title: Correlates and causes of death in patients with severe symptomatic aortic stenosis who are not eligible to participate in a clinical trial of transcatheter aortic valve implantation.
abstract: BACKGROUND
  Transcatheter aortic valve implantation is currently being evaluated in patients with severe aortic stenosis who are considered high-risk surgical candidates. This study aimed to detect incidences, causes, and correlates of mortality in patients ineligible to participate in transcatheter aortic valve implantation studies.
  
  
  RESULTS
  From April 2007 to July 2009, a cohort of 362 patients with severe aortic stenosis were screened and did not meet the inclusion/exclusion criteria necessary to participate in a transcatheter aortic valve implantation trial. These patients were classified into 2 groups: group 1 (medical): 274 (75.7%): 97 (35.4%) treated medically and 177 (64.6%) treated with balloon aortic valvuloplasty; and group 2 (surgical): 88 (24.3%). The medical/balloon aortic valvuloplasty group had significantly higher clinical risk compared with the surgical group, with significantly higher Society of Thoracic Surgeons score (12.8±7.0 versus 8.5±5.1; P<0.001) and logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) (42.4±22.8 versus 24.4±18.1; P<0.001). The medical/balloon aortic valvuloplasty group had a higher New York Heart Association functional class, incidence of renal failure, and lower ejection fraction. During median follow-up of 377.5 days, mortality in the medical/balloon aortic valvuloplasty group was 102 (37.2%), and during median follow-up of 386 days, mortality in the surgical group was 19 (21.5%). Multivariable adjustment analysis identified renal failure (hazard ratio [HR]: 5.60), New York Heart Association class IV (HR: 5.88), and aortic systolic pressure (HR: 0.99) as independent correlates for mortality in the medical group, whereas renal failure (HR: 7.45), Society of Thoracic Surgeons score (STS; HR: 1.09) and logistic EuroSCORE (HR: 1.45) were correlates of mortality in the in the surgical group.
  
  
  CONCLUSIONS
  Patients with severe symptomatic aortic stenosis not included in transcatheter aortic valve implantation trials do poorly and have extremely high mortality rates, especially in nonsurgical groups, and loss of quality of life in surgical groups.
authors.affiliation: Division of Cardiology, Washington Hospital Center, Washington, DC 20010, USA.
authors.forename: Itsik
authors.initials: I
authors.lastname: Ben-Dor
authors.forename: Augusto D
authors.initials: AD
authors.lastname: Pichard
authors.forename: Manuel A
authors.initials: MA
authors.lastname: Gonzalez
authors.forename: Gaby
authors.initials: G
authors.lastname: Weissman
authors.forename: Yanlin
authors.initials: Y
authors.lastname: Li
authors.forename: Steven A
authors.initials: SA
authors.lastname: Goldstein
authors.forename: Petros
authors.initials: P
authors.lastname: Okubagzi
authors.forename: Asmir I
authors.initials: AI
authors.lastname: Syed
authors.forename: Gabriel
authors.initials: G
authors.lastname: Maluenda
authors.forename: Sara D
authors.initials: SD
authors.lastname: Collins
authors.forename: Cedric
authors.initials: C
authors.lastname: Delhaye
authors.forename: Kohei
authors.initials: K
authors.lastname: Wakabayashi
authors.forename: Michael A
authors.initials: MA
authors.lastname: Gaglia
authors.forename: Rebecca
authors.initials: R
authors.lastname: Torguson
authors.forename: Zhenyi
authors.initials: Z
authors.lastname: Xue
authors.forename: Lowell F
authors.initials: LF
authors.lastname: Satler
authors.forename: William O
authors.initials: WO
authors.lastname: Suddath
authors.forename: Kenneth M
authors.initials: KM
authors.lastname: Kent
authors.forename: Joseph
authors.initials: J
authors.lastname: Lindsay
authors.forename: Ron
authors.initials: R
authors.lastname: Waksman
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001020:Aortic Stenosis, Subvalvular / Q000150:complications / Q000401:mortality / Q000503:physiopathology / Q000601:surgery; D001021:Aortic Valve / Q000601:surgery*; D001794:Blood Pressure; D006328:Cardiac Catheterization; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D051437:Renal Insufficiency / Q000209:etiology / Q000401:mortality; D012307:Risk Factors; D012720:Severity of Illness Index; D015996:Survival Rate