No severe paravalvular leak with Acurate Neo TF

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Data presented at PCR London Valves (28–30 September, London, UK) indicate that the Acurate Neo transfemoral (TF) transcatheter aortic valve implantation (TAVI) system, which recently received the CE mark, is not associated with any incidences of severe paravalvular leak. Additionally, the device is associated with a low mortality rate of 2.5%.

Dimytri Siqueira (Institute Dante Pazzanese of Cardiology, São Paulo, Brazil) reported that data for the Acurate transapical (TA) bioprosthesis indicate that it is associated with “good clinical results that are comparable with other TAVI systems.” He added that the purpose of the current study was to investigate the feasibility and short-term clinical outcomes of a new version of the Acurate valve—Acurate Neo (Symetis)—that is implanted with the transfemoral approach. According to Siqueira, the device is made of nitinol with pericardial leaflets, is available in three sizes (that covers annuluses from 21mm to 27mm in diameter), and has a pericardial inner and outer skirt that acts as a “seal to prevent paravalvular leak”.


In the single-centre study, after evaluation by a multidisciplinary team for suitability for TAVI, 40 patients with severe aortic stenosis who were at high-risk for surgery or who were inoperable underwent TAVI with the Acurate Neo TF device. The mean age of the group was 82.3±5.8 years, the mean Euroscore I was 21.6±9.4%, and 87.5% of patients were New York Heart Association Class III/IV. Clinical follow-up was obtained at 30 days and clinical events were categorised according to the Valve Academic Research Consortium (VARC) II criteria.


At 30 days, mean effective orifice area significantly increased (from 0.8±0.4 at baseline to 2±0.4 cm2; p<0.01) and mean gradient significantly decreased (from 51.8±13.4 at baseline to 9.1±2.9 mmHg; p<0.01). Siqueira commented that “of note”, only two patients developed moderate paravalvular leak and there were no cases of severe paravalvular leak. He also reported that the mortality rate was low (2.5%) and that there were “no strokes, few access-site complications (2.5%), and a low pacemaker rate (8.1%).”


Siqueira concluded: “Patients felt better, the clinical improvement at 30 days was remarkable and the majority of patients were in Class I or II NYHA. So in our initial experience, TAVI with the new Acurate Neo TF bioprosthesis implanted by the transfemoral approach is feasible, safe and associated with good short-term clinical and haemodynamic outcomes in high-risk patients with severe aortic stenosis.” He added that all valves were implanted at the intended location.


Siqueira told Cardiovascular News: “Acurate Neo is one of the easiest and most predictable transfemoral self-expanding TAVI systems, designed to provide a stable positioning within the native annulus, which translates in very good clinical outcomes

 

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