Development of Central Venous Stenosis Upon ICD Implantation in Dialysis Patients: A Non-Negligible Issue.

Background: In hemodialysis patients, implantable cardioverter-defibrillator (ICD) implantation may result in central venous stenosis (CVS) with associated symptoms, such as pain, edema of the ipsilateral arm, facial edema, and loss of dialysis access. However, literature concerning CVS in dialysis patients with a cardiac implantable electronic device is scarce. Methods: We conducted a prospective cohort study in which we investigated the incidence of CVS in end-stage renal disease patients on chronic dialysis who received an ICD as part of participation in the randomized ICD2 trial. A venography was performed before ICD implantation and at 1 year follow-up. Results: Between 2007 and 2017, 80 patients on dialysis received an ICD according to ICD2 trial protocol. Our population mainly consisted of males (76.3%), and had a median age of 67 years. Hemodialysis was the predominant dialysis modality (71.3%). The ICD was implanted in the right pectoral region in 58 patients (72.5%). A minority of the patients (27.5%) had a history of central venous catheters use, ipsilateral to ICD implantation site. Median follow-up was 16 months (IQR 13-35). Prospective assessment of central vein patency was possible in 56 patients (70.0%). Partial obstruction of central vein at follow-up was present in 19 out of 56 patients (33.9%) and complete occlusion in 4 patients (7.1%). With a complete clinical follow-up of all patients with a median duration of 3.5 years (IQR 2.7 - 6.3), 3 patients developed clinically significant symptoms of CVS. Conclusions: Development of CVS in patients on chronic dialysis who received an ICD is a cause of concern. Prevention of such complications deserves attention and further research. Trial Registration: ISRCTN20479861.

The impact of transvenous cardioverter-defibrillator implantation on quality of life, depression and optimism in dialysis patients: report on the secondary outcome of QOL in the randomized controlled ICD2 trial.

RATIONALE: The impact of prophylactic implantable cardioverter-defibrillator (ICD) implantation on the psychological well-being of patients on dialysis is unknown. OBJECTIVE: We aimed to identify the effect of primary ICD implantation on quality of life (QoL), mood and dispositional optimism in patients undergoing dialysis. METHODS AND RESULTS: We performed a prespecified subanalysis of the randomized controlled ICD2 trial. In total, 177 patients on chronic dialysis, with an age of 55-81 years, and a left ventricular ejection fraction of ≥ 35%, were included in the per-protocol analysis. Eighty patients received an ICD for primary prevention, and 91 patients received standard care. The Short Form-36 (SF-36), Geriatric Depression Scale-15 (GDS-15), Revised Life Orientation Test (LOT-R) questionnaires were administered prior to ICD implantation (T0), and at 1-year follow-up (T1) to assess QoL, depression and optimism, respectively. The patients were predominantly male (76.0%), with a median age of 67 years. Hemodialysis was the predominant mode of dialysis (70.2%). The GDS-15 score difference (T1 - T0) was 0.5 (2.1) in the ICD group compared with 0.3 (2.2) in the control group (mean difference - 0.3; 95% CI - 1.1 to 0.6; P = 0.58). The LOT-R score difference was - 0.2 (4.1) in the ICD group compared with - 1.5 (4.0) in the control group (mean difference - 1.1 (0.8); 95% CI - 2.6 to 0.4; P = 0.17). The mean difference scores of all subscales of the SF-36 were not significantly different between randomization groups. CONCLUSIONS: In our population of patients on dialysis, ICD implantation did not affect QoL, mood or dispositional optimism significantly during 1-year follow-up. CLINICAL TRIAL REGISTRATION: Unique identifier: ISRCTN20479861. http://www.controlled-trials.com .

Prophylactic Use of Implantable Cardioverter-Defibrillators in the Prevention of Sudden Cardiac Death in Dialysis Patients.

BACKGROUND: Patients with end-stage renal disease who are undergoing dialysis are reported to be at high risk of sudden cardiac death (SCD), and to date, no therapy has been shown to be effective in reducing this risk. The feasibility and value of prophylactic implantable cardioverter-defibrillator (ICD) implantation to prevent SCD is uncertain. METHODS: We conducted the ICD2 trial (Implantable Cardioverter-Defibrillator in Dialysis Patients), a prospective, randomized, controlled study investigating the value and safety of ICD implantation to prevent SCD in 200 patients on dialysis with a left ventricular ejection fraction ≥35%, after adequate screening and optimization of other treatments. The primary end point was SCD. Secondary end points were all-cause mortality and ICD-related complications. RESULTS: The trial was stopped as per the recommendation of the data and safety monitoring board for futility reasons after inclusion of 188 patients, 97 in the ICD group and 91 in the control group. The median duration of follow-up was 6.8 years (interquartile range, 3.8-8.8 years). SCD occurred in 19 of 188 cases (10.1%), 11 of 97 in the ICD group and 8 of 91 in the control group. The cumulative SCD incidence at 5 years was 9.7% (95% CI, 3.3%-16.2%) in the ICD group and 7.9% (95% CI, 1.7-14.0%) in the control group, resulting in a hazard ratio of 1.32 (95% CI, 0.53-3.29; P=0.55). Overall, 99 of 188 patients died (52.7%), 52 in the ICD group and 47 in the control group. Five-year survival probability was 50.6% (95% CI, 39.8%-61.5%) in the ICD group and 54.5% (95% CI, 43.0-66.0%) in the control group, resulting in a hazard ratio of 1.02 (95% CI, 0.69-1.52; P=0.92). Among 80 patients who received an ICD, 25 adverse events related to ICD implantation occurred. CONCLUSIONS: In a well-screened and well-treated population undergoing dialysis, prophylactic ICD therapy did not reduce the rate of SCD or all-cause mortality, which remained high. CLINICAL TRIAL REGISTRATION: URL: http://www.controlled-trials.com . Unique identifier: ISRCTN20479861.

Application and comparison of the FADES, MADIT, and SHFM-D risk models for risk stratification of prophylactic implantable cardioverter-defibrillator treatment.

AIMS: Implantable cardioverter-defibrillator (ICD) treatment is beneficial in selected patients. However, it remains difficult to accurately predict which patients benefit most from ICD implantation. For this purpose, different risk models have been developed. The aim was to validate and compare the FADES, MADIT, and SHFM-D models. METHODS AND RESULTS: All patients receiving a prophylactic ICD at the Leiden University Medical Center were evaluated. Individual model performance was evaluated by C-statistics. Model performances were compared using net reclassification improvement (NRI) and integrated differentiation improvement (IDI). The primary endpoint was non-benefit of ICD treatment, defined as mortality without prior ventricular arrhythmias requiring ICD intervention. A total of 1969 patients were included (age 63 ± 11 years; 79% male). During a median follow-up of 4.5 ± 3.9 years, 318 (16%) patients died without prior ICD intervention. All three risk models were predictive for event-free mortality (all: P < 0.001). The C-statistics were 0.66, 0.69, and 0.75, respectively, for FADES, MADIT, and SHFM-D (all: P < 0.001). Application of the SHFM-D resulted in an improved IDI of 4% and NRI of 26% compared with MADIT; IDI improved 11% with the use of SHFM-D instead of FADES (all: P < 0.001), but NRI remained unchanged (P = 0.71). Patients in the highest-risk category of the MADIT and SHFM-D models had 1.7 times higher risk to experience ICD non-benefit than receive appropriate ICD interventions [MADIT: mean difference (MD) 20% (95% CI: 7-33%), P = 0.001; SHFM-D: MD 16% (95% CI: 5-27%), P = 0.005]. Patients in the highest-risk category of FADES were as likely to experience ICD intervention as ICD non-benefit [MD 3% (95% CI: -8 to 14%), P = 0.60]. CONCLUSION: The predictive and discriminatory value of SHFM-D to predict non-benefit of ICD treatment is superior to FADES and MADIT in patients receiving prophylactic ICD treatment.

Echocardiographic associates of atrial fibrillation in end-stage renal disease.

BACKGROUND: The prevalence of atrial fibrillation (AF) in end-stage renal disease (ESRD) patients is relatively high. The present study evaluated the association between left atrial (LA) remodelling, including an increased size and myocardial fibrosis, and slow LA conduction and the occurrence of AF. METHODS: In 171 ESRD patients enrolled in the Implantable Cardioverter Defibrillators in Dialysis patients (ICD2) trial, the LA dimensions, LA conduction delay [as reflected by the time difference between P-wave onset on surface electrocardiogram and A'-wave on tissue Doppler imaging (PA-TDI)] and LA function were compared between patients who exhibited AF versus patients without AF. Based on ICD remote monitoring or clinical records, the occurrence of AF was detected. RESULTS: Of 171 patients, 47 (27%) patients experienced AF. Despite comparable left ventricular ejection fraction and prevalence of significant mitral regurgitation, patients with AF had significantly larger LA volume index (mean ± standard deviation) (29 ± 11 versus 23 ± 10 mL/m2, P = 0.001), longer PA-TDI duration (144 ± 30 versus 131 ± 27 ms, P = 0.010) and reduced late diastolic mitral annular velocity (A') (7.1 ± 2.8 versus 8.2 ± 2.4 cm/s, P = 0.012) compared with patients without AF. On multivariable analysis, larger LA volume index [odds ratio (OR) 1.04, 95% confidence interval (CI) 1.01-1.08, P = 0.017], longer PA-TDI duration (OR 1.02, 95% CI 1.00-1.03, P = 0.025) and reduced A' (OR 0.84, 95% CI 0.72-0.98, P = 0.025) were independently associated with AF after adjusting for age and left ventricle diastolic relaxation. CONCLUSION: ESRD patients with AF show more advanced changes in the LA substrate than ESRD patients without AF.

Serum Cardiac Troponin-I is Superior to Troponin-T as a Marker for Left Ventricular Dysfunction in Clinically Stable Patients with End-Stage Renal Disease.

BACKGROUND: Serum troponin assays, widely used to detect acute cardiac ischemia, might be useful biomarkers to detect chronic cardiovascular disease (CVD). Cardiac-specific troponin-I (cTnI) and troponin-T (cTnT) generally detect myocardial necrosis equally well. In dialysis patients however, serum cTnT levels are often elevated, unlike cTnI levels. The present study aims to elucidate the associations of cTnI and cTnT with CVD in clinically stable dialysis patients. METHODS: Troponin levels were measured using 5th generation hs-cTnT assays (Roche) and STAT hs-cTnI assays (Abbott) in a cohort of dialysis patients. Serum troponin levels were divided into tertiles with the lowest tertile as a reference value. Serum troponins were associated with indicators of CVD such as left ventricular mass index (LVMI), left ventricular ejection fraction (LVEF) and the presence of coronary artery disease (CAD). Associations were explored using regression analysis. RESULTS: We included 154 consecutive patients, 68±7 years old, 77% male, 70% hemodialysis. Median serum cTnT was 51ng/L (exceeding the 99th percentile of the healthy population in 98%) and median serum cTnI was 13ng/L (elevated in 20%). A high cTnI (T3) was significantly associated with a higher LVMI (Beta 31.60; p=0.001) and LVEF (Beta -4.78; p=0.005) after adjusting for confounders whereas a high serum cTnT was not. CAD was significantly associated with a high cTnT (OR 4.70 p=0.02) but not with a high cTnI. Unlike cTnI, cTnT was associated with residual renal function (Beta:-0.09; p=0.006). CONCLUSION: In the present cohort, serum cTnI levels showed a stronger association with LVMI and LVEF than cTnT. However, cTnT was significantly associated with CAD and residual renal function, unlike cTnI. Therefore, cTnI seems to be superior to cTnT as a marker of left ventricular dysfunction in asymptomatic dialysis patients, while cTnT might be better suited to detect CAD in these patients.

Soluble Klotho is not independently associated with cardiovascular disease in a population of dialysis patients.

BACKGROUND: Dialysis patients suffer from a high burden of cardiovascular disease (CVD). Partly this is due to progressive deterioration of calcium-phosphate homeostasis. Previous studies suggested that besides FGF-23, low levels of Klotho, a protein linked to aging, might constitute a key factor in this detrimental relationship. The purpose of the present study was to determine the relationship between serum Klotho (sKlotho) and the presence of CVD in dialysis patients. METHODS: Plasma levels of sKlotho were measured in a cohort of dialysis patients and related to left ventricular (LV) dysfunction (defined as a LV ejection fraction<45%) and LV mass using echocardiography. Coronary artery disease (CAD) and calcification score were assessed using computed tomography angiography. Abdominal aortic calcification score (AACscore) was measured by abdominal X-ray. RESULTS: We included 127 dialysis patients, 67±7 years old, 76% male, 67% on hemodialysis, median sKlotho 460 pg/mL (25th-75th percentile 350-620 pg/mL). Patients with a low sKlotho (<460 pg/mL) showed significantly more CAD (81% versus 61%; p=0.02) and LV dysfunction (19% versus 3%; p<0.01). However, after adjusting for confounders, sKlotho was not independently associated with the presence of CVD or the AACscore. CONCLUSIONS: In the present cohort of dialysis patients, sKlotho was not independently associated with CVD. However, patients with a low sKlotho level (<460 pg/mL) did show CAD and LV dysfunction more frequently. Therefore, while sKlotho might be a marker for CVD in dialysis patients, the current data does not support a direct cardioprotective effect of sKlotho.

Chronic kidney disease and implantable cardioverter defibrillator related complications: 16 years of experience.

INTRODUCTION: Implantable cardioverter defibrillator (ICD) implantation has become an accepted therapy for the prevention of sudden cardiac death. However, serious comorbidities such as chronic kidney disease (CKD) are influencing the beneficial effects of ICD therapy. In this study, the association between kidney function and the occurrence of ICD related complications was assessed. METHODS: All patients receiving an ICD or cardiac resynchronization therapy-defibrillator between 1996 and 2012 were included. Renal function was categorized as: glomerular filtration rate (GFR) >90, GFR 30-90 or GFR <30 mL/min/1.73 m(2) . Registered complications were pocket hematoma, pneumothorax, lead complications, and device infection. RESULTS: In 3,147 device recipients, 236 patients (7.5%) suffered from at least 1 complication. Patients with a GFR <30 (n = 110) had a higher event rate for hematoma, pneumothorax, and infection. These patients were older, had a higher incidence of hypertension, diabetes, and a lower body mass index (BMI; P < 0.05). After correcting for these risk factors, hematoma remained independently associated with a GFR <30 mL/min (OR 2.7, CI: 1.05-6.9, P = 0.04). Device infection, pneumothorax, and lead complications were not independently associated with a GFR <30 mL/min/1.73 m(2) . CONCLUSIONS: Patients with CKD suffered from more ICD related complications than patients without kidney disease. This was partially associated with kidney dysfunction itself as was the case with the occurrence of hematoma. However, the high burden of risk factors associated with device complications in patients with renal disease played an important role as well.

Cost-effectiveness of primary prevention implantable cardioverter defibrillator treatment: data from a large clinical registry.

BACKGROUND: Although randomized trials have shown the beneficial effect on survival of an implantable cardioverter defibrillator (ICD) as primary prevention therapy in selected patients, data concerning the cost-effectiveness in routine clinical practice remain scarce. Accordingly, the purpose of this study was to assess the cost-effectiveness of primary prevention ICD implantation in the real world. METHODS: Patients receiving primary prevention single-chamber or dual-chamber ICD implantation at the Leiden University Medical Center were included in the study. Using a Markov model, lifetime cost, life years (LYs), and gained quality-adjusted life years (QALYs) were estimated for device recipients and control patients. Data on mortality, complication rates, and device longevity were retrieved from our center and entered into the Markov model. To account for model assumptions, one-way deterministic and probabilistic sensitivity analyses were performed. Importantly, calculations for the estimated incremental cost-effectiveness rate (ICER) per QALY gained are based on several numbers of assumptions, and accordingly findings may have over- or underestimated the cost-effectiveness of ICD therapy. RESULTS: Primary prevention ICD implantation adds an estimated mean of 2.07 LYs and 1.73 QALYs. Increased lifetime cost for single-chamber and dual-chamber ICD recipients were estimated at €60,788 and €64,216, respectively. This resulted for single-chamber ICD recipients, in an estimated ICER of €35,154 per QALY gained. In dual-chamber ICD recipients, an estimated ICER of €37,111 per QALY gained was calculated. According to the probabilistic sensitivity analysis, estimated cost per QALY gained are €35,837 (95% confidence interval [CI]: €28,368-€44,460) for single-chamber and €37,756 (95% CI: €29,055-€46,050) for dual-chamber ICDs. CONCLUSIONS: On the basis of data and detailed costs, derived from routine clinical practice, ICD therapy in selected patients with a reduced left ventricular ejection fraction appears to be cost-effective.

Echocardiographical determinants of an abnormal spatial QRS-T angle in chronic dialysis patients.

BACKGROUND: The spatial QRS-T angle describes the relation between ventricular depolarization and repolarization. Having a wide (abnormal) angle is considered an important predictor of arrhythmic events. Given the high incidence of sudden cardiac death in dialysis patients, this parameter is of particular interest in this patient group. The objective of this study was to assess the association of (modifiable) echocardiographic parameters and an abnormal spatial QRS-T angle in dialysis patients. METHODS: A total of 94 consecutive dialysis patients were included. In all patients a 12-lead electrocardiogram (ECG), a two-dimensional echocardiogram and routine blood samples were obtained. The spatial QRS-T angle was then calculated from the 12-lead ECG. An abnormal spatial QRS-T angle was defined as ≥130° in males and ≥116° in females. RESULTS: An abnormal spatial QRS-T angle was present in 27 (29%) patients. Patients with an abnormal spatial angle had a lower left ventricular ejection fraction (LVEF) of 47 ± 7 versus 55 ± 6% (P < 0.001) and had a higher left ventricular (LV) dyssynchrony, with a septal to lateral (S-L) delay of peak systolic velocity of 70 inter quartile range (iIQR) (40, 100) ms versus 30 IQR (10, 70) ms (P = 0.001), respectively. Multivariate logistic regression analysis controlling for possible confounders demonstrated that LVEF [odds ratio (OR) 0.82; 95% confidence interval (CI) 0.72-0.93, P = 0.001] and LV dyssynchrony (OR 1.19 per 10 ms; 95% CI 1.03-1.38, P = 0.02) were independent determinants of an abnormal spatial QRS-T angle in this patient group. CONCLUSIONS: LVEF and dyssynchrony are echocardiographic determinants of an abnormal spatial QRS-T angle in dialysis patients and might therefore represent a potential target for the prevention of sudden cardiac death in these patients.

CT coronary angiography is feasible for the assessment of coronary artery disease in chronic dialysis patients, despite high average calcium scores.

PURPOSE: Significant obstructive coronary artery disease (CAD) is common in asymptomatic dialysis patients. Identifying these high risk patients is warranted and may improve the prognosis of this vulnerable patient group. Routine catheterization of incident dialysis patients has been proposed, but is considered too invasive. CT-angiography may therefore be more appropriate. However, extensive coronary calcification, often present in this patient group, might hamper adequate lumen evaluation. The objective of this study was to assess the feasibility of CT-angiography in this patient group. METHODS: For this analysis all patients currently participating in the ICD2 trial (ISRCTN20479861), with no history of PCI or CABG were included. The major epicardial vessels were evaluated on a segment basis (segment 1-3, 5-8, 11 and 13) by a team consisting of an interventional and an imaging specialist. Segments were scored as not significant, significant and not interpretable. RESULTS: A total of 70 dialysis patients, with a mean age of 66±8 yrs and predominantly male (70%) were included. The median calcium score was 623 [79, 1619]. Over 90% of the analyzed segments were considered interpretable. The incidence of significant CAD on CT was 43% and was associated with cardiovascular events during follow-up. The incidence of cardiovascular events after 2-years follow-up: 36% vs. 0% in patients with no significant CAD (p<0.01). CONCLUSION: Despite the high calcium scores CT-angiography is feasible for the evaluation of the extent of CAD in dialysis patients. Moreover the presence of significant CAD on CT was associated with events during follow-up.

Suitability for subcutaneous defibrillator implantation: results based on data from routine clinical practice.

OBJECTIVE: To assess the proportion of current implantable cardioverter defibrillator (ICD) recipients who would be suitable for a subcutaneous lead ICD (S-ICD). DESIGN: A retrospective cohort study. SETTING: Tertiary care facility in the Netherlands. PATIENTS: All patients who received a single- or dual-chamber ICD in the Leiden University Medical Center between 2002 and 2011. Patients with a pre-existent indication for cardiac pacing were excluded. MAIN OUTCOME MEASURE: Suitability for an S-ICD defined as not reaching one of the following endpoints during follow-up: (1) an atrial and/or right ventricular pacing indication, (2) successful antitachycardia pacing without a subsequent shock or (3) an upgrade to a CRT-D device. RESULTS: During a median follow-up of 3.4 years (IQR 1.7-5.7 years), 463 patients (34% of the total population of 1345 patients) reached an endpoint. The cumulative incidence of ICD recipients suitable for an initial S-ICD implantation was 55.5% (95% CI 52.0% to 59.0%) after 5 years. Significant predictors for the unsuitability of an S-ICD were: secondary prevention, severe heart failure and prolonged QRS duration. CONCLUSIONS: After 5 years of follow-up, approximately 55% of the patients would have been suitable for an S-ICD implantation. Several baseline clinical characteristics were demonstrated to be useful in the selection of patients suitable for an S-ICD implantation.

Incremental prognostic value of an abnormal baseline spatial QRS-T angle in chronic dialysis patients.

AIMS: In order to improve the abysmal outcome of dialysis patients, it is critical to identify patients with a high mortality risk. The spatial QRS-T angle, which can be easily calculated from the 12 lead electrocardiogram (ECG), might be useful in the prognostication in dialysis patients. The objective of this study was to establish the prognostic value of the spatial QRS-T angle. METHODS AND RESULTS: All patients who initiated dialysis therapy between 2002 and 2009 in the hospitals of Leiden (LUMC) and Amsterdam (AMC) at least 3 months on dialysis were included. The spatial QRS-T angle was calculated, from a routinely acquired ECG, and its relationship with mortality was assessed. An abnormal spatial QRS-T angle was defined as ≥ 130° in men and ≥ 116° in women. In total, 277 consecutive patients (172 male, mean age 56.3 ± 17.0) were included. An abnormal spatial QRS-T angle was associated with a higher risk of death from all causes [hazard ratio (HR) 2.33; 95% confidence interval (CI) 1.46-3.70] and especially a higher risk of sudden cardiac death (HR 2.99; 95% CI 1.04-8.60). Furthermore, an abnormal spatial QRS-T angle was of incremental prognostic value, when added to a risk model consisting of known risk factors. CONCLUSION: In chronic dialysis patients the spatial QRS-T angle is a significant and independent predictor of all-cause and especially sudden cardiac death. It implies that this parameter can be used to identify high risk patients.

Left ventricular diastolic dysfunction in dialysis patients assessed by novel speckle tracking strain rate analysis: prevalence and determinants.

Background. Diastolic dysfunction is common among dialysis patients and is associated with increased morbidity and mortality. Novel echocardiographic speckle tracking strain analysis permits accurate assessment of left ventricular diastolic function, independent of loading conditions and taking all myocardial segments into account. The aim of the study was to evaluate the prevalence of diastolic dysfunction in chronic dialysis patients using this novel technique, and to identify its determinants among clinical and echocardiographic variables. Methods. Patients currently enrolled in the ICD2 study protocol were included for this analysis. Next to conventional echo measurements diastolic function was also assessed by global diastolic strain rate during isovolumic relaxation (SRIVR). Results. A total of 77 patients were included (age 67 ± 8 years, 74% male). When defined as E/SRIVR ≥236, the prevalence of diastolic dysfunction was higher compared to more conventional measurements (48% versus 39%). Left ventricular mass (OR 1.02, 95% CI 1.00-1.04, P = 0.014) and pulse wave velocity (OR 1.34, 95% CI 1.07-1.68, P = 0.01) were independent determinants of diastolic dysfunction. Conclusion. Diastolic dysfunction is highly prevalent among dialysis patients and might be underestimated using conventional measurements. Left ventricular mass and pulse wave velocity were the only determinants of diastolic dysfunction in these patients.

Cardiac device infections are associated with a significant mortality risk.

BACKGROUND: Cardiac device infections (CDIs) are a serious complication associated with the implantation of cardiac rhythm devices. However, the effect of CDI on the subsequent risk of mortality is unknown. OBJECTIVE: To assess the prognostic importance of CDI in recipients of implantable cardioverter-defibrillator and cardiac resynchronization therapy - defibrillator. METHODS: All patients who received their initial implantable cardioverter-defibrillator/cardiac resynchronization therapy - defibrillator between January 2000 and September 2009 were included. During follow-up, the occurrence of CDI and all-cause mortality were noted. The prognostic importance of the first CDI on mortality was assessed by modeling CDI as a time-dependent covariate in the Cox proportional hazards model. RESULTS: A total of 2476 patients (79% men; mean age 62 ± 13 years) were included in this analysis. During follow-up, CDI occurred in 64 (2.6%) patients. The 1-year mortality following first CDI was 16.9% (95% confidence interval 6.7%-27.1%). Experiencing the first CDI was associated with a 1.9-fold (hazard ratio 1.87; 95% confidence interval 1.07-3.26) increased risk of mortality compared to patients who did not experience CDI. After controlling for possible confounders, this increased to a 2.4-fold (hazard ratio 2.40; 95% confidence interval 1.35-4.28) increased risk of mortality. CONCLUSIONS: In a large cohort of patients who receive implantable cardioverter-defibrillator/cardiac resynchronization therapy - defibrillator after their initial implant, the 3-year incidence of CDI was 2.6%. The occurrence of CDI was associated with substantial 1-year mortality, and patients experiencing CDI had a more than 2-fold increased risk of mortality compared with patients who remained free from CDI.

Implantable cardioverter-defibrillator longevity under clinical circumstances: an analysis according to device type, generation, and manufacturer.

BACKGROUND: One of the major drawbacks of implantable cardioverter-defibrillator (ICD) treatment is the limited device service life. Thus far, data concerning ICD longevity under clinical circumstances are scarce. In this study, the ICD service life was assessed in a large cohort of ICD recipients. OBJECTIVE: To assess the battery longevity of ICDs under clinical circumstances. METHODS: All patients receiving an ICD in the Leiden University Medical Center were included in the analysis. During prospectively recorded follow-up visits, reasons for ICD replacement were assessed and categorized as battery depletion and non-battery depletion. Device longevity and battery longevity were calculated. The impact of device type, generation, manufacturer, the percentage of pacing, the pacing output, and the number of shocks on the battery longevity was assessed. RESULTS: Since 1996, 4673 ICDs were implanted, of which 1479 ICDs (33%) were replaced. Mean device longevity was 5.0 ± 0.1 years. A total of 1072 (72%) ICDs were replaced because of battery depletion. Mean battery longevity of an ICD was 5.5 ± 0.1 years. When divided into different types, mean battery longevity was 5.5 ± 0.2 years for single-chamber ICDs, 5.8 ± 0.1 for dual-chamber ICDs, and 4.7 ± 0.1 years for cardiac resynchronization therapy-defibrillators (P <.001). Devices implanted after 2002 had a significantly better battery longevity as compared with devices implanted before 2002 (5.6 ± 0.1 years vs 4.9 ± 0.2 years; P <.001). In addition, large differences in battery longevity between manufacturers were noted (overall log-rank test, P <.001). CONCLUSIONS: The majority of ICDs were replaced because of battery depletion. Large differences in longevity exist between different ICD types and manufacturers. Modern ICD generations demonstrated improved longevity.

Trans-venous lead removal without the use of extraction sheaths, results of >250 removal procedures.

AIMS: The number of implanted cardiac rhythm devices has rapidly increased in the past decade. Subsequently, the need for lead extraction has also increased. Several techniques of lead removal have been documented from manual traction of the lead to lead extraction assisted with mechanical or laser sheaths. The goal of this study was to review our experience with lead removal using manual traction without the assistance of extraction sheaths. METHODS AND RESULTS: In the Leiden University Medical Center all leads are removed using manual traction without the assistance of extraction sheaths. We have retrospectively reviewed all lead removal procedures performed between 2000 and 2009. Procedures were reviewed for indication, success, complication rates, and mortality. In total, 279 lead removal procedures were included. During these procedures 445 leads were removed. Time since lead implantation: 4.2 ± 4.7 years. During extraction 53(11.9%) leads fractured, of which >50% could still be completely removed using a femoral approach. A longer implantation duration [odds ratio (OR) 1.16 per year, 95% confidence interval (CI) 1.09-1.23] and passive fixation (OR 2.52, 95%CI 1.17-5.45) significantly associated with the chance of lead fracture during lead removal. Clinical success, using the primary approach of manual traction from the pectoral area, was obtained in 228 (84.8%) procedures. Major complications occurred in 2(0.7%) and minor in 13(4.7%) procedures. One patient died within 24 h after the procedure due to septic shock. There was no further mortality within the first month after the procedure. CONCLUSION: Lead removal using manual traction, without the assistance of lead extraction sheaths, is clinically successful in ~85% of the lead extraction procedures. Concomitant morbidity and mortality are low. The highest clinical success (~95%) was observed in patients with leads implanted less than 2.6 years.

Prophylactic implantable cardioverter-defibrillator treatment in the elderly: therapy, adverse events, and survival gain.

AIMS: In elderly patients, obscurity remains regarding the benefit of implantable cardioverter-defibrillator (ICD) treatment as primary prevention of sudden cardiac death. This study assesses implant rates, therapy, adverse events, and survival gain in the elderly primary prevention ICD patient. METHODS AND RESULTS: A total of 1395 patients treated with an ICD for primary prevention of sudden cardiac death at the Leiden University Medical Center were included and allocated to three groups according to age. Endpoints consisted of appropriate shocks and survival gain, defined as the time following first appropriate ICD shock to death. Mean follow-up was 2.9 ± 2.1 years. Fifty-one per cent of the patients were <65 years, 35% were 65-74 years, and 14% were ≥75 years. Prior to the year 2000, no ICDs were implanted in patients ≥75 years; 29% of the ICDs were implanted in patients 65-74 years. After 2005, 53% of the ICD recipients were ≥65 years at the time of implant, including 16% aged ≥75 years (P = 0.03). Five-year cumulative incidence of appropriate shocks was 19% for patients <65 years, 23% for patients 65-74 years, and 13% for patients ≥75 years (P = 0.47). At 1-year following appropriate shock, cumulative incidence for death was 35% for patients ≥75 years as compared with 7% for patients <65 years (P < 0.01). CONCLUSION: In routine clinical practice, the percentage of patients ≥75 years receiving an ICD for primary prevention is increasing. Despite experiencing comparable rates of appropriate ICD shocks, life prolongation by ICD is significantly less in elderly as compared to younger patients.