Subcutaneous Array (Endotak SQ Model 0048) Notes

The Subcutaneous Array - Endotak SQ Model 0048

  • Electrode system with three conductive elements ("Lead Array") inserted subcutaneously.
  • Developed to replace the SQ patch in most configurations, acting as an anode or part of the anode.
  • Depolarizes a greater cardiac surface area compared to the SQ patch (51 cm² vs. 28 cm²).
  • Conductive elements: electrically common multifilar coil.
  • Three elements (25 cm length, 6 French diameter) joined in a silicone yoke connected to a terminal pin.
  • Each leg is introduced separately using a lead tunneler and peel-away sheaths.

Implantation Technique

  • 3 cm incision to position the yoke.
  • Lead elements introduced with three separate sheaths after tunneling to the left lateral part of the chest using a dilator.
  • Elements are individually sutured after sheath removal.
  • Fluoroscopy is used during implantation.
  • (A) Initial lead position - may show failing shocks.
  • (B) After dispersion of array branches, the patient can be defibrillated with biphasic bi-directional shocks of 10 J.

Chest Radiographs

  • Illustrate typical location for Endotak and SQ Array leads.
  • Postero-anterior radiograph (left panel): distal array leads extend posteriorly in subcutaneous tissue of the chest wall.
  • Leads inserted through incision at approximately the mid-clavicular line anteriorly.
  • Lateral view (right panel): three SQ Array lead elements splayed but paralleling the ribs.

Study Results & Observations (Higgins, S.L.; et al; PACE Vol 18; 1540:48; August 1995)

  • SQ Array results were superior to lead-alone configurations, but DFT reduction wasn't universal.
  • 20% of patients had identical DFT with lead-alone and lead-SQ Array.
  • 5% of patients had lower DFT with lead-alone intraoperatively; postoperatively, lead-alone was incapable of successful defibrillation.

Pediatric and Alternative Implantation Techniques

  • 2001 report: Subcutaneous arrays in right and left chest walls showed good defibrillation thresholds in a 2-year-old with ventricular tachycardia and repaired congenital heart disease.
  • Other reports: ICD implantation in a child using a single subcutaneous array lead and an abdominal active can via an ileofemoral approach.

Concerns and Complications

  • Major concern: potential for lead trauma and damage with alternative techniques.
  • Superficially placed leads (not under rib cage) are exposed to external trauma.

Kettering Study (Cannon, B.C.; et al; PACE Vol 29; 181:187; Feb 2006)

  • 6% of patients with subcutaneous array had a major complication, the most common being lead fracture (approximately 4%).
  • An additional 6% had minor lead insulation defects that might affect future performance and cause serious complications.
  • Children are more prone to falls and blunt trauma, potentially damaging superficially placed leads.