Bryan H Goldstein1, Lisa Bergersen2, Aimee K Armstrong3, Brian A Boe3, Howaida El-Said4, Diego Porras2, Shabana Shahanavaz5, Ryan A Leahy6, Jacqueline Kreutzer7, Jeffrey D Zampi8, Michael R Hainstock9, Todd M Gudausky10, George T Nicholson11, Kimberlee Gauvreau2, Andrea Goodman2, Christopher J Petit12. 1. Heart Institute, UPMC Children's Hospital of Pittsburgh and Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania. Electronic address: bryan.goldstein@gmail.com. 2. Department of Cardiology, Boston Children's Hospital, Boston, Massachusetts. 3. The Heart Center, Nationwide Children's Hospital, Columbus, Ohio. 4. Division of Cardiology, Rady Children's Hospital, San Diego, California. 5. Division of Pediatric Cardiology, St. Louis Children's Hospital, St. Louis, Missouri. 6. Department of Cardiology, Norton Children's Hospital, Louisville, Kentucky. 7. Heart Institute, UPMC Children's Hospital of Pittsburgh and Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania. 8. Divison of Pediatric Cardiology, University of Michigan Medical School, Ann Arbor, Michigan. 9. Division of Pediatric Cardiology, University of Virginia Children's Hospital, University of Virginia, Charlottesville, Virginia. 10. Division of Cardiology, Children's Hospital of Wisconsin, Milwaukee, Wisconsin. 11. Division of Pediatric Cardiology, Monroe Carell Jr. Children's Hospital at Vanderbilt University Medical Center, Nashville, Tennessee. 12. Division of Pediatric Cardiology, Children's Healthcare of Atlanta Sibley Heart Center, Emory University School of Medicine, Atlanta, Georgia.
Abstract
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.
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.
Authors: Omar Abu-Anza; Luis Ochoa; Daniel McLennan; Prashob Porayette; Jennifer R Maldonado; Ian H Law; Osamah Aldoss Journal: Pediatr Cardiol Date: 2020-10-13 Impact factor: 1.655
Authors: Brian P Quinn; Mary Yeh; Kimberlee Gauvreau; Fatima Ali; David Balzer; Oliver Barry; Sarosh Batlivala; Darren Berman; Susan Foerster; Bryan Goldstein; Michael Hainstock; Ralf Holzer; Dana Janssen; Michael L O'Byrne; Lauren Shirley; Sara Trucco; Wendy Whiteside; Lisa Bergersen Journal: J Am Heart Assoc Date: 2021-12-22 Impact factor: 6.106