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Article Dans Une Revue Journal of Vascular Surgery Année : 2023

Transatlantic multicenter study on the use of a modified preloaded delivery system for fenestrated endovascular aortic repair.

Nikolaos Tsilimparis
  • Fonction : Auteur
Ryan Gouveia E Melo
  • Fonction : Auteur
Andres Schanzer
  • Fonction : Auteur
Martin Austermann
  • Fonction : Auteur
Roberto Chiesa
  • Fonction : Auteur
Timothy Resch
  • Fonction : Auteur
Mauro Gargiulo
  • Fonction : Auteur
Carlos Timaran
  • Fonction : Auteur
Donald Adam
  • Fonction : Auteur
Nuno Dias
  • Fonction : Auteur
Gustavo S. Oderich
  • Fonction : Auteur
T. Kölbel
  • Fonction : Auteur
F. Gomez Palones
  • Fonction : Auteur
Gioele Simonte
  • Fonction : Auteur
Rocco Giudice
  • Fonction : Auteur
Diletta Loschi
  • Fonction : Auteur
Nicola Leone
  • Fonction : Auteur
Enrico Gallito
  • Fonction : Auteur
Paolo Spath
  • Fonction : Auteur
Jesus Porras Cólon
  • Fonction : Auteur
Amro Elboushi
  • Fonction : Auteur
Melker Wachtmeister
  • Fonction : Auteur
Bjorn Sonesson
  • Fonction : Auteur
Emanuel Tenorio
  • Fonction : Auteur
Giuseppe Panuccio
  • Fonction : Auteur
Giacomo Isernia
  • Fonction : Auteur
Luca Bertoglio
  • Fonction : Auteur

Résumé

Objective Analyze the outcomes of endovascular complex abdominal and thoracoabdominal aortic aneurysm repair using the Cook fenestrated device with the modified preloaded delivery system (MPDS) with a biport handle and preloaded catheters. Methods A multicenter retrospective single arm cohort study was performed, including all consecutive patients with complex abdominal aortic aneurysm repair and thoracoabdominal aortic aneurysms treated with the MPDS fenestrated device (Cook Medical). Patient clinical characteristics, anatomy, and indications for device use were collected. Outcomes, classified according to the Society for Vascular Surgery reporting standards, were collected at discharge, 30 days, 6 months, and annually thereafter. Results Overall, 712 patients (median age, 73 years; interquartile range [IQR], 68-78 years; 83% male) from 16 centers in Europe and the United States treated electively were included: 35.4% (n = 252) presented with thoracoabdominal aortic aneurysms and 64.6% (n = 460) with complex abdominal aortic aneurysm repair. Overall, 2755 target vessels were included (mean ,3.9 per patient). Of these, 1628 were incorporated via ipsilateral preloads using the MPDS (1440 accessed from the biport handle and 188 from above). The mean size of the contralateral femoral sheath during target vessel catheterization was 15F ± 4, and in 41 patients (6.7%) the sheath size was ≤8F. Technical success was 96.1%. Median procedural time was 209 minutes (IQR, 161-270 minutes), contrast volume was 100 mL (IQR, 70-150mL), fluoroscopy time was 63.9 minutes (IQR, 49.7-80.4 minutes) and median cumulative air kerma radiation dose was 2630 mGy (IQR, 838-5251 mGy). Thirty-day mortality was 4.8% (n = 34). Access complications occurred in 6.8% (n = 48) and 30-day reintervention in 7% (n = 50; 18 branch related). Follow-up of >30 days was available for 628 patients (88%), with a median follow-up of 19 months (IQR, 8-39 months). Branch-related endoleaks (type Ic/IIIc) were observed in 15 patients (2.6%) and aneurysm growth of >5 mm was observed in 54 (9.5%). Freedom from reintervention at 12 and 24 months was 87.1% (standard error [SE],1.5%) and 79.2% (SE, 2.0%), respectively. Overall target vessel patency at 12 and 24 months was 98.6% (SE, 0.3%) and 96.8% (SE, 0.4%), respectively, and was 97.9% (SE, 0.4%) and 95.3% (SE, 0.8%) for arteries stented from below using the MPDS, respectively. Conclusions The MPDS is safe and effective. Overall benefits include a decrease in contralateral sheath size in the treatment of complex anatomies with favorable results.
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Dates et versions

hal-04477432 , version 1 (26-02-2024)

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Citer

Nikolaos Tsilimparis, Ryan Gouveia E Melo, Andres Schanzer, Jonathan Sobocinski, Martin Austermann, et al.. Transatlantic multicenter study on the use of a modified preloaded delivery system for fenestrated endovascular aortic repair.. Journal of Vascular Surgery, 2023, Journal of Vascular Surgery, 78, pp.863-873. ⟨10.1016/j.jvs.2023.05.043⟩. ⟨hal-04477432⟩

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