title: Long-term clinical effects of ventricular pacing reduction with a changeover mode to minimize ventricular pacing in a general pacemaker population.
abstract: OBJECTIVE
  Right ventricular pacing (VP) has been hypothesized to increase the risk in heart failure (HF) and atrial fibrillation (AF). The ANSWER study evaluated, whether an AAI-DDD changeover mode to minimize VP (SafeR) improves outcome compared with DDD in a general dual-chamber pacemaker population.
  
  
  RESULTS
  ANSWER was a randomized controlled multicentre trial assessing SafeR vs. standard DDD in sinus node disease (SND) or AV block (AVB) patients. After a 1-month run-in period, they were randomized (1 : 1) and followed for 3 years. Pre-specified co-primary end-points were VP and the composite of hospitalization for HF, AF, or cardioversion. Pre-specified secondary end-points were cardiac death or HF hospitalizations and cardiovascular hospitalizations. ANSWER enrolled 650 patients (52.0% SND, 48% AVB) at 43 European centres and randomized in SafeR (n = 314) or DDD (n = 318). The SafeR mode showed a significant decrease in VP compared with DDD (11.5 vs. 93.6%, P < 0.0001 at 3 years). Deaths and syncope did not differ between randomization arms. No significant difference between groups [HR = 0.78; 95% CI (0.48-1.25); P = 0.30] was found in the time to event of the co-primary composite of hospitalization for HF, AF, or cardioversion, nor in the individual components. SafeR showed a 51% risk reduction (RR) in experiencing cardiac death or HF hospitalization [HR = 0.49; 95% CI (0.27-0.90); P = 0.02] and 30% RR in experiencing cardiovascular hospitalizations [HR = 0.70; 95% CI (0.49-1.00); P = 0.05].
  
  
  CONCLUSIONS
  SafeR safely and significantly reduced VP in a general pacemaker population though had no effect on hospitalization for HF, AF, or cardioversion, when compared with DDD.
authors.affiliation: Charité University Hospital, Experimental and Clinical Research Center (ECRC), Berlin, Germany Department of Cardiology, Havelland Kliniken GmbH, Nauen, Germany martin.stockburger@charite.de.
authors.forename: Martin
authors.initials: M
authors.lastname: Stockburger
authors.affiliation: Arrhythmia Department, Clinique Pasteur, Toulouse, France.
authors.forename: Serge
authors.initials: S
authors.lastname: Boveda
authors.affiliation: Arrhythmia Department, Cardiovascular Institute, San Carlos University Hospital, Madrid, Spain Arrhythmia Department, Hospital Ramón y Cajal, Madrid, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Moreno
authors.affiliation: North Hospital, Saint-Etienne, France.
authors.forename: Antoine
authors.initials: A
authors.lastname: Da Costa
authors.affiliation: Narodny Ustav Srdcovych a Cievnych Chorob, Bratislava, Slovak Republic.
authors.forename: Robert
authors.initials: R
authors.lastname: Hatala
authors.affiliation: Klinikum Coburg, Coburg, Germany.
authors.forename: Johannes
authors.initials: J
authors.lastname: Brachmann
authors.affiliation: Herzzentrum Brandenburg, Cardiology, Bernau, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Butter
authors.affiliation: Hospital Clinico Universitario de Santiago, Santiago de Compostela, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Garcia Seara
authors.affiliation: Sorin Group International SA, Lausanne, Switzerland.
authors.forename: Mara
authors.initials: M
authors.lastname: Rolando
authors.affiliation: Arrhythmia Unit, Cardiology Department, University Hospital, Grenoble, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Defaye
mesh_terms: D000368:Aged; D054537:Atrioventricular Block / Q000401:mortality / Q000628:therapy*; D002304:Cardiac Pacing, Artificial / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D016757:Death, Sudden, Cardiac / Q000209:etiology; D004554:Electric Countershock / Q000401:mortality / Q000706:statistics & numerical data; D004868:Equipment Failure; D005260:Female; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D010138:Pacemaker, Artificial / Q000009:adverse effects; D011446:Prospective Studies; D012804:Sick Sinus Syndrome / Q000401:mortality / Q000628:therapy*; D016037:Single-Blind Method; D016896:Treatment Outcome
keywords: Atrial fibrillation; Dual-chamber pacing; Heart failure; Minimization of ventricular pacing; Randomized controlled trial; SafeR