December 2, 2019
Study Compares Outcomes of Edwards' Sapien 3 Versus Previous-Generation Sapien XT TAVR Devices
December 3, 2019—Gerhard Schymik, MD, et al published a study comparing two generations of Sapien transfemoral (TF) balloon-expandable transcatheter aortic valve replacement (TAVR) devices (Edwards Lifesciences). The study is available online in Catheterization & Cardiovascular Interventions.
According to the investigators, the Sapien 3 (S3) device is designed to address several limitations of the previous-generation Sapien XT (SXT) for TF TAVR. The objective of this study was to determine whether the altered features translate into improved outcomes in a real‐world TF TAVR patient population.
The investigators extracted data for 3,314 patients from the SOURCE‐XT and SOURCE‐3 European registries, and patients were propensity score (PS)–matched (n = 1,169 per group).
As summarized in Catheterization & Cardiovascular Interventions, the PS-matched comparison showed that device success was higher in the S3 group compared to the SXT group (99.2% vs 98.2%; P = .04). There was a lower rate of procedural death (0.7% vs 2.6%; P = .0004), moderate/severe paravalvular leakage (PVL; 1.4% vs 5.5%; P < .0001), and procedure‐related stroke (1.2% vs 2.4%; P = .04) in the S3 versus SXT group. However, the S3 group had higher rates of mean aortic valve gradients ≥ 20 mm Hg and new permanent pacemaker implantations.
The investigators further reported that at 30 days, all‐cause mortality was lower in the S3 versus SXT group (2.1% vs 4.3%; P = .003), which was maintained after 1 year (10.7% vs 14.9%; P = .002). A Cox regression predicting 1‐year mortality resulted in a hazard ratio of 0.684 in favor of S3 (P = .0026). Additionally, results favored S3 for stroke (2.8% vs 5.7%; P = .0007) and moderate/severe PVL (2.7% vs 7.3%; P = .0002) at 1 year. The rate of new pacemaker implantations (13.6% vs 9.5%; P = .001) and New York Heart Association class III/IV (12.8% vs 8.6%; P = .004) was higher with the S3 as compared with the SXT.
The improved features of the S3 appear to translate into improved survival and reduced rates of adverse complications, with the exception of a higher rate of new pacemaker implantations, concluded the investigators in Catheterization & Cardiovascular Interventions.