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.