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J Thorac Cardiovasc Surg 2003;126:511-520
© 2003 The American Association for Thoracic Surgery
Surgery for congenital heart disease |
a Department of Cardiac Surgery, The General Hospital, Southampton, United Kingdom
b Department of Paediatric Cardiology,b The General Hospital, Southampton, United Kingdom
Read at the Eighty-second Annual Meeting of The American Association for Thoracic Surgery, Washington, DC, May 5-8, 2002.
Received for publication June 11, 2002; revisions received October 9, 2002; accepted for publication December 9, 2002.
* Address for reprints: James L. Monro, FRCS, Consultant Cardiac Surgeon, Department of Cardiac Surgery, The General Hospital, Tremona Rd, Southampton SO16 6YD, United Kingdom
Monro1711{at}aol.com
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Abstract |
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METHODS: We present a retrospective analysis of 1220 consecutive children under 16 years [649 (53%) under 1 year] operated on between 1976 and 2001 by 1 surgeon (J.L.M.).
RESULTS: The early (30-day) mortality was 6.9%; 171 patients had 206 reoperations. The early mortality for the first reoperation was 10.4% and for second reoperation, 3.8%. Of the first-time reoperations 63% were inevitable, 15% were planned, and 22% were unexpected. The overall 20-year freedom from reoperation was 83% and survival (including early mortality) was 86%. The 10-year freedom from reoperation and survival, respectively, was as follows: aortic valvotomy, 77% and 92%; pulmonary valvotomy, 90% and 95%; atrial septal defect, 99% and 100%; partial atrioventricular septal defect (AVSD), 81% and 94%; complete AVSD, 74% and 70%; VSD, 95% and 97%; double-outlet right ventricle, 66% and 68%; truncus arteriosus, 54% and 71%; Mustard, 85% and 86%; arterial switch, 78% and 74%; Fontan, 77% and 66%; Fallot, 91% and 93%; and total anomalous pulmonary venous drainage, 89% and 84%. Of those undergoing aortic valvotomy, 53% were infants, but when aortic valve replacement became necessary an adult valve could be inserted. Introduction of the total cavopulmonary connection to the Fontan procedure in 1990 with prior cavopulmonary anastomoses has greatly improved outcome, with only 1 reoperation and no deaths since then. Patients with AVSD required 12 reoperations for mitral regurgitation, mostly through the "cleft," the closure of which in the past 5 years has provided promising results.
CONCLUSIONS: The majority of reoperations after repair of congenital heart defects in children are inevitable, and their incidence varies for different types of procedures. These findings will help in informing parents about the possible outcome of surgery, but the introduction of newer techniques may reduce the need for reoperation further. The survival is encouraging.
Key Words: Keyword: 20 • 21
Although results of surgery for congenital heart disease are now good, apart from some simpler conditions, for example, atrial (ASD) and ventricular septal defect (VSD), it has become apparent that many children may require further surgery. Therefore, to describe the initial operation as a "repair" rather than correction seems to be appropriate.
Increasingly, parents need more information about the operations their children are to undergo, not only the immediate risks but also the long-term prospects including the need for further intervention.
The main purpose of this study was to determine how many patients require reoperation, when, why, and the outcome. The reasons for reoperation are classified into planned, inevitable, and unexpected. As surgeons, we probably cannot do much about the inevitable group, but we must try to minimize the unexpected group.
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Methods |
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Between 1976 and 2001, a total of 1220 consecutive children (mean age 32.2 ± 34.5 months, range 1 day to 15 years) had a first-time cardiac operation with cardiopulmonary bypass (CPB) performed or supervised by 1 surgeon (J.L.M.). There were 581 girls (48%) and 639 boys (52%) with a mean age of 32.2 ± 34.5 months (range 1 day to 16 years). Of these patients, 649 (53%) were infants (up to 1 year old).
Patient demographics
Data on early (30-day) death and the incidence of reoperation were collected retrospectively from the department’s computerized database. Patients who had had previous surgery without the use of CPB were included, but patients who had had a previous CPB operation elsewhere or by the principal surgeon before 1976 were excluded. Patients were grouped according to their first operation on bypass, and "miscellaneous" was defined as those groups with less than 15 patients (appendix).
Technical considerations
All operations (apart from a few ASDs closed through the right side of the chest) were performed through the midline. For the first 15 years of this series the great majority of infants were operated on with the use of deep hypothermia and circulatory arrest. This has become increasingly infrequent and now circulatory arrest would be used only for short periods, for example, in repair of an interrupted aortic arch. Otherwise, standard CPB techniques were used with membrane oxygenators since 1987. Crystalloid cardioplegia has been used since 1978 and cold blood cardioplegia for the past 7 years. Standard operative procedures were used as previously described.1-4
Reoperations
Reoperations were considered to be those requiring CPB. They could be classified into the following groups:
Follow-up
Patients were followed up by the pediatric cardiologists, both in the main unit and in peripheral clinics. If all was well, patients with the simplest conditions such as ASDs and VSDs would be discharged. All others would be continually observed, and, if patients were well, with increasing intervals between appointments. Follow-up of the patients has therefore been obtained by contacting the pediatric cardiologists, other physicians, or the patient‘s general practitioner. With the exception of 3 cases, we performed all the reoperations.
Statistics
Continuous variables are expressed as means ± SD and proportions as percentages. Freedom from reoperation and survival (±SEM) were calculated by the product-limit method of Kaplan and Meier and include both early mortality and reoperations performed within the same hospital admission after the initial repair. Statistical analysis was done with the statistical package SPSS PC (version 8.0; SPSS Inc, Chicago, Ill).
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Discussion |
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In advising parents and patients what to expect in the way of further operations, this article gives a guide, but it must be interpreted with care. For closure of isolated ASDs and VSDs, the likelihood of reoperation is very small. In fact, there was only 1 reoperation for recurrent VSD out of 237 isolated VSD closures. The remaining reoperations in the VSD group were for unrelated factors. Thus, as the likelihood of complications requiring further surgery is so small, most of these patients would be discharged after 1 or 2 follow-up visits. However, virtually all other patients are observed for reasons illustrated in this article.
Of the 108 inevitable reoperations, 11 were for conduit replacement and 50 for valve surgery. It seems unlikely that the need for these procedures will change much in the future.
The number of unexpected "first reoperations" at 3.2% of survivors was reasonably low. Sixteen of the 37 were within 30 days of the first operation. Eight of these unexpected reoperations can be regarded as technical failures (eg, for residual VSDs) and 3 as "bailout" operations (eg, Fontan takedown). In 24 patients various stenoses developed (Table 2) between 1 day and 7 years postoperatively and 1 patient required mitral valve repair 7 days after repair of CAVSD. Ideally, pulmonary artery stenosis after a switch procedure and Mustard baffle obstruction will become less common. Furthermore, it is perhaps unfair to include recurrent right ventricular outflow tract reconstruction after repair of Fallot’s tetralogy occurring more than a year later after a good repair with a low postoperative right ventricular/left ventricular pressure ratio in this group at all. Therefore, the number of unexpected reoperations should fall.
Although the number of second reoperations was small, it is gratifying that the early mortality was less than for first reoperations and that there was no mortality for subsequent reoperation. Clearly one of the risks at reoperation is from bleeding when the sternum is opened. Cannulation of the femoral artery before sternal opening has only been used rarely (eg, when it is known that a conduit is directly behind the sternum).
In advising parents about the likely outcome of an operation, the early mortality and late outcome are equally important. Therefore, although this report is chiefly concerned with reoperations, unlike Lange’s series,12 we have included the early mortality. Clearly the patient who has a suboptimal operation and dies will not have postoperative complications requiring reoperation. Therefore, to just report reoperations without the early mortality does not give the whole picture.
Patients undergoing aortic valvotomy are almost certain to need further surgery, and the parents should be warned accordingly. However, the freedom from operation at 10 years in this series was 77% even though 33 (53%) of the patients undergoing aortic valvotomy were less than 1 year of age. Because of the good results with open surgical valvotomy, we still opt for this mode of treatment rather than balloon valvotomy. We suggest that this results in less early regurgitation and, because of a precise splitting of fused cusps, delays the eventual reoperation, at which time an adult-size valve can usually be inserted.13 Occasionally it is possible to perform repair rather than replacement at reoperation.14 Although the occurrence of severe aortic regurgitation in an infant is an indication for a Ross procedure, none has been done in this series. When aortic valve replacement has been necessary, we have favored mechanical valves.15
The patients undergoing repair of PAVSD and CAVSD had a relatively high incidence of subsequent mitral valve regurgitation, which is related to leaving the cleft unsutured, as recommended by Carpentier.16 We now suture it, which should result in less late mitral regurgitation, and parents can be advised accordingly.
The 25% mortality for truncus arteriosus compares favorably with that in the United Kingdom,17 which was 41% between 1978 and 2000. We used large homografts whenever possible and the mean interval before replacement was 12.7 years.18 This compares favorably with the 6.2 years reported by Lange and coworkers.12 In comparison, only 2 of 28 survivors after repair of pulmonary atresia and VSD have had their homografts replaced, possibly because larger valves were inserted.
The Mustard procedure was the treatment of choice for TGA until about 1986 when the switch procedure was introduced, although they overlapped for a few years. It is an interesting example of a technique that at that time had a low mortality but with an inevitable falloff in years to come, being superseded by an operation that at the time had a high mortality but ideally a trouble-free late outcome. As Figures 3 and 4 show, in this small experience, the lines have still not met, mainly because the early experience with the switch procedure in this series had a high mortality by today’s standards and a relatively high incidence of pulmonary artery stenosis.
Of those patients undergoing a Fontan procedure before 1990, only 26% are alive without having further surgery, but since 1990, with the total cavopulmonary connection2 and subsequently extracardiac conduit,19 there have been no early or late deaths among 20 patients. This is a good example of how a planned reoperation (after a cavopulmonary anastomosis) has improved survival despite increasing the total number of operations.
In Fallot’s tetralogy we have always had a policy of correcting rather than palliating where possible. During the period of this study, the principal surgeon has only palliated 10 infants. It was interesting that 5 patients developed recurrent right ventricular outflow tract obstruction (even when the immediate postoperative right ventricular/left ventricular pressure ratio was less than 0.5) and this was usually within 2 years. However, many patients will have received transannular patches and inevitably will have pulmonary regurgitation, which may necessitate the insertion of a valve in the pulmonary region in due course. However, in 89 infants among this group undergoing correction of Fallot’s tetralogy, although 77% had a transannular patch, 95% were free of pulmonary valve replacement 20 years later.20
The miscellaneous group is so diverse that comment is difficult. So many complicated patients fall into this group that it is not surprising that the mortality was high at 20% and the reoperation rate also high at 28%.
In conclusion, although obviously the longer a group of patients is observed, the more reoperations they will need, it is encouraging that only 15% of operative survivors required reoperation up to 26 years postoperatively. This is clearly dependent on the case mix but gives a good idea of the likelihood of reoperation when it comes to giving advice to parents. Also, some of the operations have been superseded or changed considerably, which ideally will result in fewer reoperations being required in the future.
This study has shown that in probably less than 1% of operations were there avoidable surgical errors resulting in reoperation. However, errors may be concealed in the early mortality, which is why it has also been reported here.
The overall 86% 20-year Kaplan-Meier survival in this group is encouraging for a group containing patients operated on many years ago. The early mortality has declined so much in most centers that the overall survival must improve, but most patients should be observed to detect any need for reoperation, which can be achieved with low mortality. However, the inevitable group of reoperations will probably not reduce much and we should continue to consider operations for congenital heart disease as repairs rather than corrections.
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Discussion |
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What has been presented here this afternoon is the product of an archival database reflecting 25 years of experience in the management of infants and children with congenital heart disease. Although it was perhaps less apparent 25 years ago, the importance of this archival process is all too apparent today. Quality assurance and quality improvement, outcomes research in general, are mere phrases without the discipline and the diligence to prospectively record accurate clinical data. For his pioneering effort in this regard with respect to congenital heart disease, Mr Monro deserves a great deal of credit.
This analysis focuses on issues of reoperation and survival. Entry into the overall data set required that a child underwent a primary repair with CPB. Reoperations were assigned to 1 of 3 categories: inevitable, planned, or unexpected.
In some instances, as, for example, with respect to partial AVSD, changes in surgical strategy led to a significant reduction in the need for secondary operations. In other instances, such as the move toward staging of single ventricle repairs, a strategy that virtually ensures the need for secondary operations, resulted in a significant survival advantage.
Mr Monro, I have a few questions:
Mr Monro. Thank you very much, Marshall.
Your first point is well taken. We had to stop somewhere and I decided that we would just include patients who had initial repair on CPB. This excluded some that I had done previous repairs on before 1976, when this study started. It excluded a lot of patients with patent ductus artriosus, coarctation, and so on. Every patient who had a primary CPB operation is included. There are several with pulmonary atresia and intact septum in this group, but a relatively small number. As I say, we had to stop somewhere.
With regard to your point about how did we define what was inevitable, I think I like your suggestion of anticipated better. I agree that with partial AVSD, when you have to go back later to repair the mitral valve, should it be inevitable or not? As I mentioned, if you get a patient who develops a right ventricular outflow tract obstruction 2 years after repair of tetralogy of Fallot, having had a low right ventricular/left ventricular pressure ratio at the end of the operation, is that inevitable or is it unexpected? We put it in the unexpected group, but it might be fairer to call it inevitable or anticipated. So it was difficult, but we just tried to classify the reoperations into what seemed the most appropriate groups. As you say, we must try to keep the unexpected group as small as possible.
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