Die hämodynamische und klinische Funktion der Medtronic Mosaic Bioprothese in Aortenposition
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vor 20 Jahren
Background: Study aim was to collect intermediate-term data of the
Mosaic bioprosthesis in aortic position after implanting the first
device worldwide in February 1994 in our hospital. Methods: The
Mosaic bioprosthesis is a stented porcine aortic valve, which
combines glutaraldehyde fixation with zero pressure and root
pressure techniques and antimineralization treatment with amino
oleic acid for improved hemodynamics and tissue durability.
Included in a multicenter study, 100 patients (49 females)
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%. Patients
were followed-up within 30 days postoperative, after six months and
at annual intervals. Mean follow-up was 3.8 years (range 0.1-7.1
years); total follow-up was 383.1 patient-years (pt-yr) and was
100% complete. Results: Early mortality (within 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 rates at seven years were 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
antithromboembolic hemorrhage, 98.9% ± 1.1% for endocarditis and
93.9 % ± 3.2% for reoperation and explant. Mean systolic pressure
gradient was 15.3 ± 6.7mmHg (21mm), 14.5 ± 5.7mmHg (23mm), 12.7 ±
4.1mmHg (25mm) and 13.0 ± 4.8mmHg (27mm) after one year; effective
orifice area was 1.4 ± 0.4cm2 (21mm), 1.7 ± 0.4cm2 (23mm), 1.8 ±
0.4cm2 (25mm) and 2.6 ± 0.4cm2 (27mm); effective orifice area index
was 0.8 ± 0.3cm2/m2 (21mm), 0.9 ± 0.2cm2/m2 (23mm), 0.9 ± 0.2cm2/m2
(25mm) and 1.3 ± 0.1cm2/m2 (27mm). Left ventricular mass index
decreased significantly from 159.7 ± 56.8g/m2 to 137.3 ± 40.8g/m2
for all sizes after one year. Conclusions: Clinical and hemodynamic
performance of the Mosaic bioprosthesis was highly satisfactory
during the first seven years after clinical introduction.
Mosaic bioprosthesis in aortic position after implanting the first
device worldwide in February 1994 in our hospital. Methods: The
Mosaic bioprosthesis is a stented porcine aortic valve, which
combines glutaraldehyde fixation with zero pressure and root
pressure techniques and antimineralization treatment with amino
oleic acid for improved hemodynamics and tissue durability.
Included in a multicenter study, 100 patients (49 females)
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%. Patients
were followed-up within 30 days postoperative, after six months and
at annual intervals. Mean follow-up was 3.8 years (range 0.1-7.1
years); total follow-up was 383.1 patient-years (pt-yr) and was
100% complete. Results: Early mortality (within 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 rates at seven years were 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
antithromboembolic hemorrhage, 98.9% ± 1.1% for endocarditis and
93.9 % ± 3.2% for reoperation and explant. Mean systolic pressure
gradient was 15.3 ± 6.7mmHg (21mm), 14.5 ± 5.7mmHg (23mm), 12.7 ±
4.1mmHg (25mm) and 13.0 ± 4.8mmHg (27mm) after one year; effective
orifice area was 1.4 ± 0.4cm2 (21mm), 1.7 ± 0.4cm2 (23mm), 1.8 ±
0.4cm2 (25mm) and 2.6 ± 0.4cm2 (27mm); effective orifice area index
was 0.8 ± 0.3cm2/m2 (21mm), 0.9 ± 0.2cm2/m2 (23mm), 0.9 ± 0.2cm2/m2
(25mm) and 1.3 ± 0.1cm2/m2 (27mm). Left ventricular mass index
decreased significantly from 159.7 ± 56.8g/m2 to 137.3 ± 40.8g/m2
for all sizes after one year. Conclusions: Clinical and hemodynamic
performance of the Mosaic bioprosthesis was highly satisfactory
during the first seven years after clinical introduction.
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