Key result
Acurate neo2 is associated with ~40% lower relevant paravalvular regurgitation compared to neo.
Why the study?
Few data exist on immediate outcomes of the next-generation Acurate neo2 prosthesis compared with its predecessor, the Acurate neo.
Does the Acurate neo2 prosthesis reduce relevant paravalvular regurgitation compared to the Acurate neo prosthesis in patients undergoing transfemoral transcatheter aortic valve replacement?
Cohort (n=2,865)
Yes
Does the Acurate neo2 prosthesis reduce relevant paravalvular regurgitation compared to the Acurate neo prosthesis in patients undergoing transfemoral transcatheter aortic valve replacement?
Absolute Event Rate: 2.7% vs 4.5%
p-value: p=.04
The next-generation Acurate neo2 transcatheter heart valve demonstrates superior procedural outcomes with a lower rate of relevant paravalvular regurgitation and higher 30-day device success compared to its predecessor.
May support neo2 selection to reduce paravalvular regurgitation in TAVR; hypothesis-generating pending randomized confirmation.
BACKGROUND: Few data exist on immediate outcomes of the next-generation Acurate neo2 prosthesis (Boston Scientific), which is distinguished by an active sealing mechanism. We sought to determine procedural outcomes of transfemoral transcatheter aortic valve replacement using the neo2 in comparison with its predecessor, the Acurate neo. METHODS: In this retrospective analysis, consecutive neo2 and neo cases were compared from 2 high-volume centers. The primary outcome of interest was the rate of relevant paravalvular regurgitation (PVR), defined as PVR ≥ moderate, or valve-in-valve and/or surgical aortic valve replacement for PVR ≥ moderate. Secondary outcomes of interest were assessed according to Valve Academic Research Consortium (VARC)-3 criteria. Logistic regression analysis was used to identify predictors of relevant PVR. RESULTS: A total of 810 neo2 and 2055 neo cases comprised the study cohort. The rate of relevant PVR was significantly lower in the neo2 group (2.7% vs 4.5%; P=.04). The technical success rate was numerically higher in the neo2 group (91.5% vs 89.3%; P=.10) and the rate of device success at 30 days was significantly higher (86.5% vs 82.9%; P=.02). In the neo group, a greater amount of aortic valve calcification (AVC), the presence of eccentric AVC, less oversizing, and a higher sinotubular junction annulus index were predictors of relevant PVR, whereas in the neo2 population only the presence of eccentric AVC, less oversizing, and a higher sinotubular junction annulus index was predictive. CONCLUSION: The neo2 valve shows superior outcomes over the neo valve, with a lower burden of PVR and a higher device success rate at 30 days.
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Eckel et al. (2022) conducted a cohort in Aortic stenosis requiring TAVR (n=2,865). Acurate neo2 prosthesis vs. Acurate neo prosthesis was evaluated on Rate of relevant paravalvular regurgitation (PVR ≥ moderate, or valve-in-valve and/or surgical aortic valve replacement for PVR ≥ moderate) (p=.04). The Acurate neo2 prosthesis had a significantly lower rate of relevant paravalvular regurgitation compared to the neo prosthesis (2.7% vs 4.5%; P=.04).
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