Cardiac Valve Replacement Clinical Trial
Official title:
Medtronic's MOSAIC Bioprosthesis Versus Baxter Carpentier-Edwards SAV Porcine Valve: A Longterm Prospective Randomized Clinical Evaluation
The study compares the clinical performance of the Mosaic valve with that of the Baxter valve
(Carpentier-Edwards) which is widely used throughout the UK and is considered to be the
"bench mark".
Specific objectives will be to determine structural failure and valve explantation rates,
thromboembolic events and mortality rates for each valve.
Haemodynamic assessments will also be made using echocardiography to measure gradients across
the valves and changes in left ventricular function and wall thickness.
The bioprostheses (xenografts) to be used in this study are third generation valves derived
from porcine aortic valves. The chief advantage over mechanical prostheses is that they do
not require lifelong anticoagulation with warfarin with its attendant risks of haemorrhage if
the patient becomes over anticoagulated, or thromboembolism if anticoagulation is inadequate.
However their disadvantage is that they are prone to calcification and mechanical failure
over time. Because of this, bioprosthetic valves are usually reserved for older patients in
whom the chance of repeat surgery is reduced.
The Medtronic Mosaic stented bioprosthesis has been recently introduced. The Mosaic
bioprosthesis utilizes Physiological Fixation (root fixation with zero pressure differential
across the valve leaflets). This allows valves to maintain their natural leaflet structure
and root geometry. The Mosaic bioprosthesis uses the AOA anti-mineralisation treatment.
Developed in collaboration with Biomedical Design, Inc., AOA has been shown in multiple
animal studies to be an effective treatment in preventing leaflet calcification.
Baxter currently produces the Carpentier Edwards SAV porcine bioprosthesis that has abundant
long-term follow-up data and is widely used. Low pressure fixation (less than 1.5mmHg) and
anti-mineralisation treatment with FET 80TM are used in its preparation. The stent (which
supports the cusps) has been designed to allow for the wider opening angle of the softer
leaflets.
These features aim to improve on the haemodynamic performance of earlier generation valves
and offer the potential for increased durability. Early results look promising with excellent
haemodynamic parameters and remarkably low rates of structural failure.
If zero pressure fixation and anti-mineralisation treatment can be shown to increase the
longevity of the bioprosthetic valve, the age criteria for implantation will undoubtedly be
lowered allowing a younger cohort of patients to benefit from anticoagulation-free therapy
and freedom from associated morbidities.
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