Objectives: To evaluate the very long term patient survival, clinical and hemodynamic status after aortic valve replacement with the Stentless Porcine Aortic Valve (Edwards Prima).
Methods: A cohort of 50 patients was prospectively followed from September 1991 until November 2006, with yearly clinical evaluation and echocardiography. Age at implantation was 72,2 ± 5,2 years. Mean valve size was 24 mm (range 19-29). Most patients were in New York Heart Association class II or III before implantation.
Results: Early mortality was 4% (2 patients). Early morbidity included 2 revisions for bleeding and thromboembolic events in 4 patients. 41 patients died during follow-up which was cardiac-related or sudden in 19 patients (40%) and undefined in 7 (15%) cases. Prosthetic valve endocarditis was diagnosed in 5 patients and late thromboembolic events were reported in 9 patients. Bioprosthesis explantation was performed in 4 patients because of severe structural deterioration. At 10 years aortic regurgitation was 1+ or 2+ in 12 (71%) and 3+ or more in 3 (18%) of the 17 survivors. At that time the effective orifice area was 1,81 ± 0,59cm2. After 12 years aortic regurgitation was 1+ or 2+ in 2 (28%) and 3+ or more in 4 (57%) of 7 patients. Survival did not differ significantly from an age-matched Belgian population.
Conclusions: Patient survival is comparable with an age-matched population after aortic valve replacement with the Stentless Porcine Aortic Valve (PRIMA). Structural valve deterioration is mainly characterized by development of aortic regurgitation.
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