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Published on: May 23, 2025
Clinical experience with the ATS 3f Enable® Sutureless Bioprosthesis
Sven Martens1, Jerzy Sadowski, Friedrich S Eckstein
1Department for Thoracic and Cardiovascular Surgery, Johann Wolfgang Goethe University, Frankfurt, Germany. martens.herz@gmx.de
Summary
The ATS 3f Enable Bioprosthesis demonstrated safe and effective midterm outcomes for aortic valve replacement, showing excellent hemodynamics and significant clinical improvement in patients. This sutureless valve offers a viable option for aortic valve procedures.
Area of Science:
- Cardiovascular Surgery
- Biomaterials Science
- Medical Devices
Background:
- The ATS 3f Enable Bioprosthesis is a self-expanding, stented bioprosthesis designed for aortic valve replacement.
- Its tubular design aims to reduce leaflet stress and preserve aortic sinuses.
Purpose of the Study:
- To evaluate the midterm safety and efficacy of the ATS 3f Enable Bioprosthesis.
- To assess clinical outcomes in patients undergoing isolated aortic valve replacement.
Main Methods:
- A prospective, multicenter clinical study involving 140 patients.
- Patients received the ATS 3f Enable Bioprosthesis between March 2007 and December 2009.
- Total follow-up was 121.8 patient-years.
Main Results:
- Significant improvement in patient symptoms and excellent hemodynamics (mean gradient 8.6-9.0 mmHg, effective orifice area 1.67-1.69 cm²).
- Low rates of early complications: 2.1% paravalvular leaks (PVL) and 0.7% thrombo-embolic events.
- Late adverse events included 2.5% explantations per patient-year (due to PVL and endocarditis) and 0.8% endocarditis per patient-year (medically managed). No structural deterioration, thrombosis, or hemolysis observed.
Conclusions:
- Sutureless valve implantation with the ATS 3f Enable Bioprosthesis is feasible and safe.
- The bioprosthesis provides excellent hemodynamics and significant clinical benefits.
- Confirms the safety and clinical utility for aortic valve replacement.