Mario Giordano1, Giuseppe Santoro2, Gabriella Agnoletti3, Mario Carminati4, Andrea Donti5, Paolo Guccione6, Maurizio Marasini7, Ornella Milanesi8, Maria Giovanna Russo1, Biagio Castaldi8, Martino Cheli7, Roberto Formigari6, Gianpiero Gaio1, Luca Giugno4, Alessia Lunardini9, Carlotta Pepino3, Isabella Spadoni9. 1. Pediatric Cardiology, "Ospedali dei Colli", University of Campania "Luigi Vanvitelli", Naples, Italy. 2. Pediatric Cardiology, "Ospedali dei Colli", University of Campania "Luigi Vanvitelli", Naples, Italy; Pediatric Cardiology and GUCH Unit, "Ospedale del Cuore", National Research Council-Tuscany Region Foundation "G. Monasterio", Massa, Italy. Electronic address: santoropino050562@gmail.com. 3. Pediatric Cardiology, "Regina Margherita" Hospital, University of Turin, Italy. 4. Pediatric Cardiology and GUCH Unit, Policlinico San Donato, Milan, Italy. 5. Pediatric Cardiology and GUCH Unit, "S. Orsola-Malpighi" Hospital, University of Bologna, Italy. 6. Pediatric Cardiology, "Bambino Gesù" Hospital, Rome, Italy. 7. Pediatric Cardiology, "IRCCS Istituto Giannina Gaslini", Genoa, Italy. 8. Pediatric Cardiology, University of Padua, Italy. 9. Pediatric Cardiology and GUCH Unit, "Ospedale del Cuore", National Research Council-Tuscany Region Foundation "G. Monasterio", Massa, Italy.
Abstract
BACKGROUND: Despite recent technical advances, interventional cardiac catheterization is still challenging in neonatal age and no specific data concerning early outcome are so far published in literature. METHODS: Neonatal trans-catheter cardiac interventions performed in high-volume Italian referral centers were retrospectively analyzed. Primary outcomes were procedural major adverse events, in-hospital mortality and procedural failure. Secondary outcomes were minor adverse events and need for blood transfusion. RESULTS: From January 2000 to December 2017, 1423 newborns (mean weight 3.0 ± 0.6 kg, range 1.0-5.8; median age 2.0 days) underwent interventional cardiac catheterization. Overall, global procedure adverse event rate and in-hospital mortality were 10.2% and 5.2%, respectively. At multi-variable analysis, primary composite outcome was significantly related to low-weight (<2.5 kg) (p < 0.01) and younger age (≤7 days) (p < 0.01) at the procedure, prematurity (p < 0.01), uni-ventricular physiology (p < 0.01), associated genetic syndromes (p < 0.01) and procedure risk category (p < 0.01). No relationship between volume of activity of any single center and procedure outcome was found. Over time, a trend toward an increased number of procedures and their complexity was recorded. Trans-catheter management of cardiac malformations with critical, duct-dependent pulmonary blood flow by arterial duct stenting or right ventricular outflow tract stenting showed the highest increase. CONCLUSIONS: Interventional cardiac catheterization is relatively safe and feasible in neonatal age. Peri-natal age, low weight, uni-ventricular physiology and genetic syndromes still significantly contribute to procedural morbidity and in-hospital mortality of this approach.
BACKGROUND: Despite recent technical advances, interventional cardiac catheterization is still challenging in neonatal age and no specific data concerning early outcome are so far published in literature. METHODS: Neonatal trans-catheter cardiac interventions performed in high-volume Italian referral centers were retrospectively analyzed. Primary outcomes were procedural major adverse events, in-hospital mortality and procedural failure. Secondary outcomes were minor adverse events and need for blood transfusion. RESULTS: From January 2000 to December 2017, 1423 newborns (mean weight 3.0 ± 0.6 kg, range 1.0-5.8; median age 2.0 days) underwent interventional cardiac catheterization. Overall, global procedure adverse event rate and in-hospital mortality were 10.2% and 5.2%, respectively. At multi-variable analysis, primary composite outcome was significantly related to low-weight (<2.5 kg) (p < 0.01) and younger age (≤7 days) (p < 0.01) at the procedure, prematurity (p < 0.01), uni-ventricular physiology (p < 0.01), associated genetic syndromes (p < 0.01) and procedure risk category (p < 0.01). No relationship between volume of activity of any single center and procedure outcome was found. Over time, a trend toward an increased number of procedures and their complexity was recorded. Trans-catheter management of cardiac malformations with critical, duct-dependent pulmonary blood flow by arterial duct stenting or right ventricular outflow tract stenting showed the highest increase. CONCLUSIONS: Interventional cardiac catheterization is relatively safe and feasible in neonatal age. Peri-natal age, low weight, uni-ventricular physiology and genetic syndromes still significantly contribute to procedural morbidity and in-hospital mortality of this approach.