Key result
Early pulmonary valve replacement (age ≤16 years) showed no significant difference in survival compared to late or no replacement (P=0.990), but was associated with worse safety outcomes (P<0.001).
Why the study?
Does early pulmonary valve replacement improve outcomes compared to late or no replacement in patients with repaired tetralogy of Fallot?
Cohort (n=273)
Does early pulmonary valve replacement improve outcomes compared to late or no replacement in patients with repaired tetralogy of Fallot?
p-value: p=0.990
Early pulmonary valve replacement in repaired tetralogy of Fallot does not improve midterm survival and is associated with higher morbidity, but better preserves right ventricular morphology and function.
OBJECTIVES: Although the effects of pulmonary regurgitation after tetralogy of Fallot repair are detrimental, timing of pulmonary valve replacement (PVR) is unclear. Our goal was to evaluate the midterm efficacy and safety of early PVR. METHODS: Patients with tetralogy of Fallot who underwent repair from 1962 to 2015 were included from the local database. Statistical analyses compared patients who underwent early PVR (age ≤16 years), late PVR and no PVR. The timing of the intervention was compared for efficacy-all-cause mortality and the combined end-point of all-cause mortality, ventricular tachycardia and defibrillator implantation-and for safety-the combined end-point of 1-year postoperative mortality after PVR, endocarditis and reintervention. Echocardiographic and electrocardiographic data at the last follow-up examination were compared across the 3 groups. RESULTS: Two hundred seventy-three patients (age 21 ± 5 years; 52% female) were included. The mean follow-up was 24 (95% confidence interval 22.7-26.2) years; the observed median was 21 years (interquartile range 11-31). No significant difference in survival was found between the early PVR (n = 106; 39%), the late PVR (n = 47; 17%) and the no PVR groups (n = 120; 44%) (P = 0.990). No significant difference in the combined efficacy end-point was noted between patients who underwent early PVR compared with patients who underwent late PVR (P = 0.247). Worse event-free survival for the 3-point safety end-point was observed after early PVR (P < 0.001). Right ventricular morphology (P < 0.001) and function (P < 0.001) were better preserved in the patient group that underwent PVR before the age of 16 years. CONCLUSIONS: As expected, PVR-related morbidity was higher in patients who underwent early PVR but the midterm outcome was similar. Nevertheless, better preservation of right ventricular morphology and function in the early PVR group might result in better long-term survival.
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Dobbels et al. (2017) conducted a cohort in transannular patch-repaired tetralogy of Fallot (n=273). Early pulmonary valve replacement (age ≤16 years) vs. Late pulmonary valve replacement and no pulmonary valve replacement was evaluated on survival (p=0.990). Early pulmonary valve replacement (age ≤16 years) showed no significant difference in survival compared to late or no replacement (P=0.990), but was associated with worse safety outcomes (P<0.001).
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