Results from multiple prospective single-center clinical trials of the off-the-shelf p-Branch fenestrated stent graft
Farber, Mark A. ; Eagleton, Matthew J. ; Mastracci, Tara M. ; McKinsey, James F. ; Vallabhaneni, Raghuveer ; Sonesson, Björn LU ; Dias, Nuno LU
and Resch, Timothy
LU
(2017)
In Journal of Vascular Surgery
66(4).
p.982-990
- Abstract
Objective: The purpose of this study was to report prospective data of an off-the-shelf fenestrated endograft (Zenith p-Branch; Cook Medical, Bloomington, Ind) from four centers for the treatment of patients with pararenal abdominal aortic aneurysms. Methods: Data were combined from four single-center investigational studies conducted in the United States and Europe. The p-Branch endograft consists of a proximal off-the-shelf component incorporating a scallop for the celiac artery, a superior mesenteric artery fenestration, and two conical pivot fenestrations to preserve flow to the renal vessels. The device is available in two configurations, a left renal fenestration at the same (configuration A) or lower (configuration B)... (More)
Objective: The purpose of this study was to report prospective data of an off-the-shelf fenestrated endograft (Zenith p-Branch; Cook Medical, Bloomington, Ind) from four centers for the treatment of patients with pararenal abdominal aortic aneurysms. Methods: Data were combined from four single-center investigational studies conducted in the United States and Europe. The p-Branch endograft consists of a proximal off-the-shelf component incorporating a scallop for the celiac artery, a superior mesenteric artery fenestration, and two conical pivot fenestrations to preserve flow to the renal vessels. The device is available in two configurations, a left renal fenestration at the same (configuration A) or lower (configuration B) longitudinal position than the right to accommodate varied anatomy of the patients. Results: Between August 2011 and September 2015, 76 patients (82% male; mean age, 72 years; 65 elective and 11 emergent) were enrolled, with 55% implanted with option A and 45% with B. The device was deployed successfully in all patients, and stents were placed in all target vessels except in three cases (one elective, two emergent): a left kidney was sacrificed in one patient, and a right renal artery was left unstented in two patients during the index procedure. There was no 30-day mortality. During follow-up (mean, 25 ± 13 months), 10 late deaths occurred (6 elective, 4 emergent; none related to device or procedure), and there were no ruptures or conversions to open repair. Two patients experienced bowel ischemia; one case resolved with nonoperative treatment and one required superior mesenteric artery and celiac artery angioplasty and stent placement. Renal artery occlusion occurred in eight patients (11%) and was deemed procedure related in 63% (5/8) of these patients. Four of these were successfully intervened on with preservation of renal function. The overall renal insufficiency incidence was 7% (5/76). One patient developed renal failure requiring dialysis. Conclusions: Early results incorporating learning curves for physicians with a new device and delivery system indicate that the use of the Zenith p-Branch device is feasible and safe. Long-term follow-up is needed to assess the effectiveness and durability of this treatment strategy and to refine the indications for use.
(Less)
- author
- Farber, Mark A.
; Eagleton, Matthew J.
; Mastracci, Tara M.
; McKinsey, James F.
; Vallabhaneni, Raghuveer
; Sonesson, Björn
LU
; Dias, Nuno
LU
and Resch, Timothy
LU
- publishing date
- 2017
- type
- Contribution to journal
- publication status
- published
- subject
- in
- Journal of Vascular Surgery
- volume
- 66
- issue
- 4
- pages
- 982 - 990
- publisher
- Mosby-Elsevier
- external identifiers
-
- scopus:85019690297
- pmid:28559176
- ISSN
- 0741-5214
- DOI
- 10.1016/j.jvs.2017.01.068
- language
- English
- LU publication?
- no
- id
- 4a8add88-0dd2-4e72-9fb6-f2126503e043
- date added to LUP
- 2017-06-27 09:10:33
- date last changed
- 2024-04-14 13:40:06
@article{4a8add88-0dd2-4e72-9fb6-f2126503e043,
abstract = {{<p>Objective: The purpose of this study was to report prospective data of an off-the-shelf fenestrated endograft (Zenith p-Branch; Cook Medical, Bloomington, Ind) from four centers for the treatment of patients with pararenal abdominal aortic aneurysms. Methods: Data were combined from four single-center investigational studies conducted in the United States and Europe. The p-Branch endograft consists of a proximal off-the-shelf component incorporating a scallop for the celiac artery, a superior mesenteric artery fenestration, and two conical pivot fenestrations to preserve flow to the renal vessels. The device is available in two configurations, a left renal fenestration at the same (configuration A) or lower (configuration B) longitudinal position than the right to accommodate varied anatomy of the patients. Results: Between August 2011 and September 2015, 76 patients (82% male; mean age, 72 years; 65 elective and 11 emergent) were enrolled, with 55% implanted with option A and 45% with B. The device was deployed successfully in all patients, and stents were placed in all target vessels except in three cases (one elective, two emergent): a left kidney was sacrificed in one patient, and a right renal artery was left unstented in two patients during the index procedure. There was no 30-day mortality. During follow-up (mean, 25 ± 13 months), 10 late deaths occurred (6 elective, 4 emergent; none related to device or procedure), and there were no ruptures or conversions to open repair. Two patients experienced bowel ischemia; one case resolved with nonoperative treatment and one required superior mesenteric artery and celiac artery angioplasty and stent placement. Renal artery occlusion occurred in eight patients (11%) and was deemed procedure related in 63% (5/8) of these patients. Four of these were successfully intervened on with preservation of renal function. The overall renal insufficiency incidence was 7% (5/76). One patient developed renal failure requiring dialysis. Conclusions: Early results incorporating learning curves for physicians with a new device and delivery system indicate that the use of the Zenith p-Branch device is feasible and safe. Long-term follow-up is needed to assess the effectiveness and durability of this treatment strategy and to refine the indications for use.</p>}},
author = {{Farber, Mark A. and Eagleton, Matthew J. and Mastracci, Tara M. and McKinsey, James F. and Vallabhaneni, Raghuveer and Sonesson, Björn and Dias, Nuno and Resch, Timothy}},
issn = {{0741-5214}},
language = {{eng}},
number = {{4}},
pages = {{982--990}},
publisher = {{Mosby-Elsevier}},
series = {{Journal of Vascular Surgery}},
title = {{Results from multiple prospective single-center clinical trials of the off-the-shelf p-Branch fenestrated stent graft}},
url = {{http://dx.doi.org/10.1016/j.jvs.2017.01.068}},
doi = {{10.1016/j.jvs.2017.01.068}},
volume = {{66}},
year = {{2017}},
}