According to Symetis, the discharge and 30-day results of its Symetis ACURATE TA Valve Implantation (SAVI) registry indicated that the valve is associated with a 30-day all-cause mortality rate of 6.8%—one of the lowest rates reported in registries of other TAVI devices.
According to a company press release, SAVI is a post-market registry of the first 250 patients treated with the ACURATE TA (which was granted the CE mark in September 2011). The included patients were implanted at 17 centres in Germany, Switzerland, Argentina and Italy, and reflect real-life clinical use of the second generation TAVI device.
The press release commented that the results of this post-market registry of the ACURATE TA revealed a high procedure success rate (98%), which it claimed confirmed the system’s unparalleled ease-of-use and nearly non-existent learning curve. Additionally, a very good safety profile and minimal paravalvular leak rate, as had already been observed in pre-market clinical trials of the device, were also reported.
The SAVI Registry shows a 30-day all-cause mortality rate of 6.8%, which is one of the lowest rates reported in registries of other TAVI valves. Haemodynamics and functional class improved solidly after the ACURATE TA implant procedure. Serious adverse events such as stroke (2.8%), myocardial infarction (0.8%), and new permanent pacemaker implantation (7.2%) rates were also very low. Furthermore, the ACURATE TA exhibits the lowest paravalvular reported in a TAVI registry with only 2.7% of patients with a leak ≥ Grade 2 at follow-up.
Thomas Walther, Kerckhoff Klinik, Bad Nauheim and principal investigator of the study, commented: “Patient safety is my highest priority. I am impressed by these real-world results and the consistent safety profile of ACURATE TA.”