Alterra Adaptive Prestent and SAPIEN 3 THV for Congenital Pulmonic Valve Dysfunction : An Early Feasibility Study
Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved..
OBJECTIVES: The aim of this study was to demonstrate the safety and functionality of the Alterra Adaptive Prestent and SAPIEN 3 transcatheter heart valve (THV) in patients with dysfunctional, dilated right ventricular outflow tract (RVOT) greater or equal to moderate pulmonary regurgitation (PR).
BACKGROUND: Significant variations in the size and morphology of the RVOT affect the placement of transcatheter pulmonary valves. The Alterra Prestent internally reduces and reconfigures the RVOT, providing a stable landing zone for the 29-mm SAPIEN 3 THV.
METHODS: Eligible patients had moderate or greater PR, weighed >20 kg, and had RVOT diameter 27 to 38 mm and length >35 mm. The primary endpoint was device success, a 5-item composite: 1 Alterra Prestent deployed in the desired location, 1 SAPIEN 3 THV implanted in the desired location within the Prestent, right ventricular-to-pulmonary artery peak-to-peak gradient <35 mm Hg after THV implantation, less than moderate PR at discharge, and no explantation 24 h post-implantation. The secondary composite endpoint was freedom from THV dysfunction (RVOT/pulmonary valve (PV) reintervention, greater or equal to moderate total PR, mean RVOT/PV gradient ≥ 35 mm Hg at 30 days and 6 months. Descriptive statistics are reported.
RESULTS: Enrolled patients (N = 15) had a median age and weight of 20 years and 61.7 kg, respectively; 93.3% were in New York Heart Association functional class I or II. Device success was 100%. No staged procedures were necessary. No THV dysfunction was reported to 6 months. No serious safety signals were reported.
CONCLUSIONS: This early feasibility study demonstrated the safety and functionality of the Alterra Adaptive Prestent in patients with congenital RVOT dysfunction and moderate or greater PR. Durability and long-term outcome data are needed.
Errataetall: |
CommentIn: JACC Cardiovasc Interv. 2020 Nov 9;13(21):2525-2527. - PMID 33069645 |
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Medienart: |
E-Artikel |
Erscheinungsjahr: |
2020 |
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Erschienen: |
2020 |
Enthalten in: |
Zur Gesamtaufnahme - volume:13 |
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Enthalten in: |
JACC. Cardiovascular interventions - 13(2020), 21 vom: 09. Nov., Seite 2510-2524 |
Sprache: |
Englisch |
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Beteiligte Personen: |
Shahanavaz, Shabana [VerfasserIn] |
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Links: |
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Anmerkungen: |
Date Completed 11.08.2021 Date Revised 11.08.2021 published: Print-Electronic CommentIn: JACC Cardiovasc Interv. 2020 Nov 9;13(21):2525-2527. - PMID 33069645 Citation Status MEDLINE |
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doi: |
10.1016/j.jcin.2020.06.039 |
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funding: |
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Förderinstitution / Projekttitel: |
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PPN (Katalog-ID): |
NLM316390895 |
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500 | |a CommentIn: JACC Cardiovasc Interv. 2020 Nov 9;13(21):2525-2527. - PMID 33069645 | ||
500 | |a Citation Status MEDLINE | ||
520 | |a Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. | ||
520 | |a OBJECTIVES: The aim of this study was to demonstrate the safety and functionality of the Alterra Adaptive Prestent and SAPIEN 3 transcatheter heart valve (THV) in patients with dysfunctional, dilated right ventricular outflow tract (RVOT) greater or equal to moderate pulmonary regurgitation (PR) | ||
520 | |a BACKGROUND: Significant variations in the size and morphology of the RVOT affect the placement of transcatheter pulmonary valves. The Alterra Prestent internally reduces and reconfigures the RVOT, providing a stable landing zone for the 29-mm SAPIEN 3 THV | ||
520 | |a METHODS: Eligible patients had moderate or greater PR, weighed >20 kg, and had RVOT diameter 27 to 38 mm and length >35 mm. The primary endpoint was device success, a 5-item composite: 1 Alterra Prestent deployed in the desired location, 1 SAPIEN 3 THV implanted in the desired location within the Prestent, right ventricular-to-pulmonary artery peak-to-peak gradient <35 mm Hg after THV implantation, less than moderate PR at discharge, and no explantation 24 h post-implantation. The secondary composite endpoint was freedom from THV dysfunction (RVOT/pulmonary valve (PV) reintervention, greater or equal to moderate total PR, mean RVOT/PV gradient ≥ 35 mm Hg at 30 days and 6 months. Descriptive statistics are reported | ||
520 | |a RESULTS: Enrolled patients (N = 15) had a median age and weight of 20 years and 61.7 kg, respectively; 93.3% were in New York Heart Association functional class I or II. Device success was 100%. No staged procedures were necessary. No THV dysfunction was reported to 6 months. No serious safety signals were reported | ||
520 | |a CONCLUSIONS: This early feasibility study demonstrated the safety and functionality of the Alterra Adaptive Prestent in patients with congenital RVOT dysfunction and moderate or greater PR. Durability and long-term outcome data are needed | ||
650 | 4 | |a Journal Article | |
650 | 4 | |a Research Support, Non-U.S. Gov't | |
650 | 4 | |a Alterra Adaptive Prestent | |
650 | 4 | |a SAPIEN 3 THV | |
650 | 4 | |a pulmonary regurgitation | |
650 | 4 | |a right ventricle outflow tract/pulmonary valve dysfunction | |
650 | 4 | |a transcatheter pulmonary valve replacement | |
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700 | 1 | |a Babaliaros, Vasilis |e verfasserin |4 aut | |
700 | 1 | |a Kim, Dennis |e verfasserin |4 aut | |
700 | 1 | |a Dimas, Vivian |e verfasserin |4 aut | |
700 | 1 | |a Veeram Reddy, Suredranath R |e verfasserin |4 aut | |
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700 | 1 | |a Gorelick, Jeremy |e verfasserin |4 aut | |
700 | 1 | |a Zahn, Evan M |e verfasserin |4 aut | |
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