The Omnicarbon prosthetic valve was implanted in 168 patients (mean age, 53 years); 84 had aortic valve replacement (AVR), 57 had mitral valve replacement (MVR), and 27 had both aortic and mitral valve replacement (DVR). The mean follow-up period was 6.8 years, with a maximum of 13.7 years. Three patients (1.8%) were lost to follow-up. There were 4 (2.4%) early deaths and 26 late deaths. Survival at 10 years was 76% in the AVR and MVR groups, and 85% in the DVR group. Freedom from thromboembolism at 10 years was 94% in the AVR group, 80% in the MVR group, and 92% in the DVR group. Freedom from hemorrhagic complications at 10 years was 86% in the AVR group and 92% in the MVR group. At 10 years, 97% in the AVR group and 96% in the MVR group were free from endocarditis. One patient in the DVR group suffered a paravalvular leak. At 10 years, 97% in the AVR group and 95% in the MVR group had not needed reoperation. Elevation of the postoperative serum lactate dehydrogenase levels were acceptable in the three groups. In conclusion, the Omnicarbon prosthetic valve has shown excellent long-term clinical results.

Fourteen year experience with the Omnicarbon prosthetic heart valve

We have previously reported mid-term results of a study, which ended in January 2000, on the Bicarbon valve. The study concluded that the valve showed excellent clinical results, associated with a low incidence of valve-related complications. In the present study, the same patients were prospectively followed for an additional 5 years. Forty-four patients had aortic valve replacement (AVR), 48 had mitral valve replacement (MVR), and 13 had both aortic and mitral valve replacement (DVR). The mean age of the 105 patients was 61.2 ± 11.3 years. The mean follow-up was 6.1 ± 1.9 years with a cumulative follow-up of 616 patient-years. There were 5 early deaths (4.7%: 4 in the AVR group and 1 in the MVR group) and 21 late deaths (3.4%/patient-year: 5 valve related deaths and 16 valve unrelated deaths). Survival at 8 years was 75.2 ± 7.0% in the AVR group, 76.6 ± 6.2% in the MVR group, and 55.4 ± 16.1% in the DVR group. The linearized incidence of thrombo-embolic complications, hemorrhagic complications, and paravalvular leaks in all patients was 0.65 ± 1.48%, 0.81 ± 1.69%, and 0.16 ± 0.54%/patient-year respectively. No other complications were observed. The Bicarbon prosthetic heart valve has shown excellent long-term clinical results, associated with a low incidence of valve-related complications.

/pdf/clinical-experience-with-the-bicarbon-heart-valve-prosthesis-1y0be3fess.pdf

Clinical experience with the Bicarbon heart valve prosthesis

We analyzed midterm results using the Bicarbon valve in a single center. Forty-four patients had aortic valve replacement (AVR), 48 had mitral valve replacement (MVR), and 13 had both aortic and mitral valve replacement (DVR). The mean age of the 105 patients was 61.2 +/- 11.3 years. The mean follow-up was 1.8 +/- 1.1 years with a cumulative follow-up of 188 patient-years. There were 5 early deaths (4.7%: 4 in the AVR group and 1 in the MVR group) and 5 late deaths (2.7% per patient-year: 3 malignancy, 1 cerebral hemorrhage, 1 myocardial infarction). Survival at 3 years was 91 +/- 4% in the AVR group, 92 +/- 5% in the MVR group, and 66 +/- 23% in the DVR group. The linearized incidence of thromboembolic complications, hemorrhagic complications, and paravalvular leaks in all patients was 1.06 +/- 2.34%, 1.60 +/- 2.53%, and 0.53 +/- 2.22% per patient-year, respectively. No other complications were observed. In conclusion, the Bicarbon prosthetic heart valve has shown excellent clinical results associated with a low incidence of valve-related complications.

Single-center experience with the bicarbon bileaflet prosthetic heart valve in Japan.

Pannus formation may disturb the leaflet movement of the prosthetic valve. A 61-year-old woman presented with exertional dyspnea. She had undergone mitral valve replacement with a bioprosthetic valve 31 years ago, which was replaced with a tilting disc valve 22 years ago. The present laboratory findings revealed hemolytic anemia. Echocardiography showed an increased mean pressure gradient through the mitral valve and moderate to severe regurgitation around the minor orifice of the tilting disc valve. She therefore underwent a third operation. Pannus formation was found on the prosthetic valve ring, but it did not obliterate the prosthetic valve orifice. After removing the valve, the posterior wall of the left ventricle was seen to be associated with thickened endocardium. A bileaflet valve was implanted. Postoperative echocardiography showed that the implanted valve functioned well. Nonstructural dysfunction of the mechanical heart valve might occur long after operation. These changes are particularly observed with a tilting disc valve.

/pdf/unique-nonstructural-dysfunction-of-the-omnicarbon-valve-sbj45c21fp.pdf

Unique nonstructural dysfunction of the omnicarbon valve: case report

In a prospective study, 292 consecutive patients received 336 Omnicarbon cardiac valves from September 1984 through September 1992 at the Montpellier University Hospital. There were 153 aortic (52%), 95 mitral (33%) and 44 double (15%) mitral and aortic replacements. Mean age was 58 years; 57% were male. Total follow up was 1,383 patient-years, with a maximum of nine and a mean of 4.87 years. Early mortality was 2.75% overall. Late mortality occurred at a rate of 1.9%/patient-year. Nine-year probability of freedom from mortality (including early mortality) was 85.0% +/- 2.6% overall. There were no cases of structural failure. Thromboembolic events occurred in nine patients, producing a linearized rate of 0.7%/patient-year. Hemorrhage associated with anticoagulant therapy occurred at a rate of 0.8%/patient-year. Therefore, the combined rate of thromboembolic/hemorrhagic events was 1.5%/patient-year. Cumulative overall freedom from thromboembolism and hemorrhage was 91.5% +/- 1.9% at nine years; it was 86.2% +/- 4.3% after mitral and 95.1% +/- 2.0% after aortic valve replacement. Hemolytic anemia was not observed. Endocarditis occurred eight times (0.6%/patient-year), and there were seven cases of perivalvular lead (0.5%/patient-year). At the end of the follow up, 86% of the patients were in NYHA class I. It is concluded that clinical results over a nine-year period are excellent with the Omnicarbon prosthesis.

0083 International Session Long-Term Follow-up of 292 Patients after Valve Replacement with the Omnicarbon Prosthetic Valve

The Bicarbon prosthetic heart valve with two curved leaflets is designed so that the blood flows through the three orifices are parallel jets of equal size. This study was conducted to confirm that the Bicarbon valve functions clinically as designed. Forty-three patients underwent valve replacement with the Bicarbon valve. Forty-eight Bicarbon valves were implanted: 25 valves in the mitral position and 23 in the aortic position. Peak blood flow velocity through the three prosthetic orifices was measured postoperatively by Doppler echocardiography. The three flow jets through the prosthesis were parallel. The velocity through the lateral orifice was 2.33±0.38 m/min, and the velocity through the central orifice was 2.14±0.43 m/min at the aortic position (P>0.05). The velocity through the lateral orifice was 1.72±0.06 m/min at the mitral position, and that through the central orifice was 1.73±0.06 m/min (P>0.05). Serum lactic acid dehydrogenase values were also lower than those of patients or whom another bileaflet prosthesis had been implanted. The results confirm that the Bicarbon prosthetic heart valve performs clinically as designed, producing three parallel blood flow jets with equal flow velocity.

/pdf/echocardiographic-characteristics-of-transprosthetic-blood-3j94e5fa4p.pdf

Echocardiographic characteristics of transprosthetic blood peak velocity in the Sorin Bicarbon bileaflet prosthetic heart valve

We wanted to determine whether there is any advantage of using a mitral tissue valve, when aortic and mitral valves are simultaneously replaced. We placed a tissue valve in the mitral position and a mechanical valve in the aortic position in 22 cases (combined group). In 31 other double valve replacements, mechanical prostheses were chosen for both positions (mechanical group). The mean follow-up time for the combined group was 8.9 years, and that for the mechanical group was 7.2 years. The 10-year survival rate and freedom from thromboembolism at 10 years were not different in the two groups. Treatment-related hemorrhage was seen in 3 patients of the combined group alone. Five patients among the combined group underwent reoperation because of bioprosthetic dysfunction, and the rate of freedom from reoperation at 10 years was 75 ±12%. The rate of freedom from all complications at 10 years was 43±11% for the combined group and 70±8% for the mechanical group. We find no advantage in mixing aortic mechanical and mitral tissue valves when performing double valve replacement.

Increased risk for double valve replacement with tissue and mechanical prostheses

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Echocardiographic characteristics of transprosthetic blood peak velocity in the Sorin Bicarbon bileaflet prosthetic heart valve

Increased risk for double valve replacement with tissue and mechanical prostheses