title: Prospective multicenter clinical trial (STABLE) on the endovascular treatment of complicated type B aortic dissection using a composite device design.
abstract: 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 compared to 0% at baseline.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Surgery, Cooper University Hospital, Camden, NJ, USA. lombardi-joseph@cooperhealth.edu
authors.forename: Joseph V
authors.initials: JV
authors.lastname: Lombardi
authors.forename: Richard P
authors.initials: RP
authors.lastname: Cambria
authors.forename: Christoph A
authors.initials: CA
authors.lastname: Nienaber
authors.forename: Roberto
authors.initials: R
authors.lastname: Chiesa
authors.forename: Omke
authors.initials: O
authors.lastname: Teebken
authors.forename: Anthony
authors.initials: A
authors.lastname: Lee
authors.forename: Peter
authors.initials: P
authors.lastname: Mossop
authors.forename: Priya
authors.initials: P
authors.lastname: Bharadwaj
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000784:Aortic Dissection / Q000150:complications / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D017545:Aortic Aneurysm, Thoracic / Q000150:complications / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D001027:Aortography / Q000379:methods; D001315:Australia; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005060:Europe; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D016014:Linear Models; D008297:Male; D008670:Metals; D008875:Middle Aged; D011183:Postoperative Complications / Q000401:mortality / Q000601:surgery; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D012086:Reoperation; D015607:Stents; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D014481:United States
chemical_list: D008670:Metals