Managing The Symptomatic Neonate With Tetralogy Of Fallot: Primary Repair, Surgical Shunt, Or Transcatheter Stent?
Samuel Mitchell Hoenig, BA1, Kunaal S. Sarnaik, BS1, Rashed Mahboubi, MD1, Miza Salim Hammoud, MD1, Karl F. Welke, MD MS2, Brian McCrindle, MD MPH3, Tara Karamlou, MD MSc1.
1Department of Pediatric Cardiac Surgery, Cleveland Clinic Heart, Vascular, and Thoracic Institute, Cleveland, OH, USA, 2Division of Pediatric Cardiothoracic Surgery, Atrium Health Levine Children's Hospital, Charlotte, NC, USA, 3Labatt Family Heart Centre, Hospital for Sick Children, University of Toronto,, Toronto, ON, Canada.
Objective: Identifying the preferred management strategy for cyanotic neonates with Tetralogy of Fallot (TOF) is challenging. We compared 2-year outcomes of three contending interventions using decision tree microsimulation modeling.
Methods: We constructed a Markov model decision tree with Monte Carlo microsimulations to simulate 2-year outcomes for 10,000 comparable neonates with symptomatic TOF eligible for all strategies (Figure 1a). Input transition state probabilities, utilities, and costs were collected from published reports. Outputs included complications, mortality, quality-adjusted-life-years (QALYs), and cost after 50 iterations. Sensitivity analysis which varied input transition probabilities within the range of published values determined whether the preferred strategy would change.
Results: Early (4-month) mortality after primary repair, staged stent, and staged shunt was 5.90%, 4.16%, and 3.86%, respectively (Figure 1b). Late (2-year) mortality was 7.39%, 10.21%, and 10.69%. Cumulative postoperative utility was 1.63, 1.52, and 1.51 QALYs, respectively. Cumulative costs were $515,366, $616,576, and $843,623. Primary repair was therefore preferred from baseline analysis. Sensitivity analysis performed on 26 transition probabilities did not identify any critical values that would result in a switch from primary repair as the preferred strategy.
Conclusions: For the management of cyanotic neonates with TOF, comprehensive modeling of diverse outcomes and utilities suggests that primary repair may be superior to staging with a shunt or stent, with reduced 2-year mortality and improved cost-utility. 
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