EurekaMag.com logo
+ Site Statistics
References:
53,869,633
Abstracts:
29,686,251
+ Search Articles
+ Subscribe to Site Feeds
EurekaMag Most Shared ContentMost Shared
EurekaMag PDF Full Text ContentPDF Full Text
+ PDF Full Text
Request PDF Full TextRequest PDF Full Text
+ Follow Us
Follow on FacebookFollow on Facebook
Follow on TwitterFollow on Twitter
Follow on LinkedInFollow on LinkedIn

+ Translate

Prospective multicenter clinical trial (STABLE) on the endovascular treatment of complicated type B aortic dissection using a composite device design



Prospective multicenter clinical trial (STABLE) on the endovascular treatment of complicated type B aortic dissection using a composite device design



Journal of Vascular Surgery 55(3): 629-640.E2



This study evaluates the safety and effectiveness of a unique composite thoracic endovascular aneurysm repair (TEVAR) construct (proximal stent graft and distal bare metal stent) for the treatment of patients with complicated type B aortic dissection (cTBAD). In this prospective, single-arm, multicenter study, patients with cTBAD were treated with an endovascular system consisting of proximal TX2 thoracic stent grafts and distal bare metal dissection stents (Zenith Dissection Endovascular System; Cook Medical, Bloomington, Ind). Indications for enrollment were branch vessel malperfusion, impending rupture, aortic diameter ?4 mm, rapid aortic expansion, and persistent pain or hypertension despite maximum medical therapy. One-year follow-up results, including clinical and radiographic (computerized tomography [CT] and X-ray) evaluation, were available for this report. Ten centers enrolled 4 patients (7% men; mean age 58 years old) between December 27 and August 29. The onset of symptoms was acute (?14 days) in 24 patients (6%), subacute (15-3 days) in six patients (15%), and chronic (31-9 days) in 1 patients (25%); the overall mean time from symptom onset to treatment was 2 days (range, -78 days). A majority of patients (77.5%; 31 of 4 patients) presented with impending aortic rupture (indicated by periaortic effusion/hematoma) or branch vessel malperfusion. Seven combinations of stent grafts and dissection stents were used, and all devices were successfully deployed and patent. The 3-day mortality rate was 5% (2 of 4); two deaths occurred after 3 days, leading to a 1-year survival rate of 9%. Two deaths, occurring at 11 and 81 days postprocedure, respectively, were secondary to aortic rupture. Morbidity occurring within 3 days included stroke (7.5%), transient ischemic attack (2.5%), paraplegia (2.5%), retrograde progression of dissection (5%), and renal failure (12.5%). Additional morbidity after 3 days included one case of retrograde progression of dissection and one case of renal failure. None of the patients with renal failure became dialysis-dependent. Four patients (1%) underwent secondary interventions within 1 year. Favorable aortic remodeling was observed during the course of follow-up, indicated by an increase in the true lumen size and a concomitant decrease in the false lumen size along the dissected aorta, with completely thrombosed thoracic false lumen observed in 31% of patients at 12 months as compared to % at baseline. Initial data with a composite TEVAR construct have demonstrated favorable clinical and anatomic results. Continued enrollment and long-term data are needed to assess the overall effectiveness of this treatment strategy.

(PDF emailed within 0-6 h: $19.90)

Accession: 036356525

Download citation: RISBibTeXText

PMID: 22169668

DOI: 10.1016/j.jvs.2011.10.022



Related references

Initial results of a prospective multicenter clinical trial STABLE on the endovascular treatment of complicated type B aortic dissection using a composite device design. 2011

Aortic remodeling after endovascular treatment of complicated type B aortic dissection with the use of a composite device design. Journal of Vascular Surgery 59(6): 1544-1554, 2014

Volume analysis of true and false lumens in acute complicated type B aortic dissections after thoracic endovascular aortic repair with stent grafts alone or with a composite device design. Journal of Vascular Surgery 63(5): 1216-1224, 2016

INvestigation of STEnt grafts in patients with type B Aortic Dissection: design of the INSTEAD trial--a prospective, multicenter, European randomized trial. American Heart Journal 149(4): 592-599, 2005

Multicenter clinical trial of the conformable stent graft for the treatment of acute, complicated type B dissection. Journal of Vascular Surgery 62(2): 271-278, 2015

Endovascular Treatment of a Complicated Acute Type B Aortic Dissection in a Patient With Aortic Coarctation. Revista Espanola de Cardiologia: -, 2016

Complicated acute type B aortic dissection with involvement of an aberrant right subclavian artery and rupture of a thoracoabdominal aortic aneurysm, Crawford type I: successful emergency endovascular treatment. Journal of Thoracic and Cardiovascular Surgery 134(4): 1055-1057, 2007

The LIBERTY study: Design of a prospective, observational, multicenter trial to evaluate the acute and long-term clinical and economic outcomes of real-world endovascular device interventions in treating peripheral artery disease. American Heart Journal 174(): 14-21, 2016

Morphologic outcome after endovascular treatment of complicated type B aortic dissection. Journal of Vascular and Interventional Radiology 24(12): 1826-1833, 2014

Midterm results of endovascular treatment of complicated acute type B aortic dissection. Journal of Thoracic and Cardiovascular Surgery 138(3): 625-631, 2009

Midterm results after endovascular treatment of acute, complicated type B aortic dissection. Annals of Thoracic Surgery 90(5): 1444-1448, 2010

Outcomes of endovascular management for complicated chronic type B aortic dissection: effect of the extent of stent graft coverage and anatomic properties of aortic dissection. Journal of Vascular and Interventional Radiology 24(10): 1451-1460, 2014

Endovascular treatment of complicated type-B aortic dissection with stent-grafts:: midterm results. Journal of Vascular and Interventional Radiology 14(2 Pt 1): 195-203, 2003

Midterm results after endovascular treatment of acute, complicated type B aortic dissection: the Talent Thoracic Registry. Journal of Thoracic and Cardiovascular Surgery 145(1): 159-165, 2013