Transcatheter Aortic Valve Implantation for Failed Surgical Aortic Bioprostheses using a Self-Expanding Device (From the Prospective VIVA Post Market Study).
Patients with symptomatic aortic stenosis are often treated with a surgical valve replacement. Surgical bioprosthetic valves degenerate overtime and therefore may require a redo surgery. This analysis reports the 2-year clinical outcomes of the Valve-in-Valve (VIVA) study which evaluated transcatheter aortic valve implantation (TAVI) using the CoreValve and Evolut R devices in patients with degenerated surgical aortic bioprostheses at high risk for surgery. The prospective VIVA study enrolled 202 eligible patients with failing surgical aortic bioprostheses due to stenosis, regurgitation or a combination of both. The Evolut R bioprosthesis was used in 90.5% of valve-in-valve (ViV) TAVI cases. 2-year all-cause and cardiovascular mortality rates were 16.5% and 11.1%, respectively. Other clinical events included stroke (7.9%), disabling stroke (1.7%), and new pacemaker implantation (10.1%). The 2-year all-cause mortality was significantly higher in patients with discharge mean gradients ≥20 mmHg vs. those with lower mean gradients (21.0% vs. 7.6%, p = 0.025). Discharge mean gradients ≥20 mmHg were associated with smaller surgical bioprostheses (OR, 7.2 [95% CI 2.3-22.1]. In patients with failing surgical aortic bioprostheses, ViV treatment using a supra-annular self-expanding bioprosthesis provides significant functional improvements with acceptable rates of complications, especially if a postprocedural mean gradient of <20 mmHg can be achieved.