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

• Published in: Journal of vascular surgery 2012-03, Vol.55 (3), p.629-640.e2
• Main Authors: Lombardi, Joseph V., MD, Cambria, Richard P., MD, Nienaber, Christoph A., MD, Chiesa, Roberto, MD, Teebken, Omke, MD, PhD, Lee, Anthony, MD, Mossop, Peter, MD, Bharadwaj, Priya, PhD
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Aneurysm, Dissecting - complications; Aneurysm, Dissecting - diagnostic imaging; Aneurysm, Dissecting - mortality; Aneurysm, Dissecting - surgery; Aortic Aneurysm, Thoracic - complications; Aortic Aneurysm, Thoracic - diagnostic imaging; Aortic Aneurysm, Thoracic - mortality; Aortic Aneurysm, Thoracic - surgery; Aortography - methods; Australia; Biological and medical sciences; Blood and lymphatic vessels; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation - adverse effects; Blood Vessel Prosthesis Implantation - instrumentation; Blood Vessel Prosthesis Implantation - mortality; Cardiology. Vascular system; Diseases of the aorta; Endovascular Procedures - adverse effects; Endovascular Procedures - instrumentation; Endovascular Procedures - mortality; Europe; Female; Humans; Kaplan-Meier Estimate; Linear Models; Male; Medical sciences; Metals; Middle Aged; Postoperative Complications - mortality; Postoperative Complications - surgery; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Reoperation; Stents; Surgery; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Time Factors; Tomography, X-Ray Computed; Treatment Outcome; United States; Vascular surgery: aorta, extremities, vena cava. Surgery of the lymphatic vessels
• ISSN: 0741-5214; 1097-6809
• DOI: 10.1016/j.jvs.2011.10.022

Objective 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). Methods 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 ≥40 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. Results Ten centers enrolled 40 patients (70% men; mean age 58 years old) between December 2007 and August 2009. The onset of symptoms was acute (≤14 days) in 24 patients (60%), subacute (15-30 days) in six patients (15%), and chronic (31-90 days) in 10 patients (25%); the overall mean time from symptom onset to treatment was 20 days (range, 0-78 days). A majority of patients (77.5%; 31 of 40 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 30-day mortality rate was 5% (2 of 40); two deaths occurred after 30 days, leading to a 1-year survival rate of 90%. Two deaths, occurring at 11 and 81 days postprocedure, respectively, were secondary to aortic rupture. Morbidity occurring within 30 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 30 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 (10%) 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 c