Allison K Cabalka1, William E Hellenbrand2, Andreas Eicken3, Jacqueline Kreutzer4, Robert G Gray5, Lisa Bergersen6, Felix Berger7, Aimee K Armstrong8, John P Cheatham8, Evan M Zahn9, Doff B McElhinney10. 1. Division of Pediatric Cardiology, Mayo Clinic, Rochester, Minnesota. Electronic address: cabalka.allison@mayo.edu. 2. Division of Pediatric Cardiology, Yale University School of Medicine, New Haven, Connecticut. 3. Deutsches Herzzentrum München, Klinik für Kinderkardiologie und angeborene Herzfehler, Technische Universität München, Munich, Germany. 4. Division of Pediatric Cardiology, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania. 5. Department of Pediatric Cardiology, University of Utah, Salt Lake City, Utah. 6. Department of Cardiology, Boston Children's Hospital, Boston, Massachusetts. 7. Department of Congenital Heart Disease/Pediatric Cardiology, Deutsches Herzzentrum Berlin, Berlin, Germany; German Center of Cardiovascular Research, Berlin, Germany. 8. The Heart Center, Nationwide Children's Hospital, Columbus, Ohio. 9. The Guerin Family Congenital Heart Program, The Heart Institute and Department of Pediatrics, Cedars-Sinai Heart Institute, Los Angeles, California. 10. Department of Cardiothoracic Surgery, Lucille Packard Children's Hospital Stanford, Palo Alto, California.
Abstract
OBJECTIVES: This study sought to evaluate the incidence of and risk factors for conduit and stent-related outcomes following transcatheter pulmonary valve replacement (TPVR). BACKGROUND: Stent fracture (SF) and right ventricular outflow tract (RVOT) reintervention are among the most important adverse outcomes after TPVR using the Melody valve (Medtronic, Minneapolis, Minnesota). The conduit environment and conduit preparation practices vary among patients who undergo TPVR. METHODS: Data from 3 prospective Melody valve multicenter studies were pooled and analyzed. All patients who had successful implant of a Melody valve that was present at hospital discharge comprised the study cohort; patients who had TPVR into a stentless conduit comprised the analysis cohort. SF was diagnosed using protocol-specified or clinical fluoroscopy or radiography, and classified as major or minor. RESULTS: Of 358 patients who underwent catheterization with intent to perform TPVR, 309 were discharged with the Melody valve in place (study cohort) of which 251 patients had TPVR into a stentless conduit (analysis cohort). Median follow-up was 5 years. New pre-stents were placed in 68% of patients with a stentless conduit, and 22% received multiple pre-stents. At 3 years, freedom from any SF and major SF was 74 ± 3% and 85 ± 2%, respectively, and freedom from RVOT reintervention was 85 ± 2%. New pre-stents were associated with longer freedom from SF and RVOT reintervention than was no pre-stent. CONCLUSIONS: Risks of SF and reintervention after TPVR with a Melody valve were reduced by implantation of pre-stents, which has become standard practice. This study supports pre-stenting as an important component of TPVR therapy.
OBJECTIVES: This study sought to evaluate the incidence of and risk factors for conduit and stent-related outcomes following transcatheter pulmonary valve replacement (TPVR). BACKGROUND: Stent fracture (SF) and right ventricular outflow tract (RVOT) reintervention are among the most important adverse outcomes after TPVR using the Melody valve (Medtronic, Minneapolis, Minnesota). The conduit environment and conduit preparation practices vary among patients who undergo TPVR. METHODS: Data from 3 prospective Melody valve multicenter studies were pooled and analyzed. All patients who had successful implant of a Melody valve that was present at hospital discharge comprised the study cohort; patients who had TPVR into a stentless conduit comprised the analysis cohort. SF was diagnosed using protocol-specified or clinical fluoroscopy or radiography, and classified as major or minor. RESULTS: Of 358 patients who underwent catheterization with intent to perform TPVR, 309 were discharged with the Melody valve in place (study cohort) of which 251 patients had TPVR into a stentless conduit (analysis cohort). Median follow-up was 5 years. New pre-stents were placed in 68% of patients with a stentless conduit, and 22% received multiple pre-stents. At 3 years, freedom from any SF and major SF was 74 ± 3% and 85 ± 2%, respectively, and freedom from RVOT reintervention was 85 ± 2%. New pre-stents were associated with longer freedom from SF and RVOT reintervention than was no pre-stent. CONCLUSIONS: Risks of SF and reintervention after TPVR with a Melody valve were reduced by implantation of pre-stents, which has become standard practice. This study supports pre-stenting as an important component of TPVR therapy.
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: Thomas K Jones; Doff B McElhinney; Julie A Vincent; William E Hellenbrand; John P Cheatham; Darren P Berman; Evan M Zahn; Danyal M Khan; John F Rhodes; Shicheng Weng; Lisa J Bergersen Journal: Circ Cardiovasc Interv Date: 2021-12-21 Impact factor: 6.546
Authors: Juan Antonio Meca Aguirrezabalaga; Jacobo Silva Guisasola; Rocío Díaz Méndez; Alain Eliott Escalera Veizaga; Daniel Hernández-Vaquero Panizo Journal: Ann Transl Med Date: 2020-08