The Prospective,Multiple Center Study of a Novel Embedded Modular Single-Branched Stent-Graft for Type B Aortic Dissection Involving the Left Subclavian Artery

Abstract

Objectives:

This study aimed to assess the midterm outcomes of a novel embedded modular single-branched stent-graft (EMSBSG) designed to preserve the left subclavian artery (LSA) of type B aortic dissection (TBAD).

Methods:

From December 2020 to November 2021, a total of 120 patients with TBAD treated with an EMSBSG were enrolled in a multicenter prospective clinical trial at 18 Chinese tertiary hospitals. Follow-up computed tomography angiography scanning was conducted at 1, 6, and 12 months postprocedure.

Results:

The technical success rate was 99.17% (n = 119/120), with only 1 technical failure attributed to aortic intimo-intimal intussusception. The 30-day mortality rate was 0.83% (n = 1). Thirty-day major complications included 2 cases (1.67%) of retrograde type A aortic dissection (RTAD), 3 cases (2.50%) of stroke, and 6 cases (5.22%) of Type Ia endoleaks. The median follow-up time was 12.84 (range, 11–16) months. The 1-year mortality rate was 4.17% (n = 5/120), and the follow-up patency rate of the branch section was 99.09% (n = 109/110). The overall 12-month reintervention rate was 4.17% (n = 5), including 3 RTAD cases, 2 Type I endoleaks, and 1 stent-induced new entry.

Conclusion:

For patients with TBAD involving the LSA, the midterm outcomes are encouraging for EMSBSG as a relatively safe, effective, and noncustomized endovascular option. However, long-term outcomes warrant attention and further investigation.

Clinical Impact

The midterm outcomes indicate that EMSBSG offers a safe, and effective endovascular option for preserving the LSA in patients with TBAD. The EMSBSG achieves LSA preservation through a non-customized endovascular solution, making it particularly suitable for emergency procedures. The core innovation of EMSBSG lies in its flexible, modular Embedded design, which adapts to the anatomical characteristics of TBAD in patients.

Keywords

type B aortic dissection left subclavian artery thoracic endovascular aortic repair

Get full access to this article

View all access options for this article.

References

Leurs

Bell

Degrieck

, et al. Endovascular treatment of thoracic aortic diseases: combined experience from the EUROSTAR and United Kingdom Thoracic Endograft registries. J Vasc Surg. 2004;40:670–679.

Thurnher

Grabenwöger

Endovascular treatment of thoracic aortic aneurysms: a review. Eur Radiol. 2002;12:1370–1387.

Huang

Chen

Yang

, et al. Effect of left subclavian artery revascularisation in thoracic endovascular aortic repair: a systematic review and meta-analysis. Eur J Vasc Endovasc Surg. 2018;56:644–651.

Antonello

Menegolo

Maturi

, et al. Intentional coverage of the left subclavian artery during endovascular repair of traumatic descending thoracic aortic transection. J Vasc Surg. 2013;57:684–690.

Matsumura

Lee

Mitchell

, et al. The society for vascular surgery practice guidelines: management of the left subclavian artery with thoracic endovascular aortic repair. J Vasc Surg. 2009;50:1155–1158.

Zhang

M-T

Zhu

G-L

, et al. Off-the-shelf devices for treatment of thoracic aortic diseases: midterm follow-up of TEVAR with chimneys or physician-made fenestrations. J Endovasc Ther. 2020;27:132–142.

Hua

, et al. Early and midterm outcomes of in situ laser fenestration during thoracic endovascular aortic repair for acute and subacute aortic arch diseases and analysis of its complications. J Vasc Surg. 2020;72:1524–1533.

Benrashid

Wang

Keenan

, et al. Evolving practice pattern changes and outcomes in the era of hybrid aortic arch repair. J Vasc Surg. 2016;63:323–331.

Feng

Zhou

, et al. Endovascular repair by customized branched stent-graft: a promising treatment for chronic aortic dissection involving the arch branches. J Thorac Cardiovasc Surg. 2015;150:1631–1638.e5.

10.

Lombardi

Hughes

Appoo

, et al. Society for Vascular Surgery (SVS) and Society of Thoracic Surgeons (STS) reporting standards for type B aortic dissections. Ann Thorac Surg. 2020;109:959–981.

11.

Fillinger

Greenberg

McKinsey

, et al. Reporting standards for thoracic endovascular aortic repair (TEVAR). J Vasc Surg. 2010;52:1022–1033.

12.

Fiorucci

Kölbel

Rohlffs

, et al. The role of thoracic endovascular repair in elective, symptomatic and ruptured thoracic aortic diseases. Eur J Cardiothorac Surg. 2019;56:197–203.

13.

Zhang

Huang

Zhang

, et al. Comparison of chimney technique and single-branched stent graft for treating patients with type B aortic dissections that involved the left subclavian artery. Cardiovasc Interv Radiol. 2019;42:648–656.

14.

Xue

Sun

Zheng

, et al. The chimney technique for preserving the left subclavian artery in thoracic endovascular aortic repair. Eur J Cardiothorac Surg. 2015;47:623–629.

15.

Canaud

Morishita

Gandet

, et al. Homemade fenestrated stent-graft for thoracic endovascular aortic repair of zone 2 aortic lesions. J Thorac Cardiovasc Surg. 2018;155:488–93.

16.

Kuo

H-S

Huang

J-H

Chen

J-S.

Handmade stent graft fenestration to preserve left subclavian artery in thoracic endovascular aortic repair. Eur J Cardiothorac Surg. 2019;56:587–594.

17.

Crawford

Sanford

Forbes

, et al. Clinical outcomes and material properties of in situ fenestration of endovascular stent grafts. J Vasc Surg. 2016;64:244–250.

18.

Inoue

Hosokawa

Iwase

, et al. Aortic arch reconstruction by transluminally placed endovascular branched stent graft. Circulation. 1999;100(19 Suppl):II316–II321.

19.

Jing

Feng

, et al. Endovascular repair of aortic dissection involving the left subclavian artery by castor stent graft: a multicentre prospective trial. Eur J Vasc Endovasc Surg. 2020;60:854–61.

20.

Dake

Fischbein

Bavaria

, et al. Evaluation of the gore TAG thoracic branch endoprosthesis in the treatment of proximal descending thoracic aortic aneurysms. J Vasc Surg. 2021;74:1483–1490.

21.

Patel

Dake

Bavaria

, et al. Branched endovascular therapy of the distal aortic arch: preliminary results of the feasibility multicenter trial of the gore thoracic branch endoprosthesis. Ann Thorac Surg. 2016;102:1190–1198.

22.

Liang

Dake

Fischbein

, et al. Midterm outcomes of endovascular repair of aortic arch aneurysms with the gore thoracic branch endoprosthesis. Eur J Vasc Endovasc Surg. 2022;64:639–645.

23.

Zhang

Chen

, et al. Functional evaluation of embedded modular single-branched stent graft: application to type B aortic dissection with aberrant right subclavian artery. Front Cardiovasc Med. 2022;9:869505.

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