Real-World Evaluation of the Off-the-Shelf Precannulated Inner-Branched Endograft for Pararenal Aortic Aneurysms

Abstract

Purpose:

To analyze the early performance and efficacy of the first commercially available off-the-shelf precannulated multibranched endograft in the endovascular repair of pararenal abdominal aortic aneurysms (PAAAs). The device received European marketing approval in late 2020.

Materials and methods:

Between January 2021 and June 2023, a retrospective analysis of prospectively collected data from all consecutive patients with pAAAs undergoing implantation of the E-nside precannulated inner-branched endograft was conducted in 2 centers. The primary outcome measure was technical success defined as the composite endpoint of successful (1) delivery of the 24F endograft, (2) use of the precannulation tubes, and (3) implantation of the bridging stent-grafts (BSGs) to the target vessels. Main secondary endpoints were mortality, target vessel instability (TVI), absence of type I or III endoleak, reintervention, spinal cord ischemia, and supra-celiac aortic coverage.

Results:

Twenty-one patients (20 men, mean age: 71 years) were included in this study with a mean follow-up of 14±7.7 months. Nine patients had a symptomatic aneurysm (43%). Technical success amounted to 95% (in one patient, an iliofemoral conduit was necessary to advance the device). One out of 112 BSGs (1%, right renal artery) occluded at 30 days, resulting in freedom from TVI and reintervention rate at 12 months of 95%. No type I or III endoleaks were identified during follow-up. One patient (5%) died at 13 months due to non-aneurysm-related death, and 1 patient (5%) developed spinal cord ischemia. No other major perioperative complications were observed. Mean supra-celiac aortic coverage reached 52±8%.

Conclusions:

Given the imperative need for an off-the-shelf endograft tailored to address PAAAs, the E-nside stent-graft demonstrated encouraging outcomes in this study. Nevertheless, it is essential to emphasize that the extent of aortic coverage mandates the production of a truncated variant.

Clinical Impact

The endovascular repair of urgent pararenal aortic aneurysms remains still an unsolved problem in the endovascular era since there are no available off-the-shelf dedicated fenestrated or branched endografts. This paper confirms the safety and efficacy of the off-the-shelf precannulated inner branched endograft for this specific indication.

Keywords

abdominal aortic aneurysm aneurysm device design endograft endovascular aneurysm repair off-the-shelf device

Get full access to this article

View all access options for this article.

References

Donas

Torsello

Bisdas

, et al. Early outcomes for fenestrated and chimney endografts in the treatment of pararenal aortic pathologies are not significantly different: a systematic review with pooled data analysis. J Endovasc Ther. 2012;19(6):723–728.

Varkevisser

RRB

O’Donnell

TFX

Swerdlow

, et al. Fenestrated endovascular aneurysm repair is associated with lower perioperative morbidity and mortality compared with open repair for complex abdominal aortic aneurysms. J Vasc Surg. 2019;69(6):1670–1678.

Oderich

Ribeiro

Hofer

, et al. Prospective, nonrandomized study to evaluate endovascular repair of pararenal and thoracoabdominal aortic aneurysms using fenestrated-branched endografts based on supraceliac sealing zones. J Vasc Surg. 2017;65(5):1249–1259.e10.

Walker

Kaushik

Hoffman

, et al. Long-term durability of multibranched endovascular repair of thoracoabdominal and pararenal aortic aneurysms. J Vasc Surg. 2019;69(2):341–347.

Schroeder

Donas

Stavroulakis

, et al. Anatomical suitability of the Zenith off-the-shelf (p-Branch) endograft in juxtarenal aortic aneurysms previously treated using the chimney technique. J Endovasc Ther. 2017;24(2):223–229.

Farber

Eagleton

Mastracci

, et al. Results from multiple prospective single-center clinical trials of the off-the-shelf p-Branch fenestrated stent graft. J Vasc Surg. 2017;66(4):982–990.

Spath

Tsilimparis

Furlan

, et al. Additional aortic coverage with an off-the-shelf, multibranched endograft compared with custom-made devices for endovascular repair of pararenal abdominal aortic aneurysms. Eur J Vasc Endovasc Surg. 2023;65(5):710–718.

Bisdas

Austermann

Commentary: the Zenith t-branch endograft: what have we learned so far?

J Endovasc Ther. 2016;23(1):216–219.

Bisdas

Panuccio

Sugimoto

, et al. Risk factors for spinal cord ischemia after endovascular repair of thoracoabdominal aortic aneurysms. J Vasc Surg. 2015;61(6):1408–1416.

10.

Simonte

Isernia

Gatta

, et al. Inner branched complex aortic repair outcomes from a national multicenter registry using the E-xtra design platform. J Vasc Surg. 2023;77(2):338–346.

11.

Schaefers

Murtaja

Oberhuber

Retrograde approach for antegrade inner branches in a precannulated off-the-shelf multibranch device. J Endovasc Ther. 2022;29(4):512–515.

12.

Yazar

Huysmans

Lacquet

, et al. Single-center experience with inner-branched endograft for the treatment of pararenal abdominal aortic aneurysms. J Endovasc Ther. 2023;15266028231204286 doi:10.1177/15266028231204286.

13.

Youssef

Deglise

Szopinski

, et al. A multicenter experience with a new fenestrated-branched device for endovascular repair of thoracoabdominal aortic aneurysms. J Endovasc Ther. 2018;25(2):209–219.

14.

Oderich

Forbes

Chaer

, et al. Reporting standards for endovascular aortic repair of aneurysms involving the renal mesenteric arteries. J Vasc Surg. 2021;73:4S–52S.

15.

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.

16.

Bisdas

Austermann

The Zenith t-branch endograft: what have we learned so far?

J Endovasc Ther. 2016;23(1):216–219.

17.

Mastracci

Greenberg

Eagleton

, et al. Durability of branches in branched and fenestrated endografts. J Vasc Surg. 2013;57(4):926–933.

18.

Taneva

Criado

Torsello

, et al. Results of chimney endovascular aneurysm repair as used in the PERICLES Registry to treat patients with suprarenal aortic pathologies. J Vasc Surg. 2020;71(5):1521–1527.

19.

Spanos

Kölbel

Heidemann

, et al. Early and mid-term durability of surgeon-modified and custom-made fenestrated devices for the treatment of complex aortic pathology. Ann Vasc Surg. 2022;83:212–221.

20.

Ferreira

Mannarino

Cunha

, et al. Stent graft modification to preserve intercostal arteries using thoracoabdominal off-the-shelf multibranched (t-Branch) endograft. J Endovasc Ther. 2021;28(3):382–387.