Impact of diabetes mellitus on female subjects undergoing transcatheter aortic valve implantation: Insights from the WIN-TAVI international registry

Highlights

• One fourth of female subjects undergoing transcatheter aortic valve implantation have diabetes mellitus at baseline.

• DM female patients undergoing TAVI have higher comorbidities and lower transvalvular gradients.

• DM in female subjects is associated with lower risk of VARC-2 life threatening bleeding up to 1 year after TAVI.

Abstract

Background

Female subjects constitute half of all transcatheter aortic valve implantation (TAVI) candidates, but the association between important comorbidities such as diabetes mellitus (DM) and clinical outcomes after TAVI remains unclear in this group.

Method

WIN-TAVI is a real-world international registry of exclusively female subjects undergoing TAVI. The study population was stratified into those with (DM) and those without DM (NDM). Valve Academic Research Consortium (VARC)-2 efficacy (composite of all-cause death, stroke, myocardial infarction, hospitalization for valve-related symptoms or worsening congestive heart failure, or valve-related dysfunction) was the primary endpoint for this analysis.

Results

Of the 1012 subjects included in this study, 264 (26.1%) had DM at baseline. DM patients were younger but had a higher burden of comorbidities. There were no differences in VARC-2 efficacy events between DM and NDM patients at 30 days or 1 year. Conversely, patients with DM had a lower risk of VARC-2 life threatening bleeding at 30 days and 1 year after TAVI compared to NDM patients, which remained significant even after multivariable adjustment (HR, 0.34, 95% CI, 0.12–0.99; p = .047). In the subgroup analysis, insulin-dependent DM was not associated with an increased risk of adverse outcomes.

Conclusions

Among female patients undergoing TAVI, more than one-fourth of the subjects presented with DM. At 1-year follow-up, DM was associated with lower bleeding complications and no increase in the risk of other adverse events, including mortality, after TAVI.

Introduction

Degenerative aortic stenosis (AS) is the most frequently encountered valvular heart disorder requiring treatment in developed countries. If severe symptomatic AS is left untreated, it culminates in significantly impaired survival [1]. Although originally ascribed to tissue degeneration and wear-and-tear from older age, pathophysiology of AS has now been ascertained to occur along a continuum of inflammation and calcification [2]. Therefore, metabolic derangements in diabetes mellitus (DM) and female sex, both of which have been associated with higher levels of circulating inflammatory biomarkers, have also been associated with more severe AS and worse outcomes [3,4].

Transcatheter aortic valve implantation (TAVI) has emerged as a viable treatment option, especially in elderly patients across the entire surgical risk spectrum [[5], [6], [7]]. Several studies have been conducted in patients ranging from inoperable to high, intermediate, and low surgical risk to establish the efficacy and safety of TAVI compared to SAVR. Approximately 200,000 patients are eligible for TAVI annually between North America and Europe, and these numbers are only expected to rise as the indications for TAVI are broadened [7,8]. Although about half of all subjects undergoing TAVI are female, the association between important comorbidities like DM and clinical outcomes after TAVI in this subgroup remain uncertain [9,10].

The Women's International Transcatheter Aortic Valve implantation (WIN-TAVI) registry is the only international study that exclusively enrolled female subjects with severe AS undergoing TAVI [11]. In this subanalysis, we aimed to evaluate the prevalence of DM among female TAVI patients and its influence on clinical outcomes up to 1-year follow-up.