Device Generator Change

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  • Generator battery depletion
  • Manufacturer recall of defective device
  • Upgrade of existing device for new lead(s)
  • Device damage (eg, due to trauma)
  • Infection at time of procedure
    • Suspected
    • Confirmed
  • Risk of bleeding from elevated serum INR, partial thromboplastin time, or thrombocytopenia
  • If patient is pacemaker dependent, do not perform without temporary pacing wire to provide adequate ventricular rate during procedure.
  • Sterile mask, gown, gloves, shoe covers, and full sheet
  • Antibiotics
    • IV
    • Irrigation
  • Surgical instrument tray
  • Sterile surgical drapes
  • Surgical topical antiseptic solution
    • Chlorhexidine
    • Povidone-iodine
  • Sterile marking pen
  • Electrocautery
  • Suture
    • Deep layer
    • Subcutaneous
  • Dressing
    • Nonadhesive dressing
    • Skin adhesive
    • Adhesive strips
  • Standard monitoring equipment: ECG, blood pressure cuff, pulse oximeter, external defibrillator/pacing patches
  • Resuscitation cart, including intubation equipment, resuscitation drugs, defibrillator, suction
  • Oxygen source and method of delivery: mask, nasal cannula
  • Anesthesia equipment adequate to support moderate sedation
  • Local anesthetic
    • Lidocaine
    • Bupivacaine
  • New pulse generator
  • Device programmer and/or pacing system analyzer with ability to perform lead interrogation

Position of pulse generator

  • Usual placement is subcutaneously below the fat of the chest wall, superficial to the muscles, in a pocket created just below the clavicle on the side of the patient’s nondominant hand. Occasional abdominal placement may be seen, and exact placement is individualized.
  • Unlike the anatomy seen in an initial implantation, the pulse generator and redundant portion of the lead(s) in a previously placed system will be encased within a fibrous capsule.

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  • Step-by-step text instructions for performing the procedure
  • Clinical pearls providing practical clinical tips from medical experts
  • Patient safety guidelines consistent with Joint Commission and OHSA standards
  • Links to medical evidence and related procedures

  • Transfer the patient to an appropriate post-procedure monitoring setting.
  • Monitor recovery from conscious sedation, including respiratory status, blood pressure, cardiac rhythm, arterial oxygen saturation.
  • Monitor for hemostasis.
  • Monitor for adequate pain control.
  • When patient is stable, remove IV and apply clean bandage.

Complications of sedation

  • Respiratory depression
  • Aspiration
  • Acute heart failure decompensation
  • Medication reaction

Complications of change

  • Bleeding from the incision
  • Discomfort from incision or repositioning of generator in pocket
  • Pocket hematoma
  • Infection
  • Damage to insulation of lead(s) resulting in failure to pace
  • Lead reversal within header block of pacemaker generator
  • Improper connection of lead to generator (loose set-screw)
  • Errors in pacemaker generator programming
  • Death, rarely

Common problems seen during interrogation of the pacemaker:

  • Failure to capture is defined as a pacing stimulus without subsequent cardiac depolarization. This is most frequently due to lead dislodgment or an increase in pacing threshold. Pacing outputs should be programmed at least 2× threshold voltage or 3× threshold pulse width. In the setting of ischemia, electrolyte abnormalities, or drug effects, pacing threshold may change significantly.
  • Failure to pace is commonly due to oversensing of physiologic or nonphysiologic signals, resulting in inhibition of the pacing output.
  • High lead impedance suggests lead fracture or loose set-screw at the lead connection into the generator.
  • Low lead impedance suggests insulation breach.
  • Failure of sensing. Ideally, P waves are >1.5 mV and R waves are > 7 mV. Sensitivity should be programmed for an adequate sensing safety margin.
  • New pulse generators may have programming features not present on previous devices, which may be unfamiliar to the physician performing the procedure.
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