AATS: American Association for Thoracic Surgery.
Watch the AATS Leadership Video
 
The Direct Flow Valve: First in Man Experience with a Repositionable and Retrievable Pericardial Valve for Percutaneous Aortic Valve Replacement
Hendrik Treede1, Jochen Schofer2, Thilo Tuebler2, Olaf Franzen1, Thomas Meinertz1, Reginald Low3, Steven F. Bolling4, Hermann Reichenspurner1; 1Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany; 2Hamburg University Cardiovascular Center, Hamburg, Germany; 3University of California Davis, Davis, CA; 4University of Michigan Hospital, Ann Arbor, MI
READER COMMENTS
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 flexibility 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 two sizes.
Methods: 31 patients were enrolled in this clinical trial. 9 patients were excluded due to excessive calcifications or other reasons. A total of 22 patients underwent percutaneous valve replacement. All patients had a high risk for operation (Mean Log. Euroscore 28±7%, mean STS score 24±9%). Mean pre-interventional gradients were 50±13 mmHg, mean aortic orifice area was 0.55±0.16cm2. The device was placed transfemoral 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 and then pulled against the aortic annulus. After inflation of the upper ring valve performance was controlled and eventual repositioning performed. Polymer media were infused in the rings once correct position was confirmed.
Results: Permanent implantation could be achieved in 20 of 22 patients with good hemodynamic result. Two patients had to be converted to surgical aortic valve replacement due to increased gradients caused by distortion of the prosthesis. Implanted valves showed a good post-procedural performance with a mean gradient of 14.7 mmHg (mean) and a mean orifice area of 1.53 cm2. 50% of patiens showed small paravalvular leaks without hemodynamic influence. 4 patients died due to intraprocdural septal rupture, pulmonary embolism, non device related myocardial infarction and decompensated congestive heart failure. One patient developed a major stroke, 3 patients underwent pacemaker implantation due to av-blockage. 13 patients showed no peri- or post-procedural complications.
Conclusion: The Direct Flow aortic valve prosthesis gives the operator unprecedented freedom of handling the device during implantation process. Despite the patients‘ high surgical risk profile, implantation without hemodynamic compromise during the procedure appears safe. The amount and distribution of leaflet and LVOT calcification impacts procedural outcome, therefore sufficient patient selection is crucial.
Back to 2009 Annual Meeting
Back to Program Outline
Back to Main Program
Policies | Find a Surgeon | About | Contact
We Model Excellence
 Follow AATS on Facebook
Copyright © American Association for Thoracic Surgery. All rights reserved.
Read the Privacy Policy.
IMPORTANT REMINDER: The preceding information is intended only to provide
general guidance and not as a definitive basis for diagnosis or treatment in any particular case.
It is very important that you consult a doctor about any specific medical problem or question.