The association of diabetes mellitus treated with oral antidiabetic drugs and insulin with mortality after transcatheter valve implantation: a 3-year follow-up of the TAVIK registry

Abstract

Background Diabetes mellitus (DM) on insulin is a patient-related factor in the assessment of surgical risk based on the EuroSCORE II and, as such, it confers additional risk on outcomes after transcatheter aortic valve implantation (TAVI). The aim of this study was to investigate the effect of diabetes mellitus treated with insulin and oral antidiabetic drugs on clinical outcomes after TAVI. Methods This study is an analysis of 2000 patients who underwent TAVI between 2008 and 2015. Patients were stratified post hoc into the following categories: without diabetes (n = 1337), with diabetes treated with oral antidiabetic drugs (OAD; n = 387) and with diabetes treated using insulin (n = 276). Results There was no significant difference in device success (89.5% vs 89.4% vs 88.8%, adjusted odds ratio (adjOR) 1.10 [95% confidence interval (CI) 0.64–1.91]) and VARC-2-defined major complications among the three groups of patients (without DM, OAD, and insulin, respectively). Minor but not major or disabling strokes (adjOR 2.19; 95% CI 1.11–4.3) and overall renal complications (but not stage 2/3 alone) (adjOR 1.46; 95% CI 1.18–1.81) were more common in patients with diabetes than in those without diabetes. Insulin-treated patients had a significantly lower survival rate than that of patients with orally treated diabetes and of those without diabetes at 1 year (75.7% vs. 84.5% vs 84.7%, pairwise p < 0.01) and 3 years (56.9% vs. 65.9% vs. 67.9%, adj. p < 0.05) after TAVI. However, insulin-treated diabetes was not identified as an independent risk factor for higher mortality in the first (HR 1.29; 95% CI 0.97–1.72, p = 0.084) and 3rd years (HR 1.21; 95% CI 0.98–1.49; p = 0.079) after multivariable adjustment. Conclusions Although insulin-dependent DM is an established component of surgical risk assessment, it was not identified as an independent factor associated with reduced survival in TAVI. DM treated with oral antidiabetic drugs or insulin may have less role in decision making of treatment in TAVI candidates.

Diabetes Mellitus and Its Implications in Aortic Stenosis Patients

“…p < 0.05) after TAVI. However, insulin-treated diabetes was not identified as an independent risk factor for higher mortality in the 1st (HR 1.29; 95% CI 0.97-1.72, p = 0.084) and 3rd years (HR 1.21; 95% CI 0.98-1.49; p = 0.079) after multivariable adjustment [116]. Similarly, DM was not associated with a higher 30-day or 12-month allcause mortality after TAVI, nor was it associated with decreased post-procedural QoL [117].…”

Impact of diabetes mellitus on outcome after transcatheter aortic valve replacement: Identifying high‐risk diabetic population from the OCEAN‐TAVI registry

“…These findings question whether 1‐year is sufficient period to evaluate impact of DM on clinical outcome in patients with TAVR. Most recent multicenter registry, 10 which analyzed data of 3‐year follow up, suggested that DM group had significantly higher mortality. However, previous studies which evaluated diabetic effects on 1‐ or 2‐year mortality have reported mixed results 5,6,8,9 .…”

“…Diabetes mellitus (DM) is a well‐established marker of poor prognosis in various cardiovascular diseases 3,4 . However, controversy remains regarding impact of DM on clinical outcomes after TAVR 5–12 . Various factors may exist for the different results among previous reports.…”

“…Various factors may exist for the different results among previous reports. For instance, data of glycated hemoglobin A1c (HbA1c), which demonstrates glycemic control and is one of the most important diagnostic tools of DM, were not available in most of the previous studies concerning diagnostic accuracy and its impact on clinical outcome after TAVR 7–12 . In the present study, we aimed to investigate the association between DM and clinical outcome of TAVR and to identify the specific cohort which was considered to be a beneficial target of DM control, by using data of a prospective multicenter registry.…”

Gender Differences after Transcatheter Aortic Valve Replacement (TAVR): Insights from the Italian Clinical Service Project

“…DM is an established component of pre-operative risk assessment in AS patients and was an independent predictor of mortality also in our research. Although diabetic patients presented an overall lower survival than those without diabetes, insulin-treated diabetes was not an independent risk factor for higher mortality in a recent analysis [ 28 ]. Among female patients of the WIN-TAVI international registry, DM was not associated with increased mortality after TAVR [ 29 ].…”