Long-Term Outcome in Patients Undergoing Surgical Repair of Tetralogy of Fallot
Joseph G. Murphy, Bernard J. Gersh, Douglas D. Mair, Valentin Fuster, Michael D. McGoon, Duane M. Ilstrup, Dwight C. McGoon, John W. Kirklin, and Gordon K. Danielson
Background Although corrective surgery for tetralogy of Fallothas been available for more than 30 years, the occurrence oflate sudden death in patients in whom surgery was apparentlysuccessful remains worrisome.
Methods We studied long-term survival among 163 patients whosurvived 30 days after complete repair of tetralogy of Fallot,examining follow-up hospital records and death certificateswhen relevant.
Results The overall 32-year actuarial survival rate among allpatients who survived surgery was 86 percent, as compared withan expected rate of 96 percent in a control population matchedfor age and sex (P<0.01). Thirty-year actuarial survivalrates were calculated for the patient subgroups. The survivalrates 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 timeof surgery, the survival rate was 76 percent, as compared withan expected rate of 93 percent (P<0.001). The performanceof 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 wasthe need for a transannular patch at the time of surgery. Independentpredictors of long-term survival were older age at operation(P = 0.02) and a higher ratio of right ventricular to left ventricularsystolic pressure after surgery (P = 0.008). Late sudden deathfrom cardiac causes occurred in 10 patients during the 32-yearperiod.
Conclusions Among patients with surgically repaired tetralogyof Fallot, the rate of long-term survival after the postoperativeperiod is excellent but remains lower than that in the generalpopulation. The risk of late sudden death is small.
Tetralogy of Fallot (obstruction of right ventricular outflow,ventricular septal defect, right ventricular hypertrophy, andan overriding aorta) is the commonest cause of cyanotic congenitalheart disease worldwide. It is estimated to occur in approximately2700 infants per year born in the United States1. Studies ofthe late results of surgery2,3,4,5 have documented a favorablelong-term outcome in most patients6.
Several authors have drawn attention to the unexpected occurrenceof sudden death from cardiac causes both early and late afterapparently successful corrective surgery,7,8 although the incidenceof sudden death is not as high as in patients who have undergoneoperations for other congenital heart defects, especially repairof a double-outlet right ventricle9. Although the number ofsudden deaths from cardiac causes after repair of tetralogyof Fallot in almost every series was small, the specter of latesudden death is of increasing concern, since the number of patientswith long-term survival is increasing.
We report here the findings of long-term follow-up of patientswith tetralogy of Fallot who underwent corrective surgery atthe Mayo Clinic between 1955 and 1960. We paid particular attentionto the influence of age at the time of operation, the presenceand type of earlier palliative surgery, the need for transannularpatching, and the postoperative ratio of systolic blood pressurein the right ventricle to that in the left ventricle (RV:LVsystolic pressure ratio) on late survival and sequelae.
Methods
Patients
We reviewed the records of all patients who underwent completesurgical repair of tetralogy of Fallot at the Mayo Clinic between1955 and 1960 and survived the immediate postoperative period(defined as the 30 days after operation or the interval betweenoperation and hospital discharge, whichever was shorter), andattempted to contact them. We selected patients with repairfrom 1955 to 1960 to allow a minimal follow-up period of 29years 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 hospitalrecords indicated that they were alive at least 17, 19, and29 years after surgery, respectively. Patients who had undergonea previous palliative shunt procedure were included in thisstudy if definitive surgical correction had been carried outfrom 1955 to 1960. We excluded patients with other hemodynamicallyimportant complex congenital heart lesions, including double-outletright ventricle, situs inversus, and ventricular septal defectwith pulmonary atresia. We also excluded 33 foreign patientsbecause of the difficulty in obtaining follow-up informationabout them so long after surgery, and 5 patients who had beendischarged from the hospital with complete heart block beforethe advent of permanent pacemakers, because we believed thattheir inclusion would unfairly bias the late results of surgeryand would be of little relevance to current practice. Survivalamong the patients was compared with that in a model populationgenerated from cumulative age- and sex-specific mortality rates.
Data Collection
The follow-up status of the patients was determined principallyby a written questionnaire and telephone interview. An initialquestionnaire was sent to all patients, followed by a secondquestionnaire if there was no response. Telephone interviewswere conducted with patients who did not respond to the twowritten requests. The patients were asked about their functionalstatus and the occurrence of cardiovascular events (stroke,transient ischemic events, myocardial infarction, infectiveendocarditis, and pacemaker implantation). If the patient haddied, the closest living relative was contacted. If death, hospitalization,or a cardiovascular event had occurred in the interim, eitherthe death certificate or the records of the hospital and physicianwere reviewed.
Statistical Analysis
Differences between age groups in continuous variables wereassessed by analysis of variance. The probability of survivalwas estimated by the Kaplan-Meier method10. The survival curvesof the patients were compared with the expected curves of personsof the same age and sex born at the same time,11 as derivedfrom vital statistics for the West North Central region of theUnited States (as defined by the U.S. Bureau of the Census)and for the state of Minnesota. The statistical significanceof each comparison was calculated with a one-sample log-ranktest12. The association of continuous variables with survivaland the association of combinations of variables with survivalwere estimated by proportional-hazards analysis13. Variablesfound to be significant (P<0.05) or that approached significance(P 0.15) according to univariate analysis were then evaluatedin the multivariate analyses.
Results
Two hundred fifty-one patients underwent complete repair oftetralogy of Fallot between 1955 and 1960. Fifty patients (20percent) died during the immediate postoperative period. Asnoted in the Methods section, 5 patients discharged from thehospital with chronic complete heart block and 33 foreign patientswho survived the postoperative period were excluded from thisanalysis. The mean (±SD) age at operation was 10 ±9years (range, <1 to 47; median, 8).
Among the remaining 163 patients, current follow-up informationwas available for 160 patients (98 percent), and the other 3patients 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 (56patients). Four patients were less than two years old at thetime of surgery. The age groups were formed so that each groupcontained enough patients to permit a meaningful analysis ofthe effect of age at the time of surgery on long-term survival.No patient had Down's syndrome or other syndromes of multiplecongenital anomalies.
Previous Operations and Details of Corrective Surgery
Table 1 lists the previous operations in the 163 patients. Thevariables examined included whether a previous palliative shuntprocedure had been performed and whether the pulmonary-outflowtract had required patching. The median bypass time for repairof the tetralogy of Fallot was 65 minutes. In six patients,cardiac defects associated with tetralogy of Fallot were repairedat the same time, including an atrial septal defect and a patentductus. Hypothermic cardiac arrest was induced in 40 of thepatients, with a mean core temperature of 25.6 °C (range,2 to 34 °C).
Table 1. Surgical Variables in 163 Patients Undergoing Complete Repair of Tetralogy of Fallot.
Overall Survival
The mean (±SD) duration of follow-up was 21 ±13years (median, 29 years; range, 30 days to 34 years). The Kaplan-Meierestimates of actuarial survival rates, excluding perioperativemortality, were 95 percent 5 years after operation, 92 percentafter 10 and 15 years, 91 percent after 20 years, 87 percentafter 25 years, and 86 percent after 32 years (Figure 1). Althoughthe long-term survival rate among those who survived the operationwas good, it was significantly lower than the expected rate.
Figure 1. Long-Term Survival of Patients with Complete Repair of Tetralogy of Fallot Who Survived the Immediate Postoperative Period.
The top panel shows the actuarial survival rate up to 32 years after surgery for all patient groups combined and the expected survival rate in an age- and sex-matched control population. The bottom panels show survival rates up to 30 years according to age at the time of operation in patients who survived the postoperative period (patient numbers were too small for 32-year analyses), as well as the expected survival rates in the model population. The P values for the comparisons of the observed and expected rates were calculated with the log-rank test. Values below the curves are the numbers of patients who are alive at this writing and who have completed the period of actuarial follow-up.
Survival According to Age at Operation
Thirty-year actuarial survival rates were calculated for thepatient subgroups, because there were insufficient numbers ofpatients alive to provide meaningful analyses up to 32 years.In the patients less than 5 years old, 5 to 7 years old, and8 to 11 years old at the time of surgery, the 30-year survivalrates were 90, 93, and 91 percent, respectively -- slightlyless than expected (Figure 1). In the patients 12 years oldor older at the time of surgery, the survival rate was 76 percent,as compared with an expected rate of 93 percent. Mortality continuedto 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 palliativeshunt procedure on long-term survival are shown in Figure 2.The patients who had not had such a procedure and those whohad undergone a Blalock-Taussig shunt procedure had similar30-year survival rates (87 and 86 percent, respectively). Thepatients who had previously had a Waterston or Potts shunt procedurehad a significantly lower 30-year survival rate (73 percent).
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.
The top panel shows the long-term survival rate among patients who did not have a palliative shunt procedure; the middle panel, survival among patients who had a Blalock-Taussig shunt procedure before definitive repair; and the bottom panel, survival among patients who had either a Waterston or a Potts palliative shunt procedure before definitive repair. The expected survival rate in an age- and sex-matched model population is also shown. Values below the curves are the numbers of patients who are alive at this writing and who have completed the period of actuarial follow-up; NS denotes not significant.
Survival According to Patching of the Pulmonary Annulus
The 30-year survival rates among the patients without a pulmonary-outflowpatch, those with a patch through the annulus, and those witha patch up to the annulus were 87, 85, and 88 percent, respectively(Figure 3). The patients were also grouped according to whetherthey had isolated pulmonary infundibular stenosis (73 patients)or combined obstruction of the infundibulum and the pulmonaryvalve (90 patients). The 30-year survival rates were similarin these two groups (88 and 85 percent).
Figure 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 top panel shows the long-term survival rate among patients without a pulmonary annular patch; the middle panel, survival among patients in whom a patch was placed through the pulmonary annulus; and the bottom panel, survival among patients with a patch up to but not through the pulmonary annulus. The expected survival rate in an age- and sex-matched model population is also shown. The values below the curves are the numbers of patients who are alive at this writing and who have completed the period of actuarial follow-up; NS denotes not significant.
Predictors of Late Mortality
Univariate analysis showed that an older age at surgery (P =0.01), previous heart failure (P = 0.02), and a postoperativeRV:LV systolic pressure ratio 0.5 (P = 0.028) were significantlyassociated with higher rates of long-term mortality (Table 2).Multivariate analysis showed that the predictors of long-termmortality were an older age at operation (P = 0.02) and a high( 0.5) postoperative RV:LV systolic pressure ratio (P = 0.008).
Table 2. Significant Predictors of Long-Term Survival, According to Univariate and Multivariate Analysis, in Patients Undergoing Complete Repair of Tetralogy of Fallot.
Late Mortality
There were 22 late deaths. The reported cause was known in allcases (Table 3); it was determined by examination of the deathcertificate in 18 cases and by review of hospital records in4 cases. Autopsies were performed in two cases. The commonestcause of death was sudden death from cardiac causes, which occurredin 10 patients. Three patients died during late reoperation,and three died of heart failure. There was one accidental deathand one suicide. None of the deaths were due to late infectiveendocarditis.
Table 3. Causes of Late Death in Patients Who Survived Complete Repair of Tetralogy of Fallot.
Functional Status
Late functional status was determined in all 138 patients aliveat 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 inclass III.
Poorer functional class at late follow-up evaluation was notassociated with the performance of a palliative shunt procedurebefore corrective surgery (P = 0.75) or the need for a patchup to or through the pulmonary annulus at the time of surgery(P = 0.71).
Approximately a third of the survivors (55 patients) had clinicalevidence of pulmonary valvular insufficiency. This was classifiedas clinically mild in 53 of these patients (96 percent) andwas not associated with a poorer late functional status (P =0.26). The two patients who had moderate-to-severe pulmonaryvalvular insufficiency were in NYHA functional class II at thetime of late follow-up evaluation.
Reoperation
Sixteen patients (10 percent) required late reoperation. The30-year probability of survival without reoperation was 88 percent(Figure 4). The principal reasons for late reoperation werea 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 ventricularoutflow tract and in 5 of the 10 patients who had recurrentor residual ventricular septal defects, reoperation was necessarybecause of failure of the patch material originally used forreconstruction (i.e., Ivalon, a polyvinyl alcohol formerly usedin prostheses). Two other patients had severe pulmonary valvularinsufficiency that required valve replacement. In all the patientswith patch failure who underwent reoperation, the residual ventricularseptal defect or pulmonary-artery false aneurysm was directlyrelated to the failure.
Figure 4. Long-Term Survival without Reoperation in Patients with Tetralogy of Fallot Who Underwent Complete Repair.
The value under the curve is the number of surviving patients who have completed the period of actuarial follow-up at this writing and have not undergone reoperation.
A longer cardiopulmonary-bypass time was a risk factor for latereoperation, according to univariate analysis (P = 0.04) (hazardratio [10-minute increments], 1.3; 95 percent confidence interval,1.0 to 1.8). Variables not predictive of late reoperation werethe patient's age at surgery, the degree of operative hypothermia,the degree of preoperative dyspnea, and an increased RV:LV systolicpressure ratio. On multivariate analysis, longer bypass timewas the only statistically significant variable predictive ofreoperation.
The mean time to reoperation was 9 years (range, <1 to 29);there were three late deaths due to reoperation (Table 3). Twoof these deaths occurred during the repair of pulmonary-arteryaneurysms and one during the repair of a residual ventricularseptal defect.
Early postoperative infective endocarditis after repair of tetralogyof Fallot occurred in three patients, two of whom died in thehospital. There were no episodes of late infective endocarditis.
Conduction Abnormalities
Seven patients had complete right-bundle-branch block and left-axisdeviation (bifascicular block) at the time of hospital discharge.Five of these patients were alive at the time of late follow-upevaluation. There was no association between a higher deathrate 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. Noneof these seven patients were among those who had complete heartblock when discharged from the hospital. The mean time to implantationof a pacemaker was 23 years (range, 7 to 26). There was no associationbetween reoperation and late pacemaker implantation; only onepatient 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 measuredintraoperatively or at the time of cardiac catheterization in160 patients. A pressure ratio of 0.5 or more was predictiveof higher mortality during the first 20 years after surgery,but the difference in mortality in relation to the ratio hadlargely disappeared by 30 years after surgery: the survivalrates among patients with ratios of less than 0.5 and thosewith ratios of 0.5 or more were, respectively, 94 and 88 percentat 10 years, 93 and 88 percent at 15 years, 92 and 88 percentat 20 years, 88 and 86 percent at 25 years, and 87 and 85 percentat 30 years. The increased mortality associated with a highratio after repair could be attributed in part to deaths atthe time of reoperation. Two of three patients who died at thetime of reoperation had had ratios above 0.7 after their firstoperation.
Discussion
This study provides evidence that long-term survival after repairof tetralogy of Fallot, even in the earliest era of open-heartsurgery, is excellent. Although other investigators have alsodocumented the favorable outcome of surgery for tetralogy ofFallot,3,5,14,15,16,17 this study shows that outcome may remainfavorable 29 to 34 years after repair. In our patients, the30-year actuarial survival rate was 90 percent of the expectedsurvival rate. Late functional status was also excellent.
An older age at surgery was a powerful predictor of poorer latesurvival according to both univariate and multivariate analyses.Patients 12 years old or older at the time of surgery had a30-year survival rate of 76 percent, as compared with an expectedrate of 93 percent. Katz et al.6 and Hu et al.18 reported asimilar decrease in long-term survival among older patientswho underwent repair of tetralogy of Fallot. The trend towardhigher rates of late mortality among older patients stronglysupports the current policy of repairing defects when patientsare young.
Among the patients who had a previous Blalock-Taussig shuntprocedure, late mortality was no different from that among patientswithout previous palliative surgery. Undergoing a Waterstonor a Potts shunt procedure before repair of tetralogy of Fallotwas associated with increased late mortality in both this studyand others5,6. This increase has been attributed to progressivepulmonary vascular disease and possibly to left ventricularvolume overload as a consequence of abnormally high pulmonaryblood flow5,6,19.
Placement of a transannular patch may lead to late pulmonaryvalvular insufficiency and right ventricular volume overload.Although Klinner et al.20 identified the use of a transannularpatch as a risk factor for late mortality, the results of thestudy of James et al.8 and a large study by Kirklin et al.15suggested that the compensatory responses to right ventricularvolume overload were adequate for a 20-year period, at leastwith respect to mortality. Our data extend these observationsand do not demonstrate any difference in survival among patientswithout a patch, those with a patch up to the pulmonary annulus,and those with a transannular patch, although other investigatorshave implicated transannular patching as a risk factor for reoperation.
The occurrence of late sudden death from cardiac causes aftersurgical repair of tetralogy of Fallot is well recognized,21,22and in the present study it accounted for approximately halfof all late deaths. Nonetheless, there was no trend toward increasedlate mortality and sudden death during the 20 to 32 years offollow-up. The incidence of sudden death was highest in thefirst few years after repair, and overall, sudden death fromcardiac causes occurred in only 10 patients (6 percent) duringthe 30-year period. These results are similar to those of Lilleheiet al.3. Bifascicular block after surgery was not predictiveof late sudden death. The cause of late sudden death is probablymultifactorial. Both late mortality and ventricular arrhythmiasare strongly associated with older age at operation23,24.
The correct approach to the management of late ventricular arrhythmiasin patients with repaired tetralogy of Fallot remains controversial25.The finding that relatively few patients die suddenly (1 to6 percent), although the frequency of ventricular arrhythmiasduring Holter monitoring is high (up to 50 percent), implies,however, that the occurrence of ventricular arrhythmias maybe a marker of patients at risk rather than a causal agent26.Antiarrhythmic drugs may decrease the incidence of sudden deathfrom cardiac causes,7 but their value is unproved, particularlybecause of the potentially deleterious effects of antiarrhythmictherapy in patients with ventricular dysfunction.
For the physician seeing a patient in whom tetralogy of Fallotwas repaired many years previously, this study provides helpfulguidelines. Among patients undergoing repair when young, long-termsurvival is good but slightly less than expected. The specterof late sudden death warrants regular surveillance for ventriculararrhythmias, but the absence of any increase in the frequencyof sudden death is reassuring. Asymptomatic complex cardiacectopy may be a marker of increased risk; nonetheless, thereis insufficient evidence to warrant prophylactic antiarrhythmictherapy in patients with this disorder. The outlook for patientswho were older at the time of surgery and those who had a Waterstonor Potts shunt procedure before complete surgical repair ismore guarded. This group will continue to have a higher mortalityrate 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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0.15) according to univariate analysis were then evaluated in the multivariate analyses. 
0.5 (P = 0.028) were significantly associated with higher rates of long-term mortality (Table 2). Multivariate analysis showed that the predictors of long-term mortality were an older age at operation (P = 0.02) and a high ( 
