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行政院國家科學委員會專題研究計畫 成果報告

心臟移植後冠狀動脈疾病之疾病標的因子研究

計畫類別: 個別型計畫 計畫編號: NSC93-2314-B-002-268- 執行期間: 93 年 08 月 01 日至 94 年 07 月 31 日 執行單位: 國立臺灣大學醫學院外科 計畫主持人: 許榮彬 共同主持人: 蔡有光 報告類型: 精簡報告 處理方式: 本計畫可公開查詢

中 華 民 國 94 年 10 月 30 日

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Heart Transplantation in Patients with End-Stage Heart failure and Cardiac Ascites

Ron-Bin Hsu, MD

Department of Surgery, National Taiwan University Hospital, National Taiwan University

College of Medicine, Taipei, Taiwan, ROC

Short title: HTX and ascites

Category: original article

Word count:

Key words: heart transplantation, ascites

Address for reprints:: Dr. Ron-Bin Hsu, National Taiwan University Hospital, No.7,

Chung-Shan S. Rd. Taipei, Taiwan 100, R.O.C. Tel: 886-2-2312-3456 ext 5580.Fax:

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ABSTRACT

Objective: Donor shortage and improved medical treatment of heart failure increase the

prevalence of patients with end-stage heart failure and cardiac ascites to heart transplantation.

The clinical outcome of heart transplantation in these patients has not been reported. Here, we

sought to evaluate the clinical outcome of heart transplantation in patients with end-stage

heart failure and ascites.

Methods: Data were collected by retrospective chart review.

Results: Between 1989 and 2005, 45 patients with end-stage heart failure and moderate to

severe ascites underwent orthotopic heart transplantation. There were 33 men and 12 women

with median age of 44 years (range 10-63 years). The causes of heart failure were congenital

heart disease in 4 patients (9%), dilated cardiomyopathy in 21 patients (47%), rheumatic

heart disease in 7 patients (16%), coronary artery disease in 10 patients (22%), and restrictive

cardiomyopathy and transplant coronary artery disease each in 1 patient. Twenty of 45

patients (44%) had previous cardiac operation. There were 10 in-hospital deaths (22%):

bleeding in 4 patients, sepsis with multiple organ failure in 5 patients and non-diagnostic

graft failure in 1 patient. Profuse postoperative bleeding requiring reoperation occurred in 14

patients (31%). The independent risk factors for hospital death were low serum albumin

(odds ratio, 0.05; 95% confidence interval, 0.003-0.591; p=0.018) and reoperation for

(4)

Conclusions: Heart transplantation in patients with end-stage heart failure and ascites was

associated with high hospital mortality and morbidity. The co-existence of cardiac ascites and

hypoalbuminemia implied poor prognosis.

(5)

Ultramini-abstract

Between 1989 and 2005, 45 patients with end-stage heart failure and ascites underwent

orthotopic heart transplantation. Heart transplantation in patients with end-stage heart failure

and ascites was associated with high hospital mortality and morbidity. The co-existence of

(6)

Introduction

The continuous improvement in clinical outcome after heart transplantation has established

heart transplantation as a standard and efficient therapy for end-stage heart failure [1].

Long-term survival is limited by transplant coronary artery disease and the complications

produced by the toxicities of maintenance immunosuppression [1-3]. In recent decades,

survival after heart transplantation is gradually improving, and there is increasing patient risk

profiles before transplantation [4]. The increasing patient risk profiles include previous

cardiac operations, use of mechanical assist devices, diabetes mellitus, critically ill recipients,

high pulmonary vascular resistance, prior sensitization, long allograft ischemic time, and use

of nonstandard or marginal donors [4]. Both donor shortage and improved medical treatment

of end-stage heart failure will increase the prevalence of patients with severe or late-stage

heart failure to heart transplantation. Right ventricular failure and cardiac ascites occur as late

complications of end-stage heart failure, and its development usually reduces patient survival

[5-7]. Cardiac ascites and cirrhosis might develop in patients with a long history of

congestive heart failure and systemic venous hypertension [8,9]. The clinical outcome of

heart transplantation in these patients has not been reported in series [10]. Here, we sought to

evaluate the clinical outcome of heart transplantation in patients with end-stage heart failure

and cardiac ascites.

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Patients. A total of 241 consecutive patients underwent heart transplantation from June 1989

through July 2005 at National Taiwan University Hospital. Patients with moderate to massive

ascites before transplantation were included in this study.

Definitions. The diagnosis of cardiac ascites was based on clinical history, physical

examination and findings of abdominal sonography. Patients with liver cirrhosis secondary to

hepatitis virus infection or alcoholism were excluded from transplant candidates. The

diagnosis of liver cirrhosis was based on ultrasonic findings [11-13]. The cause of ascites was

considered as cardiac if patients had severe congestive heart failure and no evidence of

alcoholic or post-hepatitis liver cirrhosis. None of our patients received liver biopsy to

confirm the diagnosis of liver cirrhosis.

Data on age, sex, diagnosis of heart disease, renal and liver function tests, hemodynamics,

allograft ischemic time, and clinical outcome were recorded. Data of right atrial pressure,

transpulmonary gradient and pulmonary vascular resistance were derived from cardiac

catheterization. The severity of liver function impairment was graded according to the

Child-Pugh score [14].

Heart transplantation. All of the procedures of heart transplantation were performed

through a median sternotomy. The techniques of cardiopulmonary bypass were described

previously [15]. The operative techniques of heart transplantation in patients with prior

(8)

procedure. In patients with previous cardiac operation, we spent a liberal time for tissue

dissection and relief of dense adhesion. Preliminary exposure of femoral vessels was

performed in cases with a high risk of severe hemodynamic compromise during

re-sternotomy. Femorofemoral cardiopulmonary bypass can be instituted very rapidly if

needed.

Immunosuppression

All patients received triple-drug immunosuppressive therapy according to our heart

transplantation protocol previously described [16,17]. Since 1995, we started to use rabbit

antithymocyte globulins for induction therapy. Azathioprine (4mg/kg) was given one hour

before the operation. Solumedrol (1000mg) was infused while release of the aortic

cross-clamp. Rabbit antithymocyte globulin (1.5-2.5 mg/kg/day) was given after

transplantation for five days. Cyclosporine was started orally within five days after

transplantation or after the recovery of renal function. Cyclosporine dose was adjusted

according to renal function and serum cyclosporine level, which was maintained at the trough

level of 300-500 ng/ml during the first three months after transplantation and 200-300ng/ml

one year after transplantation. Azathioprine was given at 1-2 mg/kg/day after transplantation,

with the dose adjusted to maintain a white blood cell count 4000-6000/mm3. Prednisone

(0.5mg/kg/day) was started on the second postoperative day and tapered to 0.2 mg/kg/day by

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(Cellcept) were used for recurrent rejection or severe adverse reactions to cyclosporine and

azathioprine. Since 2004, we started to use mycophenolate mofetil for primary

immunosuppression instead of azathioprine. To prevent nephrotoxicity, cyclosporine dose

was decreased to maintain serum trough level of 250-350 ng/ml during the first three months

after transplantation and 150-250 ng/ml one year after transplantation.

All patients were followed monthly at special cardiac transplantation clinic. Standard chest

roentgenogram, blood tests, electrocardiogram and physical examinations were routinely

performed at regular intervals.

Statistical analysis. The results are expressed as median with a range or as frequencies for

the categorical variables. Data analysis was performed using the Chi-squaretest,Fisher’s

exact test and Mann-Whitney test. Univariate and multivariate stepwise logistic regression

was used to identify independent risk factors for hospital death. The patient and graft survival

curve was plotted by the Kaplan-Meier method. Survival was compared by log-rank test

between patients with and without ascites. P ≤ 0.05 wasconsidered statistically significant.

Results

Patient characteristics. From 1989 through 2005, 241 patients with end-stage heart failure

underwent heart transplantation. There were 198 men and 43 women, and the median age was

49 years (range 0-71 years). The causes of heart failure were congenital heart disease in 8

(10)

patients (29%), and others. Eight patients received a re-transplantation and 4 patients received

combined heart-kidney transplantation. None of the patients had signs of chronic hepatitis

virus B or C infection. Chronic alcohol abuse was denied by all patients.

Forty-five patients with end-stage heart failure had moderate to massive ascites before

transplantation. The rate of transplant patients with ascites increased slightly from 14%

(14/102) during the 1989 to 1998 to 22% (31/139) during the 1999 to 2005. There were 33

men and 12 women, and the median age was 44 years (range 10-63 years). The causes of

heart failure were congenital heart disease in 4 patients (9%), dilated cardiomyopathy in 21

patients (47%), rheumatic heart disease in 7 patients (16%), coronary artery disease in 10

patients (22%), and restrictive cardiomyopathy and transplant coronary artery disease each in

1 patient. Patient demographics and laboratory data before transplantation were listed in

Table 1. Twenty of 45 patients (44%) had previous cardiac operation including 2 multiple

valve replacements, 1 coronary artery bypass surgery, 1 total cavopulmonary connection, 1

Fontan operation, 1 Rastelli operation, 1 heart transplantation, and 1 Senning operation. The

median level of serum total bilirubin was 1.9 mg/dl (range, 0.5 to 9.6); serum albumin, 3.4

g/dl (range, 1.4 to 4.8); serum blood urea nitrogen, 26 mg/dl (range, 9.6 to 109); serum

creatinine, 1.3 mg/dl (range, 0.49 to 11); serum asparate aminotransferase, 34 U/L (range, 12

to 223), and serum alanine aminotransferase, 21 U/L (range, 7 to 196). Twenty patients (44%)

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abdominal sonography were moderate ascites in 23 patients and massive ascites in 22 patients.

Two patients had cardiac cirrhosis before transplantation. The median level of Child score

was 9 (range, 6 to 12).

Before transplantation, 13 patients were in UNOS status IA, 14 patient in UNOS status IB,

and 18 patients in UNOS status II. Before transplantation, 9 patients had endotracheal

intubation and mechanical ventilation, 4 patients had intra-aortic balloon pump, 5 patients

had mechanical support with extracorporeal membrane oxygenation, 1 patient had ventricular

assist device, and 4 patients required dialysis treatment because of anuria.

Among donors, there were 33 men and 12 women, and the median age was 27 years (range, 7

to 66). ABO blood types between donors and recipients were identical in 35 cases and

compatible in 10 cases. The body weight ratio between donors and recipients ranged from

0.72 to 1.74. The median duration of allograft ischemic time was 160 minutes (range, 40 to

320). All patients underwent orthotopic heart transplantation. One patient who had transplant

coronary artery disease and severe renal impairment underwent combined heart and kidney

transplantations.

Clinical outcomes. For all patients, there were 30 hospital deaths (12%). For 45 transplant

patients with cardiac ascites, there were 10 hospital deaths (22%) occurring between 1 and

152 days after transplantation (Table 1). Patients with cardiac ascites had a higher hospital

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causes of hospital death in patients with cardiac ascites were bleeding in 4 patients, sepsis

with multiple organ failure in 5 patients and non-diagnostic graft failure in 1 patient. Profuse

postoperative bleeding requiring reoperation occurred in 14 (31%) of 45 patients with cardiac

ascites. Autopsy was performed in 4 of 10 patients with hospital death. Pathological

examination of the livers in these patients showed pictures of cardiac cirrhosis with

centrilobular necrosis and varying degree of fibrosis.

Follow-up was complete in all patients. The mean duration of follow-up was 50.6 ± 43.8

months. For all patients, the 6-month, 1-year, 3-year, 5-year, and 10-year patient and graft

survival rates were 86.2 ± 2.2%, 81.8 ± 2.5%, 71.0 ± 3.1%, 62.8 ± 3.5%, and 44.1 ± 5.3%.

For 45 patients with cardiac ascites, the 6-month, 1-year, 3-year, 5-year, and 10-year patient

and graft survival rates were 75.4 ± 6.4%, 70.1 ± 7.0%, 70.1 ± 7.0%, 61.6 ± 8.4%, and 51.2 ±

9.7% (Figure 1). For 196 patients without ascites, the 6-month, 1-year, 3-year, 5-year, and

10-year patient and graft survival rates were 88.7 ± 2.3%, 84.4 ± 2.6%, 71.4 ± 3.5%, 63.2 ±

3.9%, and 42.7 ± 6.1% (Figure 1). As shown in Figure 1, patients with cardiac ascites had

lower 6-month and 1-year patient and graft survival rates than patients without ascites. The

survival curves showed no difference since 3 years after transplantation.

Among patients with cardiac ascites, there were 7 late deaths. The causes of late death were

sudden death in 3 patients, sepsis with multiple organ failure in 2 patients, non-diagnostic

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Risks of hospital death. As shown in Table 1, patients with hospital death had more

congenital heart disease, low recipient and donor body weight, low serum albumin, massive

ascites, low Child score, and high incidence of postoperative reoperation for bleeding. In

multivariate logistic regression analysis, the independent risk factors for hospital death were

low serum albumin (odds ratio, 0.05; 95% confidence interval, 0.003-0.591; p=0.018) and

reoperation for bleeding (odds ratio, 30.11; 95% confidence interval, 2.38-380.26; p=0.009).

Discussion

Heart transplantation. The clinical outcome of heart transplantation is improving. The

30-day survival rate improved from 84% during the early 1980 to 91% during the late 1990

[1]. The overall 1-year, 5-year and 10-year survival rates for heart transplantation were 80%,

70% and 50% [1]. However, the long-term survival remains unchanged in spite of the

ongoing stepwise improvement in early transplant survival. The survival rate for the entire

patient cohort of the worldwide registry showed that, after the steep fall in survival during the

first 6 months, the survival decreases at a linear rate of 3.4% per year [18]. We had a similar

result with the hospital survival rate of 88% and the 1-year patient and graft survival rate of

81.8%.

In view of increasing donor shortage, it is imperative to allocate organs to patients with the

greatest need and the greatest chance to derive the maximum benefit [19]. But, the quest for

(14)

over-selective in transplant candidates [20]. The risk factors for early mortality included old

donor age, old recipient age, having congenital heart disease or coronary artery disease as the

indication for heart transplantation, requiring mechanical circulatory support (temporary or

pulsatile ventricular assist device), mechanical ventilation, or dialysis at the time of transplant,

hospitalized at transplant, prolonged allograft ischemic time, and renal or hepatic dysfunction

at the time of transplant [18]. However, the impact of cardiac ascites on the survival of heart

transplantation has not been evaluated. In this study, we first demonstrated that the presence

of moderate to massive cardiac ascites at the time of transplant was a significant risk factor

for hospital death and early mortality after heart transplantation. The significant reduction of

patient and graft survival was sustained till 3 years after transplantation.

Ascites. Cardiac ascites and cirrhosis usually develop in patients with a long history of

congestive heart failure [5-9]. The occurrence of signs and symptoms of right ventricular

failure with ascites and high right atrial pressure is a well-known poor prognostic sign in

patients with end-stage heart failure. In a previous study, patients with a right atrial pressure

> 12 mmHg had a 47% 1-year survival rate as compared with the 68% survival rate for those

with a right atrial pressure < 12 mmHg [21]. Elevated right atrial pressure resulting from

right ventricular failure was also associated with a significantly increased risk of early death

after heart transplantation [22]. In addition, liver insufficiency with prolonged prothrombin

(15)

predictor of early death after heart transplantation [23]. Prolonged right ventricular failure

and systemic venous hypertension will lead to cardiac cirrhosis. Severe bleeding and

infection were usually the terminal events. Cardiac cirrhosis was found at autopsy in 75% of

the early deaths of heart-lung transplant recipients with right ventricular failure and

hyperbilirubinemia [24]. In our study, 31% of patients with cardiac ascites required

reoperation for profuse postoperative bleeding. Bleeding and sepsis accounted for 9 of 10

hospital death in patients with cardiac ascites. Although preoperative abdominal sonography

in 43 of 45 patients with cardiac ascites showed no liver cirrhosis, congestive liver fibrosis

(cardiac cirrhosis) was confirmed in 4 patients on postmortem pathological examination.

Cardiac cirrhosis is a clinically silent disorder characterized by a spectrum of morphologic

alterations in the liver ranging from mild deposition of sinusoidal collagen to emergence of

broad fibrous septa [25,26]. Occurrence of cardiac ascites is the hallmark of cardiac cirrhosis

[9]. Laboratory tests have a little role in the diagnosis of cardiac cirrhosis. In the majority of

patients with cardiac cirrhosis, serum levels of liver enzymes, bilirubin, and albumin are

within the normal range [9]. Ascites is also a manifestation of congestive heart failure and

reflects longstanding systemic venous hypertension. The clinical pictures of cardiac cirrhosis

usually are masked by symptoms and signs of right ventricular failure. A liver needle biopsy

may be required to evaluate the presence and severity of cardiac cirrhosis in patients with

(16)

Hypoalbuminemia. Child-Pugh score is significantly associated with hepatic

decompensation and mortality after cardiac surgery in patients with cirrhosis. Patients with a

Child-Pugh score ≧ 8 have a high mortality rate of 67% [27]. In this study, Child-Pugh

score was associated with a high hospital mortality rate (Figure 1).

Preoperative serum albumin was used to quantify nutritional status and underlying disease.

An albumin level of less than 2.5 g/dL was independently associated with increased risk of

reoperation for bleeding, postoperative renal failure, and prolonged ventilatory support,

intensive care unit stay, and total length of stay after cardiac surgery [28]. Hypoalbuminemia

was a powerful risk factor for perioperative complications in elderly patients and children

undergoing cardiac surgery [29,30]. Dichtl et al [31] reported no perioperative mortality after

heart transplantation in patients with cardiac hepatopathy and normal plasma protein levels.

In our study, hypoalbuminemia was the most powerful risk factor for hospital death after

heart transplantation. Nine of 25 patients (36%) with cardiac ascites and serum albumin < 3.5

g/dl had hospital death, and only 1 of 20 patients (5%) with ascites and serum albumin > 3.5

g/dl had hospital death. The co-existence of cardiac ascites and hypoalbuminemia was

associated with poor hospital outcome.

Study limitation. This study was limited by small case number and retrospective study. In

addition, the duration of right ventricular failure was unknown and the diagnosis of cardiac

(17)

complications in patients with advanced liver dysfunction [32]. Although our results were

preliminary, this was the first study of heart transplantation in patients with end-stage heart

failure and cardiac ascites. Patients should be carefully selected for heart transplantation,

especially in patients with cardiac ascites and serum albumin < 3.5 g/dl. Because the hospital

mortality rate was not low in patients with cardiac ascites and normal serum albumin, we

recommended that an invasive liver biopsy may be indicated only in patients with cardiac

ascites and hypoalbuminemia before transplantation.

Conclusions. Heart transplantation in patients with end-stage heart failure and ascites was

associated with high hospital mortality and morbidity. The co-existence of cardiac ascites and

(18)

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cirrhosis. Ann Thorac Surg 2005;79:1551-4.

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clinical outcome in pediatric cardiac surgery. Nutrition 2005;21:553-8.

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Spengler U. Bleeding complications after percutaneous liver biopsy. An analysis of risk

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Table 1. Patient characteristics in 45 patients with cardiac ascites: comparison between patients with and without hospital death by Fisher exact test and Mann-Whitney U test.

Variables Died (n=10) Alive (n=35) P-value

Male 5 (50%) 28 (80%) 0.101

Median age in years (range) 40 (17-60) 45 (10-63) 0.4443

Diagnosis of heart disease

Dilated cardiomyopathy 2 (20%) 19 (54%) 0.078

Coronary artery disease 2 (20%) 8 (23%) 0.999

Rheumatic heart disease 3 (30%) 4 (11%) 0.172

Congenital heart disease 3 (30%) 1 (3%) 0.03

Others 0 3

Body weight in kilograms 48.95 (32-65) 59.8 (23-100) 0.026

Blood type-identical 8 (80%) 27 (77%) 0.999

Previous cardiac operation 7 (70%) 13 (37%) 0.083

Diabetes mellitus 3 (30%) 6 (17%) 0.393

Donor-age in years 25.5 (12-66) 27 (7-58) 0.6324

Donor-male 7 (70%) 26 (74%) 0.999

Donor-body weight in kilograms 55 (45-70) 65 (20-85) 0.0105 Recipient/donor body weight ratio 1.1 (0.78-1.5) 1.08 (0.72-1.74) 0.5755

Serum albumin (g/dl) 2.8 (1.4-3.73) 3.7 (2.2-4.8) 0.0005

Serum total bilirubin (mg/dl) 1.1 (0.5-6.27) 2.1 (0.5-9.6) 0.6522 Serum asparate aminotransferase (U/L) 37.5 (16-96) 34 (12-223) 0.7431 Serum alanine aminotransferase (U/L) 21.5 (9-72) 21 (7-196) 0.6036 Serum blood urea nitrogen (mg/dl) 29 (13.7-85) 24.3 (9.6-109) 0.6039 Serum creatinine (mg/dl) 1.25 (0.6-3.19) 1.3 (0.49-11) 0.8695 Prothrombin time prolongation > 4 seconds 3 (30%) 17 (49%) 0.473

Ascites-massive 8 (80%) 14 (40%) 0.035

Child-Pugh score 9.5 (7-12) 8 (6-12) 0.0286

UNOS status IA or IB 7 (70%) 20 (57%) 0.606

Right atrial pressure 19 (8-26) 20 (6-36) 0.902

Transpulmonary gradient 9 (4-20) 8 (0-28) 0.6614

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Figure legends

Figure 1. Patient and graft survival curves plotted by Kaplan-Meier method in patients with

數據

Table 1. Patient characteristics in 45 patients with cardiac ascites: comparison between patients with and without hospital death by Fisher exact test and Mann-Whitney U test.

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