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

N H M Kooistra; M Abawi; M Voskuil; K Urgel; M Samim; F Nijhoff; H M Nathoe; P A F M Doevendans; S A J Chamuleau; G E H Leenders; T Leiner; A C Abrahams; H B van der Worp; P Agostoni; P R Stella

doi:10.1007/s12471-020-01414-0

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

Neth Heart J. 2020 May;28(5):253-265. doi: 10.1007/s12471-020-01414-0.

Authors

N H M Kooistra¹, M Abawi¹, M Voskuil², K Urgel¹, M Samim^{1

3}, F Nijhoff¹, H M Nathoe¹, P A F M Doevendans^{1

4}, S A J Chamuleau¹, G E H Leenders¹, T Leiner⁵, A C Abrahams⁶, H B van der Worp⁷, P Agostoni^{1

3}, P R Stella¹

Affiliations

¹ Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.
² Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands. mvoskuil@umcutrecht.nl.
³ Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands.
⁴ Netherlands Heart Institute (ICIN), Utrecht, The Netherlands.
⁵ Department of Radiology, University Medical Centre Utrecht, Utrecht, The Netherlands.
⁶ Department of Nephrology and Hypertension, University Medical Centre Utrecht, Utrecht, The Netherlands.
⁷ Department of Neurology and Neurosurgery, Brain Centre Rudolf Magnus, University Medical Centre Utrecht, Utrecht, The Netherlands.

Abstract

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 < 0.001] or death [0 (0%) vs 5 (19%); p = 0.02] in the 1st year compared with SEV.

Conclusions: The use of the latest generation of BEV was associated with less AR as quantitatively assessed by MRI. Although the use of MRI to quantify AR is not feasible in daily clinical practice, it should be considered as a surrogate endpoint for clinical outcomes in comparative studies of valves for TAVI. ClinicalTrials.gov number NCT01982032.

Keywords: Aortic valve stenosis; Balloon-expandable heart valve; Magnetic resonance imaging; Quantitative aortic regurgitation; Self-expandable heart valve; Transcatheter aortic valve implantation.

Associated data

ClinicalTrials.gov/NCT01982032