Abstract
Background
In situ fenestration (ISF) is an effective approach for reconstructing supra-aortic
branches during thoracic endovascular aortic repair (TEVAR). A dedicated device is
needed for ISF.
Methods
The Quick Fenestrater (QF) underwent in vitro, animal-based, and initial clinical
testing. In vitro, the polytetrafluoroethylene and Dacron aortic endografts were fenestrated
using the QF, and the structure of the graft, fenestration hole, and shed particulate
material were evaluated. Eight white swine had QF-aided ISF combined with TEVAR and
bridge-stent implantation. The outcomes were assessed using intraoperative angiography
and biopsy. Finally, 13 patients were treated with QF-assisted ISF combined with TEVAR,
and the success rate, technical details, and intra- and postoperative complications
were recorded.
Results
The endograft structure was not damaged during in vitro testing. The fenestration
hole was clean, and no particulate material was detected. In animal studies, all animals
survived, the supra-aortic arteries were patent, and the endografts and bridge stents
had normal morphology. In clinical studies, the technical success rate was 100%, and
no fenestration-related neurologic complications or death occurred. One patient had
a local access-related hematoma perioperatively and recovered after conservative treatment.
Three patients had type III endoleaks, which resolved with no additional treatment.
During a mean follow-up of 22.1 ± 6 months, no thoracic complications were identified,
and the bridge stents were patent with no endoleaks. No adverse cerebrovascular events,
cardiovascular events, or death occurred.
Conclusions
QF-assisted ISF is a safe and effective method for the reconstruction of supra-aortic
branches during TEVAR. Intermediate-term follow-up results validate the application
of the novel fenestration device.
Résumé
Contexte
L'endogreffe fenestrée est une approche efficace pour reconstruire les branches supra-aortiques
lors d'une réparation endovasculaire de l'aorte thoracique (TEVAR). Elle nécessite
toutefois un dispositif dédié.
Méthodologie
Le Quick Fenestrater (QF) a fait l'objet de tests in vitro, sur des animaux et de
tests cliniques initiaux. In vitro, les endogreffes aortiques en polytétrafluoroéthylène
et en Dacron ont été fenestrées à l'aide du QF, et la structure de la greffe, le trou
de fenestration et le matériau particulaire éliminé ont été évalués. Huit porcs blancs
ont subi une endogreffe fenestrée assistée par le QF, combinée à une TEVAR et à l'implantation
d'une endoprothèse de pontage. Les résultats ont été évalués par angiographie et biopsie
peropératoires. À terme, 13 patients ont été traités par une endogreffe fenestrée
assistée par QF combinée à une TEVAR, et le taux de réussite, les détails techniques
et les complications peropératoires et postopératoires ont été consignés.
Résultats
La structure de l'endogreffe n'a pas été endommagée pendant les tests in vitro. Le
trou de fenestration était propre, et aucune particule n'a été détectée. Dans les
études animales, tous les animaux ont survécu, les artères supra-aortiques étaient
perméables, et les endogreffes et les endoprothèses de pontage avaient une morphologie
normale. Dans les études cliniques, le taux de réussite technique était de 100 % et
aucune complication neurologique liée à la fenestration ni aucun décès ne sont survenus.
Un patient a eu un hématome périopératoire lié à l'accès local et s'est rétabli après
un traitement conservateur. Trois patients ont présenté des endofuites de type III,
qui se sont résorbées sans traitement supplémentaire. Au cours d'un suivi moyen de
22,1 ± 6 mois, aucune complication thoracique n'a été relevée, et les endoprothèses
de pontage sont restées perméables, sans endofuites. Aucune manifestation vasculaire
cérébrale indésirable, aucune manifestation cardiovasculaire, ni aucun décès n'est
survenu.
Conclusions
Une endogreffe fenestrée assistée par QF est une méthode sûre et efficace pour la
reconstruction des branches supra-aortiques lors d'une TEVAR. Les résultats du suivi
à moyen terme valident l'application de ce nouveau dispositif de fenestration.
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Article info
Publication history
Published online: May 10, 2021
Accepted:
April 18,
2021
Received:
August 10,
2020
Footnotes
See page 1546 for disclosure information.
Identification
Copyright
© 2021 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.
