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Ann Thorac Surg 1996;62:70-76
© 1996 The Society of Thoracic Surgeons
Sections of Cardiothoracic Surgery and Pediatric Cardiology, James W. Riley Hospital for Children and Indiana University Medical Center, Indianapolis, Indiana
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Abstract |
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 TopFootnotes Abstract IntroductionPatients and MethodsResultsCommentAppendix 1. Possible Risk...References |
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Methods. To assess the operative management and intermediate-term outcome, we retrospectively analyzed our surgical experience with 50 newborns with hypoplastic left heart syndrome operated on between January 1989 and June 1995.
Results. Surgical palliation with a first-stage Norwood operation was offered to 28 patients. The remaining 22 infants were initially listed for heart transplantation, and 15 underwent the operation. Ten of the 15 recipients are alive, and all are in New York Heart Association class I. Seven infants underwent a Norwood procedure after being on the list for transplantation for 12 to 42 days. A total of 34 patients underwent Norwood procedures with one operation aborted because of inoperable anatomy. Two infants who survived the first-stage Norwood operation underwent subsequent heart transplantation and are currently doing well. The 1-year mortality rate for heart transplantation was 18% (3/17) versus 50% (17/34) for the Norwood procedure. Risk factors for early mortality after a Norwood procedure include longer circulatory arrest time (>50 minutes), preoperative acidosis (pH < 7.20), larger systemic–pulmonary artery shunt (
4 mm), diminutive ascending aorta (
2.0 mm), and anatomic subtype of aortic and mitral atresia. The 1-year survival rate for the Norwood procedure improved from 36% for the patients operated on during 1989 through 1992 to 75% during 1993 to mid-1995 (p = 0.005). Of the 17 survivors of a first-stage Norwood operation, 10 have undergone the second stage (bidirectional Glenn procedure), and 7 have completed a Fontan procedure. Heart transplantation results have also improved, with no deaths since 1992.
Conclusions. Both the Norwood procedure and heart transplantation have encouraging early to intermediate results in infants with hypoplastic left heart syndrome. Hypoplastic left heart syndrome should be managed selectively on the basis of cardiac morphology, donor availability, and family wishes. Development of a flexible program involving the use of both procedures may aid in the successful management of infants with hypoplastic left heart syndrome.
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Introduction |
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TopFootnotesAbstractIntroductionPatients and MethodsResultsCommentAppendix 1. Possible Risk...References |
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The treatment of infants with hypoplastic left heart syndrome (HLHS) has been challenging. The first successful palliation procedure was reported by Norwood and associates [1, 2]. However, few centers could reproduce their results, and the uncertainty concerning the optimal management of these infants has continued [3, 4]. Because of disappointing early results with palliative procedures, heart transplantation was introduced to provide a structurally and physiologically normal heart for these children [5]. The early and intermediate success of heart transplantation reported by the Loma Linda group [6] and others [7, 8] made a persuasive argument in favor of heart transplantation as the optimal treatment of HLHS in the late 1980s. Recently, however, additional experience with the Norwood operation has led to improved surgical results with an increasing number of children surviving to completion of the Fontan procedure [9–12].
Although many centers have decided to perform either palliative operations or transplantation, we have had a flexible program of doing both procedures since 1989. Our decision to offer both procedures was based on the fact that the results of these surgical options continue to evolve and that neither has emerged as clearly superior. This policy was further stimulated by the shortage of available donors for infant heart transplantation.
The current study was performed to assess the operative and intermediate-term results of our surgical management of HLHS. Risk factors for early mortality in each procedure were also analyzed to identify the subgroup of patients who might be better treated by the alternative measure or who might not be a candidate for either procedure.
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Patients and Methods |
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TopFootnotesAbstractIntroductionPatients and MethodsResultsCommentAppendix 1. Possible Risk...References |
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).
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. The families of these infants were informed of the risks, benefits, expected results, and socioeconomic impact of either palliation or transplantation.
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). The families who selected cardiac transplantation were informed of the possibility of crossover if their child's condition began to deteriorate during the wait for a donor. Crossover was considered when symptoms of congestive heart failure appeared and were associated with pulmonary overcirculation, or systemic hypoperfusion, or both. Since 1993, crossover has been strongly recommended if a suitable donor heart is not available by the 30th day of life.
Palliative Procedure
STAGE-ONE NORWOOD OPERATION.
Our operative management has evolved during the 6
years of the study. Currently, infants are cannulated with a single venous cannula, and a systemic perfusion cannula is inserted in the proximal pulmonary artery. Cardiopulmonary bypass (CPB) is instituted, and core cooling is initiated. The left side of the heart is vented with a catheter inserted through the left atrial appendage. When the systemic temperature falls to 25°C, cardiopulmonary bypass is reduced. The venous cannula is removed, and a pump sucker is used for venous return. With a reduced bypass flow rate of 0.5 to 1.0 L•min-1•m-2, an atrial septectomy is performed and the atriotomy, closed. The venous cannula is reinserted, and cooling is continued. When the systemic temperature reaches 20°C, a vascular clamp is applied to the innominate artery, and the proximal anastomosis of a 3.5- or 4-mm polytetrafluoroethylene shunt is performed. When the core temperature reaches 15°C, flow is maintained for another 15 minutes. The atrial septectomy, proximal shunt anastomosis, and trimming of the pulmonary homograft patches are done before total circulatory arrest to shorten the total circulatory arrest time. The head vessels are snared, CPB is terminated, and the inflow cannula is removed.
The main pulmonary artery is divided, and the bifurcation of the pulmonary artery is closed with a homograft patch. The ductus is divided, and all ductal tissue is excised from the aorta. The aortotomy is extended 1 cm distal to the ductal insertion site and then proximally along the lesser curve to the level of the transected main pulmonary artery. Crystalloid cardioplegic solution is given directly into the ascending aorta. The diminutive aorta and the main pulmonary artery are then brought together with a few interrupted 7-0 monofilament absorbable sutures. A previously fashioned pulmonary homograft is used to reconstruct the aorta. The neonate is recannulated, and CPB and rewarming are initiated. During rewarming, the distal anastomosis of the polytetrafluoroethylene shunt is placed centrally on the distal pulmonary artery adjacent to the pulmonary artery end of the divided ductus arteriosus.
POSTOPERATIVE MANAGEMENT OF STAGE-ONE NORWOOD PROCEDURE.
At the completion of the operation, the sternum is left open. A silicone rubber barrier is sewn to the skin edges and sealed with antibiotic ointment, and dressings are applied. The sternum is closed when tissue edema subsides, usually on postoperative day 3 to 6.
Inotropic support is started after the termination of CPB if necessary. The most common inotropic drips used are dopamine hydrochloride, 3 to 7 µg•kg-1•min-1, and dobutamine hydrochloride, 3 to 7 µg•kg-1•min-1; occasionally epinephrine, 25 to 50 ng•kg-1•min-1, is also used. Pulmonary vasoreactivity is managed in an anticipatory fashion with infusion of nitroglycerin, 0.5 to 2 µg•kg-1•min-1, sodium nitroprusside, 0.25 to 1 µg•kg-1•min-1, or both. Inotropic support with dopamine, dobutamine, or both is variably continued until the infant is extubated.
THE SECOND AND THIRD STAGES OF PALLIATION.
The second-stage palliative operation was performed 6 to 17 months (median time, 9.5 months) after the first-stage operation. The timing of the second-stage operation is determined by polycythemia and decreasing arterial oxygen saturations. The second-stage hemi-Fontan procedure is performed as a bidirectional Glenn procedure (superior vena cava–pulmonary artery anastomosis) with ligation or division of the azygos vein and patch closure of the atrial–pulmonary artery anastomosis immediately above the atrial septal defect [13, 14]. Atrioventricular valve repair and pulmonary artery augmentation, if necessary, are performed at this time. The third-stage (fenestrated) Fontan procedure is performed 13 to 30 months (median time, 22 months) after the hemi-Fontan procedure. The most common indication for timing of the Fontan procedure is critical cyanosis [15]. In most cases, the modified Fontan operation consists of a cavopulmonary connection constructed as a lateral atrial tunnel using a polytetrafluoroethylene baffle with a 3-mm central fenestration [16–18]. Postoperatively, the infants are extubated in the operating room or after a few hours in the intensive care unit. This enhances pulmonary blood flow by the negative intrathoracic pressure that occurs during spontaneous ventilation. Bilateral chest tubes remain in place until the infants have established a good oral intake of a low-fat diet and chest tube output decreases to less than 1 mL•kg-1•d-1. Depending on the intravascular volume status, the children often are given captopril, digoxin, aspirin, a low dose of crystalline warfarin sodium, and a diuretic.
Cardiac Transplantation
OPERATIVE PROCEDURE.
Before circulatory arrest is initiated, the donor heart and aorta are prepared; the patent foramen is closed, and the ascending aorta is trimmed to the appropriate size and shape. The right and left atriums are also trimmed. After core cooling to 15°C, circulatory arrest is established. After snaring of the head vessels and ligation of the ductus, the hypoplastic heart is excised. The aorta is then opened distal to the insertion of the patent ductus and proximal to the level of the innominate artery. Unlike the palliative operation, much of the ascending aorta is excised with the heart. The cardiac allograft is sewn in place with monofilament absorbable sutures beginning with the left atrial anastomosis and ending with the aortic anastomosis, which is sewn on the hypoplastic aorta as an onlay graft augmenting the aorta. Recannulation is performed, and circulation and rewarming are instituted. The pulmonary artery anastomosis is performed during rewarming.
POSTOPERATIVE MANAGEMENT AND IMMUNOSUPPRESSION PROTOCOL.
At the time of reperfusion of the transplanted heart, methylprednisolone, 10 mg/kg, is given. Infants are weaned from CPB with dopamine, 5 to 7 µg•kg-1•min-1, Isuprel (isoproterenol hydrochloride), 20 to 50 ng•kg-1•min-1, and prostaglandin E1, 25 to 50 ng•kg-1•min-1. Postoperative immunosuppression includes a three-drug protocol of cyclosporine, azathioprine, and prednisone. Since 1990, all patients have received OKT3 (Ortho Biotech, Raritan, NJ) induction therapy and have then been maintained on a regimen of triple agents. The OKT3 therapy is initiated on the first postoperative day and administered daily for 14 days at 1 mg/7.5 kg of body weight. Oral cyclosporine is given every 8 hours at an average dosage of 12 mg•kg-1•d-1 beginning on postoperative day 2 or 3. Azathioprine is given to leukocyte tolerance (white blood cell count > 4,000 cells/mL). After completion of OKT3 therapy, prednisone is given in a tapering dosage beginning at 1.0 mg•kg-1•d-1. Before 1990, prednisone was tapered off within 4 weeks. Because 2 patients died of severe acute rejection, we modified the tapering protocol to wean to 0.2 to 0.3 mg•kg-1•d-1 by 3 to 4 months [19].
Cardiac rejection in infants has been detected mainly with noninvasive echocardiography. Cardiac biopsies are performed if the infant continues to have impaired cardiac function after treatment of rejection using noninvasive methods or if any question exists on the status of rejection [20].
Statistical Methods
Data were entered into a computerized database and analyzed with Statistica software (Statsoft, Inc, Tulsa, OK). The data are presented as the mean ± the standard deviation. Statistical representation of significance was calculated with analysis of variance, and the p value was determined with the F test. The cumulative survival estimates of patients were made by the actuarial (life-table) method, and the 95% confidence intervals for the estimates were determined by the Greenwood formula [21].
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Results |
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TopFootnotesAbstractIntroductionPatients and MethodsResultsCommentAppendix 1. Possible Risk...References |
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).
Palliative Operations
Thirty-five infants, including the 7 crossover patients, were taken to the operating room at a median age of 16 days (range, 7 to 64 days). For 1 infant, palliation was aborted because of incorrectable anatomy (ie, ascending aorta connected to right innominate artery with arch vessels arising from ductal tissue). Seventeen of the 34 infants (50%) survived the first-stage Norwood operation. If the palliative results are examined by two different time frames (1989–1992 versus 1993–1995), significant differences in overall survival are realized. Twenty-two infants underwent palliation from 1989 to 1992 with 8 survivors (36%), and 12 infants underwent palliation from 1993 through June 1995 with 9 survivors (75%) (p = 0.05) (Fig 2). The causes of early deaths are depicted in Table 2.
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2.0 mm) (p = 0.01); larger size of systemic–pulmonary artery shunt (4 mm) (p = 0.01); and circulatory arrest time longer than 50 minutes (p = 0.02).
Among the 17 discharged infants who received palliation, there was one late death. This patient had deterioration of right ventricular function associated with severe tricuspid valve regurgitation and died on the transplant list before an adequate donor became available. Of the remaining 16 stage-one survivors, 2 patients underwent subsequent heart transplantation because of critical tricuspid regurgitation and family request. Ten patients had a successful bidirectional Glenn (hemi-Fontan) procedure, and the remaining 4 patients are waiting for stage-two palliation. Coarctation of the aorta developed in the follow-up period in 3 infants. All 3 underwent coarctation repair through a left thoracotomy prior to stage-two palliation. All of the patients survived the hemi-Fontan procedure; 7 have undergone a completed Fontan operation, and the other 3 are awaiting a completion Fontan procedure (Fig 3).
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). Overall 1-year survival was 77% ± 20% (Fig 4). If the 1-year survival results for transplantation are divided into two different time frames (1989–1992 versus 1993–1995), survival was 69% ± 25% up to 1992 and 100% since then. None of the variables entered into the risk factor analysis was predictive of early death by analysis of variance (see Appendix 1).
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Comment |
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TopFootnotesAbstractIntroductionPatients and MethodsResultsCommentAppendix 1. Possible Risk...References |
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Since 1989, we have had a flexible approach that incorporates both palliation and transplantation. Many lessons learned in the first 3 years of our experience from 1989 to 1992 enabled us to improve operative mortality of palliation and transplantation in the 3 years 1993 to July 1995.
Operative survival in infants with palliation improved significantly from 36% in 1989 to 1992 to 75% in 1993 to mid-1995 (p < 0.01). We believe this improvement can be attributed to several technical refinements. Our risk factor analysis revealed that shorter circulatory arrest time and smaller shunt size (3.5 mm) are critical for fewer early deaths. Over the last 6 years, mean circulatory arrest time was significantly reduced from 53 minutes (range, 44 to 80 minutes) in 1989 to 1992 to 43 minutes (range, 35 to 54 minutes) in 1993 to mid-1995 (p = 0.04). In addition to experience, performing the atrial septostomy, atriotomy closure, and proximal anastomosis of the systemic–pulmonary artery shunt during the cooling phase plays a major role in shortening the circulatory arrest time.
Since 1993, more precise determination of the optimal shunt size has been adopted, and the majority of patients weighing less than 4 kg received a 3.5-mm conduit. As a result, 7 (88%) of 8 infants with a 3.5-mm conduit survived operation, whereas only 10 (38%) of 26 with a 4-mm or larger shunt were operative survivors (p = 0.01). Large shunts result in excessive pulmonary flow, low diastolic blood pressure, and reduced coronary blood flow and may aggravate ventricular failure. In contrast, smaller shunts reduce pulmonary blood flow, ventricular volume overload, and tricuspid regurgitation. The use of smaller shunts also decreases the need of high concentrations of carbon dioxide in the inspired gas.
There are major differences among surgeons in the construction of the shunt anastomosis. The original description of this procedure by Norwood included a central shunt between the inferior aspect of the augmented aortic arch and the confluence of the branch pulmonary arteries [9]. In our modification, the proximal anastomosis of the shunt is completed during cooling, thus minimizing the total circulatory arrest time. The Boston group [22] prefers a modified right Blalock-Taussig shunt from the distal innominate artery or the proximal subclavian artery to the right pulmonary artery and avoids a central shunt because of the difficulty with control and takedown of such shunts at the time of the Fontan operation. We believe that uniform development of the left pulmonary artery relative to the right pulmonary artery is important, and we have never encountered difficulty placing the distal anastomosis adjacent to the pulmonary artery end of the divided ductus arteriosus. This more central location of the distal end of the shunt has resulted in uniform growth of both pulmonary arteries. Pericardial patch anastomosis of the branch pulmonary arteries during the second- and third-stage Norwood palliations has not been necessary.
Aortic and mitral atresia as well as a diminutive ascending aorta (2.0 mm) were significant risk factors for early mortality over the entire experience, as suggested by the Boston group [23]. Since 1993, however, 3 infants with ascending aortic diameters of 1 to 1.5 mm are currently alive. Aortic root size may disappear as a risk factor with increasing experience.
Early survival in heart transplant recipients also improved from 69% (1989–1992) to 100% (1993–1995). Our first 2 transplant recipients died of acute rejection. Since the charge in the immunosuppression protocol after these 2 patients, a total of seven acute rejection episodes have been successfully treated without any deaths. The last 12 patients received OKT3 induction therapy. Although OKT3 may increase the chance of pulmonary hypertension postoperatively [24], only 29% (5/17) had transient mild to moderate pulmonary hypertension at the first or second administration or both, and no patient so treated died of a pulmonary hypertensive crisis.
Donor shortage remains the critical problem. Seven infants in our series originally listed for cardiac transplantation crossed over to the first-stage palliation after a mean of 25 days (range, 12 to 42 days) on the transplant list. Progressive congestive heart failure despite intensive medical therapy was the most common reason for the crossover. The patients who crossed over after 36 and 42 days died immediately after operation of a pulmonary hypertensive crisis. At postmortem examination, the lungs showed grade IV Heath-Edwards pulmonary vascular change. Five of 6 patients crossing over within 30 days of life are long-term survivors, and the only death occurred secondary to acute ventricular failure. Similar findings were observed in the study from the University of Michigan [11]. In that series, 91% of infants younger than 1 month survived the first-stage palliation, whereas only 29% of patients older than 1 month survived, and the majority of older patients died of a pulmonary hypertensive crisis. In our series, 1 transplant candidate who waited for a donor heart for 100 days also died of a pulmonary hypertensive crisis immediately after cardiac transplantation. Although some institutions successfully maintain the hemodynamic stability of infants with HLHS for 2 to 3 months before donors become available [25], longer waiting times increase the risk of postoperative pulmonary hypertension. Accordingly, if a family selects cardiac transplantation and a donor does not become available within 30 days of life, we currently recommend elective crossover to the palliative procedure before irreversible pulmonary vascular changes develop.
Although the majority of patients who survive the first-stage Norwood procedure are potential candidates for a hemi-Fontan procedure, a completion Fontan operation, or both, not all will be suitable at an acceptable risk. These patients can be treated by cardiac transplantation [26]. In our series, 2 patients who survived the first-stage Norwood procedure underwent heart transplantation because of severe tricuspid regurgitation and family wishes, and both are currently well. The risk of antigen sensitization can occur after initial palliation because of exposure to numerous antigens involved with blood transfusion. Both of our patients had 0% panel reactive antibody at the time of transplantation, and neither had increased episodes of acute or chronic rejection. Cardiac transplantation after the first-stage palliation for HLHS will be an acceptable option in such patients with severe heart failure or tricuspid regurgitation.
Prenatal diagnosis of HLHS may improve perinatal management. Prenatal diagnosis could decrease the donor waiting time if the neonate is placed on a transplant list before birth. In our series, the families of 2 babies who were diagnosed prenatally chose palliation and did not risk deterioration, and both infants survived the first-stage palliation. The families of 4 other babies who were diagnosed prenatally chose transplantation, and an adequate donor was found after 0 to 29 days on the list; all 4 survived transplantation.
In summary, the results of staged palliation and cardiac transplantation improved over the 6 years of this study, and now both can produce outcomes that offer encouraging options for families of infants with HLHS. Increased experience and technical refinements with reduced ischemic time and smaller shunt size have improved early survival of infants receiving staged palliation. Donor shortage remains the major impediment to neonatal heart transplantation. When a family selects cardiac transplantation but a donor does not become available within a reasonable period, first-stage palliation becomes the only bridge to future transplantation.
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Appendix 1. Possible Risk Factors for Early Death |
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TopFootnotesAbstractIntroductionPatients and MethodsResultsCommentAppendix 1. Possible Risk...References |
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Footnotes |
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TopFootnotesAbstractIntroductionPatients and MethodsResultsCommentAppendix 1. Possible Risk...References |
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Address reprint requests to Dr Brown, Section of Cardiothoracic Surgery, Indiana University Medical Center, 545 Barnhill Dr, EM 215, Indianapolis, IN 46202.
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References |
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TopFootnotesAbstractIntroductionPatients and MethodsResultsCommentAppendix 1. Possible Risk...References |
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