A randomized pilot study of optimization of cardiac resynchronization therapy in sinus rhythm patients using a peak endocardial acceleration sensor vs. standard methods

Philippe Ritter, Peter Paul H M Delnoy, Luigi Padeletti, Maurizio Lunati, Herbert Naegele, Alberto Borri-Brunetto, Jorge Silvestre

Research output: Contribution to journalArticle

Abstract

AimsNon-response rate to cardiac resynchronization therapy (CRT) might be decreased by optimizing device programming. The Clinical Evaluation on Advanced Resynchronization (CLEAR) study aimed to assess the effects of CRT with automatically optimized atrioventricular (AV) and interventricular (VV) delays, based on a Peak Endocardial Acceleration (PEA) signal system. Methods and resultsThis multicentre, single-blind study randomized patients in a 1: 1 ratio to CRT optimized either automatically by the PEA-based system, or according to centres' usual practices, mostly by echocardiography. Patients had heart failure (HF) New York Heart Association (NYHA) functional class III/IV, left ventricular ejection fraction (LVEF) 150 or >120 ms with mechanical dyssynchrony. Follow-up was 1 year. The primary endpoint was the proportion of patients who improved their condition at 1 year, based on a composite of all-cause death, HF hospitalizations, NYHA class, and quality of life. In all, 268 patients in sinus rhythm (63 men; mean age: 73.1 ± 9.9 years; mean NYHA: 3.0 ± 0.3; mean LVEF: 27.1 ± 8.1; and mean QRS duration: 160.1 ± 22.0 ms) were included and 238 patients were randomized, 123 to PEA and 115 to the control group. At 1 year, 76 of patients assigned to PEA were classified as improved, vs. 62 in the control group (P=0.0285). The percentage of patients with improved NYHA class was significantly (P=0.0020) higher in the PEA group than in controls. Fatal and non-fatal adverse events were evenly distributed between the groups. ConclusionPEA-based optimization of CRT in HF patients significantly increased the proportion of patients who improved with therapy, mainly through improved NYHA class, after 1 year of follow-up.

Original languageEnglish
Pages (from-to)1324-1333
Number of pages10
JournalEuropace
Volume14
Issue number9
DOIs
Publication statusPublished - Sep 2012

Keywords

  • Atrioventricular delay
  • Cardiac dyssynchrony
  • Cardiac resynchronization therapy
  • Heart failure
  • Peak endocardial acceleration

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

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