TY - JOUR
T1 - Complication rates associated with pacemaker or implantable cardioverter-defibrillator generator replacements and upgrade procedures
T2 - Results from the REPLACE registry
AU - Poole, Jeanne E.
AU - Gleva, Marye J.
AU - Mela, Theofanie
AU - Chung, Mina K.
AU - Uslan, Daniel Z.
AU - Borge, Richard
AU - Gottipaty, Venkateshwar
AU - Shinn, Timothy
AU - Dan, Dan
AU - Feldman, Leon A.
AU - Seide, Hanscy
AU - Winston, Stuart A.
AU - Gallagher, John J.
AU - Langberg, Jonathan J.
AU - Mitchell, Kevin
AU - Holcomb, Richard
PY - 2010/10/19
Y1 - 2010/10/19
N2 - 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.
AB - 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.
KW - complications
KW - electrophysiology
KW - implantable cardioverter defibrillators
KW - pacemakers
UR - http://www.scopus.com/inward/record.url?scp=78049506986&partnerID=8YFLogxK
U2 - 10.1161/CIRCULATIONAHA.110.976076
DO - 10.1161/CIRCULATIONAHA.110.976076
M3 - Article
C2 - 20921437
AN - SCOPUS:78049506986
SN - 0009-7322
VL - 122
SP - 1553
EP - 1561
JO - Circulation
JF - Circulation
IS - 16
ER -