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Updated: Jul 20, 2026
12:17
Full-root Aortic Valve Replacement by Stentless Aortic Xenografts in Patients with Small Aortic Roots
Published on: May 21, 2017
[Early single-center experience with the 3F-enable aortic valve bioprosthesis]
Rainer Leyh1, Chagatay Yildirim, Thomas Buck
1Abteilung für Thorax- und Kardiovaskuläre Chirurgie, Westdeutsches Herzzentrum, Universitätsklinikum Essen, Essen. rainer.leyh@uniduisburg-essen.de
Herz
|September 1, 2006
Summary
The novel 3F-Enable sutureless aortic valve (AV) prosthesis shows feasibility in early clinical use. However, further enhancements are needed to address paravalvular leakage in patients undergoing AV repair.
Area of Science:
- Cardiovascular Surgery
- Medical Devices
- Prosthetic Heart Valves
Background:
- Severe comorbidities necessitate reduced myocardial ischemic and extracorporeal circulation (ECC) times during aortic valve (AV) pathology treatment.
- Sutureless AV prosthesis implantation offers a potential method to significantly decrease these critical surgical times.
Purpose of the Study:
- To report preliminary findings from the initial clinical applications of the 3F-Enable sutureless AV prosthesis.
- To evaluate the feasibility and early outcomes of this novel sutureless AV device.
Main Methods:
- The 3F-Enable prosthesis was surgically implanted in a cohort of five patients.
- Echocardiographic assessments were performed intraoperatively, at discharge, and at 3 and 6 months postoperatively to evaluate prosthesis function.
Main Results:
- Mean ECC time was 87 minutes, myocardial ischemic time was 55 minutes, and AV implant time averaged 184 seconds.
- Postoperative echocardiography revealed a fully competent AV in three patients; however, two patients experienced paravalvular leakage (AR II-III degrees).
- Mean transvalvular pressure gradients were 5.8 mmHg, with a valve orifice area of 3.2 cm2.
Conclusions:
- The initial clinical results suggest the 3F-Enable sutureless AV prosthesis is feasible.
- A significant rate of paravalvular leakage (40%) was observed, indicating a need for device and procedural improvements for secure prosthesis positioning and anchoring.
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