Summary

  • With any cardiac implantable lead, implanters must consider a long-term management strategy which includes the possibility of the need for future extraction.
  • The labeling for the Medtronic SelectSecure™ MRI SureScan™ pacing lead includes a warning that serious harm could result if chronic lead repositioning or removal is attempted.
  • The publications included here describe techniques for SelectSecure™ MRI SureScan™ pacing lead preparation and removal/extraction from the conduction system, for consideration when removal is deemed clinically necessary.
  • Vatterot et al reviews benchtop testing that evaluated the unique characteristics of lumenless lead design on different lead preparation techniques, lead rail tensile strength, traction force requirements and lead damage under multiple conditions with the goal of providing an approach for pacing lead extraction.
  • The TECSPAM study published in 2024 is a multicenter, retrospective, observational study that reports on safety, feasibility, procedural success and clinical outcomes of conduction system pacing lead extraction with a lead dwell time of three years or less. A summary of removal techniques (including manual traction and use of extraction tools) is provided as well as the impact of lead dwell time on lead removal/extraction success. This is the largest study of CSP lead removal/extraction published to date (321 pacing leads).

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Articles of interest

Medtronic summary

  • Bench testing methodologies were used to characterize the physical properties and unique design of lumenless leads and to describe related lead preparation techniques for removal/extraction.
  • Lead rail tensile strength of SelectSecure™ pacing lead was assessed using three lead preparation techniques and two use conditions.
  • The authors conclude with recommendations for pacing lead lead preparation for extraction and considerations for the use of extraction tools.
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Vatterott PJ, Mondésert B, Marshall M, Lulic T, Wilkoff BL. Mechanics of lumenless pacing lead strength during extraction procedures based on laboratory bench testing. Heart Rhythm. 2023;20(6):902–909. doi:10.1016/j.hrthm.2023.02.025.

Disclosures: This work was funded by Medtronic. Dr. Vatterott reports being a consultant for Medtronic. Dr. Mondésert reports being a consultant for Medtronic. Dr. Wilkoff reports being a consultant for Medtronic. Mark Marshall and Thomas Lulic are employees and shareholders in Medtronic, Inc.

Medtronic summary

  • The TECSPAM study, published simultaneous to data presentation at HRS 2024, is a multicenter, retrospective, observational study. It reports on safety, feasibility, procedural success and clinical outcomes of conduction system pacing lead extraction with a lead dwell time of three years or less.
  • Lead removal techniques (including manual traction and use of extraction tools) are described for patients undergoing extraction of leads implanted in the conduction system. Procedural success, the impact of lead dwell time, and complications are reported.
  • This is the largest investigation of conduction system pacing lead removal/extraction (321 SelectSecure™ pacing leads) published to date.
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Vijayaraman P, Trivedi RS, Koneru JN, et al. Transvenous extraction of conduction system pacing leads: an international multicenter (TECSPAM) study. Heart Rhythm. 2024. 21(10):1953–1961. doi:10.1016/j.hrthm.2024.04.054.

Disclosures: Dr. Vijayaraman has received honoraria and research support from, and is a consultant and serves on, the advisory board for Medtronic. Dr. Koneru has received honoraria fellowship support from Medtronic. Dr. Sharma has received honoraria from Medtronic and is a consultant for Medtronic. Dr. DePooter has received speaker honoraria and consultancy fees from Medtronic. Dr. Schaller has received honoraria from Medtronic. Dr. Cano has received honoraria from and is a consultant for Medtronic. Dr. Whinnett has received honoraria from Medtronic and is a consultant for Medtronic. Dr. Ponnusamy has received honoraria from Medtronic. Dr. Zanon has received honoraria from Medtronic. Dr. Ellenbogen is a consultant for Medtronic and has received honoraria from Medtronic. Dr. Herweg has received fellowship support from Medtronic.

Considerations associated with removal/extraction of SelectSecure™ pacing lead

Indications

The pacing lead is intended for pacing and sensing in the atrium or right ventricle. It is also intended for pacing and sensing at the bundle of His or in the left bundle branch area as an alternative to right ventricular pacing in a single or dual chamber pacing system.

Contraindications

The following are contraindications for use of Medtronic implantable, screw-in, catheter delivered, transvenous leads:

  • Use of ventricular transvenous leads is contraindicated in patients with tricuspid valvular disease.
  • Use of ventricular transvenous leads is contraindicated in patients with mechanical tricuspid heart valves. 
  • Use of steroid eluting transvenous leads is contraindicated in patients for whom a single dose of 40.0 µg beclomethasone dipropionate may be contraindicated.
  • Use of catheter-delivered transvenous leads is contraindicated in patients with obstructed or inadequate vasculature for intravenous catheterization.

Warnings and precautions

Chronic repositioning or removal — Proceed with extreme caution if a lead must be removed or repositioned. Chronic repositioning or removal of screw-in transvenous leads may not be possible because the helix may become deformed and/or entangled as a result of manipulating the lead. In most clinical situations, it is preferable to abandon unused leads in place. Return all removed or unused leads, or lead sections to Medtronic for analysis.

  • Observe the helix via fluoroscopy on X-ray before attempting to reposition to determine if the helix shape is intact. If the helix appears deformed, removal may be difficult and is not recommended.
  • Lead removal may result in avulsion of the endocardium, valve, or vein.
  • Lead junctions may separate, leaving the lead tip and bare wire in the heart or vein. 
  • Chronic repositioning of a lead may adversely affect a steroid lead’s low-threshold performance.
  • Abandoned leads should be capped to avoid transmitting electrical signals.
  • Severed leads should have the remaining lead end sealed, and the lead body sutured to adjacent tissue.

Potential adverse events

  • Lead removal may result in avulsion of the endocardium, valve, or vein.
  • Lead junctions may separate, leaving the lead tip and bare wire in the heart or vein. 

FDA approved labeling.