Hendrik Treede1, Joachim Schofer2, Thilo Tübler2, Olaf Franzen1, Thomas Meinertz1, Steven F. Bolling3, Hermann Reichenspurner1.
1University Heart Center Hamburg, Hamburg, Germany, 2Hamburg University Cardiovascular Center, Hamburg, Germany, 3University of Michigan Hospital, Ann Arbor, MI, USA.
OBJECTIVE:
Percutaneous aortic valve replacement is a considerable alternative for patients carrying a high risk for operation. The Direct Flow percutaneous aortic valve is the first that is not based on stent technology. The stentless tissue valve with bovine pericardial leaflets is connected to two inflatable rings showing a high flexibiliy and deliverability. It is immediately competent upon initial inflation. Implantation does not require rapid pacing or cardiac support. The valve is repositionable, retrievable and available in multiple sizes.
METHODS:
Four patients underwent percutaneous valve replacement using the Direct Flow valve. All patients had a high risk for operation (Euroscore>20). The Device was placed in the left ventricle by a flexible sheath under flouroscopic control. The lower ring was inflated and the valve was positioned in the LV outflow tract against the aortic annulus using control wires. After inflation of the upper ring valve performace was controlled and eventual repositioning performed. Polymer media were infused in the rings once correct position was confirmed.
RESULTS:
Procedure was successfull in three of four patients. In one patient the valve could not be correctly positioned due to extreme calcifications of the native aortic valve. The valve was removed and the the patient underwent successfull operation a week later without complications. Implanted valves showed a good postprocedural performance with a mean peak gradient of 26 mmHg and a mean orifice area of 1.8 cm2. In one patient a small paravalvular leak of < 1° was seen. Patients showed no peri- or postprocedural complications and were discharged from hospital with five days.
CONCLUSIONS:
Percutaneous aortic valve replacement using the Direct Flow Valve is safe and efficative in patients with a high operative risk. In contrast to other devices the valve is repositionable and retrievable. The neurologic risk of the procedure is low due to the high flexibility of the valve and the delivery system.
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