Ann Thorac Surg 1996;61:635-639
© 1996 The Society of Thoracic Surgeons
Original Article: Cardiovascular
Efficacy of a Partnership in Enhancing Veterans Affairs Cardiac Transplantation Activity
Charles C. Canver, MD,
Eldora K. Luick, MS,
Jacalyn A. Friar, RN,
Robert M. Mentzer, Jr, MD
Division of Cardiothoracic Surgery, University of Wisconsin School of Medicine, Madison, Wisconsin
Accepted for publication October 4, 1995.
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Abstract
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Background. Despite a nationwide surplus of cardiac transplantation programs, the number of United States armed forces veterans who receive heart transplants has declined over the past several years. This study reviews the efficacy of a partnership between a Veterans Affairs hospital and a university hospital in maximizing the access of veterans to the limited donor heart supply.
Methods. As part of a contract-based sharing agreement between the University of Wisconsin Hospital and the William S. Middleton Memorial Veterans Affairs Hospital, 25 veterans underwent orthotopic heart transplantation between October 1993 and April 1995. Care of the patients was provided at the Veterans Affairs Hospital. The transplantation operations were performed at the University of Wisconsin Hospital, and all patients were transferred back to the Veterans Affairs Hospital 5 to 7 days afterward. All patients were men (mean age, 52.1 ± 2.1 years) and were referred from Veterans Affairs hospitals in nine different states.
Results. During the 19-month period, the average length of hospital stay for pretransplantation evaluation was 7.0 ± 0.7 days (range, 2 to 15 days). Average status I waiting time was 26.9 ± 3.3 days (range, 5 to 54 days); the average waiting time for status II was 115.1 ± 16 days (range, 15 to 242 days). Posttransplantation length of stay at the Veterans Affairs Hospital was 22 ± 1.8 days (range, 11 to 41 days). Only 1 patient (4%) experienced a lethal postoperative complication. Ten patients (40%) exhibited graft rejection within the first month after transplantation, requiring treatment with augmented immunosuppressive therapy (steroids, orally in 2 patients and intravenously in 8). The overall 30-day mortality rate was 4% (1 patient). The cause of death was acute grade 4 graft rejection 3 weeks after transplantation. Overall patient survival was 96%.
Conclusions. A partnership between a Veterans Affairs hospital and a university hospital committed to transplantation can increase Veterans Affairs cardiac transplantation activity, with excellent 30-day mortality and early survival results.
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Introduction
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During the past 2 decades, heart transplantation has become the treatment of choice for selected patients with end-stage heart failure. The major obstacle for a patient with cardiomyopathy in receiving a cardiac transplant is the scarcity of donor hearts [1]. The 1994 Registry of the International Society for Heart and Lung Transplantation reported 26,704 heart transplantations at 251 centers since its inception in 1982 [2]. About 3,300 cardiac transplantations were performed worldwide in 1993 alone [2]. This activity in cardiac transplantation falls well short of the estimated needs, largely because of the limited donor supply. In a recent report [3], the waiting list mortality rate in 1993 was cited as 12.2%, which exceeds that of the heart transplantation operation itself. The actual number of United States armed forces veterans in need of heart transplantation is uncertain.
In the last decade, the therapeutic success of cardiac transplantation resulted in the establishment of 166 heart transplantation centers nationwide, including four hospitals of the Department of Veterans Affairs [4]. The Department of Veterans Affairs is one of the largest single providers of health care and includes 171 hospitals, 350 outpatient clinics, and 126 nursing homes [5]. Of these four hospitals, only two (Salt Lake City, Utah, and Richmond, Virginia) offer veterans cardiac transplantation as a therapeutic modality without major restrictions. As in many other centers, veteran heart transplantation programs are challenged by the small numbers of transplantation operations performed annually, particularly in the past several years [3]. A recent study documented that the risk of death at early and intermediate times after transplantation was substantially higher in low-activity cardiac transplantation centers, which made up more than half of the centers performing cardiac transplantation in the United States. In this retrospective study, the risk of death at 1 month and 12 months was greater in centers in which fewer than nine cardiac transplantations were performed per year [6].
It is unlikely that the number of donor hearts available will increase enough to allow these veteran cardiac transplantation centers to achieve activity levels associated with better outcomes or to meet the potential need in the health care system of the Department of Veterans Affairs.
To maximize the access of veterans to cardiac transplantation, a sharing agreement was established between the William S. Middleton Memorial Veterans Affairs Hospital (VAH) and the University of Wisconsin Hospital (UWH) (Madison, Wisconsin). The objective of this report is to evaluate the efficacy of such a partnership in terms of Veterans Affairs cardiac transplantation activity and patient outcome.
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Material and Methods
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The contract between the VAH and the UWH was signed in August 1993. Multidisciplinary VAH medical and support services personnel involved in heart transplantation were consulted, and appropriate commitments were obtained from each discipline. Three series of educational conferences and workshops on heart transplantation were held to familiarize the VAH care givers with cardiomyopathy patients, heart transplantation, pre- and postoperative care, clinical immunosuppression protocols, and long-term management of the heart transplantation patient.
Patient referrals were primarily from three sources: the Veterans Affairs Central Office, Washington, DC; our own VAH; and other regional veteran health care facilities, including Alaska, 1 patient (4%), Illinois, 11 patients (44%), Indiana, 3 patients (12%), Iowa, 2 patients (8%), Michigan, 2 patients (8%), Minnesota, 1 patient (4%), Ohio, 2 patients (8%), South Dakota, 1 patient (4%), and Wisconsin, 2 patients (8%) (total, 25 patients [100%]). All patients were admitted to the VAH for pretransplantation evaluation. They underwent thorough clinical and laboratory examinations by appropriate consultants. Pretransplantation evaluation comprised assessment of cardiac function, exercise tolerance, and general health status. Table 1
presents characteristics of the veteran patient population. The causes of cardiomyopathy were ischemic in 14 patients (56%), idiopathic in 9 (36%), viral in 1 (4%), and valvular in 1 (4%). Cytomegalovirus (CMV) antibody was positive in 16 patients (64%) and negative in 9 (36%). Ten patients (40%) had had prior cardiac operations: 7 patients (28%) had undergone coronary artery bypass grafting and 1 (4%) had had mitral valve replacement; an implantable cardioverter-defibrillator and permanent pacemaker were present in 2 patients (8%).
Most patients were accepted for transplantation if they had New York Heart Association class IV symptoms of heart failure, peak oxygen consumption during exercise less than 15 mL•kg-1•min-1, and lack of contraindications. Additional criteria for acceptance included at least 6-month freedom from the use of addictive substances (tobacco, alcohol, analgesic drugs) and a stable psychosocial background, such that they were able to cope with heart transplantation and its associated requirements for drug compliance. Contraindications to heart transplantation included untreated malignancy, uncontrolled active infection, severe symptomatic cerebrovascular and peripheral vascular disease, and advanced end-organ damage due to noncardiac diseases.
All prospective patients were reviewed at the bimonthly VAH transplantation review conference. Patients found to be suitable for transplantation at this conference were reviewed at the weekly transplantation review conference at UWH (Table 2). The final recommendation from this multidisciplinary transplantation team was submitted to the Veterans Affairs Central Office. Upon approval by the Veterans Affairs Central Office, patients were listed with the United Network for Organ Sharing as part of the UWH transplantation program. In accordance with United Network for Organ Sharing requirements, they were listed as either status I or status II. The status I patients were those receiving mechanical circulatory support (left or right ventricular assist device, ventilator, or intraaortic balloon pump) or those who were in an intensive care unit receiving inotropic therapy to maintain an adequate cardiac output. According to United Network for Organ Sharing guidelines, status I patients had priority over status II patients.
When a donor heart became available, the VAH patient was taken directly to the operating room at UWH. Physical connection of the two hospitals through a tunnel, forming a single health care complex, allowed easy and fast transportation of the patients. The same two-staff transplantation surgical team was available at all times. The donor heart was harvested by one of two staff surgeons and was always implanted by the same team. Immediately after the transplantation, the patient was cared for in the intensive care unit of UWH. Standard postoperative care, established at UWH over the years, was provided to all veteran patients. In general, patients were moved to the intermediate care unit from the intensive care unit on the second postoperative day. As part of the contract agreement, all patients were transferred back to VAH within 7 days.
Prophylaxis for CMV consisted of intravenous ganciclovir (Syntex Laboratories, Inc, Palo Alto, CA) (5 mg•kg-1•day-1) for 7 days for the recipients who were CMV seropositive before transplantation or for transplantation patients who had received a heart from a CMV-seropositive donor. Prophylactic ganciclovir was not given to the CMV-seronegative recipients when the donor hearts were procured from CMV-seronegative individuals. Patients seropositive for CMV who had transplantation with CMV-seropositive donor hearts received ganciclovir (5 mg•kg-1•day-1) for 14 days.
According to the protocol, endomyocardial biopsies were performed in the operating room of the VAH at 1, 2, 3, 4, 6, and 8 weeks; at 3, 4, 6, and 12 months; and then at yearly intervals. After two consecutive endomyocardial biopsies showing no major histologic evidence of graft rejection, patients were released from the hospital to a hotel or adjacent housing unit built especially for transplantation patients. Diagnostic biopsy specimens were also obtained when rejection was suspected clinically. Guidelines for long-term monitoring of graft rejection and complications of immunosuppression therapy were identical to those used for nonveteran patients at the UWH. Outpatient care of the transplantation patients was primarily monitored by the transplantation coordinators from VAH. The majority of outpatient laboratory tests and radiologic studies were performed at the VAH closest to the patient's home.
Data were expressed as simple frequency distributions and percentages. Average follow-up was 7 months (range, 1 to 17 months). Survival estimates were calculated using actuarial methods [7]. The date of heart transplantation was used as the starting point, and data were plotted at monthly intervals.
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Results
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The average hospital stay for pretransplantation evaluation was 7.0 ± 0.7 days (range, 2 to 15 days). In the 20 veteran patients (80%), total status I waiting time averaged 26.9 ± 3.3 days (range, 5 to 54 days). Of these, 9 patients (36%) were classified as status I at the time of listing. These patients were treated with intravenous infusions of dobutamine with or without milrinone to maintain adequate cardiac function until heart transplantation. Eleven (44%) of the 16 status II patients deteriorated clinically and required hospitalization, and their listing status was changed from status II to status I (see Table 1
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Donor heart ischemia time after procurement was 186 ± 10 minutes in the 25 veteran heart transplantation recipients. Cardiac preservation consisted primarily of flushing through the aortic root with cold (4°C) University of Wisconsin solution, in a total volume of 1,500 to 2,000 mL. The donor heart was then immersed in the University of Wisconsin solution until implantation. The immunosuppression protocol included induction therapy with OKT3 (10 days) plus cyclosporine, azathioprine, and steroids.
Posttransplantation hospital stay at the VAH was 22 ± 1.8 days (range, 11 to 41 days). All patients were and are followed closely to monitor graft rejection, posttransplantation hypertension, weight gain, hypercholesterolemia, and complications of immunosuppressive therapy. Postoperative complications for the 25 patients were nonfatal in 14 (56%): postoperative hemorrhage in 1 (4%), sinus node dysfunction in 3 (12%), and low-grade graft rejection in the first month in 10 (40%). Ten patients (40%) had no complications. The case of the hemorrhage that required reexploration was a 62-year-old man who had undergone a previous cardiac operation and was receiving oral warfarin until transplantation. The posttransplantation sinus node dysfunction was manifested by tachyarrhythmia-bradyarrhythmia syndrome and was treated in all 3 patients by the implantation of permanent pacemakers. For the patients experiencing graft rejection necessitating treatment (grade 2 or greater), augmented immunosuppressive therapy included oral corticosteroids (2 patients, 8%) and intravenous corticosteroids in (8 patients, 32%).
The overall 30-day mortality rate for heart transplantation was 4% (1 of 25). The death occurred in a 56-year-old patient with ischemic cardiomyopathy and was due to acute grade 4 rejection 3 weeks after transplantation. First-week and second-week endomyocardial biopsies had shown only grade 1A rejection. On the day of death, the level of cyclosporine was within an acceptable range. Overall patient survival at 1 year was 96% (Fig 1). A second patient's death 17 months after transplantation occurred at home and was unexplained; an autopsy could not be obtained.
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Fig 1. . Overall survival of veteran patients who underwent orthotopic heart transplantation during a 19-month period. The actual number of patients at a specific time point is shown in parentheses.
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Comment
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Recent reports have described the veteran health care organization both as a national asset [8] and as a second-class health care system for poor elderly men [9]. We believe that the quality of clinical care of a veteran at VAH is indistinguishable from that provided in the private sector. Nevertheless, as efforts are under way to improve access, quality, and efficiency in the national health care system, it is important to develop innovative ways to refine health care delivery in the Veterans Affairs system. Our experience clearly demonstrates that a Veterans Affairs hospital committed to heart transplantation can provide this highly specialized therapeutic service through a partnership-based agreement with its academic affiliate.
Medical and surgical services at a Veterans Affairs hospital traditionally are influenced by the affiliated academic university hospital. Two possible disadvantages of this structure with respect to cardiac transplantation programs at Veterans Affairs hospitals are the lack of involvement in decisions for the organ procurement process and the difficulty of justifying a team committed exclusively to heart transplantation at the Veterans Affairs hospital in view of its low level of heart transplantation activity. The recent downward trend in the annual number of heart transplantations performed at the existing veteran heart transplantation centers [3] could ultimately create difficulty in maintaining satisfactory veteran patient outcomes. In a recent report, Laffel and associates [10] could not demonstrate any effect of overall activity on the mortality rate from cardiac transplantation, but they characterized a definite learning curve effect, showing higher mortality rates in a given center's early transplantation experience. Heck and colleagues [11] have also shown that those centers with low activity are likely to have significantly reduced patient survival at all time points up to 3 years after transplantation. Our experience suggests that low transplantation activity can be modulated by establishment of a single heart transplantation service between a Veterans Affairs hospital and a university hospital. In 1994, more veterans received heart transplants at our veteran cardiac transplantation program than at all other Veterans Affairs hospitals in the country combined. Currently, one third of the heart transplantations performed at the UWH heart transplantation program are done in veteran patients. This is due, we believe, to elimination of the ``two list'' system that separates veteran and nonveteran patients for donor heart allocation.
The fact that the majority of veteran patients (20 patients, 80%) were status I at the time of transplantation may be due to the delay in timely referral of ill veterans and the limited flexibility of the Veterans Affairs system. None of the patients required the use of intraaortic balloon pump. However, a recent veteran transplantation candidate with ischemic cardiomyopathy rapidly progressed into a severe low cardiac output state despite maximum inotropic therapy. This patient was ultimately treated with an implantable left ventricular assist device (HeartMate; Thermo Cardiosystems, Woburn, MA). Currently, he is stable and awaiting heart transplantation. Although efforts are currently under way to offer implantation of ventricular assist devices at the veteran cardiac transplantation centers, this was accomplished in this extremely ill veteran as a bridge to transplantation through a special approval process by the Veterans Affairs Central Office.
In our experience, the average waiting times for both status I and II patients were short. This is, for the most part, attributed to our extremely productive organ procurement organization. In the 1994 Association of Organ Procurement Organizations survey on local donor organ activity, the University of Wisconsin organ procurement organization was ranked first in the United States, with 56 successful donor heart procurements. This represented 21.5 donor hearts per million population in an area where the total population is 2.6 million. Our heart transplantation surgical team, staffed by the same two surgeons at all times, thoroughly evaluated every possible donor heart to use as many as possible. Other helpful adjuncts for achieving good outcomes among the veteran patient population included development of a dedicated care giver team for veteran heart transplantation patients and elimination of all variations with respect to operative and postoperative care (including clinical immunosuppression protocols).
The partnership concept pairing Veterans Affairs hospitals with other health care providers has recently been proposed by Fisher and Welch [12] as an alternative for the Veterans Affairs health care system to deal with the challenges imposed by the managed care–oriented, highly competitive private-sector health care providers. With respect to the heart transplantation partnership scenario, the university hospital assumes responsibility for overall administration, enrollment, actuarial estimates, and financial planning. The Veterans Affairs hospital provides most services to veterans; services not available through the Veterans Affairs hospital are provided by the university hospital. Payments to the partnership plan are capitated. Under such an arrangement, a veteran at our hospital receives heart transplantation service identical in quality to that provided by the university hospital.
One limiting factor may be the transportation costs of the veteran patients being cared for through such a partnership. Although the cost could be substantial, to date this has not precluded access to a donor heart and a successful outcome. Currently, efforts are under way to ensure minimized transportation expenditures.
It is doubtful that the number of heart donors will increase in the future. Because the Transplant Act of 1985 specifically states that donor organs are a national resource [13], it is paramount that veterans have optimal access to heart transplantation. It is probably unreasonable to develop a heart transplantation program at each Veterans Affairs hospital nationwide to meet the potential need of veterans with end-stage heart failure. Nevertheless, because the objective is to benefit veterans, this may well be achieved by the establishment of a veteran heart transplantation program under a university hospital that has a proven track record of success in organ transplantation. Based on our experience, this alliance increases annual veteran cardiac transplantation activity with good early outcome.
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Acknowledgments
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The assistance provided by Wanda L. Stroyny in the preparation of the manuscript is greatly appreciated.
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Footnotes
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Address reprint requests to Dr Canver, Division of Cardiothoracic Surgery, University of Wisconsin-Madison, H4/352, Clinical Science Center, 600 Highland Ave, Madison, WI 53792.
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References
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- Evans R, Mannien D, Garrison L, Maier A. Donor availability as the primary determinant of the future of heart transplantation. JAMA 1986;255:1982–8.
- Hosenpud JD, Novick RJ, Breen TJ, Daily OP. The registry of the International Society for Heart and Lung Transplantation: eleventh official report, 1994. J Heart Lung Transplant 1994;13:561–70.[Medline]
- United Network for Organ Sharing and United States Department of Health and Human Services. 1994 annual report of the U.S. Scientific Registry of Transplant Recipients and the Organ Procurement and Transplantation Network—transplant data: 1988–1993. H-46. Richmond, VA, and Bethesda, MD: United States Department of Health and Human Services Health Resources and Services Administration, 1994.
- United Network for Organ Sharing. Committee reports. UNOS Update 1995;11:10.
- Strategy 2000: the VA responsibility in tomorrow's national health care system. Washington, DC: Paralyzed Veterans of America, 1992.
- Hosenpud JD, Breen TJ, Edwards EB, Daily OP, Hunsicker LG. The effect of transplant center volume on cardiac transplant outcome: a report of the United Network for Organ Sharing Scientific Registry. JAMA 1994;271:1844–9.[Abstract/Free Full Text]
- Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958;53:4457–81.
- Hollingsworth JW, Bondy PK. The role of Veterans Affairs hospitals in the health care system. N Engl J Med 1990;322:1851–7.[Medline]
- Greenberg DS. Washington perspective: the veteran's medical empire. Lancet 1990;335:1391–2.
- Laffel GL, Barnett AI, Finkelstein S, Kaye MP. The relation between experience and outcome in heart transplantation. N Engl J Med 1992;327:1220–5.[Abstract]
- Heck CF, Shumway SJ, Kaye MP. The registry of the International Society for Heart Transplantation: sixth official report, 1989. J Heart Lung Transplant 1989;8:271–6.
- Fisher ES, Welch G. The future of the Department of Veterans Affairs health care system. JAMA 1995;273:651–5.[Abstract/Free Full Text]
- The national organ transplant act. Publ L No. 98-507, 1985.
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Abstract
Introduction
