Adverse Events, Radiation Exposure, and Reinterventions Following Transcatheter Pulmonary Valve Replacement. J Am Coll Cardiol 2020 Feb 04;75(4):363-376
Date
02/01/2020Pubmed ID
32000947DOI
10.1016/j.jacc.2019.11.042Scopus ID
2-s2.0-85077933666 (requires institutional sign-in at Scopus site) 25 CitationsAbstract
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.
Author List
Goldstein BH, Bergersen L, Armstrong AK, Boe BA, El-Said H, Porras D, Shahanavaz S, Leahy RA, Kreutzer J, Zampi JD, Hainstock MR, Gudausky TM, Nicholson GT, Gauvreau K, Goodman A, Petit CJAuthor
Todd M. Gudausky MD Associate Professor in the Pediatrics department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
AdolescentAdult
Cardiac Catheterization
Cardiac Surgical Procedures
Catheterization
Child
Endocarditis
Female
Heart Defects, Congenital
Heart Valve Prosthesis
Heart Valve Prosthesis Implantation
Humans
Incidence
Male
Multivariate Analysis
Pulmonary Valve
Pulmonary Valve Insufficiency
Radiation Exposure
Radiation, Ionizing
Registries
Risk
Tetralogy of Fallot
Young Adult
