Original article: cardiovascularThe Carbomedics Top Hat supraannular aortic valve: a multicenter study
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.
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Cited by (19)
Improving the hemocompatibility of heart valves
2018, Hemocompatibility of Biomaterials for Clinical Applications: Blood-Biomaterials InteractionsImproving the hemocompatibility of heart valves
2017, Hemocompatibility of Biomaterials for Clinical Applications: Blood-Biomaterials InteractionsThe CarboMedics supra-annular Top Hat valve improves long-term left ventricular mass regression
2014, Journal of Thoracic and Cardiovascular SurgeryCitation Excerpt :It has been suggested that supra-annular valves, including the Top Hat valve, should be avoided if the coronary ostia are placed downward in the aortic sinus.27 Several cases of coronary ostia obstruction after AVR with the Top Hat valve have been reported.6,28 A particular fact to be stressed was that we did not observe any functional obstruction of the coronary ostia in our series, even when the supra-annular valve was used in 51.7% of the double valve replacement surgeries and 20.8% of redo surgeries in which an small aortic root is remarkably rigid and fibrotic.
Clinical evaluation of new heart valve prostheses: Update of objective performance criteria
2014, Annals of Thoracic SurgeryAssessment of the St. Jude Medical Regent Prosthetic Valve by Continuous-Wave Doppler and Dobutamine Stress Echocardiography
2010, Annals of Thoracic SurgeryCitation Excerpt :DSE was performed on 2 patients with PPM, showing that EF did not exceed 100 mm Hg by dobutamine stress in both cases. In recent years, the HP series of the SJM valve [15], the AP series of the ATS valve [16] (ATS Medical Inc, Minneapolis, MN), and the TopHat series of the CarboMedics valve (Carbomedics, Austin, TX) [17] were developed to secure a wide valve area for replacement of a small aortic annulus without annular enlargement, and these valves have been used clinically. Patients still have PPM, however, so the development of mechanical valves with a wider effective orifice area is awaited.
Bhagavant Kalke and His Pioneering Work on the Bi-Leaflet Heart Valve Prosthesis
2009, Annals of Thoracic SurgeryCitation Excerpt :On May 4, 1992, Nicoloff assisted Professor Hossein Sadeghi at the University of Lausanne, Switzerland, during the implantation of the first ATS open pivot prosthesis [7]. In 1986, Bokros founded Carbomedics and began production of the Carbomedics bi-leaflet prosthesis, which was similar in design to the St Jude valve but its housing could be rotated within the sewing ring [2, 8. The first Carbomedics bi-leaflet prosthesis was implanted in Paris in 1986.