ITAL-neo Registry Shows Better Performance For Neo2 Over Neo THV
The frequency of moderate or greater paravalvular aortic regurgitation was three-fold lower after transfemoral TAVI using the second-generation ACURATE neo2 valve vs. the first-generation ACURATE neo valve, according to a late-breaking clinical trial presented May 17 at EuroPCR 2022 and simultaneously published in JACC: Cardiovascular Interventions.
Andrea Buono, MD, and colleagues, used data from the real-world, multicenter ITAL-neo Registry of patients with severe aortic valve stenosis, treated with first- and second-generation ACURATE neo transcatheter heart valves (THV) in 13 Italian centers. From 900 patients treated, 680 received an ACURATE neo valve and 220 were treated with the ACURATE neo2 valve. Propensity score matching yielded 205 matched pairs for comparison.
ACURATE neo is a first-generation self-expanding THV composed of porcine pericardial leaflets mounted on a self-expanding nitinol stent. It is designed to minimize periprocedural outflow obstruction and allow for stable positioning, but has been associated with a high rate of moderate or greater paravalvular regurgitation (PVR). The second-generation ACURATE neo2 valve maintains most of the first-generation device characteristics, but is equipped with a taller outer pericardial skirt, extended to the upper crown of the THV stent, "which has the potential to reduce post implantation PVR."
The study's primary endpoint of moderate or greater PVR was seen in 11.2% of patients implanted with ACURATE neo valve and in 3.5% of those who received the ACURATE neo2 valve (p<0.001). No other hemodynamic differences were observed. Postprocedural technical success was similar between the two cohorts. Fewer adverse events were observed in patients treated with the ACURATE neo2 valve at 90 days.
Acknowledging the nonrandomized, preliminary nature of their findings, Buono, et al., conclude: "Transfemoral TAVI using the ACURATE neo2 [valve] was associated with a significantly lower frequency of moderate or greater paravalvular aortic regurgitation compared to the earlier generation ACURATE neo device, with encouraging short-term safety and efficacy."
The proposed advantage of the ACURATE neo2 valve is being further investigated in the ongoing U.S. randomized controlled ACURATE IDE trial, which will randomly assign up to 1,500 patients to the ACURATE neo2 TAVR System, the SAPIEN 3 TAVR System or the CoreValve TAVR System.
Importantly, the ACURATE IDE trial incorporates core laboratory imaging analysis and a screening committee to ensure uniform sizing approaches, both of which were not used in the present study and in earlier studies of ACURATE neo2.
The reduction in PVR seen with ACURATE neo2 compared with ACURATE neo is "very impressive," write Won-Keun Kim, MD, PhD, and Helge Mollmann, MD, PhD, in an accompanying editorial comment. They suggest the improvement seen with ACURATE neo2 likely reflects not just the adjustments made to the device but also reflects "global learning curves with TAVR in general as well as operators becoming increasingly familiar with this specific valve platform over time."
Keywords: ACC International, Transcatheter Aortic Valve Replacement, Aortic Valve Insufficiency, Propensity Score, Laboratories, Aortic Valve Stenosis, Hemodynamics, Registries, Stents, Heart Valve Prosthesis, Aortic Valve
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