Rapid Deployment Device Streamlines Aortic Valve Replacement

An innovative rapid deployment system facilitates minimally invasive aortic valve replacement (AVR) procedures.

The Edwards Intuity Elite Valve System is a bovine pericardial heart valve based on the Carpentier-Edwards Perimount design, and features an innovative, balloon-expandable frame designed to facilitate rapid annular placement and a rapid deployment delivery system for easier access and visibility through smaller incisions. The system can also reduce the time it takes to cross-clamp the aorta, as well as the amount of time spent under cardiopulmonary bypass, thus improving patient safety and outcomes and leading to shorter recovery times.

The replacement valve is constructed with an Elgiloy stent at the orifice and commissures for flexibility, and has an incomplete supra-annular configuration with an intra-annular component. The pericardium tissue is fixed by a stress-free process using glutaraldehyde. Data from an 839-patient trial that took place in 29 centers across the United States showed that one year post-procedure, the system was safe and effective. The Edwards Intuity Elite Valve System is a product of Edwards Lifesciences (Irvine, CA, USA), and has been approved by the U.S. Food and Drug Administration (FDA).

“Many patients with aortic stenosis have more than one type of heart disease, most commonly coronary artery disease,” said Kevin Accola, MD, program director at the Florida Hospital Cardiovascular Institute Valve Center for Excellence (Orlando, FL, USA). “The Edwards Intuity Elite valve system enables surgeons to streamline concomitant procedures, which can be beneficial for patients undergoing these longer, more complex surgeries.”

“Patients request less invasive surgical options, and the Edwards Intuity Elite valve system meets this need by facilitating multiple approaches to minimally invasive operations, which can mean less trauma, early recovery, and decreased need for blood transfusions for many patients,” said Mubashir Mumtaz, MD, chief of cardiothoracic surgery and surgical director of the structural heart program at Pinnacle Health (Harrisburg, PA, USA).

The Carpentier-Edwards Perimount heart valve design mounts matched leaflets under the flexible stent, thus minimizing commissural stress points. The leaflets are produced by computer-aided design (CAD) for optimal leaflet to stent matching, using tissue deflection testing that enables the leaflets to be matched accurately.

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