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


METHODS
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.


RESULTS
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.


CONCLUSIONS
The ELSV, when implanted as a miniroot, provided good early and long-term results in terms of survival and freedom from major complications.
Auriemma
Stefano
S
Division of Cardiac Surgery San Bortolo Hospital, Vicenza, Italy. stefano.auriemma@tin.it
D'Onofrio
Augusto
A
Brunelli
Massimo
M
Magagna
Paolo
P
Paccanaro
Mariemma
M
Rulfo
Fanny
F
Fabbri
Alessandro
A
D000206:Actuarial Analysis; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000784:Aortic Dissection / Q000601:surgery; D001014:Aortic Aneurysm / Q000601:surgery; D001022:Aortic Valve Insufficiency / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000601:surgery*; D001705:Bioprosthesis; D004108:Dilatation, Pathologic / Q000601:surgery; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000209:etiology / Q000601:surgery; D011474:Prosthesis Design; D012086:Reoperation; D012720:Severity of Illness Index; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome