title: Early- and mid-term outcomes of transcatheter aortic valve implantation in patients with logistic EuroSCORE less than 20%: a comparative analysis between different risk strata.
abstract: BACKGROUND
  Transcatheter aortic valve implantation (TAVI) is an emerging alternative to medical therapy reserved to a limited population with severe aortic stenosis. The European consensus document recommended TAVI for prohibitive-risk patients not eligible for conventional surgery (prohibitive risk defined as expected mortality ≥ 20% calculated with the Logistic EuroScore (LES) in association with clinical judgment). To date, there is lack of clarity on data about outcomes of TAVI in lower risk patients. We sought to evaluate the outcomes of patients undergoing TAVI with LES ≥ 20% in comparison with patients with LES < 20%.
  
  
  METHODS
  Of 165 patients who underwent TAVI using the 18-French Medtronic CoreValve (N = 153) and the Sapien Edwards™ (N = 12) at our Institution between June 2007 and September 2010, we identified those with LES < 20%, with prosthesis implantation (n = 84), and reported on their clinical outcome compared with patients with LES ≥ 20% (n = 78). The primary endpoint was the incidence of overall death and major adverse cerebrovascular and cardiac events (MACCE) at 30-day and midterm follow-up stratifying patients by clinical characteristics.
  
  
  RESULTS
  At 30-day, a significant higher incidence of MACCE (20.8% vs. 6.0%, odds ratio [OR] 4.08 95% confidence interval [CI] 1.42-11.74, P = 0.009) and death (15.6% vs. 2.4%, OR 7.45 95% CI 1.61-34.48, P = 0.010) was reported in the LES ≥ 20% group as compared with the LES < 20% group, respectively. The 12-month MACCE rates was (27.1% vs. 11.4%, hazard ratio [HR] 2.47 95% CI 0.93-6.63, P = 0. 071) for LES ≥ 20% and LES < 20% patients, respectively (mortality rates was 25.7% vs. 6.8% HR 4.21 95% CI 1.24-14.30, P = 0.021).
  
  
  CONCLUSIONS
  This study tends to suggest that current mortality reported after TAVI could be significantly affected by the very-high risk profile of the population which currently undergoes this procedure, making comparison with surgical series rather unreliable.
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy.
authors.forename: Corrado
authors.initials: C
authors.lastname: Tamburino
authors.forename: Marco
authors.initials: M
authors.lastname: Barbanti
authors.forename: Davide
authors.initials: D
authors.lastname: Capodanno
authors.forename: Kunal
authors.initials: K
authors.lastname: Sarkar
authors.forename: Valeria
authors.initials: V
authors.lastname: Cammalleri
authors.forename: Marilena
authors.initials: M
authors.lastname: Scarabelli
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Mulè
authors.forename: Sebastiano
authors.initials: S
authors.lastname: Immè
authors.forename: Patrizia
authors.initials: P
authors.lastname: Aruta
authors.forename: Gian Paolo
authors.initials: GP
authors.lastname: Ussia
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality; D002561:Cerebrovascular Disorders / Q000209:etiology; D016009:Chi-Square Distribution; D005260:Female; D006331:Heart Diseases / Q000209:etiology; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods* / Q000401:mortality; D006801:Humans; D007558:Italy; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D016017:Odds Ratio; D018579:Patient Selection; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome