The Mosaic porcine bioprosthesis: role of age on clinical performance in aortic position.
BACKGROUND
The Mosaic bioprosthesis is a third-generation stented porcine bioprosthesis combining physiologic fixation and α-amino oleic acid antimineralization treatment to improve durability and hemodynamic function. This single-center study reports on the performance of the Mosaic bioprosthesis in patients 65 years of age or less and patients older than 65 years at implantation.


METHODS
Between 1994 and 1999, 88 younger patients (mean age, 58 years) and 167 older patients (mean age, 72 years) were enrolled in this prospective nonrandomized clinical trial. Follow-up visits were performed after 30 days, 6 months, and annually. Cumulative follow-up was 751 patient-years in the younger group and 1223 patient-years in the older group.


RESULTS
Mean systolic gradient increased significantly to 17.0 and 14.7 mm Hg in younger and older patients, respectively, at their latest follow-up (P < .001). Effective orifice area values decreased significantly to 1.8 and 1.6 cm(2) (P < .001). Overall, effective orifice area values were significantly higher in younger patients (P < .001). Transvalvular regurgitation increased over time (P < .001) but remained mild or less in more than 95% of the patients. Freedom from adverse events at latest follow-up in younger and older patients, respectively, were as follows: structural valve deterioration, 85.7% and 86.2% (P < .05); endocarditis, 87.5% and 98.5% (P < .01); valvular thrombosis, 98.8% and 97.1% (not significant); and explantation, 68.9% and 77.9% (P < .01).


CONCLUSIONS
Hemodynamic performance is similar in both groups. In the younger patients the incidence of structural valve disease, endocarditis, valve-related reoperation, and explantation is higher. The incidence in structural valve deterioration in the younger patients tends to be similar or lower compared with that seen in the literature.
Riess
Friedrich-Christian
FC
Department of Cardiac Surgery, Albertinen Heart Center, Hamburg, Germany. Friedrich-Christian.Riess@albertinen.de
Bader
Ralf
R
Cramer
Eva
E
Hansen
Lorenz
L
Schiffelers
Sandra
S
Wallrath
Jürgen
J
Wahl
Gunter
G
D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D001022:Aortic Valve Insufficiency / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D001705:Bioprosthesis; D016009:Chi-Square Distribution; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D006439:Hemodynamics; D006801:Humans; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012086:Reoperation; D018570:Risk Assessment; D012307:Risk Factors; D013552:Swine; D013997:Time Factors; D016896:Treatment Outcome; D014463:Ultrasonography; D055815:Young Adult