This study evaluated the long-term clinical performance of the Mosaic bioprosthesis (Medtronic Inc, Minneapolis, MN) after aortic valve replacement.From 1995 to 2008, 178 patients (48 women; mean age, 74±6 years) had aortic valve replacement. Mean functional class was 2.3±0.5, and 157 patients (88\%) were in sinus rhythm. Prosthetic sizes were 23 mm in 98 patients and 25 mm in 66. Follow-up was completed in December 2009 with a cumulative duration of 1,015 patient/years (mean, 5.7±3.5 years, maximum, 13.7 years).Early mortality was 4\%, none being valve-related; of 38 late deaths 7 were valve-related. Actuarial survival at 13 years was 48\%±8\%. Mean functional class of current survivors was 1.2±0.6. Six embolic episodes occurred and four cases of endocarditis, with respective actuarial freedom of 92\%±5\% for embolism and 97\%±2\% for endocarditis at 13 years. Four patients required reoperations for endocarditis and 2 for structural deterioration. Actuarial freedom from structural deterioration and from reoperation for all causes was 89\%±7\% and 86\%±7\% at 13 years, with an actuarial freedom from prosthesis-related deaths of 86\%±5\%. Results of echocardiographic evaluation at 1 year were mean peak gradient, 20±6 mm Hg and mean effective orifice area index, 1.07±0.21 cm2/m2 for size 23 mm and 22±6 mm Hg and 1.11±0.26 cm2/m2 for size 25 mm; at 10 years, mean peak gradient and mean effective orifice area index were 28±13 mm Hg and 1.01±0.19 cm2/m2 for size 23 mm and 26±8 mm Hg and 1.08±0.18 cm2/m2 for size 25 mm.The Mosaic bioprosthesis showed good overall performance, with low incidence of structural valve deterioration and hemodynamic stability in the long-term. Expected increased durability of this device should be verified at longer follow-up intervals.
Aortic valve replacement with the medtronic mosaic bioprosthesis: a 13-year follow-up.
MILANO, Aldo Domenico;
2012-01-01
Abstract
This study evaluated the long-term clinical performance of the Mosaic bioprosthesis (Medtronic Inc, Minneapolis, MN) after aortic valve replacement.From 1995 to 2008, 178 patients (48 women; mean age, 74±6 years) had aortic valve replacement. Mean functional class was 2.3±0.5, and 157 patients (88\%) were in sinus rhythm. Prosthetic sizes were 23 mm in 98 patients and 25 mm in 66. Follow-up was completed in December 2009 with a cumulative duration of 1,015 patient/years (mean, 5.7±3.5 years, maximum, 13.7 years).Early mortality was 4\%, none being valve-related; of 38 late deaths 7 were valve-related. Actuarial survival at 13 years was 48\%±8\%. Mean functional class of current survivors was 1.2±0.6. Six embolic episodes occurred and four cases of endocarditis, with respective actuarial freedom of 92\%±5\% for embolism and 97\%±2\% for endocarditis at 13 years. Four patients required reoperations for endocarditis and 2 for structural deterioration. Actuarial freedom from structural deterioration and from reoperation for all causes was 89\%±7\% and 86\%±7\% at 13 years, with an actuarial freedom from prosthesis-related deaths of 86\%±5\%. Results of echocardiographic evaluation at 1 year were mean peak gradient, 20±6 mm Hg and mean effective orifice area index, 1.07±0.21 cm2/m2 for size 23 mm and 22±6 mm Hg and 1.11±0.26 cm2/m2 for size 25 mm; at 10 years, mean peak gradient and mean effective orifice area index were 28±13 mm Hg and 1.01±0.19 cm2/m2 for size 23 mm and 26±8 mm Hg and 1.08±0.18 cm2/m2 for size 25 mm.The Mosaic bioprosthesis showed good overall performance, with low incidence of structural valve deterioration and hemodynamic stability in the long-term. Expected increased durability of this device should be verified at longer follow-up intervals.
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