Skip to main content

Lund University Publications

LUND UNIVERSITY LIBRARIES

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

Tsilimparis, Nikolaos ; Gouveia e Melo, Ryan ; Schanzer, Andres ; Sobocinski, Jonathan ; Austermann, Martin ; Chiesa, Roberto ; Resch, Timothy ; Gargiulo, Mauro ; Timaran, Carlos and Maurel, Blandine , et al. (2023) In Journal of Vascular Surgery 78(4). p.3-873
Abstract

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.... (More)

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.

(Less)
Please use this url to cite or link to this publication:
author
; ; ; ; ; ; ; ; and , et al. (More)
; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; and (Less)
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Aortic aneurysm, Fenestrated aortic repair, FEVAR, Modified delivery system, Preloaded
in
Journal of Vascular Surgery
volume
78
issue
4
pages
3 - 873
publisher
Mosby-Elsevier
external identifiers
  • pmid:37330705
  • scopus:85164326946
ISSN
0741-5214
DOI
10.1016/j.jvs.2023.05.043
language
English
LU publication?
yes
id
affae640-3d09-46c6-ba9b-49c2c30004ce
date added to LUP
2023-11-07 10:22:40
date last changed
2024-04-19 03:43:58
@article{affae640-3d09-46c6-ba9b-49c2c30004ce,
  abstract     = {{<p>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 &gt;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 &gt;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.</p>}},
  author       = {{Tsilimparis, Nikolaos and Gouveia e Melo, Ryan and Schanzer, Andres and Sobocinski, Jonathan and Austermann, Martin and Chiesa, Roberto and Resch, Timothy and Gargiulo, Mauro and Timaran, Carlos and Maurel, Blandine and Adam, Donald and Dias, Nuno and Oderich, Gustavo S. and Kölbel, Tilo and Gomez Palones, Francisco and Simonte, Gioele and Giudice, Rocco and Mesnard, Thomas and Loschi, Diletta and Leone, Nicola and Gallito, Enrico and Spath, Paolo and Porras Cólon, Jesus and Elboushi, Amro and Wachtmeister, Melker and Sonesson, Bjorn and Tenorio, Emanuel and Panuccio, Giuseppe and Isernia, Giacomo and Bertoglio, Luca}},
  issn         = {{0741-5214}},
  keywords     = {{Aortic aneurysm; Fenestrated aortic repair; FEVAR; Modified delivery system; Preloaded}},
  language     = {{eng}},
  number       = {{4}},
  pages        = {{3--873}},
  publisher    = {{Mosby-Elsevier}},
  series       = {{Journal of Vascular Surgery}},
  title        = {{Transatlantic multicenter study on the use of a modified preloaded delivery system for fenestrated endovascular aortic repair}},
  url          = {{http://dx.doi.org/10.1016/j.jvs.2023.05.043}},
  doi          = {{10.1016/j.jvs.2023.05.043}},
  volume       = {{78}},
  year         = {{2023}},
}