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ACURATE Neo Transcatheter Heart Valve
Study Questions:
What are the factors that affect procedural outcomes of transcatheter aortic valve replacement (TAVR) using the ACURATE neo prosthesis?
Methods:
The investigators analyzed 500 patients who underwent transfemoral AVR with the ACURATE neo prosthesis. Device landing zone calcification was stratified as severe, moderate, or mild. Anatomic and procedural predictors of second-degree or greater paravalvular leakage (PVL) and permanent pacemaker implantation (PPI) were assessed. A stepwise logistic regression analysis (forward logistic regression) was carried out to specify independent predictors of second-degree or greater PVL and PPI.
Results:
Post-procedural second-degree or greater PVL was more frequent with increasing device landing zone calcification (mild 0.8% vs. moderate 5.0% vs. severe 13.0%, p < 0.001), whereas PPI was independent of device landing zone calcification. More severe periannular calcification (odds ratio [OR], 1.007; 95% confidence interval [CI], 1.003-1.010; p < 0.001), less oversizing (OR, 0.867; 95% CI, 0.773-0.971; p = 0.014), the presence of annular plaque protrusions (OR, 2.756; 95% CI, 1.138-6.670; p = 0.025), and aortic movement of the delivery system after full deployment (OR, 5.593; 95% CI, 1.299-24.076; p = 0.02), and sinotubular junction height (OR, 1.156; 95% CI, 1.007-1.328; p = 0.04) independently predicted second-degree or greater PVL. Predictors of PPI were pre-existing right bundle branch block (OR, 3.122; 95% CI, 1.261-7.731; p = 0.01) and more oversizing (OR, 1.111; 95% CI, 1.009-1.222; p = 0.03).
Conclusions:
The authors concluded that successful TAVR using the ACURATE neo device depends on careful patient selection with appropriate oversizing, and taking into account the individual anatomy and calcium distribution of the aortic root.
Perspective:
This study reports that procedural success of transfemoral implantation of the ACURATE neo device requires careful patient selection with appropriate oversizing, and best outcomes may be achieved in cases with only mild to moderate device landing zone calcification. Furthermore, less aggressive pre-dilatation may help reduce PPI rates, and maintaining forward pressure on the delivery system during deployment may decrease the likelihood of post-procedural PVL. With a variety of TAVR devices now available, the selection of the appropriate type and size of a prosthesis tailored to patients’ individual anatomic characteristics will become more important in transcatheter valve therapies to identify patients with an anatomy that is particularly suitable for a specific device with a goal of precision medicine for TAVR.
Keywords: Aortic Valve Stenosis, Bundle-Branch Block, Calcification, Physiologic, Dilatation, Heart Valve Diseases, Heart Valve Prosthesis, Pacemaker, Artificial, Secondary Prevention, Transcatheter Aortic Valve Replacement
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