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Defenders of the Pulmonary Artery Catheter
A pro81Jective, randomized, controlled trial is a ~asonable if the catheter ~sults in a significant increase in mortality, patient safety dictates a rapid moratorium. BJtients may not have the time to wait. This is not such an unp~cedented altemtJtive. In the case of drugs with adverse effects, drug companies voluntarily withdraw the suspected agent from patient use. Faulty automobiles may be withdrawn from the market: Equipment mtJnufiu;tu~svoluntarily withdraw suspect equipmentfrom the mtJrket. My editorial was negative but not fierce. If and when a proper clinical trial is performed and should it show a significant rate ofexcess death associated with the use ofthe catheter; then I will become fierce.
long-term altemtJtive; but,
To the Editor: Some scientific papers achieve the designation "classic" simply because they demonstrate errors in methodology or logic which are so obvious that they serve as enduring examples. Take the study of blind, deaf infants with heart disease. Ninety percent of their mothers had rubella in the first trimester; therefore, it was concluded that the incidence of major anomalies following rubella is 90 percent. Or the study of fat embolism following femur fracture in which fat embolism was defined at any PaO! <50 torr. The incidence of fat embolism was very high and mortality very low Or the studies which point out that most chest x-ray films (or ECG or mammogram results) are normal, therefore not useful as a screening test. Now you have provided us with another classic. The October, 1987 issue of Chest contains a paper by Gore et al on the subject of pulmonary artery catheterization in patients with acute myocardial infarction. The authors had data on 3,263 patients in the area of Worcester, Massachusetts who had acute myocardial infarction. Approximately 15 percent of these patients had a pulmonary catheter placed, and mortality in these patients was higher than in noncatheterized patients. The article was followed by an editorial by Dr: Robin praising the research and calling for a moratorium on the use of this potentially deadly device. This publication certainly blazes a new path in clinical investigation which will rapidly increase the productivity of academic scholars. Using this new methodology we have already prepared dozens of manuscripts which we will send off in the next month or two, but some of the early data are worthy of preliminary communication. Following up on the observations of Gore et al, we have discovered that patients in our surgical intensive care unit with pulmonary artery catheters have a higher mortality than those who do not Moreover, those patients who have pulmonary artery catheters, radial artery catheters, and endotracheal tubes have a higher mortality than those with PA catheters alone, and if the endotracheal tube is attached to a mechanical ventilator the mortality is higher yet Therefore, we can add to the obs~rvations of Gore et al by identifying several devices' which add to the mortality risk in the intensive care unit. Next, we reviewed the records of all patients in the Ann Arbor, MI, area who had bacterial infection. There was a 1082
direct correlation between the number of antibiotics given to the patient and mortality rate. Moreover, mortality was higher in the patients who received the most expensive antibiotics, and higher yet if patients were hospitalized. We conclude that the use of newer, multiple, expensive antibiotics in the hospital (once thought to be a significant medical advance) contributes to the high mortality of severe bacterial infection. We hope to reverse this high mortality rate by reducing the cost of antibiotics and discharging septic inpatients. We are searching for a venerable infectious disease person to write an editorial entitled "Death by Expensive Antibiotics." Fmally we reviewed the outcome of 8,000 major operations and found that patients who received blood transfusions had a higher mortality than those who did not. Moreover, there was a direct correlation between the number of transfusions and mortality rates with an r value of .98. Blood transfusions were associated with an increased length of stay compared to patients who were not transfused, and there appeared to be no beneficial effect of transfusion when patients were followed-up after hospital discharge. Although these findings are preliminary we plan to notify the FDA, the Red Cross, the ACC£ the SPCA, and US News and World Report. We are preparing an editorial calling for a nationwide moratorium on blood transfusion until the f~ctors responsible for this lethal epidemic can be clearly identified. We are grateful to Chest for publishing this fascinating new approach to clinical investigation, along with the method of venerable validation. It certainly is a classic. Robert H. Bartlett, M.D., Professor; General and Thoracic Surgery, University of Michigan Medical Center, Ann Arbor
Reprint requests: Dr. Bartlett, University of Michigan Medical Center, 2920 Taubman Health Care Center, Ann Arbor 48109
Dr: Bartletts letter is written as satire and I appreciate the delicacy ofstyle. His argument is largely based on a single assumption-that the patients in whom the catheter was used we~ more iU than the control subpopulations-which enti~ly explains the diffe~nce in outcome. He is, of course, entitled to any assumption that he wishes to espouse. But, in fact, the data ofG~ et al do not support the validity of Dr. Bartletts assumption. When patients with pulmonary edema with and without the catheter were studied, those with the catheter had a significantly higher case fatality rate (CFR) (p<0'()()1). Does he maintain that those in whom the catheter was used we~ significantly sicker with pulmonary edema than those with pulmonary edema without the catheter? There is no evidence that this was the case. Use or nonuse ofthe catheter in pulmonary edema usuaUy reflects physician style or institutional pattern, not severity of pulmonary edema. When patients with hypotension were studied, those with the catheter had a significantly higher CFR (p<0.001). Was the catheterized subgroup significantly more iU than those not catheterized? Again, there is no such evidence. Finally, when extensiveness of infarct (more extensive in the catheterized group than in the noncatheterized group) was adjusted by multifactorial analysis to permit comparison of the two groups, there was still a higher CFR in the Defenders of the Pulmonary Artery Catheter
long-term altemtJtive; but,
To the Editor: Some scientific papers achieve the designation "classic" simply because they demonstrate errors in methodology or logic which are so obvious that they serve as enduring examples. Take the study of blind, deaf infants with heart disease. Ninety percent of their mothers had rubella in the first trimester; therefore, it was concluded that the incidence of major anomalies following rubella is 90 percent. Or the study of fat embolism following femur fracture in which fat embolism was defined at any PaO! <50 torr. The incidence of fat embolism was very high and mortality very low Or the studies which point out that most chest x-ray films (or ECG or mammogram results) are normal, therefore not useful as a screening test. Now you have provided us with another classic. The October, 1987 issue of Chest contains a paper by Gore et al on the subject of pulmonary artery catheterization in patients with acute myocardial infarction. The authors had data on 3,263 patients in the area of Worcester, Massachusetts who had acute myocardial infarction. Approximately 15 percent of these patients had a pulmonary catheter placed, and mortality in these patients was higher than in noncatheterized patients. The article was followed by an editorial by Dr: Robin praising the research and calling for a moratorium on the use of this potentially deadly device. This publication certainly blazes a new path in clinical investigation which will rapidly increase the productivity of academic scholars. Using this new methodology we have already prepared dozens of manuscripts which we will send off in the next month or two, but some of the early data are worthy of preliminary communication. Following up on the observations of Gore et al, we have discovered that patients in our surgical intensive care unit with pulmonary artery catheters have a higher mortality than those who do not Moreover, those patients who have pulmonary artery catheters, radial artery catheters, and endotracheal tubes have a higher mortality than those with PA catheters alone, and if the endotracheal tube is attached to a mechanical ventilator the mortality is higher yet Therefore, we can add to the obs~rvations of Gore et al by identifying several devices' which add to the mortality risk in the intensive care unit. Next, we reviewed the records of all patients in the Ann Arbor, MI, area who had bacterial infection. There was a 1082
direct correlation between the number of antibiotics given to the patient and mortality rate. Moreover, mortality was higher in the patients who received the most expensive antibiotics, and higher yet if patients were hospitalized. We conclude that the use of newer, multiple, expensive antibiotics in the hospital (once thought to be a significant medical advance) contributes to the high mortality of severe bacterial infection. We hope to reverse this high mortality rate by reducing the cost of antibiotics and discharging septic inpatients. We are searching for a venerable infectious disease person to write an editorial entitled "Death by Expensive Antibiotics." Fmally we reviewed the outcome of 8,000 major operations and found that patients who received blood transfusions had a higher mortality than those who did not. Moreover, there was a direct correlation between the number of transfusions and mortality rates with an r value of .98. Blood transfusions were associated with an increased length of stay compared to patients who were not transfused, and there appeared to be no beneficial effect of transfusion when patients were followed-up after hospital discharge. Although these findings are preliminary we plan to notify the FDA, the Red Cross, the ACC£ the SPCA, and US News and World Report. We are preparing an editorial calling for a nationwide moratorium on blood transfusion until the f~ctors responsible for this lethal epidemic can be clearly identified. We are grateful to Chest for publishing this fascinating new approach to clinical investigation, along with the method of venerable validation. It certainly is a classic. Robert H. Bartlett, M.D., Professor; General and Thoracic Surgery, University of Michigan Medical Center, Ann Arbor
Reprint requests: Dr. Bartlett, University of Michigan Medical Center, 2920 Taubman Health Care Center, Ann Arbor 48109
Dr: Bartletts letter is written as satire and I appreciate the delicacy ofstyle. His argument is largely based on a single assumption-that the patients in whom the catheter was used we~ more iU than the control subpopulations-which enti~ly explains the diffe~nce in outcome. He is, of course, entitled to any assumption that he wishes to espouse. But, in fact, the data ofG~ et al do not support the validity of Dr. Bartletts assumption. When patients with pulmonary edema with and without the catheter were studied, those with the catheter had a significantly higher case fatality rate (CFR) (p<0'()()1). Does he maintain that those in whom the catheter was used we~ significantly sicker with pulmonary edema than those with pulmonary edema without the catheter? There is no evidence that this was the case. Use or nonuse ofthe catheter in pulmonary edema usuaUy reflects physician style or institutional pattern, not severity of pulmonary edema. When patients with hypotension were studied, those with the catheter had a significantly higher CFR (p<0.001). Was the catheterized subgroup significantly more iU than those not catheterized? Again, there is no such evidence. Finally, when extensiveness of infarct (more extensive in the catheterized group than in the noncatheterized group) was adjusted by multifactorial analysis to permit comparison of the two groups, there was still a higher CFR in the Defenders of the Pulmonary Artery Catheter