title: Importance of implant technique on risk of major paravalvular leak (PVL) after St. Jude mechanical heart valve replacement: a report from the Artificial Valve Endocarditis Reduction Trial (AVERT).
abstract: OBJECTIVE
  To examine risk factors for major paravalvular leak (PVL) events after mechanical heart valve replacement.
  
  
  METHODS
  We analyzed outcome of 807 patients randomized into the Artificial Valve Endocarditis Reduction Trial (AVERT). The mean follow-up time was 30.6 months and 21 major PVL events were reported. Three additional major PVL events associated with endocarditis were excluded from analysis. All baseline medical history variables, as well as operative parameters (including use of pledgets and suture technique) were examined using Cox regression.
  
  
  RESULTS
  Major PVL was reported after 11 aortic, 9 mitral, and 1 double valve replacement. 6/404 (1.5%) patients with conventional valves experienced a major PVL event versus 15/403 (3.7%) in the Silzone group. 10/172 (5.8%) patients with valve suture technique without pledgets experienced a major PVL event versus 11/635 (1.7%) patients with pledgets. Final multivariable model showed that only suture technique without pledgets (p=0.005) was an independent significant risk factor for major PVL events. Silzone cuff showed a strong trend (p=0.055).
  
  
  CONCLUSIONS
  Suture technique without pledgets is an independent significant risk factor for major PVL events. In this study, use of pledgets during valve replacement had a protective effect against subsequent paravalvular leak, supporting the use of buttress reinforcement for valve suture. The use of Silzone cuff, although not statistically significant, showed a strong trend as a risk factor.
authors.affiliation: Department of Cardiovascular Surgery, Inselspital, University Hospital, Freiburgstrasse, 3010 Berne, Switzerland. lars.englberger@insel.ch
authors.forename: Lars
authors.initials: L
authors.lastname: Englberger
authors.forename: Hartzell V
authors.initials: HV
authors.lastname: Schaff
authors.forename: W R Eric
authors.initials: WR
authors.lastname: Jamieson
authors.forename: Elizabeth D
authors.initials: ED
authors.lastname: Kennard
authors.forename: Kyung A
authors.initials: KA
authors.lastname: Im
authors.forename: Richard
authors.initials: R
authors.lastname: Holubkov
authors.forename: Thierry P
authors.initials: TP
authors.lastname: Carrel
mesh_terms: D000368:Aged; D001021:Aortic Valve / Q000601:surgery; D020099:Coated Materials, Biocompatible; D004697:Endocarditis, Bacterial / Q000209:etiology / Q000517:prevention & control; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation / Q000379:methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000601:surgery; D011475:Prosthesis Failure; D012307:Risk Factors; D012834:Silver / Q000627:therapeutic use; D013536:Suture Techniques
chemical_list: D020099:Coated Materials, Biocompatible; D012834:Silver