title: When does transapical aortic valve replacement become a futile procedure? An analysis from a national registry.
abstract: OBJECTIVE
  Patient selection is crucial to achieve good outcomes and to avoid futile procedures in patients undergoing transcatheter aortic valve replacement. The aim of this multicenter retrospective study was to identify independent predictors of 1-year mortality in patients surviving after transapical transcatheter aortic valve replacement.
  
  
  METHODS
  We analyzed data from the Italian registry of transapical transcatheter aortic valve replacement that includes patients undergoing operation in 21 centers from 2007 to 2012. Futility was defined as mortality within 1 year after transapical transcatheter aortic valve replacement in patients surviving at 30 days. Thirty-day survivors were divided in 2 groups: futility (group F) and nonfutility (group NF). Cox proportional hazard regression analysis was performed to identify independent predictors of futility.
  
  
  RESULTS
  We analyzed data from 645 patients with survival of 30 days or more after transapical transcatheter aortic valve replacement. Groups F and NF included 60 patients (10.8%) and 585 patients (89.2%), respectively. Patients in group F were more likely to have insulin-dependent diabetes (15% vs 7.2%, P = .03), creatinine 2.0 mg/dL or greater or dialysis (18.3% vs 8.2%, P = .01), logistic European System for Cardiac Operative Risk Evaluation greater than 20% (66.7% vs 50.3%, P = .02), preoperative rhythm disorders (40% vs 25.3%, P = .03), critical preoperative state (8.3% vs 1.8%, P = .002), and left ventricular ejection fraction less than 30% (15% vs 2.9%, P < .001). The multivariate analysis identified the following as independent predictors of futility: insulin-dependent diabetes (odds ratio, 3.1; P = .003), creatinine 2.0 mg/dL or greater or dialysis (odds ratio, 2.52; P = .012), preoperative rhythm disorders (odds ratio, 1.88; P = .04), and left ventricular ejection fraction less than 30% (odds ratio, 4.34; P = .001).
  
  
  CONCLUSIONS
  According to our data, among patients undergoing transapical transcatheter aortic valve replacement, those with insulin-dependent diabetes, advanced chronic kidney disease, rhythm disorders, and low left ventricular ejection fraction have a higher risk to undergo futile procedures.
authors.affiliation: Division of Cardiac Surgery, University of Padova, Padova, Italy. Electronic address: adonofrio@hotmail.it.
authors.forename: Augusto
authors.initials: A
authors.lastname: D'Onofrio
authors.affiliation: Division of Cardiac Surgery, University of Torino, Torino, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Salizzoni
authors.affiliation: Division of Cardiac Surgery, Monzino Hospital, Milano, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Agrifoglio
authors.affiliation: Division of Cardiac Surgery, Clinica Montevergine, Mercogliano, Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Lucchetti
authors.affiliation: Department of Cardiac Surgery, San Camillo Hospital, Roma, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Musumeci
authors.affiliation: Division of Cardiac Surgery, Humanitas Gavazzeni Hospital, Bergamo and Rozzano, Italy.
authors.forename: Giampiero
authors.initials: G
authors.lastname: Esposito
authors.affiliation: Division of Cardiac Surgery, San Bortolo Hospital, Vicenza, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Magagna
authors.affiliation: Division of Cardiac Surgery, University of Pavia, Pavia, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Aiello
authors.affiliation: Division of Cardiac Surgery, Policlinico S. Orsola Malpighi, Bologna, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Savini
authors.affiliation: Division of Cardiac Surgery, Clinica S. Maria, Bari, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Cassese
authors.affiliation: Ospedale del Cuore, Fondazione Monastiero, Massa, Italy.
authors.forename: Mattia
authors.initials: M
authors.lastname: Glauber
authors.affiliation: Division of Cardiac Surgery, Ordine Mauriziano Hospital, Torino, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Punta
authors.affiliation: San Raffaele University Hospital, Milano, Italy.
authors.forename: Ottavio
authors.initials: O
authors.lastname: Alfieri
authors.affiliation: Cardiac Surgery, Hesperia Hospital, Modena, Italy.
authors.forename: Davide
authors.initials: D
authors.lastname: Gabbieri
authors.affiliation: Division of Cardiac Surgery, Ospedale dell'Angelo, Mestre, Italy.
authors.forename: Domenico
authors.initials: D
authors.lastname: Mangino
authors.affiliation: Division of Cardiac Surgery, University of Parma, Parma, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Agostinelli
authors.affiliation: Division of Cardiac Surgery, S. Maria della Misericordia Hospital, Udine, Italy.
authors.forename: Ugolino
authors.initials: U
authors.lastname: Livi
authors.affiliation: Division of Cardiac Surgery, S. Croce e Carle Hospital, Cuneo, Italy.
authors.forename: Omar
authors.initials: O
authors.lastname: Di Gregorio
authors.affiliation: Division of Cardiac Surgery, Azienda Ospedaliera-Universitaria, Trieste, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Minati
authors.affiliation: Cardiovascular Surgery, University of Verona, Verona, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Faggian
authors.affiliation: Division of Cardiac Surgery, University of Torino, Torino, Italy.
authors.forename: Claudia
authors.initials: C
authors.lastname: Filippini
authors.affiliation: Division of Cardiac Surgery, University of Torino, Torino, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Rinaldi
authors.affiliation: Division of Cardiac Surgery, University of Padova, Padova, Italy.
authors.forename: Gino
authors.initials: G
authors.lastname: Gerosa
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D001145:Arrhythmias, Cardiac / Q000401:mortality; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000401:mortality; D016009:Chi-Square Distribution; D015897:Comorbidity; D003661:Decision Support Techniques; D003922:Diabetes Mellitus, Type 1 / Q000401:mortality; D005260:Female; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D006439:Hemodynamics; D006801:Humans; D007558:Italy; D016015:Logistic Models; D008297:Male; D018447:Medical Futility; D015999:Multivariate Analysis; D016017:Odds Ratio; D018579:Patient Selection; D016016:Proportional Hazards Models; D012042:Registries; D051436:Renal Insufficiency, Chronic / Q000401:mortality; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D013318:Stroke Volume; D013997:Time Factors; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left / Q000401:mortality / Q000503:physiopathology; D016277:Ventricular Function, Left