Managing all types of AV block and reducing unnecessary RV pacing.

SafeR allows for intelligent management of AV conduction, significantly reducing unnecessary RV pacing in all pacemaker patients, including AV block patients.1–8

How does it works

SafeR diagnoses all types of AV block: AAI > DDD

  • AVB III –> 2 consecutive blocked atrial events
  • AVB II –> 3 blocked atrial events out of 12 consecutive cycles
  • AVB I –> 6 consecutive long PR intervals
 

The ANSWER study1,7

The clinical benefits of SafeR were investigated during the ANSWER study after 3 years follow-up.1 The ANSWER study proved that SafeR is:

  • Safe & effective for all brady patients1,7
  • Proven to strongly reduce ventricular pacing for AV block patients as well as for SND patients1,7
  • Significantly increases the number of patients with less than 40% pacing1,7

 

 

Unique benefits of SafeR

Reduces VP while managing Long PR

SafeR is the only AV management solution proven to reduce ventricular pacing while at the same time managing long PR intervals.

Safe & effective

Proven to be safe and effective1,7 for all pacemaker patients even for patients with permanent or complete heart block.

Responds to rest and exercise

The duration of the PR intervals is programmable ranging from 200 to 450ms. The settings can be adjusted to suit the patient’s activity both at rest and during exercise.

Improves patient management

Offers a full diagnostic data and unique categorization of AVB episodes:

  • Detailed diagnosis of each AV block episode experienced by the patient
  • Report on the occurrence of AV block episodes at night and during the day
  • Evolution of PR duration versus heart rate
 

References:

  1. Stockburger M, et al. Long-term clinical effects of ventricular pacing reduction with a changeover mode to minimize ventricular pacing in general population (ANSWER study). European Heart Journal. 2015;36:151–57.
  2. Andersen HR, et al. Long-term follow-up of patients from a randomized trial of atrial versus ventricular pacing for sick-sinus syndrome. Lancet. 1997;350:1210–16.
  3. Skanes AC, et al. Progression to chronic atrial fibrillation after pacing: The Canadian Trial Of Physiologic Pacing (CTOPP). J Am Coll Cardiol. 2001;38:167–72.
  4. Nielsen J, et al. A randomized comparison of atrial and dual chamber pacing in 177 consecutive patients with sick sinus syndrome. J Am Coll Cardiol. 2003; 42: 614–23.
  5. Sweeney M, et al. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation. 2003;107:2932–37.
  6. Wilkoff BL, et al. Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator (DAVID trial). JAMA. 2002;288:3115–23.
  7. Stockburger M, et al. Safety and efficiency of ventricular pacing prevention with an AAI-DDD changeover mode in patients with sinus node disease or atrioventricular block: impact on battery longevity-a substudy of the ANSWER trial. Europace 2016;18:739–46.
  8. Benkemoun H, et al. Optimizing pacemaker longevity with pacing mode and settings programming: results from a pacemaker multicenter registry. Pacing Clin Electrophysiol 2012;35:403–08.
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