title: Primary results from the SmartDelay determined AV optimization: a comparison to other AV delay methods used in cardiac resynchronization therapy (SMART-AV) trial: a randomized trial comparing empirical, echocardiography-guided, and algorithmic atrioventricular delay programming in cardiac resynchronization therapy.
abstract: BACKGROUND
  one variable that may influence cardiac resynchronization therapy response is the programmed atrioventricular (AV) delay. The SmartDelay determined av optimization: a comparison to other AV delay methods used in cardiac resynchronization therapy (SMART-AV) trial prospectively randomized patients to a fixed empirical AV delay (120 milliseconds), echocardiographically optimized AV delay, or AV delay optimized with SmartDelay, an electrogram-based algorithm.
  
  
  RESULTS
  a total of 1014 patients (68% men; mean age, 66 ± 11 years; mean left ventricular ejection fraction, 25 ± 7%) who met enrollment criteria received a cardiac resynchronization therapy defibrillator, and 980 patients were randomized in a 1:1:1 ratio. All patients were programmed (DDD-60 or DDDR-60) and evaluated after implantation and 3 and 6 months later. The primary end point was left ventricular end-systolic volume. Secondary end points included New York Heart Association class, quality-of-life score, 6-minute walk distance, left ventricular end-diastolic volume, and left ventricular ejection fraction. The medians (quartiles 1 and 3) for change in left ventricular end-systolic volume at 6 months for the SmartDelay, echocardiography, and fixed arms were -21 mL (-45 and 6 mL), -19 mL (-45 and 6 mL), and -15 mL (-41 and 6 mL), respectively. No difference in improvement in left ventricular end-systolic volume at 6 months was observed between the SmartDelay and echocardiography arms (P=0.52) or the SmartDelay and fixed arms (P=0.66). Secondary end points, including structural (left ventricular end-diastolic volume and left ventricular ejection fraction) and functional (6-minute walk, quality of life, and New York Heart Association classification) measures, were not significantly different between arms.
  
  
  CONCLUSIONS
  neither SmartDelay nor echocardiography was superior to a fixed AV delay of 120 milliseconds. The routine use of AV optimization techniques assessed in this trial is not warranted. However, these data do not exclude possible utility in selected patients who do not respond to cardiac resynchronization therapy.
authors.affiliation: Division of Cardiology, VCU School of Medicine, PO Box 980053, Richmond, VA 23298-0053, USA. kellenbogen@mcvh-vcu.edu
authors.forename: Kenneth A
authors.initials: KA
authors.lastname: Ellenbogen
authors.forename: Michael R
authors.initials: MR
authors.lastname: Gold
authors.forename: Timothy E
authors.initials: TE
authors.lastname: Meyer
authors.forename: Ignacio
authors.initials: I
authors.lastname: Fernndez Lozano
authors.forename: Suneet
authors.initials: S
authors.lastname: Mittal
authors.forename: Alan D
authors.initials: AD
authors.lastname: Waggoner
authors.forename: Bernd
authors.initials: B
authors.lastname: Lemke
authors.forename: Jagmeet P
authors.initials: JP
authors.lastname: Singh
authors.forename: Francis G
authors.initials: FG
authors.lastname: Spinale
authors.forename: Jennifer E
authors.initials: JE
authors.lastname: Van Eyk
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Whitehill
authors.forename: Stanislav
authors.initials: S
authors.lastname: Weiner
authors.forename: Maninder
authors.initials: M
authors.lastname: Bedi
authors.forename: Joshua
authors.initials: J
authors.lastname: Rapkin
authors.forename: Kenneth M
authors.initials: KM
authors.lastname: Stein
mesh_terms: D000368:Aged; D000465:Algorithms; D001283:Atrioventricular Node / Q000503:physiopathology*; D058406:Cardiac Resynchronization Therapy / Q000379:methods*; D017147:Defibrillators, Implantable; D004452:Echocardiography; D005260:Female; D006333:Heart Failure / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D013318:Stroke Volume / Q000502:physiology; D013599:Systole / Q000502:physiology; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left / Q000503:physiopathology / Q000628:therapy*; D016138:Walking / Q000502:physiology