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Midterm Results Of Early Feasibility Clinical Study (EFS) Of A Regenerative ECM Tricuspid Valve
Marc W. Gerdisch1, Doug Boyd2.
1Franciscan Health Heart Center, Indiannapolis, IN, USA, 2East Carolina University Heart Institute, Greenville, NC, USA.

OBJECTIVE: Previous animal studies have demonstrated the regenerative potential of an ECM (Extra-Cellular Matrix) cylindrical valve in the tricuspid atrio-ventricular (AV) position. The objective of this EFS clinical study was to evaluate the safety of this design in human subjects while allowing for design and protocol changes as needed during the study.
METHODS: The EFS Protocol called for the recruitment of 30 patients in need of surgical replacement of a diseased tricuspid valve regardless of etiology. The study was multicenter, enrolling at 9 sites, and prospective open label. Each site required surgeon training prior to valve implantation and IRB approval. Follow-up consisted of transthoracic echocardiograms at hospital discharge, one month, 6 months, one year, and annually thereafter. Redacted echocardiograms were sent to an independent core lab.
RESULTS: Thirty adult patients were consented, 27 of whom underwent valve replacement using the study device. Average follow up is 18 months, range 7 to 32 months. The etiology of the native valve pathology included endocarditis (17), congenital (2), traumatic (2), functional (3), and other (3). In 9 patients, the ECM valves required replacement during the follow up period, 5 for recurrent endocarditis related to illicit drug use recidivism, and 4 for pull-out from papillary attachment. Gradients across the neo-valves averaged 2-3 mmHg; all valves had none, trivial, or mild regurgitation at one year except 2 that were moderate. There were no deaths. One minor paravalvular leak was identified. Histology will be presented.
CONCLUSIONS: The EFS demonstrates the feasibility of the clinical application of a remodeling AV cylinder valve. The ECM valve design has been modified to mitigate papillary detachment during the remodeling phase. Recurrent drug use remains a critical problem for patients presenting with endocarditis secondary to drug abuse.


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