Common Designs of Custom-Made Fenestrated Arch Devices and Applicability of an Off-the-Shelf Design
(2025) In Journal of Endovascular Therapy 32(2). p.481-489- Abstract
Objectives: To analyze device designs, similarities and overlaps of custom-made fenestrated arch endografts intended for mid/distal arch thoracic endovascular aortic repair. Materials and Methods: A multicenter cross-sectional study analyzing custom-made anonymized graft plans was performed. Graft plans were included from a cohort of mid/distal aortic arch repairs using custom-made fenestrated aortic endografts treated at 8 centers. Grafts targeting >2 arteries were excluded. No patient/clinical data were analyzed. A descriptive analysis was performed followed by an analysis of overlap of the designs to reach a common design in which the greatest number of grafts would overlap. Results: One hundred thirty-one graft plans were... (More)
Objectives: To analyze device designs, similarities and overlaps of custom-made fenestrated arch endografts intended for mid/distal arch thoracic endovascular aortic repair. Materials and Methods: A multicenter cross-sectional study analyzing custom-made anonymized graft plans was performed. Graft plans were included from a cohort of mid/distal aortic arch repairs using custom-made fenestrated aortic endografts treated at 8 centers. Grafts targeting >2 arteries were excluded. No patient/clinical data were analyzed. A descriptive analysis was performed followed by an analysis of overlap of the designs to reach a common design in which the greatest number of grafts would overlap. Results: One hundred thirty-one graft plans were included. All grafts were custom-made grafts from the COOK Medical Fenestrated arch platform. Ninety-four (71.8%) had a scallop-and-single-fenestration design, 33 (25.2%) had a single fenestration and 4 (4.3%) a single scallop. For analysis purposes, these latter 4 grafts were excluded. Two main graft plans (Plans 1 and 2) were proposed after analysis with similar configuration (1 scallop with 30 mm width, 20 mm height, 12:00 position; 1 preloaded fenestration with 8 mm diameter, 26 mm from the top of the graft and 12:00 position; tapered, with a 193 mm length and 32 mm distal diameter) but with 2 different proximal diameters of 38 mm (Plan 1) and 44 mm (Plan 2), reaching an overall feasibility of 85.8% (n=109), being 47.2% (n=60) and 38.6% (n=49) for each design, respectively. Conclusion: The degree of overlap between the studied fenestrated and/or scalloped thoracic endovascular aneurysm repair (TEVAR) graft designs was high. Future studies analyzing these designs in a real-world cohort of patients are needed to further address off-the-shelf feasibility. Clinical Impact: In a multicenter study analyzing 127 fenestrated aortic arch endograft plans from 9 aortic centers, we found that the degree of overlap between the studied fenestrated and/or scalloped arch graft designs was high and that 2 proposed graft designs would be theoretically applicable in 85.8% of cases. Future studies analyzing these designs in a real-world cohort of patients are needed to further address off-the-shelf feasibility.
(Less)
- author
- Gouveia e Melo, Ryan
; Fernández Prendes, Carlota
; Khanafer, Adib
; Wanhainen, Anders
; Mani, Kevin
; Rouhani, Guido
; Chao, Victor
; Tay, Kiang Hiong
; Chong, Tze Tec
; Adam, Donald
; Dias, Nuno
LU
; Agaev, Arzou
and Tsilimparis, Nikolaos
(Less) - organization
- publishing date
- 2025-04
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- device design, fenestrated TEVAR, fenestration, off-the-shelf, scallop, TEVAR, thoracic endovascular aortic repair
- in
- Journal of Endovascular Therapy
- volume
- 32
- issue
- 2
- pages
- 9 pages
- publisher
- International Society of Endovascular Specialists
- external identifiers
-
- pmid:37300282
- scopus:85162712058
- ISSN
- 1526-6028
- DOI
- 10.1177/15266028231179593
- language
- English
- LU publication?
- yes
- id
- 6bb74794-7cf5-4590-964e-6fb66cc0f1c2
- date added to LUP
- 2025-12-19 12:26:27
- date last changed
- 2025-12-20 03:00:20
@article{6bb74794-7cf5-4590-964e-6fb66cc0f1c2,
abstract = {{<p>Objectives: To analyze device designs, similarities and overlaps of custom-made fenestrated arch endografts intended for mid/distal arch thoracic endovascular aortic repair. Materials and Methods: A multicenter cross-sectional study analyzing custom-made anonymized graft plans was performed. Graft plans were included from a cohort of mid/distal aortic arch repairs using custom-made fenestrated aortic endografts treated at 8 centers. Grafts targeting >2 arteries were excluded. No patient/clinical data were analyzed. A descriptive analysis was performed followed by an analysis of overlap of the designs to reach a common design in which the greatest number of grafts would overlap. Results: One hundred thirty-one graft plans were included. All grafts were custom-made grafts from the COOK Medical Fenestrated arch platform. Ninety-four (71.8%) had a scallop-and-single-fenestration design, 33 (25.2%) had a single fenestration and 4 (4.3%) a single scallop. For analysis purposes, these latter 4 grafts were excluded. Two main graft plans (Plans 1 and 2) were proposed after analysis with similar configuration (1 scallop with 30 mm width, 20 mm height, 12:00 position; 1 preloaded fenestration with 8 mm diameter, 26 mm from the top of the graft and 12:00 position; tapered, with a 193 mm length and 32 mm distal diameter) but with 2 different proximal diameters of 38 mm (Plan 1) and 44 mm (Plan 2), reaching an overall feasibility of 85.8% (n=109), being 47.2% (n=60) and 38.6% (n=49) for each design, respectively. Conclusion: The degree of overlap between the studied fenestrated and/or scalloped thoracic endovascular aneurysm repair (TEVAR) graft designs was high. Future studies analyzing these designs in a real-world cohort of patients are needed to further address off-the-shelf feasibility. Clinical Impact: In a multicenter study analyzing 127 fenestrated aortic arch endograft plans from 9 aortic centers, we found that the degree of overlap between the studied fenestrated and/or scalloped arch graft designs was high and that 2 proposed graft designs would be theoretically applicable in 85.8% of cases. Future studies analyzing these designs in a real-world cohort of patients are needed to further address off-the-shelf feasibility.</p>}},
author = {{Gouveia e Melo, Ryan and Fernández Prendes, Carlota and Khanafer, Adib and Wanhainen, Anders and Mani, Kevin and Rouhani, Guido and Chao, Victor and Tay, Kiang Hiong and Chong, Tze Tec and Adam, Donald and Dias, Nuno and Agaev, Arzou and Tsilimparis, Nikolaos}},
issn = {{1526-6028}},
keywords = {{device design; fenestrated TEVAR; fenestration; off-the-shelf; scallop; TEVAR; thoracic endovascular aortic repair}},
language = {{eng}},
number = {{2}},
pages = {{481--489}},
publisher = {{International Society of Endovascular Specialists}},
series = {{Journal of Endovascular Therapy}},
title = {{Common Designs of Custom-Made Fenestrated Arch Devices and Applicability of an Off-the-Shelf Design}},
url = {{http://dx.doi.org/10.1177/15266028231179593}},
doi = {{10.1177/15266028231179593}},
volume = {{32}},
year = {{2025}},
}