Cargando…

Early results from a prospective, single-arm European trial on decellularized allografts for aortic valve replacement: the ARISE study and ARISE Registry data

OBJECTIVES: Decellularized aortic homografts (DAH) may provide an additional aortic valve replacement option for young patients due to their potential to overcome the high early failure rate of conventional allogenic and xenogenic aortic valve prostheses. METHODS: A prospective, European Union-funde...

Descripción completa

Detalles Bibliográficos
Autores principales: Horke, Alexander, Tudorache, Igor, Laufer, Günther, Andreas, Martin, Pomar, Jose L, Pereda, Daniel, Quintana, Eduard, Sitges, Marta, Meyns, Bart, Rega, Filip, Hazekamp, Mark, Hübler, Michael, Schmiady, Martin, Pepper, John, Rosendahl, U, Lichtenberg, Artur, Akhyari, Payam, Jashari, Ramadan, Boethig, Dietmar, Bobylev, Dmitry, Avsar, Murat, Cebotari, Serghei, Haverich, Axel, Sarikouch, Samir
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7577293/
https://www.ncbi.nlm.nih.gov/pubmed/32386409
http://dx.doi.org/10.1093/ejcts/ezaa100
_version_ 1783598170728562688
author Horke, Alexander
Tudorache, Igor
Laufer, Günther
Andreas, Martin
Pomar, Jose L
Pereda, Daniel
Quintana, Eduard
Sitges, Marta
Meyns, Bart
Rega, Filip
Hazekamp, Mark
Hübler, Michael
Schmiady, Martin
Pepper, John
Rosendahl, U
Lichtenberg, Artur
Akhyari, Payam
Jashari, Ramadan
Boethig, Dietmar
Bobylev, Dmitry
Avsar, Murat
Cebotari, Serghei
Haverich, Axel
Sarikouch, Samir
author_facet Horke, Alexander
Tudorache, Igor
Laufer, Günther
Andreas, Martin
Pomar, Jose L
Pereda, Daniel
Quintana, Eduard
Sitges, Marta
Meyns, Bart
Rega, Filip
Hazekamp, Mark
Hübler, Michael
Schmiady, Martin
Pepper, John
Rosendahl, U
Lichtenberg, Artur
Akhyari, Payam
Jashari, Ramadan
Boethig, Dietmar
Bobylev, Dmitry
Avsar, Murat
Cebotari, Serghei
Haverich, Axel
Sarikouch, Samir
author_sort Horke, Alexander
collection PubMed
description OBJECTIVES: Decellularized aortic homografts (DAH) may provide an additional aortic valve replacement option for young patients due to their potential to overcome the high early failure rate of conventional allogenic and xenogenic aortic valve prostheses. METHODS: A prospective, European Union-funded, single-arm, multicentre, safety study was conducted in 8 centres evaluating non-cryopreserved DAH for aortic valve replacement. RESULTS: One hundred and forty-four patients (99 male) were prospectively enrolled between October 2015 and October 2018, mean age 33.6 ± 20.8 years; 45% had undergone previous cardiac operations. Mean implanted DAH diameter 22.6 ± 2.4 mm and mean durations for the operation, cardiopulmonary bypass and cross-clamp were 341 ± 140, 174 ± 80 and 126 ± 43 min, respectively. There were 2 early deaths (1 LCA thrombus on day 3 and 1 ventricular arrhythmia 5 h postop) and 1 late death due to endocarditis 4 months postoperatively, resulting in a total mortality of 2.08%. One pacemaker implantation was necessary and 1 DAH was successfully repaired after 6 weeks for early regurgitation following subcoronary implantation. All other DAH were implanted as a free-standing root. After a mean follow-up of 1.54 ± 0.81 years, the primary efficacy end points peak gradient (mean 11.8 ± 7.5 mmHg) and regurgitation (mean 0.42 ± 0.49, grade 0–3) were excellent. At 2.5 years, freedom from explantation/endocarditis/bleeding/stroke was 98.4 ± 1.1%/99.4 ± 0.6%/99.1 ± 0.9%/99.2 ± 0.8%, respectively, with results almost identical to those in an age-matched Ross operation cohort of 212 patients (mean age 34 years) despite DAH patients having undergone >2× more previous procedures. CONCLUSIONS: The initial results of the prospective multicentre ARISE trial show DAH to be safe for aortic valve replacement with excellent haemodynamics in the short follow-up period.
format Online
Article
Text
id pubmed-7577293
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher Oxford University Press
record_format MEDLINE/PubMed
spelling pubmed-75772932020-10-28 Early results from a prospective, single-arm European trial on decellularized allografts for aortic valve replacement: the ARISE study and ARISE Registry data Horke, Alexander Tudorache, Igor Laufer, Günther Andreas, Martin Pomar, Jose L Pereda, Daniel Quintana, Eduard Sitges, Marta Meyns, Bart Rega, Filip Hazekamp, Mark Hübler, Michael Schmiady, Martin Pepper, John Rosendahl, U Lichtenberg, Artur Akhyari, Payam Jashari, Ramadan Boethig, Dietmar Bobylev, Dmitry Avsar, Murat Cebotari, Serghei Haverich, Axel Sarikouch, Samir Eur J Cardiothorac Surg Conventional Valve Operations OBJECTIVES: Decellularized aortic homografts (DAH) may provide an additional aortic valve replacement option for young patients due to their potential to overcome the high early failure rate of conventional allogenic and xenogenic aortic valve prostheses. METHODS: A prospective, European Union-funded, single-arm, multicentre, safety study was conducted in 8 centres evaluating non-cryopreserved DAH for aortic valve replacement. RESULTS: One hundred and forty-four patients (99 male) were prospectively enrolled between October 2015 and October 2018, mean age 33.6 ± 20.8 years; 45% had undergone previous cardiac operations. Mean implanted DAH diameter 22.6 ± 2.4 mm and mean durations for the operation, cardiopulmonary bypass and cross-clamp were 341 ± 140, 174 ± 80 and 126 ± 43 min, respectively. There were 2 early deaths (1 LCA thrombus on day 3 and 1 ventricular arrhythmia 5 h postop) and 1 late death due to endocarditis 4 months postoperatively, resulting in a total mortality of 2.08%. One pacemaker implantation was necessary and 1 DAH was successfully repaired after 6 weeks for early regurgitation following subcoronary implantation. All other DAH were implanted as a free-standing root. After a mean follow-up of 1.54 ± 0.81 years, the primary efficacy end points peak gradient (mean 11.8 ± 7.5 mmHg) and regurgitation (mean 0.42 ± 0.49, grade 0–3) were excellent. At 2.5 years, freedom from explantation/endocarditis/bleeding/stroke was 98.4 ± 1.1%/99.4 ± 0.6%/99.1 ± 0.9%/99.2 ± 0.8%, respectively, with results almost identical to those in an age-matched Ross operation cohort of 212 patients (mean age 34 years) despite DAH patients having undergone >2× more previous procedures. CONCLUSIONS: The initial results of the prospective multicentre ARISE trial show DAH to be safe for aortic valve replacement with excellent haemodynamics in the short follow-up period. Oxford University Press 2020-05-09 /pmc/articles/PMC7577293/ /pubmed/32386409 http://dx.doi.org/10.1093/ejcts/ezaa100 Text en © The Author(s) 2020. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. http://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Conventional Valve Operations
Horke, Alexander
Tudorache, Igor
Laufer, Günther
Andreas, Martin
Pomar, Jose L
Pereda, Daniel
Quintana, Eduard
Sitges, Marta
Meyns, Bart
Rega, Filip
Hazekamp, Mark
Hübler, Michael
Schmiady, Martin
Pepper, John
Rosendahl, U
Lichtenberg, Artur
Akhyari, Payam
Jashari, Ramadan
Boethig, Dietmar
Bobylev, Dmitry
Avsar, Murat
Cebotari, Serghei
Haverich, Axel
Sarikouch, Samir
Early results from a prospective, single-arm European trial on decellularized allografts for aortic valve replacement: the ARISE study and ARISE Registry data
title Early results from a prospective, single-arm European trial on decellularized allografts for aortic valve replacement: the ARISE study and ARISE Registry data
title_full Early results from a prospective, single-arm European trial on decellularized allografts for aortic valve replacement: the ARISE study and ARISE Registry data
title_fullStr Early results from a prospective, single-arm European trial on decellularized allografts for aortic valve replacement: the ARISE study and ARISE Registry data
title_full_unstemmed Early results from a prospective, single-arm European trial on decellularized allografts for aortic valve replacement: the ARISE study and ARISE Registry data
title_short Early results from a prospective, single-arm European trial on decellularized allografts for aortic valve replacement: the ARISE study and ARISE Registry data
title_sort early results from a prospective, single-arm european trial on decellularized allografts for aortic valve replacement: the arise study and arise registry data
topic Conventional Valve Operations
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7577293/
https://www.ncbi.nlm.nih.gov/pubmed/32386409
http://dx.doi.org/10.1093/ejcts/ezaa100
work_keys_str_mv AT horkealexander earlyresultsfromaprospectivesinglearmeuropeantrialondecellularizedallograftsforaorticvalvereplacementthearisestudyandariseregistrydata
AT tudoracheigor earlyresultsfromaprospectivesinglearmeuropeantrialondecellularizedallograftsforaorticvalvereplacementthearisestudyandariseregistrydata
AT laufergunther earlyresultsfromaprospectivesinglearmeuropeantrialondecellularizedallograftsforaorticvalvereplacementthearisestudyandariseregistrydata
AT andreasmartin earlyresultsfromaprospectivesinglearmeuropeantrialondecellularizedallograftsforaorticvalvereplacementthearisestudyandariseregistrydata
AT pomarjosel earlyresultsfromaprospectivesinglearmeuropeantrialondecellularizedallograftsforaorticvalvereplacementthearisestudyandariseregistrydata
AT peredadaniel earlyresultsfromaprospectivesinglearmeuropeantrialondecellularizedallograftsforaorticvalvereplacementthearisestudyandariseregistrydata
AT quintanaeduard earlyresultsfromaprospectivesinglearmeuropeantrialondecellularizedallograftsforaorticvalvereplacementthearisestudyandariseregistrydata
AT sitgesmarta earlyresultsfromaprospectivesinglearmeuropeantrialondecellularizedallograftsforaorticvalvereplacementthearisestudyandariseregistrydata
AT meynsbart earlyresultsfromaprospectivesinglearmeuropeantrialondecellularizedallograftsforaorticvalvereplacementthearisestudyandariseregistrydata
AT regafilip earlyresultsfromaprospectivesinglearmeuropeantrialondecellularizedallograftsforaorticvalvereplacementthearisestudyandariseregistrydata
AT hazekampmark earlyresultsfromaprospectivesinglearmeuropeantrialondecellularizedallograftsforaorticvalvereplacementthearisestudyandariseregistrydata
AT hublermichael earlyresultsfromaprospectivesinglearmeuropeantrialondecellularizedallograftsforaorticvalvereplacementthearisestudyandariseregistrydata
AT schmiadymartin earlyresultsfromaprospectivesinglearmeuropeantrialondecellularizedallograftsforaorticvalvereplacementthearisestudyandariseregistrydata
AT pepperjohn earlyresultsfromaprospectivesinglearmeuropeantrialondecellularizedallograftsforaorticvalvereplacementthearisestudyandariseregistrydata
AT rosendahlu earlyresultsfromaprospectivesinglearmeuropeantrialondecellularizedallograftsforaorticvalvereplacementthearisestudyandariseregistrydata
AT lichtenbergartur earlyresultsfromaprospectivesinglearmeuropeantrialondecellularizedallograftsforaorticvalvereplacementthearisestudyandariseregistrydata
AT akhyaripayam earlyresultsfromaprospectivesinglearmeuropeantrialondecellularizedallograftsforaorticvalvereplacementthearisestudyandariseregistrydata
AT jashariramadan earlyresultsfromaprospectivesinglearmeuropeantrialondecellularizedallograftsforaorticvalvereplacementthearisestudyandariseregistrydata
AT boethigdietmar earlyresultsfromaprospectivesinglearmeuropeantrialondecellularizedallograftsforaorticvalvereplacementthearisestudyandariseregistrydata
AT bobylevdmitry earlyresultsfromaprospectivesinglearmeuropeantrialondecellularizedallograftsforaorticvalvereplacementthearisestudyandariseregistrydata
AT avsarmurat earlyresultsfromaprospectivesinglearmeuropeantrialondecellularizedallograftsforaorticvalvereplacementthearisestudyandariseregistrydata
AT cebotariserghei earlyresultsfromaprospectivesinglearmeuropeantrialondecellularizedallograftsforaorticvalvereplacementthearisestudyandariseregistrydata
AT haverichaxel earlyresultsfromaprospectivesinglearmeuropeantrialondecellularizedallograftsforaorticvalvereplacementthearisestudyandariseregistrydata
AT sarikouchsamir earlyresultsfromaprospectivesinglearmeuropeantrialondecellularizedallograftsforaorticvalvereplacementthearisestudyandariseregistrydata