When to Consider Leadless Pacemakers—A Look at the Literature

January 23, 2019 | Evaluations & Guidance

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Like any implantable device, conventional transvenous pacemakers present certain risks to patients. Many of these risks are associated with the leads used to deliver the electric current from the subcutaneous pulse generator to the myocardial tissue. In a 2012 study (Udo et al.), approximately 5.5% of patients experienced lead-related complications within two months of implantation. The most common short- and long-term complications included:

  1. Lead dislodgment (3.3% overall within two months, variable by lead and fixation type)

  2. Stimulation of the diaphragm or the pocket that houses the pulse generator (0.73% within two months)

  3. Lead infection (0.2% long term)

  4. Lead fracture (0.13% within two months)

Other risks are associated with creation of pectoral and abdominal pulse generator pockets—within two months of implantation, approximately 4.75% of patients experienced these complications. The most common pocket-related complications included:

  1. Hematoma (2.9%...

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