New Aortic Bioprosthesis Designed for Durability Makes Its U.S. Debut

Cleveland Clinic has performed some of the very first commercial U.S. implantations of the Inspiris Resilia aortic valve following the device’s FDA approval last year. The successful operations, performed in several patients in mid-January, follow Cleveland Clinic’s investigational use of the bovine pericardial bioprosthesis in numerous patients as part of the ongoing multicenter COMMENCE trial, whose two-year results formed the basis for FDA approval (see prior Consult QD post). Cleveland Clinic investigators plan to soon report three-year results of the COMMENCE trial, which remain positive.

“We are proud to be among the very first U.S. centers to offer this promising new bioprosthesis to appropriate surgical aortic valve replacement (AVR) patients outside of a research context,” says cardiothoracic surgeon Lars Svensson, MD, PhD, Chairman of Cleveland Clinic’s Miller Family Heart & Vascular Institute.

Dr. Svensson performed Cleveland Clinic’s first commercial implantations of the Inspiris Resilia device and is an investigator with COMMENCE. He says the new prosthesis is notable in several ways:

• Use of dry-storage technology developed at Cleveland Clinic. This aspect of the valve’s novel Resilia tissue technology makes transporting the valve less costly and may give it longer shelf life.
• New anti-calcification properties. These also derive from the valve’s Resilia tissue technology and involve additional steps to dehydrate the valve tissue and reduce fat content. The aim is to enhance durability relative to other bioprostheses. “If this valve resists deterioration over time, we see tremendous potential for its use in younger patients,” says Dr. Svensson.
• An expandable frame. This aspect, designed to enable pliability similar to that of the older Edwards model 2700 (Perimount) valve, promises enhanced potential to facilitate a later valve-in-valve transcatheter AVR procedure if needed. “Until now, this hasn’t been possible with the newer valves, which are more rigid,” Dr. Svensson explains.

That pliability enabled Dr. Svensson to combine use of the Inspiris prosthesis with placement of a composite valve graft in one of the cases he performed in mid-January — the first time the new prosthesis has been used in such a combination. The composite valve graft was needed to address an aortic root aneurysm with valve stenosis.

He notes that while this pliability and the resulting option for later valve-in-valve procedures is welcome, the new device’s greatest prospective benefit lies in its potential for longer durability relative to other bioprostheses. “If it is proven over the long term, it would be a game changer for younger patients,” he says.

On that score, the latest COMMENCE results — through three years of follow-up — remain encouraging. “The clinical outcomes and freedom from structural failures observed at two years have been maintained,” Dr. Svensson says.

Photo of Inspiris Resilia valve courtesy of Edwards Lifesciences.