At the time of this writing, the V-Wave® Ventura® Interatrial Shunt system is an investigational device aiming to improve the quality of life (fewer symptoms, reduced hospital admissions, etc.) for patients with heart failure.
The shunt is hourglass-shaped with a nitinol frame deployed through the interatrial septum (IAS). After accessing the femoral vein, a right heart catheterization is performed to get baseline pressures. The Swan-Ganz catheter is then exchanged for an intracardiac echocardiography (ICE) catheter, and after heparin is administered, a transseptal puncture is created using fluoroscopy with ICE. The V-Wave shunt dilator/delivery sheath is passed through the transseptal puncture, the dilator removed, and the V-Wave shunt deployed. The device’s shape holds it in place as it straddles the IAS on both sides.
Left-sided heart failure is often associated with dilation of the left ventricle. This stretches apart the mitral valve annulus and tethers the chordae leading to mitral regurgitation and increased left atrial pressure (LAP). The V-Wave shunt aims to reduce the resulting left atrial pressure by acting as a “pop-off” valve. Due to the pressure gradient between the left atrium (high) and right atrium (low), blood is transferred across the shunt via a Venturi effect to the right heart, thereby decongesting the left atrium and pulmonary venous system.
Follow the RELIEVE-HF randomized controlled trial to learn more (ClinicalTrials.gov Identifier: NCT03499236).