Key result
Transcatheter pulmonary valve replacement is associated with a 13% incidence of serious adverse events.
Why the study?
TPVR is associated with procedural serious adverse events and ionizing radiation exposure, prompting this study to define their risks and associations using large-scale registry data.
Observational (n=530)
Yes
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“To surveil for uncommon device-related adverse outcomes and establish therapeutic outcomes in a larger and more heterogeneous population of patients in a real-world environment, we developed a multicenter longitudinal registry of patients treated with self-expanding TPVR”
Clinical evaluation reveals complication rates, radiation doses, and reintervention risks after transcatheter pulmonary valve replacement, highlighting procedural safety and long-term monitoring.
BACKGROUND Transcatheter pulmonary valve replacement (TPVR) is associated with a risk of procedural serious adverse events (SAE) and exposure to ionizing radiation. OBJECTIVES The purpose of this study was to define the risk of, and associations with, SAE and high-dose radiation exposure using large-scale registry data. METHODS The analysis of the multicenter C3PO-QI registry was limited to patients who underwent TPVR from January 1, 2014, to December 31, 2016. SAE were defined as the occurrence of ≥1 moderate, major, or catastrophic events. Radiation dose was reported as dose area product adjusted for weight. Associations with outcome measures were explored in univariate and multivariable analyses. RESULTS A total of 530 patients (59% male) underwent TPVR at a median age of 18.3 years (interquartile range [IQR]: 12.9 to 27.3 years) and weight of 58 kg (IQR: 43 to 77 kg) at 14 centers. Implant substrate included homograft (41%), bioprosthesis (30%), native right ventricular outflow tract (RVOT) (27%) and other (2%). TPVR indications were pulmonary insufficiency (28%), stenosis (23%), and mixed (49%). AE and SAE occurred in 26% and 13% of cases, respectively, including 1 mortality. SAE were more frequent in homograft conduit than other RVOT substrates, although SAE type and severity differed between implant substrates. Median radiation dose was 198 μGy·m2/kg (IQR: 94 to 350 μGy·m2/kg). Higher radiation dose was associated with older age, greater RVOT obstruction, and concomitant interventions (p < 0.001). During a median follow-up duration of 1 year, 13.3% underwent catheterization, surgery, or both, unrelated to infection. Younger age, smaller size, and hemodynamic and anatomic factors indicative of greater RVOT obstruction were associated with TPV reintervention. CONCLUSIONS The incidence of SAE during TPVR in the C3PO-QI registry is high, but mortality is uncommon. Radiation dose is greater than for other congenital interventions and is associated with patient and procedural factors. Reintervention is common during early follow-up.
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Goldstein et al. (2020) conducted an observational in Transcatheter pulmonary valve replacement (n=530). Transcatheter pulmonary valve replacement (TPVR) was evaluated on Serious adverse events (SAE). Transcatheter pulmonary valve replacement was associated with a 13% incidence of serious adverse events and a median radiation dose of 198 μGy·m2/kg, with 13.3% requiring reintervention at 1 year.
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