Results from multiple prospective single-center clinical trials of the off-the-shelf p-Branch fenestrated stent graft

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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; Dias, Nuno; Resch, Timothy.

In: Journal of Vascular Surgery, Vol. 66, No. 4, 2017, p. 982-990.

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Farber, Mark A. ; Eagleton, Matthew J. ; Mastracci, Tara M. ; McKinsey, James F. ; Vallabhaneni, Raghuveer ; Sonesson, Björn ; Dias, Nuno ; Resch, Timothy. / Results from multiple prospective single-center clinical trials of the off-the-shelf p-Branch fenestrated stent graft. In: Journal of Vascular Surgery. 2017 ; Vol. 66, No. 4. pp. 982-990.

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TY - JOUR

T1 - Results from multiple prospective single-center clinical trials of the off-the-shelf p-Branch fenestrated stent graft

AU - Farber, Mark A.

AU - Eagleton, Matthew J.

AU - Mastracci, Tara M.

AU - McKinsey, James F.

AU - Vallabhaneni, Raghuveer

AU - Sonesson, Björn

AU - Dias, Nuno

AU - Resch, Timothy

PY - 2017

Y1 - 2017

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85019690297&partnerID=8YFLogxK

U2 - 10.1016/j.jvs.2017.01.068

DO - 10.1016/j.jvs.2017.01.068

M3 - Article

C2 - 28559176

AN - SCOPUS:85019690297

VL - 66

SP - 982

EP - 990

JO - Journal of Vascular Surgery

JF - Journal of Vascular Surgery

SN - 1097-6809

IS - 4

ER -