The objective of this paper recently published in J Am Coll Cardiol Intv was to compare the outcomes of transcatheter aortic valve replacement (TAVR) with the new Sapien 3 Ultra vs. Sapien 3.
Successful implantation was extremely high with both balloon-expandable devices, which also had a very low adverse event rates. However, Sapien Ultra was significantly better than Sapien 3 in terms of paravalvular leak.
Both valves are made of bovine pericardium, with a cobalt-chromium stent plus a low-profile delivery system and high radial force. Sapien Ultra additionally has a polyethylene external skirt, which increases the device height by 40%, providing a 50% bigger contact surface with the native valve so as to improve annular sealing. The release system features differences too.
This registry included all consecutive patients who underwent TAVR with Sapien 3 and Sapien Ultra between 2014 and 2020. Propensity score matching was used to compare both arms.
A total of 310 matched patients were included (155 for each device). After propensity score matching, no difference was detected in baseline clinic characteristics.
Procedures were more frequently done under conscious sedation with Sapien Ultra (97.4% vs. 71.6%; p < 0.001) and pre-dilation was significantly less (42.6% vs. 85.2%; p < 0.001).
In-hospital results, including implantation success (91.6% vs. 95.5%; p = 0.165), major vascular complications (12.3% vs. 11.0%; p = 0.723), and pacemaker implantation (5.8% vs. 4.5%; p = 0.608) were comparable between Sapien 3 and Ultra, respectively.
The postprocedural gradient was similar (13.2 ± 5.7 mmHg vs. 13.1 ± 4.7 mmHg; p = 0.829) and so were the rates for moderate and higher paravalvular leak (1.3% vs. 2.7%; p = 0.414).
The significant difference in favor of Sapien Ultra was in mild leak with a rate that was less than half the rate for Sapien 3 (18.7% vs. 43%; p < 0.001).
With excellent results in both devices, adding a polyethylene skirt in the Sapien Ultra device managed to reduce the rate of mild paravalvular leak to less than half.
Original Title: Transcatheter Aortic Valve Replacement With Balloon-Expandable Valves Comparison of SAPIEN 3 Ultra Versus SAPIEN 3.
Reference: Tobias Rheude et al. J Am Coll Cardiol Intv 2020;13:2631–8. https://doi.org/10.1016/j.jcin.2020.07.013.