Shabana Shahanavaz1, Evan M Zahn2, Daniel S Levi3, Jamil A Aboulhousn4, Sebastien Hascoet5, Athar M Qureshi6, Diego Porras7, Gareth J Morgan8, Holly Bauser Heaton9, Mary Hunt Martin10, Britton Keeshan11, Jeremy D Asnes11, Damien Kenny12, Jeremy M Ringewald13, Jenny E Zablah8, Margaret Ivy8, Brian H Morray14, Alejandro J Torres15, Darren P Berman16, Matthew J Gillespie17, Kasey Chaszczewski17, Jeffrey D Zampi18, Kevin P Walsh12, Plessis Julien19, Bryan H Goldstein20, Shyam K Sathanandam21, Clement Karsenty22, David T Balzer23, Doff B McElhinney24. 1. Division of Cardiology, Department of Pediatrics, Washington University School of Medicine, St. Louis, Missouri, USA. Electronic address: Shabana.Shahanavaz@cchmc.org. 2. Guerin Family Congenital Heart Program, The Heart Institute and Department of Pediatrics Cedars-Sinai Medical Center, Los Angeles, California, USA. 3. Department of Pediatrics, Division of Cardiology, UCLA Mattel Children's Hospital, Los Angeles, California, USA. 4. Department of Medicine, Ahmanson Adult Congenital Heart Disease Center, David Geffen School of Medicine at UCLA, Los Angeles, California, USA. 5. Hôpital Marie Lannelongue, Le Plessis-Robinson, France. 6. The Lillie Frank Abercrombie Section of Cardiology, Texas Children's Hospital, Baylor College of Medicine, Houston, Texas, USA. 7. Department of Cardiology, Boston Children's Hospital, Boston, Massachusetts, USA. 8. The Heart Institute, Children's Hospital of Colorado, Anschutz Medical Campus, Denver, Colorado, USA. 9. Division of Cardiology Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA. 10. Division of Pediatric Cardiology, University of Utah, Primary Children's Hospital, Salt Lake City, Utah, USA. 11. Yale University, New Haven, Connecticut, USA. 12. Our Lady's Children's Hospital and Mater Hospital, Dublin, Ireland. 13. St. Joseph's Children's Hospital, Tampa, Florida, USA. 14. Division of Pediatric Cardiology, Seattle Children's Hospital, University of Washington School of Medicine, Seattle, Washington, USA. 15. Division of Pediatric Cardiology, NewYork-Presbyterian/Morgan Stanley Children's Hospital, Columbia University Irving Medical Center, New York, New York, USA. 16. The Heart Center, Nationwide Children's Hospital, Columbus, Ohio, USA. 17. University of Pennsylvania School of Medicine, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA. 18. Department of Pediatrics and Communicable Diseases, University of Michigan C.S. Mott Children's Hospital, Ann Arbor, Michigan, USA. 19. Centre Hospitalier Universitaire de Nantes, Institut du Thorax, Fédération des Cardiopathies Congénitales, Service de Cardiologie, Nantes, France. 20. The Heart Institute, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA. 21. Le Bonheur Children's Hospital, Memphis, Tennessee, USA. 22. Hopital des enfants CHU, Toulouse, France. 23. Division of Cardiology, Department of Pediatrics, Washington University School of Medicine, St. Louis, Missouri, USA. 24. Lucile Packard Children's Hospital Stanford, Palo Alto, California, USA.
Abstract
BACKGROUND: There are limited published data focused on outcomes of transcatheter pulmonary valve replacement (TPVR) with either a Sapien XT or Sapien 3 (S3) valve. OBJECTIVES: This study sought to report short-term outcomes in a large cohort of patients who underwent TPVR with either a Sapien XT or S3 valve. METHODS: Data were entered retrospectively into a multicenter registry for patients who underwent attempted TPVR with a Sapien XT or S3 valve. Patient-related, procedural, and short-term outcomes data were characterized overall and according to type of right ventricular outflow tract (RVOT) anatomy. RESULTS: Twenty-three centers enrolled a total of 774 patients: 397 (51%) with a native/patched RVOT; 183 (24%) with a conduit; and 194 (25%) with a bioprosthetic valve. The S3 was used in 78% of patients, and the XT was used in 22%, with most patients receiving a 29-mm (39%) or 26-mm (34%) valve. The implant was technically successful in 754 (97.4%) patients. Serious adverse events were reported in 67 patients (10%), with no difference between RVOT anatomy groups. Fourteen patients underwent urgent surgery. Nine patients had a second valve implanted. Among patients with available data, tricuspid valve injury was documented in 11 (1.7%), and 9 others (1.3%) had new moderate or severe regurgitation 2 grades higher than pre-implantation, for 20 (3.0%) total patients with tricuspid valve complications. Valve function at discharge was excellent in most patients, but 58 (8.5%) had moderate or greater pulmonary regurgitation or maximum Doppler gradients >40 mm Hg. During limited follow-up (n = 349; median: 12 months), 9 patients were diagnosed with endocarditis, and 17 additional patients underwent surgical valve replacement or valve-in-valve TPVR. CONCLUSIONS: Acute outcomes after TPVR with balloon-expandable valves were generally excellent in all types of RVOT. Additional data and longer follow-up will be necessary to gain insight into these issues.
BACKGROUND: There are limited published data focused on outcomes of transcatheter pulmonary valve replacement (TPVR) with either a Sapien XT or Sapien 3 (S3) valve. OBJECTIVES: This study sought to report short-term outcomes in a large cohort of patients who underwent TPVR with either a Sapien XT or S3 valve. METHODS: Data were entered retrospectively into a multicenter registry for patients who underwent attempted TPVR with a Sapien XT or S3 valve. Patient-related, procedural, and short-term outcomes data were characterized overall and according to type of right ventricular outflow tract (RVOT) anatomy. RESULTS: Twenty-three centers enrolled a total of 774 patients: 397 (51%) with a native/patched RVOT; 183 (24%) with a conduit; and 194 (25%) with a bioprosthetic valve. The S3 was used in 78% of patients, and the XT was used in 22%, with most patients receiving a 29-mm (39%) or 26-mm (34%) valve. The implant was technically successful in 754 (97.4%) patients. Serious adverse events were reported in 67 patients (10%), with no difference between RVOT anatomy groups. Fourteen patients underwent urgent surgery. Nine patients had a second valve implanted. Among patients with available data, tricuspid valve injury was documented in 11 (1.7%), and 9 others (1.3%) had new moderate or severe regurgitation 2 grades higher than pre-implantation, for 20 (3.0%) total patients with tricuspid valve complications. Valve function at discharge was excellent in most patients, but 58 (8.5%) had moderate or greater pulmonary regurgitation or maximum Doppler gradients >40 mm Hg. During limited follow-up (n = 349; median: 12 months), 9 patients were diagnosed with endocarditis, and 17 additional patients underwent surgical valve replacement or valve-in-valve TPVR. CONCLUSIONS: Acute outcomes after TPVR with balloon-expandable valves were generally excellent in all types of RVOT. Additional data and longer follow-up will be necessary to gain insight into these issues.
Authors: Barry O'Callaghan; Jenny Zablah; Ryan Leahy; Michael Shorofsky; Joseph Kay; Gareth Morgan Journal: Postepy Kardiol Interwencyjnej Date: 2021-07-09 Impact factor: 1.426
Authors: Abhay A Divekar; Yousef M Arar; Stephen Clark; Animesh Tandon; Thomas M Zellers; Surendranath R Veeram Reddy Journal: Children (Basel) Date: 2022-04-02