Final 5-year results of the United States Zenith Fenestrated prospective multicenter study for juxtarenal abdominal aortic aneurysms

Oderich, Gustavo S.; Farber, Mark A.; Schneider, Darren B.; Makaroun, Michel S.; Sánchez, Luis A.; Schanzer, Andres; Beck, Adam W.; Starnes, Benjamin W.; Fillinger, Mark F.; Tenorio, Emanuel R.; Chen, Min; Zhou, Qing; Investigators, Zenith Fenestrated Study

doi:10.1016/j.jvs.2020.08.128

Cited by 60 publications

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“…Developments in techniques of renal and mesenteric artery stenting allowed treatment of patients with more complex aortic aneurysms using fenestrated and branched endovascular aortic repair (FB-EVAR) 3–5 . Evidence from single and multicenter studies, systematic reviews and prospective physician-sponsored investigational device exemption studies (PS-IDEs) have shown that FB-EVAR can be performed with high technical success and is associated with lower morbidity and mortality compared to open surgical repair 6–9 . The European Society for Vascular Surgery practice guidelines have recently recommended FB-EVAR over open surgical repair in patients with complex abdominal aortic aneurysms who have suitable anatomy 10 .…”

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confidence: 99%

“…[3][4][5] Evidence from single and multicenter studies, systematic reviews and prospective physiciansponsored investigational device exemption studies (PS-IDEs) have shown that FB-EVAR can be performed with high technical success and is associated with lower morbidity and mortality compared to open surgical repair. [6][7][8][9] The European Society for Vascular Surgery practice guidelines have recently recommended FB-EVAR over open surgical repair in patients with complex abdominal aortic aneurysms who have suitable anatomy. 10 Although the technique has been widely adopted in several countries, access to company manufactured devices is still limited in the United States to a few centers with ongoing PS-IDE studies.…”

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confidence: 99%

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Midterm Outcomes of a Prospective, Nonrandomized Study to Evaluate Endovascular Repair of Complex Aortic Aneurysms Using Fenestrated-Branched Endografts

et al. 2021

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Objective: The aim of this study was to investigate the midterm outcomes of fenestrated and branched endovascular aortic repair (FB-EVAR) of pararenal (PRA) and thoracoabdominal aortic aneurysms (TAAAs). Summary Background Data: FB-EVAR has been associated with decreased morbidity compared to open repair, but there is limited midterm data. Methods: A total of 430 patients (302 males, mean age 74 AE 8 years) treated by FB-EVAR were enrolled in a prospective, nonrandomized investigational device exemption study. Endpoints included 30-day mortality and major adverse events (MAEs), freedom from all cause and aortic-related mortality, target vessel patency, and freedom from secondary intervention and target vessel instability. Results: There were 133 PRAs and 297 TAAAs with 1673 renal-mesenteric arteries incorporated by fenestrations or directional branches (3.9 AE 0.5 vesvessels/patient). At 30 days or within the hospital stay if longer than 30 days, there were 4 (0.9%) deaths. MAEs included new-onset dialysis in 8 patients (2%), permanent paraplegia or stroke in 10 patients each (2%), and respiratory failure requiring tracheostomy in 2 patients (0.5%). After a mean follow-up of 26 AE 20 months, there were 3 (0.7%) aortic-related deaths from SMA stent occlusion, gastrointestinal hemorrhage, or complications of open arch repair. At 5 years, freedom from all-cause and aortic-related mortality were 57% AE 5% and 98% AE 1%, respectively. Freedom from secondary intervention was 64% AE 4%, primary target vessel patency was 94% AE 1%, and freedom from target vessel instability was 89% AE 2% at same interval. One patient (0.2%) had nonfatal aneurysm treated using endovascular repair. Conclusion: FB-EVAR is safe and effective for treatment of PRA and TAAAs with low rate of aortic-related mortality and aneurysm rupture on midterm follow-up.

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Midterm Outcomes of a Prospective, Nonrandomized Study to Evaluate Endovascular Repair of Complex Aortic Aneurysms Using Fenestrated-Branched Endografts

et al. 2021

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“…Mehrere Studien zeigen ausgezeichnete Erfolgsraten und eine niedrige Morbidität und Mortalität auch im Langzeitverlauf [ 20 ]. Die Ergebnisse von Implantationen mit 4 Fenestrierungen zeigen ähnlich gute Daten im Vergleich zu zweifach fenestrierten Implantationen, wobei ein Vorteil des vierfach fenestrierten Zugangs darin besteht, dass die suprazöliakale Stentkomponente im Bedarfsfall relativ einfach nach proximal verlängert werden kann, sollte die Krankheit im Intervall fortschreiten [ 12 , 21 ].…”

Section: Fenestrierte Endoprothesenunclassified

Fenestrierte und verzweigte endovaskuläre Aortenprothesen

Dachs

Hauck

Kern³

et al. 2022

Radiologie

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Zusammenfassung Hintergrund Komplexe abdominelle aortale Pathologien, welche die Abgänge der Viszeralarterien miterfassen und bei denen kein adäquater proximaler Hals gegeben ist, können heute mittels fortgeschrittener FEVAR/BEVAR-Technik („fenestrated/branched endovascular aneurysm repair“) mit ähnlicher Sicherheit und vergleichbaren Erfolgsraten behandelt werden wie infrarenale Pathologien mit konventionellem EVAR. Methodische Innovationen und Probleme Zur Versorgung der Viszeralarterien können Fenestrierungen (bei Abgang der Viszeralarterie aus der nichtdilatierten Aorta) oder Verzweigungen (bei Abgang aus der dilatierten Aorta) verwendet werden. Beide Arten von Öffnungen werden mit Verbindungsstentgrafts (VSG) zu den Viszeralarterien abgedichtet. Mehrere Hersteller bieten fenestrierte oder verzweigte Endoprothesen an, wobei diese nur in Einzelfällen CE-zertifiziert und überwiegend in Europa als individuelle Sonderanfertigungen patientenbezogen erhältlich sind. Dies setzt eine entsprechende Lieferzeit voraus, was die Behandlung akuter Patienten mit solchen Prothesen unmöglich macht. Es liegen allerdings zwei Produkte von vierfach verzweigten Endoprothesen vor, die einen größeren Bereich der anatomischen Gegebenheiten bei thorakoabdominellen Aneurysmen auch im Akutfall abdecken und behandelbar machen. Sämtliche FEVAR- und BEVAR-Hauptkörper benötigen VSG, die durchgehend von Fremdherstellern stammen und von denen gegenwärtig noch kein einziges Produkt für diese Anwendung zertifiziert ist. Empfehlungen Da Probleme an Verbindungsstentgrafts eine wesentliche Ursache für Reinterventionen sind, sollte in der Nachsorge Knickbildungen und Brüchen an diesen Verbindungsstents besonderes Augenmerk geschenkt und von der Verwendung einschichtiger Designs beim BEVAR abgesehen werden.

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“…Fenestrated and branched aortic endografts (F/B EVAR) are now widely used as the main treatment option for a variety of aneurysmal aortic pathology from atherosclerotic degenerative aneurysm to chronic aortic dissection. 1 , 2 The majority of these endografts are custom grafts where the F/B are designed according to the patient’s anatomy. In some countries, Cook Medical t-Branch ® aortic endografts (Cook Medical), Gore TAMBE (Gore Medical), and Jotec E-nside TAAA (Cryolife) are available as off-the-shelf device branches for the renal and visceral arteries.…”

Section: Introductionmentioning

confidence: 99%

Endovascular Management of Unused Fenestrations or Branches in Fenestrated/Branched Aortic Endograft

2021

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Fenestrated and branched aortic endograft (F/B EVAR) has become a widely accepted technique in the management of aneurysmal aortic pathology. However, intra-procedurally in some situations, there are F/B that remain unused because of target vessel occlusion or failure to cannulate the target artery. Leaving the F/B open will result in an ongoing endoleak, unless treated at the time. Herein we described the necessary considerations and several endovascular techniques to occlude these fenestrations and branches in this situation.

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Final 5-year results of the United States Zenith Fenestrated prospective multicenter study for juxtarenal abdominal aortic aneurysms

Cited by 60 publications

References 34 publications

Midterm Outcomes of a Prospective, Nonrandomized Study to Evaluate Endovascular Repair of Complex Aortic Aneurysms Using Fenestrated-Branched Endografts

Midterm Outcomes of a Prospective, Nonrandomized Study to Evaluate Endovascular Repair of Complex Aortic Aneurysms Using Fenestrated-Branched Endografts

Fenestrierte und verzweigte endovaskuläre Aortenprothesen

Endovascular Management of Unused Fenestrations or Branches in Fenestrated/Branched Aortic Endograft

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