PMID- 22549295 OWN - NLM STAT- MEDLINE DCOM- 20130221 LR - 20220317 IS - 1532-2092 (Electronic) IS - 1099-5129 (Linking) VI - 14 IP - 9 DP - 2012 Sep TI - A randomized pilot study of optimization of cardiac resynchronization therapy in sinus rhythm patients using a peak endocardial acceleration sensor vs. standard methods. PG - 1324-33 LID - 10.1093/europace/eus059 [doi] AB - AIMS: Non-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 RESULTS: This 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) <35%, QRS duration >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. CONCLUSION: PEA-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. FAU - Ritter, Philippe AU - Ritter P AD - University Hospital of Bordeaux, Pessac, France. ritterph@free.fr FAU - Delnoy, Peter Paul H M AU - Delnoy PP FAU - Padeletti, Luigi AU - Padeletti L FAU - Lunati, Maurizio AU - Lunati M FAU - Naegele, Herbert AU - Naegele H FAU - Borri-Brunetto, Alberto AU - Borri-Brunetto A FAU - Silvestre, Jorge AU - Silvestre J LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20120501 PL - England TA - Europace JT - Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology JID - 100883649 SB - IM MH - Aged MH - Aged, 80 and over MH - Cardiac Resynchronization Therapy/*methods MH - Cause of Death MH - Electrocardiography MH - Endocardium/*physiopathology MH - Female MH - Heart Failure/mortality/physiopathology/*therapy MH - Humans MH - Male MH - Middle Aged MH - Pilot Projects MH - Quality of Life MH - Stroke Volume/physiology MH - Treatment Outcome EDAT- 2012/05/03 06:00 MHDA- 2013/02/22 06:00 CRDT- 2012/05/03 06:00 PHST- 2012/05/03 06:00 [entrez] PHST- 2012/05/03 06:00 [pubmed] PHST- 2013/02/22 06:00 [medline] AID - eus059 [pii] AID - 10.1093/europace/eus059 [doi] PST - ppublish SO - Europace. 2012 Sep;14(9):1324-33. doi: 10.1093/europace/eus059. Epub 2012 May 1.