Evaluation of surgical procedures

Evaluation of surgical procedures

Cardiac and Pulmonary Transplantation Evaluation of surgical procedures Changing patterns ofpatient selection and costs in heart transplantation Duri...

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Cardiac and Pulmonary Transplantation

Evaluation of surgical procedures Changing patterns ofpatient selection and costs in heart transplantation During the past 4 years we have observed a marked increase in costs of heart transplantation in our center. This trend coincides with a shift in our recipient population toward the more severely ill patients. The percentage of patients bound for the intensive care unit has doubled. In analyzing the components of cost, we find that the length of stay, both in special care and regular nursing units, accounts for most of the cost increase. In our study of outcomes we find no significant difference in survival, at 1 month and 1 year, between recipients operated on from the intensive care unit and those not in intensive care. We find that at 1 year after transplantation, approximately 80 % of patients are rehabilitated, which we define as the ability to work or to go to school. Only 20 % of patients are off disability roDs, however, primarily because of problems related to insurance and the cost of continuing care, including drugs. We conclude that the comprehensive evaluation of surgical procedures requires an approach that balances costs with results on a continuing and long-term basis. (J THoRAc CARDIOVASC SURG 1992;104:1308-13)

Keith Reemtsma, MD, Gretchen Berland, BA (by invitation), Jeffrey Merrill, MPH (by invitation), Ray Arons, DrPH (by invitation), Craig Evans, MBA, JD (by invitation), Ronald Drusin, MD (by invitation), Craig R. Smith, MD, and Eric A. Rose, MD, New York, N. Y

h e selection of patients for heart transplantation has become increasingly difficult because the need for donor organs has outstripped the supply. During the last 4 years, for example, the number of heart transplantations done in the United States has been stable while the waiting lists have increased from 3472 in 1988 to 5636 in 1991 (Table I). From the Departments of Surgery and Medicine, Columbia University College of Physicians and Surgeons, Office of Case Mix Studies of the Presbyterian Hospital, and the School of Public Health, Columbia University. Read at the Seventy-second Annual Meeting of The American Association for Thoracic Surgery, Los Angeles, Calif., April 26-29, 1992. Address for reprints: Keith Reemtsma, MD, Department of Surgery, Columbia-Presbyterian Medical Center, 622 West 168th St., New York, NY 10032.

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The criteria used for selection of patients include ABO blood group, body size, and severity of illness. As demand has increased, waiting lists become top-heavy with sicker patients. The selection process, therefore, has become skewed with a larger proportion of severely ill patients receiving transplants. If this trend continues, soon all donor organs will be used for emergencies, according to calculations by Stevenson and colleagues.' In this study we report the effect of this trend on medical outcomes and costs. We review, in addition, the changes in patient selection that we believe account for increased costs. Finally, we present information on medical outcomes, including rehabilitation of these patients. In the past society has been concerned primarily with medical results, and surgeons responded by providing rates of mortality and morbidity. Rising health care costs have focused more attention on costs as well as outcomes

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Heart transplantation

Number 5 November 1992

Table I. Number ofpatients receiving heart transplants and number ofpatients on waiting lists (1988-1991)* Year

No. receiving transplants

No. on waiting list

1988 1989 1990 1991

1674 1699 2100 2127

3472 3949 4920 5636

'United Network for Organ Sharing, 1992.

Table II. From 1988 through 1991, estimated costs for heart transplantations at Columbia-Presbyterian Medical Center (dollars are listed in thousands) Year

Low

Mean

High

1988 1989 1990 1991

$38 60 80 93

$45 81 105 121

$62 104 132 158

of surgical procedures, however. There have been many studies directed toward immediate costs of medical and surgical care, but relatively little work has been focused on the long-term costs and consequences of procedures, especially expensive ones with significant continuing costs. Now, however, society is asking additional questions about our work, particularly about our high technologyprocedures: What do they cost and how much are they worth? Heart transplantation differs from most surgical effortsin that this work is limited by a scarce resource, the donor organ. We have, therefore, a special need to evaluate this procedure on the basis of long-term costs and consequences. Weare developing a method for continuous evaluation that we believe may find application in other areas of medicine and surgery. Observations Our heart transplantation program was begun in 1977. Now in our fifteenth year, we have experience with 544 patients receiving heart transplants as of April 15, 1992. Allpatients are seen at least annually, and none has been lostto follow-up. Although we have accurate statistics on morbidity and mortality for all patients, our information on costs was fragmentary before 1988. We found a marked increase in costs from 1988 to 1991 (Table 11). Thisdegree of increase was not seen in other procedures, such as hip replacement and coronary artery bypass (Table III). In analyzing components of costs of heart transplantation (Table IV), we found that the major factor that

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Table III. Comparison of cost of hip replacement, coronary artery bypass graft (CARG), and heart transplantation from 1988 through 1991 at Columbia-Presbyterian Medical Center (dollars are listed in thousands) Year

Hip replacement

CABG

Heart transplantation

1988 1989 1990 1991

$18.1 23.4 20.8 22.3

$35.4 45.5 43.5 63.9

$50.2 83.7 106.7 125.3

Table IV. Listing of the five greatest charges incurred for patients receiving heart transplants at Columbia-Presbyterian Medical Center in 1991 Item

Cost

Special care days Operating room costs Routine care days Drugs and intravenous therapy Perfusion

$29,429 23,330 20,621 14,588 10,604

explained the increase was the increasing length of stay, both in the special care units and in the regular nursing units. The length of stay in the pretransplantation period rosefrom 8.9 days in 1988 to 17.5 days in 1991, and the total length of stay rose from 29.5 days in 1988 to 44.9 days in 1991 (Table V). We found that the percentage of our heart transplant recipients who were intensive care unit (lCU) bound preoperatively rose from 34% in 1988 to 62% in 1991 (Table VI). In analyzing medical outcomes we found no difference in 30-day and I-year survival figures between the ICU-bound and the non-ICU-bound patients (Table VII). We examined, in addition to survival figures, the rate of rehabilitation, which we define as the ability to return to work or to school. We found that approximately 80% of our patients were rehabilitated after the first posttransplant year. We observed, however, that only 20% of the patients were not receiving disability payments (Table VIII). The most frequent explanation given by patients is related to difficultiesin obtaining health insurance and the need for coverage of costs for care, induding the costs of immunosuppressive drugs, in the period after transplantation.

Discussion As the medical outcome of heart transplantation has improved, the indications for operation have been broadened and the waiting lists have lengthened. The increased

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Reemtsma et at.

Surgery

Table V. Comparison of the preoperative and total length of stay (LOS) for patients receiving heart transplants at Columbia-Presbyterian Medical Center from 1988 through 1991 Year

Preoperative LOS (days)

Total LOS (days)

1988 1989 1990 1991

8.9 6 4.8 17.5

29.5 31 29 44.9

Table VI. Number of patients receiving heart transplants at Columbia-Presbyterian Medical Center from 1988 through 1991 and the percentage of these patients who were lCU bound Year

No. of patients

% leu bound

1988 1989 1990 1991

59 79 104 85

34 28 47 62

severity of illness among recipients is not unique to our institution. Stevenson and colleagues 1 calculate that soon all donor organs will be required for emergency heart transplantation. The relationship of severity of illness preoperatively with outcome is somewhat controversial. The role of markedly elevated pulmonary vascular resistance in producing high mortality is undisputed. The relationship between hemodynamic instability and outcome after heart transplantation, however, is not precisely defined. Four previous studies (Table IX) have focused on this issue; two studies- 3 showed a relationship between hemodynamic instability and postoperative mortality; two studies" 5 did not. Our findings support the position that patients receiving heart transplants have an equivalent chance of survival, regardless of the severity of their preoperative illness. The differences among these various studies probably can be accounted for by different selection of patients and by nonuniform definitions of severity of illness in preoperative patients. Whatever the exact relationship is, remarkable progress has been made in achieving a high percentage of survival among these seriously ill patients. Certainly much of the credit for the improved results in these patients should go to our colleagues in anesthesiology, in cardiology, and in nursing. The improving survival statistics in recipients who are extremely ill preoperatively focuses attention on the eth-

Table VII. Comparison in survival of the ICU-bound versus the non-lCU-bound patients at 3D-day and I-year intervals after receiving heart transplants at Columbia-Presbyterian Medical Center Interval

ICU-bound

Non-ICU-bound

30 days I year

90.7 74.5

88 75

Table VIII. Comparison ofpatients receiving heart transplants who are rehabilitated (able to work or go to school) versus those who are off disability 80% 20%

Patients rehabilitated Patients off disability

Table IX. Is preoperative hemodynamic instability correlated with survival after cardiac transplantation? Hardesty, Pittsburgh Stevenson, UCLA O'Connell, Utah Costard-Jackle, Stanford Reemtsma, Columbia-Presbyterian

1986 1987 1988 1991 1992

No Yes No Yes No

ics of distributing scarce donor organs. If the mortality rates were widely disparate based on preoperative severity of illness, one could make a case for selection of elective patients from the waiting list. Under the present circumstances, however, the most severely ill patients rise to the top of waiting lists. The less severely ill patients wait longer and usually become sicker. Approximately one third of these patients die awaiting transplantation," Apart from ethical considerations, the current trend places increased pressures on heart transplantation programs because of rising costs. Various agencies are beginning to consider costs in the future rationing of medical services, and several studies have been focused on costs of heart transplantation.i!' For procedures such as heart transplantation, the high cost must be balanced against the benefits. In evaluating procedures, one must consider not only medical costs (including those of chronic care without operation) but also the effectiveness of the procedure. Value may be defined in terms of the patient and of society. In our series approximately 80% of patients are rehabilitated, which we define as the ability to return to work or to school. Only 20% of these patients, however, are no longer receiving disability payments. The patients attribute this largely to their inability to obtain and afford medical insurance that will cover their continuing ex-

Volume 104 Number 5

Heart transplantation

November 1992

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penses, including medications. This suggests that although the procedure is medically effective, there are socioeconomic factors limiting the economic returns to society. While this study does not providea definitiveanswer to selection and care of heart transplant recipients, it focuses attention on several factors. The present method of selection has resulted in increased costs. We believe an understanding of the components of cost is the first step in their control. For example, the largest component of increased cost in our patients involved the preoperative length of stay in the special care areas. To control such costs, we are examining alternate methods of preparing these severelyill patients for transplantation in less costly settings such as stepdown units. We must also recognize that we are, in part, responsible for the skewing of the waiting list toward the sicker patients. The distribution of donor organs is determined, in part, by the United Network for Organ Sharing classification. As a consequence there is pressure to admit patients to specialcare areas to gain priority on the waiting list. Consequently there have been suggestions for a rule change that would make time on the waiting list, rather than degree of illness, the major determinant of priority. For the longer term, we need a data base that will provideus with information for comprehensive and continuous monitoring, both of medical outcomes and economic costs. In particular, we need predictors of long-term resultsto enable us to selectrecipients more rationally. On the basis of this and other studies, the preoperative physiologic state of the patient (excluding elevated pulmonary vascular resistance) is not predictive of long-term results. There may be immunologic indicators, as yet unidentified, that might yield such information. Such data would be particularly important in view of the limited donor supply,providingidentificationof subgroups of patients in which long-term results could be predicted with reasonable accuracy. The eventual use of mechanical devicesor xenografts, or both, willchange drastically the processof selectionof recipientsfor cardiac transplantation. Such complementary procedures for patients with end-stage heart disease will increase the need to select with precision patients in whom cardiac allografts carry a high rate of success.

between the patients operated on from intensivecare units and those operated on on an elective basis. 4. The majority of heart transplant recipients are able to return to work or to school. There are socioeconomic hurdles, often related to insurance, however, that prevent full rehabilitation of most patients. 5. In evaluating a procedure such as heart transplantation, one must consider both costs of the procedure and the cost of long-term care; in addition, one should calculate the value of a procedure by estimating the economic return to society and the quality of life of the recipients.

Summary

Dr. Robert L. Hardesty (Pittsburgh, Pa.). Dr. Reemtsma hasoutlined thedilemmas ofcardiac transplantation today, that is,thelonger waiting time, thesicker patient, andtheconsequent spiraling Costs ofcardiac transplantation. Our system ofallocation contributes to some degree to the spiraling costs in that, in our institution, it is virtually impossible, or at least a veryrare exception, that a patient who is not hospitalized receives a

I. There is a trend toward selection of the most seriously ill patients for heart transplantation. 2. This trend is increasing the costs of heart transplantation, primarily because of increased length of stay. 3. Survivalfigures are similar, at I month and I year,

REFERENCES I. Stevenson LW, WarnerSL, Kobashigawa JA, Drinkwater

D, Laks H. Alldonor heartswill soon berequired forurgent candidates. J Heart LungTransplant 1992; II: 191. 2. Stevenson LW, Donohue BC, Tillisch JH, Schulman B, Dracup KA,LaksH. Urgentpriority transplantation: when should it be done? J Heart Transplant 1987;6:267-72. 3. Costard-Jackle A, Hill I, Schroeder JS, Fowler MB. The influence of preoperative patient characteristics on early and late survival following cardiac transplantation. Circulation 1991;84(Pt 2):III329-36. 4. O'Connell JB, Renlund DG, Robinson JA, et al. Effect of preoperative hemodynamic support onsurvival after cardiac transplantation. Circulation 1988;78(Pt 2):III78-82. 5. Hardesty RL, Griffith BP,TrentoA,Thompson ME, Ferson PF, Bahnson HT. Mortally ill patients and excellent survival following cardiac transplantation. Ann Thorac Surg 1986;41:126-9. 6. McManus RP,O'Hair DP,Beitzinger J, et al.Patients who die awaiting heart transplantation. J Heart Lung Transplant 1992;11 :191. 7. Evans RW. Executive summary: the national cooperative transplantation study. BHARC-100-91-020. Seattle, Wash.: Battelle-Seattle Research Center, June 1991. 8. Evans RW. Cost-effectiveness analysis of transplantation. Surg Clin North Am 1986;66:603-15. 9. Drummond MF.Allocating resources. IntJ Technol Assess Health Care 1990;6:77-92. 10. Transplantation in Quebec: preliminary report on effectiveness, costs and organizational characteristics. Conseil d'evaluation destechnologies de la sante. November 1991. II. Buxton MJ. Problems in the economic appraisal of new health technology: theevaluation ofhearttransplants inthe UK. Oxford: Oxford University Press, 1987:102-18. Discussion

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transplant. The current system of allocation requires that for a status I patient to be listed as status I, the patient not only needs to be hospitalized but also must be maintained in an intensive care unit even though that degree of surveillance is not required. We do not have the physical space to maintain them in the intensive care unit, and, of course, the implication with respect to the difference in costs is evident. Currently we have 67 patients who are listed for cardiac transplantation. Six are hospitalized and receiving inotropic support; their range of hospitalization is 5 months to 11/ 2 months. One of these patients has depleted his financial resources for medical care. We do have one patient on a mechanical left ventricular assist device awaiting transplantation in the hospital, and we have one awaiting in a nearby facility, the family house, again, with the Novacor left ventricular assist device (Baxter Healthcare Corp., Novacor Division, Oakland, Calif.). I think the implications with respect to the waits and the severity of illness are evident, and we definitely agree that the results, even in those patients supported with the left ventricular assist device, have been equivalent to those not so critically ill. Dr. Reemtsma, having identified the problem, do you have a short-term solution, is there a long-term solution, should we change the system of allocation so that time waiting is the only indication as to the priority for allocation of the donor heart, a system that I understand has been in effect in the British Isles for some time? Dr. Adnan Cobanoglu (Portland, Ore.). At the Oregon Health Sciences University in Portland 185 patients have received transplants in the last 6 years, and toda y more than 50% of our patients who need a transplant are in the unstable or critically ill category. These are patients who have been in the hospital because of severe heart failure, and some have needed ventilators, multiple inotropic drugs, and even biventricular assist devices. It is unusual not to have four or five patients in the hospital waiting for a donor heart to become available. These facts certainly go along with Columbia-Presbyterian's experience. Interestingly, despite an increasingly sick group of patients, we have not seen an increase in the postoperative hospitalization period through the years, indicating that although unstable, these patients have done quite well after receiving transplants. The postoperative ICU stay may be a little longer in the pastfew years, but the overall hospital stay has not increased markedly despite transplantation in this much sicker group of recipients. The quality of life during long-term follow-up is considered to be good to excellent in more than 80% of the patients. To be exact, despite 88% good to excellent results and rehabilitation in these patients months after operation, only half (44% of the entire patient population) have gone back to work or to being full-time homemakers. Another 44% are disabled, but from a medical standpoint they really are not considered by us to be disabled. This has been one of the frustrating areas for us. It is a very difficult problem to deal with. As you know, the Oregon legislature is trying to deal with all health care globally. The Oregon Health Plan, if it comes to pass, will prioritize medical problems and treatment modalities and will draw a line somewhere below which services will not be covered by the state. We are hoping that heart transplantation willstay above the line, but there are no guarantees. The formula that the Health Services Commission for the governor of Oregon used was much more complex than Dr. Reemtsma presented here today. Difficulty arises in understanding numerous factors, including how socioeconomic values were incorporated into the formula. The pub-

The Journal of Thoracic and Cardiovascular Surgery

lie, I agree, is getting more and more aware of long-term outcomes (degree of contribution to the society after access), to certain health care modalities and 1 think we as surgeons will have to deal with this issue on a regular basis. How firm a policy do you have as far as directing the patients postoperatively to search for jobs? We have been somewhat firm in Oregon, and that is probably why we have a 40% return to work rate, which is double yours. We have basically told the patients that, 6 months after transplantation, if they are able to return to work we will not sign their disability papers except for extenuating circumstances. Dr. William A. Gay, Jr. (Salt Lake City, Utah). The rapid escalation of expenditures for health care has caused us all to scrutinize our practices more carefully and to attempt to get a better definition of this thing we call cost, which heretofore has been equated with, or at least believed to relate to, another entity called charges. Until recently the relationship of cost to charges in most hospital settings has been at best inconsistent. I compared Dr. Reemtsma's data with that of our Veterans Administration (VA) group of patients in Salt Lake City, since charges in the VA system are more likely to closely reflect actual "cost." We have used the Salt Lake City VA in our program since its inception in 1986 and have consistently done transplantations on about 20 to 25 patients per year. The increase in length of stay in our group has been comparable to that in the Columbia group, that is, their's is 15.4 days and ours is 16.6 days. Whereas only 55% of their increase in stay was in the pretransplantation period, 72% of our increase (I 1.9 of 16 days) was in patients before operation. There was, however, also some increase in postoperative stay, with a mean of 4.7 days. The charges related to this in the Columbia series increased by a factor of 2.6 times from 1988 to 1991. Ours increased somewhat less than that, by about 1.6 times in the VA population, the cost reflecting not only length of stay and acuity but also some increase in organ recovery costs during that period. Are we justified in our programs in being more selective, taking only "good-risk" recipients based on the finite aspect of the donor and dollar resources? Similarly, do your observations on the return to work rate ofthis group of patients (and by the way ours is similar to yours) indicate that a program such as the end-stage renal disease program might be efficacious for postoperative heart transplant recipients? Dr. Charles Yankah (Berlin, Germany). I would like to describe our experience in Berlin. Since April 1986 our heart transplantation program has increased considerably. During that time we have transplanted about 565 hearts, and we have been confronted more and more with patients who are in a low cardiac output state and need ICU therapy. We have to consider an alternative type of therapy if medical treatment is not effective. Consequently, we have used mechanical assist devices in 41 patients. Of the 41 patients in whom an assist device was used as a bridge, 24 have survived and been discharged, two patients are waiting for a donor organ, and 15 of the 41 patients have died. The question now is this: When and which of the patient groups do we have to put on the assist device program? Our current policy is to "bridge" patients who are under 50 years of age and have no severe organ dysfunction or early organ dysfunction, so that these patients can regain better organ function for transplantation. For our total heart transplantation program, our 5-year survival is 65%, with a yearly prevalence of coronary artery diseases of 9%. About 40% of the patients returned to work, school, and normal household activities, about

Volume 104 Number 5 November 1992

39% are having an active retirement, and about 21% are planning to return to work. My question for Dr. Reemtsma is related to those patients who had to be treated in an ICU. Which of the group of patients would you consider for bridging or for a biventricular assist device, so that they could regain normal organ function and therefore might have a better chance for surgery and normal postoperative recovery, as well as rehabilitation? Second, how much are the costs involved in patients treated in the ICU with and without ventricular assist devices? Do you consider patients with renal diseases who are supported by dialysis to be different from patients supported by ventricular assist devices? If you could select patients for a bridging program according to our criteria, they might recover earlier for transplantation and thus lead a normal life after the operation. Dr. R. Morton Holman III (Minneapolis. Minn.). Dr. Reemtsma has demonstrated very well that we can obtain equivalent outcomes in patients who are ICU bound or so-called status I patients and in those we would consider better risk candidates. It has also been true that programs in the New York area in the last 3 or 4 years have had an increased supply of donors compared with many of the other programs in the country. How has your selection process been affected by the relative wealth of donors that you have experienced? Do you perform transplant operations in older patients, sicker patients, and what do you think the message should be for those of us who may not have as many donors as you have? I think you made a very good point about the rehabilitation of these patients. If we are goingto be asked to defend this procedure as a cost-effective one, adjustments have to be made for these patients to return to employment and to get insurance if heart transplantation is to move to the next plateau. Dr. Safuh Attar (Baltimore. M d.). Another aspect of reducing the cost of heart transplantation is through an input into the disability program of the Social Security Administration. Until recently the government has considered patients having heart transplantation to be disabled for 3 years and has funded them for that period; subsequently this has been extended. There is a tendency toward reducing this period to I year. Dr. Reemtsma, on the basis of your experience, what would you recommend to the government regarding the period of time before patients

Heart transplantation

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should be returned to work after heart transplantation? Also, what limitations would you impose on these patients? Dr. Reemtsma. I thank the discussers, and I shall respond in reverse order. Dr. Attar, it is our experience that most of our patients are able to return to work or school by the end of I year after operation. Many of them remain on disability rolls because of difficulties with insurance coverage for continuing medical costs and immunosuppressive drugs. Dr. Bolman, even though we have relatively more donors, I doubt that that has affected our patient selection in terms of severity of illness. I agree with you that we need to find ways to enable patients to be fully rehabilitated. I am pleased to learn of the Berlin experience and the observation that 40% of patients are able to return to work. Dr. Gay, I support your view that proliferation of heart transplantation centers is inefficient and costly. We believe the opening of transplant centers should be related to the number of donors available. In regard to the Oregon experience, Dr. Cobanoglu, I believe our experience is similar to yours. Your slide shows that the length of stay after transplantation is similar in the severely ill patients and in the elective ones. Our findings are the same. The increased length of stay in our patients was related to hospitalization before transplantation. Dr. Hardesty, you have been a pioneer in this field, and I appreciate your comments. I agree with your suggestion that our system of allocation may be, in part, responsible for skewing the patient population for transplantation. A strong case can be made for allocation on the basis of time on the waiting list and less emphasis on severity of illness. You asked for suggestions for short- and long-term solutions. In the short term I believe we can prepare these patients in less costly ways. In the long term I believe we shall be able to identify immunologic factors that will be highly predictive of longterm survival. We do not have such methods now, but some new approaches, such as antiidiotype studies, may prove valuable. Finally, the use of mechanical devices and xenografts will change markedly our allocation of organs. We will then be in a situation similar to that of end-stage renal disease, in which there is a choice of transplantation or dialysis.