Key result
The Sorin Bicarbon bileaflet valve showed no statistically significant differences in echocardiographic parameters compared to matched patients with St. Jude Medical or CarboMedics valves.
Why the study?
Does the Sorin Bicarbon valve demonstrate comparable echocardiographic performance to St. Jude Medical and CarboMedics valves in patients undergoing isolated mitral or aortic valve replacement?
Cohort (n=100)
Does the Sorin Bicarbon valve demonstrate comparable echocardiographic performance to St. Jude Medical and CarboMedics valves in patients undergoing isolated mitral or aortic valve replacement?
The Sorin Bicarbon bileaflet valve demonstrates satisfactory midterm clinical outcomes and comparable echocardiographic performance to established mechanical valves.
Supports consideration of Sorin Bicarbon as alternative mechanical valve; extends matched cohort data but leaves open randomized confirmation.
A clinical and echocardiographic study was carried out to evaluate the performance of the Sorin Bicarbon bileaflet valve. From December 1990 to December 1994, 100 patients underwent isolated mitral (64) or aortic (36) valve replacement. There were 39 males and 61 females, with ages ranging from 21 to 73 years (mean 62 ± 9.6 years). Forty-three patients underwent a transthoracic continuous pulsed color Doppler echocardiogram at 3 and 6 months postoperatively. For mitral prostheses, the parameters calculated were valve area, pressure half-time and mean gradient; for aortic prostheses, peak and mean gradients were measured. Results were compared by analysis of variance to those obtained in patients matched for sex, body surface area, cardiac rhythm, site, and size of the prosthesis who had St. Jude Medical or CarboMedics valves implanted. No statistically significant differences were found among the 3 prosthetic heart valves. The operative mortality was 7%; 3 cases of fatal cerebral hemorrhage occurred in the early postoperative period. There was 1 late mortality, 1 case of transient cerebral ischemia, and 1 of gastric bleeding, all occurring inpatients with mitral prostheses. Midterm follow-up was satisfactory, although a larger series is required to confirm these results.
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Renzulli et al. (1996) conducted a cohort in Isolated mitral or aortic valve replacement (n=100). Sorin Bicarbon bileaflet valve vs. St. Jude Medical or CarboMedics valves was evaluated on Echocardiographic parameters (valve area, pressure half-time, and gradients). The Sorin Bicarbon bileaflet valve showed no statistically significant differences in echocardiographic parameters compared to matched patients with St. Jude Medical or CarboMedics valves.
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