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Relationships Among Conduit Type, Pre-Stenting, and Outcomes in Patients Undergoing Transcatheter Pulmonary Valve Replacement in the Prospective North American and European Melody Valve Trials.
JACC Cardiovasc Interv. 2017 09 11; 10(17):1746-1759.JC

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.

Authors+Show Affiliations

Division of Pediatric Cardiology, Mayo Clinic, Rochester, Minnesota. Electronic address: cabalka.allison@mayo.edu.Division of Pediatric Cardiology, Yale University School of Medicine, New Haven, Connecticut.Deutsches Herzzentrum München, Klinik für Kinderkardiologie und angeborene Herzfehler, Technische Universität München, Munich, Germany.Division of Pediatric Cardiology, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania.Department of Pediatric Cardiology, University of Utah, Salt Lake City, Utah.Department of Cardiology, Boston Children's Hospital, Boston, Massachusetts.Department of Congenital Heart Disease/Pediatric Cardiology, Deutsches Herzzentrum Berlin, Berlin, Germany; German Center of Cardiovascular Research, Berlin, Germany.The Heart Center, Nationwide Children's Hospital, Columbus, Ohio.The Heart Center, Nationwide Children's Hospital, Columbus, Ohio.The Guerin Family Congenital Heart Program, The Heart Institute and Department of Pediatrics, Cedars-Sinai Heart Institute, Los Angeles, California.Department of Cardiothoracic Surgery, Lucille Packard Children's Hospital Stanford, Palo Alto, California.

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study

Language

eng

PubMed ID

28823778

Citation

Cabalka, Allison K., et al. "Relationships Among Conduit Type, Pre-Stenting, and Outcomes in Patients Undergoing Transcatheter Pulmonary Valve Replacement in the Prospective North American and European Melody Valve Trials." JACC. Cardiovascular Interventions, vol. 10, no. 17, 2017, pp. 1746-1759.
Cabalka AK, Hellenbrand WE, Eicken A, et al. Relationships Among Conduit Type, Pre-Stenting, and Outcomes in Patients Undergoing Transcatheter Pulmonary Valve Replacement in the Prospective North American and European Melody Valve Trials. JACC Cardiovasc Interv. 2017;10(17):1746-1759.
Cabalka, A. K., Hellenbrand, W. E., Eicken, A., Kreutzer, J., Gray, R. G., Bergersen, L., Berger, F., Armstrong, A. K., Cheatham, J. P., Zahn, E. M., & McElhinney, D. B. (2017). Relationships Among Conduit Type, Pre-Stenting, and Outcomes in Patients Undergoing Transcatheter Pulmonary Valve Replacement in the Prospective North American and European Melody Valve Trials. JACC. Cardiovascular Interventions, 10(17), 1746-1759. https://doi.org/10.1016/j.jcin.2017.05.022
Cabalka AK, et al. Relationships Among Conduit Type, Pre-Stenting, and Outcomes in Patients Undergoing Transcatheter Pulmonary Valve Replacement in the Prospective North American and European Melody Valve Trials. JACC Cardiovasc Interv. 2017 09 11;10(17):1746-1759. PubMed PMID: 28823778.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Relationships Among Conduit Type, Pre-Stenting, and Outcomes in Patients Undergoing Transcatheter Pulmonary Valve Replacement in the Prospective North American and European Melody Valve Trials. AU - Cabalka,Allison K, AU - Hellenbrand,William E, AU - Eicken,Andreas, AU - Kreutzer,Jacqueline, AU - Gray,Robert G, AU - Bergersen,Lisa, AU - Berger,Felix, AU - Armstrong,Aimee K, AU - Cheatham,John P, AU - Zahn,Evan M, AU - McElhinney,Doff B, Y1 - 2017/08/16/ PY - 2016/12/20/received PY - 2017/03/30/revised PY - 2017/05/04/accepted PY - 2017/8/22/pubmed PY - 2018/5/23/medline PY - 2017/8/22/entrez KW - Ross procedure KW - percutaneous valve KW - stent fracture KW - tetralogy of Fallot KW - transcatheter pulmonary valve replacement SP - 1746 EP - 1759 JF - JACC. Cardiovascular interventions JO - JACC Cardiovasc Interv VL - 10 IS - 17 N2 - 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. SN - 1876-7605 UR - https://www.unboundmedicine.com/medline/citation/28823778/Relationships_Among_Conduit_Type_Pre_Stenting_and_Outcomes_in_Patients_Undergoing_Transcatheter_Pulmonary_Valve_Replacement_in_the_Prospective_North_American_and_European_Melody_Valve_Trials_ DB - PRIME DP - Unbound Medicine ER -