Details of self-expanding prostheses

Acurate Neo vs. Evolut PRO

The new generations of prostheses implanted via transcatheter bring a series of adjustments and adaptations to avoid as much as possible the occurrence of complications such as paravalvular Leak, mismatch and the need for a pacemaker. To this end, bioengineers invested in different parts of the device, such as skirts, the use of supra-annular leaflets and even the basic principle of the prosthesis, self-expanding or expandable balloon.

In the market for self-expanding prostheses, we find several devices with their peculiar characteristics. Symetis was recently acquired by Boston and launched its new version, Acurate Neo 2, which shares the market with Evolut PRO (Medtronic) and PORTICO (Abbott).

Recently, a multicenter cohort study was published with a comparison of outcomes and safety between Evolut PRO and Acurate NEO and the findings were very similar.

When implant success was assessed, the rates were above 90% and were the same between the prostheses, showing excellent results. The paravalvular Leak rates were also similar, around 5%. However, Evolut PRO showed a higher incidence of need for a pacemaker (13.2% vs. 8.8%) than Acurate NEO, but compared to the previous results of the company’s previous models, there was great progress, because initially with the CoreValve, we had rates above 30% incidence.

Currently, the results of the largest cohort studies of this new generation of prostheses are similar to the findings of this publication and are considered acceptable for the self-expanding model. It is worth mentioning that when patients were matched by the propensity score, there was no difference in pacemaker incidence, but in absolute values across the cohort, there was.

Other data in which the prostheses differed was the bleeding rate during the procedure. The Acurate NEO prosthesis had a higher incidence of bleeding and strokes, but in terms of major bleeding or life-threatening, there was no significant difference. Currently, with sheaths that allow less calibrated accesses, this complication tends to be greatly reduced, most likely equaling the incidence of Evolut PRO.

In the analysis of short-term outcomes, which is the most important, the incidence was low (values between 2-3%) and among prostheses it was very similar in the criteria of general mortality, cardiovascular mortality and stroke. Long-term evaluation was not included in this publication, but several other publications show excellent results, both from Evolut PRO and Acurate NEO, which confirms the short-term findings mentioned and the good results.

With the recent launch of Acurate NEO 2, the results of this prosthesis (self-expanding) can improve the presence of Leak, as a “skirt” around the device has been adapted to reduce such incidence. It is worth mentioning that the incidence of pacemaker below the other prostheses of the same class is probably due to not so deep implantation in the LV outflow tract, avoiding compression of the conduction system and also because it presents less radial force in the annulus.

     Suggested literature:

1 – Pagnesi M, Kim WK, Conradi L, et al. Transcatheter Aortic Valve Replacement With Next-Generation Self-Expanding Devices: A Multicenter, Retrospective, Propensity-Matched Comparison of Evolut PRO Versus Acurate neo Transcatheter Heart Valves. JACC Cardiovasc Interv. 2019; 12 (5): 433–443.

2 – Barth S, Reents W, Zacker M, et al. Multicentre propensity-matched comparison of transcatheter aortic valve implantation using the ACURATE TA / neo selfexpanding versus the SAPIEN 3 balloon-expandable prosthesis. EuroIntervention 2019; 15: 884-891.

 

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