title: Prosthesis-patient mismatch in high-risk patients with severe aortic stenosis: A randomized trial of a self-expanding prosthesis.
abstract: OBJECTIVE
  We compared the incidence of prosthesis-patient mismatch (PPM) between transcatheter aortic valve replacement (TAVR) using a self-expanding bioprosthesis and surgical aortic valve replacement (SAVR) in the CoreValve US High Risk Pivotal Trial. We sought to determine the influence of PPM on clinical outcomes.
  
  
  METHODS
  Patients with severe aortic stenosis and at increased risk for surgery were randomized 1:1 to TAVR or SAVR. Postoperative PPM was defined by the effective orifice area index (EOAi) as severe PPM (EOAi ≤ 0.65 cm(2)/m(2)) and no severe PPM (EOAi > 0.65 cm(2)/m(2)); clinical outcomes were analyzed in the TAVR arm (n = 389) and SAVR arm (n = 353). Left ventricular mass index and regression were analyzed at baseline and 1 year.
  
  
  RESULTS
  The incidence of severe PPM in the SAVR group at 1 year was 25.7% versus 6.2% in the TAVR group (P < .0001). Left ventricular mass index regression at 1 year was 6.8% for TAVR and 15.1% for SAVR in patients with severe PPM. At 1 year the rate of all-cause mortality and acute kidney injury were significantly greater in all patients (TAVR + SAVR) with severe PPM compared with no severe PPM (20.6% vs 12.0% [P = .0145] for death and 19.2% vs 8.5% [P = .0008] for acute kidney injury).
  
  
  CONCLUSIONS
  In patients with high surgical risk and severe aortic stenosis, severe PPM is more common in patients treated with SAVR than those treated with TAVR. Patients with severe PPM are a greater risk for death and acute kidney injury than patients without severe PPM.
authors.affiliation: Cardiovascular Research Institute, University of Kansas Hospital, Kansas City, Kan. Electronic address: gzorn@kumc.edu.
authors.forename: George L
authors.initials: GL
authors.lastname: Zorn
authors.affiliation: Houston Methodist DeBakey Heart and Vascular Center, The Houston Methodist Hospital, Houston, Tex.
authors.forename: Stephen H
authors.initials: SH
authors.lastname: Little
authors.affiliation: Cardiovascular Research Institute, University of Kansas Hospital, Kansas City, Kan.
authors.forename: Peter
authors.initials: P
authors.lastname: Tadros
authors.affiliation: University of Michigan Medical Center, Ann Arbor, Mich.
authors.forename: G Michael
authors.initials: GM
authors.lastname: Deeb
authors.affiliation: University of Pittsburgh School of Medicine, Pittsburg, Pa.
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Gleason
authors.affiliation: Spectrum Health Hospitals, Grand Rapids, Mich.
authors.forename: John
authors.initials: J
authors.lastname: Heiser
authors.affiliation: Houston Methodist DeBakey Heart and Vascular Center, The Houston Methodist Hospital, Houston, Tex.
authors.forename: Neal S
authors.initials: NS
authors.lastname: Kleiman
authors.affiliation: Mayo Clinic, Rochester, Minn.
authors.forename: Jae K
authors.initials: JK
authors.lastname: Oh
authors.affiliation: Beth Israel Deaconess Medical Center, Boston, Mass.
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Popma
authors.affiliation: Mount Sinai Medical Center, New York, NY.
authors.forename: David
authors.initials: D
authors.lastname: Adams
authors.affiliation: Medtronic, Minneapolis, Minn.
authors.forename: Jian
authors.initials: J
authors.lastname: Huang
authors.affiliation: Houston Methodist DeBakey Heart and Vascular Center, The Houston Methodist Hospital, Houston, Tex.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Reardon
mesh_terms: D058186:Acute Kidney Injury / Q000453:epidemiology; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D001705:Bioprosthesis; D006328:Cardiac Catheterization / Q000009:adverse effects* / Q000295:instrumentation* / Q000401:mortality; D015150:Echocardiography, Doppler; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects* / Q000295:instrumentation* / Q000401:mortality; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D011183:Postoperative Complications / Q000175:diagnosis / Q000453:epidemiology* / Q000401:mortality; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011474:Prosthesis Design; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D016277:Ventricular Function, Left; D020257:Ventricular Remodeling
keywords: aortic stenosis; prosthesis-patient mismatch; transcatheter aortic valve replacement