title: A novel methodology for AV and VV delay optimization in CRT: results from a randomized pilot clinical trial.
abstract: 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.
authors.affiliation: Cardiovascular Engineering Group, Institute of Clinical Physiology, Italian National Research Council, via San Martino della Battaglia, 44, 00185, Rome, Italy, arianna.dimolfetta@ifc.cnr.it.
authors.forename: Arianna
authors.initials: A
authors.lastname: Di Molfetta
authors.forename: Giovanni B
authors.initials: GB
authors.lastname: Forleo
authors.forename: Luca
authors.initials: L
authors.lastname: Santini
authors.forename: Libera
authors.initials: L
authors.lastname: Fresiello
authors.forename: Lida P
authors.initials: LP
authors.lastname: Papavasileiou
authors.forename: Giulia
authors.initials: G
authors.lastname: Magliano
authors.forename: Domenico
authors.initials: D
authors.lastname: Sergi
authors.forename: Ambrogio
authors.initials: A
authors.lastname: Capria
authors.forename: Francesco
authors.initials: F
authors.lastname: Romeo
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Ferrari
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D058406:Cardiac Resynchronization Therapy / Q000379:methods*; D005260:Female; D006333:Heart Failure / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008955:Models, Cardiovascular; D010865:Pilot Projects; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left / Q000503:physiopathology / Q000628:therapy*