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3-year follow-up of a prospective, multicenter study of the Amplatzer Piccolo™ Occluder for transcatheter patent ductus arteriosus closure in children ≥ 700 grams.
Morray, Brian H; Sathanandam, Shyam K; Forbes, Thomas; Gillespie, Matthew; Berman, Darren; Armstrong, Aimee K; Shahanavaz, Shabana; Jones, Thomas; Rockefeller, Toby; Justino, Henri; Nykanen, David; Weiler, Courtney; Gutfinger, Dan; Zahn, Evan M.
Afiliación
  • Morray BH; Division of Pediatric Cardiology, Seattle Children's Hospital, Seattle, WA, USA. brian.morray@seattlechildrens.org.
  • Sathanandam SK; LeBonheur Children's Hospital, Memphis, TN, USA.
  • Forbes T; Joe DiMaggio Children's Hospital, Hollywood, FL, USA.
  • Gillespie M; Children's Hospital of Philadelphia, Philadelphia, PA, USA.
  • Berman D; Children's Hospital of Los Angeles, Los Angeles, CA, USA.
  • Armstrong AK; Nationwide Children's Hospital, Columbus, OH, USA.
  • Shahanavaz S; Cincinnati Children's Hospital, Cincinnati, OH, USA.
  • Jones T; Division of Pediatric Cardiology, Seattle Children's Hospital, Seattle, WA, USA.
  • Rockefeller T; Mercy Children's Hospital, Kansas City, MO, USA.
  • Justino H; Rady Children's Hospital, San Diego, CA, USA.
  • Nykanen D; Arnold Palmer Hospital, Orlando, FL, USA.
  • Weiler C; Abbott Structural Heart, Santa Clara, CA, USA.
  • Gutfinger D; Abbott Structural Heart, Santa Clara, CA, USA.
  • Zahn EM; Cedars-Sinai Medical Center, Los Angeles, CA, USA.
J Perinatol ; 43(10): 1238-1244, 2023 10.
Article en En | MEDLINE | ID: mdl-37587183
OBJECTIVE: This study describes 3-year follow-up of 200 infants weighing ≥ 700 grams who underwent transcatheter patent ductus arteriosus (PDA) closure with the Amplatzer Piccolo™ Occluder. STUDY DESIGN: Between June 2017 and February 2019, 200 children were enrolled in this U.S. study (NCT03055858). PDA closure, survival, and device- or procedure-related events were evaluated. A total of 156 of the available 182 patients (86%) completed the study. RESULTS: The implant success rate was 95.5% (191/200). At 3 years, PDA closure was observed in 100% (33/33) of patients. Survival was >95% with 9 reported deaths. No deaths were adjudicated as device- or procedure-related. Notable events included aortic obstruction (2) requiring stent placement and tricuspid regurgitation (5), for which no interventions were required. CONCLUSIONS: This follow-up study demonstrates high rates of PDA closure, low serious complication rates, and survival > 95% at 3 years. The Amplatzer Piccolo™ Occluder is a safe and effective therapy for PDA treatment in premature infants. CLINICALTRIALS: gov identifier: NCT0305585.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Conducto Arterioso Permeable / Dispositivo Oclusor Septal Tipo de estudio: Clinical_trials / Observational_studies / Prognostic_studies Límite: Child / Humans / Infant Idioma: En Revista: J Perinatol Asunto de la revista: PERINATOLOGIA Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Conducto Arterioso Permeable / Dispositivo Oclusor Septal Tipo de estudio: Clinical_trials / Observational_studies / Prognostic_studies Límite: Child / Humans / Infant Idioma: En Revista: J Perinatol Asunto de la revista: PERINATOLOGIA Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos