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.
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.
Authors: Jay Sengupta; Arthur C Kendig; Marlene Goormastic; Eui-Seock Hwang; Elizabeth A Ching; Roy Chung; Bruce D Lindsay; Patrick J Tchou; Bruce L Wilkoff; Mark J Niebauer; David O Martin; Niraj Varma; Oussama Wazni; Walid Saliba; Mohamed Kanj; Mandeep Bhargava; Thomas Dresing; Tyler Taigen; Christopher Ingelmo; Mohamed Bassiouny; Edmond M Cronin; Bradley Wilsmore; John Rickard; Mina K Chung Journal: Heart Rhythm Date: 2012-07-03 Impact factor: 6.343
Authors: Ariel R Green; Bruce Leff; Yongfei Wang; Erica S Spatz; Frederick A Masoudi; Pamela N Peterson; Stacie L Daugherty; Daniel D Matlock Journal: Circ Cardiovasc Qual Outcomes Date: 2015-12-29
Authors: Selcuk Adabag; Kristen K Patton; Alfred E Buxton; Thomas S Rector; Kristine E Ensrud; Kairav Vakil; Wayne C Levy; Jeanne E Poole Journal: JAMA Cardiol Date: 2017-07-01 Impact factor: 14.676