Intravenous iron supplement for iron deficiency in patients with severe aortic stenosis scheduled for transcatheter aortic valve implantation: results of the IIISAS randomised trial

Abstract

The aim of this trial was to evaluate whether intravenous iron could provide benefit beyond transcatheter aortic valve implantation (TAVI) in iron-deficient patients with severe aortic stenosis.

July 2022 at a glance: focus on prognosis, devices and valvular heart disease

“…Only 104 patients who completed the 6‐min walk test at baseline and 3 months after successful TAVI (primary endpoint) were included in the modified intention‐to‐treat population. Iron stores were restored in the 76% of treated patients vs. 13% of the untreated, but no changes in 6‐min walk distance, quality of life and number of adverse events were reported 25 …”

“…Iron stores were restored in the 76% of treated patients vs. 13% of the untreated, but no changes in 6-min walk distance, quality of life and number of adverse events were reported. 25 Left atrial function is a major prognostic index in patients with HF. 26,27 Iliadis et al 28 investigated the role of left atrial volume index (LAVi) in a large cohort of 1074 patients with secondary mitral regurgitation (SMR) undergoing transcatheter edge-to-edge mitral valve repair.…”

Enough iron in transcatheter aortic valve implantation already

“…and the high drop-out rate, as this trial was specifically designed as a pragmatic trial, feasible to conduct at a single centre. 1 Although neutral, the findings of this trial are not discouraging. Rather, they remind us of the successful development of TAVI, from an experimental approach approximately 20 years ago, which was primarily used in patients with aortic stenosis and prohibitive surgical risk, to a guideline-recommended, standard-of-care intervention nowadays, which even competes with surgical aortic valve repair to be the primary treatment option for patients with a low surgical risk.…”

“…In this meticulously conducted single‐centre study, the authors observe no effect of i.v. iron supplementation on clinical endpoints such as 6‐min walk distance, quality of life, or symptoms 1 …”

“…iron supplementation in this study population. When interpreting the neutral results of this randomized trial, one must bear in mind its limitations, which are mainly the small sample size and the high drop‐out rate, as this trial was specifically designed as a pragmatic trial, feasible to conduct at a single centre 1 …”