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Bicuspid aortic valve repair using geometric ring annuloplasty: A first-in-humans pilot trial

OBJECTIVE: As bicuspid aortic valve (BAV) repair evolves, more effective annular reduction and stabilization could be advantageous. A geometric annuloplasty ring has been developed, and 2-year regulatory outcomes of a first-in-humans pilot trial are reported. METHODS: A prospective first-in-humans t...

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Autores principales: Rankin, J. Scott, Mazzitelli, Domenico, Fischlein, Theodor J.M., Choi, Yeong-Hoon, Aicher, Diana, Wei, Lawrence M., Badhwar, Vinay
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8288553/
https://www.ncbi.nlm.nih.gov/pubmed/34317698
http://dx.doi.org/10.1016/j.xjtc.2019.12.005
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author Rankin, J. Scott
Mazzitelli, Domenico
Fischlein, Theodor J.M.
Choi, Yeong-Hoon
Aicher, Diana
Wei, Lawrence M.
Badhwar, Vinay
author_facet Rankin, J. Scott
Mazzitelli, Domenico
Fischlein, Theodor J.M.
Choi, Yeong-Hoon
Aicher, Diana
Wei, Lawrence M.
Badhwar, Vinay
author_sort Rankin, J. Scott
collection PubMed
description OBJECTIVE: As bicuspid aortic valve (BAV) repair evolves, more effective annular reduction and stabilization could be advantageous. A geometric annuloplasty ring has been developed, and 2-year regulatory outcomes of a first-in-humans pilot trial are reported. METHODS: A prospective first-in-humans trial of BAV ring annuloplasty was completed in 16 patients. Patient age was 44.4 ± 11.3 (mean ± standard deviation) years, preoperative aortic insufficiency grade was 2.5 ± 1.0, New York Heart Association class 1.8 ± 0.4, and mean systolic gradient 13.4 ± 12.9 mm Hg. Three patients had Sievers type 0 BAV, 11 had type 1, and 2 were type 2. The Dacron-covered titanium rings had circular base geometry with 180° subcommissural posts and were implanted subannularly. Leaflets were reconstructed using plication/cleft closure, creating an effective height of ≥8 mm, even if modest gradients were induced. RESULTS: Mean pre-repair annular diameter was 28.6 ± 3.3 mm, and the average ring diameter was 22.3 ± 1.6 mm. All valves required leaflet plication/reconstruction; pericardium was avoided; and 7 patients had aortic replacement for aneurysms. No early mortalities or major complications occurred. Two patients required early prosthetic valve replacement for technical errors, and all were between 24-38 months’ postoperative at follow-up. No late mortalities or valve-related complications occurred, and all patients reverted to New York Heart Association class I. Aortic insufficiency reduction was significant to grade 0.9 ± 0.5 at 2-years (P < .0001). Mean valve gradients were acceptable (13.3 ± 5.0 mm Hg at 2 years; overall P = .11) and tended to fall over time (P < .0001). CONCLUSIONS: Geometric ring annuloplasty was safe and effective for BAV repair. AI reduction was significant, valve gradients were satisfactory, and clinical outcomes were excellent. Geometric ring annuloplasty could simplify and standardize BAV repair.
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spelling pubmed-82885532021-07-26 Bicuspid aortic valve repair using geometric ring annuloplasty: A first-in-humans pilot trial Rankin, J. Scott Mazzitelli, Domenico Fischlein, Theodor J.M. Choi, Yeong-Hoon Aicher, Diana Wei, Lawrence M. Badhwar, Vinay JTCVS Tech Adult: Aorta Valve: Surgical Techniques OBJECTIVE: As bicuspid aortic valve (BAV) repair evolves, more effective annular reduction and stabilization could be advantageous. A geometric annuloplasty ring has been developed, and 2-year regulatory outcomes of a first-in-humans pilot trial are reported. METHODS: A prospective first-in-humans trial of BAV ring annuloplasty was completed in 16 patients. Patient age was 44.4 ± 11.3 (mean ± standard deviation) years, preoperative aortic insufficiency grade was 2.5 ± 1.0, New York Heart Association class 1.8 ± 0.4, and mean systolic gradient 13.4 ± 12.9 mm Hg. Three patients had Sievers type 0 BAV, 11 had type 1, and 2 were type 2. The Dacron-covered titanium rings had circular base geometry with 180° subcommissural posts and were implanted subannularly. Leaflets were reconstructed using plication/cleft closure, creating an effective height of ≥8 mm, even if modest gradients were induced. RESULTS: Mean pre-repair annular diameter was 28.6 ± 3.3 mm, and the average ring diameter was 22.3 ± 1.6 mm. All valves required leaflet plication/reconstruction; pericardium was avoided; and 7 patients had aortic replacement for aneurysms. No early mortalities or major complications occurred. Two patients required early prosthetic valve replacement for technical errors, and all were between 24-38 months’ postoperative at follow-up. No late mortalities or valve-related complications occurred, and all patients reverted to New York Heart Association class I. Aortic insufficiency reduction was significant to grade 0.9 ± 0.5 at 2-years (P < .0001). Mean valve gradients were acceptable (13.3 ± 5.0 mm Hg at 2 years; overall P = .11) and tended to fall over time (P < .0001). CONCLUSIONS: Geometric ring annuloplasty was safe and effective for BAV repair. AI reduction was significant, valve gradients were satisfactory, and clinical outcomes were excellent. Geometric ring annuloplasty could simplify and standardize BAV repair. Elsevier 2020-01-23 /pmc/articles/PMC8288553/ /pubmed/34317698 http://dx.doi.org/10.1016/j.xjtc.2019.12.005 Text en © 2020 by The American Association for Thoracic Surgery. Published by Elsevier Inc. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Adult: Aorta Valve: Surgical Techniques
Rankin, J. Scott
Mazzitelli, Domenico
Fischlein, Theodor J.M.
Choi, Yeong-Hoon
Aicher, Diana
Wei, Lawrence M.
Badhwar, Vinay
Bicuspid aortic valve repair using geometric ring annuloplasty: A first-in-humans pilot trial
title Bicuspid aortic valve repair using geometric ring annuloplasty: A first-in-humans pilot trial
title_full Bicuspid aortic valve repair using geometric ring annuloplasty: A first-in-humans pilot trial
title_fullStr Bicuspid aortic valve repair using geometric ring annuloplasty: A first-in-humans pilot trial
title_full_unstemmed Bicuspid aortic valve repair using geometric ring annuloplasty: A first-in-humans pilot trial
title_short Bicuspid aortic valve repair using geometric ring annuloplasty: A first-in-humans pilot trial
title_sort bicuspid aortic valve repair using geometric ring annuloplasty: a first-in-humans pilot trial
topic Adult: Aorta Valve: Surgical Techniques
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8288553/
https://www.ncbi.nlm.nih.gov/pubmed/34317698
http://dx.doi.org/10.1016/j.xjtc.2019.12.005
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