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Ann Thorac Surg 1997;64:1230
© 1997 The Society of Thoracic Surgeons
Section of Cardiovascular and Thoracic Surgery, University of Arizona Health Sciences Center, Tucson, Arizona
Man is a creature of habit.—Anonymous
Since the introduction of endomyocardial biopsy by Caves and associates in 1972, all transplant centers have followed the Stanford recommended practice of routine surveillance endomyocardial biopsy at regular intervals. It continues to be the gold standard to diagnose rejection, as well as to evaluate the response of treatment for rejection. With the evolution of triple-drug therapy, cardiac recipients are surviving longer. This, along with increased number of patients undergoing transplantation, has caused the volume of routine surveillance biopsies to increase proportionately. The endomyocardial biopsies are invasive, labor-intensive, expensive, and dreaded by the patients because of discomfort and disruption of their schedule, as well as loss of revenue if they are employed. Occasionally, they may be associated with significant and even fatal complications. Any attempt to reduce the frequency of these biopsies will be appreciated by the patients, as well as by the health maintenance organizations. We applaud Heimansohn and associates [1] for their effort to identify a group of patients in whom the routine surveillance endomyocardial biopsy may not be necessary.
It is uniformly agreed upon that in most cardiac recipients the incidence of rejection drops precipitously 3 months after transplantation. The factors that may identify a group of recipients with increased risk of rejection include human lymphocyte antigen donor-recipient mismatch, younger age, female sex, longer ischemic time, and increased number of previous rejections [2]. Except for human lymphocyte antigen mismatch, the association of other factors with rejection has no clear-cut explanation.
Several years ago we were impressed with the observation that very few of the late routine surveillance biopsies showed rejection and almost all the patients who had late rejection were symptomatic. Based on these observations, we concluded that the routine surveillance endomyocardial biopsies are not necessary beyond 6 months and the late biopsies should be performed only if they are clinically indicated. Since then, a validity study has confirmed our earlier recommendation [3]. Heimansohn and associates' "high-risk" group, for which they are recommending routine surveillance endomyocardial biopsy, include patients who continue to experience rejection beyond 36 months or have a higher number of accumulative routine surveillance endomyocardial biopsy-identified rejection episodes. We agree that the patients who continue to have rejection episodes should be monitored closely. We have a low threshold to obtain endomyocardial biopsy in this group of patients; however, we do not perform routine surveillance biopsies.
Apart from patient discomfort and potential complications, the routine surveillance biopsies represent a major ongoing expense after transplantation. For example, the total charges (professional fee and hospital charge) for an uncomplicated endomyocardial biopsy at our institution are around $2,000. Assuming $2,000 charge per biopsy, we can estimate the cost for routine surveillance endomyocardial biopsy. As of December 1995, about 12,204 heart transplant patients were alive. We presume that of these, about 10,000 patients have survived for more than 1 year and are candidates for surveillance endomyocardial biopsies. If the surveillance biopsies are performed every 3 months, which is the practice in many centers, then the total charges per year would be $80,000,000. If the biopsies are performed once a year, which used to be our routine, then the charges would be $20,000,000. Thus, by avoiding the routine surveillance biopsies, we would save $20 million to $80 million per year. Because many of these patients are also employed, the loss of wages and absence from work during the biopsy procedure should also be considered in the cost–benefit equation. This cost would obviously escalate with time, as more recipients are being added to the pool and as they are surviving for a longer time.
We believe that most of the transplant centers continue to perform routine surveillance endomyocardial biopsies because of "habit" and probably feel uncomfortable in changing their routine. In our experience routine surveillance endomyocardial biopsy is not necessary in the majority of the patients. If we want more than retrospective comparisons, a prospective, randomized clinical trial will be necessary. This would compare a routine surveillance biopsy versus "clinically indicated" biopsy groups. Due to inadequate sample size in individual institutions, this should probably be a multicenter trial.
Footnotes
Address reprint requests to Dr Sethi, Section of Cardiovascular and Thoracic Surgery, University of Arizona Health Sciences Center, PO Box 245071, Tucson, AZ 85724.
References
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