Original Article
Long-Term Outcome in Patients Undergoing Surgical Repair of Tetralogy of Fallot
N Engl J Med 1993; 329:593-599August 26, 1993
- Abstract
Background
Although corrective surgery for tetralogy of Fallot has been available for more than 30 years, the occurrence of late sudden death in patients in whom surgery was apparently successful remains worrisome.
Methods
We studied long-term survival among 163 patients who survived 30 days after complete repair of tetralogy of Fallot, examining follow-up hospital records and death certificates when relevant.
Results
The overall 32-year actuarial survival rate among all patients who survived surgery was 86 percent, as compared with an expected rate of 96 percent in a control population matched for age and sex (P<0.01). Thirty-year actuarial survival rates were calculated for the patient subgroups. The survival rates among patients less than 5 years old, 5 to 7 years old, and 8 to 11 years old were 90, 93, and 91 percent, respectively -- slightly less than the expected rates (P<0.001, P = 0.06, and P = 0.02). Among patients 12 years old or older at the time of surgery, the survival rate was 76 percent, as compared with an expected rate of 93 percent (P<0.001). The performance of a palliative Blalock-Taussig shunt procedure before repair, unlike the performance of a Waterston or Potts shunt procedure, was not associated with reduced long-term survival, nor was the need for a transannular patch at the time of surgery. Independent predictors of long-term survival were older age at operation (P = 0.02) and a higher ratio of right ventricular to left ventricular systolic pressure after surgery (P = 0.008). Late sudden death from cardiac causes occurred in 10 patients during the 32-year period.
Conclusions
Among patients with surgically repaired tetralogy of Fallot, the rate of long-term survival after the postoperative period is excellent but remains lower than that in the general population. The risk of late sudden death is small.
Media in This Article
Figure 1
Long-Term Survival of Patients with Complete Repair of Tetralogy of Fallot Who Survived the Immediate Postoperative Period.Figure 2
Long-Term Survival of Patients with Tetralogy of Fallot with or without an Earlier Palliative Shunt Procedure Who Survived the Immediate Postoperative Period.Article Activity
- Article
Tetralogy of Fallot (obstruction of right ventricular outflow, ventricular septal defect, right ventricular hypertrophy, and an overriding aorta) is the commonest cause of cyanotic congenital heart disease worldwide. It is estimated to occur in approximately 2700 infants per year born in the United States1. Studies of the late results of surgery2-5 have documented a favorable long-term outcome in most patients6.
Several authors have drawn attention to the unexpected occurrence of sudden death from cardiac causes both early and late after apparently successful corrective surgery,7,8 although the incidence of sudden death is not as high as in patients who have undergone operations for other congenital heart defects, especially repair of a double-outlet right ventricle9. Although the number of sudden deaths from cardiac causes after repair of tetralogy of Fallot in almost every series was small, the specter of late sudden death is of increasing concern, since the number of patients with long-term survival is increasing.
We report here the findings of long-term follow-up of patients with tetralogy of Fallot who underwent corrective surgery at the Mayo Clinic between 1955 and 1960. We paid particular attention to the influence of age at the time of operation, the presence and type of earlier palliative surgery, the need for transannular patching, and the postoperative ratio of systolic blood pressure in the right ventricle to that in the left ventricle (RV:LV systolic pressure ratio) on late survival and sequelae.
Methods
Patients
We reviewed the records of all patients who underwent complete surgical repair of tetralogy of Fallot at the Mayo Clinic between 1955 and 1960 and survived the immediate postoperative period (defined as the 30 days after operation or the interval between operation and hospital discharge, whichever was shorter), and attempted to contact them. We selected patients with repair from 1955 to 1960 to allow a minimal follow-up period of 29 years in surviving patients; the maximal follow-up was 34 years. We were unable to determine the current status of three patients (2 percent of the patients in our final analysis), but the hospital records indicated that they were alive at least 17, 19, and 29 years after surgery, respectively. Patients who had undergone a previous palliative shunt procedure were included in this study if definitive surgical correction had been carried out from 1955 to 1960. We excluded patients with other hemodynamically important complex congenital heart lesions, including double-outlet right ventricle, situs inversus, and ventricular septal defect with pulmonary atresia. We also excluded 33 foreign patients because of the difficulty in obtaining follow-up information about them so long after surgery, and 5 patients who had been discharged from the hospital with complete heart block before the advent of permanent pacemakers, because we believed that their inclusion would unfairly bias the late results of surgery and would be of little relevance to current practice. Survival among the patients was compared with that in a model population generated from cumulative age- and sex-specific mortality rates.
Data Collection
The follow-up status of the patients was determined principally by a written questionnaire and telephone interview. An initial questionnaire was sent to all patients, followed by a second questionnaire if there was no response. Telephone interviews were conducted with patients who did not respond to the two written requests. The patients were asked about their functional status and the occurrence of cardiovascular events (stroke, transient ischemic events, myocardial infarction, infective endocarditis, and pacemaker implantation). If the patient had died, the closest living relative was contacted. If death, hospitalization, or a cardiovascular event had occurred in the interim, either the death certificate or the records of the hospital and physician were reviewed.
Statistical Analysis
Differences between age groups in continuous variables were assessed by analysis of variance. The probability of survival was estimated by the Kaplan-Meier method10. The survival curves of the patients were compared with the expected curves of persons of the same age and sex born at the same time,11 as derived from vital statistics for the West North Central region of the United States (as defined by the U.S. Bureau of the Census) and for the state of Minnesota. The statistical significance of each comparison was calculated with a one-sample log-rank test12. The association of continuous variables with survival and the association of combinations of variables with survival were estimated by proportional-hazards analysis13. Variables found to be significant (P<0.05) or that approached significance (P ≤ 0.15) according to univariate analysis were then evaluated in the multivariate analyses.
Results
Two hundred fifty-one patients underwent complete repair of tetralogy of Fallot between 1955 and 1960. Fifty patients (20 percent) died during the immediate postoperative period. As noted in the Methods section, 5 patients discharged from the hospital with chronic complete heart block and 33 foreign patients who survived the postoperative period were excluded from this analysis. The mean (±SD) age at operation was 10 ±9 years (range, <1 to 47; median, 8).
Among the remaining 163 patients, current follow-up information was available for 160 patients (98 percent), and the other 3 patients were known to be alive 17 to 29 years after surgery. These 163 patients were grouped according to their age at operation: less than 5 years old (30 patients), 5 to 7 years old (43 patients), 8 to 11 years old (34 patients), and 12 years old or older (56 patients). Four patients were less than two years old at the time of surgery. The age groups were formed so that each group contained enough patients to permit a meaningful analysis of the effect of age at the time of surgery on long-term survival. No patient had Down's syndrome or other syndromes of multiple congenital anomalies.
Previous Operations and Details of Corrective Surgery
Table 1Table 1
Surgical Variables in 163 Patients Undergoing Complete Repair of Tetralogy of Fallot. lists the previous operations in the 163 patients. The variables examined included whether a previous palliative shunt procedure had been performed and whether the pulmonary-outflow tract had required patching. The median bypass time for repair of the tetralogy of Fallot was 65 minutes. In six patients, cardiac defects associated with tetralogy of Fallot were repaired at the same time, including an atrial septal defect and a patent ductus. Hypothermic cardiac arrest was induced in 40 of the patients, with a mean core temperature of 25.6 °C (range, 2 to 34 °C).Overall Survival
The mean (±SD) duration of follow-up was 21 ±13 years (median, 29 years; range, 30 days to 34 years). The Kaplan-Meier estimates of actuarial survival rates, excluding perioperative mortality, were 95 percent 5 years after operation, 92 percent after 10 and 15 years, 91 percent after 20 years, 87 percent after 25 years, and 86 percent after 32 years (Figure 1Figure 1
Long-Term Survival of Patients with Complete Repair of Tetralogy of Fallot Who Survived the Immediate Postoperative Period.). Although the long-term survival rate among those who survived the operation was good, it was significantly lower than the expected rate.Survival According to Age at Operation
Thirty-year actuarial survival rates were calculated for the patient subgroups, because there were insufficient numbers of patients alive to provide meaningful analyses up to 32 years. In the patients less than 5 years old, 5 to 7 years old, and 8 to 11 years old at the time of surgery, the 30-year survival rates were 90, 93, and 91 percent, respectively -- slightly less than expected (Figure 1). In the patients 12 years old or older at the time of surgery, the survival rate was 76 percent, as compared with an expected rate of 93 percent. Mortality continued to be higher than expected throughout the period of follow-up.
Survival According to Previous Palliative Shunt Procedure
The results of analysis of the effect of a previous palliative shunt procedure on long-term survival are shown in Figure 2Figure 2
Long-Term Survival of Patients with Tetralogy of Fallot with or without an Earlier Palliative Shunt Procedure Who Survived the Immediate Postoperative Period.. The patients who had not had such a procedure and those who had undergone a Blalock-Taussig shunt procedure had similar 30-year survival rates (87 and 86 percent, respectively). The patients who had previously had a Waterston or Potts shunt procedure had a significantly lower 30-year survival rate (73 percent).Survival According to Patching of the Pulmonary Annulus
The 30-year survival rates among the patients without a pulmonary-outflow patch, those with a patch through the annulus, and those with a patch up to the annulus were 87, 85, and 88 percent, respectively (Figure 3Figure 3
Long-Term Survival of Patients with Tetralogy of Fallot with or without a Patch up to or through the Pulmonary Annulus Who Survived the Immediate Postoperative Period.). The patients were also grouped according to whether they had isolated pulmonary infundibular stenosis (73 patients) or combined obstruction of the infundibulum and the pulmonary valve (90 patients). The 30-year survival rates were similar in these two groups (88 and 85 percent).Predictors of Late Mortality
Univariate analysis showed that an older age at surgery (P = 0.01), previous heart failure (P = 0.02), and a postoperative RV:LV systolic pressure ratio ≥ 0.5 (P = 0.028) were significantly associated with higher rates of long-term mortality (Table 2Table 2
Significant Predictors of Long-Term Survival, According to Univariate and Multivariate Analysis, in Patients Undergoing Complete Repair of Tetralogy of Fallot.). Multivariate analysis showed that the predictors of long-term mortality were an older age at operation (P = 0.02) and a high ( ≥ 0.5) postoperative RV:LV systolic pressure ratio (P = 0.008).Late Mortality
There were 22 late deaths. The reported cause was known in all cases (Table 3Table 3
Causes of Late Death in Patients Who Survived Complete Repair of Tetralogy of Fallot.); it was determined by examination of the death certificate in 18 cases and by review of hospital records in 4 cases. Autopsies were performed in two cases. The commonest cause of death was sudden death from cardiac causes, which occurred in 10 patients. Three patients died during late reoperation, and three died of heart failure. There was one accidental death and one suicide. None of the deaths were due to late infective endocarditis.Functional Status
Late functional status was determined in all 138 patients alive at the time of late follow-up. Most patients (106, or 77 percent) were in New York Heart Association (NYHA) functional class I; 24 (17 percent) were in class II, and 8 (6 percent) were in class III.
Poorer functional class at late follow-up evaluation was not associated with the performance of a palliative shunt procedure before corrective surgery (P = 0.75) or the need for a patch up to or through the pulmonary annulus at the time of surgery (P = 0.71).
Approximately a third of the survivors (55 patients) had clinical evidence of pulmonary valvular insufficiency. This was classified as clinically mild in 53 of these patients (96 percent) and was not associated with a poorer late functional status (P = 0.26). The two patients who had moderate-to-severe pulmonary valvular insufficiency were in NYHA functional class II at the time of late follow-up evaluation.
Reoperation
Sixteen patients (10 percent) required late reoperation. The 30-year probability of survival without reoperation was 88 percent (Figure 4Figure 4
Long-Term Survival without Reoperation in Patients with Tetralogy of Fallot Who Underwent Complete Repair.). The principal reasons for late reoperation were a recurrent or residual ventricular septal defect (10 patients), false aneurysm of the pulmonary-outflow tract (3 patients), and residual stenosis of the main pulmonary artery (1 patient). In the 3 patients who had false aneurysms of the right ventricular outflow tract and in 5 of the 10 patients who had recurrent or residual ventricular septal defects, reoperation was necessary because of failure of the patch material originally used for reconstruction (i.e., Ivalon, a polyvinyl alcohol formerly used in prostheses). Two other patients had severe pulmonary valvular insufficiency that required valve replacement. In all the patients with patch failure who underwent reoperation, the residual ventricular septal defect or pulmonary-artery false aneurysm was directly related to the failure.A longer cardiopulmonary-bypass time was a risk factor for late reoperation, according to univariate analysis (P = 0.04) (hazard ratio [10-minute increments], 1.3; 95 percent confidence interval, 1.0 to 1.8). Variables not predictive of late reoperation were the patient's age at surgery, the degree of operative hypothermia, the degree of preoperative dyspnea, and an increased RV:LV systolic pressure ratio. On multivariate analysis, longer bypass time was the only statistically significant variable predictive of reoperation.
The mean time to reoperation was 9 years (range, <1 to 29); there were three late deaths due to reoperation (Table 3). Two of these deaths occurred during the repair of pulmonary-artery aneurysms and one during the repair of a residual ventricular septal defect.
Early postoperative infective endocarditis after repair of tetralogy of Fallot occurred in three patients, two of whom died in the hospital. There were no episodes of late infective endocarditis.
Conduction Abnormalities
Seven patients had complete right-bundle-branch block and left-axis deviation (bifascicular block) at the time of hospital discharge. Five of these patients were alive at the time of late follow-up evaluation. There was no association between a higher death rate and bifascicular block (P = 0.22).
Pacemaker Implantation
Seven patients (4 percent) required late implantation of a pacemaker; all were alive at the time of late follow-up evaluation. None of these seven patients were among those who had complete heart block when discharged from the hospital. The mean time to implantation of a pacemaker was 23 years (range, 7 to 26). There was no association between reoperation and late pacemaker implantation; only one patient required both procedures, performed three years apart.
Effect of RV:LV Systolic Pressure Ratio after Repair
The RV:LV systolic pressure ratios after repair were measured intraoperatively or at the time of cardiac catheterization in 160 patients. A pressure ratio of 0.5 or more was predictive of higher mortality during the first 20 years after surgery, but the difference in mortality in relation to the ratio had largely disappeared by 30 years after surgery: the survival rates among patients with ratios of less than 0.5 and those with ratios of 0.5 or more were, respectively, 94 and 88 percent at 10 years, 93 and 88 percent at 15 years, 92 and 88 percent at 20 years, 88 and 86 percent at 25 years, and 87 and 85 percent at 30 years. The increased mortality associated with a high ratio after repair could be attributed in part to deaths at the time of reoperation. Two of three patients who died at the time of reoperation had had ratios above 0.7 after their first operation.
Discussion
This study provides evidence that long-term survival after repair of tetralogy of Fallot, even in the earliest era of open-heart surgery, is excellent. Although other investigators have also documented the favorable outcome of surgery for tetralogy of Fallot,3,5,14-17 this study shows that outcome may remain favorable 29 to 34 years after repair. In our patients, the 30-year actuarial survival rate was 90 percent of the expected survival rate. Late functional status was also excellent.
An older age at surgery was a powerful predictor of poorer late survival according to both univariate and multivariate analyses. Patients 12 years old or older at the time of surgery had a 30-year survival rate of 76 percent, as compared with an expected rate of 93 percent. Katz et al.6 and Hu et al.18 reported a similar decrease in long-term survival among older patients who underwent repair of tetralogy of Fallot. The trend toward higher rates of late mortality among older patients strongly supports the current policy of repairing defects when patients are young.
Among the patients who had a previous Blalock-Taussig shunt procedure, late mortality was no different from that among patients without previous palliative surgery. Undergoing a Waterston or a Potts shunt procedure before repair of tetralogy of Fallot was associated with increased late mortality in both this study and others5,6. This increase has been attributed to progressive pulmonary vascular disease and possibly to left ventricular volume overload as a consequence of abnormally high pulmonary blood flow5,6,19.
Placement of a transannular patch may lead to late pulmonary valvular insufficiency and right ventricular volume overload. Although Klinner et al.20 identified the use of a transannular patch as a risk factor for late mortality, the results of the study of James et al.8 and a large study by Kirklin et al.15 suggested that the compensatory responses to right ventricular volume overload were adequate for a 20-year period, at least with respect to mortality. Our data extend these observations and do not demonstrate any difference in survival among patients without a patch, those with a patch up to the pulmonary annulus, and those with a transannular patch, although other investigators have implicated transannular patching as a risk factor for reoperation.
The occurrence of late sudden death from cardiac causes after surgical repair of tetralogy of Fallot is well recognized,21,22 and in the present study it accounted for approximately half of all late deaths. Nonetheless, there was no trend toward increased late mortality and sudden death during the 20 to 32 years of follow-up. The incidence of sudden death was highest in the first few years after repair, and overall, sudden death from cardiac causes occurred in only 10 patients (6 percent) during the 30-year period. These results are similar to those of Lillehei et al.3. Bifascicular block after surgery was not predictive of late sudden death. The cause of late sudden death is probably multifactorial. Both late mortality and ventricular arrhythmias are strongly associated with older age at operation23,24.
The correct approach to the management of late ventricular arrhythmias in patients with repaired tetralogy of Fallot remains controversial25. The finding that relatively few patients die suddenly (1 to 6 percent), although the frequency of ventricular arrhythmias during Holter monitoring is high (up to 50 percent), implies, however, that the occurrence of ventricular arrhythmias may be a marker of patients at risk rather than a causal agent26. Antiarrhythmic drugs may decrease the incidence of sudden death from cardiac causes,7 but their value is unproved, particularly because of the potentially deleterious effects of antiarrhythmic therapy in patients with ventricular dysfunction.
For the physician seeing a patient in whom tetralogy of Fallot was repaired many years previously, this study provides helpful guidelines. Among patients undergoing repair when young, long-term survival is good but slightly less than expected. The specter of late sudden death warrants regular surveillance for ventricular arrhythmias, but the absence of any increase in the frequency of sudden death is reassuring. Asymptomatic complex cardiac ectopy may be a marker of increased risk; nonetheless, there is insufficient evidence to warrant prophylactic antiarrhythmic therapy in patients with this disorder. The outlook for patients who were older at the time of surgery and those who had a Waterston or Potts shunt procedure before complete surgical repair is more guarded. This group will continue to have a higher mortality rate than an age- and sex-matched control population.
We are indebted to Mrs. Kim D. Jones, Mrs. Kirsten J. Fleming, and Mrs. Chu-Pin Chu for their invaluable help.
Source Information
From the Division of Cardiovascular Diseases and Internal Medicine (J.G.M., B.J.G., M.D.M.), the Section of Pediatric Cardiology (D.D.M.), the Section of Biostatistics (D.M.I.), and the Division of Thoracic and Cardiovascular Surgery (D.C.M. [emeritus member], G.K.D.), Mayo Clinic and Mayo Foundation, Rochester, Minn.; the Division of Cardiology, Massachusetts General Hospital, Boston (V.F.); and the Department of Surgery, University of Alabama Medical Center, Birmingham (J.W.K.).
Address reprint requests to Dr. Murphy at the Mayo Clinic, 200 First St. SW, Rochester, MN 55905.
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