Young infants with symptomatic tetralogy of Fallot: Shunt or primary repair?

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Abstract

Objectives

The optimal treatment strategy for symptomatic young infants with tetralogy of Fallot (TOF) is unclear. We sought to compare the outcomes of staged repair (SR) (shunt palliation followed by second-stage complete repair) versus primary repair (PR) at 2 institutions that have exclusively adopted each strategy.

Methods

We performed propensity score-matched comparison of 143 infants under 4 months of age who underwent shunt palliation at one institution between 1993 and 2021 with 122 infants who underwent PR between 2004 and 2018 at another institution. The primary outcome was mortality. Secondary outcomes were postoperative complications, durations of perioperative support and hospital stays, and reinterventions. Median follow-up was 8.3 years (interquartile range, 8.1-13.4 years).

Results

After the initial procedure, hospital mortality (shunt, 2.8% vs PR, 2.5%; P = .86) and 10-year survival (shunt, 95%; 95% confidence interval [CI], 90%-98% vs PR, 90%; 95% CI, 81%-95%; P = .65) were similar. The SR group had a greater risk of early reinterventions but similar rates of late reinterventions. Propensity score matching yielded 57 well-balanced pairs. In the matched cohort, the SR group had similar freedom from reintervention (55%; 95% CI, 39%-68% vs 59%; 95% CI, 43%-71%; P = .85) and greater survival (98%; 95% CI, 88%-99.8% vs 85%; 95% CI, 69%-93%; P = .02) at 10 years, as the result of more noncardiac-related mortalities in the PR group.

Conclusions

In symptomatic young infants with TOF operated at 2 institutions with exclusive treatment protocols, the SR strategy was associated with similar cardiac-related mortality and reinterventions as the PR strategy at medium-term follow-up.

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Most cited references 31

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Propensity-score matching in the cardiovascular surgery literature from 2004 to 2006: a systematic review and suggestions for improvement.

P. Austin (2007)

I conducted a systematic review of the use of propensity score matching in the cardiovascular surgery literature. I examined the adequacy of reporting and whether appropriate statistical methods were used. I examined 60 articles published in the Annals of Thoracic Surgery, European Journal of Cardio-thoracic Surgery, Journal of Cardiovascular Surgery, and the Journal of Thoracic and Cardiovascular Surgery between January 1, 2004, and December 31, 2006. Thirty-one of the 60 studies did not provide adequate information on how the propensity score-matched pairs were formed. Eleven (18%) of studies did not report on whether matching on the propensity score balanced baseline characteristics between treated and untreated subjects in the matched sample. No studies used appropriate methods to compare baseline characteristics between treated and untreated subjects in the propensity score-matched sample. Eight (13%) of the 60 studies explicitly used statistical methods appropriate for the analysis of matched data when estimating the effect of treatment on the outcomes. Two studies used appropriate methods for some outcomes, but not for all outcomes. Thirty-nine (65%) studies explicitly used statistical methods that were inappropriate for matched-pairs data when estimating the effect of treatment on outcomes. Eleven studies did not report the statistical tests that were used to assess the statistical significance of the treatment effect. Analysis of propensity score-matched samples tended to be poor in the cardiovascular surgery literature. Most statistical analyses ignored the matched nature of the sample. I provide suggestions for improving the reporting and analysis of studies that use propensity score matching.

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Repair of tetralogy of Fallot in neonates and young infants.

Laurel Mayer, R Jonas, Philipe N. Khalil … (1999)

The timing of repair of tetralogy of Fallot (TOF) remains controversial. Advantages to early complete repair include removal of right ventricular outflow tract obstruction, alleviation of systemic hypoxia, and avoidance of palliation with an arteriopulmonary shunt. This is a retrospective review of 99 children with TOF pulmonary stenosis (TOF/PS) or TOF pulmonary atresia (TOF/PA) who were <90 days of age undergoing early complete repair. Fifty-nine were prostaglandin E dependent, and 91% of neonates were symptomatic at the time of repair. Univariate and multivariate analyses of patient characteristics, anatomic features, and operative management showed the diagnosis of TOF/PA and smaller body surface area to be the only independent risk factors for death. Early mortality was 3% (3 of 99), and actuarial survival rates were 94% at 1 year and 91.6% at 5 years. Freedom from catheterization was 86% at 1 year and 73% at 5 years. Patients repaired for TOF/PA had a significantly lower freedom from reoperation than did those repaired for TOF/PS. Early complete TOF repair can be accomplished with a low mortality. Children with TOF/PA repaired had a lower freedom from reoperation that did those with TOF/PS. Longer follow-up, with emphasis on arrhythmias and right ventricular function, is required to define the long-term benefits of early repair.

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Complete repair of tetralogy of Fallot in the neonate: results in the modern era.

Harry J Hirsch, R Mosca, Kevin Bove (2000)

To review more than a decade of experience with complete repair of tetralogy of Fallot (TOF) in neonates at the University of Michigan; to assess early and late survival, perioperative complications, and the incidence of reoperation; and to analyze patient, procedural, and morphologic risk factors to determine their effects on outcome. Palliation of TOF with systemic-to-pulmonary artery shunts has been the accepted standard for symptomatic neonates and infants. Complete repair has traditionally been reserved for infants older than 6 months of age because of the perception that younger and smaller infants face an unacceptably high surgical risk. A retrospective review from August 1988 to November 1999 consisted of 61 consecutive symptomatic neonates with TOF who underwent complete repair. Thirty-one patients had TOF with pulmonary stenosis, 24 had TOF with pulmonary atresia, and 6 had TOF with nonconfluent pulmonary arteries. The mean age at repair was 16 +/- 13 days, and the mean weight was 3.2 +/- 0.7 kg. Before surgery, 36 patients were receiving an infusion of prostaglandin, 26 were mechanically ventilated, and 11 required inotropic support. Right ventricular outflow tract obstruction was managed with a transannular patch in 49 patients and a right ventricle-to-pulmonary artery conduit in 12. Cardiopulmonary bypass time averaged 71 +/- 26 minutes. Hypothermic circulatory arrest was used in 52 patients (mean 38 +/- 12 minutes). After cardiopulmonary bypass, the average intraoperative right/left ventricular pressure ratio was 55% +/- 13%. There were no new clinically apparent neurologic sequelae after repair. The postoperative intensive care unit stay was 9.1 +/- 8 days, with 6.8 +/- 7 days of mechanical ventilation. There was one hospital death from postoperative necrotizing enterocolitis on postoperative day 71 and four late deaths, only one of which was cardiac-related. Actuarial survival was 93% at 5 years. Follow-up was available for all 60 hospital survivors and averaged 62 months (range 1-141 months). Twenty-two patients required a total of 24 reoperations at an average interval of 26 months after repair. Indications for reoperation included right ventricular outflow tract obstruction (19), branch pulmonary artery stenosis (11), severe pulmonary insufficiency (4), and residual ventricular septal defect (1). The 1-month, 1-year, and 5-year freedom from reoperation rates were 100%, 89%, and 58%, respectively. Complete repair of TOF in the neonate is associated with excellent intermediate-term survival. Although the reoperation rate is significant, this is to be expected with the complex right ventricular outflow tract and pulmonary artery anatomy seen in symptomatic neonates and the need for conduit replacement in patients with TOF with pulmonary atresia.

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Author and article information

Contributors

Igor E. Konstantinov

Journal

Journal ID (nlm-ta): JTCVS Open

Journal ID (iso-abbrev): JTCVS Open

Title: JTCVS Open

Publisher: Elsevier

ISSN (Electronic): 2666-2736

Publication date PMC-release: 11 April 2024

Publication date Collection: June 2024

Publication date (Electronic): 11 April 2024

Volume: 19

Pages: 241-256

Affiliations

[a ]Department of Cardiac Surgery, Royal Children’s Hospital, Melbourne, Victoria, Australia

[b ]Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia

[c ]Heart Research Group, Murdoch Children’s Research Institute, Melbourne, Victoria, Australia

[d ]Division of Cardiac Surgery, Children's National Hospital, Washington, DC

[e ]The George Washington University School of Medicine and Health Sciences, Washington, DC

[f ]The Melbourne Centre for Cardiovascular Genomics and Regenerative Medicine, Murdoch Children’s Research Institute, Melbourne, Victoria, Australia

Author notes

[∗ ]Address for reprints: Igor E. Konstantinov, MD, PhD, Cardiac Surgery Unit, Royal Children’s Hospital, Flemington Rd, Parkville, Victoria 3029, Australia. igor.konstantinov@ 123456rch.org.au

Article

Publisher Item ID: S2666-2736(24)00105-0

DOI: 10.1016/j.xjon.2024.04.003

PMC ID: 11247207

PubMed ID: 39015442

SO-VID: 2666c9f2-8bff-4189-a508-36ec4d85d41c

License:

This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

History

Date received : 29 October 2023

Date revision received : 11 March 2024

Date accepted : 2 April 2024

Young infants with symptomatic tetralogy of Fallot: Shunt or primary repair?

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Abstract

Objectives

Methods

Results

Conclusions

Related collections

Orthopedics

Most cited references 31

Propensity-score matching in the cardiovascular surgery literature from 2004 to 2006: a systematic review and suggestions for improvement.

Repair of tetralogy of Fallot in neonates and young infants.

Complete repair of tetralogy of Fallot in the neonate: results in the modern era.

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