Direct Approach to TAVR Using Edwards' Sapien XT Valve Studied

July 11, 2016–Data from a study evaluating the feasibility and safety of the Sapien XT valve (Edwards Lifesciences) without predilatation in transcatheter aortic valve replacement (TAVR) procedures were published by Alykhan Bandali, MRCP, et al online ahead of print in Catheterization and Cardiovascular Interventions. 

The background of this study is that TAVR is an established therapy for patients with severe aortic stenosis and is often preceded by balloon aortic valvuloplasty. However, the investigators sought to determine whether this practice was necessary for successful device implantation or if it could potentially contribute to procedural risk.

As noted in Catheterization and Cardiovascular Interventions, 81 patients (mean age, 84 years 62% men; median EuroSCORE, 22.8%) underwent transfemoral TAVR (35 by direct implantation [no predilatation] and 46 with balloon predilatation) between 2010 and 2013. The outcomes were analyzed for efficacy and safety endpoints.

The investigators reported 100% procedural success, with pre- and postprocedural peak gradients in the direct group of 66 mm Hg (95% confidence interval [CI],59–72.8) and 14 mm Hg (95% CI, 12–17.8; P < .0001) compared to 76.5 mm Hg (95% CI, 73.7–94) and 17 mm Hg (95% CI, 16–19; P < .0001) in the balloon group, respectively. Postdilatation was performed in four of 35 (11.4%) patients in the direct group and in three of 46 (6.5%) patients in the balloon group (P = .83). Moderate aortic regurgitation postprocedure was noted in one of 35 (2.9%) patients in the direct group and in none of those in the balloon group. The results in terms of in-hospital mortality (2.9% direct vs 0% balloon group), stroke (2.9% vs 4.4%), tamponade (2.9% vs 2.2%), major vascular complications (2.9% vs 8.7%), and new permanent pacing (2.2% vs 0) were similar between the two groups. However, the pacing time, number of inflations, radiation dose, and contrast use were all significantly lower in the direct TAVR group.

Direct implantation of the Sapien XT valve without predilatation during TAVR via the transfemoral route appears safe, efficacious, and feasible in patients without extreme calcification, the investigators concluded.