Long-term results with a stentless porcine aortic valve: the Edwards PRIMA model 2500

Abstract

Background and aim of the study: The study aim was to evaluate the very long-term patient survival, clinical and hemodynamic status after aortic valve replacement (AVR) with the Edwards PRIMA model 2500 stentless porcine aortic valve.

Methods: A cohort of 50 patients was prospectively followed between September 1991 and November 2006, with clinical evaluation and echocardiography. The mean patient age at implantation was 72.2 +/- 5.2 years, and the mean valve size 24 mm (range: 19-29 mm). Most patients were in NYHA class II or III before valve implantation.

Results: The early mortality was 4% (n=2). Early morbidity included two revisions for bleeding, and thromboembolic events in four patients. A total of 41 patients died during the follow up period; death was cardiac-related or sudden in 19 patients (40%) and undefined in seven (15%). Prosthetic valve endocarditis was diagnosed in five patients, and late thromboembolic events were reported in nine. Bioprosthesis explantation was performed in four patients because of severe structural valve deterioration (SVD). After 10 years, the aortic regurgitation (AR) was grade 1+ or 2+ in 12 of the 17 survivors (71%), and grade > or = 3+ in three (18%); at this time the effective orifice area was 1.81 +/- 0.59 cm2. After 12 years, the aortic regurgitation was grade 1+ or 2+ in two of seven survivors (28%), and grade > or = 3+ in four (57%). Survival of the patients did not differ significantly from that of an age-matched Belgian population.

Conclusion: Patient survival was comparable with that of an age-matched population after AVR with the Edwards PRIMA model 2500 valve. SVD was mainly characterized by the development of AR.