title: Outcomes of inoperable symptomatic aortic stenosis patients not undergoing aortic valve replacement: insight into the impact of balloon aortic valvuloplasty from the PARTNER trial (Placement of AoRtic TraNscathetER Valve trial).
abstract: OBJECTIVE
  The aim of this report is to characterize the impact of balloon aortic valvuloplasty (BAV) in patients not undergoing aortic valve replacement in the PARTNER (Placement of AoRtic TraNscathetER Valves) trial.
  
  
  BACKGROUND
  The PARTNER trial is the only randomized trial with independently adjudicated data of inoperable severe symptomatic aortic stenosis patients, allowing outcome analysis of unoperated-on patients.
  
  
  METHODS
  The design and initial results of the PARTNER trial (Cohort B) were reported previously. After excluding patients with pre-randomization BAV, we compared patients undergoing BAV within 30 days of randomization (BAV group) with those not having BAV within 30 days of randomization (no BAV group) to characterize the use and impact of BAV.
  
  
  RESULTS
  In the PARTNER Cohort B study, 179 inoperable patients were randomized to standard treatment including 39 patients (21.8%) who had undergone a BAV before randomization (previous BAV group). Of the 140 patients who did not have BAV before enrollment in the study, 102 patients (73%) had BAV within 30 days of study randomization (BAV group). Survival at 3 months was greater in the BAV group compared with the no BAV group (88.2%; 95% confidence interval [CI]: 82.0% to 94.5% vs. 73.0%; 95% CI: 58.8% to 87.4%). However, survival was similar at 6-month follow-up (74.5%; 95% CI: 66.1% to 83.0% vs. 73.1%; 58.8% to 87.4%). There was improvement in quality of life parameters when paired comparisons were made between baseline and 30 days and 6 months between the BAV and no BAV groups, but this effect was lost at 12-month follow-up.
  
  
  CONCLUSIONS
  BAV improves functional status and survival in the short term, but these benefits are not sustained. BAV for aortic stenosis patients who cannot undergo aortic valve replacement is a useful palliative therapy. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).
authors.affiliation: Cleveland Clinic Foundation, Cleveland, Ohio.
authors.forename: Samir
authors.initials: S
authors.lastname: Kapadia
authors.affiliation: Cleveland Clinic Foundation, Cleveland, Ohio.
authors.forename: William J
authors.initials: WJ
authors.lastname: Stewart
authors.affiliation: Irvine, California.
authors.forename: William N
authors.initials: WN
authors.lastname: Anderson
authors.affiliation: Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Vasilis
authors.initials: V
authors.lastname: Babaliaros
authors.affiliation: NorthShore University Health System, Evanston, Illinois.
authors.forename: Ted
authors.initials: T
authors.lastname: Feldman
authors.affiliation: Saint Luke's Mid America Heart Institute, Kansas City, Missouri.
authors.forename: David J
authors.initials: DJ
authors.lastname: Cohen
authors.affiliation: Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Pamela S
authors.initials: PS
authors.lastname: Douglas
authors.affiliation: Cedars-Sinai Medical Center, Los Angeles, California.
authors.forename: Raj R
authors.initials: RR
authors.lastname: Makkar
authors.affiliation: Cleveland Clinic Foundation, Cleveland, Ohio.
authors.forename: Lars G
authors.initials: LG
authors.lastname: Svensson
authors.affiliation: St. Paul's Hospital/University of British Columbia, Vancouver, British Columbia, Canada.
authors.forename: John G
authors.initials: JG
authors.lastname: Webb
authors.affiliation: New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, New York.
authors.forename: S Chiu
authors.initials: SC
authors.lastname: Wong
authors.affiliation: Medical City Dallas Hospital, Dallas, Texas.
authors.forename: David L
authors.initials: DL
authors.lastname: Brown
authors.affiliation: Stanford University, Stanford, California.
authors.forename: D Craig
authors.initials: DC
authors.lastname: Miller
authors.affiliation: New York-Presbyterian Hospital/Columbia University Medical Center, New York, New York.
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Moses
authors.affiliation: New York-Presbyterian Hospital/Columbia University Medical Center, New York, New York.
authors.forename: Craig R
authors.initials: CR
authors.lastname: Smith
authors.affiliation: New York-Presbyterian Hospital/Columbia University Medical Center, New York, New York.
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.affiliation: Cleveland Clinic Foundation, Cleveland, Ohio. Electronic address: tuzcue@ccf.org.
authors.forename: E Murat
authors.initials: EM
authors.lastname: Tuzcu
mesh_terms: D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000628:therapy*; D005260:Female; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D006439:Hemodynamics; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011788:Quality of Life; D012720:Severity of Illness Index; D015996:Survival Rate; D016896:Treatment Outcome
keywords: BAV; aortic stenosis; valvuloplasty