Am Rev Respir Dis. 1984; 129: 1006-1009PubMed Google Scholar,19Sibbald W.J. Paterson J.A.M. Holliday R.L. Anderson R.A. Loob T.R. Duff J.H. Pulmonary hypertension in sepsis.Chest. 1978; 73: 583-591Crossref PubMed Scopus (120) Google Scholar It has also been possible to demonstrate improved survival and cost-efficiency from PA catheterization in certain specific disease categories when clear management goals have been prospectively defined and rigorously followed. For example, Shoemaker et al20Shoemaker WC, Appel PL, Kram HB, Waxman K, Lee T-S. Prospective trial of therapeutic goals based on empirically derived values of survivors of high risk surgery. Chest (in press)Google Scholar prospectively studied preoperative and postoperative patients and demonstrated decreased mortality and reduced hospitalization in patients undergoing PA catheterization when the hemodynamic values of previously reported survivors were utilized as the goals of concurrent therapy.21Shoemaker W.C. Appel P.L. Bland R.D. Use of physiologic monitoring to predict outcome and to assist in clinical decisions in critically ill postoperative patients.Am J Surg. 1983; : 146-153Google Scholar Risks and efficacies have been evaluated for PA catheterization, albeit not as extensively as many of us would like. Improved survival of a greater number of patients may well be shown with other prospective studies. Unfortunately, improved survival can only be expected to follow when therapy is available to treat the many diagnoses potentially defined by data obtained with PA catheterization. A clear understanding of this fundamental principle in the evaluation of diagnostic tests has been apparent in studies of the ability of left heart catheterization to define coronary artery disease as a cause of chest pain.22Bolli R. Bypass surgery in patients with coronary artery disease. Indications based on the multicentre randomized trials.Chest. 1987; 91: 760-764Crossref PubMed Scopus (3) Google Scholar Thus, when a specific diagnostic question is asked prior to PA catheterization, ie,“What is the cause of pulmonary edema in a patient with acute respiratory failure?”18Fein A.M. Goldberg S.K. Walkenstein M.D. Dershaw B. Braitman L. Lippman M.L. Is pulmonary artery catheterization necessary for the diagnosis of pulmonary edema?.Am Rev Respir Dis. 1984; 129: 1006-1009PubMed Google Scholar the answer must then result in initiation of a therapeutic algorithm with a greater likelihood of restoring health than existed with the management undertaken prior to the information made available by the diagnostic test. Appropriate clinical trials to unequivocally define the management with the greatest likelihood of restoring health are, unfortunately, not yet available for the majority of disordered and life-threatening pathophysiologic conditions defined by PA catheterization. The clinicians ability to alter the outcome of the grave diagnoses often identified with this procedure, therefore, remains wanting. What should be done now? Even Dr. Robin2Robin E.D. Death by pulmonary artery flow-directed catheter (editorial).Chest. 1987; 92: 727-731Crossref PubMed Google Scholar agrees that the study by Gore et al did not unequivocally establish that a major problem exists. Nonetheless, we contend that Dr. Robin continues to express an opinion without adequate scientific data to support his contention of an iatroepidemic, or his subsequent call for a moratorium. The public process he has chosen in raising concern about the efficacy of the PA catheter has the potential for minimizing the constructive criticism of current medical practice which is traditionally available to senior clinicians. We agree that a more comprehensive clinical evaluation of PA catheterization, with appropriate care to avoid methodologic difficulties inherent in the study by Gore et al, is indicated. In any such study, appropriate concern must be placed on the process by which care is provided after the data available with PA catherization are obtained. For example, when the influence of excessively high mortality rates in three of 13 participating hospitals was excluded, the impact of bypass surgery in triple vessel coronary artery disease on six-year survival reached significance.23Takaro T. Hultgren H.N. Detre K.M. Peduzzi P. The Veterans Administration cooperative study of stable angina: current status.Circulation. 1982; 65 (Suppl):: II-60Crossref Google Scholar Similarly, an audit of the benefit of pulse oximeters and end-tidal CO2ss monitors would necessitate an evaluation of the process by which respiratory support is provided in a patient when such technology led to a diagnosis of acute respiratory failure. Until prospective studies demonstrate that it is the procedure itself which increases morbidity and/or mortality and not the lack of effective treatment for the diagnoses made with PA catheterization, physicians will have to use clinical judgment, based upon their interpretation of data present in the medical literature, and their individual clinical experiences and value systems, in assessing the benefits and safety of PA catheterization. Individual physicians will obviously give different weights to what they consider beneficial or safe. We do not believe the data of Gore et al support Robin's call for a moratorium on the use of the PA catheter at the present time. A moratorium may provide safety for some patients; it might also lead to increased morbidity and mortality in others. The study by Gore et al identified only one group of patients undergoing PA catheterization, and suffered from other deficiencies previously noted. Generalizations to other groups of patients seem unjustified at this time. Many will be justifiably confused with the present situation. Until adequate prospective studies are available, clinicians will have to continue to do what they believe is best for their patients. In this process, we should take the example of one of the premier physicians and philosophers, Maimonides, who would suggest that physicians follow the “golden path,” or middle road.24Maimonides M. Mishneh Torah. Hilchoth Deoth. 1978; 1: 4Google Scholar Extreme positions, based on emotionalism from either side of the controversy concerning PA catheterization, will not help the physician in improving patient care." @default.
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