Two-Part Heart Valve System Restores Active Lifestyle

The ValveXchange Vitality two-part valve system is comprised of a permanently implanted base and an easily replaceable leaflet set, which is designed to be accessed transapically, via a small incision between the ribs and thus not requiring any future open-heart surgeries. The leaflets are made from chemically preserved bovine pericardium, delivered in a collapsed state and subsequently expanded and seated in the permanent docking station; they can be recollapsed when replacement is required. The exchangeable components collapse into a size small enough to be inserted and removed through an incision in the heart, without requiring the patient to be placed on a cardiopulmonary bypass.

The exchange procedure is designed to be performed using a range of approaches, from open surgical to minimally invasive, to off-pump transapical, depending on the clinical indication of the patient and physician recommendation. The exchange tools, which include a valve stabilizer, a valve removal tool, and a valve insertion tool, are scalable between the surgical and transapical approaches, and robust enough to extract the leaflet set regardless of the degree of fibrotic overgrowth. All three tools nest within each other coaxially so that once one tool is aligned to the stent posts, all others become aligned also. The valve stabilizer grabs onto the docking station and the extraction tool grabs onto the exchangeable leaflet set; force is then applied between the two tools to pull the leaflet set off the docking station. The ValveXchange Vitality two-part valve system is a product of ValveXchange (Denver, CO, USA).

The first in man (FIM) surgeries of the Vitality two-part heart valve system were performed in Asuncion (Paraguay), during September 2011. Three men aged 49, 62, and 72 received the heart valves, and all have been discharged and are recovering normally.

Heart muscle is more friable and tears along natural cleavage planes; if a slit is made in the myocardium, it begins to tear away from the edge of the incision. The transapical approach is used to safely access the interior of the heart by using a circular cutter to create a round access port. First, a sewing cuff is first sutured onto the heart, using deep interrupted sutures; a coring device is then inserted to cut the access port. The sewing cuff acts as a stress relief and the circular hole prevents crack propagation and tearing, protecting the integrity of the heart muscle and avoids the tearing of the heart muscle. After the procedure, the cuff is folded over, cut, and sutured to the myocardium without pulling on any of the original sutures out of the cuff. The hole that was cut in the muscle tissue remains protected until it heals and fills with scar tissue.

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