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J Thorac Cardiovasc Surg. 2010 Oct;140(4):897-903. doi: 10.1016/j.jtcvs.2010.01.017. Epub 2010 Apr 14.

Six-month results of a repositionable and retrievable pericardial valve for transcatheter aortic valve replacement: the Direct Flow Medical aortic valve.

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  • 1Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany. treede@uke.de



Transcatheter aortic valve implantation is considered an alternative for patients at high risk for conventional surgery. The Direct Flow Medical aortic valve (Direct Flow Medical, Inc, Santa Rosa, Calif) is a nonmetallic tissue valve prosthesis intended to treat patients with severe aortic stenosis at high risk for surgery.


Thirty-one patients at high surgical risk were enrolled in the trial (logistic EuroSCORE 28% ± 7%, Society of Thoracic Surgeons score 23% ± 9%). Twenty-two patients underwent successful retrograde transcatheter aortic valve implantation, and 9 patients did not undergo implantation owing to excessive calcifications or access issues. Mean preinterventional gradient and effective orifice area were 49 ± 14 mm Hg and 0.54 ± 0.16 cm(2), respectively, and 71% of patients were in New York Heart Association functional class III.


Mean postprocedural gradient was 14.9 ± 5.5 mm Hg with an effective orifice area of 1.4 ± 0.31 cm(2). Two patients were converted to surgery and 2 patients died after implantation: 1 of myocardial infarction and 1 of congestive heart failure. One patient had a stroke 2 days after the procedure and 3 patients required a pacemaker. At 6 months the mean aortic valve gradient and effective orifice area were 19.8 mm Hg and 1.30 cm(2), respectively. The majority of patients had no paravalvular leak (58%) and 42% had grade 1/4 paravalvular leak; 69% were in New York Heart Association functional class I and 25% were in class II. The 3- and 6-month survivals were 87.1% and 80.6%, respectively (4/6 deaths in 31 patients).


Transcatheter aortic valve implantation using the study valve appears safe and results are promising at 6 months. Severe leaflet and left ventricular outflow tract calcification affects procedural outcome; therefore, careful patient selection is crucial.

Copyright © 2010 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

[PubMed - indexed for MEDLINE]
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