Last week saw the 79th running of the Annual German Cardiac Society meeting in Mannheim. At the event Swiss transcatheter valve developer Symetis Inc., saw registry data from the Symetis ACURATE TA™ Valve Implantation (SAVI) Registry presented.
SAVI is a post-market registry of the first 250 patients treated with the ACURATE TA™ that was granted CE mark in September 2011. Patients were implanted at 17 centers in Germany, Switzerland, Argentina and Italy and reflect real-life clinical use of this 2nd generation TAVI device.
Regular followers of developments in transcatheter aortic valve implantation (TAVI) will by now know that there exist challenges in placing valves minimally invasively. Not the least of these is the avoidance of paravalvular leakage (PVL) or regurgitation, which is the most commonly referenced complication.
Symetis claims to have addressed the issue with its self-expanding ACURATE TA™ which it says has a unique and intelligent design featuring a two-step single operator deployment technique. Symetis says its valve’s so-called “self-seating and self-sealing” design, combined with outstanding ease-of-use throughout the procedure, ensures optimal fit of the bioprosthesis the first time.
This should result in less risk for incorrect placement and promote sealing at the correct position for minimal leak. And it seems the clinical data may support the claim: The results of the post-market registry of the ACURATE TA™ reveal a high procedure success rate (98.0%), which Symetis says confirms the system’s unparalleled ease-of-use and nearly non-existent learning curve.
Additionally, the SAVI Registry shows a 30-day all-cause mortality rate of 6.8% – one of the lowest rates reported in registries of other transcatheter aortic valves (1-5).
Hemodynamics and functional class improved after the ACURATE TA™ implant procedure and serious adverse events such as stroke (2.8%), myocardial infarction (0.8%), and new permanent pacemaker implantation (7.2%) rates were also very low.
To cap it off, Symetis is trumpeting the lowest PVL reported in a TAVI registry with only 2.7% of patients with a PV leak ≥ Grade 2 at follow-up.
Prof. Thomas Walther MD, 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™.
Laura Brenton, VP Clinical & Regulatory Affairs at Symetis, added: “The ACURATE TA™ has proven to be the most user-friendly and patient-effective transapical TAVI today on the market. Our TA R&D pipeline will further raise this new standard and expand the TA indication. I also wish to thank all the investigators for their active support.”
Thomas M, Schymik G, Walther T, Himbert D, Lefèvre T, Treede H, et al. One-year outcomes of cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry: the European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation 2011 Jul 26; 124(4):425-33.
Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, et al. Registry of transcatheter aortic-valve implantation in high-risk patients. N. Engl. J. Med. 2012 May 3; 366(18):1705-15.
Di Mario C, Eltchaninoff H, Moat N, Goicolea J, Ussia GE 80 A, Kala P, et al. The 2011-12 pilot European Sentinel Registry of Transcatheter Aortic Valve Implantation: in-hospital results in 4,571 patients. EuroIntervention. 2012 Dec 21;
Abdel-Wahab M, Zahn R, Horack M, Gerckens U, Schuler G, Sievert H, et al. Aortic regurgitation after transcatheter aortic valve implantation: incidence and early outcome. Results from the German transcatheter aortic valve interventions registry. Heart. 2011 Jun; 97(11):899-906.
Thomas M, Schymik G, Walther T, Himbert D, Lefèvre T, Treede H, et al. Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) Registry: A European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2010 Jul 6; 122(1):62-9.
Source: Symetis, Inc., Marketwired