Background: The performance of small diameter implantable cardioverter defibrillator (ICD) leads is questionable. However, data on performance during long-term follow-up are scarce. The aim of this... Show moreBackground: The performance of small diameter implantable cardioverter defibrillator (ICD) leads is questionable. However, data on performance during long-term follow-up are scarce. The aim of this study is to provide an update for the lead failure and cardiac perforation rate of Medtronic's Sprint Fidelis ICD lead (Medtronic Inc., Minneapolis, MN, USA) and St. Jude Medical's Riata ICD lead (St. Jude Medical Inc., St. Paul, MN, USA). Methods: Since 1996, all ICD system implantations at the Leiden University Medical Center, the Netherlands, are registered. For this study, data up to February 2011 on 396 Sprint Fidelis leads (follow-up 3.4 ± 1.5 years), 165 8-French (F) Riata leads (follow-up 4.6 ± 2.6 years), and 30 7-F Riata leads (follow-up 2.9 ± 1.3 years) were compared with a benchmark cohort of 1,602 ICD leads (follow-up 3.4 ± 2.7 years) and assessed for the occurrence of lead failure and cardiac perforation. Results: During follow-up, the yearly lead failure rate of the Sprint Fidelis lead, 7-F Riata lead, 8-F Riata lead, and the benchmark cohort was 3.54%, 2.28%, 0.78%, and 1.14%, respectively. In comparison to the benchmark cohort, the adjusted hazard ratio of lead failure was 3.7 (95% confidence interval [CI] 2.4-5.7, P < 0.001) for the Sprint Fidelis lead and 4.2 (95% CI 1.0-18.0, P < 0.05) for the 7-F Riata lead. One cardiac perforation was observed (3.3%) in the 7-F Riata group versus none in the 8-F Riata and Sprint Fidelis lead population. Conclusion: The current update demonstrates that the risk of lead failure during long-term follow-up is significantly increased for both the Sprint Fidelis and the 7-F Riata lead in comparison to the benchmark cohort. Only one cardiac perforation occurred. (PACE 2012; 1-7). Show less
Although the beneficial effect of ICD treatment has been proven in selected patients, the population assessed in large clinical trials does not reflect the population with ICDs in the real world.... Show moreAlthough the beneficial effect of ICD treatment has been proven in selected patients, the population assessed in large clinical trials does not reflect the population with ICDs in the real world. The aim of the current thesis is to give better insight in these patients at risk for lifethreatening arrhythmias by studying a large population of patients treated with an ICD, outside the setting of a clinical trial. In part I, the actual need for defibrillator backup during long-term follow-up is evaluated. Chapter 2 describes differences in mortality and the occurrence of ventricular arrhythmia between patients receiving an ICD as primary vs. secondary prevention of SCD. The actual need for device replacement after an event-free first battery service-life is studied in Chapter 3. In part II, an attempt is made to improve risk stratification by evaluating currently available parameters and the additive value of novel parameters. In Chapter 4 all classic baseline variables are combined to construct a clinically applicable mortality risk score in primary prevention ICD recipients with ischemic heart disease. Chapter 5 demonstrates the importance of atrial fibrillation in patients with ICD or CRT-D. Chapter 6 shows that usage of a risk model can predict the risk of non-benefit (death, prior to first ventricular arrhythmia) which might have important clinical consequences. In Chapter 7 the spatial QRS-T angle is evaluated in the prediction of ventricular arrhythmia. Chapter 8 demonstrates the risk of lead failure in smalldiameter defibrillation leads compared with a benchmark cohort. Show less
Aims The beneficial effects of implantable cardioverter defibrillators (ICDs) in primary and secondary prevention patients are well established. However, data on potential differences between both... Show moreAims The beneficial effects of implantable cardioverter defibrillators (ICDs) in primary and secondary prevention patients are well established. However, data on potential differences between both groups in mortality and ICD therapy rates during long-term follow-up are scarce. The aim of the study was to assess differences in mortality and ICD therapy between secondary and primary prevention ICD recipients. Methods and results With the exception of patients with congenital monogenetic cardiac disease, all patients treated with an ICD, regardless of the underlying cardiac pathology, from 1996 to 2008 at the Leiden University Medical Center were included in the current analysis. The study population was grouped by the type of prevention (secondary or primary) for sudden cardiac death. The primary endpoint was all-cause mortality. The secondary endpoint was the occurrence of device therapy (appropriate or inappropriate). A total of 2134 (80% men, mean age 63 ± 12 years) ICD recipients were included. Of these, 1302 (61%) patients received an ICD for primary prevention of sudden cardiac death and 832 (39%) patients for secondary prevention. During a mean follow-up of 3.4 ± 2.8 years, 423 (20%) patients died. The 5-year cumulative incidence of mortality was 25% [95% confidence intervals (CI): 21-29%] for primary prevention patients and 23% (95% CI: 20-26%) for secondary prevention patients. Secondary prevention patients exhibited a 74% increased risk for appropriate therapy when compared with primary prevention patients [hazard ratios (HR): 1.7; P< 0.001]. A comparable risk for inappropriate shocks was observed (HR: 1.0; P= 0.9). Conclusion During long-term follow-up, primary prevention patients exhibited a lower risk of appropriate therapy, but comparable mortality rates were observed between both groups. Both groups showed similar occurrence of inappropriate shocks. Show less
Methods: From 1992 to 2008, 2,415 patients receiving an ICD at the Leiden University Medical Center were analyzed. Pocket-related complications requiring surgical re-intervention following ICD... Show moreMethods: From 1992 to 2008, 2,415 patients receiving an ICD at the Leiden University Medical Center were analyzed. Pocket-related complications requiring surgical re-intervention following ICD implantation or replacement were noted. Elective device replacement, lead failure, and device malfunction were not considered pocket-related complications. Results: A total of 3,161 ICDs were included in the analysis. In total, 145 surgical re-interventions were required in 122 (3.9%) ICDs implanted in 114 (4.7%) unique patients. Three-year cumulative incidence for first surgical re-intervention in all ICDs was 4.7% (95% confidence interval [CI] 3.9-5.5%). Replacement ICDs exhibited a doubled requirement for surgical re-intervention (rate ratio 2.2, 95% CI 1.5-3.0). Compared to first implanted ICDs, the occurrence of surgical re-intervention in replacements was 2.5 (95% CI 1.6-3.7) times higher for infectious and 1.7 (95% CI 0.9-3.0) for noninfectious causes. Subdivision by the number of ICD replacements showed an increase in the annual risk for surgical re-intervention, ranging from 1.5% (95% CI 1.2-1.9%) for the first, to 8.1% (95% CI 1.7-18.3%) for the fourth implanted ICD. Conclusions: ICD replacement is associated with a doubled risk for pocket-related surgical re-interventions. Furthermore, the need for re-intervention increases with every consecutive replacement. (PACE 2010; 1013-1019). Show less
To assess survival and to construct a baseline mortality risk score in primary prevention implantable cardioverter defibrillator (ICD) patients with non-ischaemic or ischaemic heart disease. Since... Show moreTo assess survival and to construct a baseline mortality risk score in primary prevention implantable cardioverter defibrillator (ICD) patients with non-ischaemic or ischaemic heart disease. Since 1996, data of all consecutive patients who received an ICD system in the Leiden University Medical Center were collected and assessed at implantation. For the current study, all 1036 patients [age 63 (SD 11) years, 81% male] with a primary indication for defibrillator implantation were evaluated and followed for 873 (SD 677) days. During follow-up, 138 patients (13%) died. Non-ischaemic and ischaemic patients demonstrated similar survival but exhibited different factors that influence risk for mortality. A risk score, consisting of simple baseline variables could stratify patients in low, intermediate, and high risk for mortality. In non-ischaemic patients, annual mortality was 0.4% (95% CI 0.0-2.2%) in low risk and 9.4% (95% CI 6.6-13.1%) in high risk patients. In ischaemic patients, mortality was 1.0% (95% CI 0.2-3.0%) in low risk and 17.8% (95% CI 13.6-22.9%) in high risk patients. Utilization of an easily applicable baseline risk score can create an individual patient-tailored estimation on mortality risk to aid clinicians in daily practice. Show less
Objectives This study aimed to assess the prevalence of different types of atrial fibrillation (AF) and their prognostic importance in implantable cardioverter-defibrillator (ICD) patients.... Show moreObjectives This study aimed to assess the prevalence of different types of atrial fibrillation (AF) and their prognostic importance in implantable cardioverter-defibrillator (ICD) patients. Background The prevalence of AF has taken epidemic proportions in the population with cardiovascular disease. The prognostic importance of different types of AF in ICD patients remains unclear. Methods Data on 913 consecutive patients (79% men, mean age 62 +/- 13 years) receiving an ICD at the Leiden University Medical Center were prospectively collected. Among other characteristics, the existence and type of AF (paroxysmal, persistent, or permanent) were assessed at implantation. During follow-up, the occurrence of appropriate or inappropriate device therapy as well as mortality was noted. Results At implantation, 73% of patients had no history of AF, 9% had a history of paroxysmal AF, 7% had a history of persistent AF, and 11% had permanent AF. During 833 +/- 394 days of follow-up, 117 (13%) patients died, 228 (25%) patients experienced appropriate device discharge, and 139 (15%) patients received inappropriate shocks. Patients with permanent AF exhibited more than double the risk of mortality, ventricular arrhythmias triggering device discharge, and inappropriate device therapy. Patients with paroxysmal or persistent AF did not show a significant increased risk of mortality or appropriate device therapy but demonstrated almost 3 times the risk of inappropriate device therapy. Conclusions In the population currently receiving ICD treatment outside the setting of clinical trials, a large portion has either a history of AF or permanent AF. Both types of AF have prognostic implications for mortality and appropriate as well as inappropriate device discharge. (J Am Coll Cardiol 2010; 55: 879-85) (C) 2010 by the American College of Cardiology Foundation Show less
