A new study evaluating the safety and performance of the Acurate neo2 (Boston Scientific) transcatheter aortic valve implantation (TAVI) system demonstrated a high procedural success rate and a low rate of paravalvular aortic regurgitation at 30-day post procedure.
Results from the Acurate neo2 CE-mark study—a single-arm, multicentre study—were presented at PCR London Valves (9–11 September, London, UK). Core laboratory adjudicated data showed 97% of patients had mild or less occurrence of paravalvular aortic regurgitation. Data also demonstrated that the system could be implanted with a high procedural success rate of over 97%, very short device usage times and low complication rates. Other key 30-day results include the following:
- All-cause mortality rate was 3.3%; disabling stroke was 1.7%
- Approximately 3% had moderate paravalvular leak and no cases of greater than moderate paravalvular were observed.
- Procedural data showed a high procedural success rate of 97.5% with a very short average device usage time of 3.9 minutes
- Patients experienced marked haemodynamic improvement with the mean pressure gradients and effective orifice areas (EOA), measures used to assess the hemodynamic performance of the valve, were 7.9 +/- 3.2mmHg and 1.7 cm2, respectively.
According to a press release, the Acurate neo2 valve system maintains key features of the original Acurate neo TAVI device—including a self-expanding nitinol frame, supra-annular positioning and a two-step, top-down deployment method. The press release states that new to Acurate neo2 is the incorporation of an annular sealing technology, intended to further reduce occurrences of paravalvular leak. The Acurate neo2 delivery system also features a new radiopaque marker designed to enhance visibility of positioning and ease of use by clinicians to further improve procedural safety and efficiency.
Ian Meredith, executive vice president and global chief medical officer at Boston Scientific, states: “We are very pleased with the initial performance of the Acurate neo2 valve system and the low paravalvular regurgitation rates, lower than previously reported with Acurate neo, which can be attributed to the new advanced sealing technology. Boston Scientific is committed to gathering clinical evidence that advances transcatheter heart valve therapies and expands our reach in patient care, especially in addressing unique patient pathologies and anatomies.”