CARDIOVASCULAR
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Clinical Evidence

In addition to allowing for full-body, 1.5T and 3T MRI scans,* the Assurity MRI™ pacemaker provides other clinical benefits.

Minimize Risk of Heart Failure Hospitalization

Unnecessary right ventricular (RV) pacing can exacerbate heart conditions:

  • Pacing > 40% can lead to increased HF hospitalizations and mortality1
  • Patients with low RV pacing (0-9%) have the same negative outcomes as those with high RV pacing (40-49%)2

The Abbott Ventricular Intrinsic Preference (VIP™) algorithm with dynamic AV delay is clinically proven to reduce unnecessary RV pacing.3 The VIP algorithm is shown to reduce heart-failure-related hospitalization3, and offers RV pacing at desirable levels (10-19%).3

Early Insight

The Assurity MRI pacemaker works together with a wireless remote monitoring system. Remote monitoring capabilities, combined with the audible patient notifier, provide earlier notification of actionable clinical events—allowing you to detect patient status changes sooner.

  • The ASSERT clinical trial has shown that subclinical atrial tachyarrhythmias (AT) are associated with a 2.5-fold increased risk of stroke or systemic embolism4
  • Remote monitoring has been shown to reduce mortality in pacemaker patients5
  • The Assurity MRI pacemaker can help you identify patients at risk for stroke earlier, with clinically proven AT/AF diagnostic tools4
  • The Abbott remote follow-up system, Merlin.net™ Patient Care Network (PCN), reduces clinician6,7 and patient follow-up costs7
  • Wireless, radio-frequency telemetry offers faster access to clinical data, increasing the possibility for clinical efficiency at implant and follow-up8

References

*For additional information about specific MR Conditional devices and leads, inlcuding scan parameters, warnings, precautions, adverse conditions to MRI scanning and potential adverse events, please refer to the Abbott MRI Ready Systems Manual.

  1. Sweeney MO, Hellkamp AS, Ellenbogen KA, Greenspon AJ, Freedman RA, Lee KL & Lamas GA. 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, 2932-2037.
  2. Olshansky B, Day J, Lerew D, Brown S, & Stolen K. Eliminating right ventricular pacing may not be best for patients requiring implantable cardioverter–defibrillators. HeartRhythm, 2007;4(7), 886-891.
  3. Faulknier B, Richards M. The association of the use of the Ventricular Intrinsic Preference (VIP™) feature with heart failure hospitalization in pacemaker patients. Paper presented at the XV International Symposium on Progress in Clinical Pacing; December 4-7, 2012; Rome, Italy.
  4. Healey JS, Connolly SJ, Gold MR, Israel CW, Van Gelder IC, Capucci A, … Hohnloser SH. Subclinical atrial fibrillation and the risk of stroke. New England Journal of Medicine. 2012;366, 120-129.
  5. Mittal, S., Piccini, J. P., Snell, J., Prillinger, J. B., Dalal, N., & Varma, N. (2016). Improved survival in patients enrolled promptly into remote monitoring following cardiac implantable electronic device implantation. Journal of Interventional Cardiac Electrophysiology: an international journal of arrhythmias and pacing, 46(2), 129–136. https://doi.org/10.1007/s10840-016-0112-y
  6. Lazarus A. Remote, wireless, ambulatory monitoring of implantable pacemakers, cardioverter defibrillators, and cardiac resynchronization therapy systems: Analysis of a worldwide database. Pacing and Clinical Electrophysiology. 2007;30(1), S2-S12.
  7. St. Jude Medical. Remote Monitoring. Technical Monograph; GMCRM494. 2009.
  8. Crossley GH, Boyle A, Vitense H, Chang Y, Mead RH, & CONNECT Investigators. The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) trial: The value of wireless remote monitoring with automatic clinician alerts. Journal of the American College of Cardiology. 2011;57(10), 1181-1189.
Indications, Safety & Warnings

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