Long-term results of aortic valve replacement with Edwards Prima Plus stentless bioprosthesis: eleven years' follow up

• Published in: The Journal of heart valve disease Vol. 15; no. 5; pp. 691 - 5; discussion 695
• Main Authors: Auriemma, Stefano, D'Onofrio, Augusto, Brunelli, Massimo, Magagna, Paolo, Paccanaro, Mariemma, Rulfo, Fanny, Fabbri, Alessandro
• Format: Journal Article
• Language: English
• Published: England 01-09-2006
• Subjects: Actuarial Analysis; Adult; Aged; Aged, 80 and over; Aneurysm, Dissecting - surgery; Aortic Aneurysm - surgery; Aortic Valve Insufficiency - surgery; Aortic Valve Stenosis - surgery; Bioprosthesis; Dilatation, Pathologic - surgery; Female; Follow-Up Studies; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation - instrumentation; Humans; Male; Middle Aged; Postoperative Complications - etiology; Postoperative Complications - surgery; Prosthesis Design; Reoperation; Severity of Illness Index; Survival Analysis; Time Factors; Treatment Outcome
• ISSN: 0966-8519

The Edwards Lifesciences Prima Plus stentless valve (ELSV) is a bioprosthesis manufactured from a porcine aortic root. The study aim was to evaluate late clinical outcomes after aortic valve replacement (AVR) with ELSV implanted as a miniroot in patients with aortic valve disease.
Between 1993 and 2004, 318 patients (232 males, 86 females; mean age 69 +/- 9 years; range: 37-83 years) underwent AVR with the ELSV. Preoperatively, 102 patients (32%), 162 (51%) and 54 (17%) were in NYHA classes I/II, III and IV, respectively. Aortic stenosis, aortic regurgitation and combined lesions were present in 124 patients (39%), 114 (36%) and 41 (13%), respectively. Twenty patients (6%) were referred for an acute aortic dissection, 20 (6%) for an aortic root aneurysm, and 139 (44%) had an associated aneurysmal dilatation of the ascending aorta. The ascending aorta was replaced in 159 patients (50%); aortic arch replacement was required in 10 (3%). Coronary artery bypass graft was performed in 86 patients (27%). The follow up was based on clinical data.
Operative mortality was 5% (n = 17). There were 49 late deaths (5.2%/pt-yr). Valve-related mortality occurred in 10 patients (1%/pt-yr). Actuarial survival at five and 10 years was 78% and 33%, respectively. Actuarial freedom from valve reoperation and structural valve deterioration at 10 years were 100% and 64%. Actuarial freedom from embolic events and endocarditis at 10 years were 84% and 81%, respectively.
The ELSV, when implanted as a miniroot, provided good early and long-term results in terms of survival and freedom from major complications.