title: Late hemodynamic and clinical outcomes of aortic valve replacement with the Carpentier-Edwards Perimount pericardial bioprosthesis.
abstract: OBJECTIVE
  The aim of this study was to investigate the long-term clinical and hemodynamic outcomes after aortic valve replacement with the Carpentier-Edwards Perimount bioprosthesis (Edwards Lifesciences, Irvine, Calif), which has been used in our institution since 1984.
  
  
  METHODS
  From January 1984 to December 1995, the Carpentier-Edwards pericardial bioprosthesis was used for aortic valve replacement in 254 patients (male/female ratio 117:137) with a mean age of 71 years (range 25-87 years). Before the operation, 216 patients (85%) were in New York Heart Association functional class III or IV. The predominant diagnosis was aortic stenosis (n = 219, 86%). Associated surgical procedures included coronary artery bypass grafting in 130 cases (51%), mitral valve replacement in 11 cases (4%), and tricuspid or mitral valve repair in 12 cases (5%). Previous cardiac operations had been performed in 36 cases (14%). Follow-up was 100% complete at a mean of 60 +/- 31 months. Univariate estimates of time-related cumulative probabilities were calculated by the Kaplan-Meier method. Multivariable adjustment was performed by Cox proportional hazards regression. Echocardiography was performed in 61% of long-term survivors.
  
  
  RESULTS
  There were 11 early deaths (4%) and 58 late deaths. Actuarial survivals at 5, 10, and 12 years were 80% +/- 3%, 50% +/- 8%, and 36% +/- 9%, respectively. At 12 years the freedom from cardiac death was 73% +/- 7%, the freedom from valve-related death was 84% +/- 11%, the freedom from valve reoperation was 83% +/- 9%, the freedom from primary tissue failure was 86% +/- 9%, the freedom from thromboembolism was 67% +/- 13%, and the freedom from endocarditis was 98% +/- 1%. Echocardiography was performed on long-term survivors (mean follow-up 67 +/- 25 months) and showed that transvalvular peak and mean pressure differences measured with Doppler echocardiography were 23.2 +/- 9.6 and 12.3 +/- 4.8 mm Hg, respectively. Aortic regurgitation was found by Doppler echocardiography to be none or trivial, mild, moderate, and severe in 64%, 30%, 3%, and 1% of patients, respectively. Mean left ventricular mass index was 107.2 +/- 35.3 g/m(2) (118.9 +/- 40.2 g/m(2) in men and 98.8 +/- 28.8 g/m(2) in women) at late follow-up. One third of all patients, regardless of sex (n = 26/64 women and n = 14/45 men), had evidence of left ventricular hypertrophy. However, our analyses indicate that the residual left ventricular hypertrophy was not caused by valve mismatch but was probably multifactorial.
  
  
  CONCLUSIONS
  The Carpentier-Edwards Perimount bioprosthesis has provided satisfactory clinical and hemodynamic outcome. However, at long-term follow-up about one third of the patients being investigated still had left ventricular hypertrophy examined by echocardiography.
authors.affiliation: Division of Cardiovascular Surgery of Toronto General Hospital and the University of Toronto, Toronto, Ontario, Canada.
authors.forename: Göran
authors.initials: G
authors.lastname: Dellgren
authors.forename: Tirone E
authors.initials: TE
authors.lastname: David
authors.forename: Ehud
authors.initials: E
authors.lastname: Raanani
authors.forename: Susan
authors.initials: S
authors.lastname: Armstrong
authors.forename: Joan
authors.initials: J
authors.lastname: Ivanov
authors.forename: Harry
authors.initials: H
authors.lastname: Rakowski
mesh_terms: D000368:Aged; D001021:Aortic Valve; D001024:Aortic Valve Stenosis / Q000601:surgery; D001705:Bioprosthesis; D015150:Echocardiography, Doppler; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D006439:Hemodynamics / Q000502:physiology*; D006801:Humans; D017379:Hypertrophy, Left Ventricular / Q000000981:diagnostic imaging; D008297:Male; D010496:Pericardium; D011183:Postoperative Complications / Q000453:epidemiology; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D012086:Reoperation / Q000706:statistics & numerical data; D012189:Retrospective Studies; D015996:Survival Rate; D013997:Time Factors