title: Are stentless valves hemodynamically superior to stented valves? Long-term follow-up of a randomized trial comparing Carpentier-Edwards pericardial valve with the Toronto Stentless Porcine Valve.
abstract: OBJECTIVE
  The benefit of stentless valves remains in question. In 1999, a randomized trial comparing stentless and stented valves was unable to demonstrate any hemodynamic or clinical benefits at 1 year after implantation. This study reviews long-term outcomes of patients randomized in the aforementioned trial.
  
  
  METHODS
  Between 1996 and 1999, 99 patients undergoing aortic valve replacement were randomized to receive either a stented Carpentier-Edwards pericardial valve (CE) (Edwards Lifesciences, Irvine, Calif) or a Toronto Stentless Porcine Valve (SPV) (St Jude Medical, Minneapolis, Minn). Among these, 38 patients were available for late echocardiographic follow-up (CE, n = 17; SPV, n = 21). Echocardiographic analysis was undertaken both at rest and with dobutamine stress, and functional status (Duke Activity Status Index) was compared at a mean of 9.3 years postoperatively (range, 7.5-11.1 years). Clinical follow-up was 82% complete at a mean of 10.3 years postoperatively (range, 7.5-12.2 years).
  
  
  RESULTS
  Preoperative characteristics were similar between groups. Effective orifice areas increased in both groups over time. Although there were no differences in effective orifice areas at 1 year, at 9 years, effective orifice areas were significantly greater in the SPV group (CE, 1.49 +/- 0.59 cm(2); SPV, 2.00 +/- 0.53 cm(2); P = .011). Similarly, mean and peak gradients decreased in both groups over time; however, at 9 years, gradients were lower in the SPV group (mean: CE, 10.8 +/- 3.8 mm Hg; SPV, 7.8 +/- 4.8 mm Hg; P = .011; peak: CE, 20.4 +/- 6.5 mm Hg; SPV, 14.6 +/- 7.1 mm Hg; P = .022). Such differences were magnified with dobutamine stress (mean: CE, 22.7 +/- 6.1 mm Hg; SPV, 15.3 +/- 8.4 mm Hg; P = .008; peak: CE, 48.1 +/- 11.8 mm Hg; SPV, 30.8 +/- 17.7 mm Hg; P = .001). Ventricular mass regression occurred in both groups; however, no differences were demonstrated between groups either on echocardiographic, magnetic resonance imaging, or biochemical (plasma B-type [brain] natriuretic peptide) assessment (P = .74). Similarly, Duke Activity Status Index scores of functional status improved in both groups over time; however, no differences were noted between groups (CE, 27.5 +/- 19.1; SPV, 19.9 +/- 12.0; P = .69). Freedom from reoperation at 12 years was 92% +/- 5% in patients with CEs and 75% +/- 5% in patients with SPVs (P = .65). Freedom from valve-related morbidity at 12 years was 82% +/- 7% in patients with CEs and 55% +/- 7% in patients with SPVs (P = .05). Finally, 12-year actuarial survival was 35% +/- 7% in patients with CEs and 52% +/- 7% in patients with SPVs (P = .37).
  
  
  CONCLUSIONS
  Although offering improved hemodynamic outcomes, the SPV did not afford superior mass regression or improved clinical outcomes up to 12 years after implantation.
authors.affiliation: Division of Cardiovascular Surgery at Sunnybrook Health Sciences Centre and the University of Toronto, H-429, 2075 Bayview Ave, Toronto, Ontario M4 N 3M5, Canada. gideon.cohen@sunnybrook.ca
authors.forename: Gideon
authors.initials: G
authors.lastname: Cohen
authors.forename: Brandon
authors.initials: B
authors.lastname: Zagorski
authors.forename: George T
authors.initials: GT
authors.lastname: Christakis
authors.forename: Campbell D
authors.initials: CD
authors.lastname: Joyner
authors.forename: Jessica
authors.initials: J
authors.lastname: Vincent
authors.forename: Jeri
authors.initials: J
authors.lastname: Sever
authors.forename: Sumaya
authors.initials: S
authors.lastname: Harbi
authors.forename: Randi
authors.initials: R
authors.lastname: Feder-Elituv
authors.forename: Fuad
authors.initials: F
authors.lastname: Moussa
authors.forename: Bernard S
authors.initials: BS
authors.lastname: Goldman
authors.forename: Stephen E
authors.initials: SE
authors.lastname: Fremes
mesh_terms: D000368:Aged; D001021:Aortic Valve; D005260:Female; D005500:Follow-Up Studies; D006349:Heart Valve Diseases / Q000601:surgery*; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation; D006439:Hemodynamics; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome