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Transcatheter Self-Expandable Valves in Small Aortic Annuli
Study Questions:
What are the outcomes of transcatheter self-expandable prostheses in patients with small annuli?
Methods:
The TAVI-SMALL (International Multicenter Registry to Evaluate the Performance of Self-Expandable Valves in Small Aortic Annuli) investigators conducted a retrospective registry study of patients with severe aortic stenosis and a small annuli (annular perimeter <72 mm or area <400 mm2) treated with transcatheter self-expandable valves (n = 859; Evolut R, n = 397; Evolut PRO, n = 84; ACURATE, n = 201; Portico, n = 177). Primary endpoints were post-procedure mean aortic gradient, indexed effective orifice area (iEOA), and rate of severe prosthesis-patient mismatch (PPM). A multivariate binary logistic regression was performed to assess if the implantation of any self-expandable valves could be independently associated with moderate or severe PPM.
Results:
Pre-discharge gradients were consistently low in every group, with a slight benefit with the Evolut R (8.1 mm Hg; 95% confidence interval [CI], 7.7-8.5 mm Hg) and Evolut PRO (6.9 mm Hg; 95% CI, 6.3-7.6 mm Hg) compared with the ACURATE (9.6 mm Hg; 95% CI, 8.9-10.2 mm Hg) and Portico (8.9 mm Hg; 95% CI, 8.2-9.6 mm Hg) groups (p < 0.001). Mean iEOA was 1.04 cm2/m2 (95% CI, 1.01-1.08) with a trend for lower value with the Portico. No significant differences were reported in terms of severe PPM (overall rate, 9.4%; p = 0.134), permanent pacemaker implantation (15.6%), and periprocedural and 1-year adverse events. Pre-discharge more than mild paravalvular leaks were significantly more common with the Portico (19.2%) and less common with the Evolut PRO (3.6%) compared with the Evolut R (11.8%) and ACURATE (9%) groups.
Conclusions:
The authors concluded that transcatheter self-expandable valves showed optimal clinical and echocardiographic results in patients with small aortic annuli, although supra-annular functioning transcatheter aortic heart valves seemed to slightly outperform the intra-annular functioning ones.
Perspective:
This registry study reports that self-expandable valves showed optimal clinical and echocardiographic results in patients with a small aortic annulus, although the supra-annular functioning device (Evolut R, Evolut PRO, and ACURATE) seemed to slightly outperform the intra-annular functioning Portico. Additional larger prospective trials with long-term follow-up are indicated to assess the role of transcatheter aortic valve replacement with self-expandable valves for treatment of aortic stenosis in patients with small annuli, and the clinical impact of supra-annular versus intra-annular valve design on outcomes.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and VHD, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound
Keywords: Aortic Valve Stenosis, Echocardiography, Heart Valve Diseases, Heart Valve Prosthesis Implantation, Outcome Assessment, Health Care, Pacemaker, Artificial, Patient Discharge, Secondary Prevention, Transcatheter Aortic Valve Replacement
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