Product Education Brief: Integrated bipolar RV leads concomitant with other intracardiac hardware
Transvenous Defibrillation Leads
Original Date of Communication:
February 2026
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Applicable Product
Integrated bipolar, transvenous, right ventricular, defibrillation leads (including OmniaSecure™) concomitantly implanted with any other intracardiac hardware (abandoned or otherwise)
Overview
Integrated bipolar (IB), transvenous, right ventricular (RV) defibrillation leads utilize the RV high-voltage coil in a dual-purpose function: as a defibrillation electrode and as the dedicated anode in the pace/sense circuit.
As such, the anode of the pace/sense circuit in an IB defibrillation lead includes the full surface area of the defibrillation coil, which can be >370-600mm2, depending on lead model.1,2 True Bipolar (TB) transvenous RV lead's pace/sense anode ring surface area can be much smaller at ~25mm2.3 If TB leads are programmed IB to utilize the defibrillation coil as the anode, similar surface area considerations should be made.
Implant Considerations
Accurate sensing is imperative for proper function of a defibrillators' algorithms and therapies. Implanting an IB defibrillation lead in a chamber where other hardware exists may cause sensing interference due to mechanical interactions.1 The contact between an RV anode and other hardware is known as "chatter" or "noise".
OmniaSecure labeling states that previously implanted pacemakers and implantable cardioverter defibrillators should generally be explanted.1 In scenarios where an IB RV lead must be implanted in a chamber with existing hardware, allow enough space between the separate systems to avoid sensing interference.1,4 Published literature describes cases of oversensing, under-pacing, and inappropriate therapy when the anode of an IB RV lead contacted other hardware in the cardiac chamber.5,6,7 In some of these cases, chatter was reduced when sensitivity was adjusted.8
Medtronic OmniaSecure training recommends starting RV sensitivity at 0.45mV and suggests consideration for 0.6mV if sensing can be improved at this lower sensitivity setting.
Summary
Consider all potential interactions when multiple products are implanted in the RV*; including, but not limited to, chatter on active electrodes and/or abrasion between lead bodies.9 Due to the larger anode size in an IB RV lead circuit compared to a TB RV lead circuit, there is a greater potential of electrode interference when an active IB RV lead is implanted concomitant with other RV hardware compared to an active TB RV lead.
*Abandoned leads should be capped to avoid transmitting electrical signals.1
1Medtronic OmniaSecure™ MRI SureScan 3930M Manual Document Number: M007754C001 REV. D
2Boston Scientific Reliance 4-Front™ Physician's Lead Manual Document Number: 92482151-001
3Medtronic SPRINT QUATTRO SECURE S MRI™ SURESCAN™ 6935M Manual Document Number: M984256A001 REV. A
4Medtronic Micra™ VR2 MC2VR01 Manual Document Number: M019292C001 REV. F
5Sossalla S, Seegers J, Luthje L, Sohns C, Zabel M, Vollmann D. Ventricular Oversensing after ICD Lead Replacement: What Is the Mechanism? Pacing and Clinical Electrophysiology. 2013;37(8):1076-1079. doi:https://doi.org/10.1111/pace.12316
6Pfitzner P, Trappe HJ. Oversensing in a Cardioverter Defibrillator System Caused by Interaction Between Two Endocardial Defibrillation Leads in the Right Ventricle. Pacing and Clinical Electrophysiology. 1998;21(4):764-768. doi:https://doi.org/10.1111/j.1540-8159.1998.tb00136.x
7Gunderson BD, Swerdlow CD, Wilcox JM, Hayman JE, Ousdigian KT, Ellenbogen KA. Causes of ventricular oversensing in implantable cardioverter-defibrillators: Implications for diagnosis of lead fracture. Heart Rhythm. 2010;7(5):626-633. doi:https://doi.org/10.1016/j.hrthm.2010.01.013
8François C, De Becker B, De Smet M, et al. Interaction between left bundle branch area pacing lead and defibrillator lead: A case report. HeartRhythm Case Reports. 2024;10(1):72-75. doi:https://doi.org/10.1016/j.hrcr.2023.10.026
9Mahajan A, Pokharel P, Vijayaraman P. Lead-to-lead interaction leading to left bundle branch area pacing lead failure. HeartRhythm Case Reports. 2022;9(2):72-75. doi:https://doi.org/10.1016/j.hrcr.2022.10.007
This communication is not associated with specific implanted device models
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