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Right arrow Congenital - cyanotic

Eur J Cardiothorac Surg 2006;30:917-922
© 2006 Elsevier Science NL

Medium term outcome for infant repair in tetralogy of Fallot: indicators for timing of surgery

Adrian Ooia,*, Narain Moorjania, Giedrius Baliulisa, Barry R. Keetonb, Anthony P. Salmonb, James L. Monroa, Marcus P. Hawa

a Department of Cardiothoracic Surgery, Wessex Cardiothoracic Centre, Southampton University Hospital, Tremona Road, Southampton, United Kingdom
b Department of Paediatric Cardiology, Wessex Cardiothoracic Centre, Southampton University Hospital, Southampton, United Kingdom

Received 2 October 2005; received in revised form 14 August 2006; accepted 24 August 2006.

* Corresponding author. Tel.: +44 2380 796234; fax: +44 2380 798508. (Email: adrianooisw{at}yahoo.co.uk).


   Abstract
Top
 Abstract
1. Introduction
 2. Material and methods
 3. Results
 4. Discussion
 Appendix A
 References
 
Objective: To assess the impact of early corrective surgery on the short and medium term outcome in tetralogy of Fallot (TOF). Materials and methods: All patients under 12 months of age undergoing correction of isolated TOF between February 1997 and July 2003 were reviewed retrospectively. Outcome data for mortality, post-operative care management, major morbidity and clinical follow-up were analysed. Results: Fifty-two operations were performed. The mean age at surgery was 5 months (range 1–12) of whom 16 (30.8%) were less than 3 months old, including 2 neonates, 22 (42.3%) were 3–6 months old and 14 (26.9%) were 7–12 months old. There was 1 (1.9%) early death caused by a cerebro-vascular accident and 1 (1.9%) late death secondary to acute infective endocarditis. There were no differences in post-operative morbidities attributable to age. Patients under 3 months old required greater duration of post-operative ventilation, ITU stay and in-hospital stay. At a mean follow-up of 4.0 years (range 1.5–8.0), 33 (63.5%) patients had well-tolerated pulmonary regurgitation (PR) and 3 (5.8%) patients required re-operation for right ventricular outflow tract obstruction (RVOTO). All patients had right bundle-branch-block but with QRS < 150 ms. Conclusion: Early definitive repair of TOF can be performed safely on patients under 6 months old. Age at surgery does not appear to affect the medium term haemodynamic outcome. However, early surgery does escalate the need for ICU care. This data suggests repair in asymptomatic patients be delayed until 3–6 months of age.

Key Words: Tetralogy of Fallot • Trans-annular patch • Pulmonary regurgitation


   1. Introduction
Top
 Abstract
 1. Introduction
2. Material and methods
 3. Results
 4. Discussion
 Appendix A
 References
 
Corrective surgery for tetralogy of Fallot (TOF) is now routinely performed under 1 year of age, and the age of elective repair has been steadily decreasing. Early complete correction can have a low operative mortality, provide acceptable asymptomatic long-term survival and may be associated with a low rate of re-intervention [1–5]. The single-stage surgical repair avoids a primary palliative shunt procedure, prolonged right ventricular hypertrophy and long-standing cyanosis [6–9]. The one-stage repair may also avoid inhibition of angio- and alveologenesis and hence allow for more normal development of pulmonary arterial system [10].

Small size and under weight infant, however, may make the repair technically challenging and lead to an imperfect haemodynamic outcome. Furthermore, there may be increased morbidity and mortality in the younger infants. In this study, the impact of age at corrective surgery on morbidity and mortality were assessed, while also comparing elective versus urgent surgery in the different age groups of infants less than 3 months, 3–6 months and 7–12 months old. Medium term outcome of corrective surgery in infancy were also assessed as the secondary objective, particularly the clinical outcome of patients with trans-annular patch (TAP), the progression of right ventricular function and pulmonary regurgitation (PR). Using these data, we hope to gain insight into and try to determine the optimum timing for definitive repair of tetralogy of Fallot under the age of 12 months.


   2. Material and methods
Top
 Abstract
 1. Introduction
 2. Material and methods
3. Results
 4. Discussion
 Appendix A
 References
 
Consecutive data was collected retrospectively on all infants undergoing correction of TOF between February 1997 and July 2003. Two surgeons at a single cardio-thoracic centre performed all the operations. Outcome data was analysed for post-operative morbidity, mortality and post-operative care management. Follow up at six monthly intervals was by paediatric cardiologists and included echocardiography and 12-leads ECG. Data was obtained by retrospective review of the hospital records.

The anatomic diagnosis of TOF was made by echocardiography and was supplemented in most cases by cardiac catheterization. All cases displayed anterior deviation of the infundibular septum, a large perimembranous VSD, and an overriding aorta. All cases displayed some degree of pulmonary stenosis and or infundibular obstruction. Pulmonary valve annulus was measured at surgery with a metal obturator. Patients with multiple major associated cardiac anomalies such as complete atrio-ventricular (AV) canal defect and pulmonary atresia with VSD were excluded.

Urgent operation denotes surgical repair during the same admission as referral for cyanotic spells and/or persistent desaturation (≤80%). Inotrope therapy is defined as Dopamine > 5 mcg/kg/min, any dosage of adrenaline and noradrenaline. Early operative mortality includes any death occurring within 30 days after the operation or during the same hospital admission. After surgical correction, procedures performed by the paediatric cardiologists at recatheterization such as balloon angioplasty and stenting, are defined as re-intervention. Colour-flow and continuous-wave Doppler echocardiography was used to detect PR and to assess its severity, and classified as mild moderate or severe dependant on the distance of the regurgitant jet into the right ventricle. The patients were divided into three groups according to age at surgery, <3 months (GpA), 3–6 months (GpB), and 6–12 months (GpC). The outcome of surgery was compared between the groups.

The data is presented as mean ± standard error of mean (SEM) for statistical analysis. P values <0.05 were considered significant and comparisons made using chi-squire test and Student t-test. Freedom from time related events were analysed using the Kaplan–Meier method and all data analyses were evaluated using the Statistical Package for the Social Science Programme (SPSS Inc, Chicago, IL).


   3. Results
Top
 Abstract
 1. Introduction
 2. Material and methods
 3. Results
4. Discussion
 Appendix A
 References
 
A total of 52 operations were performed over a period of 6 (1/2) years. There were 23 (44.2%) male patients. The mean and median age to surgery was 5 and 4 months of age respectively with the range of 0–12 months old. Fig. 1a shows the age distribution of patients in each group with 16 (30.8%) patients under the age of 3 months old. The mean weights for each group were 4.1 kg for GpA, 5.7 kg for GpB and 6.8 kg for GpC. Overall, one third of patients were below 5 kg of body weight with the smallest child was 1.8 kg and the largest 9.2 kg (Fig. 1b). Fig. 1c shows that younger patients are also smaller and lighter in weight at surgery. The average weight of the patients decreased accordingly to the decreasing age, with the exception of one patient at 9 month old. He was a large infant and being the only patient in that age group slightly deviates from the linear age–weight relationship.


Figure 1
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  		Fig. 1. (a) Age distributions of patients in Groups A, B and C. (b) Weight distribution of infants operated for Tetralogy of Fallot. (c) Patients pre-operative weight versus age at surgery.

 
Thirty patients (58%) had a diminutive pulmonary valve annulus with a Z-score measured at surgery of –2 or less. Pulmonary valve annulus was not affected by the age at surgery. The type of surgical repair was dependant on the anatomy found in each child, and varied from closure of VSD with minimal infundibular muscle resection to closure of VSD, extensive infundibular muscle resection, trans-annular patch, and branch pulmonary artery augmentation. The trans-annular patch rate was no different in the three age groups (Table 1 ).


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  		Table 1. Operative repair procedures and immediate post-operative complications
 
It has been our general policy to perform elective repair in TOF at about 6 months of age. Fourteen of 16 cases in Group A required intervention on symptomatic grounds and our policy has been to perform full repair in preference to modified Blalock–Tausig shunt. Thus, 13/16 patients in Group A were urgent cases due to spells or sustained cyanosis. 1/16 was an emergency who was born at 1.1 kg and 32 weeks gestation and had diminutive pulmonary arteries. After 4 weeks feeding the child had a 3 mm RMBTS. In the ICU she suffered pulmonary oedema and pulmonary overflow and cardiac arrest. She then underwent emergency full repair with reconstruction of the left pulmonary artery, and after a stormy postoperative period has made a full recovery.

3.1 Early outcome
The post-operative complications in Groups A, B and C are summarized in Table 1. The number and percentage of urgent surgery performed in these groups were 14 (87.5%), 12 (54.5%) and 6 (42.9%), respectively. There was 1 (1.9%) early death in Group A due to heart failure. There was 1 (1.9%) late death in Group C. This child had been discharged home well and was readmitted 5 weeks post-operation with acute infective endocarditis and overwhelming sepsis. Post-operative effusions occurred in 11 (21%) of cases. Infective complications were few, required only medical treatment with 1 (1.9%) pneumonia and 2 (3.8%) superficial sternal wound infection. There were 3 (5.8%) in-hospital elective re-operations due to RVOTO. One patient needed further excision of infundibular muscle and 2 patients had revision of subpulmonary patch to a trans-annular patch. Although there was no pattern to the individual complications, when complications requiring further anaesthetic were added together the data showed some differences. In Group A six patients (38%) required a further anaesthetic mostly for drainage of effusions. In Group B two patients (9%) required further invasive treatment during hospitalisation. In Group C, five patients (36%) required further invasive treatment.

The need for post-operative ventilatory and circulatory support was recorded. In Group A, all 16 patients (100%) received inotrope support, in Group B, 10 of 22 patients (46%) required inotrope support and in Group C, 9 of 14 patients (64%) required inotrope support. The increase in inotrope requirement in Group A was significant using chi square analysis (Table 2 ). The mean duration of ventilation, ITU stay and in-hospital stay were compared in different age groups (Table 3 ). The data showed that Group A patients had significantly prolonged ventilation times and ITU stay. (P < 0.05) while the in-hospital stay was shorter for patients in the older age groups.


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  		Table 2. Post-operative inotrope usage (percent of patients) compared in different age groups, also in urgent and elective surgery
 

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  		Table 3. Mean duration of ventilation, length of ITU and hospital stay
 
3.2 Medium term follow-up
Medium term clinical follow-up was achieved in the 50 (100%) survivors after surgical correction of TOF. The mean follow-up time was 4 years, ranging from 1.5 to 8 years with Kaplan–Meier survival showed in (Fig. 2a). The rate of re-operation was 3/52 (5.8%) and catheter re-intervention was also 3/52 (5.8%). Cumulative freedom from surgery and catheter re-intervention are shown in (Fig. 2b and c).


Figure 2
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  		Fig. 2. (a) Kaplan–Meier survival at 8 years including operative mortality. (b) Kaplan–Meier freedom from re-operation at 8 years. (c) Kaplan–Meier freedom from re-intervention at 8 years.

 
There were three re-operations, one for severe pulmonary regurgitation and two for RVOTO (Table 4 ). There were three catheter re-interventions. All three patients had balloon angioplasty ± stenting for branch pulmonary artery stenosis. All patients had right bundle branch block with QRS complex < 150 ms. There was no incidence of sudden death and no patient presented with ventricular arrhythmia. During the follow up, 33 (63.5%) patients had various degrees of pulmonary regurgitation (PR). The incidence of PR when compared in the three different age groups was at 56.3%, 63.6% and 71.4%, respectively. This study has shown a slight increased in the incidence of PR in the older age groups with all patients having moderate to good ventricle function. The degree of PR was compared in the 30 (58%) patients who had a trans-annular patch (Table 5 ). In Group A 6/10 (60%) patients had documented PR, in Group B 11/12 (92%) had PR, and in Group C 7/8 (88%) patients had PR. If a TAP had been performed the incidence of severe PR as documented by 2D-echcardiographic assessment was 10%, 25% and 38% in Groups A, B and C, respectively.


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  		Table 4. Medium term outcome at 4 years mean follow-up
 

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  		Table 5. Percentage of patients with PR following TAP at medium term follow-up
 

   4. Discussion
Top
 Abstract
 1. Introduction
 2. Material and methods
 3. Results
 4. Discussion
Appendix A
 References
 
The timing and nature of first surgical treatment tetralogy of Fallot remains controversial. There are supporters of early complete repair in all cases and other authors who favour staged repair in those presenting very young. Both philosophies are supported by clinical reports of excellent early results [11]. In this study we attempted to examine any age related differences in outcome both early and medium term for complete repair of tetralogy of Fallot in infants. Our unit philosophy had been developed by one of the authors over 30 years and can be summarized as elective corrective surgery performed at 6–12 months, but if cyanotic spells, sustained cyanosis or acyanotic heart failure ensue then complete repair should be performed when the infant presents with the complication. Palliation has been reserved for patients with extreme hypoplasia of the pulmonary arteries and was only performed once in this consecutive series. By examining our results in three age groups we hoped to see if urgent complete repair in neonatal life or early infancy lead to an adverse early or medium term outcome.

The three in-hospital re-operations were attributed to the unsuccessful attempt to avoid TAP and retain the borderline pulmonary annulus by using the sub-pulmonary technique. Subsequently, the sub-pulmonary technique is no longer practice in this unit. There were no age or weight related differences in post-operative mortality or individual post-operative complications. However, when grouped together, the effusive complications were greater in Groups A and C. There was also a clear age related difference in the ICU resources required in our study groups, with Group A requiring more inotrope and more pulmonary support than Groups B and C. The alternative to complete repair for these children would be to perform a MBTS. Although most palliative BT shunts are well tolerated it was noticed that the smallest child in the series (1.8 kg) had a palliative 3mm BT shunt as a first procedure and then had pulmonary oedema and cardiac arrest secondary to shunt overflow. Subsequent emergency complete repair in very difficult circumstances stabilized the haemodynamic and allowed full recovery.

Surgical correction of TOF often results in pulmonary regurgitation when a trans-annular patch is used [12,13]. Most patients with TAP in the surgical repair developed PR, which seems to be its pathophysiological mechanism [13,14]. The use of TAP is a critical decision in the repair of tetralogy and is clearly the most likely cause, over a lifetime, for re-operation [2,3]. In this study there was no difference in the trans-annular patch rate between the groups. Our study confirmed that pulmonary regurgitation was the result of performing a trans-annular patch. However, the younger infants (Group A) with trans-annular patch had a lower incidence and less severe pulmonary regurgitation at medium term follow up than those in Groups B and C. It will be fascinating to see if the need for pulmonary valve replacement is less in this group over time. One possible explanation for this finding is that pulmonary artery development is arrested in unrepaired tetralogy and that early repair leads to a greater number of pulmonary arteries radicals when division ceases at about 1 year of age [15]. Thus, patients with TAP and later repair would have a greater pulmonary afterload, and therefore perhaps be more subject to pulmonary regurgitation [16]. In addition, although patients in Group B had the least re-intervention and re-operation in the medium term follow-up, patients who had TAP have as much PR as the patients in Group C at 92% and 88%, respectively. Hence, on longer term follow-up, these patients may need re-operation or PVR.

All patients examined at follow-up were in New York Heart Association (NYHA) class I, with normal or mildly impaired right and left ventricular function. One patient who received TAP at initial surgical correction required pulmonary homograft valve replacement (PVR). At medium term follow-up, no patients have died and no patients with RV dilatation or dysfunction suffered from ventricular arrhythmias and sudden death. No patients are on medication for atrial arrhythmia. All patients with moderate RV function are being referred for MRI for further assessment of PR and RV function as a protocol for RV follow-up. The timing of PVR is guided by MRI assessment of PR, RV volume overload and RV function, as well as clinical status and arrhythmia status [13,14,17].

The limitations of this study are that it is retrospective and small. However, all patients were infants and a significant number were under the age of three months with surgery performed by two surgeons at a single cardiothoracic centre. This study has shown an encouraging result with early definitive repair, and corrective surgery of TOF can be performed safely on young and very small infants under 3 months of age [4]. In conclusion, early definitive repair of TOF can be performed safely on patients under 6 months old with good early and medium term outcome. Age at surgery does not appear to affect the early or late mortality, re-operation and re-intervention rate. However, surgery in infants less than 3 months of age results in significantly greater inotrope usage and escalates the need for ITU care. This study has concluded that although surgical correction can be performed in patients under 3 months of age with comparable early survival, they have an increased in post-operative morbidity. The duration of ventilation, ITU and in-hospital stay were not much different between the 3–6 months and 7–12 months of age but the inotrope given post-operatively were less in patients of the 3–6 months age group. In addition, there was no re-operation or re-intervention at follow-up in this age group. This study suggests that therefore, the optimum timing of surgical repair in asymptomatic TOF patients may be between 3 and 6 months of age. In symptomatic young infant less than 3 months old, a modified Blalock–Tausig shunt would be considered and performed initially to avoid the morbidity of prolonged ventilation and hospital stay. Finally, the referral of infants with asymptomatic TOF by cardiologists to surgery, ideally should not be delayed beyond 6 months of age to prevent the progression of RV dysfunction and hypertrophy or worst of all, myocardial fibrosis and scarring, which may lead to ventricular arrhythmias and sudden death in later life [18].


   Appendix A
Top
 Abstract
 1. Introduction
 2. Material and methods
 3. Results
 4. Discussion
 Appendix A
References
 
Conference discussion

Dr C. Pizarro (Wilmington, Delaware, USA): Could you please tell us how did you define the need for urgent operation?

And did you have a specific criteria for the use of inotropes? Because we all know sometimes just because a patient is younger, people are more compelled to use a strategy versus other, but unless you have a specific criteria it's hard to really compare a different subset of patients.

And lastly, did you have any chance to look at your data in regarding variables that could influence the need for reintervention? We presented our own data here at this meeting last year, and we found that surgical weight less than 2.5 kg was associated with the need for reintervention, especially on the pulmonary arteries, and I wonder if you found anything like that?

Dr Ooi: The first question is the definition of urgency. Urgent surgery in our unit is defined as patient being operated on the next available list, after being referred by cardiology, for infant with increased episodes of cyanosis and desaturation.

Regarding the inotropes, inotropes in our unit is defined as dopamine equal to or more than 5 mcg/kg/min or any dosage of noradrenalin and adrenalin.

Dr Pizarro: But was there a specific criteria?

Dr Ooi: No, it has been difficult to have a uniformed criteria for use of inotropes because we have five anaesthetic consultants who do pediatric surgery and they all think very differently. They have different ideas of how to use inotrope or when not to use it. But whatever they are doing, they must be doing right, because overall the patients did very well.

What's the last question again?

Dr Pizarro: The variables that could determine reintervention.

Dr Ooi: No, we have not run any statistics on that. But at a glance, age does not seem to affect any of the outcome or the reintervention rate.

There were reinterventions on one very young infant and two on older infants, but nothing in between.

Dr Y. d’Udekem (Melbourne, Australia): I’m surprised, if I read well from your numbers, your patients from 3 to 6 months and 7 to 12 months stay in ICU for a median of 5 and 7 days. I was wondering, what do you do with your patients in ICU for so long?

In our experience, 80% of our Fallot patients would stay overnight in ICU and go to the ward the following morning. And if we transpose your study in our centre, we would have effectively a very big difference then in the ICU stay of patients of Tetralogy of Fallot less than 3 months old, which leads us to our present policy to delay the repair for after 3–4 months of age.

Dr Ooi: I do not have answers to your questions. Obviously you must be doing something better than ours.

But in our unit, patients are being cared for by the intensivists in the intensive care unit, also there is a joint care between intensivists and cardiac surgeons and also the pediatric cardiologists. Anything that happens to the baby or any treatments that are to be given, we have a joint meeting and decide on what would be the best solution.

I do not have the criteria of discharging patients to the ward. In our unit, there is no high-dependency unit, so it's either ICU or the ward.

Dr G. Sarris (Athens, Greece): It seems that this is a study of a cohort of patients over the study period who were operated on in infancy. Have you compared this cohort of patients with the remaining tetralogy patients who were operated on over the same time period, either outside of this age group, more than 12 months of age, or who were operated on during infancy but who had, let's say, a shunting procedure?

What I am trying to understand is what your current protocol is for treating a patient who presents with tetralogy in infancy. Who do you recommend repair for, let's say, at 3 months of age, and when do you decide to either shunt or delay repair until after a year of age?

Dr Ooi: This is actually two questions.

The first one, thank you for suggestions, give me idea what to do for my next paper, and for my next presentation.

Secondly, from this limited data, we have a relatively large number of patients under the age of 6 months with relevant data of clinical outcome.

In terms of asymptomatic patients, we will try to operate on them between the age of 3–6 months. For symptomatic very young patients, now we know our results, we would recommend, or we would perform a modified BT shunt and then perform a correction at a later date between 3 and 6 months of age.

However, for asymptomatic patients’ referral, the message we are trying to pass to the cardiologists is that it should not be delayed more than 6 months of age. That would prolong the right ventricle hypertrophy with myocardial fibrosis, which will ultimately contribute to late arrhythmia and sudden death, in which we should try to prevent.

Dr Monro: Could I answer that question. During those 8 years we operated on 1 patient over 1 year, and did 2 shunts. So our policy is to correct rather than palliate.


   Footnotes
 
\#9734; Presented at the joint 19th Annual Meeting of the European Association for Cardio-thoracic Surgery and the 13th Annual Meeting of the European Society of Thoracic Surgeons, Barcelona, Spain, September 25–28, 2005.


   References
Top
 Abstract
 1. Introduction
 2. Material and methods
 3. Results
 4. Discussion
 Appendix A
 References
 

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  5. Bacha EA, Scheule AM, Zurakowski D, Erikson LC, Hung J, Lang P, Mayer Jr. JE, del Nido PJ, Jonas RA. Long-term results after early primary repair of Tetralogy of Fallot. J Thorac Cardiovasc Surg 2001;122(1):154-161.[Abstract/Free Full Text]
  6. Walsh EP, Rockenmacher S, Keane JF, Lock JE, Castaneda AR. Late results in patients with Tetralogy of Fallot repaired during infancy. Circulation 1988;77:1062-1067.[Abstract/Free Full Text]
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