Randomised comparison of a balloon-expandable and self-expandable valve with quantitative assessment of aortic regurgitation using magnetic resonance imaging

Introduction Transcatheter aortic valve implantation (TAVI) is a safe and effective treatment for inoperable, intermediate- or high-risk patients with severe symptomatic aortic stenosis and has been associated with excellent clinical outcomes. A clinically relevant remaining problem is aortic regurg...

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Published in:Netherlands heart journal 2020-05, Vol.28 (5), p.253-265
Main Authors: Kooistra, N. H. M., Abawi, M., Voskuil, M., Urgel, K., Samim, M., Nijhoff, F., Nathoe, H. M., Doevendans, P. A. F. M., Chamuleau, S. A. J., Leenders, G. E. H., Leiner, T., Abrahams, A. C., van der Worp, H. B., Agostoni, P., Stella, P. R.
Format: Article
Language:English
Subjects:
Body mass index
Cardiology
Cardiovascular disease
Clinical outcomes
Coronary vessels
Magnetic resonance imaging
Medical Education
Medicine
Medicine & Public Health
Mortality
Original
Original Article
Pacemakers
Quality of life
Vein & artery diseases
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Summary:Introduction Transcatheter aortic valve implantation (TAVI) is a safe and effective treatment for inoperable, intermediate- or high-risk patients with severe symptomatic aortic stenosis and has been associated with excellent clinical outcomes. A clinically relevant remaining problem is aortic regurgitation (AR) post-TAVI, which is associated with increased mortality. Therefore, we conducted a prospective randomised trial to assess the safety and efficacy of a first-generation self-expandable valve (SEV; CoreValve) and a third-generation balloon-expandable valve (BEV; Sapien 3) with respect to clinical outcomes and AR as determined quantitatively by magnetic resonance imaging (MRI). Methods The ELECT study was an investigator-initiated, single-centre trial involving patients with severe symptomatic aortic stenosis and with a clinical indication for transfemoral TAVI. Fifty-six patients were randomly assigned to the BEV or SEV group. Results AR determined quantitatively by MRI was lower in the BEV than in the SEV group [regurgitant fraction: 1.1% (0–8.0) vs 8.7% (3.0–14.8) for SEV; p  = 0.01]. Secondary endpoints according to the criteria of the Second Valve Academic Research Consortium (VARC-2) showed BEV to have better early safety [0 (0%) vs 8 (30%); p  = 0.002] at 30 days and a lower risk of stroke [0 (0%) vs 5 (21%); p  = 0.01], major adverse cardiac and cerebrovascular events [0 (0%) vs 10 (38%); p  
ISSN:1568-5888
1876-6250
DOI:10.1007/s12471-020-01414-0