title: Will stentless valves be durable? The Toronto valve (TSPV) at 5 to 6 years.
abstract: The early hemodynamic benefits of stentless aortic valves have been well documented. The issue of long-term functional integrity remains unanswered. We report the clinical results of a multicenter registry with prospective data on 621 patients monitored for 7.1 years. Patient data were collected and analyzed at St Jude Medical Inc, St Paul, Minnesota. In all, 66% of patients were male; the average age was 65.9 years +/-11.0 years, with 39% older than 70 years. Native aortic valves were bicuspid in 40.6%, 91.5% were calcified and 65.7% stenotic. Most valves implanted (83.1%) were sizes 25, 27, or 29 mm. Concomitant coronary bypass was performed in 42% of patients. Total follow-up time for the 621 patients was 1,944.5 valve years (mean 3.1 years per patient). At 5 years, 86.1% (n = 137) and at 6 years 80.4% (n = 51) were in New York Heart Association class I, and 78% had no or trivial atrial insufficiency. The average mean systolic gradient for all valves at 6 years was 4.0 mm Hg, and the peak gradient was 8.6 mm Hg. The effective orifice area varied from 1.4 cm2 (23-mm valve) to 2.7 cm2 (29-mm valve). The decrease in left ventricular mass index was significant and sustained. Actuarial survival at 6 years was 84.2%, and freedom from cardiac-related deaths was 90.1%. Freedom from valve-related deaths was 95.7%, and freedom from prosthetic endocarditis was 98.6%. There were no instances of primary tissue valve failure during follow-up, with 97.2% freedom from reoperation. The early hemodynamic benefits of the TSPV are well maintained during more than 6 years of follow-up, without evident valvular dysfunction. Longer follow-up time is required to validate durability, but there is increasing evidence for well-maintained structural and functional integrity.
authors.affiliation: Sunnybrook & Women's College Health Sciences Centre, Toronto, Ontario, Canada.
authors.forename: B
authors.initials: B
authors.lastname: Goldman
authors.forename: G
authors.initials: G
authors.lastname: Christakis
authors.forename: T
authors.initials: T
authors.lastname: David
authors.forename: H
authors.initials: H
authors.lastname: Rakowski
authors.forename: D
authors.initials: D
authors.lastname: Bach
authors.forename: J
authors.initials: J
authors.lastname: Wood
authors.forename: S
authors.initials: S
authors.lastname: Goldman
authors.forename: J
authors.initials: J
authors.lastname: Pepper
authors.forename: M
authors.initials: M
authors.lastname: Yacoub
authors.forename: E
authors.initials: E
authors.lastname: Verrier
authors.forename: M
authors.initials: M
authors.lastname: Petracek
mesh_terms: D000206:Actuarial Analysis; D000368:Aged; D005260:Female; D006350:Heart Valve Prosthesis; D006439:Hemodynamics; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011474:Prosthesis Design; D013997:Time Factors; D016896:Treatment Outcome