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A New Single Chamber Implantable Defibrillator with Atrial Sensing: A Practical Demonstration of Sensing and Ease of Implantation
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A New Single Chamber Implantable Defibrillator with Atrial Sensing: A Practical Demonstration of Sensing and Ease of Implantation

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Complication rates associated with pacemaker or implantable cardioverter-defibrillator generator replacements and

Jeanne E Poole1, Marye J Gleva, Theofanie Mela

  • 1University of Washington, Division of Cardiology, 1959 NE Pacific Street, Seattle, WA 98198-6422, USA. jpoole@u.washington.edu

Circulation
|October 6, 2010
PubMed

Insights

Pacemaker and implantable cardioverter-defibrillator generator replacement surgeries carry significant risks, especially when lead additions are involved. Careful consideration is crucial before proceeding with these device procedures.

Area of Science:

  • Cardiology
  • Medical Devices
  • Surgical Risk Assessment

Background:

  • Limited prospective data exists on the risks of pacemaker and implantable cardioverter-defibrillator replacement surgeries.
  • These procedures are often perceived as low-risk, contrasting with recent retrospective findings of higher complication rates.

Purpose of the Study:

  • To prospectively evaluate complication rates associated with elective pacemaker and implantable cardioverter-defibrillator generator replacements.
  • To compare risks between device replacements without and with transvenous lead additions.

Main Methods:

  • A prospective study involving 72 US centers assessed complication rates over 6 months.
  • Two cohorts were studied: Cohort 1 (generator replacement only) and Cohort 2 (generator replacement with lead addition/upgrade).
  • Complications were adjudicated by an independent committee.

Main Results:

  • Major complications occurred in 4.0% of Cohort 1 and 15.3% of Cohort 2 patients.
  • Implantable cardioverter-defibrillator replacements had higher major complication rates than pacemaker replacements in both cohorts.
  • Upgrades to cardiac resynchronization therapy devices showed the highest complication rate (18.7%); 8 late deaths occurred in Cohort 2.

Conclusions:

  • Pacemaker and implantable cardioverter-defibrillator generator replacements carry a notable risk, particularly when lead additions are performed.
  • Findings underscore the need for careful decision-making before device replacement, managing advisories, and considering complex system upgrades.
Abstract

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