PARIS – A post-hoc analysis of the ACURATE IDE trial shows that under-expansion of the ACURATE neo2 valve is associated with a higher risk for death, stroke or rehospitalization. These findings were presented by Raj Makkar, MD, from the Cedars-Sinai Medical Center in Los Angeles, during a Late-Breaking Trial session on Wednesday at the EuroPCR 2025 Congress. The data were simultaneously published in the Journal of the American College of Cardiology. The ACURATE IDE trial — results originally published in the Lancet in 2024 — demonstrated that ACURATE neo2 valve (Boston Scientific) failed to be non-inferior to the available balloon-expandable (SAPIEN 3/3 Ultra [Edwards Lifesciences]) and self-expanding valves (Evolut R/PRO/PRO+/FX [Medtronic]). Investigators in this post-hoc analysis examined the factors that potentially contributed to the outcomes of the ACURATE IDE trial. Upon review of individual cases, angulated, non-parallel commissure posts were present in some ACURATE neo2 valves. Thus, the valves were under-expanded. Angiograms for all patients who received ACURATE neo2 (n=752) were evaluated by an independent core laboratory. In this present exploratory analysis, researchers discovered that 21.6% of the 624 patients implanted with ACURATE neo2 (under-expanded: mean age=77 years, 48.9% men; expanded: mean age=78 years, 46.0% men) and with evaluable procedural angiograms also had under-expanded valves (odd ratio=1.92, 95% confidence interval [CI]=1.27-2.91, p=0.002). Predilation and postdilation had similar rates in both groups, and balloon sizing did not change between the under-expanded and expanded valves. Under-expansion in the ACURATE neo2 group led to higher rates of the composite endpoint of death, stroke or rehospitalization (under-expanded=18.7%, expanded=11.8%; p=0.04), as confirmed by multivariable analysis (hazard ratio=1.92, 95% CI=1.27-2.91, p=0.002). Overall, patients in the ACURATE IDE trial who had under-expanded ACURATE neo2 valves were at greater risk for death, stroke or rehospitalization. “Given the post-hoc nature of these analysis, the study findings should be considered hypothesis generating,” the authors noted. Source: Makkar RR, Chakravarty T, Gupta A, Soliman O, Gnall E, Ramana RK, Ramlawi B, Diamantouros P, Potluri S, Kleiman N, Samy S, Rassi A, Yadav P, Thourani V, Yakubov S, Frawley C, Patel D, Kapadia S, Chalekian A, Modolo R, Sathananthan J, Kim W-K, Reardon MJ, Valve Under-Expansion and Clinical Outcomes with ACURATE neo2: Findings from the ACURATE IDE Trial, J Am Coll Cardiol. 2025 May 21 (Article in press) Image Credit: K Abrahams/peopleimages.com – stock.adobe.com