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 heart failure (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 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 embolism.4
- Remote monitoring has been shown to reduce mortality in pacemaker patients.5
- The Assurity MRI pacemaker can help you identify patients at risk for stroke earlier, with clinically proven AT/atrial fibrillation (AF) diagnostic tools.4
- The Abbott remote follow-up system, Merlin.net™ Patient Care Network (PCN), reduces clinician6,7 and patient follow-up costs.7
- Wireless, radio-frequency telemetry offers faster access to clinical data, increasing the possibility for clinical efficiency at implant and follow-up.8
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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- St. Jude Medical. Remote Monitoring. Technical Monograph; GMCRM494. 2009.
- 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.
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