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

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.