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(Circulation. 2007;116:I-307 – I-313.)
© 2007 American Heart Association, Inc.

Surgery for Valvular Heart Disease

Limited Long-Term Durability of the Cryolife O’Brien Stentless Porcine Xenograft Valve

Daisy Pavoni, MD; Luigi P. Badano, MD; Fabio Ius, MD; Enzo Mazzaro, MD; Romeo Frassani; Sandro Gelsomino, MD; Ugolino Livi, MD

From the Department of Cardiopulmonary Sciences (D.P., L.P.B., F.I., E.M., R.F., U.L.), Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia", Udine, Italy; and the Cardiovascular Surgery Unit (S.O.), "Careggi" Hospital, Florence, Italy.

Correspondence to Daisy Pavoni, Cardiology Unit, Echo-lab; Department of Cardiopulmonary Sciences, Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia", P.le S Maria della Misericordia 15, 33100 Udine, Italy. E-mail daisy_pav{at}libero.it

Background— Despite the fact that early and midterm hemodynamic and clinical results of the Cryolife O’Brien (CLOB) stentless valve have been reported to be favorable, the long-term durability and clinical results of this valve are largely unknown. Accordingly, we analyzed 10-year outcomes after aortic valve replacement with this valve.

Methods and Results— From January 1994 to September 2004, 185 patients (67, 73, and 75 years, 25th, 50th, and 75th quartiles, respectively; 38% older than 75 years; 56% females) underwent aortic valve replacement with the CLOB valve. Sixty-eight percent of patients were in NYHA class 3 to 4. Standard EuroSCORE was 7.1±2.7. Pure aortic stenosis accounted for 42% (n=79), and pure insufficiency for 12% of cases (n=22). Concomitant surgery: 28% coronary artery bypass (n=51), 11% mitral valve replacement/annuloplasty (n=21), and 2% ascending aorta replacement (n=3). Sixty-one percent of patients received a 23-mm valve or smaller size. Follow-up was 100% completed, and cumulative follow-up was 65 months/patient. The 30-day mortality was 5.4% (none were valve related). Actuarial survival at 5 and 10 years were 68% and 40%, respectively. Actuarial freedom from structural valve deterioration was 91% at 5 years and dropped to 44% at 10 years. Actuarial freedom from reoperation was 94% at 5 years and declined to 57% at 10 years.

Conclusions— In a population with a high prevalence of elderly females with small aortic root, the CLOB valve demonstrated satisfactory clinical results till 8-years. Afterward, a significant increase in hazard for structural valve deterioration and reoperation occurred in late follow-up.

Key Words: prostheses • follow-up studies • survival • valve surgery