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The Colibri heart valve (CHV) is a pre-mounted, pre-packaged, low-profile, ready-for-use dry TAVR valve with conical cusp design mounted upon a balloon-expandable delivery system encapsulated within within a 14 Fr sheath. Though dry at insertion, the membrane leaflets function immediately on deployment in the body.
The first-in-human use of the Colibri valve was conducted in the COSTAS safety and feasibility study initiated November 2012. Primary endpoints at 30 days included: successful valve implantation, valve performance including gradient, valve area, regurgitation/paravalvular leak (PVL), MACCE at 30 days. Five patients with severe aortic stenosis were enrolled and successfully implanted.
In all 5 cases there was successful delivery and deployment of a single device in the proper anatomical location and retrieval of the delivery system with immediate valve function on deployment. At 30 days aortic valve area ranged from 2.0 to 2.3 cm2 and one patient had mild PVL. There was no MACCE at 30 days. As we have previously reported, at one year there was one death at 4 months due to complications of urologic surgery and urosepsis. The remaining cohort had AVA of 1.8 to 2.2 cm2 and only none/trace PVL. We report the late outcome of these patients at 4.5 years. There were two additional deaths due to hypertensive crisis in one and to COPD exacerbation complicated by pneumonia in the other. There were no cardiac or valvular events. We will present the final echocardiographic performance measures of the surviving patients at the 5 year mark of the study.
In the first human cases of the Colibri pre-mounted dry valve technology, clinical outcome early and in late survivors showed sustained clinical benefits. Continuing development of the dry valve tissue technology in further generations incorporated advances including glutaraldehyde residuals of less than 1 ppm and improved flexibility. This tissue received FDA approval for soft tissue repair applications and was incorporated into the next generation CHV dry valve. We will report the early experience with the next generation Colibri pre-mounted, pre-packaged dry valve system.
STRUCTURAL: Valvular Disease: Aortic