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Ann Thorac Surg 2001;72:2081-2087
© 2001 The Society of Thoracic Surgeons
a Department of Cardiac and Thoracic Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, USA
b Department of Pediatric Cardiology, Vanderbilt University Medical Center, Nashville, Tennessee, USA
c Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA
d Department of Anesthesia, Vanderbilt University Medical Center, Nashville, Tennessee, USA
* Address reprint requests to Dr Drinkwater, Cardiac and Thoracic Surgery, Vanderbilt University Medical Center, 1301 22nd Ave S, 2986 The Vanderbilt Clinic, Nashville, TN 37232-5734, USA
e-mail: davis.drinkwater{at}mcmail.vanderbilt.edu
Presented at the Forty-seventy Annual Meeting of the Southern Thoracic Surgical Association, Marco Island, FL, Nov 9–11, 2000.
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Abstract |
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Methods. Medical records were reviewed retrospectively.
Results. Between April 1997 and March 2001, 50 infants underwent a modified Norwood operation for hypoplastic left heart syndrome. Mean age at operation was 7.5 ± 5.7 days, and mean weight was 3.1 ± 0.5 kg. Five infants had a delayed operation because of sepsis. The mean diameter of the ascending aorta by echocardiography was 3.6 ± 1.8 mm. Ductal cannulation was used to establish cardiopulmonary bypass in all patients. Mean circulatory arrest time was 39.4 ± 4.8 minutes. The size of the pulmonary-systemic shunt was 3.0 mm in 6 infants, 3.5 mm in 37, and 4.0 mm in 7. Infants with persistent hypoxia (partial pressure of oxygen < 30 mm Hg) received nitric oxide after they were weaned from cardiopulmonary bypass. Extracorporeal membrane oxygenation was initiated in 8 infants in the pediatric intensive care unit primarily for low cardiac output and in 8 in the operating room because of the inability to separate them from cardiopulmonary bypass. The 30-day mortality rate was 22% (11 of 50 patients), and the hospital mortality rate was 32% (16 of 50 patients). Mean follow-up was 17 months. Ten patients (20%) underwent stage-two repair, with one operative death. One survivor had a Fontan procedure, and 2 underwent heart transplantation, with one death.
Conclusions. Early application of extracorporeal membrane oxygenation for hemodynamic instability and selective use of nitric oxide for persistent hypoxia in the immediate postoperative period may improve survival of patients with hypoplastic left heart syndrome. Renal failure requiring hemofiltration during extracorporeal membrane oxygenation (p < 0.05) and cardiopulmonary arrest in the pediatric intensive care unit (p < 0.05) were predictors of hospital mortality.
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Introduction |
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Recently, the Congenital Heart Surgery Nomenclature and Database Project on HLHS [4] defined the constellation of left ventricular obstructive lesions as follows: HLHS is a spectrum of cardiac malformations, characterized by a severe underdevelopment of the left heart-aorta complex, consisting of aortic and/or mitral valve atresia, stenosis, or hypoplasia with marked hypoplasia or absence of the LV [left ventricle], and hypoplasia of the ascending aorta and of the aortic arch". This classification system simplifies comparison between surgical reports and clearly identifies known anatomic risk factors in palliative repair of HLHS. The physiologic consequence of HLHS is that the systemic and pulmonary circulations are parallel systems that derive their blood flow from the right ventricle through the ductus arteriosus.
Surgical management of HLHS began in the 1970s with the availability of prostaglandin E1 that could maintain patency of the ductus arteriosus. Despite early attempts at surgical repair by Albert and Bryant [5], Mohri and colleagues [6], Levitsky and associates [7], and Doty and colleagues [8], it was not until the pioneering work of Norwood in 1980 that surgical palliation of HLHS became reproducible. The general goal of palliative repair is to provide unobstructed blood flow from the right ventricle to the systemic circulation that is not ductal dependent. The results of staged repair for HLHS continue to improve. Here we review our institutional experience with staged palliative repair in children with HLHS.
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Material and methods |
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All patients were treated preoperatively with intravenous infusion of prostaglandin E1. Supplemental oxygen was avoided unless profound hypoxia was present; supplemental nitrogen (inspired oxygen fraction, 0.15 to 0.20%) was used to decrease the pulmonary shunt and improve systemic output in selective patients with high systemic saturations. Nineteen patients were mechanically ventilated, and 8 patients required moderate inotropic support in the preoperative period. All patients had echocardiographic evaluation prior to stage-one Norwood operation, and 4 patients required atrial angioplasty before operative intervention. For 5 infants, operative repair was delayed because of sepsis. The mean diameter of the ascending aorta determined by echocardiography was 3.6 ± 1.8 mm (range, 1.5 to 10.3 mm). Anatomic categories included combined aortic stenosis and mitral stenosis in 20 infants (40%), combined AA and mitral atresia (MA) in 19 (38%), and AA and mitral stenosis in 4 (8%). Associated cardiac lesions included a normal pulmonary venous connection and an associated vertical vein in 4, coronary fistula in 2, dextrocardia in 1, and interrupted aortic arch in 1.
Operative management
A conventional median sternotomy is performed, and the thymus gland is partially dissected, thus exposing the aortic arch and branch vessels, and preserved. To maintain hemodynamic stability, minimal dissection is carried out prior to institution of cardiopulmonary bypass. The infant is cannulated with a single venous cannula through the right atrial appendage and a systemic perfusion cannula inserted through the midportion of the ductus arteriosus (Fig 1). Cardiopulmonary bypass is instituted with snaring of the ductus arteriosus, and the infant is cooled to 18°C. During cooling, the branch vessels of the aortic arch are exposed and looped with silicone elastomer snares in preparation for circulatory arrest. The ascending, transverse, and distal portions of the aortic arch are completely dissected, and the proximal ductus is divided and oversewn. The main pulmonary artery is divided above the pulmonary valve, and the proximal pulmonary artery is oversewn or patched with pericardium based on confluence size. A vascular clamp is applied to the right pulmonary artery, and the distal anastomosis of the 3.0-, 3.5- or 4.0-mm polytetrafluoroethylene shunt is performed. In 8 patients, the "chimney patch" technique was used to construct the distal portion of the systemic–pulmonary shunt. In brief, an elliptical patch of autologous pericardium with an appropriately sized polytetrafluoroethylene shunt (constructed prior to initiation of cardiopulmonary bypass) is anastomosed to the defect created by division at the confluence of the right and left pulmonary arteries (Fig 2).
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All patients arrive in the pediatric intensive care unit (PICU) with open, stented chests and snared aortic and right atrial pursestring sutures to expedite extracorporeal membrane oxygenator support in the event of hemodynamic instability (Fig 3). Open chests are covered with double Ioban adhesive dressing (3M Health Care, St. Paul, MN). Inhaled nitric oxide (INO Therapeutics, Clinton, NJ) at 10 to 20 ppm is selectively initiated in the operating room in those infants with persistent hypoxia despite maximal medical management. A continuous infusion of fentanyl anesthesia and neuromuscular blockade is maintained in the PICU while the chest is open. Low-dose inotropic support is continued until the infant is extubated. Inspired oxygen is adjusted to maintain systemic oxygen saturation between 70% and 80%, with partial pressure of oxygen between 30 and 40 mm Hg. Inotropic support, afterload reduction, and inspired oxygen fraction are adjusted to maintain an estimated pulmonary to systemic blood flow ratio between 1.5:1 and 1:1. This ratio is estimated by measuring peripheral oxygen saturation [9]. Patients with persistent acidosis or hypoxia despite pharmacological doses of inotropic support are candidates for mechanical assistance. Indications for extracorporeal membrane oxygenation (ECMO) include the following: inability to wean the patient from cardiopulmonary bypass in the operating room; hemodynamic instability in the PICU with clinical findings of persistent hypotension, progressive lactic acidosis, hypoxia, progressive decline in cardiac function, or a combination of these; and cardiopulmonary arrest in the PICU requiring cardiopulmonary resuscitation.
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Results |
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Extracorporeal membrane oxygenator support was required in 14 patients (28%). Indications for ECMO were as follows: inability to be weaned from cardiopulmonary bypass, 6 (43%); cardiac arrest in the PICU, 2 (14%); low cardiac output despite high-dose inotropic support, 3 (21%); and severe hypoxia, 3 (21%). The mean duration of ECMO was 90.5 ± 56.3 hours (range, 1 to 192 hours). Ten infants (71%) were successfully weaned from mechanical support, and 9 (64%) survived to hospital discharge. Low cardiac output was the primary cause of death in infants weaned from ECMO.
Mean duration of continuous inhaled nitric oxide treatment was 5 days (range, 1 to 7 days). Hospital stay ranged from 1 to 108 days (mean stay, 24.6 ± 20.9 days), and the mean PICU stay was 14.8 ± 13.6 days (range, 1 to 67 days). Ten patients (20%) underwent stage-two repair with one operative death, which occurred in the cardiac catheterization laboratory after attempted stenting of a stenotic left pulmonary artery. Two patients required heart transplantation prior to second-stage palliation for poor cardiac function; 1 of them died secondary to multisystem organ failure. One patient has undergone a lateral-tunnel Fontan operation.
After the first-stage Norwood procedure the 30-day mortality rate was 22% (11 of 50 patients), and the hospital mortality rate was 32% (16 of 50 patients). Five patients were discharged home but died prior to performance of a Glenn shunt. The cause of early (30-day) hospital mortality was almost exclusively low cardiac output. Four of the late hospital deaths occurred secondary to sepsis, and the other occurred 2 months postoperatively and was due to thrombosis of the abdominal aorta, superior vena cava, and femoral veins. The hospital mortality rate was 42% (8 of 19 patients) in infants with AA plus MA compared with 30% (6 of 20 patients) in those with aortic stenosis plus mitral stenosis.
Fifteen patients experienced complications. Seven infants had septic complications including 2 with mediastinitis, defined as a deep sternal wound infection requiring sternal revision. Both sternal infections occurred after ECMO. Neurologic complications included seizure activity in 5 patients and stroke in 3.
Eleven balloon dilations were performed in 9 patients for postoperative aortic coarctation. Two patients required stenting of a left pulmonary artery stenosis prior to stage-two repair, and 2 patients had coil embolization of aortopulmonary collaterals. One patient required coil embolization of a Blalock-Taussig shunt after stage-two repair.
Risk factor analysis was performed on all variables with univariate and multivariate techniques. Weight, age, prenatal diagnosis, age at first operation, associated diagnosis, preoperative ventilator or inotropic requirement, presence of restrictive atrial septal defect necessitating atrial angioplasty, shunt size, homograft or pericardial arch reconstruction, cardiopulmonary bypass time, cross-clamp time, circulatory arrest time, requirement of postoperative ECMO, and prolonged dependency on nitric oxide (> 48 hours) did not have a negative impact on hospital survival when analyzed with univariate and multivariate analyses. Univariate analysis revealed the following variables to be predictive of hospital mortality: renal failure requiring hemofiltration during ECMO (p < 0.05) and cardiopulmonary arrest in the PICU (p < 0.05). Although they did not reach significance, ECMO for longer than 72 hours and infants with the anatomic subtype AA plus MA showed a trend toward increased hospital mortality.
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Comment |
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Early attempts at palliative repair were unsuccessful. Norwood was the first surgeon to clearly define the goals of palliative repair. They included the following principles: direct association of the aorta and the right ventricle allowing unobstructed blood flow to the systemic circulation; growth potential of the newly reconstructed aorta; regulation of pulmonary blood flow to ensure a balanced circulation; a large intraatrial communication to allow free drainage of the pulmonary vasculature; and staged surgical repair resulting in completion Fontan operation when patient size and pulmonary vascular resistance are appropriate [14]. In 1980, Norwood and associates [15] reported successful palliative repair for HLHS, and in 1983, Norwood’s group [16, 17] described completion Fontan repair in a child with HLHS.
The early results of staged surgical repair of HLHS had high early and late mortality with a hospital survival rate after stage-one Norwood repair of less than 50% [18]. Contemporary reports have shown marked improvement. In 1995, Norwood’s group [14] noted an 83% hospital survival rate in patients with HLHS after stage-one repair. The overall survival rate for patients progressing to Fontan completion has been greater than 60% in experienced centers [19–22].
Orthotopic heart transplantation (OHT) is a viable alternative to staged reconstruction in children with HLHS. Actuarial 1-year and 5-year survival curves for OHT in children with HLHS are 84% and 76%, respectively, in large-volume transplant institutions [23, 24]. A recent multi-institutional study [25] comparing OHT with staged reconstruction also noted better 1-year and 5-year survival rates in patients undergoing OHT versus staged repair (61% versus 42% at 1 year and 55% versus 38% at 5 years; p < 0.01). Infants with high-risk lesions including small aortic arch diameter (<2 mm) and atresia of the mitral or aortic valve or both valves tended to have the poorest outcomes with staged surgical reconstruction compared with OHT [26].
At Vanderbilt University Medical Center, we have been committed to a program of staged surgical repair. The scarcity of pediatric donors and the reported 31% mortality rate among children awaiting heart transplantation limits the efficacy of transplantation in the management of children with HLHS [26]. Further, the long-term results of heart transplantation in children are not known. In the adult population, late rejection manifested by extensive coronary artery disease has contributed to late mortality. In addition, a recent publication has noted the cost of OHT to be substantially greater than that of staged surgical repair [27]. The 1-year survival rate after OHT in children at our institution is 70%. We reserve the option of OHT for patients with poor ventricular function.
In this series, we presented a group of 50 infants with HLHS who underwent stage-one Norwood reconstruction for HLHS. Twenty-three (46%) of these 50 patients had "unfavorable anatomy," defined as AA or MA. The 30-day survival rate after the stage-one Norwood procedure was 78%, and the hospital survival rate was 68%. Ten patients (20%) have undergone stage-two repair with one early death and two late deaths. One patient had a completion Fontan operation, and 2 required OHT for poor ventricular function prior to second-stage repair. Univariate analysis revealed that only two variables—renal failure requiring hemofiltration during ECMO and cardiopulmonary arrest in the PICU—were predictive of hospital mortality (p < 0.05). Although not reaching significance, ECMO for longer than 72 hours and the combination of AA and MA may be predictors of increased hospital mortality. Preoperative variables such as acidosis, restrictive atrial septal defect necessitating atrial angioplasty, age and weight at operation, preoperative ventilator dependence, and need of preoperative inotropic support were not predictors of a poor outcome.
We have developed a cohesive approach to the treatment of children with HLHS. A team of cardiac surgeons, pediatric intensivists, and cardiologists are jointly responsible for patient care. We believe that limiting pulmonary blood flow and maintaining an estimated ratio of pulmonary to systemic flow of 1.5:1 or less is essential in the preoperative period to avoid systemic hypoperfusion and acidosis. We have limited the development of preoperative pulmonary edema and ventricular decompensation reported by several groups by applying early (< 7 days of age) operative repair when possible. Prenatal diagnosis may decrease delays in surgical repair, especially in infants referred from a distance.
Initiation of cardiopulmonary bypass with ductal cannulation allows us to reconstruct the pulmonary artery confluence using glutaraldehyde-preserved autologous pericardium prior to circulatory arrest. We have not noted any increased operative morbidity secondary to ductal cannulation in our series. We have found that reconstruction of the aortic arch with homograft or pericardium results in a relatively low incidence of aortic restenosis. In our series, 9 patients required balloon dilation for postoperative aortic coarctation. Two patients required stenting of a left pulmonary artery stenosis prior to stage-two repair. Echocardiographic and angiographic follow-up reveal adequate growth of the reconstructed aorta. Mosca and colleagues [19], Fraser and Mee [28], and Jacobs and coauthors [14] have reported encouraging early results with arch reconstruction using only autologous great-vessel tissue. The results of direct reconstruction of the aortic arch without homograft or pericardium are still preliminary, and long-term follow-up is needed. We believe that using a pericardial patch to augment a small right and left pulmonary artery confluence may limit the incidence of pulmonary artery stenosis. In our recent experience, we have used the "chimney patch" technique [29] prior to institution of circulatory arrest to reconstruct the pulmonary artery confluence and create a systemic–pulmonary shunt at the same time. We believe that this technique decreases circulatory arrest time and may decrease the incidence of pulmonary artery stenosis after a first-stage Norwood procedure.
Infants are taken to the PICU with open, stented chests with snared aortic and right atrial pursestring sutures. We have found a significant decrease in time to institution of ECMO after cardiopulmonary arrest in children when pursestring sutures are in place. Inhaled nitric oxide is instituted in all patients with persistently low oxygen saturations (<60%) or in patients with reactive pulmonary vasculature resulting in hemodynamic instability. We think that nitric oxide may decrease the incidence of sudden cardiac arrest secondary to pulmonary vascular hypertensive crisis. Low to moderate inotropic support is continued in all patients until extubation. Although some groups [30–33] have found measurement of systemic mixed venous oxygen saturation to be helpful in the postoperative period, we used serial measurements of lactic acid, base deficit, and peripheral oxygen saturation to guide management.
We use rapid ECMO as an extension of the operative procedure in patients with hemodynamic instability despite maximal medical management. Indications for rapid ECMO in our study include the following: inability to wean the patient from cardiopulmonary bypass in the operating room; hemodynamic instability in the PICU with clinical findings of persistent hypotension, acidosis, hypoxia, pulmonary hypertension, progressive decline in cardiac function, or a combination of these; ventilator failure; and cardiopulmonary arrest in the PICU requiring cardiopulmonary resuscitation. Fourteen infants (28%) required ECMO after stage-one repair. Ten (71%) of them were successfully weaned from mechanical support, and 9 (64%) survived to hospital discharge. Further, we have limited our use of nitric oxide postoperatively to those patients with persistent hypoxia despite maximal medical management. We believe that inhaled nitric oxide may decrease the incidence of sudden death in neonates with persistent hypoxia after a stage-one Norwood procedure. We did not find institution of ECMO in the operating room to have a negative impact on early survival as has been reported by other investigators [34]. Cardiopulmonary arrest in the PICU and renal failure requiring hemodialysis during mechanical support were the sole predictors of early mortality in our study. Although not reaching significance, ECMO for more than 72 hours and the anatomic subtype AA plus MA showed a trend toward increased hospital mortality.
In summary, the data presented in this study suggest that staged reconstruction can be performed for all patients with HLHS with a relatively low early mortality. Early survival data after staged Norwood repair are comparable to those of pediatric heart transplantation. Extracorporeal membrane oxygenation may provide effective support for postoperative cardiac and pulmonary failure refractory to medical management and may improve early survival after stage-one Norwood repair.
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Discussion |
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In light of that, have you changed the position of your monitoring lines in order to facilitate putting these patients on ECMO and taking them off ECMO? Secondly, has leaving the chest open routinely in your experience influenced the early outcome?
Finally, we have noticed that a number of patients die suddenly three or four months after their Norwood 1 operation while they were awaiting their second stage Norwood. Have you observed this too, what is your opinion about the cause, and do you think that staging them earlier would help prevent this?
Thank you.
DR DRINKWATER: I think you point out some very good aspects of the management of these patients. One is the open chest. I know that we can send patients to the intensive care unit in a stable condition, and I am comfortable that they generally do well. However, these patients can seem to be doing well, and then in a minute things can change. I believe that in the first 24 hours after operation, the capability to institute rapid ECMO is necessary. In the group of patients who required ECMO within 24 hours postoperatively, 9 of 14 patients were discharged from the hospital. Therefore, if patients can be salvaged at a high rate, which is what we have seen, we leave the chest open with cannulation snares in place.
The second part of your question dealt with late deaths. When he presented the results of the Boston series, Dr Jonas reported a late mortality rate of about 15%. After discharge, these infants for unknown reasons can experience an increased incidence of aspiration, respiratory infection, or both. An additional cause of late death is shunt closure. Typically these infants die late in an outlying emergency room, or they return in a critically ill state to our medical center. I agree with you that stage two represents a high watermark, and if it can be reached safely, I firmly believe that the patient will be in much more stable condition. Consequently, we are trying to operate earlier. In this series, 5 months was the mean time to stage two. We are looking at 4 months now in several patients. In our non-hypoplastic left heart syndrome patients, we are comfortable operating at 3 months if necessary, but not routinely. In answer to your question, we do think stage two represents stability to the patient.
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