Sodium Chloride/Potassium Chloride/Calcium Chloride Hydrate/Magnesium Chloride/Sodium Bicarbonate/Sodium Citrate Hydrate

To present the results of a 15-year follow-up of the Sorin Bicarbon prosthesis (SBP) from a European multicentre study.

From 1990 to 1996, a total of 1900 SBPs were implanted in 1704 patients, with a mean age of 59±13 years, as aortic (AVR, 922 patients), mitral (MVR, 586) or mitro-aortic (DVR, 196) valve replacement. Most patients received an SBP for rheumatic or degenerative valve disease. Concomitant procedures were performed in 25% of cases, mainly coronary artery bypass grafting (14%) or tricuspid annuloplasty (7%).

There were 70 (4.1%) early deaths. Actuarial survival at 15 years is 61.4% (95% confidence interval (CI): 56.4-66.0) for AVR, 63.4% (59.1-67.5) for MVR, 56.4% (47.3-64.6) for DVR. Late valve-related deaths were 260 with an actuarial freedom from valve-related deaths at 15 years of 76.4% (81.5-83.7). There were 27 cases of SBP thrombosis with an actuarial freedom from this complication at 15 years of 99.6% (98.6-99.9) after AVR, 95.8% (93.0-97.5) after MVR and 97.0% (92.8-98.7) after DVR. Thrombo-embolic episodes were 159; actuarial freedom from thrombo-embolism at 15 years is 88.8% (86.8-90.5). Haemorrhages related to anticoagulant treatment occurred in 293 cases with 39 fatal episodes; actuarial freedom at 15 years is 77.5% (74.2-80.4). There were 45 episodes of endocarditis, 21 required re-operation; actuarial freedom from endocarditis at 15 years is 96.8% (95.6-97.7). Re-operation was performed in 71 patients (non-structural valve deterioration in 28, endocarditis in 21, SBP thrombosis in 15 and non-valve-related causes in seven patients). No cases of structural failure were observed. Actuarial freedom from re-operation at 15 years is 97.6% (96.3-98.5) after AVR, 92.8% (90.1-94.8) after MVR and 90.7% (85.2-94.2) after DVR.

The SBP continues to perform satisfactorily even in the long term with low incidence of valve-related mortality and morbidity confirming to be an extremely reliable and durable mechanical valve substitute.

Sorin Bicarbon (SB) and Edwards Mira (EM) valves have an identical mechanical design but different sewing cuffs. The purpose of this retrospective study was to analyze the long-term clinical and echocardiographic outcomes after mitral valve replacement with these two valves in a combined population of patients.

We retrospectively reviewed records of 73 patients who underwent mitral valve replacement using SB (n = 19) or EM (n = 54) valves. Preoperatively, 49 patients (68.1%) were in New York Heart Association (NYHA) functional class III or IV. Concomitant procedures were performed in 52 patients (71.2%). Early and late postoperative echocardiography was performed in 69 and 57 patients, respectively.

Operative mortality was 4.1%, and early morbidity was 9.6%. Overall patient survival at 9 years was 85.1% +/- 4.8%. Actuarial freedom from valve-related death was 95.4% +/- 2.6% at 9 years. As shown by Doppler echocardiography, the early and late mean transprosthetic pressure gradients were 3.4 +/- 1.4 mmHg and 3.8 +/- 2.1 mmHg, respectively. At the end of follow-up, 98.4% of survivors were in NYHA class I or II.

The Sorin Bicarbon and, Edwards Mira mechanical valves in the mitral position provide satisfactory long-term clinical and echocardiographic performance.