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

Arianna Di Molfetta, Giovanni B. Forleo, Luca Santini, Libera Fresiello, Lida P. Papavasileiou, Giulia Magliano, Domenico Sergi, Ambrogio Capria, Francesco Romeo, Gianfranco Ferrari

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)273-283
Number of pages11
JournalJournal of Artificial Organs
Volume16
Issue number3
DOIs
Publication statusPublished - 2013

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Cardiac resynchronization therapy
Cardiac Resynchronization Therapy
Randomized Controlled Trials
Cardiovascular Models
Standard of Care
Clinical Trials

Keywords

  • AV and VV optimization
  • Cardiac resynchronization therapy
  • Cardiovascular modeling
  • Left ventricular reverse remodeling
  • Lumped parameter models

ASJC Scopus subject areas

  • Biomaterials
  • Biomedical Engineering
  • Cardiology and Cardiovascular Medicine
  • Medicine (miscellaneous)

Cite this

Di Molfetta, A., Forleo, G. B., Santini, L., Fresiello, L., Papavasileiou, L. P., Magliano, G., ... Ferrari, G. (2013). A novel methodology for AV and VV delay optimization in CRT: Results from a randomized pilot clinical trial. Journal of Artificial Organs, 16(3), 273-283. https://doi.org/10.1007/s10047-013-0701-9

A novel methodology for AV and VV delay optimization in CRT : Results from a randomized pilot clinical trial. / Di Molfetta, Arianna; Forleo, Giovanni B.; Santini, Luca; Fresiello, Libera; Papavasileiou, Lida P.; Magliano, Giulia; Sergi, Domenico; Capria, Ambrogio; Romeo, Francesco; Ferrari, Gianfranco.

In: Journal of Artificial Organs, Vol. 16, No. 3, 2013, p. 273-283.

Research output: Contribution to journalArticle

Di Molfetta, A, Forleo, GB, Santini, L, Fresiello, L, Papavasileiou, LP, Magliano, G, Sergi, D, Capria, A, Romeo, F & Ferrari, G 2013, 'A novel methodology for AV and VV delay optimization in CRT: Results from a randomized pilot clinical trial', Journal of Artificial Organs, vol. 16, no. 3, pp. 273-283. https://doi.org/10.1007/s10047-013-0701-9
Di Molfetta, Arianna ; Forleo, Giovanni B. ; Santini, Luca ; Fresiello, Libera ; Papavasileiou, Lida P. ; Magliano, Giulia ; Sergi, Domenico ; Capria, Ambrogio ; Romeo, Francesco ; Ferrari, Gianfranco. / A novel methodology for AV and VV delay optimization in CRT : Results from a randomized pilot clinical trial. In: Journal of Artificial Organs. 2013 ; Vol. 16, No. 3. pp. 273-283.
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