Early and midterm results of model 300 CryoLife O'Brien stentless porcine aortic bioprosthesis.

ABSTRACT

BACKGROUND: The Cryolife O'Brien (CLOB) is a composite stentless bioprosthesis constructed from noncoronary leaflets of three porcine aortic valves. This study aimed to investigate early and midterm results after aortic valve replacement with CLOB xenograft. METHODS: Between 1993 and 2000, the CLOB was implanted in 125 patients (62 men; mean age 71.3+/-6.4 years). Mean prosthesis size was 23.6+/-2 mm. Mean follow-up time was 37.0+/-12.1 months. Patients underwent echocardiographic studies preoperatively, at discharge, at 6 and 12 months postoperatively, and yearly thereafter. RESULTS: Early (30-day) mortality rate was 2.4% (3 of 125 patients). Of the four late deaths, none was valve related. Actuarial 7-year survival was 93.6%+/-3%. Seven-year freedom from primary valve failure was 98.1%+/-1.8%. All patients showed an improvement of functional status (p < 0.001). ANOVA revealed a significant reduction over time in peak and mean systolic gradients (p < 0.001). Effective orifice area index increased (p < 0.001) and left ventricular mass index significantly reduced in all valve sizes (p < 0.001) during this time interval. CONCLUSIONS: Because the early and midterm results with CLOB xenograft have been satisfactory, we encourage its use as a valve substitute, particularly in patients with small aortic roots.