Evaluation of Early Complications Related to De Novo Cardioverter Defibrillator Implantation

Abstract

Complications after de novo defibrillator implantation were strongly associated with device type. Major complications were associated with increased risk of mortality.

Complications in recipients of cardioverter-defibrillator or cardiac resynchronization therapy: Insights from Silesian Center Defibrillator registry

“…However, clinical characteristics of patients in our registry, even though coming from still developing European country with smaller resources and experience, is similar to the ones analyzed in American or Western European clinical trials and registries, with main differences in type of implanted devices -most patients hospitalized included in this trial had a dual-chamber ICD (40.9%) implanted, while in available results of studies and registries most common devices were single-chamber ICD [9,10]. In our opinion, the fact that more dual-chamber ICDs were implanted in the analyzed populations may be a due to the fact that the choice of the type of CIED was left at that time to the discretion of the operator or referring physician and more frequently off-label.…”

“…The complications were defined according to well known and widely observed in daily practice: traumatic complications, leadrelated complications, pocket and clinical complications, and problems with connection screw. We divided these complications into those occurring during the device therapy optimization and lead maturation phase (within 2 months after initial procedure of ICD/CRT-D implantation and likely related to the implantation procedure: short-term-2-month complications), and complications emerging during follow-up (long-term complications) [9,10]. The incidence rate of complications is reported as the number of events and also as an incidence rate per 1,000 person-years.…”

“…Most available numbers are based on randomized controlled trials (RCT) results performed on selected groups of patients and therefore fewer complications may be observed than in an all-comers evaluation due to strict patient selection criteria and more experienced operators involved. In recent years, large, registry-based studies have emerged with more extensive estimates of complications, however, data available from many registries are restricted to in-hospital follow-up, leaving a large proportion of longer-term CIED complications unaccounted for [10]. Therefore, in this large Silesian Center Defibrillator registry, we analyzed baseline characteristic of patients included in the registry and the incidence and predictors of early and long-term ICD/CRT-D follow-up complications.…”

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.…”

Cardiac autonomic imaging with SPECT tracers

“…74,101,104 This degree of benefit must be balanced against substantial risks and costs of an ICD. [105][106][107][108] The randomized trials have limitations, in particular MADIT-II and SCD-HEFT having broad enrollment criteria with limited stratification of study populations. 109 Differences among EF entry criteria were large, and most enrolled patients had EFs well below the threshold ultimately used in guidelines.…”