Valve under-expansion and clinical outcomes with ACURATE neo2: Findings from the ACURATE IDE trial

Authors

Raj R. Makkar, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Tarun Chakravarty, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Aakriti Gupta, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Osama Soliman, Department of Cardiology and Cardiovascular Research Institute (CVRI) Dublin, Mater Private Network, Dublin, Ireland, and School of Medicine, RCSI University of Medicine and Health Sciences, Dublin, Ireland.
Eric Gnall, Lankenau Hospital, Wynnewood, PA, USA.
Ravi K. Ramana, Advocate Health - MidwestFollow
Basel Ramlawi, Lankenau Hospital, Wynnewood, PA, USA.
Pantelis Diamantouros, London Health Sciences Centre, London, ON, Canada.
Srinivasa Potluri, Baylor Scott and White The Heart Hospital Baylor Plano, Plano, TX, USA.
Neal Kleiman, Houston Methodist Hospital, Houston, TX, USA.
Sanjay Samy, Albany Medical Center, Albany, New York.
Andrew Rassi, Kaiser Permanente, San Francisco, CA, USA.
Pradeep Yadav, Piedmont Hospital, Atlanta, GA, USA.
Vinod Thourani, Piedmont Hospital, Atlanta, GA, USA.
Steven Yakubov, OhioHealth Research and Innovation Institute - Riverside Methodist Hospital, Columbus, OH, USA.
Chris Frawley, Boston Scientific Corporation, Marlborough, MA, USA.
Dhairya Patel, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Samir Kapadia, Cleveland Clinic Foundation, Cleveland, OH, USA.
Aaron Chalekian, Boston Scientific Corporation, Marlborough, MA, USA.
Rodrigo Modolo, Boston Scientific Corporation, Marlborough, MA, USA.
Janarthanan Sathananthan, Boston Scientific Corporation, Marlborough, MA, USA.
Won-Keun Kim, Justus-Liebig University of Giessen, Giessen, Germany.
Michael J. Reardon, Houston Methodist Hospital, Houston, TX, USA.

Recommended Citation

Makkar RR, Chakravarty T, Gupta A, et al. Valve Under-Expansion and Clinical Outcomes with ACURATE neo2: Findings from the ACURATE IDE Trial. J Am Coll Cardiol. Published online May 7, 2025. doi:10.1016/j.jacc.2025.05.011

Affiliations

Advocate Christ Medical Center

Abstract

Objective:Assess the impact of ACURATE neo2 valve expansion on clinical outcomes in the ACURATE IDE trial.

Background:In the ACURATE IDE randomized controlled trial, ACURATE neo2 failed to demonstrate non-inferiority to commercially available balloon-expandable (SAPIEN 3/3 Ultra) and self-expanding (Evolut R/PRO/PRO+/FX) valves for the primary endpoint of all-cause mortality, stroke, or rehospitalization at 1 year. A retrospective investigation was undertaken to evaluate potential factors contributing to these outcomes.

Methods:Post-hoc case review identified angulated (non-parallel) commissure posts in a few implanted ACURATE neo2 valves, indicating valve under-expansion. Procedural angiograms for all ACURATE neo2 valves implanted in the trial's main randomized cohort (n=752) were inspected by an independent core laboratory. An exploratory analysis was performed to evaluate the association between valve expansion and clinical outcomes.

Results:Of the 624 patients implanted with ACURATE neo2 and with evaluable procedural angiograms, 135 (21.6%) had under-expanded valves. Greater aortic valve leaflet and annulus calcification at baseline was independently associated with ACURATE neo2 valve under-expansion (OR 1.92, 95% CI 1.27-2.91; p=0.002). Procedural techniques, including frequency of predilation (100% in both groups) and postdilation (26.7% vs 25.2%, p=0.72), and balloon sizing did not differ between under-expanded and expanded valve groups. ACURATE neo2 under-expansion was associated with a higher 1-year rate of death, stroke, or rehospitalization (under-expanded: 18.7%, expanded: 11.8%; P=0.04), which was confirmed in a multivariable analysis (HR 1.92, 95% CI 1.27-2.91, p=0.002).

Conclusions:Under-expansion of the ACURATE neo2 valve in the ACURATE IDE study was associated with higher risk of the composite endpoint of death, stroke or rehospitalization. Given the post-hoc nature of these analysis, the study findings should be considered hypothesis generating. Whether achieving optimal valve expansion of the ACURATE neo2 valve with improvement in device design and procedural iterations will translate into improved clinical outcomes remains to be studied.

Document Type

Article

PubMed ID

40406945