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Background and Aim of the Study: The Mosaic bioprosthesis is a stented porcine aortic valve, which combines glutaraldehyde fixation with zero-pressure and root-pressure techniques and anti-mineralization treatment with amino-oleic acid for improved hemodynamics and tissue durability. The study aim was to collect intermediate-term data of the Mosaic bioprosthesis in the aortic position, the first device having been implanted in February 1994 at the authors' institution., Methods: A total of 100 patients (49 females, 51 males) underwent aortic valve replacement with the Mosaic bioprosthesis between February 1994 and May 1999. Mean age at implant was 73.4 +/- 7.3 years. Concomitant procedures were performed in 40.0% of cases. Patients were followed up within 30 days postoperatively, after six months, and at annual intervals thereafter. Mean follow up was 3.8 years (range: 0.1-7.1 years); total follow up was 383.1 patient-years (pt-yr) and 100% complete., Results: Early mortality (< or = 30 days) was 3.0%; late mortality was 4.6%/pt-yr, including a valve-related mortality of 0.6%/pt-yr. Freedom from event at seven years was 96.8 +/- 1.8% for thromboembolic events, 97.2 +/- 2.0% for thrombosed bioprosthesis, 96.6 +/- 2.6% for structural valve deterioration, 98.2 +/- 1.8% for nonstructural dysfunction, 95.9 +/- 2.0% for anti-thromboembolic hemorrhage, 98.9 +/- 1.1% for endocarditis, and 93.9 +/- 3.2% for reoperation/explant. After one year, the mean systolic pressure gradient was 15.3 +/- 6.7, 14.5 +/- 5.7, 12.7 +/- 4.1 and 12.9 +/- 4.8 mmHg for 21, 23, 25 and 27 mm valves respectively; the effective orifice area (EOA) was 1.4 +/- 0.4, 1.7 +/- 0.4, 1.8 +/- 0.4 and 2.6 +/- 0.4 cm2 for 21, 23, 25 and 27 mm valves respectively; and the EOA index was 0.8 +/- 0.3, 0.9 +/- 0.2, 0.9 +/- 0.2 and 1.3 +/- 0.1 cm2/m2 respectively. The mean left ventricular mass index was decreased significantly, from 159.7 +/- 56.8 g/m2 to 137.3 +/- 40.8 g/m2, for all valve sizes after one year., Conclusion: Clinical and hemodynamic performance of the Mosaic bioprosthesis was highly satisfactory during the first seven years after clinical introduction.

Background and Aims of the Study: The study aim was to evaluate the hemodynamic performance and extent of left ventricular (LV) mass regression after aortic valve replacement (AVR) with the Mosaic bioprosthesis within the first postoperative year., Methods: Between 1994 and 1999, 366 patients (203 males, 163 females) underwent AVR with the Mosaic bioprosthesis at five centers in Europe. Mean age at implant was 71.1 years (range: 34.5-86.8 years). LV mass assessment and hemodynamic evaluation were performed using transthoracic echocardiography within six days postoperatively, after six months, and at annual intervals thereafter., Results: LV mass index decreased significantly in patients with valve sizes 21 to 27 mm, from 184.4+/-56.2 g/m2 postoperatively to 157.3+/-45.5 g/m2 after one year (14.7% decrease). The 19-mm valve group did not show significant LV mass index reduction (from 210.4+/-39.4 to 195.0+/-59.4 g/m2; 7.3%). Patients with significant LV mass index regression had survival benefits after seven years. Mean pressure gradients after one year were 16.0+/-4.3, 14.2+/-5.4, 12.8+/-5.3, 11.1+/-4.0 and 10.5+/-3.7 mmHg for 19, 21, 23, 25 and 27 mm valves, respectively., Conclusion: Implantation of the Mosaic bioprosthesis resulted in a significant regression of LV mass for the valves sizes 21 to 27 mm, corresponding to very low pressure gradients for a stented bioprosthesis.