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[Valvular replacement with the Bicarbon mechanical valve. Results after 7 years in 104 patients]
M Laali1, A Le Guyader, P Leprince
1Service de chirurgie thoracique et cardiovasculaire, Institut de cardiologie, groupe hospitalier La Pitié-La Salpêtrière, 47-83, bd de l'Hôpital, 75651 Paris.
Objective:
Study of the medium term results of aortic and mitral valve replacement with the Bicarbon' prosthesis.
Method:
From 1990 to 1996, 109 valves were implanted (70 in aortic position, 31 in mitral position and 4 double replacements). The average age was 61 years and 75% were male. According to the NYHA, 59% of patients were stage III or IV. The average pre-operative ejection fraction was 59.6%. There was re-intervention in 21.1% of patients and 35.3% had an associated procedure during the intervention.
Results:
The average follow up was 5.4 +/- 1.98 years in 98 patients (that is 522 patient years). One patient died post-operatively and 19 died later. The overall survival at 7 years was 69.4 +/- 6.3%. Complications, expressed in patient years, were 1.15% for thrombo-embolic complications, 2.1% for haemorrhagic complications. 0.38% for endocarditis, 1.72% for non-infectious peri-prosthetic leaks, and 0.76% for re-interventions. At 7 years, the absence of thrombo-embolic, haemorrhagic, endocarditis, and re-intervention complications was 91.8 +/- 4.2%, 85.3 +/- 4.8%, 95.8 +/- 3.2%, 93.8 +/- 3.5% respectively. According to the NYHA, 95% of patients were in stage 1 or II (p < 0.001).
Conclusion:
Valvular replacement in the aortic or mitral position with the Bicarbon' valve is satisfactory as much in terms of survival as of clinical complications.