Cardiac resynchronization therapy and its effects in patients with type 2 DIAbetes mellitus OPTimized in automatic vs. echo guided approach. Data from the DIA-OPTA investigators

Abstract

Objectives: To evaluate the effects of cardiac resynchronization therapy (CRTd) in patients with type 2 diabetes mellitus (T2DM) optimized via automatic vs. echocardiography-guided approach.

Background: The suboptimal atrio-ventricular (AV) and inter-ventricular (VV) delays optimization reduces CRTd response. Therefore, we hypothesized that automatic CRTd optimization might improve clinical outcomes in T2DM patients.

Methods: We designed a prospective, multicenter study to recruit, from October 2016 to June 2019, 191 consecutive failing heart patients with T2DM, and candidate to receive a CRTd. Study outcomes were CRTd responders rate, hospitalizations for heart failure (HF) worsening, cardiac deaths and all cause of deaths in T2DM patients treated with CRTd and randomly optimized via automatic (n 93) vs. echocardiography-guided (n 98) approach at 12 months of follow-up.

Results: We had a significant difference in the rate of CRTd responders (68 (73.1%) vs. 58 (59.2%), p 0.038), and hospitalizations for HF worsening (12 (16.1%) vs. 22 (22.4%), p 0.030) in automatic vs. echocardiography-guided group of patients. At multivariate Cox regression analysis, the automatic guided approach (3.636 [1.271-10.399], CI 95%, p 0.016) and baseline highest values of atrium pressure (automatic SonR values, 2.863 [1.537-6.231], CI 95%, p 0.006) predicted rate of CRTd responders. In automatic group, we had significant difference in SonR values comparing the rate of CRTd responders vs. non responders (1.24 ± 0.72 g vs. 0.58 ± 0.46 g (follow-up), p 0.001), the rate of hospitalizations for HF worsening events (0.48 ± 0.29 g vs. 1.18 ± 0.43 g, p 0.001), and the rate of cardiac deaths ( 1.13 ± 0.72 g vs. 0.65 ± 0.69 g, p 0.047).

Conclusions: Automatic optimization increased CRTd responders rate, and reduced hospitalizations for HF worsening. Intriguingly, automatic CRTd and highest baseline values of SonR could be predictive of CRTd responders. Notably, there was a significant difference in SonR values for CRTd responders vs. non responders, and about hospitalizations for HF worsening and cardiac deaths. Clinical trial ClinicalTrials.gov Identifier NCT04547244.

Keywords: Automatic CRTd optimization; Cardiac resynchronization therapy; Type 2 diabetes mellitus.

Fig. 1

Representation of study flow chart. CRTd: cardiac resynchronization therapy with a defibrillator; HF: heart failure

Fig. 2

a In upper part the SonR values (g) at baseline (left part) and at follow-up end in CRTd responders (green color) vs. CRTd non responders (red color) with the corresponding p value. In lower part the SonR values in g at baseline (left part) and at follow-up end in patients with hospital admission for heart failure (HF) worsening (red color) vs. patients without hospital admission for heart failure (HF) worsening (green color) with the corresponding p value. * is for statistical significant (p < 0.05). b In upper part the SonR values in g at baseline (left part) and at follow-up end for patients with all cause of deaths (red color) vs. survived patients (green color) with the corresponding p value. In lower part the SonR values in g at baseline (left part) and at follow-up end in patients with cardiac deaths (red color) vs. survived patients (green color) with the corresponding p value. * is for statistical significant (p < 0.05)

Fig. 3

Kaplan curves for “cumulative survival free” at 360 days of follow-up from Cardiac Resynchronization therapy with a defibrillator (CRTd) response (upper left, p < 0.05), hospital admission for heart failure (HF) worsening (upper right, p < 0.05), cardiac deaths (lower left, p > 0.05) and all cause of deaths (lower right, p > 0.05) comparing patients in Automatic CRTd group (green color) vs. Echo CRTd group (blue color). * is for statistical significant (p < 0.05)