A novel methodology for AV and VV delay optimization in CRT: Results from a randomized pilot clinical trial

The aim of this work was to determine whether the use of a newly developed methodology (Alg1) for AV and VV optimization improves cardiac resynchronization therapy (CRT) clinical and echocardiographic (ECHO) outcomes. In this single-center pilot clinical trial, 80 consecutive patients (79 % male; 70.1 ± 11.2 years) receiving CRT were randomly assigned to AV and VV optimization using Alg1 (group A) or standard commercial procedures (group B). Clinical status and ECHOs were analyzed at baseline (-0), 3 (fu1), and 6 months (fu2) of follow-up evaluating left ventricular end systolic (LVESV) and end diastolic (LVEDV) volumes, ejection fraction (EF), Minnesota test, and 6-min walk test (6MWT). Alg1 is based on a cardiovascular model fed with patient data. Baseline characteristics did not differ significantly between groups. Group A had a better clinical outcome and reverse remodeling. Remodeling was calculated as the difference (Δ) between fu1 and -0 and between fu2 and fu1, respectively: [LVESV (ml): ΔA-fu1 = -55.3, ΔB-fu1 = -13.5, p-fu1 = 0.002; ΔA-fu2 = -22.8, ΔB-fu2 = 3.0, p-fu2 = 0.04], [LVEDV (ml): ΔA-fu1 = -61.9, ΔB-fu1 = -16.1, p-fu1 = 0.01; ΔA-fu2 = -30.4, ΔB-fu2 = 11.3, p-fu2 = 0.02]; Minnesota test: total (p-fu1 = 0.01; p-fu2 = 0.04), physical (p-fu1 = 0.01; p-fu2 = 0.03) and emotional scores (p-fu1 = 0.04; p-fu2 = 0.03) and in 6MWT (m) (p-fu2 = 0.008). No statistically significant difference was observed in QRS width. Compared with current standard of care, CRT optimization using Alg1 is associated with better outcomes, showing the power of a tailored CRT.