Clinical results of the Medtronic Mosaic porcine bioprosthesis up to 13 years.
BACKGROUND
The Mosaic bioprosthesis is a third-generation stented porcine bioprosthesis combining physiologic fixation and alpha-amino oleic acid (AOA) antimineralisation treatment to improve haemodynamic performance and durability. This single-centre study reports the clinical results, including haemodynamic performance, of the Mosaic bioprosthesis after implant in aortic or mitral position.


METHODS
Between February 1994 and October 1999, 255 patients with aortic valve replacement (AVR; mean age: 67 years, range: 23-82 years) and 47 patients with mitral valve replacement (MVR; mean age: 67 years, range: 41-84 years) were enrolled in this prospective non-randomised clinical trial. Follow-up visits were performed 30 days and 6 months after implant and annually thereafter. The cumulative follow-up was 1976.2 patient-years (pt-yrs) after AVR (median: 8.3 years, maximum: 14.0 years) and 336.9 pt-yrs after mitral valve replacement (MVR) (median: 8.2 years, maximum: 13.3 years).


RESULTS
After AVR, mean systolic gradient and effective orifice area at 4, 8 and 13 years follow-up were 13.3+/-5.6, 15.5+/-7.7 and 16.0+/-7.2 mmHg and 1.8+/-0.5, 1.8+/-0.5 and 1.7+/-0.4 cm(2). After MVR, respective data were 4.7+/-2.1, 4.3+/-1.2 and 5.0 mmHg (only one recording) and 2.2+/-0.7, 2.3+/-0.6 and 1.8 cm(2). Transvalvular regurgitation at 13-year follow-up was mild or less in both the AVR and MVR patients. Thirteen-year survival was 63.1+/-4.5% in the AVR group and 51.2+/-13.6% in the MVR group. Early mortality after AVR and MVR was 1.2% and 0.0%, respectively; late mortality was 3.2%pt-yr(-1) and 3.3%pt-yr(-1), including a valve-related/unexplained mortality of 1.1%pt-yr(-1) and 0.9%pt-yr(-1). Freedom from adverse events in the AVR and MVR group was permanent neurological event: 97.4+/-1.2% and 96.0+/-3.9%; valvular thrombosis: 97.8+/-1.1% and 100%; structural valve deterioration: 84.8+/-7.8% and 93.8+/-6.1%; explant: 73.3+/-7.3% and 89.3+/-6.5%.


CONCLUSIONS
The Mosaic bioprosthesis demonstrates excellent clinical performance and safety after 13 years of follow-up. Continued follow-up will determine whether this new design will provide increased durability.
Riess
Friedrich-Christian
FC
Albertinen Heart Center, Department of Cardiac Surgery, Hamburg, Germany. Friedrich-Christian.Riess@albertinen.de
Cramer
Eva
E
Hansen
Lorenz
L
Schiffelers
Sandra
S
Wahl
Gunther
G
Wallrath
Jürgen
J
Winkel
Stephan
S
Kremer
Peter
P
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000627:therapeutic use; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000601:surgery*; D001705:Bioprosthesis; D004812:Epidemiologic Methods; D005260:Female; D006349:Heart Valve Diseases / Q000601:surgery*; D006350:Heart Valve Prosthesis / Q000009:adverse effects; D019918:Heart Valve Prosthesis Implantation / Q000379:methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000000981:diagnostic imaging / Q000601:surgery*; D011182:Postoperative Care / Q000379:methods; D011474:Prosthesis Design; D011475:Prosthesis Failure; D016896:Treatment Outcome; D014463:Ultrasonography; D055815:Young Adult
D000925:Anticoagulants