title: Stratification of outcomes after transcatheter aortic valve replacement according to surgical inoperability for technical versus clinical reasons.
abstract: OBJECTIVE
  The goal of this study was to examine the impact of reasons for surgical inoperability on outcomes in patients undergoing transcatheter aortic valve replacement (TAVR).
  
  
  BACKGROUND
  Patients with severe aortic stenosis may be deemed inoperable due to technical or clinical reasons. The relative impact of each designation on early and late outcomes after TAVR is unclear.
  
  
  METHODS
  Patients were studied from the inoperable arm (cohort B) of the randomized PARTNER (Placement of Aortic Transcatheter Valve) trial and the nonrandomized continued access registry. Patients were classified according to whether they were classified as technically inoperable (TI) or clinically inoperable (CLI). Reasons for TI included porcelain aorta, previous mediastinal radiation, chest wall deformity, and potential for injury to previous bypass graft on sternal re-entry. Reasons for CLI were systemic factors that were deemed to make survival unlikely.
  
  
  RESULTS
  Of the 369 patients, 23.0% were considered inoperable for technical reasons alone; the remaining were judged to be CLI. For TI, the most common cause was a porcelain aorta (42%); for CLI, it was multiple comorbidities (48%) and frailty (31%). Quality of life and 2-year mortality were significantly better among TI patients compared with CLI patients (mortality 23.3% vs. 43.8%; p < 0.001). Nonetheless, TAVR led to substantial survival benefits compared with standard therapy in both inoperable cohorts.
  
  
  CONCLUSIONS
  Patients undergoing TAVR based solely on TI have better survival and quality of life improvements than those who are inoperable due to clinical comorbidities. Both TI and CLI TAVR have significant survival benefit in the context of standard therapy. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).
authors.affiliation: Cedars-Sinai Heart Institute, Los Angeles, California. Electronic address: Raj.Makkar@cshs.org.
authors.forename: Raj R
authors.initials: RR
authors.lastname: Makkar
authors.affiliation: Cedars-Sinai Heart Institute, Los Angeles, California.
authors.forename: Hasan
authors.initials: H
authors.lastname: Jilaihawi
authors.affiliation: Baylor Health Care System, Plano, Texas.
authors.forename: Michael
authors.initials: M
authors.lastname: Mack
authors.affiliation: Cedars-Sinai Heart Institute, Los Angeles, California.
authors.forename: Tarun
authors.initials: T
authors.lastname: Chakravarty
authors.affiliation: Saint-Luke's Mid America Heart Institute, Kansas City, Missouri.
authors.forename: David J
authors.initials: DJ
authors.lastname: Cohen
authors.affiliation: Cedars-Sinai Heart Institute, Los Angeles, California.
authors.forename: Wen
authors.initials: W
authors.lastname: Cheng
authors.affiliation: Lenox Hill Heart and Vascular Institute, New York, New York.
authors.forename: Gregory P
authors.initials: GP
authors.lastname: Fontana
authors.affiliation: Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Joseph E
authors.initials: JE
authors.lastname: Bavaria
authors.affiliation: Emory University, Atlanta, Georgia.
authors.forename: Vinod H
authors.initials: VH
authors.lastname: Thourani
authors.affiliation: Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Howard C
authors.initials: HC
authors.lastname: Herrmann
authors.affiliation: Washington Hospital Center, Washington, DC.
authors.forename: Augusto
authors.initials: A
authors.lastname: Pichard
authors.affiliation: Cleveland Clinic, Cleveland, Ohio.
authors.forename: Samir
authors.initials: S
authors.lastname: Kapadia
authors.affiliation: Emory University, Atlanta, Georgia.
authors.forename: Vasilis
authors.initials: V
authors.lastname: Babaliaros
authors.affiliation: Intermountain Medical Center, Salt Lake City, Utah.
authors.forename: Brian K
authors.initials: BK
authors.lastname: Whisenant
authors.affiliation: Herbert and Sandi Feinberg Interventional Cardiology and Heart Valve at Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York.
authors.forename: Susheel K
authors.initials: SK
authors.lastname: Kodali
authors.affiliation: Herbert and Sandi Feinberg Interventional Cardiology and Heart Valve at Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York.
authors.forename: Mathew
authors.initials: M
authors.lastname: Williams
authors.affiliation: Cedars-Sinai Heart Institute, Los Angeles, California.
authors.forename: Alfredo
authors.initials: A
authors.lastname: Trento
authors.affiliation: Herbert and Sandi Feinberg Interventional Cardiology and Heart Valve at Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York.
authors.forename: Craig R
authors.initials: CR
authors.lastname: Smith
authors.affiliation: Scripps Clinic and Scripps Translational Science Institute, La Jolla, California.
authors.forename: Paul S
authors.initials: PS
authors.lastname: Teirstein
authors.affiliation: University of Miami Miller School of Medicine, Miami, Florida.
authors.forename: Mauricio G
authors.initials: MG
authors.lastname: Cohen
authors.affiliation: Herbert and Sandi Feinberg Interventional Cardiology and Heart Valve at Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York.
authors.forename: Ke
authors.initials: K
authors.lastname: Xu
authors.affiliation: Washington Hospital Center, Washington, DC.
authors.forename: E Murat
authors.initials: EM
authors.lastname: Tuzcu
authors.affiliation: St. Paul's Hospital, Vancouver, British Columbia, Canada.
authors.forename: John G
authors.initials: JG
authors.lastname: Webb
authors.affiliation: Herbert and Sandi Feinberg Interventional Cardiology and Heart Valve at Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York.
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001011:Aorta / Q000601:surgery; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000601:surgery* / Q000628:therapy*; D015331:Cohort Studies; D005260:Female; D006350:Heart Valve Prosthesis / Q000009:adverse effects*; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000401:mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D012042:Registries; D013997:Time Factors; D016896:Treatment Outcome
keywords: TAVI; TAVR; inoperable; risk; transcatheter aortic valve