Preliminary Dual-Center Experience with the Bolton Treovance Endograft

Abstract

Purpose:

To present the performance and safety of the Treovance stent graft for endovascular aortic aneurysm repair in a “real-world” patient cohort.

Methods:

Patients from 2 centers, deemed unfit for open repair, were electively treated with the Treovance endograft. Clinical preoperative, operative, and up to 1-year postoperative follow-up data of patients were retrospectively analyzed.

Results:

This study included 46 patients with abdominal aortic aneurysm (44 male), mean age of 78 years ± 8 standard deviation (SD; range: 58-93 years). All met the manufacturer’s recommended anatomical requirements: average maximum sac diameter 63 mm ± 10 SD (range: 52-86 mm), proximal neck length 29 mm ± 12 SD (range: 11-60 mm), and neck angulation 30° ± 21 SD (range: 0°-70°). Fourteen had moderate to severe iliac tortuosity. A primary technical success rate of 80% was achieved (100% assisted primary technical success rate): 7 patients required adjunctive procedures intraoperatively and 2 successful treatments for type I endoleaks, which occurred within 24 hours postoperatively. There was 100% survival at 1-year follow-up; however, 4 (8.7%) patients required reintervention: 1 for a type I endoleak, 2 for limb stenosis, and 1 for a type II endoleak with an enlarging sac. No other device-related complications were identified. Reintervention and complication rates in hostile versus nonhostile anatomies were not statistically significant (P = .28 and P = .42, respectively).

Conclusion:

The Treovance stent graft has a comparable safety profile to other next-generation stent grafts during the first year after endovascular aneurysm repair, which provides a rationale for further interrogation of its outcomes through clinical trials.

Keywords

endovascular aortic repair EVAR abdominal aortic aneurysms AAA aortic intervention

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References

England

Mc Williams

. Endovascular aortic aneurysm repair (EVAR). The Ulster Med J. 2013;82(1):3–10

Perdikides

Georgiadis

Avgerinos

Fotis

Verikokos

Hopkinson

Lagios

. The Aorfix stent-graft to treat infrarenal abdominal aortic aneurysms with angulated necks and/or tortuous iliac arteries: midterm results. J Endovasc Ther. 2009;16(5):567–576.

Rödel

Zeebregts

Huisman

Geelkerken

. Results of the Anaconda endovascular graft in abdominal aortic aneurysm with a severe angulated infrarenal neck. J Vasc Surg. 2014;59(6):1495–1501, 1501.e1.

Verhagen

Torsello

De Vries

. Endurant stent-graft system: preliminary report on an innovative treatment for challenging abdominal aortic aneurysm. J Cardiovasc Surg (Torino). 2009;50(2):153–158.

Turnbull

Criado

Sanchez

. Five-year results for the talent enhanced low profile system abdominal stent graft pivotal trial including early and long-term safety and efficacy. J Vasc Surg. 2010;51(3):537–544, 544.e1-2.

Mehta

Valdés

Nolte

; A Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the Ovation Abdominal Stent Graft System Investigators. One-year outcomes from an international study of the ovation abdominal stent graft system for endovascular aneurysm repair. J Vasc Surg. 2014;59(1):65–73.e1-e3.

Chiesa

Riambau

Coppi

. The Bolton Treovance abdominal stent-graft: European clinical trial design. J Cardiovasc Surg (Torino). 2012;53(5):595–604.

Georgakarakos

Georgiadis

Argyriou

Schoretsanitis

Antoniou

Lazarides

. Preliminary single-center experience with the Bolton Treovance endograft in the treatment of abdominal aortic aneurysms. Ann Vasc Surg. 2016;34:68–74.

Kahlberg

Mascia

Marone

Logaldo

Tshomba

Chiesa

. The Bolton Treovance endograft: single center experience. J Cardiovasc Surg (Torino). 2014;55(1):77–84.

10.

Chaikof

Blankensteijn

Harris

. Reporting standards for endovascular aortic aneurysm repair. J Vasc Surg. 2002;35(5):1048–1060.

11.

Khosa

Krinsky

Macari

Yucel

Berland

. Managing incidental findings on abdominal and pelvic CT and MRI, Part 2: white paper of the ACR Incidental Findings Committee II on vascular findings. J Am Coll Radiol. 2013;10(10):789–794.

12.

Frego

Lumachi

Bianchera

. Risk factors of endoleak following endovascular repair of abdominal aortic aneurysm. A multicentric retrospective study. In Vivo. 2007;21(6):1099–1102.

13.

Wisniowski

Barnes

Jenkins

Boyne

Kruger

Walker

. Predictors of outcome after elective endovascular abdominal aortic aneurysm repair and external validation of a risk prediction model. J Vasc Surg. 2011 54(3):644–653.

14.

Zeng

Huang

Peng

. Endovascular repair of abdominal aortic aneurysm with severely angulated neck and tortuous artery access: case report and literature review. BMC Surg. 2015;15:20.

15.

Antoniou

Georgiadis

Antoniou

Kuhan

Murray

. A meta-analysis of outcomes of endovascular abdominal aortic aneurysm repair in patients with hostile and friendly neck anatomy. J Vasc Surg. 2013;57(2):527–538.