Differences in procedural outcomes and performance between the ACURATE neo and SAPIEN 3 bioprosthetic valve devices did not translate into significant differences in clinical outcomes or device failure after 3 years. The conclusion was based on a study of an elderly population at intermediate surgical risk, who were undergoing a transfemoral transcatheter aortic valve replacement (TAVR) procedure. In the study, 739 patients with a median age of 83 years and a median Society of Thoracic Surgeons predicted risk of mortality of 3.5% and were selected to undergo a transfemoral TAVR, were enrolled. These subjects had symptomatic severe aortic stenosis and were randomized 1:1 to receive Boston Scientific’s ACURATE neo (n=372) or Edwards Lifesciences’ SAPIEN 3 (n=367) valve system. The primary endpoint at 30 days was a combination of early safety and clinical efficacy based on the Valve Academic Research Consortium (VARC)-2 definition. A 93% clinical follow-up rate was achieved to determine final clinical outcomes after 3 years. The ACURATE neo valve had originally failed to meet its primary noninferiority endpoint against the SAPIEN 3 valve at 30 days, according to results presented at TCT 2019, which showed higher mortality and paravalvular regurgitation rates for ACURATE neo. TCT presentation Jonas Lanz, MD, MSc, of Bern University Hospital, Switzerland, on behalf of the SCOPE I investigative team, presented the trial’s 3-year outcomes at the Transcatheter Cardiovascular Therapeutics (TCT) 2022 conference in Boston. These findings revealed a 3-year all-cause death rate of 24.3% for the ACURATE neo cohort (no. of events/total no. 84/346) and 25% for the SAPIEN 3 cohort (85/340) (hazard ratio [HR]/sub-hazard ratio [SHR]: 0.98; 95% confidence interval [CI]: 0.73 – 1.33). Stroke as a 3-year clinical outcome resulted in a 6.1% incidence rate for the ACURATE neo cohort (21/345) and 5.8% for the SAPIEN 3 cohort (20/343; HR/SHR: 1.04; 95% CI: 0.56 – 1.92). Findings for hospitalization rates for valve-related dysfunction or congestive heart failure (CHF) at 3 years were 13.9% for the ACURATE neo cohort (48/345) and 18.1% for SAPIEN 3 (62/342). (HR/SHR: 0.74; 95% CI: 0.51 – 1.07). Delving deeper into specific dysfunctions of the bioprosthetic valve, one incident of structural valve deterioration (n=531) was noted in the ACURATE neo device compared to eight incidences in the SAPIEN 3 cohort (SHR: 0.19; 95% CI: 0.02 – 1.76). Out of the 684 cases of valve thrombosis, one incident was recorded for the ACURATE neo device compared to six for the SAPIEN 3 (SHR: 0.16; 95% CI: 0.02 – 1.35). Five incidences were recorded for those with the ACURATE neo device vs. seven for the SAPIEN 3 (SHR: 0.71; 95% CI: 0.22 – 2.27), out of 685 total cases of endocarditis. Bioprosthetic valve failure Regarding bioprosthetic valve failure, new onset or worsening symptoms were found in 687 cases, specifically eight incidences in the ACURATE neo device vs. 14 for the SAPIEN 3 (SHR: 0.49; 95% CI: 0.20 – 1.23). Cases of aortic valve re-intervention (n=684) were found in four individuals in the ACURATE neo cohort vs. 3 in the SAPIEN 3 cohort. (SHR: 1.32; 95% CI: 0.30 – 5.85). Finally, valve-related deaths (n=686) occurred in three individuals in the ACURATE neo cohort vs. two subjects in the SAPIEN 3 cohort (SHR: 1.52; 95% CI: 0.25 – 9.28). Image Credit: Jason Wermers/CRTonline.org