The Carbomedics Top Hat supraannular aortic valve: A multicenter study

A. Marc Gillinov, Eugene H. Blackstone, Joan M. Alster, Joseph M. Craver, William A. Baumgartner, Scot A. Brewster, Leonard H. Kleinman, Nicholas G. Smedira

Research output: Contribution to journalArticlepeer-review

17 Scopus citations


Background. Introduced in 1993, the Carbomedics Top Hat (Sulzer, Carbomedics, Austin, TX) valve is a bileaflet mechanical aortic prosthesis designed to be placed in a supraannular position. Five institutions pooled their clinical experiences to evaluate early outcome in patients with this prosthesis. Methods. From 1994 to 2000, 639 patients underwent aortic valve replacement with Top Hat (Sulzer Carbomedics) valves at 5 institutions. Mean age was 60 ± 13 years. In this heterogeneous population, 28% of patients had previous cardiac operations and 64% had concomitant procedures, including procedures involving more than 1 heart valve in 32%. Implanted prostheses sizes included the 19 mm (15%), 21 mm (37%), 23 mm (33%), 25 mm (13%), and 27 mm (2%). Mean follow-up was 2.0 ± 1.5 years, and there were 1,206 patient-years of follow-up available for analysis. Results. Thirty-day mortality was 5.3%. Five-year survival was 74%. Risk factors for death included older age (p = 0.01), decreased ejection fraction (p = 0.007), and increased New York Heart Association functional class (p = 0.003). Five-year freedoms from thromboembolism and hemorrhage were 90% and 85%, respectively. Five-year freedoms from explant and endocarditis were both 99%. There were no structural valve failures. Conclusions. The Top Hat valve outcomes have been similar to those of the standard Carbomedics intraannular prostheses. The unique design of the Top Hat valve, with all its components in the aortic sinuses, has particular advantages in the small aortic root, in settings where leaflet entrapment may occur, and in multiple valve replacement.

Original languageEnglish (US)
Pages (from-to)1175-1180
Number of pages6
JournalAnnals of Thoracic Surgery
Issue number4
StatePublished - Apr 1 2003
Externally publishedYes

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine


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