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Ann Thorac Surg 2001;72:1298-1305
© 2001 The Society of Thoracic Surgeons
a Department of Surgery, Division of Thoracic and Cardiovascular Surgery, University of Virginia Health System, Charlottesville, Virginia, USA
Accepted for publication June 11, 2001.
Address reprint requests to Dr Kron, Department of Surgery, Division of Thoracic and Cardiovascular Surgery, Box 3111, MR4 Building, University of Virginia Health Sciences Center, Charlottesville, VA 22908
e-mail: ikron{at}virginia.edu
| Abstract |
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Methods. We compared clinical and financial data of 268 patients with ejection fraction less than 30% who underwent elective heart transplantation (n = 52, UNOS status 2 only), coronary bypass (n = 176), mitral repair (n = 15), or left ventricular reconstruction (n = 25). Data were evaluated for between-group differences, with p less than 0.05 as significant.
Results. Preoperative ejection fraction, although similar for heart transplantation (21.2% ± 1.3%), coronary bypass (25.8% ± 0.4%), mitral repair (22.9% ± 1.5%), and left ventricular reconstruction (24.2% ± 2.1%), was significantly different between the former two (p < 0.001). There was no difference in operative mortality: 5.8% (3 of 52), 3.4%(7 of 176), 6.7% (1 of 15), and 4.0% (1 of 25), respectively (p = 0.8). However, total hospital cost of heart transplantation was significantly greater than all others: $75,992 ± $5,380, $25,008 ± $1,446, $32,375 ± $2,379, and $26,584 ± $4,076, respectively (p < 0.001). Organ procurement expenses alone comprised 39.7% ($30,169) of total transplant cost. Kaplan-Meier survival analysis failed to show any survival difference between the various groups (p = 0.86)
Conclusions. Compared with heart transplantation, alternative operations yield a comparable early outcome and long-term survival, and are markedly less expensive. The cost of transplantation, which is largely due to procurement expenses, is yet another reason to attempt alternative operations for cardiomyopathy whenever feasible.
| Introduction |
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Heart transplantation is an established treatment modality for patients with end-stage heart failure. However, it is limited by a severe shortage of donor organs, the need for long-term immunosuppressive therapy with its attendant consequences, and problems with rejection, infection, and allograft coronary arteriosclerosis. Another serious shortcoming of heart transplantation is its expense, which has been a topic of intense scrutiny in recent years as a result of the managed care agenda as well as the health care economic crisis. Although cardiac transplantation is believed to be cost effective in the long term [4], the few studies from the recent decade that have focused on in-hospital, procedure-related costs indicate that it is an expensive therapy [57].
In response to these limitations, a variety of surgical alternatives to transplantation have been proposed for patients with cardiomyopathy. Such alternative procedures include coronary artery bypass grafting [810], mitral valve repair [1113], and left ventricular reconstruction, the latter of which includes partial left ventriculectomy [13, 14] and endoventricular patch plasty of the left ventricle [15]. Although it has been repeatedly documented that hospital costs for coronary bypass are significantly greater for patients with depressed preoperative ventricular function as opposed to those with preserved function [1619], no previous studies have analyzed costs associated with the other alternative procedures in the setting of cardiomyopathy. Furthermore, there have been no previous procedural cost comparisons between heart transplantation and alternative procedures. Therefore, it remains unknown whether these alternative surgical therapies are truly less expensive than replacing the diseased heart.
To address these unanswered questions, our primary endeavor was to compare in-hospital costs and short-term clinical outcome of patients with cardiomyopathy who underwent elective heart transplantation or one or a combination of the alternative procedures. Our secondary goal was to compare hospital costs for coronary bypass for patients who had cardiomyopathy with those for patients undergoing coronary bypass who had normal preoperative ventricular function.
| Patients and methods |
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Heart transplantation
During the study interval a total of 86 patients underwent cardiac tranplantation at the University of Virginia, of whom 34 were UNOS status 1 and 52 were UNOS status 2. Only status 2 patients were included in the current study for two reasons: one, the preoperative clinical condition of status 2 patients awaiting elective heart transplantation as stable outpatients more closely resembles the condition of cardiomyopathy patients referred for elective alternative procedures; and two, to avoid the confounding influences of higher costs due to prolonged preoperative length of stay (LOS) for UNOS status 1 patients [5]. All 52 UNOS status 2 patients were admitted from home and underwent elective orthotopic heart tranplantation (OHT) the day of admission. The etiology of cardiomyopathy in these patients was ischemic in 33 (63.5%), dilated in 17 (32.7%), and hypertrophic in 2 (3.8%).
Coronary artery bypass grafting
There were 176 patients who underwent coronary artery bypass grafting (CABG), an average of 3.1 days after admission. Two patients were revascularized by a minimally-invasive direct coronary artery bypass (MIDCAB) technique. The remainder underwent standard CABG on cardiopulmonary bypass using mild to moderate systemic hypothermia (30°C to 32°C) and either isolated antegrade or combined antegrade/retrograde cold blood cardioplegia. The mean number of grafts per patient was 3.1 (range 1 to 5). There were no concomitant cardiac procedures in the CABG group. Seven patients in this group had been evaluated for heart transplantation, of whom 4 were actually listed.
Mitral valve repair
Fifteen patients with mitral regurgitation (MR) underwent mitral valve (MV) repair as their primary operation, with an average delay of 2.6 days from admission to surgery. This group is similar but not identical to our recently reported series of MV repairs [12]. MR severity, as determined by color-flow Doppler ultrasonography, was graded as 4+ in 10 paitents and 3+ in the remaining 5 patients. MR was a sequel to ischemic cardiomyopathy in all cases. All 15 patients required adjunctive CABG, with an average of 2.5 grafts per patient (range 1 to 4). MV repair was uniformly performed through a median sternotomy on cardiopulmonary bypass, using the same cardioplegic strategy as described above. The MV was reconstructed using a prosthetic annuloplasty ring in 12 patients; the remaining 3 MV repairs were performed using the "edge-to-edge" central leaflet suture technique as originally described by Alfieri and colleagues [20]. Concomitant cardiac procedures in this group consisted of tricuspid valve repair in 3 patients. One patient in the MV repair group had been evaluated for cardiac transplantation but was not listed for this procedure.
Left ventricular reconstruction
A total of 25 patients underwent left ventricular reconstruction (LVR) an average of 2.6 days after admission. Twenty-two of these patients had sustained a remote anterior myocardial infarction and presented with anteroseptal akinesia or dyskinesia; approximately half of these manifested a true ventricular aneurysm. These 22 patients underwent exclusion of the anteroseptal akinetic/dyskinetic region by the endoventricular circular patch plasty (EVCPP) technique developed by Dor and colleagues [15]. All patients undergoing EVCPP had ischemic cardiomyopathy, necessitating concomitant CABG in 100% (mean 2.4 grafts per patient, range 1 to 4). Three of these patients also had severe MR, mandating concomitant MV repair using the edge-to-edge technique. Two patients in the EVCPP subgroup had undergone a transplant evaluation but were not included on the transplant list.
Three patients in the LVR group were diagnosed with idiopathic dilated cardiomyopathy and underwent partial left ventriculectomy as originally described by Batista [14]. Two of these 3 patients were referred for a cardiac transplant evaluation and 1 was listed. Concomitant procedures included MV replacement in all patients. Myocardial protection during EVCPP and partial left ventriculectomy was as described above.
Coronary artery bypass grafting in patients without cardiomyopathy
An additional set of 25 patients with normal preoperative ventricular function (mean EF 59%) who underwent CABG during the last year of the study period were selected at random. This group of patients was selected for the secondary goal of numerically comparing the cost of CABG for patients with ischemic cardiomyopathy with the cost for patients without cardiomyopathy.
Data acquisition
For patients in the alternative procedure groups, all demographic and clinical data were obtained from our institutions Society of Thoracic Surgeons Database. We employed the same definition for each variable as outlined in the Definition of Terms of the Society of Thoracic Surgeons National Cardiac Surgery Database [21]. For OHT patients, data for these same demographic and clinical variables were acquired from the University of Virginia Heart Transplant Registry as well as from review of each patients hospital record. The University of Virginia clinical data repository was utilized to obtain survival data on all patients included in the study.
Cost data were retrieved from our hospitals cost accounting system (Shared Medical Systems, Malvern, PA). The reported cost data represent the actual costs to the hospital for services provided (ie, actual resource consumption) and should not be confused with billed charges [22]. Cost determinations include total cost (of hospital admission), direct cost, indirect cost, fixed cost, and variable cost. Direct cost is defined as expenses directly related to patient care whereas indirect cost represents expenses attributed to hospital maintenance, administration, and utilities. Variable cost is affected by patient volume whereas fixed cost is not. For each of the alternative procedure and OHT groups, we also broke down total costs into departmental components (eg, pharmacy, operating room, blood bank, organ procurement) to determine the relative contribution of each department to total resource consumption. Professional fees were excluded from the analysis. All cost data reported herein are uncensored, which implies that these data do not take into account the financial impact of in-hospital death.
Data analysis
All numerical data are reported as the mean ± standard error of the mean. These data were analyzed for between-group differences using Students t test or analysis of variance (ANOVA) and the post hoc test of Tukeys multiple comparisons. All data reported as a fraction or percentage were analyzed by the
-square test. Survival data were analyzed using Kaplan-Meier curves, and the p value was determined using the log rank test. For all statistical analyses, a p value of less than 0.05 was considered significant.
| Results |
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Cost analyses for heart transplantation and alternative procedures
For all five cost measurements, the costs associated with OHT were significantly and markedly greater than each of the alternative procedures (Table 3). The mean total cost of OHT ranged from 2.3 to 3.0 times higher than that of MV repair and CABG, respectively. The cost differential between OHT and each alternative procedure was greatest in terms of direct cost; for OHT this value was 3.7-, 2.7-, and 3.4-fold higher than direct costs associated with CABG, MV repair, and LVR, respectively. There were no significant cost differences, however, between the alternative procedure groups. In addition, there was no significant difference in the total hospital cost of alternative procedures in patients who had undergone preoperative transplant evaluation ($30,790 ± $13,384, n = 12) compared with those who were not so evaluated ($25,427 ± $1,183, n = 204; p = 0.7). However, when compared with OHT, the mean total cost of the transplant-evaluated alternative procedure subgroup remained significantly lower ($75,992 ± $5,380 versus $30,790 ± 13,384, respectively; p = 0.002). A total cost comparison of OHT in patients who had undergone previous CABG (n = 16) versus those who had not received previous CABG (n = 36) revealed no significant difference ($72,896 ± $4,346 versus $77,368 ± $7,559, respectively; p = 0.7).
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Survival data
Kaplan-Meier survival curves were constructed for patients from all four groups. The mean survival (in months) for the various groups is as follows: CABG (67 ± 2), MV repair (66 ± 7), LVR (54 ± 5), and OHT (70 ± 4). There were no differences in survival between the various groups (p = 0.86). The Kaplan-Meier survival curves for the four groups are illustrated in Figure 1.
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| Comment |
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By replacing the failing heart, cardiac transplantation effectively decreases the subsequent readmission rate for heart failure treatment. However, it does so at the expense of a high initial procedure-related cost [57]. Additional shortcomings of heart transplantation include a critical shortage of donor organs, the adverse consequences and expense of chronic immunosuppressive therapy, and the long-term risks of rejection, infection, and graft vasculopathy. As a final concern, the age restrictions of heart transplantation limit its applicability for the increasing elderly population. In response to these numerous limitations, several nontransplant operations have been proposed as alternatives to transplantation in selected patients with heart disease. The potential mechanisms whereby coronary artery bypass, mitral valve repair, and left ventricular reconstructive procedures improve the function of the diseased heart and thus avert or postpone transplantation are the focus of several previous investigations [815, 2325]; however, such a discussion is beyond the scope of this paper. Although these operations have been proposed as potential substitutes for transplantation, it has not been previously determined how these nontransplant procedures compare to heart transplantation with regard to procedure-related costs. Since it has already been consistently demonstrated that coronary bypass is substantially more expensive in patients with cardiomyopathy as opposed to those without [1619], it seems conceivable that operations on the diseased heart are no less costly than replacing it.
Consistent with these previous studies, our data indicate that there is an average cost differential of approximately $5,000 when comparing the cost of CABG in the presence or absence of cardiomyopathy. However, we also demonstrate that the cost of elective cardiac transplantation in status 2 patients is markedly higher than each of the alternative operations for cardiomyopathy. Furthermore, we discovered that the in-hospital cost savings of these nontransplant operations is not at the expense of a higher morbidity or mortality rate. Based on our results it appears that the greatest constituent of transplant costs in status 2 patients is organ procurement expenses, which accounted for nearly 40% (about $30,000) of the total cost. However, as the trend is toward an increasing number of heart transplants performed in status 1 patients with a prolonged preoperative length of stay, room expenses are assuming an increasingly greater percentage of total transplant costs [5, 7, 26]. In our series limited to status 2 patients, despite a significantly longer postoperative length of stay compared with nontransplant operations, only 17.8% (about $13,500) of the total cost of heart transplantation was composed of room expenses. These figures would be expected to be substantially higher if status 1 patients were included; therefore our study underestimates the actual overall cost of heart transplantation. However, because postoperative costs and clinical outcome are similar for status 1 and status 2 patients [5], our results are applicable to the posttransplant course of status 1 patients as well. Whatever the total length of stay and attendant room charges may be, however, an average procurement fee of $30,000 is substantial and will continue to consume a large portion of total transplant cost. The problematic issue of organ procurement expenses has been noted previously [5, 27].
This study has several limitations that must be addressed. First, despite our efforts to define a homogeneous set of patients with chronic stable heart disease who underwent elective surgery, our series includes a widely heterogeneous patient population. Admittedly not all patients who underwent transplantation were candidates for an alternative procedure and the converse is also true. In the alternative procedure groups we defined cardiomyopathy as a preoperative EF less than 30%; therefore many of these patients did not truly have end-stage heart failure as did the transplant group. However, in many instances an alternative procedure is viewed as a preemptive procedure in a patient whose myocardium has retained the ability to undergo "reverse remodeling" and has not yet developed irreversible end-stage cardiomyopathy [13, 30]. Furthermore, even when comparing the 12 alternative procedure patients with advanced heart failure who had undergone preoperative transplant evaluation with those patients who actually underwent heart transplantation, the cost of the latter remained significantly higher. Although a higher percentage of heart transplant recipients had undergone previous CABG compared with the alternative procedure groups, it has been previously shown that reoperation does not increase the risks of heart transplantation [31]. Furthermore, we were unable to identify a significant cost differential between transplant patients who had undergone a previous CABG versus those who had not. A second limitation of our study is our failure to report uncensored cost data [18]. Because there was no difference in operative mortality between the four groups, however, and because our primary interest was in making a relative cost comparison between these groups, the overall financial impact of in-hospital deaths should be minimal. Finally, our failure to convert cost data to 1999 U.S. dollars to account for the effects of inflation might be perceived as a limitation. However, one would not expect drastic changes in the cost of each procedure over the 5-year study period, and any minor changes which might have occurred would be expected to affect each group similarly. Therefore we maintain that the relative cost comparisons reported herein are valid.
In summary, the results of this study indicate that hospital costs associated with coronary bypass, mitral valve repair, and left ventricular reconstruction in patients with cardiomyopathy are dramatically lower than the cost of heart transplantation. In addition, we note that there is no difference in survival for patients who had undergone OHT versus the alternative procedures for ischemic cardiomyopathy. These findings provide another compelling reason to attempt a nontransplant operation for cardiomyopathy whenever feasible. Future studies must focus on identifying which patients are the best candidates for these alternative procedures, as well as determining whether the favorable early cost and clinical outcome of these operations will translate into durable, long-term benefit when compared with heart transplantation. With the advent of new investigational devices for the treatment of heart failure, this could represent yet another alternative mode of treatment for such patients [28, 29].
| Acknowledgments |
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| References |
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