title: A comparison of conventional surgery, transcatheter aortic valve replacement, and sutureless valves in "real-world" patients with aortic stenosis and intermediate- to high-risk profile.
abstract: OBJECTIVE
  We sought to investigate the clinical outcomes of patients with isolated severe aortic stenosis and an intermediate- to high-risk profile treated by means of conventional surgery (surgical aortic valve replacement), sutureless valve implantation, or transcatheter aortic valve replacement in a multicenter evaluation.
  
  
  METHODS
  Among 991 consecutive patients with isolated severe aortic stenosis and an intermediate- to high-risk profile (Society of Thoracic Surgeons score >4 and logistic European System for Cardiac Operative Risk Evaluation I >10), a propensity score analysis was performed on the basis of the therapeutic strategy: surgical aortic valve replacement (n = 204), sutureless valve implantation (n = 204), and transcatheter aortic valve replacement (n = 204). Primary end points were 30-day mortality and overall survival at 24-month follow-up; the secondary end point was survival free from a composite end point of major adverse cardiac events (defined as cardiac-related mortality, myocardial infarction, cerebrovascular accidents, and major hemorrhagic events) and periprosthetic regurgitation greater than 2.
  
  
  RESULTS
  Thirty-day mortality was significantly higher in the transcatheter aortic valve replacement group (surgical aortic valve replacement = 3.4% vs sutureless = 5.8% vs transcatheter aortic valve replacement = 9.8%; P = .005). The incidence of postprocedural was 3.9% in asurgical aortic valve replacement vs 9.8% in sutureless vs 14.7% in transcatheter aortic valve replacement (P< .001) and peripheral vascular complications occurred in 0% of surgicalaortic valve replacement vs 0% of sutureless vs 9.8% transcatheter aortic valve replacement (P< .001). At 24-month follow-up, overall survival (surgical aortic valve replacement = 91.3% ± 2.4% vs sutureless = 94.9% ± 2.1% vs transcatheter aortic valve replacement = 79.5% ± 4.3%; P < .001) and survival free from the composite end point of major adverse cardiovascular events and periprosthetic regurgitation were significantly better in patients undergoing surgical aortic valve replacement and sutureless valve implantation than in patients undergoing transcatheter aortic valve replacement (surgical aortic valve replacement = 92.6% ± 2.3% vs sutureless = 96% ± 1.8% vs transcatheter aortic valve replacement = 77.1% ± 4.2%; P < .001). Multivariate Cox regression analysis identified transcatheter aortic valve replacement as an independent risk factor for overall mortality hazard ratio (hazard ratio, 2.5; confidence interval, 1.1-4.2; P = .018).
  
  
  CONCLUSIONS
  The use of transcatheter aortic valve replacement in patients with an intermediate- to high-risk profile was associated with a significantly higher incidence of perioperative complications and decreased survival at short- and mid-term when compared with conventional surgery and sutureless valve implantation.
authors.affiliation: University of Brescia Medical School, Brescia, Italy. Electronic address: claudio.muneretto@unibs.it.
authors.forename: Claudio
authors.initials: C
authors.lastname: Muneretto
authors.affiliation: San Raffaele University Hospital, Milan, Italy.
authors.forename: Ottavio
authors.initials: O
authors.lastname: Alfieri
authors.affiliation: Unit of Biostatistics and Biomathematics Department of Molecular and Translational Medicine, University of Brescia Medical School, Brescia, Italy.
authors.forename: Bruno Mario
authors.initials: BM
authors.lastname: Cesana
authors.affiliation: University of Brescia Medical School, Brescia, Italy.
authors.forename: Gianluigi
authors.initials: G
authors.lastname: Bisleri
authors.affiliation: San Raffaele University Hospital, Milan, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: De Bonis
authors.affiliation: University of Bologna, Bologna, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Di Bartolomeo
authors.affiliation: University of Bologna, Bologna, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Savini
authors.affiliation: University of Bologna, Bologna, Italy.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Folesani
authors.affiliation: University of Brescia Medical School, Brescia, Italy.
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Di Bacco
authors.affiliation: Azienda Ospedaliera Carlo Poma, Mantova, Italy.
authors.forename: Manfredo
authors.initials: M
authors.lastname: Rambaldini
authors.affiliation: CHU de Nancy, Nancy, France.
authors.forename: Juan Pablo
authors.initials: JP
authors.lastname: Maureira
authors.affiliation: Institut Mutualiste Montsouris, Parigi, France.
authors.forename: Francois
authors.initials: F
authors.lastname: Laborde
authors.affiliation: Ospedale di Seriate, Seriate, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Tespili
authors.affiliation: University of Brescia Medical School, Brescia, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Repossini
authors.affiliation: CHU de Nancy, Nancy, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Folliguet
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000601:surgery*; D005260:Female; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D011183:Postoperative Complications; D057216:Propensity Score; D011474:Prosthesis Design; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D015996:Survival Rate; D065467:Transcatheter Aortic Valve Replacement; D016896:Treatment Outcome
keywords: aortic valve replacement; sutureless bioprosthesis; transcatheter valve implantation