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The Carbomedics Top Hat supraannular aortic valve: a multicenter study
A Marc Gillinov1, Eugene H Blackstone, Joan M Alster
1Department of Thoracic and Cardiovascular Surgery, The Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA. gillinom@ccf.org
The Annals of Thoracic Surgery
|April 10, 2003
Summary
The Carbomedics Top Hat valve shows comparable outcomes to standard aortic prostheses. Its supraannular design offers advantages in specific patient groups, including those with small aortic roots or undergoing multiple valve replacements.
Area of Science:
- Cardiovascular Surgery
- Biomedical Engineering
- Prosthetic Heart Valves
Background:
- The Carbomedics Top Hat valve, introduced in 1993, is a supraannular bileaflet mechanical aortic prosthesis.
- Clinical data from five institutions were pooled to assess early outcomes.
Purpose of the Study:
- To evaluate the early clinical outcomes of the Carbomedics Top Hat aortic prosthesis.
- To identify patient characteristics and procedural factors influencing outcomes.
Main Methods:
- A cohort of 639 patients underwent aortic valve replacement with Top Hat valves between 1994 and 2000.
- Mean patient age was 60 years, with 28% having prior cardiac surgery and 64% undergoing concomitant procedures.
- Mean follow-up was 2.0 years, totaling 1,206 patient-years.
Main Results:
- Thirty-day mortality was 5.3%, and five-year survival was 74%.
- Risk factors for mortality included older age, reduced ejection fraction, and higher NYHA functional class.
- Five-year freedom from thromboembolism was 90%, from hemorrhage was 85%, and from explant or endocarditis was 99%.
Conclusions:
- Carbomedics Top Hat valve outcomes are similar to standard intra-annular prostheses.
- The supraannular design provides benefits in patients with small aortic roots, risk of leaflet entrapment, or undergoing multiple valve replacements.