November 1, 2017Heart138 citationsOpen Access
A propensity score-adjusted analysis of clinical outcomes after pulmonary valve replacement in tetralogy of Fallot
Key Result
Pulmonary valve replacement was not associated with a significantly reduced rate of death and sustained ventricular tachycardia (HR 0.65) compared to conservative management in patients with repaired tetralogy of Fallot.
Study Design
Type
Cohort (n=977)
Multicenter
Yes
Structured PICO
Does pulmonary valve replacement reduce death and sustained ventricular tachycardia in patients with repaired tetralogy of Fallot?
P
Population
977 patients with repaired tetralogy of Fallot, mean age 26.4 years, followed for an average of 5.3 years to evaluate the association of pulmonary valve replacement with clinical outcomes.
E
Exposure
Pulmonary valve replacement (PVR)
C
Comparator
No pulmonary valve replacement (propensity score-adjusted)
O
Outcome
Composite of (aborted) death and sustained ventricular tachycardia (VT)composite
In patients with repaired tetralogy of Fallot, pulmonary valve replacement was not associated with a reduced rate of death and sustained VT, and was associated with worse secondary outcomes in those not meeting consensus criteria.
Main Result
Hazard Ratio: 0.65 (95% CI 0.31–1.36)
p-value: p=0.25
Limitations
- Observational cohort design limits causal inferences
- Restricted to subjects who have undergone cardiovascular magnetic resonance (CMR)
- Low event rate (4% for the primary outcome) limits statistical power
- No standardized protocol for diagnostic testing at participating centers
- Missing pulmonary regurgitation fraction data in some subjects
Abstract
Objective To determine the association of pulmonary valve replacement (PVR) with death and sustained ventricular tachycardia (VT) in patients with repaired tetralogy of Fallot (rTOF). Methods Subjects with rTOF and cardiac magnetic resonance from an international registry were included. A PVR propensity score was created to adjust for baseline differences. PVR consensus criteria were predefined as pulmonary regurgitation >25% and ≥2 of the following criteria: right ventricular (RV) end-diastolic volume >160 mL/m 2 , RV end-systolic volume >80 mL/m 2 , RV ejection fraction (EF) 160 ms. The primary outcome included (aborted) death and sustained VT. The secondary outcome included heart failure, non-sustained VT and sustained supraventricular tachycardia. Results In 977 rTOF subjects (age 26±15 years, 45% PVR, follow-up 5.3±3.1 years), the primary and secondary outcomes occurred in 41 and 88 subjects, respectively. The HR for subjects with versus without PVR (time-varying covariate) was 0.65 (95% CI 0.31 to 1.36; P=0.25) for the primary outcome and 1.43 (95% CI 0.83 to 2.46; P=0.19) for the secondary outcome after adjusting for propensity and other factors. In subjects (n=426) not meeting consensus criteria, the HR for subjects with (n=132) versus without (n=294) PVR was 2.53 (95% CI 0.79 to 8.06; P=0.12) for the primary outcome and 2.31 (95% CI 1.07 to 4.97; P=0.03) for the secondary outcome. Conclusion In this large multicentre rTOF cohort, PVR was not associated with a reduced rate of death and sustained VT at an average follow-up of 5.3 years. Additionally, there were more events after PVR compared with no PVR in subjects not meeting consensus criteria.