Complication Rates Associated With Pacemaker or Implantable Cardioverter-Defibrillator Generator Replacements and Upgrade Procedures: Results From the REPLACE Registry

Background— Prospective studies defining the risk associated with pacemaker or implantable cardioverter-defibrillator replacement surgeries do not exist. These procedures are generally considered low risk despite results from recent retrospective series reporting higher rates. Methods and Results— We prospectively assessed predefined procedure-related complication rates associated with elective pacemaker or implantable cardioverter-defibrillator generator replacements over 6 months of follow-up. Two groups were studied: those without (cohort 1) and those with (cohort 2) a planned transvenous lead addition for replacement or upgrade to a device capable of additional therapies. Complications were adjudicated by an independent events committee. Seventy-two US academic and private practice centers participated. Major complications occurred in 4.0% (95% confidence interval, 2.9 to 5.4) of 1031 cohort 1 patients and 15.3% (95% confidence interval, 12.7 to 18.1) of 713 cohort 2 patients. In both cohorts, major complications were higher with implantable cardioverter-defibrillator compared with pacemaker generator replacements. Complications were highest in patients who had an upgrade to or a revised cardiac resynchronization therapy device (18.7%; 95% confidence interval, 15.1 to 22.6). No periprocedural deaths occurred in either cohort, although 8 later procedure-related deaths occurred in cohort 2. The 6-month infection rates were 1.4% (95% confidence interval, 0.7 to 2.3) and 1.1% (95% confidence interval, 0.5 to 2.2) for cohorts 1 and 2, respectively. Conclusions— Pacemaker and implantable cardioverter-defibrillator generator replacements are associated with a notable complication risk, particularly those with lead additions. These data support careful decision making before device replacement, when managing device advisories, and when considering upgrades to more complex systems. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00395447.

[1]  Eugene Crystal,et al.  Evaluation of early complications related to De Novo cardioverter defibrillator implantation insights from the Ontario ICD database. , 2010, Journal of the American College of Cardiology.

[2]  S. Saba,et al.  Complications of replacing implantable devices in response to advisories: a single center experience. , 2009, International journal of cardiology.

[3]  C. Israel,et al.  Complications leading to surgical revision in implantable cardioverter defibrillator patients: comparison of patients with single-chamber, dual-chamber, and biventricular devices. , 2009, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[4]  S. Harada.  [ACC/AHA 2007 Guidelines on Perioperative Cardiovascular Evaluation and Care for Noncardiac Surgery]. , 2009, Masui. The Japanese journal of anesthesiology.

[5]  J. Healey,et al.  Outcome of advisory implantable cardioverter-defibrillator replacement: one-year follow-up. , 2008, Heart rhythm.

[6]  S. Priori,et al.  HRS/EHRA expert consensus on the monitoring of cardiovascular implantable electronic devices (CIEDs): description of techniques, indications, personnel, frequency and ethical considerations. , 2008, Heart rhythm.

[7]  L. Baddour,et al.  Temporal trends in permanent pacemaker implantation: a population-based study. , 2008, American heart journal.

[8]  B. Sweitzer,et al.  ACC/AHA 2007 Guidelines on Perioperative Cardiovascular Evaluation and Care for Noncardiac Surgery , 2008 .

[9]  E. Prystowsky,et al.  Complications Associated with Generator Replacement in Response to Device Advisories , 2008, Journal of cardiovascular electrophysiology.

[10]  C. Israel,et al.  Upgrading to biventricular pacing/defibrillation systems in right ventricular paced congestive heart failure patients: prospective assessment of procedural parameters and response rate. , 2007, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[11]  Jacques Victor,et al.  Risk Factors Related to Infections of Implanted Pacemakers and Cardioverter-Defibrillators: Results of a Large Prospective Study , 2007, Circulation.

[12]  Thomas Kleemann,et al.  Annual Rate of Transvenous Defibrillation Lead Defects in Implantable Cardioverter-Defibrillators Over a Period of >10 Years , 2007, Circulation.

[13]  David L Hayes,et al.  Permanent pacemaker and implantable cardioverter defibrillator infection: a population-based study. , 2007, Archives of internal medicine.

[14]  D. Hayes,et al.  Complication risk with pulse generator change: implications when reacting to a device advisory or recall. , 2006, Pacing and clinical electrophysiology : PACE.

[15]  A. Krahn,et al.  Complications associated with implantable cardioverter-defibrillator replacement in response to device advisories. , 2006, JAMA.

[16]  W. Maisel,et al.  Pacemaker and ICD generator malfunctions: analysis of Food and Drug Administration annual reports. , 2006, JAMA.

[17]  J. Daubert,et al.  The effect of cardiac resynchronization on morbidity and mortality in heart failure. , 2005, The New England journal of medicine.

[18]  Douglas L Packer,et al.  Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. , 2005, The New England journal of medicine.

[19]  Hugh Calkins,et al.  Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. , 2004, The New England journal of medicine.

[20]  D. DeMets,et al.  Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. , 2004, The New England journal of medicine.

[21]  A. Kadish,et al.  DEFibrillators In Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE). , 2003, Cardiac electrophysiology review.

[22]  Laura P Coombs,et al.  The Society of Thoracic Surgeons: 30-day operative mortality and morbidity risk models. , 2003, The Annals of thoracic surgery.

[23]  M. Sweeney,et al.  Upgrade of Permanent Pacemakers and Single Chamber Implantable Cardioverter Defibrillators to Pectoral Dual Chamber Implantable Cardioverter Defibrillators: Indications, Surgical Approach, and Long‐Term Clinical Results , 2002, Pacing and clinical electrophysiology : PACE.

[24]  D. Delurgio,et al.  Addition of a Left Ventricular Lead to Conventional Pacing Systems in Patients with Congestive Heart Failure: Feasibility, Safety, and Early Results in 60 Consecutive Patients , 2002, Pacing and clinical electrophysiology : PACE.

[25]  D. Cannom,et al.  High incidence of device-related and lead-related complications in the dual-chamber implantable cardioverter defibrillator compared with the single-chamber version. , 2002, Circulation journal : official journal of the Japanese Circulation Society.

[26]  F. Miyake,et al.  Adrenergic stimulation immediately modifies the Ca^ channel gene expression preferentially in the atrium , 2002 .

[27]  J. Oss,et al.  PROPHYLACTIC IMPLANTATION OF A DEFIBRILLATOR IN PATIENTS WITH MYOCARDIAL INFARCTION AND REDUCED EJECTION FRACTION , 2002 .

[28]  M Gent,et al.  Canadian implantable defibrillator study (CIDS) : a randomized trial of the implantable cardioverter defibrillator against amiodarone. , 2000, Circulation.

[29]  A. J. Mangram,et al.  Guideline for the prevention of surgical site infection, 1999 , 1999 .

[30]  M. Petch,et al.  Late complications following permanent pacemaker implantation or elective unit replacement , 1998, Heart.

[31]  M. Petch,et al.  Ventricular pacemaker upgrade: experience, complications and recommendations , 1998, Heart.

[32]  M. Keller,et al.  A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. , 1997, The New England journal of medicine.

[33]  C. Yancy,et al.  ACC/AHA 2007 Guidelines on Perioperative Cardiovascular Evaluation and Care for Noncardiac Surgery: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines on Perioperative Cardiov , 2007, Circulation.

[34]  Tim Vaughn,et al.  Detection and management of an implantable cardioverter defibrillator lead failure: incidence and clinical implications. , 2003, Journal of the American College of Cardiology.

[35]  T. Horan,et al.  GUIDELINE FOR PREVENTION OF SURGICAL SITE INFECTION , 1999 , 1999 .