Predictors of Short-Term Complications After Implantable Cardioverter-Defibrillator Replacement

Abstract

Background— Complications after implantable cardioverter-defibrillator (ICD) replacement are often clinically devastating, particularly when infection or reoperation occurs. Identifying factors contributing to complications may permit identification of high-risk individuals that warrant incremental monitoring and therapy to attenuate risk. In addition, replacement may be a discretionary decision in the context of an advisory or borderline device performance and patient, device, and implanter factors that predict adverse outcome may assist in clinical decision-making. Methods and Results— In a prospective, multicenter, population-based registry of all ICD patients at 18 centers in Ontario, Canada, we examined 45-day complication and all-cause mortality rates from February 2007 to August 2009 in patients undergoing ICD generator replacement. Complications were determined longitudinally and were categorized as major or minor. ICD replacement was performed in 1081 of 5176 patients (20.8%) undergoing ICD implantation (age, 64.3±12.7 years; 78.5% men). In patients undergoing ICD replacement, 47 patients (4.3%) had a complication within 45 days, with 47 major complications in 28 patients (2.6%), most commonly infection (n=23), lead revision (n=35), electrical storm (n=14), and pulmonary edema (n=13). Minor complications occurred in 2.3% of patients, most commonly incisional infection (n=10) and pocket hematoma (n=10). On multivariable analysis, risk factors associated with major complications were Canadian Cardiovascular Society angina class (adjusted hazard ratio [HR], 3.70 for class 2 to 4 versus 0 to 1; P =0.027) and multiple previous procedures on the pocket (adjusted HR, 3.35 for >1 versus 1; P =0.058). Risk factors associated with any complication were the use of antiarrhythmic therapy (adjusted HR, 6.29; P =0.001), implanter volume (adjusted HR 10.4 for <60/y versus >120/y, P =0.026), and Canadian Cardiovascular Society angina class (adjusted HR, 3.00 for class 2 to 4 versus 0 to 1; P =0.031). In a Cox model with a time-dependent variable of major complication within 45 days after replacement, major complications after ICD replacement were associated with an increased risk of mortality at 45, 90, and 180 days (adjusted HR, 9.61, 12.69, and 6.41, respectively; P =0.002 to 0.039). Conclusions— Risk factors associated with complications after ICD replacement include the presence of angina, antiarrhythmic therapy, increased number of previous procedures, and low implanter volume. Major complications may be associated with increased risk of subsequent mortality.

Incidence and Costs Related to Lead Damage Occurring Within the First Year After a Cardiac Implantable Electronic Device Replacement Procedure

“…The incidence of lead‐related reintervention was 1.2% following PM or CRT‐PM procedures and 2.4% following an ICD or CRT‐D procedure14; however, the time to event, associated costs, and the issue necessitating reintervention were all undefined. Separately, the Ontario ICD registry evaluated the incidence of complications occurring within 45 days of an ICD‐replacement procedure in 5176 patients 15. During this short‐term follow‐up, 15 (1.4%) patients required a lead replacement and 9 (0.8%) patients required lead extraction; however, no specific information was provided as to what necessitated lead replacement or extraction 15.…”

“…Separately, the Ontario ICD registry evaluated the incidence of complications occurring within 45 days of an ICD‐replacement procedure in 5176 patients 15. During this short‐term follow‐up, 15 (1.4%) patients required a lead replacement and 9 (0.8%) patients required lead extraction; however, no specific information was provided as to what necessitated lead replacement or extraction 15. Our data show that lead damage typically occurs outside the 45‐day postprocedure window.…”

Future Research Prioritization: Implantable Cardioverter-Defibrillator Therapy in Older Patients

“…While several studies have compared outcomes between single-chamber and dual-chamber ICDs, these investigations had major limitations, yielded conflicting results, and predated the evidence on optimal programming of ICDs. [17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32] Today's health care providers and patients, therefore, often struggle in making the critical decision of what device type to choose, and professional societies and policymakers are incapable of developing evidence-based recommendations and coverage decisions. 8,33 These issues are further compounded by the advent of subcutaneous ICDs, whose outcomes, especially in the elderly, are uncertain.…”

2015 ACC/AHA/HRS Advanced Training Statement on Clinical Cardiac Electrophysiology (A Revision of the ACC/AHA 2006 Update of the Clinical Competence Statement on Invasive Electrophysiology Studies, Catheter Ablation, and Cardioversion)

“…Similarly, minimum annual numbers and a blend of procedures have been proposed for assurance of continued competence. 13,20,[57][58][59][60][61] It is important to recognize that there is a growing subspecialization career focus within EP, in which some highly skilled practitioners limit the scope of their clinical activity to pacemaker and defibrillator implantation and follow-up, whereas others focus their efforts on complex ablation, and still others do more straightforward ablations (not those that are complex) but have little continuing experience in implantable device work. Thus, although maintenance of some CCEP competencies is an expectation for all clinical cardiac electrophysiologists, the maintenance of other CCEP competencies-and the evaluation tools to assess them-can be career-focused.…”