Boston - American Association for Thoracic Surgery

AMERICAN ASSOCIATION FOR THORACIC SURGERYWEDNESDAY MORNINGMAY 13, 20097:00 a.m. EMERGING TECHNOLOGIES ANDTECHNIQUES FORUMBallroom A–C, Hynes Convention Center(5 Minutes Presentation, 7 Minutes Discussion)Moderators: Robert J. McKenna, Lars G. SvenssonT1. The Direct Flow Valve: First in Man Experience with aRepositionable and Retrievable Pericardial Valve forPercutaneous Aortic Valve ReplacementHendrik Treede, 1 Jochen Schofer, 2 Thilo Tuebler, 2 Olaf Franzen, 1Thomas Meinertz, 1 Reginald Low, 3 Steven F. Bolling, 4* Hermann Reichenspurner 1*1. Department of Cardiovascular Surgery, University Heart Center Hamburg,Hamburg, Germany; 2. Hamburg University Cardiovascular Center, Hamburg,Germany; 3. University of California Davis, Davis, CA, USA 4. University ofMichigan Hospital, Ann Arbor, MI, USAInvited Discussant: Tomislav MihaljevicOBJECTIVE: Percutaneous aortic valve replacement is a considerable alternativefor patients carrying a high risk for operation. The Direct Flow percutaneous aorticvalve is the first that is not based on stent technology. The stentless tissue valvewith bovine pericardial leaflets is connected to two inflatable rings showing a highflexibility 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 excludeddue to excessive calcifications or other reasons. A total of 22 patients underwentpercutaneous valve replacement. All patients had a high risk for operation (MeanLog. Euroscore 28 ± 7%, mean STS score 24 ± 9%). Mean pre-interventionalgradients were 50 ± 13 mmHg, mean aortic orifice area was 0.55 ± 0.16 cm 2 . Thedevice was placed transfemoral in the left ventricle by a flexible sheath underflouroscopic control. The lower ring was inflated and the valve was positioned inthe LV outflow tract and then pulled against the aortic annulus. After inflation ofthe upper ring valve performance was controlled and eventual repositioningperformed. Polymer media were infused in the rings once correct position wasconfirmed.WEDNESDAYMorning* AATS Member197