Next-generation TAVR valve confers less paravalvular aortic regurgitation vs. predecessor
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A next-generation transcatheter aortic valve replacement system was associated with less hemodynamically significant paravalvular aortic regurgitation compared with an earlier version, researchers reported at EuroPCR.
For the observational, retrospective ITAL-neo registry, Andrea Buono, MD, interventional cardiologist at Fondazione Poliambulanza Istituto Ospedaliero in Brescia, Italy, analyzed 900 patients with severe aortic valve stenosis, of whom 220 received the next-generation self-expanding valve (Acurate neo2, Boston Scientific) and 680 received an earlier generation of the valve (Acurate neo, Boston Scientific). The analysis included 410 patients (mean age, 84 years; 67% women), 205 from each group, propensity-matched to account for imbalance in baseline characteristics.
The first generation of the device was associated with a not negligible rate of moderate or worse paravalvular aortic regurgitation, according to the researchers. As Healio previously reported, the Acurate neo valve failed to meet noninferiority compared with the CoreValve Evolut valve (Medtronic) in the SCOPE 2 trial and the Sapien 3 valve (Edwards Lifesciences) in the SCOPE 1 trial.
“The Acurate neo2 valve maintains the most relevant key features of the earlier-generation device. At the same time, some engineering refinements have been incorporated aimed at improving valve performance,” Buono told Healio. “A radiopaque marker has been added on the delivery system with the advantage of a more precise implantation. The outer pericardial skirt is 60% taller and reaches the upper crown, with an active seal technology, able to guarantee a more syncronous adaptation with the native aortic annulus during the different phases of the cardiac cycle and with potential to reduce the incidence of paravalvular leak.”
The primary endpoint was moderate or worse paravalvular aortic regurgitation on echocardiography before discharge. The study was simultaneously published in JACC: Cardiovascular Interventions.
Buono and colleagues found the primary endpoint occurred three times more often in the Acurate neo group compared with the Acurate neo2 group (11.2% vs. 3.5%; P < .001).
There were no differences between the groups in any other hemodynamic parameters, in in-hospital clinical outcomes or in postprocedural technical success.
At 90 days, safety — defined as freedom from freedom from all-cause mortality; all stroke; Valve Academic Research Consortium types 2 to 4 bleeding; major vascular, access-related or cardiac complication; acute kidney injury stage 3 or 4; moderate or worse aortic regurgitation; new permanent pacemaker because of procedure-related conduction abnormalities; and need for surgery or intervention related to the device — was 80% in the Acurate neo2 group and 73.7% in the Acurate neo group.
“The new-generation ACURATE neo2 transcatheter heart valve, compared with the first-generation device, was associated with a significantly lower frequency of moderate or greater paravalvular aortic regurgitation in patients undergoing transfemoral TAVR for severe aortic valve stenosis. Although short-term clinical safety and efficacy outcomes are encouraging, further evidence from longer and randomized clinical trials is needed,” the researchers wrote in the simultaneous publication.
The Acurate neo2 device is not yet approved for commercial use in the United States. A pivotal trial, ACURATE IDE, is ongoing.
“These results corroborated the idea that ACURATE neo2 valve properly performs in a real-world population of patient affected from symptomatic severe aortic valve stenosis, minimizing the incidence of the hemodynamically significant paravalvular leak,” Buono told Healio. “Collaterally, we recorded a quite low rate of new pacemaker implantation also considering the non-negligible prevalence of baseline electrical conduction disturbances.”
In a related editorial in JACC: Cardiovascular Interventions, Won-Keun Kim, MD, PhD, from Kerckhoff Heart Center and the German Center for Cardiovascular Research (DZHK), Partner Site Rhine-Main in Bad Nauheim, Germany, and Helge Möllmann, MD, PhD, from St. Johannes Hospital in Dortmund, Germany, wrote: “The lower occurrence of adverse events in the neo2 group may have been in part due to global learning curves with TAVR in general as well as operators becoming increasingly familiar with this specific valve platform over time. Regardless, it is remarkable that the relatively small modification of adding a sealing skirt in the neo2 generation of this prosthesis effectuates such a considerable reduction of paravalvular regurgitation as shown in the present study.”
Editor's Note: This article was updated on May 20, 2022 to correct the percentage of women in the study and make some technical changes requested by Dr. Buono. The Editors regret the error.
References:
- Buono A, et al. JACC Cardiovasc Interv. 2022;doi:10.1016/j.jcin.2022.02.027.
- Kim WK, et al. JACC Cardiovasc Interv. 2022;doi:10.1016/j.jcin.2022.03.019.
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Buono A, et al. TAVI: Early Experience and Registry Results. Presented at: EuroPCR; May 17-20, 2022; Paris (hybrid meeting).
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