title: Prospective evaluation of clinical outcomes in all-comer high-risk patients with aortic valve stenosis undergoing medical treatment, transcatheter or surgical aortic valve implantation following heart team assessment.
abstract: OBJECTIVE
  Transcatheter aortic valve implantation (TAVI) has been proposed as a treatment alternative for patients with aortic valve stenosis (AS) at high or prohibitive risk for surgical aortic valve replacement (AVR). We aimed to assess real-world outcomes after treatment according to the decisions of the multidisciplinary heart team.
  
  
  METHODS
  At a tertiary centre, all high-risk patients referred between 1 March 2008 and 31 October 2011 for symptomatic AS were screened and planned to undergo AVR, TAVI or medical treatment. We report clinical outcomes as defined by the Valve Academic Research Consortium.
  
  
  RESULTS
  Of 163 high-risk patients, those selected for AVR had lower logistic EuroSCORE and STS scores when compared with TAVI or medical treatment (median [interquartile range] 18 [12-26]; 26 [17-36]; 21 [14-32]% (P = 0.015) and 6.5 [5.1-10.7]; 7.6 [5.8-10.5]; 7.6 [6.1-15.7]% (P = 0.056)). All-cause mortalities at 1 year in 35, 73 and 55 patients effectively undergoing AVR, TAVI and medical treatment were 20, 21 and 38%, respectively (P = 0.051). Cardiovascular death and major stroke occurred in 9, 8 and 33% (P < 0.001) and 6, 4 and 2% (P = 0.62), respectively. For patients undergoing valve implantation, device success was 91 and 92% for AVR and TAVI, respectively. The combined safety endpoint at 30 days was in favour of TAVI (29%) vs AVR (63%) (P = 0.001). In contrast, the combined efficacy endpoint at 1 year tended to be more favourable for AVR (10 vs 24% for TAVI, P = 0.12).
  
  
  CONCLUSIONS
  Patients who are less suitable for AVR can be treated safely and effectively with TAVI with similar outcomes when compared with patients with a lower-risk profile undergoing AVR. Patients with TAVI or AVR have better survival than those undergoing medical treatment only.
authors.affiliation: Department of Cardiovascular Diseases, University Hospitals Leuven, Leuven, Belgium. christophe.dubois@uzleuven.be
authors.forename: Christophe
authors.initials: C
authors.lastname: Dubois
authors.forename: Mark
authors.initials: M
authors.lastname: Coosemans
authors.forename: Filip
authors.initials: F
authors.lastname: Rega
authors.forename: Gert
authors.initials: G
authors.lastname: Poortmans
authors.forename: Ann
authors.initials: A
authors.lastname: Belmans
authors.forename: Tom
authors.initials: T
authors.lastname: Adriaenssens
authors.forename: Marie-Christine
authors.initials: MC
authors.lastname: Herregods
authors.forename: Kaatje
authors.initials: K
authors.lastname: Goetschalckx
authors.forename: Walter
authors.initials: W
authors.lastname: Desmet
authors.forename: Stefan
authors.initials: S
authors.lastname: Janssens
authors.forename: Bart
authors.initials: B
authors.lastname: Meyns
authors.forename: Paul
authors.initials: P
authors.lastname: Herijgers
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000175:diagnosis* / Q000188:drug therapy / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D001530:Belgium; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D016507:Cardiology Service, Hospital; D002317:Cardiovascular Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D005260:Female; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D006801:Humans; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D010348:Patient Care Team; D018579:Patient Selection; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012017:Referral and Consultation; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D062606:Tertiary Care Centers; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents
keywords: Aortic valve replacement; Transcatheter aortic valve implantation; Valve academic research consortium