title: Transcatheter aortic valve replacement and standard therapy in inoperable patients with aortic stenosis and low EF.
abstract: OBJECTIVE
  The aims of this study were to evaluate the effect of left ventricular (LV) dysfunction on clinical outcomes after transcatheter aortic valve replacement (TAVR) and standard therapy for severe aortic stenosis (AS) and to assess LV ejection fraction (LVEF) recovery and its impact on subsequent clinical outcomes.
  
  
  METHODS
  Cohort B of the Placement of AoRtic TraNscathetER Valves trial randomised 342 inoperable patients with severe AS to TAVR or standard therapy. We defined LV dysfunction as an LVEF <50% and LVEF improvement as an absolute increase in LVEF ≥10% at 30 days.
  
  
  RESULTS
  Baseline LV dysfunction did not affect survival after TAVR but was associated with increased cardiac mortality at 1 year with standard therapy (59.3% vs 45.8% with normal LVEF; HR=1.71 (95% CI 1.08 to 2.71); p=0.02). In those with LV dysfunction, LVEF improvement occurred in 48.7% and 30.4% of TAVR and standard therapy patients, respectively (p=0.08), and was independently predicted by relative wall thickness and receipt of TAVR. LVEF improvement with standard therapy portended reduced all-cause mortality at 1 year (28.6% vs 65.6% without LVEF improvement; HR=0.32 (95% CI 0.11 to 0.93); p=0.03) but not at 2 years.
  
  
  CONCLUSIONS
  In inoperable patients with severe AS, mild-to-moderate LV dysfunction is associated with higher cardiac mortality with standard therapy but not TAVR. A subset of patients undergoing standard therapy with LV dysfunction demonstrates LVEF improvement and favourable 1-year but not 2-year survival. TAVR improves survival and should be considered the standard of care for inoperable patients with AS and LVEF >20%.
  
  
  BACKGROUND
  ClinicalTrials.gov Unique Identifier #NCT00530894.
authors.affiliation: Cardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
authors.forename: Jonathan J
authors.initials: JJ
authors.lastname: Passeri
authors.affiliation: Cardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA Harvard Clinical Research Institute, Boston, Massachusetts, USA.
authors.forename: Sammy
authors.initials: S
authors.lastname: Elmariah
authors.affiliation: Columbia University Medical Center/New York-Presbyterian Hospital, The Cardiovascular Research Foundation, New York, New York, USA.
authors.forename: Ke
authors.initials: K
authors.lastname: Xu
authors.affiliation: Cardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
authors.forename: Ignacio
authors.initials: I
authors.lastname: Inglessis
authors.affiliation: Department of Cardiac Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
authors.forename: Joshua N
authors.initials: JN
authors.lastname: Baker
authors.affiliation: Columbia University Medical Center/New York-Presbyterian Hospital, The Cardiovascular Research Foundation, New York, New York, USA.
authors.forename: Maria
authors.initials: M
authors.lastname: Alu
authors.affiliation: Columbia University Medical Center/New York-Presbyterian Hospital, The Cardiovascular Research Foundation, New York, New York, USA.
authors.forename: Susheel
authors.initials: S
authors.lastname: Kodali
authors.affiliation: Columbia University Medical Center/New York-Presbyterian Hospital, The Cardiovascular Research Foundation, New York, New York, USA.
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.affiliation: Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio, USA.
authors.forename: Lars G
authors.initials: LG
authors.lastname: Svensson
authors.affiliation: Québec Heart and Lung Institute, Laval University, Québec, Canada.
authors.forename: Philippe
authors.initials: P
authors.lastname: Pibarot
authors.affiliation: Stanford University School of Medicine, Stanford, California, USA.
authors.forename: William F
authors.initials: WF
authors.lastname: Fearon
authors.affiliation: Columbia University Medical Center/New York-Presbyterian Hospital, The Cardiovascular Research Foundation, New York, New York, USA.
authors.forename: Ajay J
authors.initials: AJ
authors.lastname: Kirtane
authors.affiliation: Department of Cardiac Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
authors.forename: Gus J
authors.initials: GJ
authors.lastname: Vlahakes
authors.affiliation: Cardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
authors.forename: Igor F
authors.initials: IF
authors.lastname: Palacios
authors.affiliation: Duke Clinical Research Institute/Duke University Medical Center, Durham, North Carolina, USA.
authors.forename: Pamela S
authors.initials: PS
authors.lastname: Douglas
mesh_terms: D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000150:complications / Q000503:physiopathology* / Q000601:surgery*; D005260:Female; D006801:Humans; D008297:Male; D013318:Stroke Volume; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement; D018487:Ventricular Dysfunction, Left / Q000150:complications / Q000503:physiopathology