Ann Thorac Surg 2005;80:2285-2291
© 2005 The Society of Thoracic Surgeons
Original article: Cardiovascular
Correction of Tetralogy of Fallot and of Pulmonary Atresia with Ventricular Septal Defect in Adults
Jürgen Hörer, MD
*
,
Julia Friebe, MD,
Christian Schreiber, MD,
Martin Kostolny, MD,
Julie Cleuziou, MD,
Klaus Holper, MD, PhD,
Rüdiger Lange, MD, PhD
Clinic for Cardiovascular Surgery, German Heart Center Munich at the Technical University, Munich, Germany
Accepted for publication May 23, 2005.
* Address correspondence to Dr Hörer, Clinic for Cardiovascular Surgery, German Heart Center Munich at the Technical University, Lazarettstrasse 36, Munich, D-80636 Germany (Email: hoerer{at}dhm.mhn.de).
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Abstract
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BACKGROUND: Early correction is regarded as the treatment of choice for patients with tetralogy of Fallot or pulmonary atresia with ventricular septal defect. Nevertheless, some of these patients reach adulthood without early correction. This study sought to assess risk factors for operative mortality and determine the benefit of total correction in adolescent and adult patients.
METHODS: A retrospective analysis of 52 patients (>16 years at the time of corrective surgery) for tetralogy of Fallot (n = 42) or pulmonary atresia with ventricular septal defect (n = 10) between 1974 and 2003 was performed.
RESULTS: Age at correction was 28.9 ± 9.9 (16 to 57 years). There were 8 early deaths (15.4%). Preoperative hemoglobin concentration (p = 0.002) and reconstruction of the right ventricular outflow tract with a patch (p = 0.002) were correlated with a significantly higher early mortality. Mean follow-up time was 12.3 ± 10.4 years. Late deaths (n = 6; 11.5%) were cardiac-related in 2 of 6 cases. At follow-up, 28 patients (87.5%) were assigned to the New York Heart Association functional class I. Twenty-four patients led a normal life with full-time work, 6 patients were able to do part-time work, and only 2 patients experienced noticeable limitation on activities.
CONCLUSIONS: Repair of tetralogy of Fallot and of pulmonary atresia with ventricular septal defect in this patient group is associated with a high early mortality. Preoperative chronic cyanosis, expressed by elevated hemoglobin concentration, is predictive for early mortality. Because cyanosis has been shown to lead to multiorgan dysfunction, we conclude that preoperative multiorgan dysfunction may be the intrinsic risk factor for perioperative mortality. Surgical correction in this patient group should still be recommended because the functional status considerably improves.
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Introduction
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In recent years there has been a considerable increase in adult patients with congenital heart disease as a result of the success made in cardiac surgery during the last 30 to 40 years [1, 2]. Among these patients, tetralogy of Fallot (TOF) is a frequent diagnosis because technical progress and improved postoperative management have led to improved results after complete repair in infancy [3, 4]. However, there are still a certain number of older patients with uncorrected TOF or pulmonary atresia with ventricular septal defect (PA-VSD). These patients survive until adulthood because of favorable morphologic conditions such as systemic-to-pulmonary artery collaterals or because of relatively mild stenosis of the right ventricular outflow tract. In other patients who reach adulthood without primary correction, a shunt procedure was performed in childhood; however, due to the lack of experience, especially in underdeveloped countries, or due to the refusal to undergo redo surgery, these patients did not undergo correction. These patients represent a distinct subgroup of adults with congenital heart disease. Chronic hypoxemia stimulates the development of large systemic-to-pulmonary artery collaterals. These collaterals or preexisting shunts, or both, lead to increased pulmonary blood flow, and together with myocardial hypertrophy and myocardial hypoxia, they lead to reduced biventricular function. Impaired ventricular function, severe hypoxemia, and tricuspid regurgitation are associated with a higher operative mortality [5], whereas the influence of age at the time of operation on operative mortality is controversially discussed [5, 6].
We reviewed our long-term experience to assess risk factors for operative mortality and to determine the benefit of total correction of TOF and PA-VSD in adolescent and adult patients according to the functional status at follow-up.
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Patients and Methods
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From July 1974 to December 2003, 42 patients with TOF and 10 patients with PA-VSD, who were older than 16 years of age and lived in the European community, underwent complete surgical repair at our institution. There were 24 male and 28 female patients in the study group. Six patients were lost during follow-up, which is complete for 88.5% of the patients. Eight patients (15.4%) had required hospital admission prior to corrective surgery because of complications associated with congenital heart defect. Hereditary disposition (microdeletion 22q11) was proven in 2 patients. Forty-five patients (86.5%) underwent preoperative angiocardiography and hemodynamic assessment. Table 1 shows the preoperative characteristics of this patient group.
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Table 1. Preoperative Characteristics of 52 Adult Patients with Tetralogy of Fallot or Pulmonary Atresia With Ventricular Septal Defect Referred for Total Correction in Adulthood
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Twenty patients (38.5%) underwent primary correction. The majority of these patients (61.5%) had undergone palliative operations (45 operations) or catheter interventions (3 interventions) prior to repair. In 20 patients a total of 25 shunt procedures had been performed prior to the correction. In 11 patients these shunts were still patent at the time of correction (Table 2). Correction was performed at a mean time of 17.8 ± 9.9 years (range, 3.6 to 39.9 years) after the first palliative operation, and 15.1 ± 9.2 years (range, 1.2 to 39.9 years) after the last palliative operation.
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Table 2. Previous Palliative Operations and Interventions in 52 Adult Patients with Tetralogy of Fallot or Pulmonary Atresia with Ventricular Septal Defect Referred for Total Correction in Adulthood
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Operative Technique
A median sternotomy and standard aortic and bicaval cannulation were routinely applied. The operations were performed on cardiopulmonary bypass with moderate hypothermia. In 5 patients, circulatory arrest with deep hypothermia was required because of extensive backflow from the pulmonary arteries in 2 patients, bleeding from the ascending aorta in 1 patient, bleeding from the left pulmonary artery in 1 patient, and correction of an anomalous systemic venous connection in 1 patient. Cold antegrade crystalloid cardioplegia was used in all cases. Aprotinin was used in all patients from 1986 onward (23 patients). Mean cardiopulmonary bypass time was 118.8 ± 81.6 minutes (range, 31 to 475 minutes). Aortic cross-clamp time was 63.0 ± 35.8 minutes (range, 20 to 145 minutes). Intracardiac repair was performed through a right ventriculotomy in 48 patients, and through a transatrial approach in 4 patients. Ventricular septal defect closure was performed with a continuous suture in all patients. In 24 patients (46%), reinforced sutures were additionally used. Infundibular resection was performed in all cases. In 19 patients the right ventriculotomy was closed by direct suture, and in 10 of them a commissurotomy of the pulmonary valve was performed. In 19 patients the right ventricular outflow tract (RVOT) was enlarged with a patch; 12 of them underwent a commissurotomy. A transannular patch was implanted in 3 patients, whereas in the remaining 16 patients the patch was extended close to the annulus of the pulmonary valve. In 14 patients the RVOT was reconstructed with a right ventricle to pulmonary artery (RV-PA) conduit. Five of these patients had had prior conduit implantation as a palliative procedure, and 9 patients presented with marked pulmonary regurgitation at the time of corrective surgery. The preferential valve substitute was a homograft. In 2 patients, a xenograft was implanted. In 1 patient with additional aortic valve replacement with a mechanical prosthesis, a conduit with mechanical prosthesis was implanted. In 1 patient, a conduit with mechanical prosthesis was implanted to prevent redo surgery. Table 3
shows the operative details of right ventricular outflow tract reconstruction and associated procedures.
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Table 3. Operative Details of 52 Adult Patients With Tetralogy of Fallot or Pulmonary Atresia With Ventricular Septal Defect Referred for Total Correction in Adulthood
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Follow-Up
Follow-up was conducted between May 2002 and July 2003. Six patients were lost during follow-up (complete follow-up in 46 patients; 88.5%). All patients received a written questionnaire. In addition, a telephone interview was performed. The functional status was determined according to the New York Heart Association (NYHA) functional class and ability index as described by Warnes and Somerville [7]. The patients were asked about the occurrence of cardiovascular events, such as arrhythmias, stroke, thrombosis, and reoperation, as well as cardiac catheterization, pacemaker implantation, hospital admissions, concomitant diseases, and medication. In case of death, the relatives and the general physicians of the patients were contacted to determine the cause of death.
Statistics
Descriptive data for continuous variables are presented as means ± standard deviation; categorical variables are presented as relative frequencies. Continuous variables were analyzed by the t test if normally distributed or the Mann–Whitney U test. Pearsons 
2 test or Fischer's exact test were performed to detect significant differences between groups, and two-tailed tests were used for all analyses. Values of p < 0.05 were considered statistically significant. According to Concato and colleagues [8], multivariate analysis could not be performed because the ratio of events per variable was too small. Long-term survival and freedom from reoperation were estimated with the Kaplan-Meier method. Analyses were performed with SPSS 12.0.2 for Windows (SPSS Inc, Chicago, IL).
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Results
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Early Results
There were 8 perioperative deaths (15.4%) from 0 to 37 days after the operation. Four patients died from low cardiac output and renal failure, 1 from low cardiac output and sepsis, 1 from low cardiac output, 1 from multiorgan failure, and 1 from hepatic failure. Thirteen early complications were observed in 12 of the surviving patients. One patient had complete atrioventricular conduction block and required pacemaker implantation. Three patients had pleural effusions, and 2 patients had pericardial effusions; in 1 of these patients operative release of pericardial effusion was necessary. In 5 patients, early reoperations for postoperative bleeding were performed during the hospital stay. Two patients were reoperated on for residual ventricular septal defects. Preoperative hemoglobin concentration was not associated with a higher incidence of bleeding complications (p = 0.4). Reoperation for postoperative bleeding did not account for early mortality (p = 1.0). Among 32 patients who did not receive aprotinin, five bleeding complications were observed. In the remaining 20 patients who were treated with aprotinin, no bleeding complications were observed (p = 0.1). Mean postoperative hospital stay of the patients was 19.2 ± 9.5 days (range, 1 to 42 days). Mean stay on the intensive care unit was 5.8 ± 6.4 days (range, 1 to 37 days).
Among preoperative measurements, hemoglobin concentration was significantly related to early mortality (p = 0.002). Among operative measurements, reconstruction of the right ventricular outflow tract with a patch was significantly related to early mortality (p = 0.002). Right ventricle to left ventricle (RV/LV) pressure ratio before chest closure did not differ statistically in patients after RVOT direct closure, RVOT patch closure, or RV pulmonary artery conduit implantation. No statistically significant influence on early survival could be derived from any of the other analyzed demographic measurements as for previous palliative operations, associated anomalies, preoperative hemodynamic variables, and other operative measurements (Table 4).
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Table 4. Predictors for Early Death in 52 Adult Patients With Tetralogy of Fallot or Pulmonary Atresia With Ventricular Septal Defect Referred for Total Correction in Adulthood
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Reoperations
During long-term follow-up, 9 patients (20.5%) had to be reoperated on after a mean time of 10.3 ± 7.5 years after correction. One patient required 2 reoperations for right ventricular outflow tract obstruction. Six years after the primary correction, a residual right ventricular outflow tract stenosis was resected, and after another 16 years, a homograft had to be implanted because of pronounced pulmonary regurgitation. Freedom from reoperation in the entire study population after 5, 15, and 25 years was 89.6 ± 5.0%, 79.7 ± 5.0%, and 61.5 ± 11.3%, respectively (Fig 1). The main indication for reoperation was RVOT obstruction or re-stenosis of the RV-PA conduit in 6 patients at 3, 5, 6, 11, 17, and 18 years of age after corrective surgery. The incidence of reoperation concerning the RVOT was significantly higher in patients in whom a conduit had been implanted at correction (p = 0.003). In 4 of these patients, additional procedures had to be performed during reoperation, such as aortic valve replacement or closure of a residual ventricular septal defect, or both. Two patients had a coil occlusion of aortopulmonary collaterals 12 and 17 years after the operation. The types of reoperation and the time course of surgical interventions are summarized in Table 5.
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Fig 1. Estimated freedom from reoperation (Kaplan-Meier) in 52 adult patients with tetralogy of Fallot or pulmonary atresia with ventricular septal defect after correction. Dashes indicate censored patients.
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Late Results
Mean follow-up time was 12.3 ± 10.4 years (range, 0 to 28 years). Survival of the entire study population after 5, 15, and 25 years was 81.8 ± 5.5%, 76.9 ± 6.2%, and 58.1 ± 10.8%, respectively (Fig 2). Late death occurred in 6 patients (11.5%). Two patients died from sudden cardiac death 24 and 25 years after the operation. Both patients had undergone primary correction without a RVOT patch at the age of 20 and 39 years, respectively. Neither of them needed reoperations. One patient died from multiorgan failure after reoperation for replacement of the aortic valve and ascending aorta with a composite graft, exchange of the RV-PA conduit, closure of a residual ventricular septal defect, and revascularization of the right coronary artery. The causes of death of the remaining patients were stroke, melanoma, and undistinct abdominal tumor.
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Fig 2. Actuarial survival (Kaplan-Meier) in 52 adult patients with tetralogy of Fallot or pulmonary atresia with ventricular septal defect after correction. Dashes indicate censored patients.
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The follow-up questionnaire was answered by 32 patients. Evaluation of the questionnaires showed that the clinical status according to the NYHA functional class had improved at the time of follow-up compared with the clinical status prior to the operation. At follow-up, 28 patients (87.5%) were assigned to the NYHA functional class I (Fig 3). Twenty-four patients lead a normal life with full-time work (ability index I), 6 patients are able to do part-time work (ability index II), and only 2 patients experienced noticeable limitations on activities (ability index III). Twelve patients (37.5%) were on treatment for heart failure (angiotensin converting enzyme inhibitors, diuretics, or digitalis), 10 patients (31.2%) were on an anticoagulation regime for mechanical valve replacement or atrial fibrillation, and 9 patients (28.1%) received antiarrhythmics. None of the 32 patients had required pacemaker implantation during follow-up. There were 19 women aged 20 to 70 years, 13 of whom had given birth to children.
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Fig 3. Improvement in New York Heart Association (NYHA) functional class in 32 adult patients with tetralogy of Fallot or pulmonary atresia with ventricular septal defect after correction. Arrows indicate changes in NYHA functional class from preoperative to postoperative.
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Comment
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Among adult patients with congenital heart disease, TOF is a frequent diagnosis [1, 2]. Nowadays, most of these TOF patients reach adulthood after primary correction in infancy [3, 4]. Therefore, adult patients with uncorrected TOF or PA-VSD have become rare. In the present study group, the average number of operations decreased from 2.9 patients per year between 1974 and 1987 to 0.8 patients per year between 1988 and 2003. However, recently the number of operations of uncorrected TOF and PA-VSD has increased again due to the influx of patients from underdeveloped countries in which surgery in childhood is not available. Dittrich and colleagues [5] from the German Heart Center Berlin reported that 14 of 19 patients who were corrected for TOF at the age of greater than 18 years between 1988 and 1998 came from Eastern European countries.
Contemporary series of patients undergoing complete repair of tetralogy of Fallot in adulthood quote an early mortality of 2.5% to 24%. The lowest reported mortality (1 of 40 patients, 2.5%) was reported by Presbitero and colleagues [9] in a cohort of 40 TOF patients corrected at the age of greater than 20 years between 1974 and 1985, followed by the findings of Hu and colleagues [6]. They reported a total correction of 32 TOF patients at the age of greater than 40 years between 1960 and 1982 and observed 1 perioperative death from intractable ventricular fibrillation (1 of 32 patients, 3.1%). Rammohan and colleagues [10] observed 4 perioperative deaths from low cardiac output, hemorrhage, and renal failure in a cohort of 100 TOF patients aged 13 to 43 years at the time of correction. In the most recent study performed by Atik and colleagues [11], 2 of 39 patients (5.1%) corrected at greater than 18 years of age between 1982 and 2001 died perioperatively. One patient had right ventricular failure preoperatively and died from cardiogenic shock and multiorgan failure after transventricular repair. The other patient died from anoxic encephalopathy after a prolonged period of hypotension caused by massive hemorrhage. Dittrich and colleagues [5] observed 3 early deaths in 19 patients (16%). Preoperatively, these patients had shown enlarged RVs with impaired right and left ventricular function. One patient had severe tricuspid regurgitation, another showed severe cyanosis. These patients died from biventricular heart failure. The highest early mortality (24%) was observed by Nollert and colleagues [12] in a historical cohort of 104 patients operated on at the age of greater than 18 years between 1958 and 1977. Impaired ventricular function, tricuspid regurgitation, and severe cyanosis were elucidated as potential risk factors for operative mortality. However, no statistical significance of any possible preoperative risk factor for early mortality could be derived from these published series. In our group of 52 patients, all of these potential risk factors were present. Preoperatively elevated hemoglobin level reached statistical significance for perioperative mortality. Due to the lack of data concerning myocardial, renal, and hepatic function, these variables could not be assessed in the present study. However, because cyanosis and erythrocytosis have been shown to lead to thrombosis, infective endocarditis, stroke, brain abscess, myocardial fibrosis, and impaired ventricular function [13], one might presume that multiorgan dysfunction could be the most important risk factor for operative mortality. Five of the 8 operative deaths in the present study had severe renal or hepatic failure postoperatively. This finding affirms the previously mentioned hypothesis.
Among operative measurements, reconstruction of the RVOT with a patch was significantly related to perioperative mortality. The reason for the higher mortality in these patients is presumably not the incomplete relief of RVOT obstruction, because RV/LV pressure ratios at chest closure did not differ from the rest of the study population. Presumably pulmonary regurgitation was more often present in this subgroup. It has been shown that chronic pulmonary regurgitation has a detrimental effect on RV function [14, 15]. It seems possible that postoperative pulmonary regurgitation in this selected patient group is not tolerated, and together with impaired RV function, it leads to irreversible RV decompensation. Due to the lack of perioperative echocardiographic data concerning pulmonary regurgitation and RVOT obstruction, this hypothesis could not be proven. However, none of the 14 patients in whom the RVOT was reconstructed with a conduit died perioperatively. Hence, in patients who need enlargement of the RVOT, replacement of the pulmonary valve should be attempted. Residual pulmonary insufficiency should not be tolerated.
Older age at the time of operation is controversially discussed as a further potential risk factor for early mortality. Hu and colleagues [6] recommend surgical correction of TOF in patients older than 40 years of age, because they showed an operative mortality of only 3%. The experience of Dittrich and colleagues [5] was not equally encouraging. They observed 1 early death in a 54-year-old patient with severe cyanosis, and performed an aortopulmonary shunt instead of a total correction in another 59-year-old patient. In our cohort, the age at the time of operation did not significantly account for early mortality.
Severe postoperative bleeding that necessitates re-thoracotomy is frequently reported in the literature. Dittrich and colleagues [5] reported re-thoracotomy in 4 of 19 patients, Rammohan and colleagues [10] observed excessive bleeding in 15 of 100 patients, Atik and colleagues [11] in 4 of 39 patients. Rammohan and Atik [10, 11] each observed 1 perioperative death related to bleeding complications. In our cohort, reoperations due to excessive bleeding were necessary in 5 of 52 patients (9.6%). From 1986 onward, all patients included in this study were treated with aprotinin [16]. No reoperations due to excessive bleeding were necessary in these patients. However, this decrease did not reach statistical significance.
In contrast to the perioperative course of adult patients undergoing TOF repair, the long-term survival has been reported to be excellent. In patients operated for TOF at the age of greater than 18 years, Nollert and colleagues [12] found the long-term survival as great as 35 years after correction being comparable with the life expectancy of the general population. However, all patients who died within the first year after correction (33 of 104 patients) were excluded from this analysis. This finding was affirmed by Hu and colleaques [6], who found that 10-year survival of their cohort (30 patients, age at correction over 40 years) was not different from that of the normal age-matched population, but differed from that of medically treated TOF patients. In these patients, cardiac-related deaths occurred from arrhythmia, myocardial infarction, and congestive heart failure. Presbitero and colleagues [9] observed 3 of 40 late cardiac-related deaths after an average of 10.7 years after correction. Two of these patients had undergone a previous shunt operation. Searching for risk factors for late cardiac-related death, Nollert and colleagues [17] showed that a higher preoperative NYHA functional class and absence of previous palliation are important risk factors for sudden cardiac death in 658 patients with correction of tetralogy of Fallot. However, Nollert and colleagues' [17] study included all TOF patients who had been operated on between 1958 and 1977, regardless of age at the time of operation (median age, 12.2 years). In our study, 2 patients died from cardiac-related deaths at 24 and 25 years after primary correction. Both patients had preoperatively been in NYHA functional class II and had not had palliation prior to repair. Correction was performed without an RVOT patch in both cases. We could not determine any preoperative factor that had an influence on long-term mortality.
Not only long-term survival, but also the functional status has been shown to be excellent. Atik and colleagues [11] and Nollert and colleagues [12] demonstrated a significant improvement in NYHA functional class in their series. We could confirm these findings in our cohort. At follow-up, 75% of the patients led a normal life with full-time work, 21 patients (65.6%) were married, and 13 of 19 women had delivered children. We believe that despite the high perioperative mortality of adult patients with TOF or PA-VSD, these patients clearly benefit from total correction because the functional status improves markedly.
There were certain limitations to the study. The design was set up as a retrospective follow-up study that had missing values that were inevitable because some variables had not always been documented. Because there were only 2 late cardiac deaths, it was not possible to assess risk factors for late cardiac-related mortality by means of statistical analysis. The comparison between NYHA functional class preoperatively and at the time of follow-up is limited because patients were assigned to a NYHA functional class during the preoperative examination by a physician, whereas they were asked to rate their functional status themselves at the time of follow-up.
Controversy exists as to whether PA/VSD and TOF should be treated as two distinct entities. The PA-VSD is frequently considered the most severe end of the spectrum of TOF [18]. However, in children with PA/VSD, the origin of pulmonary blood flow is different from that in children with TOF. Because of multiple palliative operations, the origin of pulmonary blood flow was very heterogeneous in the present study population. On the one hand, 36% of the TOF patients in this cohort survived until adulthood because shunt operations had been performed in early childhood. Hence, pulmonary blood flow in these patients was not only determined by antegrade flow through an original main pulmonary artery for a long time period. On the other hand, in 40% of the PA/VSD patients, the RVOT had been reconstructed with a conduit during palliative surgery and collaterals had been ligated. Therefore, we believe it is permissible to look at TOF and PA/VSD as one entity, especially in this subgroup of uncorrected adult patients.
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F. A. Atik and G. B. Pettersson
Invited commentary
Ann. Thorac. Surg.,
December 1, 2005;
80(6):
2291 - 2292.
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Abstract
Introduction
