Interact CardioVasc Thorac Surg 2008;7:698-701. doi:10.1510/icvts.2008.180083
© 2008 European Association of Cardio-Thoracic Surgery
Best evidence topic - Congenital |
Is early primary repair for correction of tetralogy of Fallot comparable to surgery after 6 months of age?
Hunaid A. Vohra,
Louise Adamson and
Marcus P. Haw*
Department of Cardiothoracic Surgery, Southampton General Hospital, Southampton, UK
Received 18 March 2008;
received in revised form 10 April 2008;
accepted 23 April 2008
*Corresponding author. Department of Paediatric Cardiac Surgery, Wessex Cardiothoracic Centre, Southampton University Hospitals NHS Trust, Southampton General Hospital, Tremona Road, Southampton, UK. Tel.: +44-2380 777222; fax: +44-2380798508.
E-mail address: marcus.haw{at}suht.nhs.uk (M.P. Haw).
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Abstract
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A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was whether early primary repair for correction of tetralogy of Fallot (TOF) resulted in better outcomes than surgery after 6 months of age. Altogether 650 relevant papers were identified using the below mentioned search, eight papers represented the best evidence to answer the specific question. The author, journal, date and country of publication, patient group studied, study type, relevant outcomes, results and study weaknesses were tabulated. We conclude that early primary repair of TOF has been shown to be comparable to later repair, with several retrospective series concluding that there is no increase in mortality with children under 6 months of age. Freedom from reintervention has also been shown to be similar irrespective of the age primary repair is undertaken. However, it has been observed that length of intensive care unit stay, period of mechanical ventilation and the need for inotropes is increased in patients undergoing primary repair at <3 months of age.
Key Words: Tetralogy of Fallot; Cardiac surgery; Infants; Evidence based medicine
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1. Introduction
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A best evidence topic was constructed according to a structured protocol. This protocol is fully described in the ICVTS [1].
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2. Clinical scenario
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A 6-week-old male infant is referred to your clinic by the paediatric cardiologists. He first presented with cyanosis and was found to have severe right ventricular outflow tract obstruction (RVOT) with pulmonary stenosis and a large ventricular septal defect (VSD) on investigations. The cardiologist has just attended a national conference and heard about the practice of one stage repair of tetralogy of Fallot (TOF) in neonates as an alternative to a palliative procedure followed by a later repair. He asks you whether you think this case might be suitable for early primary repair. You discuss it with your consultant who asks you to review the literature.
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3. Three-part question
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In [patients with TOF] is [early primary repair] comparable to surgery after 6 months of age in [terms of outcome]?
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4. Search strategy
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Medline 1950 to March 2008 using the OVID interface. [exp ‘Tetralogy of Fallot’/or fallot.ti] AND [exp infant/OR neonat$.mp OR exp Infant, Newborn/] and [repair.mp or correction.mp].
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5. Search outcome
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A total of 650 relevant papers were found from which eight papers were selected as representing the best evidence on this topic (Table 1).
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6. Comments
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Eight clinical studies were found in 1720 patients. The studies reviewed the operative outcomes in patients undergoing surgery for correction of TOF and investigated whether age at time of primary repair affected outcome.
In a retrospective study by Ooi et al. [2], 52 operations were performed on children under 12 months of age for repair of isolated TOF. It was shown that age under 3 months at the time of correction of TOF increased the duration of post-operative ventilation, intensive care unit (ICU) stay and hospital stay, although it did not affect the incidence of post-operative morbidity. The authors concluded that early definitive repair of TOF can be performed safely in those under 6 months old, and that age at surgery does not appear to affect the medium term haemodynamic outcome. They suggest that repair in asymptomatic patients can be delayed until 3–6 months of age. Kolcz and Pizarro [3] reviewed 66 children under the age of 3 months with TOF and confluent pulmonary arteries with respect to mortality, Nakata index and freedom from reintervention at follow-up. They found that a significant increase in Nakata index occurred only in neonates and that neonatal repair afforded a freedom from reintervention no different from patients repaired in infancy. In a cohort of 56 patients with TOF operated on at <6 months, Sousa Uva et al. [4] demonstrated that early primary repair as an alternative to early palliation followed by later repair was achieved with a low mortality rate. Lee et al. [5] reviewed the outcome after one stage repair of TOF in cohort of 240 patients. They studied differences in method of RVOT reconstruction and closure of VSD as well as duration of inotropic support and ICU stay in two groups of patients. Concomitant transventricular VSD closures were performed more commonly in the early repair group (<6 months) and similar RVOT reconstruction methods were employed in both groups. Although, the duration of inotropic support and ICU stay was significantly longer in the early repair group, all survivors were asymptomatic at last follow-up. These results were similar to those reported by Ooi et al. [2]. In a similar retrospective review, van Dongen et al. [6] found that age <3 months was associated with increased use of vasoactive drugs, higher postoperative fluid requirement, higher incidence of organ dysfunction and longer duration of both ventilator support and ICU stay. They concluded that primary repair at an early age has excellent short-term outcome, although patients <3 months of age have an increased but transient intensive care morbidity. Cobanoglu and Schultz [7] retrospectively reviewed postoperative outcomes in 63 patients undergoing total correction of TOF at <1 year of age. They demonstrated that factors such as long aortic cross-clamp and cardiopulmonary bypass time as well as frequent preoperative respiratory tract infections affected operative survival, but that age under 3 months and weight <6 kg did not. In a multi-centre retrospective analysis [8], which included 938 patients who underwent surgery for TOF in 12 United States institutions, it was shown that in patients  3 months, the overall in-hospital mortality was significantly higher than that for older patients for both shunts and repairs. Multiple logistic regression analysis indicated that apart from age, weight, date of surgery and the interactions between date of surgery and institutional volume, the interaction between age and institutional volume was a significant predictor of the initial surgical management of TOF. However, there was significant inter-institutional variability. In another study from Toronto [9], the authors showed that after change of approach from initial palliation in the infant with TOF to primary repair around 6 months or earlier, if clinically indicated (227 consecutive patients), the mortality improved with time. The deaths reported were only in patients with primary repair after 12 months of age. The best survival and physiological outcomes were achieved with primary repair in children aged 3–11 months, with multivariate analysis showing that period of lactate clearance, ventilation and hospital stay being independently associated with initial repair before <3 months of age.
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7. Clinical bottom line
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Early primary repair of TOF is comparable to later repair, with several retrospective reviews concluding that there is no increase in mortality and re-intervention in infants <6 months of age. However, it has been consistently shown that the length of ICU stay, requirement for ventilation and the need for inotropes is increased in patients undergoing primary repair at <3 months of age.
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References
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- Dunning J, Prendergast B, Mackway-Jones K. Towards evidence-based medicine in cardiothoracic surgery: best BETS. Interact Cardiovasc Thorac Surg 2003;2:405–409.[Abstract/Free Full Text]
- Ooi A, Moorjani N, Baliulis G, Keeton BR, Salmon AP, Monro JL, Haw MP. Medium term outcome for infant repair in tetralogy of Fallot: indicators for timing of surgery. Eur J Cardiothorac Surg 2006;30:917–922.[Abstract/Free Full Text]
- Kolcz J, Pizarro C. Neonatal repair of tetralogy of Fallot results in improved pulmonary artery development without increased need for reintervention. Eur J Cardiothorac Surg 2005;28:394–399.[Abstract/Free Full Text]
- Sousa Uva M, Lacour-Gayet F, Komiya T, Serraf A, Bruniaux J, Touchot A, Roux D, Petit J, Planché C. Surgery for tetralogy of Fallot at less than six months of age. J Thorac Cardiovasc Surg 1994;107:1291–1300.[Abstract/Free Full Text]
- Lee C, Lee CN, Kim SC, Lim C, Chang YH, Kang CH, Jo WM, Kim WH. Outcome after one-stage repair of tetralogy of Fallot. J Cardiovasc Surg (Torino) 2006;47:65–70.[Medline]
- van Dongen EI, Glansdorp AG, Mildner RJ, McCrindle BW, Sakopoulos AG, Van Arsdell G, Williams WG, Bohn D. The influence of perioperative factors on outcomes in children aged less than 18 months after repair of tetralogy of Fallot. J Thorac Cardiovasc Surg 2003;126:703–710.[Abstract/Free Full Text]
- Cobanoglu A, Schultz JM. Total correction of tetralogy of Fallot in the first year of life: late results. Ann Thorac Surg 2002;74:133–138.[Abstract/Free Full Text]
- Mulder TJ, Pyles LA, Stolfi A, Pickoff AS, Moller JH. A multicenter analysis of the choice of initial surgical procedure in tetralogy of Fallot. Pediatr Cardiol 2002;23:580–586.[CrossRef][Medline]
- Van Arsdell GS, Maharaj GS, Tom J, Rao VK, Coles JG, Freedom RM, Williams WG, McCrindle BW. What is the optimal age for repair of tetralogy of Fallot. Circulation 2000;102, 19 Suppl 3, III123–129.[Medline]
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Abstract
1. Introduction