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TAVR with newer device shows similar safety, efficacy to other devices
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In patients undergoing transcatheter aortic valve replacement for the treatment of severe aortic stenosis, a self-expanding nitinol system yields positive safety and efficacy results vs. the two technologies approved in the United States, according to recent findings.
In the prospective study, researchers assessed 162 consecutive patients who were treated with transfemoral TAVR for severe aortic stenosis. Of these patients, 49 were implanted with the self-expanding nitinol device covered by a porcine pericardial tissue (Acurate Neo, Symetis), 56 received a self-expanding device (CoreValve, Medtronic) and 57 were treated with a balloon-expandable device (Sapien XT, Edwards Lifesciences). The Valve Academic Research Consortium (VARC-2) criteria were used to report clinical outcomes.
The researchers found that the CoreValve system yielded higher rates of valve embolization/migration vs. the other valves (Acurate Neo, none; CoreValve, 9%; Sapien XT, 2%; P = .34), resulting in lower device success in the MCV group (Acurate Neo, 98%; CoreValve, 86%; Sapien XT, 95%; P = .043). On follow-up echocardiography, the three groups demonstrated no difference in aortic valve mean pressure gradient and ejection fraction between the groups.
The incidence of moderate or severe aortic regurgitation was comparably low and not statistically different between the three groups (Acurate Neo, 4%; CoreValve, 12%; Sapien XT, 4%; P = .19). There was a lower aortic valve area in patients treated with CoreValve (Acurate Neo, 1.9 ± 0.3 cm2; CoreValve, 1.8 ± 0.3 cm2; Sapien XT, 2 ± 0.3 cm2; P = .007), as well as a higher pulmonary artery systolic pressure (Acurate Neo, 45.4 ± 13.6 mm Hg; CoreValve, 51.6 ± 11.9 mm Hg; Sapien XT, 43.4 ± 8.4 mm Hg; P = .002).
Clinical outcomes
No significant difference was seen at 30 days in the following outcomes: all-cause mortality (P = .22); CV mortality (P = .2); periprocedural MI (P = .4); stroke (P = .64); major vascular complications (P = .48); life-threatening bleeding (P = .29); acute kidney injury stage 2 or 3 (P = .69); or VARC-2 composite early safety endpoints (P = .21). On follow-up echocardiography, no significant difference was seen in aortic valve mean pressure gradient (P = .73) or moderate or severe aortic regurgitation (P = .19) between the groups.
The CoreValve group had a higher incidence of new permanent pacemaker implantation (Acurate Neo, 6%; CoreValve, 25%; Sapien XT, 11%; P = .013), according to the researchers.
Promising findings
In a multivariate logistic regression model that included device types and variables correlated with the primary outcome in the univariate analysis, the researchers found no independent predictor of VARC-2 composite early safety outcomes. The C-statistic showed an area under curve of 0.72, suggesting acceptable discrimination of the model.
“Despite the small sample size and the fact that this is not a multicenter cohort, this was the first attempt to compare the acute performance of the Acurate Neo vs. CoreValve and Sapien XT,” the researchers wrote. “Based on this hypothesis-generating study, larger trials with longer follow-up are needed to confirm these early promising findings.” – by Jennifer Byrne
Disclosure: Two of the researchers report receiving honoraria from Edwards Lifesciences, Medtronic and Symetis, and one researcher reports receiving honoraria from Edwards Lifesciences and Medtronic.