Seven-year performance of the Edwards Prima Plus stentless valve with the intact non-coronary sinus technique

OBJECTIVES: Late results after stentless aortic valve replacement (AVR) may be jeopardized by progressive aortic dilatation. To define functional outcome using the intact non-coronary sinus technique, all patients operated using the stentless Edwards Prima Plus xenograft were assessed. METHODS: Between January 2000 and August 2007, 154 patients, aged 71 +/- 9 years, underwent stentless AVR using a technique, which replaces the non-coronary sinus and stabilizes two of three commissures. Indication was aortic valve stenosis (AS) in 103 (67%) patients: 33 (21%) had bicuspid valve and four endocarditis. Ninety-six (62%) patients were in NYHA III-IV, and 13 (8%) had LVEF <30%. Associated procedures were required in 59 (38%) patients (CABG, 34; ascending aorta, 22; others 3). Study endpoints were survival, freedom from valve-related events, clinical status, and graft function. RESULTS: There were two hospital and two late deaths during a 48 +/- 19 months (1-92) follow-up (97 +/- 3% survival at seven years). Seven-year freedom from structural failure, nonstructural failure, and endocarditis was 99 +/- 1%, 97 +/- 3%, and 98 +/- 2%. Follow-up NYHA (96 vs ten patients in class III-IV, p = 0.001), and cardiac function (13 vs one patient with LVEF <30%, p = 0.02) were improved. Xenograft performance was satisfactory: 0-2 + aortic insufficiency (AI) in 147 (98%) patients, mean trans-prosthetic pressure gradient 8 +/- 4 (0-25 mmHg). Aortic root diameters were comparable to postoperative values (sinus of Valsalva, 36 +/- 8 vs 35 +/- 9 mm, p = ns; sinotubular junction, 32 +/- 7 vs 34 +/- 8 mm, p = ns). CONCLUSIONS: Stentless AVR with non-coronary sinus replacement affords excellent late outcome and low rate of valve-related events, even in complex patients (bicuspid valve, LV failure, and endocarditis). Aortic root dimensions remain stable over time allowing rewarding xenograft function.