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Ann Thorac Surg 2000;69:1369-1374
© 2000 The Society of Thoracic Surgeons

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Original articles: Cardiovascular

Effects of left ventricular assist devices on outcomes in patients undergoing heart transplantation

^a Cardiovascular Division, Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA
^b Division of Cardiovascular and Thoracic Surgery, University of Minnesota, Minneapolis, Minnesota, USA

Address reprint requests to Dr Bank, St. Paul Heart Clinic, 255 N Smith Ave, Suite 100, St. Paul, MN 55102
e-mail: bankx001{at}tc.umn.edu

	Abstract

Top Abstract Introduction Material and methods Results Comment References

 
Background. Left ventricular assist devices (LVADs) are increasingly being used to "bridge" patients to heart transplantation.

Methods. Data from 40 consecutive status 1 heart transplantation patients treated with intravenous inotrope therapy (n = 20) or the HeartMate LVAD (n = 20) were retrospectively analyzed.

Results. Baseline clinical characteristics were similar in the two groups. At the time of transplantation, LVAD patients had significantly higher blood pressure and sodium with significantly lower blood urea nitrogen and creatinine. After transplantation, renal failure (52.6% versus 16.7%) and right heart failure (31.6% versus 5.6%) occurred more frequently (p < 0.05) in the inotrope group. Six-month survival after transplantation did not significantly differ in the inotrope or LVAD groups (73.7% versus 88.9%) but event-free survival was significantly (p < 0.05) lower in the inotrope group (15.8% versus 55.6%). Total hospital charges were significantly lower in the inotrope group ($213,860 ± $107,560 versus $342,620 ± $104,420), but average daily hospital charges were not different ($3,990 ± $1,300 versus $4,130 ± $2,050).

Conclusions. Status 1 heart transplant patients treated with an LVAD as opposed to inotrope therapy have improved clinical and metabolic function at the time of transplant and improved survival to 6 months after transplant without major complications. Total costs are higher in the LVAD patients but average daily costs are similar.

	Introduction

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Approximately 30% of the more than 4,000 patients on heart transplantation waiting lists are status 1 [1]. The median waiting time until transplantation for patients initially listed as status 1 has increased from 29 days in 1991 to 57 days in 1996 [1] and is likely to continue to increase. In addition, survival to 1 year after heart transplantation is reduced in patients transplanted as status 1 (83.8%) as compared to those transplanted as status 2 (87.6%) [1]. Strategies to improve outcome after transplantation and reduce costs in status 1 patients are clearly needed.

One very successful strategy for treating critically ill status 1 heart transplantation patients has been the placement of left ventricular assist devices (LVADs). Patients with severe organ hypoperfusion or refractory pulmonary congestion despite intravenous inotropic therapy or intraaortic balloon counterpulsation have been shown to dramatically improve while awaiting heart transplantation [2–4]. However, there have been no randomized studies comparing the outcomes and costs in status 1 patients who received LVADs as compared to those receiving inpatient inotrope therapy. It is possible that LVAD placement in status 1 patients (who might not qualify for placement based on strict eligibility criteria) would result in better long-term outcomes after heart transplantation, at equivalent or decreased cost. One way of obtaining information pertinent to this issue is to determine outcomes and costs after heart transplantation in status 1 patients treated with LVADs as compared to those treated with standard inotrope or intraaortic balloon pump therapy. Improved outcomes or reduced costs in the LVAD group (despite initially more severe heart failure) would argue in favor of LVAD placement as an alternative to standard therapy in status 1 heart transplantation patients. Therefore, the present study was performed to retrospectively compare outcomes and hospital charges in 40 consecutive status 1 heart transplantation patients treated with the HeartMate pneumatic LVAD or intravenous inotropic therapy.

	Material and methods

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Patient population
We reviewed the hospital records of 40 consecutive patients at our institution between January 1995 and September 1998 listed as status 1 for heart transplantation. All patients listed as status 1 for heart transplantation were initially treated with the intravenous inotropic agents dobutamine or milrinone in an intensive care unit (ICU) while standard heart failure therapy of angiotensin converting enzyme inhibitors, diuretics, and digoxin was continued. While on intravenous inotropic medications, 26 patients developed significant clinical deterioration as manifest by worsening and severe low output heart failure, refractory pulmonary edema, or oliguric renal failure. Twenty of these patients underwent placement of a HeartMate pneumatic LVAD (Thermo Cardiosystems, Inc, Woburn, MA) as a bridge to heart transplantation. Six of these patients did not undergo LVAD placement for the following reasons: severe right heart failure (n = 1), history of several previous sternotomies (n = 3), presence of prosthetic heart valves (n = 1), and congenital heart disease (n = 1).

The average time between listing as status 1 and placement of the LVAD was 7.4 ± 1.6 days. After placement of the LVAD, patients were placed on inactive status (status 7) for heart transplantation for approximately 4 to 6 weeks to allow for postoperative recovery and improvement in overall condition. LVAD patients were transferred to a general medicine ward where they continued their postoperative recovery and were encouraged to walk, use a stationary bicycle, and participate in daily cardiac rehabilitation treadmill exercises. LVAD patients were treated with aspirin or dipyridamole but not coumadin. Inotrope patients remained in an ICU until the time of heart transplantation. After heart transplantation, patients were treated with standard triple drug therapy of cyclosporine or tacrolimus, azathioprine or mycophenolate mofetil, and prednisone.

Device description
The HeartMate LVAD is a pneumatically actuated, abdominally positioned device that consists of a pulsatile pusher-plate blood pump within a rigid titanium housing.

All blood-contacting surfaces, except the 25-mm porcine valves within the inlet and outlet conduits, are textured with sintered-titanium microspheres or integrally textured polyurethane, and these surfaces promote the formation of a biological lining. The device has a maximum stroke volume of 85 mL and is capable of providing blood flows up to 11 L/min. The 73-pound portable console, which operates on either batteries or standard alternating current, delivers pulses of air through a 1.2-cm diameter urethane tube that drives the pump. The console continuously displays pump output, stroke volume, and pump rate. The techniques for device implantation have been described [5].

Complications and outcomes
The following problems were assessed while waiting as status 1 for heart transplantation: infection, stroke, mechanical device malfunction, and operation. The following were defined as major complications after heart transplantation: severe acute renal failure, severe right heart failure, operation (reoperation for any cause), clinical cardiac rejection, severe debility, infection, and stroke. Mechanical device malfunction was defined as problems with the console/diaphragm unit, pump sensor system, or interconnect cable/battery unit [2]. Severe acute renal failure was defined as renal failure requiring dialysis. Severe right heart failure was defined as moderate or severe right ventricular dysfunction on echocardiogram with clinical right heart failure requiring intravenous inotrope therapy after the first week after heart transplantation or requiring a right ventricular assist device. Clinical cardiac rejection was defined as biopsy grade III or greater rejection [6] associated with clinical heart failure or death. Severe debility was defined as need for inpatient cardiac rehabilitation. Infection was defined as clinical evidence of systemic infection (fever, elevated white blood cell count) associated with positive cultures of blood or other fluid (eg, pericardial, pleural, peritoneal fluid) and requiring intravenous antimicrobial treatment. Stroke was defined as a focal neurologic deficit persisting for more than 24 hours.

Medical records were reviewed for each patient to acquire clinical data and determine outcomes. Cost information on each patient was obtained from hospital billing records. Clinical outcomes assessed included mortality, major morbidity and combined mortality, and major morbidity within 6 months after heart transplantation.

Statistics
To compare the LVAD and inotrope patients, clinical and laboratory data were analyzed using unpaired t tests at the following time points: time of listing as status 1, time of heart transplantation, and 6 months after transplantation. To determine if LVAD or inotrope therapy resulted in improvement in heart failure, paired t tests were performed comparing data obtained at the time of listing as status 1 with data obtained at the time of heart transplantation. Data were expressed as mean ± standard error of the mean. Values of p less than 0.05 were considered statistically significant.

	Results

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Table 1 shows the characteristics of the patients at the time of listing as status 1 for heart transplantation. Baseline demographic data were similar in the two groups. At the time of listing as status 1 for heart transplantation, the patients who subsequently received a LVAD had significantly greater heart rate, bilirubin, and aspartate aminotransferase, and significantly lower hemoglobin. A significantly (p < 0.05) greater number of patients in the LVAD group (9 of 20 versus 4 of 20) required intraaortic balloon counterpulsation before transplantation. One patient in the LVAD group required extracorporeal membrane oxygenation.

Table 2 shows data obtained in the two patient groups at the time of heart transplantation. Inotrope therapy resulted in significant improvements in systolic blood pressure, blood urea nitrogen, aspartate aminotransferase, and bilirubin levels. Hemoglobin significantly decreased with inotrope therapy possibly related to frequent phlebotomy. The LVAD therapy resulted in significant improvements in heart rate, systolic blood pressure, diastolic blood pressure, sodium, creatinine, aspartate aminotransferase, and bilirubin levels. At the time of transplantation, the LVAD patients had significantly higher systolic blood pressure, diastolic blood pressure, and serum sodium with significantly lower blood urea nitrogen and creatinine as compared to the inotrope patients.

View larger version (19K): [in this window] [in a new window]   Fig 1. Complications after heart transplantation in patients previously receiving inotrope or left ventricular assist device (LVAD) therapy. The incidence of acute renal failure and right heart failure (HF) was significantly greater in the inotrope group. (ARF = acute renal failure.) *p < 0.05.

	Comment

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In the present study 20 status 1 heart failure patients received a LVAD as a result of severe, refractory heart failure despite standard therapy. Only 2 of 20 patients (10%) died before heart transplantation. This compares favorably with a 62.5% (853 of 1,365 patients) survival to transplantation (or explant) with the HeartMate pneumatic and electrical LVADs (HeartMate Worldwide Registry). Mortality in the LVAD group while waiting for transplantation was also similar to that in the inotrope group (1 of 20 patients, 5%).

In the present study, the most frequent complication before heart transplantation in the patients receiving a LVAD was major infection. Infections occurred in 45% of our patients, with the majority of the infections drive line related. This infection rate is similar to rates of 40% to 60% reported in other single-institution studies of LVAD patients [2, 3, 7, 8]. Only 2 patients had major clinical events related to infection: 1 patient died of sepsis and 1 patient required LVAD removal for extensive pocket infection. In addition, the infection rate was not significantly greater than that in the inotrope group (40%), where the most common infections were related to central intravenous catheters.

The patients in this study were not randomized to inotrope versus LVAD therapy. A LVAD was placed only in patients who were believed by the transplant cardiologist and surgeon to have severe heart failure signs and symptoms refractory to all other therapies. Therefore, the patients receiving an LVAD subjectively had more severe heart failure than those treated with inotropic agents. Our data also provide objective evidence that the LVAD group had more severe heart failure. Patients in the LVAD group had a greater likelihood of having had an intraaortic balloon pump and had evidence of more severe liver disease (congestion or hypoperfusion) as shown by liver function tests.

Inpatient treatment of heart failure patients with either inotropic agents or LVAD resulted in objective improvement in systolic blood pressure and measures of hepatic and renal function. Improvements in hepatic and renal function with LVADs have been previously described [4]. Inotrope therapy in patients with severe heart failure waiting for heart transplantation has been shown to preserve hepatic and renal function [9]. A number of variables that were similar in the two groups at the time of admission to the hospital as status 1 were different at the time of transplantation. Systolic blood pressure, diastolic blood pressure, and serum sodium level were significantly higher, whereas blood urea nitrogen and creatinine levels were significantly lower in the LVAD group. In addition, all LVAD patients were ambulating for at least 30 minutes on a treadmill before they underwent transplantation, whereas the inotrope patients were bed-ridden or only able to walk for very short distances. Complications that occurred more frequently in the inotrope patients after heart transplantation included renal failure and right heart failure. Overall mortality at 6 months after transplantation was not significantly different in the two groups of patients in this study.

These data support the hypothesis that patients with heart failure severe enough to require continuous inpatient intravenous inotrope therapy before heart transplantation may benefit from the placement of an LVAD by having improved survival free of major complications after heart transplantation. Although the explanation for these differences in major morbidity are not known for certain, it is reasonable to speculate that improved organ perfusion, decreased organ congestion, and markedly improved overall conditioning and functional status [10, 11] of the LVAD patients contributed to their better outcomes. Consistent with this hypothesis, a retrospective study showed improved early and late survival in patients supported with a HeartMate LVAD for more than 30 days as compared with those supported for less than 30 days [12]. Although we did not quantify exercise capacity in our LVAD patients, a recent study showed that patients on LVADs demonstrate exercise capacity significantly better than that of heart transplant candidates and similar to that of patients with mild heart failure [13].

Average hospital charges in the LVAD group from the time of listing as status 1 until discharge from the hospital after transplantation were nearly $343,000. These data are consistent with data from Pennsylvania State University (average charges, $302,000) [14] and Cleveland Clinic (average charges, $244,000 up to the time of transplant only) [3]. Overall inpatient charges were significantly greater in the LVAD group. An increase in total charges or costs in patients receiving LVADs has been a consistent finding in previous studies [4, 14–16]. Factors that increased the overall inpatient cost in the LVAD group included the LVAD cost itself (approximately $50,000), the implantation cost (approximately $23,000), and the longer hospital stay before heart transplantation (77 ± 42 days versus 42 ± 30 days). The longer hospital stay before heart transplantation in the LVAD group was because LVAD patients were put on inactive status (status 7) after LVAD implantation until they had recovered from operation and had undergone extensive cardiac rehabilitation. Factors that decreased the overall inpatient cost in the LVAD group included the shorter ICU stay before heart transplantation (15 ± 11 days versus 42 ± 30 days) and the decreased incidence of complications after heart transplantation. Single institution studies of both the Novacor LVAD (Baxter Healthcare Corp, Oakland, CA) and the TCI HeartMate (Thermo Cardiosystems, Woburn, MA) have generally shown similar results, in particular with respect to reduced hospital costs related to transfer out of an ICU while awaiting transplantation [16]. An additional factor that affects the cost analysis in our study, but is very difficult to quantify or adjust for, is the different number of deaths in the two groups. Because more patients died in the inotrope group, the overall inpatient costs in this group are likely to be underestimated.

Despite greater total charges in the LVAD patients, the average daily charges in the LVAD group were not significantly greater than the average charges in the inotrope group. This finding is in concert with data from Mehta and colleagues [14] and emphasizes the critical role of the prolonged inpatient stay of status 1 patients before transplantation, necessitated by the shortage of donor hearts. The pneumatic LVAD used in these patients was only approved for inpatient therapy and thus LVAD patients had to remain in the hospital until heart transplantation, despite New York Heart Association functional class 1 or 2 symptoms. Outpatient LVAD support as a bridge to transplantation has been successful [17, 18] and is likely to increase as newer devices are developed and approved for this use. Once patients can be treated with these devices it is likely that the total costs will be considerably less, despite increased costs of the newer LVADs. For example, if the LVAD patients could be discharged after 5 weeks as an inpatient, the average length of stay before transplant would be reduced from 77 days to 42 days resulting in inpatient cost savings of $173,460 ($4130/day times 42 days).

The recent change in UNOS regulations creating a status 1A and a status 1B has major implications on the findings of this study. The costs associated with inotrope therapy for status 1 heart transplantation patients are likely to decrease significantly as patients on inotrope therapy can now be listed as status 1B without remaining continuously in an ICU. Future cost analysis studies will be needed to determine the magnitude of this change under the new guidelines.

In summary, we demonstrate that status 1 heart transplantation patients treated with the HeartMate LVAD have improved survival without major morbidity after heart transplantation as compared with patients treated with inpatient intravenous inotrope therapy. Total inpatient costs are higher in the LVAD patients, predominantly due to the longer length of hospital stay before heart transplantation. Although this study was retrospective and was performed in a relatively small group of patients at a single institution, these data raise the possibility that patients with heart failure severe enough to require continuous inpatient inotropic therapy while awaiting heart transplantation may benefit substantially from LVAD placement. With the advent of newer LVADs that can be used on an outpatient basis, this approach may reduce total costs in addition to improving clinical outcomes after heart transplantation.

	References

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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Sara J. Shumway Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Bank, A. J. Articles by Park, S. J. Search for Related Content PubMed PubMed Citation Articles by Bank, A. J. Articles by Park, S. J.