Hemodynamic performance of the Medtronic Mosaic porcine bioprosthesis up to ten years.
BACKGROUND
The Mosaic bioprosthesis (Medtronic, Minneapolis, MN) is a third-generation stented porcine bioprosthesis combining physiologic fixation and amino oleic acid antimineralization treatment to improve hemodynamic performance and durability. The findings of this single-center experience with this valve were evaluated to determine the clinical and hemodynamic performance.


METHODS
Between February 1994 and October 1999, we enrolled 255 patients with aortic valve replacement (AVR) with a mean age of 67 years (range, 23 to 82 years) and 47 patients with mitral valve replacement (MVR) with a mean age of 67 years (range, 41 to 84 years) in this post-United States Food and Drug Administration approval prospective and nonrandomized clinical trial. Patients were followed-up, including serial echocardiographic assessment, within 30 days, at 6 months, and annually thereafter. The cumulative follow-up was 1540 patient-years for AVR (mean, 6.1 years; maximum, 10 years) and 250 patient-years for MVR (mean, 5.4 years, maximum; 10 years).


RESULTS
Early mortality after AVR (<30 days) was 0.8%; late mortality per patient-year was 3.5%, including a valve-related/unexplained mortality of 1.1%. Early mortality after MVR (<30 days) was 0.0%; late mortality per patient-year was 2.8%, including a valve-related/unexplained mortality of 1.2%. Median postoperative gradient and effective orifice area for all valves after AVR were (early, n = 252; 5 years, n = 161; 9 years, n = 43) 13.7, 12.3, and 11.7 mm Hg and 1.9, 1.8, and 1.8 cm2 at early, 5 years, and 9 years, respectively. With MVR respective data were (early, n = 46; 5 years, n = 25; 7 years, n = 13) 4.6, 4.1, and 3.9 mm Hg and 1.8, 2.2, and 2.3 cm2. At 10 years, freedom from adverse events in the AVR group and MVR group was, respectively, thromboembolism, 86.6% +/- 6.6% and 86.3% +/- 9.8%; permanent neurologic event, 91.2% +/- 6.8% and 90.9% +/- 8.7%; valve thrombosis, 98.2% +/- 0.8% and 100%; structural valve deterioration, 87.1% +/- 6.7% and 100%.


CONCLUSIONS
Our midterm results demonstrate clinical safety and good performance of the Mosaic bioprosthesis. Continued follow-up will determine if this new design will provide increased durability.
Riess
Friedrich-Christian
FC
Albertinen Heart Center, Hamburg, Germany. friedrich-christian.riess@albertinen.de
Bader
Ralf
R
Cramer
Eva
E
Hansen
Lorenz
L
Kleijnen
Bèr
B
Wahl
Gunther
G
Wallrath
Jürgen
J
Winkel
Stephan
S
Bleese
Niels
N
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D001021:Aortic Valve / Q000503:physiopathology / Q000601:surgery*; D001705:Bioprosthesis; D002302:Cardiac Output / Q000502:physiology; D015150:Echocardiography, Doppler; D005260:Female; D005500:Follow-Up Studies; D006349:Heart Valve Diseases / Q000000981:diagnostic imaging / Q000401:mortality* / Q000601:surgery*; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000503:physiopathology / Q000601:surgery*; D011182:Postoperative Care; D011183:Postoperative Complications; D011336:Probability; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D018570:Risk Assessment; D012720:Severity of Illness Index; D015996:Survival Rate; D013552:Swine; D016896:Treatment Outcome