ARISE: First-In-Human Evaluation of a Novel Stent Graft to Treat Ascending Aortic Dissection

Abstract

Background:

Operative mortality for type A aortic dissection is still 10–20% at centers of excellence. Additionally, 10–20% are not considered as viable candidates for open surgical repair and not offered life-saving emergency surgery. ARISE is a multicenter investigation evaluating the novel GORE® Ascending Stent Graft (ASG; Flagstaff, AZ).

Objective:

The purpose of this study is to assess early feasibility of using these investigational devices to treat ascending aortic dissection.

Methods:

This a prospective, multicenter, non-randomized, single-arm study that enrolls patients at high surgical risk with appropriate anatomical requirements based on computed tomography imaging at 7 of 9 US sites. Devices are delivered transfemorally under fluoroscopic guidance. Primary endpoint is all-cause mortality at 30 days. Secondary endpoints include major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days, 6 months, and 12 months.

Results:

Nineteen patients were enrolled with a mean age of 75.7 years (range 47–91) and 11 (57.9%) were female. Ten (52.6%) had DeBakey type I disease, and the rest were type II. Sixteen (84.2%) of the patients were acute. Patients were treated with safe access, (7/19 (36.8%) percutaneous, 10/19 (52.6%) transfemoral, 2/19 (10.5%) iliac conduit), delivery, and deployment completed in all cases. Median procedure time was 154 mins (range 52–392) and median contrast used was 111 mL (range 75–200). MACCE at 30 days occurred in 5 patients including mortality 3/19 (15.8%), disabling stroke in 1/19 (5.3%), and myocardial infarction in 1/19 (5.3%).

Conclusion:

Results from the ARISE early feasibility study of a specific ascending stent graft device to treat ascending aortic dissection are promising.

Keywords

ascending aorta aortic dissection stent graft TEVAR ARISE

Get full access to this article

View all access options for this article.

References

Hagan

Nienaber

Isselbacher

, et al. The International Registry of Acute Aortic Dissection (IRAD): new insights into an old disease. JAMA. 2000;283:897–903.

Roselli

Hasan

Idrees

, et al. Inoperable patients with acute type A dissection: are they candidates for endovascular repair? Interact Cardiovasc Thorac Surg. 2017;25:582–588.

Lumsden

Reardon

MJ.

Once dissected always dissected! Can stent grafts change the natural history of type B dissections?: a report from the International Registry of Acute Aortic Dissection. JACC Cardiovasc Interv. 2008;1(4):403–404.

Ghoreishi

Shah

Jeudy

, et al. Endovascular repair of ascending aortic disease in high-risk patients yields favorable outcome. Ann Thorac Surg. 2020;109(3):678–685.

Roselli

Idrees

Johnston

, et al. Zone zero thoracic endovascular aortic repair: a proposed modification to the classification of landing zones. J Thorac Cardiovasc Surg. 2018;155(4):1381–1389.

Dake

MD.

On the endovascular climb to the type A dissection summit, reaching a new base camp. J Am Coll Cardiol. 2016;68:1955–1957.

Zoghbi

Adams

Bonow

, et al. Recommendations for noninvasive evaluation of native valvular regurgitation: a report from the American Society of Echocardiography developed in collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr. 2017;30(4):303–371.

Agresti

. Categorical Data Analysis. Hoboken, NJ: John Wiley & Sons, Inc; 2002:15.

Pape

Awais

Woznicki

, et al. Presentation, diagnosis, and outcomes of acute aortic dissection: 17-year trends from the International Registry of Acute Aortic Dissection. J Am Coll Cardiol. 2015;66:350–358.

10.

Yamaguchi

Nakai

Sumita

, et al. Current status of the management and outcomes of acute aortic dissection in Japan: analyses of nationwide Japanese Registry of All Cardiac and Vascular Diseases-Diagnostic Procedure Combination data. Eur Heart J Acute Cardiovasc Care. 2020;9(Suppl 3):S21-S31.

11.

Berretta

Patel

Gleason

, et al. IRAD experience on surgical type A acute dissection patients: results and predictors of mortality. Ann Cardiothorac Surg. 2016;5(4):346–351.

12.

Trimarchi

Eagle

Nienaber

, et al. Role of age in acute type A aortic dissection outcome: report from the International Registry of Acute Aortic Dissection (IRAD). J Thorac Cardiovasc Surg. 2010;140(4):784–789.

13.

Suzuki

Mehta

Ince

, et al; International Registry of Aortic Dissection. Clinical profiles and outcomes of acute type B aortic dissection in the current era: lessons from the International Registry of Aortic Dissection (IRAD). Circulation. 2003;108:II312–II317.

14.

Bozinovski

Coselli

JS.

Outcomes and survival in surgical treatment of descending thoracic aorta with acute dissection. Ann Thorac Surg. 2008;85(3):965–970.

15.

Szeto

McGarvey

Pochettino

, et al. Results of a new surgical paradigm: endovascular repair for acute complicated type B aortic dissection. Ann Thorac Surg. 2008;86(1):87–93.

16.

Zeeshan

Woo

Bavaria

, et al. Thoracic endovascular aortic repair for acute complicated type B aortic dissection: superiority relative to conventional open surgical and medical therapy. J Thorac Cardiovasc Surg. 2010;140(Suppl 6):S109–S115.

17.

Erbel

Aboyans

Boileau

, et al. 2014 ESC Guidelines on the diagnosis and treatment of aortic diseases: document covering acute and chronic aortic diseases of the thoracic and abdominal aorta of the adult. The Task Force for the Diagnosis and Treatment of Aortic Diseases of the European Society of Cardiology (ESC). Eur Heart J. 2014;35:2873–2926.

18.

Hiratzka

Bakris

Beckman

, et al. 2010 ACCF/AHA/AATS/ACR/ASA/SCA/SCAI/SIR/STS/SVM guidelines for the diagnosis and management of patients with thoracic aortic disease. A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, American Association for Thoracic Surgery, American College of Radiology, American Stroke Association, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of Thoracic Surgeons, and Society for Vascular Medicine. J Am Coll Cardiol. 2010;55:e27–e129.

19.

Nienaber

Kische

Akin

, et al. Strategies for subacute/chronic type B aortic dissection: the Investigation of Stent Grafts in Patients with type B Aortic Dissection (INSTEAD) trial 1-year outcome. J Thorac Cardiovasc Surg. 2010;140(Suppl 6):S101–S108.

20.

Nienaber

Kische

Rousseau

, et al. Endovascular repair of type B aortic dissection: long-term results of the randomized investigation of stent grafts in aortic dissection trial. Circ Cardiovasc Interv. 2013;6(4):407–416.

21.

Hossack

Patel

Gambardella

, et al. Endovascular vs. medical management for uncomplicated acute and sub-acute type B aortic dissection: a meta-analysis. Eur J Vasc Endovasc Surg. 2020;59(5):794–807.

22.

Dorros

Planton

, et al. Transseptal guidewire stabilization facilitates stent-graft deployment for persistent proximal ascending aortic dissection. J Endovasc Ther. 2000;7(6):506–512.

23.

Preventza

Henry

Cheong

, et al. Endovascular repair of the ascending aorta: when and how to implement the current technology. Ann Thorac Surg. 2014;97(5):1555–1560.

24.

Roselli

Brozzi

Albacker

, et al. Transapical endovascular ascending repair for inoperable acute type a dissection. JACC Cardiovasc Interv. 2013;6(4):425–426.

25.

Roselli

Idrees

Greenberg

, et al. Endovascular stent grafting for ascending aorta repair in high-risk patients. J Thorac Cardiovasc Surg. 2015;149(1):144–151.

26.

Harky

Chan

MacCarthy-Ofosu

The future of stenting in patients with type A aortic dissection: a systematic review. J Int Med Res. 2020;48(1):300060519871372.

27.

Wang

von Segesser

Maisano

, et al. Catheter-based treatment of the dissected ascending aorta: a systematic review. Eur J Cardiothorac Surg. 2020;4:80–91.

28.

Feng

Zhou

, et al. Endovascular repair of ascending aortic dissection: a novel treatment option for patients judged unfit for direct surgical repair. J Am Coll Cardiol. 2013;61:1917–1924.

29.

Feng

, et al. Outcomes of endovascular repair of ascending aortic dissection in patients unsuitable for direct surgical repair. J Am Coll Cardiol. 2016;68:1944–1954.

30.

Booher

Isselbacher

Nienaber

, et al. The IRAD classification system for characterizing survival after aortic dissection. Am J Med. 2013;126(8):730e19–730e24.

31.

Liu

Chang

, et al. Mid-term outcomes from a multicenter study: is TEVAR safe for ascending aortic dissection? Int J Cardiol. 2018;265:218–222.

32.

Sobocinski

O’Brien

Maurel

, et al. Endovascular approaches to acute aortic type A dissection: a CT-based feasibility study. Eur J Vasc Endovasc Surg. 2011;42(4):442–447.

33.

Moon

Greenberg

Morales

, et al. Computed tomography-based anatomic characterization of proximal aortic dissection with consideration for endovascular candidacy. J Vasc Surg. 2011;53(4):942–949.

34.

Dumfarth

Peters

Luehr

, et al. Acute type A dissection in octogenarians: does emergency surgery impact in-hospital outcome or long-term survival? Eur J Cardiothorac Surg. 2017;51:472–477.

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