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Ann Thorac Surg 1998;66:506-511
© 1998 The Society of Thoracic Surgeons

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Original articles: cardiovascular

A 26-year experience with surgical management of tetralogy of fallot: risk analysis for mortality or late reintervention

^a Section of Thoracic Surgery, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA
^b Section of Pediatric Cardiology, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA

Address reprint requests to Dr Knott-Craig, University of Oklahoma Health Sciences Center, PO Box 26901, Oklahoma City, OK 73190

Presented at the Forty-fourth Annual Meeting of the Southern Thoracic Surgical Association, Naples, FL, Nov 6–8, 1997.

	Abstract

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Background. Over the past decade repair of tetralogy of Fallot (TOF) in infancy has gained favor. It is still uncertain what effect early complete repair will have on survival or late reoperation on the right ventricular outflow tract.

Methods. To assess these outcomes, we reviewed our experience (1971–1997) with 294 patients undergoing operation at one institution. Median follow-up was 10.6 years (range, 0.1 to 26 years), and was complete for 90.2% patients.

Results. Primary complete repair was done in 199 patients (68%), and a staged repair in 62 patients (21%). Thirty-three patients had only a palliative procedure. Sixty-eight patients (23.1%) had complex pathologic processes, including pulmonary atresia in 53. Hospital mortality for primary repair was 11.1% (22/199), for staged repair was 17.7% (11/62), and for palliative procedures was 15.5% (16/103 procedures). Since 1990 mortality has been 2.1%, 11.8%, and 0% respectively (p < 0.001), despite younger age at repair (0.6 ± 0.1 versus 2.1 ± 0.2 years; p < 0.001). Multivariate analysis identified longer period of hypothermic circulatory arrest, pulmonary artery patch angioplasty, earlier year of operation, and closure of the foramen ovale as risk factors for hospital death. For hospital survivors 20-year survival was 98% ± 3% for TOF with pulmonary stenosis and 88% ± 9% for TOF with pulmonary atresia (p = 0.09). Reintervention on the right ventricular outflow tract was needed in 14.1% (37/261) patients. Freedom from reintervention on the right ventricular outflow tract at 20 years was 86% ± 4% for TOF with pulmonary stenosis and 43% ± 16% for TOF with pulmonary atresia (p = 0.001). For the subgroup TOF with pulmonary stenosis, this was 85% ± 5% after primary repair and 91% ± 8% after staged repair (not significant). At 15-year follow-up, this was 78% ± 10% for patients not older than 1 year at operation compared with 88% ± 4% for older patients (not significant).

Conclusions. Early mortality after primary repair of TOF has significantly improved and late survival is excellent. Primary repair in infancy does not increase risk for reintervention on the right ventricular outflow tract.

	Introduction

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Tetralogy of Fallot (TOF) is the most common cyanotic congenital heart disease with approximately 3,000 new cases diagnosed in the United States each year [1]. Since the first successful repair by Lillehei and colleagues in 1954 [2], several reports have documented the excellent long-term prognosis for these patients, at the same time recognizing that those repaired after about 7 years of age fared less well [1, 3–6].

Despite some advocates of routine primary repair in infancy [7, 8], unacceptable early mortality resulted in wide acceptance of a two-stage repair, with excellent results [9, 10]. During the early 1990s, reports documented improved early results with primary repair in infancy [11–19] and suggested that primary repair was associated with improved outcome compared with a two-stage approach [20]. However, the impact of this more aggressive surgical approach on late survival or recurrent right ventricular outflow tract (RVOT) pathology is still unclear.

To clarify some of these issues, we report our surgical experience during three decades with TOF patients, with emphasis on the evolution to earlier repair and the influence this has had on early outcome and recurrent right heart obstruction.

	Material and methods

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Patients
The medical records of all patients who underwent operation for TOF at the Oklahoma University Health Sciences Center between 1971 and October 1997 were reviewed. These included patients with classic TOF with pulmonary stenosis (TOF-PS) and those with associated pulmonary atresia (TOF-PA), but excludes other complex associated pathologic processes such as absent pulmonary valve syndrome or common atrioventricular canal.

There were 294 patients in the study group. One hundred ninety-nine patients had primary complete repair of TOF without an initial palliative procedure (primary repair group). Sixty-two patients had initial palliation followed by a complete repair at a later stage (staged repair group). Thirty-three patients have undergone only a palliative procedure, of which 12 late survivors are awaiting staged repair.

Two hundred twenty-six patients had uncomplicated TOF, 53 had TOF-PA, and 15 had other associated complications such as anomalous coronary artery, diffuse pulmonary artery hypoplasia or branch pulmonary artery stenoses, or coronary artery fistulas. There were 169 male and 125 female patients in the study group. The mean age at complete repair was 2.4 ± 0.2 years, and weight was 11.0 ± 1.5 kg. Patient and procedural characteristics are depicted in Table 1. Although the percentage of patients having primary complete repair has not changed during the study period (83.7% before 1990 versus 83.3% since 1990), the age at repair has decreased significantly. Currently, 82.6% patients are repaired in infancy, about half with a transatrial approach. The choice of transatrial closure of ventricular septal defect has been surgeon’s preference, although more recently both surgeons (R.C.E. and C.K.C.) have used this approach preferentially.

Fifty-five percent (17 of 31) of patients with TOF-PA had RVOT reconstructed with a valved conduit, compared with 3% (7 of 230) of patients with TOF-PS.

Data collection
From review of the medical record, data were collected relevant to the date of complete repair. An attempt was made to achieve follow-up on all the patients by means of telephone interviews with the patients, their parents, or their primary care physicians; cardiology clinic follow-up visits were also reviewed.

Recent follow-up was achieved in 266 patients (90.2%). Mean and median follow-up was 10.6 ± 7.4 years and 10.67 years (range, 0.1 to 25.9 years). Information gleaned at follow-up included their current functional status and whether they had undergone any reinterventions on the RVOT. Arrhythmia information was not collected.

Statistical analysis
In addition to analyzing the data as a single time period, we also used three intervals for comparison of the data: 1971 through 1980, 1981 through 1990, and 1991 through 1997. Categoric variables were compared using ² or Fisher’s exact methods and continuous variables were analyzed using the Wilcoxon rank-sum method or Student’s t test. Hospital mortality was defined as death before hospital discharge or within 30 days of operation. Kaplan-Meier methods were used to analyze long-term survival and freedom from reoperation. Differences between survival distributions were assessed by log-rank testing. Probability values less than 0.05 were considered significant for all tests. Multiple logistic regression was used to investigate potential risk factors for hospital mortality, and Cox proportional hazards regression was used to assess factors associated with reoperation on the RVOT. Forward stepwise selection methods were used to add variables to the regression models, requiring significance at p less than 0.10 for entry and p less than 0.05 for retention in the model.

The variables evaluated as potential risk factors for (1) early mortality or (2) need for reintervention included age and weight at operation, transatrial versus transventricular closure of ventricular septal defect, aortic cross-clamp time, transannular versus no transannular patch, patch augmentation of pulmonary arteries, use and duration of hypothermic circulatory arrest, closure of small atrial septal defect or persistent foramen ovale, presence of significant comorbidity such as multiple congenital abnormalities or intercurrent respiratory syncytial viral pneumonias, TOF-PS versus TOF-PA, complex pathologic processes including TOF-PA, sex, and year of operation.

	Results

Top Abstract Introduction Material and methods Results Comment Acknowledgments References

 
Overall hospital mortality for primary repair was 11.1% (22 of 199), for a completed staged repair was 17.7% (11/62), and for all initial palliative procedures was 15.5% (16/103). For the current decade, these results are 2.1%, 11.8%, and 0% (p = 0.001) (Fig 1). During the study period, the age at which complete repair was effected has steadily decreased, and in the current decade 82.6% of new patients were repaired in infancy (1 year old). Overall, 90 patients (34.7%) were repaired as infants.

View larger version (18K): [in this window] [in a new window]   Fig 1. Early mortality by decade for repair of tetralogy of Fallot either as a primary repair (n = 199) or as a staged repair (n = 62) between 1971 and 1997.

Logistic regression analysis identified the following variables to be significantly associated with hospital mortality: need for pulmonary artery patch angioplasty, closure of foramen ovale, longer period of hypothermic circulatory arrest for repair, and year of operation (Table 2). Neither transannular patch for RVOT reconstruction, nor age at operation were risk factors. Twenty-year survival for hospital survivors was 98% ± 3% for TOF-PS and 88% ± 9% for TOF-PA (not significant) (Fig 2).

View larger version (16K): [in this window] [in a new window]   Fig 2. Late survival after complete repair of tetralogy of Fallot by presence or absence of associated pulmonary atresia (excluding early mortality).

Reintervention on RVOT was needed in 14.1% (37/261). Multivariate analysis identified only the presence of complex disease (including TOF-PA and those needing pulmonary artery patch angioplasty) and longer period of circulatory arrest time to be significantly associated with occurrence of reoperation on the RVOT (p = 0.05). Variables not associated with risk for reoperation included staged repair, younger age at repair, and transannular patch reconstruction of the RVOT.

Freedom from reintervention on the RVOT was 86% ± 4% at 20 years for patients with TOF-PS and 43% ± 16% for those with TOF-PA (Fig 3). When we analyzed only those with TOF-PS having repair (n = 230), at 15-year follow-up there was no difference in the freedom from reintervention for patients having a primary complete repair compared with those having a staged repair, 85% ± 5% versus 91% ± 8% (Fig 4). Neither was there any difference between patients repaired at equal to or younger than 1 year compared with older patients, 86% ± 8% versus 90% ± 4% (Fig 5).

View larger version (22K): [in this window] [in a new window]   Fig 3. Freedom from reintervention on the right ventricular outflow tract after tetralogy of Fallot repair.

View larger version (18K): [in this window] [in a new window]   Fig 4. Freedom from reintervention on the right ventricular outflow tract after tetralogy of Fallot repair, excluding patients with associated pulmonary atresia, as a function of primary or staged repair.

View larger version (18K): [in this window] [in a new window]   Fig 5. Freedom from reintervention on the right ventricular outflow tract after tetralogy of Fallot repair, excluding patients with associated pulmonary atresia, as a function of age at repair.

	Comment

Top Abstract Introduction Material and methods Results Comment Acknowledgments References

These benefits all presuppose that the repair can be done safely and that the long-term outcome parallels that of older patients [1, 3–6]. Previous studies have shown that age at operation less than about 6 months, low weight, and transannular patch reconstruction of the RVOT are all associated with increased mortality after intracardiac repair [8, 25]. In contrast, recent reports document current safety of repair within the first year of life [11–19]. The late outcome is still uncertain, however, as most follow-up periods have only been 2 to 5 years [11, 15, 17, 24].

Our study confirms the trend toward earlier repair and further substantiates the current safety of repair in early infancy. Furthermore, our study reaffirms that repair within 1 year of age is associated with significantly higher incidence of transannular patch [11, 26]. However, in contrast to the European Congenital Heart Surgeons Foundation report of 1,283 children with TOF repaired since 1992 [27], young age and transannular patch was not associated with increased risk. The higher need for transannular patch is a function of the small difference between an acceptable and a hypoplastic pulmonary annulus in small infants.

Both early and late survival was significantly poorer in patients with TOF-PA, and in addition, the risk of RVOT reoperation was also considerably higher. These data are in agreement with other reports [25, 26]. When we analyzed risk of reoperation on the RVOT for patients with TOF-PS, we could find no difference in risk whether they had primary complete repair or whether they had a prior palliative shunt. In both groups the risk was about 10% at 10 years (Fig 4). Equally interesting was the comparison between patients repaired as infants (1 year old) and those repaired at older age (Fig 5). There was no significant difference in their risk for reoperation at 10 to 15-year follow-up. These data suggest, therefore, that there is no disadvantage in terms of late reoperation risk if the repair is done in infancy, despite the fact that more of these patients need a transannular patch at the time of operation. In fact, it has been suggested by some authors that transannular patch is, in fact, not detrimental and may be beneficial to right ventricular function; furthermore, it may convey some protection from late arrhythmias by contributing to a restrictive right ventricular diastolic flow pattern [14, 28–31].

We have not studied late arrhythmias, the influence of peripheral pulmonary arterial pathology on RVOT reintervention, nor the possible influence of patch materials used. These are caveats that need to be taken into consideration in evaluating our conclusions. Because the early mortality and late survival after primary repair of TOF is excellent and there does not appear to be an increased risk of reoperation when the repair is carried out in infancy, we continue to encourage early primary repair in infancy, and reserve a staged repair for those patients with complex pathologic processes or significant noncardiac comorbidity.

	Acknowledgments

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We thank Ms Karen Dale for the excellent preparation of the manuscript.

	References

Top Abstract Introduction Material and methods Results Comment Acknowledgments References

 

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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Christopher J. Knott-Craig Ronald C. Elkins Mary M. Lane Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Knott-Craig, C. J. Articles by Ward, K. E. Search for Related Content PubMed PubMed Citation Articles by Knott-Craig, C. J. Articles by Ward, K. E.