Short-term adverse events low with novel TAVR system
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A next-generation transcatheter aortic valve replacement system was associated with low rates of mortality, stroke and other adverse events at 30 days, researchers reported at PCR London Valves.
For the single-arm, prospective study, Lars Søndergaard, MD, DMSc, FESC, professor of cardiology at the Rigshospitalet, Copenhagen University Hospital, Denmark, analyzed the performance of the TAVR system (Acurate neo2, Boston Scientific) in 250 patients with severe aortic stenosis (mean age, 81 years; 64% women) treated in routine clinical practice at 18 European centers.
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The findings were simultaneously published in EuroIntervention.
The procedure was successful in 98.4% of patients, according to the researchers.
At 30 days, the rate of mortality was 0.8% and the rate of stroke was 0%, Søndergaard and colleagues found.
The rate of new permanent pacemaker implantation at 30 days was 6.5%, and the rate of hypoattenuated leaflet thrombosis of more than 50% at 30 days was 9.3%, according to the researchers.
Mean aortic valve gradient improved from 47.6 mm Hg at baseline to 8.6 mm Hg at 30 days, whereas mean aortic valve area improved from 0.7 cm2 at baseline to 1.6 cm2 at 30 days, the researchers found.
The proportion of paravalvular leak at 30 days was as follows: none/trace in 79.2%, mild in 18.9%, moderate in 1.9% and severe in 0%.
“With this foundational data set, we now have postmarket surveillance results that validate the use of the current-generation Acurate neo2 valve for the management of patients with severe aortic stenosis,” Søndergaard said in a press release. “The data suggest that the annular sealing technology minimizes leakage around the valve — providing greater improvement in [paravalvular leak] than observed with the prior-generation ACURATE neo valve — all while maintaining single-digit permanent pacemaker rates, which contributes to better long-term patient outcomes.”
References:
- Boston Scientific. news.bostonscientific.com/2022-11-27-Late-Breaking-Post-Market-Study-Data-Reinforce-Clinical-Procedural-Success-and-Safety-of-the-ACURATE-neo2-TM-Aortic-Valve-System. Published Nov. 27, 2022. Accessed Nov. 28, 2022.
- Kim WK, et al. EuroIntervention. 2022;doi:10.4244/EIJ-D-22-00914.
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Søndergaard L, et al. Top Late-Breaking Trials. Presented at: PCR London Valves; Nov. 27-29, 2022; London.
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