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

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?

SUBMITTER: Kooistra NHM

PROVIDER: S-EPMC7190770 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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

Kooistra N H M NHM Abawi M M Voskuil M M Urgel K K Samim M M Nijhoff F F Nathoe H M HM Doevendans P A F M PAFM Chamuleau S A J SAJ Leenders G E H GEH Leiner T T Abrahams A C AC van der Worp H B HB Agostoni P P Stella P R PR

Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation 20200501 5

<h4>Introduction</h4>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-expand ...[more]

PMID: 32246266

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Project description:BackgroundCoronary obstruction during transcatheter aortic valve replacement (TAVR) is a rare, yet life-threatening, complication. The routine use of left main (LM) protection with or without stent placement in high-risk patients remains controversial. The aim of this study was to evaluate the outcomes of LM protection during TAVR and identify anatomic factors associated with need for stent placement.MethodsWe retrospectively reviewed all TAVR cases (native and valve-in-valve) performed in our institution between 2014 and 2019 and identified patients who underwent LM protection with a coronary wire, balloon, and/or stent during the procedure. We compared the pre-TAVR computed tomography aortic root characteristics, procedural data, short-, and long-term outcomes among the patients who eventually received an LM stent and those who did not.ResultsAmong 1925 TAVR patients, 41 (2.1%) underwent LM protection, and 10 of them (25%) had eventually a stent placed in the LM for threatened obstruction after valve deployment. In the native TAVR group (n = 35), 8 patients underwent LM stenting. A larger TAVR prosthesis, larger annular circumference (83.8 vs 76.1 mm; P = .038), lower ratio of sinotubular junction diameter to prosthesis size (1.02 vs 1.11; P = .032), and longer left coronary cusp (15.1 vs 13.9 mm; P = .18) were associated with higher incidence of LM stenting. In the valve-in-valve TAVR group (n = 6), 5 patients had a valve-to-coronary distance of less than 4 mm, and 2 of them received an LM stent. Both stent and nonstent groups had excellent outcomes with no major adverse cardiovascular events or coronary obstruction at 30 days. After a median follow-up of 351 days, 4 patients died (9.7%) (1 in the stent and 3 in the nonstent group), without any cases of late coronary obstruction or percutaneous coronary intervention in either group.ConclusionsLM protection with a coronary guidewire, balloon, or stent is a safe and effective method of coronary protection during TAVR in appropriately selected high-risk patients. Annular circumference, prosthesis size, left coronary cusp length, LM ostial height, and ratio of sinotubular junction to prosthesis size are important predictors of stent deployment.

Dataset Information

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

Publications

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

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