New Preloaded System for Renal and Visceral Arteries in Fenestrated Endografting

Abstract

Aim/Background:

The New Preloaded System (NPS) for renal/visceral arteries (TVVs) is an emerging technology in fenestrated endografting (FEVAR) that allows TVVs cannulation and stenting through the same access of the endograft main body. However, only few preliminary experiences are currently available in the literature. The aim of this study is to report the outcomes of NPS-FEVAR in juxta/para-renal (J/P-AAAs) and thoracoabdominal (TAAAs) aneurysms repair.

Methods:

This is a prospective (NCT05224219), single-center/observational study of patients submitted to NPS-FEVAR for J/PAAAs and TAAAs between 2019 and 2022 (July). Definitions and outcomes were evaluated according to the current SVS-reporting standard. Technical success (TS) and TS preloaded related, spinal cord ischemia (SCI), and 30-day mortality were assessed as early endpoints. Survival, freedom from reinterventions (FFRs), and freedom from TTVs-instability (FFTVVs-instability) were analyzed during follow-up.

Results:

Among 157 F/B-EVAR cases, 74 (47%) NPS-FEVAR were planned and enrolled in the study [48 (65%) J/P-AAAs; 26 (35%) TAAAs]. The main indication for NPS-FEVAR was the presence of a hostile iliac axis (54%–73%) or the necessity of expeditious pelvic/lower-limb reperfusion for SCI prevention in TAAAs (20%–27%). Overall, 292 TVVs were accommodated by 289 fenestrations and 3 branches; 188 of 289 (65%) fenestrations were preloaded. NPS-FEVAR configuration was from “below” and “from below to above” in 28 (38%) and 46 (62%) cases, respectively. TS and TS preloaded system-related was 96% (71/74) and 99% (73/74), respectively. Target visceral vessels patency at the completion angiography was 99% (290/292). Failures were 2 renal arteries loss and 1 massive bleeding from a percutaneous closure system breakage. The latter patient developed postoperative multiorgans failure and died on the fifth postoperative day, causing only 30-day/in-hospital mortality (1.3%). One (1.3%) patient with a JAAA and preoperative bilateral occlusion of the hypogastric arteries suffered SCI. The median follow-up was 14 (IQR: 8) months. The estimated 3-year survival was 91% with no aneurysm-related mortality during follow-up. The estimated 3-year FFR and FFTVVs-instability were 85 and 92%, respectively.

Conclusion:

New preloaded system FEVAR is a safe and effective option in the treatment of J/PAAAs and TAAAs in the presence of hostile iliac access or to guarantee an expeditious pelvic/lower limb reperfusion, leading to satisfactory results in terms of TS, early and mid-term clinical outcomes.

Clinical Impact

New preloaded system for fenestrated and branched endografting allows to increase the feasibility of the advanced endovascular aortic repair in challenging iliac access, thoracoabdominal aneurysm repair and reduce difficulties in target visceral vessels cannulation.

Keywords

abdominal aortic aneurysm custom-made device endovascular aneurysm repair fenestrated stent-graft juxtarenal aneurysm thoracoabdominal aortic aneurysm

Get full access to this article

View all access options for this article.

References

Oderich

Ribeiro

Reis

Souza

, et al. Endovascular repair of thoracoabdominal aortic aneurysms using fenestrated and branched endografts. J Thorac Cardiovasc Surg. 2017;153(2):S32–S41.e7.

Verhoeven

Katsargyris

Bekkema

, et al. Editor’s choice—ten-year experience with endovascular repair of thoracoabdominal aortic aneurysms: results from 166 consecutive patients. Eur J Vasc Endovasc Surg. 2015;49(5):524–531.

Gallitto

Faggioli

Melissano

, et al; Italian Multicenter Fenestrated and Branched Study Group. Preoperative and postoperative predictors of clinical outcome of fenestrated and branched endovascular repair for complex abdominal and thoracoabdominal aortic aneurysms in an Italian multicenter registry. J Vasc Surg. 2021;74(6):1795–1806.e6.

Maurel

Delclaux

Sobocinski

, et al. The impact of early pelvic and lower limb reperfusion and attentive peri-operative management on the incidence of spinal cord ischemia during thoracoabdominal aortic aneurysm endovascular repair. Eur J Vasc Endovasc Surg. 2015;49(3):248–254.

Hertault

Bianchini

Daniel

, et al. Experience with unfavorable iliac access when performing fenestrated/branched endovascular aneurysm repair. J Endovasc Ther. 2021;28(2):315–322.

Gallitto

Gargiulo

Faggioli

, et al. Impact of iliac artery anatomy on the outcome of fenestrated and branched endovascular aortic repair. J Vasc Surg. 2017;66(6):1659–1667.

Manning

Harris

Hartley

, et al. Preloaded fenestrated stent-grafts for the treatment of juxtarenal aortic aneurysms. J Endovasc Ther. 2010;17(4):449–455.

Bisdas

Donas

Torsello

, et al. Technical assessment of the preloaded fenestrated stent-graft in the management of pararenal aortic aneurysms. J Endovasc Ther. 2013;20(4):461–468.

Maurel

Resch

Spear

, et al. Early experience with a modified preloaded system for fenestrated endovascular aortic repair. J Vasc Surg. 2017;65(4):972–980.

10.

Bertoglio

Loschi

Grandi

, et al. Early limb reperfusion using routinely preloaded fenestrated stent-graft designs for complex endovascular aortic procedures. Cardiovasc Intervent Radiol. 2020;43(12):1868–1880.

11.

Oderich

Forbes

Chaer

, et al; Writing Committee Group. Reporting standards for endovascular aortic repair of aneurysms involving the renal-mesenteric arteries. J Vasc Surg. 2021;73(suppl 1):4S–52S.

12.

Gallitto

Faggioli

Pini

, et al. Endovascular repair of thoraco-abdominal aortic aneurysms by fenestrated and branched endografts. Eur J Cardiothorac Surg. 2019;56(5):993–1000.

13.

Gallitto

Faggioli

Fenelli

, et al. Multi-staged endovascular repair of thoracoabdominal aneurysms by fenestrated and branched endografts. Ann Vasc Surg. 2022;81:48–59.

14.

Gallitto

Faggioli

Pini

, et al. Reinterventions after fenestrated and branched endografting for degenerative aortic aneurysms. J Vasc Surg. 2021;74(6):1808–1816.e4.

15.

Gargiulo

Gallitto

Serra

, et al. Could four-dimensional contrast-enhanced ultrasound replace computed tomography angiography during follow up of fenestrated endografts? Results of a preliminary experience. Eur J Vasc Endovasc Surg. 2014;48(5):536–542.

16.

Gallitto

Faggioli

Vacirca

, et al. The benefit of combined carbon dioxide automated angiography and fusion imaging in preserving perioperative renal function in fenestrated endografting. J Vasc Surg. 2020;72(6):1906–1916.

17.

Katsargyris

Oikonomou

Kouvelos

, et al. Spinal cord ischemia after endovascular repair of thoracoabdominal aortic aneurysms with fenestrated and branched stent grafts. J Vasc Surg. 2015;62(6):1450–1456.

18.

Pini

Faggioli

Paraskevas

, et al. A systematic review and meta-analysis of the occurrence of spinal cord ischemia after endovascular repair of thoracoabdominal aortic aneurysms. J Vasc Surg. 2022;75(4):1466–1477.e8.

19.

Kärkkäinen

Cirillo-Penn

Sen

, et al. Cerebrospinal fluid drainage complications during first stage and completion fenestrated-branched endovascular aortic repair. J Vasc Surg. 2020;71(4):1109–1118.e2.

20.

Rinaldi

Melloni

Gallitto

, et al. Spinal cord ischemia after thoracoabdominal aortic aneurysms endovascular repair: from the Italian Multicenter Fenestrated/Branched Endovascular Aneurysm Repair Registry. J Endovasc Ther. 2023;30:281–288.

21.

Juszczak

Murray

Koutsoumpelis

, et al. Elective fenestrated and branched endovascular thoraco-abdominal aortic repair with supracoeliac sealing zones and without prophylactic cerebrospinal fluid drainage: early and medium-term outcomes. Eur J Vasc Endovasc Surg. 2019;57(5):639–648.

22.

Marques

Marino

Hagen

Katsargyris

, et al. Outcomes of upper extremity access with surgical exposure of the axillary artery in fenestrated and branched endovascular aneurysm repair. Eur J Vasc Endovasc Surg. 2022;64(4):332–338.

23.

Tenorio

Oderich

Sandri

, et al. Impact of onlay fusion and cone beam computed tomography on radiation exposure and technical assessment of fenestrated-branched endovascular aortic repair. J Vasc Surg. 2019;69(4):1045–1058.

Supplementary Material

Please find the following supplemental material available below.

For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.

For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.

0.00 MB

0.02 MB

5.84 MB

21.72 MB

14.92 MB