Germany: TAVI Study Findings

TAVI using the latest generation self-expanding ACURATE neo2 (Neo2) and the balloon-expandable SAPIEN 3 Ultra (Ultra) valves led to comparable short-term outcomes, which were excellent, says a recent study in EuroIntervention. However, transvalvular gradients were found to be lower with the Neo2 resulting in higher device success rates.

Considering the non-existence of data on the Neo2 and Ultra transcatheter heart valves (THV), Costanza Pellegrini and the research team from Germany aimed to compare the outcomes after transcatheter aortic valve implantation (TAVI) using the Neo2 and the Ultra THV.

The study included 1,356 patients at four centers who were treated with either the Ultra (n=748) or the Neo2 (n=608). The researchers assessed the association of the THV and the primary endpoint using inverse probability treatment weighting (IPTW) and 1:1 propensity score matching (PSM), which resulted in the identification of the 472 matched pairs. According to the latest Valve Academic Research Consortium definitions, device success was the study's primary endpoint.

Study Findings

• After PSM, there were no relevant differences between the groups.
• While rates of moderate to severe paravalvular leakage (PVL) were overall low (0.6% vs. 1.1%), elevated transvalvular gradients (≥20 mmHg) were less frequent with the Neo2 (2.4% vs. 7.7%), which translated into a significantly higher rate of device success with the Neo2 compared with the Ultra (91.9% vs. 85.0%).
• Consistently, the Neo2 was associated with higher device success rates in the IPTW analysis (odds ratio [OR] 1.961).
• Rates of mild PVL were significantly lower with the Ultra compared with the Neo2 (20.0% vs. 32.8%).
• Clinical events at 30 days were comparable between the two groups.

"Findings showed excellent and overall comparable short-term outcomes after TAVI using the Neo2 or Ultra THV," the researchers wrote in their conclusion. "However, transvalvular gradients were lower with the Neo2, which translated into higher device success rates. Mild paravalvular leakage rates were remarkably lower with the Ultra THV."

What is TAVI?

The surgery may be called transcatheter aortic valve implantation (TAVI) or transcatheter aortic valve replacement (TAVR). It is a minimally invasive method of inserting a new valve without removing the old, damaged valve. The new valve is placed inside the diseased valve.

The TAVI is similar to stent placement in an artery; it delivers a fully collapsible replacement valve to the valve site through a catheter. Once the new valves expand, it pushes the old valve leaflets out of the way, and tissue in the replacement valves functions to regulate the blood flow.

Reference

The study, "ACURATE neo2 versus SAPIEN 3 Ultra for transcatheter aortic valve implantation," was published in the EuroIntervention journal.
DOI: 10.4244/EIJ-D-22-00164