Results from SORIN GROUP’s long-term clinical randomized trialshowed that the SafeR pacing mode significantly reduces heart failure
events (death and hospitalization)
Previous studies have shown that unnecessary right ventricular pacing (Vp) has a detrimental effect on the hemodynamic function of the pacemaker patient’s heart. The ANSWER study evaluated whether the minimization of Vp using the SafeR algorithm improves clinical outcomes for dual chamber pacemaker (PM) patients implanted for sinus node disease (SND) or for atrio-ventricular block (AVB).
The percentage of Vp at one-year follow-up, the first primary endpoint, was significantly reduced in SafeR mode compared to a standard dual chamber pacing (DDD) mode (4.8% vs. 95.4%, p<0.001). This reduction was maintained after three years (11.5% vs. 93.6%, p<0.001). SafeR significantly reduced Vp in SND patients as well as in AVB patients without generating additional adverse events.
The second primary endpoint, the number of patients hospitalized for atrial fibrillation (AF) or heart failure (HF), was not significantly different between the two groups (p=0.33). Nevertheless, the ANSWER study showed a significant reduction of HF events; the SafeR mode provided a 51% relative risk reduction of cardiac death or HF hospitalization (p=0.02).
"As the principal investigator of the ANSWER study, I am very pleased with the long-term results which show that SafeR reduces the risk of heart failure hospitalizations and cardiac death. This is important for individual patients and has the potential to provide financial benefit for the healthcare system,” commented Dr.Stockburger.
About the ANSWER study
ANSWER is a multicenter, international controlled randomized trial with three-year follow-up that involved 44 European centers in seven countries. One month after enrollment, patients (n=650) were randomized to either the SafeR mode (n=314) or the DDD mode (n=318) (i.e., without minimized ventricular pacing) over a three-year period.
The following results were released:
About SafeR pacing mode
The SafeR algorithm was developed to manage sinus node dysfunction as well as all types of atrio-ventricular blocks (types I, II and III) and eliminate unnecessary ventricular pacing (Vp) at rest and exercise by combining the benefits of AAI and DDD pacing1. This signature feature is present in all
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1. Davy JM et al. Pacing clin electrophysiol 2012; 35(4): 392–402
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