Original articleAdult cardiacUnited States Feasibility Study of Transcatheter Insertion of a Stented Aortic Valve by the Left Ventricular Apex
Section snippets
Patients and Methods
Food and Drug Administration approval was obtained in November 2006 for a TA-AVI feasibility study in the US for the study of 20 patients. Subsequently, in October 2007, a further 20 TA-AVI patients were approved for additional inclusion in the feasibility study. The FDA-approved protocol was ratified by the Institutional Review Boards of the participating hospitals, and the first patients underwent study on 4 December 2006. To be included, patients were required to be 70 years of age or older,
Results
In the 40 TA-AVI patients, crossing the aortic valve and deployment was successful in all patients and seating of the valve was successful in all but four patients. In three patients the valve embolized, and in one patient the valve migrated during CPR.
In one patient, in whom the cine was automatically switched off and failed during the critical moment of deployment, the valve embolized distally shortly after deployment. Retrospective analysis revealed the valve became displaced during breath
Comment
Severe comorbid disease and technical reasons, making patients largely inoperable or extremely high risk, has prevented many patients from undergoing aortic valve replacement to improve both quality and duration of life [1, 2, 3, 4, 5]. Indeed, approximately two thirds of these symptomatic patients are likely to die within one year [1, 2, 3, 4, 5]. This early study of a new innovative technology clearly shows TA-AVI is both feasible and durable out to 6 months and may offer an alternative
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