Author + information
- Received August 22, 2019
- Revision received September 26, 2019
- Accepted November 11, 2019
- Published online January 27, 2020.
- Bryan H. Goldstein, MDa,∗ (, )@ccrcresearch,
- Lisa Bergersen, MD, MPHb,
- Aimee K. Armstrong, MDc,
- Brian A. Boe, MDc,
- Howaida El-Said, MDd,
- Diego Porras, MDb,
- Shabana Shahanavaz, MDe,
- Ryan A. Leahy, MDf,
- Jacqueline Kreutzer, MDa,
- Jeffrey D. Zampi, MDg,
- Michael R. Hainstock, MDh,
- Todd M. Gudausky, MDi,
- George T. Nicholson, MDj,
- Kimberlee Gauvreau, ScDb,
- Andrea Goodman, MPHb and
- Christopher J. Petit, MDk
- aHeart Institute, UPMC Children's Hospital of Pittsburgh and Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
- bDepartment of Cardiology, Boston Children’s Hospital, Boston, Massachusetts
- cThe Heart Center, Nationwide Children’s Hospital, Columbus, Ohio
- dDivision of Cardiology, Rady Children’s Hospital, San Diego, California
- eDivision of Pediatric Cardiology, St. Louis Children’s Hospital, St. Louis, Missouri
- fDepartment of Cardiology, Norton Children’s Hospital, Louisville, Kentucky
- gDivison of Pediatric Cardiology, University of Michigan Medical School, Ann Arbor, Michigan
- hDivision of Pediatric Cardiology, University of Virginia Children’s Hospital, University of Virginia, Charlottesville, Virginia
- iDivision of Cardiology, Children’s Hospital of Wisconsin, Milwaukee, Wisconsin
- jDivision of Pediatric Cardiology, Monroe Carell Jr. Children's Hospital at Vanderbilt University Medical Center, Nashville, Tennessee
- kDivision of Pediatric Cardiology, Children’s Healthcare of Atlanta Sibley Heart Center, Emory University School of Medicine, Atlanta, Georgia
- ↵∗Address for correspondence:
Dr. Bryan H. Goldstein, UPMC Children's Hospital of Pittsburgh, 4401 Penn Avenue, 5th Floor Faculty Pavilion, Pittsburgh, Pennsylvania 15224.
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.
- adverse events
- congenital heart disease
- dose area product
- infective endocarditis outcomes research
- tetralogy of Fallot
- transcatheter PVR
The C3PO-QI registry is funded, in part, by a grant from the Children’s Heart Foundation. Dr. Goldstein has served as a consultant for Medtronic, Edwards Lifesciences, and W.L. Gore & Associates. Dr. Armstrong has served as a consultant for and received research grants from Medtronic and Edwards Lifesciences; and has received research support from Edwards Lifesciences. Dr. Shahanavaz has served as a consultant for Medtronic and Edwards Lifesciences. Dr. Kreutzer has served as a consultant for Medtronic and Edwards Lifesciences; and has received research grant support from Siemens. Dr. Gudausky has served as a consultant for Medtronic, Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received August 22, 2019.
- Revision received September 26, 2019.
- Accepted November 11, 2019.
- 2020 American College of Cardiology Foundation
This article requires a subscription or purchase to view the full text. If you are a subscriber or member, click Login or the Subscribe link (top menu above) to access this article.