Evaluation of valve-related complications in patients with Sorin Bicarbon prosthesis: a seven-year experience.

BACKGROUND AND AIM OF THE STUDY: The study aim was to evaluate the medium-term results of aortic valve replacement (AVR), mitral valve replacement (MVR) and double valve replacement (DVR) with the Sorin Bicarbon prosthesis. METHODS: A total of 990 patients (568 men, 422 women; mean age 60+/-10 years; range: 20-86 years) was reviewed who received 1,108 Sorin Bicarbon prostheses between 1992 and 1998 at three institutions. AVR was performed in 541 patients (55%), MVR in 330 (33%) and DVR in 119 (12%). Concomitant procedures, mainly coronary artery grafting, were performed in 222 patients (22%). Follow up was 98% complete; total cumulative follow up was 3,091 patient-years. RESULTS: Hospital mortality was 3.7% (n = 37). There were 49 late deaths; actuarial survival at seven years was 88+/-2% after AVR, 86+/-5% after MVR, and 78+/-8% after DVR. At last follow up, 915 survivors were in NYHA functional class I or II. At seven years, actuarial freedom from valve-related deaths, valve thrombosis, embolism and bleeding respectively was 96+/-1%, 99+/-1%, 93+/-2% and 91+/-3% after AVR; 97+/-2%, 97+/-3%, 90+/-3% and 86+/-7% after MVR; and 92+/-6%, 98+/-1%, 64+/-2% and 82+/-2% after DVR. Reoperation was required in 20 patients (due to valve thrombosis in six, endocarditis in five and periprosthetic leak in nine). At seven years, actuarial freedom from reoperation was 97+/-1%, 96+/-2% and 84+/-9% after AVR, MVR and DVR, respectively; actuarial freedom from endocarditis was 99+/-1%, 99+/-1% and 95+/-5%. Nine patients experienced a nonstructural valve dysfunction (all periprosthetic leak), while no cases of structural failure were observed. CONCLUSION: The Sorin Bicarbon prosthesis has shown good medium-term results with regard to clinical improvement, and low incidence of valve-related complications. Thus, it appears to be a reliable valve substitute when the use of a mechanical prosthesis is indicated.

Heparin-coated circuits for high-risk patients: a multicenter, prospective, randomized trial.

BACKGROUND: Heparin-coated circuits (HCCs) in low-risk cardiac patients who have coronary revascularization have a limited impact on postoperative outcome. In this prospective, randomized investigation, we studied high-risk patients who had cardiac operations with or without HCCs. METHODS: A total of 886 patients who had cardiac operations with cardiopulmonary bypass and at least one patient-related or procedure-related risk factor were enrolled in a multicenter study. They were randomly allocated to have cardiopulmonary bypass with Duraflo II HCCs (HCC group, n = 442) or conventional circuits (control group, n = 444). Postoperative outcome was investigated with respect to the occurrence of organ dysfunction. RESULTS: HCCs are associated with a shorter intensive care unit and postoperative hospital stay and with a lower rate of patients having a severely impaired clinical outcome (stay in intensive care unit for more than 5 days or death) (relative risk 0.66, p = 0.045). Lung dysfunction rate was significantly lower for the patients in HCC group affected by chronic obstructive pulmonary disease or who had mitral procedure (relative risk, respectively, 0.31, p = 0.018 and 0.05, p = 0.02). Renal dysfunction rate was significantly (p = 0.05) lower for diabetics in the HCC group (relative risk 0.28). CONCLUSIONS: When HCCs were used postoperative times decreased and they had a protective effect on lung and kidney function in high-risk patients.