title: Outcomes of Thoracic Endovascular Aortic Repair in Acute Type B Aortic Dissection: Results From the Valiant United States Investigational Device Exemption Study.
abstract: BACKGROUND
  Acute type B aortic dissection complicated by malperfusion or rupture carries a risk of death. We report 30-day and 12-month results of endovascular treatment with the Valiant Captivia Thoracic Stent Graft (Medtronic, Santa Rosa, CA) in patients with acute, complicated type B aortic dissection.
  
  
  METHODS
  The Medtronic DISSECTION Trial is a prospective, nonrandomized, United States Food and Drug Administration-regulated, pivotal trial that enrolled patients at 16 United States sites between June 2010 and May 2012. Follow-up examinations were at 1, 6, and 12 months, and annually through 5 years.
  
  
  RESULTS
  Fifty patients were enrolled. Mean age was 57 years (range, 18 to 83 years). Rupture was present in 20% and malperfusion in 86%. Mean time from symptom onset to procedure was 4.7 days (range, 0 to 23 days). Successful deployment and coverage of the primary entry tear was achieved in all patients. Two patients (4%) underwent open repair 5 and 56 days postprocedure for retrograde aortic dissections. Thirty-day mortality was 8% (4 of 50) and 12-month mortality was 15% (7 of 48). Spinal ischemia was 6%. Serious adverse events occurred in 23 of 49 patients within 12 months. Four patients underwent secondary endovascular procedures. Through 12 months, true lumen diameter in the stented region remained stable or increased in 93.1% (27 of 29) of patients. False lumen diameter remained stable or decreased in 22 patients and was partially or completely thrombosed in 91% (30 of 33).
  
  
  CONCLUSIONS
  The initial results of the Valiant Thoracic Stent Graft in the treatment of acute type B aortic dissection are encouraging, but longer-term outcomes are needed.
authors.affiliation: Division of Cardiovascular Surgery, University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: joseph.bavaria@uphs.upenn.edu.
authors.forename: Joseph E
authors.initials: JE
authors.lastname: Bavaria
authors.affiliation: Division of Cardiothoracic Surgery, The Heart Hospital Baylor, Plano, Texas.
authors.forename: William T
authors.initials: WT
authors.lastname: Brinkman
authors.affiliation: Division of Cardiovascular and Thoracic Surgery, Duke University, Durham, North Carolina.
authors.forename: G Chad
authors.initials: GC
authors.lastname: Hughes
authors.affiliation: Cedars-Sinai Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California.
authors.forename: Ali
authors.initials: A
authors.lastname: Khoynezhad
authors.affiliation: Division of Cardiovascular Surgery, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Wilson Y
authors.initials: WY
authors.lastname: Szeto
authors.affiliation: Department of Cardiothoracic and Vascular Surgery, Memorial Hermann Heart and Vascular Institute, Houston, Texas.
authors.forename: Ali
authors.initials: A
authors.lastname: Azizzadeh
authors.affiliation: Division of Vascular Surgery and Endovascular Therapy, Lynn Heart and Vascular Institute, Boca Raton, Florida.
authors.forename: W Anthony
authors.initials: WA
authors.lastname: Lee
authors.affiliation: Division of Cardiothoracic Surgery, Harbor-UCLA Medical Center, Torrance, California.
authors.forename: Rodney A
authors.initials: RA
authors.lastname: White
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001013:Aorta, Thoracic / Q000601:surgery*; D001018:Aortic Diseases / Q000145:classification / Q000601:surgery*; D057510:Endovascular Procedures / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015607:Stents; D019616:Thoracic Surgical Procedures; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration; D055815:Young Adult