title: Health Status After Transcatheter or Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Increased Surgical Risk: Results From the CoreValve US Pivotal Trial.
abstract: OBJECTIVE
  This study sought to compare the health status outcomes for patients treated with either self-expanding transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (AVR).
  
  
  BACKGROUND
  In patients at increased surgical risk, TAVR with a self-expanding bioprosthesis is associated with improved 1-year survival compared with AVR. However, elderly patients may be just as concerned with quality-of-life improvement as with prolonged survival as a goal of treatment.
  
  
  METHODS
  Between 2011 and 2012, 795 patients with severe aortic stenosis at increased surgical risk were randomized to TAVR or AVR in the CoreValve US Pivotal Trial. Health status was assessed at baseline, 1 month, 6 months, and 1 year using the Kansas City Cardiomyopathy Questionnaire, Medical Outcomes Study Short-Form 12 Questionnaire, and EuroQOL 5-dimension questionnaire; growth curve models were used to examine changes over time.
  
  
  RESULTS
  Over the 1-year follow-up period, disease-specific and generic health status improved substantially for both treatment groups. At 1 month, there was a significant interaction between the benefit of TAVR over AVR and access site. Among surviving patients eligible for iliofemoral (IF) access, there was a clinically relevant early benefit with TAVR across all disease-specific and generic health status measures. Among the non-IF cohort, however, most health status measures were similar for TAVR and AVR, although there was a trend toward early benefit with TAVR on the Short-Form 12 Questionnaire's physical health scale. There were no consistent differences in health status between TAVR and AVR at the later time points.
  
  
  CONCLUSIONS
  Health status improved substantially in surviving patients with increased surgical risk who were treated with either self-expanding TAVR or AVR. TAVR via the IF route was associated with better early health status compared with AVR, but there was no early health status benefit with non-IF TAVR compared with AVR. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).
authors: Saint Luke's Mid America Heart Institute, Kansas City, Missouri; University of Missouri-Kansas City, Kansas City, Missouri.
authors: Suzanne V
authors: SV
authors: Arnold
authors: Harvard Clinical Research Institute, Boston, Massachusetts.
authors: Matthew R
authors: MR
authors: Reynolds
authors: Saint Luke's Mid America Heart Institute, Kansas City, Missouri.
authors: Kaijun
authors: K
authors: Wang
authors: Saint Luke's Mid America Heart Institute, Kansas City, Missouri; University of Missouri-Kansas City, Kansas City, Missouri.
authors: Elizabeth A
authors: EA
authors: Magnuson
authors: Saint Luke's Mid America Heart Institute, Kansas City, Missouri; University of Missouri-Kansas City, Kansas City, Missouri.
authors: Suzanne J
authors: SJ
authors: Baron
authors: Saint Luke's Mid America Heart Institute, Kansas City, Missouri.
authors: Khaja M
authors: KM
authors: Chinnakondepalli
authors: Houston-Methodist-DeBakey Heart and Vascular Center, Houston, Texas.
authors: Michael J
authors: MJ
authors: Reardon
authors: University of Kansas Hospital, Kansas City, Kansas.
authors: Peter N
authors: PN
authors: Tadros
authors: University of Kansas Hospital, Kansas City, Kansas.
authors: George L
authors: GL
authors: Zorn
authors: Pinnacle Health, Harrisburg, Pennsylvania.
authors: Brij
authors: B
authors: Maini
authors: Pinnacle Health, Harrisburg, Pennsylvania.
authors: Mubashir A
authors: MA
authors: Mumtaz
authors: Morristown Memorial Hospital, Morristown, New Jersey.
authors: John M
authors: JM
authors: Brown
authors: Morristown Memorial Hospital, Morristown, New Jersey.
authors: Robert M
authors: RM
authors: Kipperman
authors: Mount Sinai Medical Center, New York, New York.
authors: David H
authors: DH
authors: Adams
authors: Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors: Jeffrey J
authors: JJ
authors: Popma
authors: Saint Luke's Mid America Heart Institute, Kansas City, Missouri; University of Missouri-Kansas City, Kansas City, Missouri. Electronic address: dcohen@saint-lukes.org.
authors: David J
authors: DJ
authors: Cohen
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D001705:Bioprosthesis; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods* / Q000401:mortality; D005260:Female; D006304:Health Status; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods* / Q000401:mortality; D006801:Humans; D008297:Male; D008603:Mental Health; D011474:Prosthesis Design; D011788:Quality of Life; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D012919:Social Behavior; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
keywords: aortic stenosis; health status; quality of life; transcatheter aortic valve replacement