of the CarboMedics bileaflet prosthetic heart valve.

N2 - Background and aims of the study: This study details the authors' experience with the CarboMedics bileaflet mechanical prosthesis, and assesses the valve's efficacy in terms of early mortality and long-term morbidity. Methods: Between July 1994 and December 2000, a total of 696 CarboMedics valves was implanted in 616 patients. Aortic valve replacement (AVR) was performed in 350 (57%) patients, mitral valve replacement (MVR) in 161 (26%), double (aortic + mitral) valve replacement (DVR) in 79 (13%), and other procedures in 26 (4%). Results: There were 32 operative deaths. Operative mortality was 4.3% for AVR, 6.8% for MVR, and 7.6% for DVR. Linearized rates for late death were 3.4%/patient-year (pt-yr), 5.5%/pt-yr and 7.7%/pt-yr for AVR, MVR and DVR, respectively. Survival at five years was 80.1% for AVR, 73.0% for MVR, and 64.6% for DVR (p = 0.004). Freedom from reoperation at five years was 97.6% for AVR, 98.1% for MVR, and 94.1% for DVR (p = 0.718); freedom from thromboembolism at five years was 96.3% for AVR, 98.6% for MVR, and 88.3% for DVR (p = 0.04). Linearized rates of late thromboembolism were 0.7%/pt-yr, 0.4%/pt-yr and 2.3%/pt-yr, respectively. Freedom from PVE at five years was 98.4% for AVR, 97.0% for MVR, and 89.7% for the DVR group (p = 0.172). Linearized rates of PVE were 0.5%/pt-yr, 0.9%/pt-yr and 1.8%/pt-yr, respectively. Freedom from anticoagulant-related bleeding at five years was 98.0% in the AVR group, 97.8% in the MVR group, and 88.3% in the DVR group (p

Patent US4276658 - Heart valve prosthesis - Google …

T1 - Spontaneous echocardiographic contrast with the carbomedics mitral valve prosthesis

Heart valve prosthesis selection in patients with end ..

The results obtained from this study indicate that standard St. Jude Medical and CarboMedics aortic valve prostheses offer similar excellent clinical performance. Definitive judgment must await trials that are extensive, randomized, and prospective.

Patente US6206918 - Heart valve prosthesis having a …

We designed this study to compare long-term results of St. Jude Medical and CarboMedics mechanical heart valves in the aortic position. We retrospectively analyzed the results of 174 consecutive patients who received either a St. Jude (n=80) or a CarboMedics (n=94) mechanical aortic valve from March 1992 through October 2004.

Patent US4357715 - Heart valve prosthesis - Google …

We designed this retrospective study in order to compare the long-term results of these most widely used mechanical heart valves in the aortic position.

NEW PROSTHETIC HEART VALVE IN FINAL PHASE OF …

Background: Two-dimensional (2D) and Doppler-derived echocardiographic data on normal CarboMedics (CM) mechanical mitral valve prosthesis function have been reported but are limited. Methods: Comprehensive retrospective 2D and Doppler echocardiographic assessment of 305 normal CM mechanical mitral valve prostheses (272 Standard and 33 Optiform) was performed early after implantation. The early postimplantation hemodynamic profiles of 80 patients were compared with profiles obtained by follow-up transthoracic echocardiography performed MVP), 20 to 50 cm; ratio of TVI MVP to the TVI of the left ventricular outflow tract, 0.9 to 2.5; pressure half-time, 35 to 99 msec; and effective orifice area, 1.17 to 3.25 cm 2. Patients with severe prosthesis-patient mismatch (indexed effective orifice area ≤ 0.9 cm 2/m 2) had significantly higher mean gradients, peak early mitral diastolic velocities, TVI MVP, ratios of TVI MVP to the TVI of the left ventricular outflow tract, and pressure half-time values than values without severe prosthesis-patient mismatch, but none had pressure half-time values > 120 msec. Among the 80 patients with follow-up transthoracic echocardiography within 1 year after implantation, no significant differences were noted between early postimplantation findings and follow-up hemodynamic profiles. Conclusions: This study establishes parameters (mean ± 2 SD) defining the distribution of findings for Doppler-derived hemodynamic data with normal CM mechanical mitral valve prostheses. Prostheses with hemodynamic values outside these parameters are likely dysfunctional; however, prosthesis dysfunction may be present even when hemodynamic values are within these ranges.

CHOOSING A PROSTHETIC HEART VALVE - Cardiology …

AB - 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.