The mosaic valve clinical performance at seven years: results from a multicenter prospective clinical trial.
OBJECTIVE
The Mosaic valve is a third-generation stented porcine bioprosthesis built upon the historical durability of the Hancock II valve in an attempt to improve hemodynamic performance and durability.


METHODS
This multicenter trial was prospective and non-randomized in design. Between February 1994 and October 1999, six centers following a common study protocol enrolled 797 patients (mean age 70 years: range: 21-88 years) who underwent aortic valve replacement (AVR), and 232 patients (mean age 68 years; range: 17-84 years) who underwent mitral valve replacement (MVR). The cumulative follow up was 3,442 patient-years (pt-yr) for AVR (mean 4.3 years; maximum 8 years), and 870 pt-yr for MVR (mean 3.7 years; maximum 7 years). Follow up was complete for 95% of AVR patients, and for 97% of MVR patients.


RESULTS
The mean gradient and calculated effective orifice area average across all valve sizes remained stable at one, four and six years. Freedom from valve-related adverse events (mean +/- SE) at one, four and seven years after AVR were, respectively: Antithromboembolic-related hemorrhage (ARH) 97.0 +/- 0.6, 95.6 +/- 0.9, and 94.6 +/- 5.1%; primary hemolysis 100, 100, and 100%; and structural valve deterioration (SVD) 100, 100 and 100%. Freedom at one, four and seven years after MVR were: ARH 96.9 +/- 1.2, 95.6 +/- 2.0, and 95.6 +/- 7.6%; primary hemolysis 100, 100, and 100%; and SVD 100, 100, and 100%.


CONCLUSIONS
These mid-term results demonstrate the clinical safety and excellent performance of the Mosaic valve. Continued follow up will determine if this new-design, third-generation bioprosthesis will provide increased durability.
Fradet
Guy
G
Vancouver Hospital and Health Sciences Center, Vancouver, British Columbia, Canada. gfradet@interchange.ubc.ca
Bleese
Niels
N
Busse
Edward
E
Jamieson
Eric
E
Raudkivi
Peter
P
Goldstein
Jacob
J
Metras
Jacques
J
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery; D001705:Bioprosthesis / Q000009:adverse effects; D004869:Equipment Safety; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D005500:Follow-Up Studies; D006349:Heart Valve Diseases / Q000401:mortality / Q000601:surgery; D006350:Heart Valve Prosthesis / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000601:surgery; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011183:Postoperative Complications / Q000188:drug therapy / Q000209:etiology / Q000401:mortality; D011446:Prospective Studies; D011474:Prosthesis Design; D012720:Severity of Illness Index; D016019:Survival Analysis; D013995:Time; D016896:Treatment Outcome
D005343:Fibrinolytic Agents; D010975:Platelet Aggregation Inhibitors