Original article: cardiovascular
The Carbomedics Top Hat supraannular aortic valve: a multicenter study

https://doi.org/10.1016/S0003-4975(02)03991-7Get rights and content

Abstract

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.

Section snippets

Patients

We identified 639 consecutive patients from five institutions who underwent aortic valve replacement with Top Hat prostheses (Table 1) between September 1994 and September 2000. All patients receiving the Top Hat valve were included in the study to reflect real world use of this device in clinical practice.

Mean age of this heterogeneous group was 60 ± 13 years, and most patients were in the New York Heart Association functional classes II and III (Table 2). Among 182 patients with a history of

Survival

Thirty-day mortality was 5.3%, and 1-year, 3-year, and 5-year survivals were 91%, 83%, and 74%, respectively (Fig 1). Risk factors for death included older age, worse left ventricular function, advanced symptoms, and previous or concomitant tricuspid valve procedure (Table 7). Factors not associated with higher risk of mortality included previous cardiac operations, concomitant or previous mitral valve replacements, prosthetic size, and patient size relative to prosthetic size.

Thromboembolism and hemorrhage

Five-year

Comment

The Carbomedics Top Hat valve is a bileaflet prosthesis with pyrolytic carbon leaflets. Although the valve mechanism is identical to that of the Carbomedics standard intraannular valve, the Top Hat valve is designed for supraannular implantation. This unique design positions all valve components in the aortic sinuses. This feature may facilitate aortic valve replacement in patients with a small aortic root and affords a particular advantage when combined aortic and mitral valve replacements are

Acknowledgements

This study was funded in part by Sulzer Medica Carbomedics. We thank Colleen Laffey, Diane Alejo, and Barbara Dobbs for their assistance in compiling the data and follow-up, and Tess Knerik for her editorial assistance.

References (17)

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