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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.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.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.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.ISRCTN20479861.

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.

Background Transvenous left ventricular (LV) lead placement for cardiac resynchronization therapy–defibrillator (CRT-D) delivery is unsuccessful in 8% to 10% of cases. These patients might benefit from an epicardial lead. However, data on long-term epicardial lead performance are scarce. Furthermore, extracting an epicardial lead requires a rethoracotomy. Objective The purpose of this study was to determine data on almost a decade of experience with epicardial leads and investigate the safety of partially leaving this lead in place after device infection. Methods All adult patients receiving an epicardial lead (Medtronic CapSure Epi, model 4968) for CRT-D in the Leiden University Medical Center were included. Leads were implanted during a standalone procedure or in combination with other cardiothoracic procedures. Electrical lead parameters were assessed at implantation and every 6 months thereafter. In case of device infection the epicardial lead was cut off parasternal, just outside the thoracic cavity, leaving the distal part of the lead in place. Results Two-hundred sixteen patients were included with a median follow-up of 3 years (25th–75th percentile 1.0–5.5). LV pacing threshold decreased within 6 months after implantation [1.1 V (95% confidence interval [CI] 0.9–1.2) vs 0.8 V (95% CI 0.7–0.9), P = .01] and stabilized thereafter. Mean LV electrogram was 15.2 ± 7.5mV, and average lead impedance was 633.5 ± 174.0 Ω. Five-year cumulative incidence was 1.6% for lead failure and 9.6% for device infection. The retained epicardial lead caused skin erosion in 3 patients and fistula formation in 1. Conclusion This study demonstrates that epicardial LV leads have an excellent long-term performance. Partially retaining the lead after device infection was associated with a risk of reinfection with limited long-term clinical implications for the patient.

Currently several extraction tools are available in order to allow safe and successful transvenous lead extraction (TLE) of pacemaker and ICD leads; however, no directives exist to guide physicians in their choice of extraction tools and approaches. To aim of the current review is to provide an overview of the success and complication rates of different extraction methods and tools available. A comprehensive search of all published literature was conducted in the databases of PubMed, Embase, Web of Science, and Central. Included papers were original articles describing a specific method of TLE and the corresponding success rates of at least 50 patients. Fifty-three studies were included; the majority (56%) utilized 2 (1-4) different venous extraction approaches (subclavian and femoral), the median number of extraction tools used was 3 (1-6). A stepwise approach was utilized in the majority of the studies, starting with simple traction which resulted in successful TLE in 7-85% of the leads. When applicable the procedure was continued with non-powered tools resulting in a successful extraction of 34-87% leads. Subsequently, powered tools were applied whereby success rates further increased to 74-100%. The final step in TLE was usually utilized by femoral snare leading to an overall TLE success rate of 96-100%. The median procedure-related mortality and major complication described were, respectively, 0% (0-3%) and 1% (0-7%) per patient. In conclusion, a stepwise extraction approach can result in a clinical successful TLE in up to 100% of the leads with a relatively low risk of procedure-related mortality and complications.

CKD and ICD Related Complications 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

Atrial fibrillation (AF) is common in dialysis patients and is associated with increased morbidity and mortality. The pathophysiology may be related to common risk factors for both AF and renal disease or to dialysis-specific factors. The purpose of this study was to determine whether and how AF onset relates to the dialysis procedure itself.All dialysis patients enrolled in the implantable cardioverter defibrillator-2 (ICD-2) trial until January 2012, who were implanted with an ICD, were included in this study. Using the ICD remote monitoring function, the exact time of onset of all AF episodes was registered. Subsequently, this was linked to the timing of dialysis procedures.For the current study, a total of 40 patients were included, follow-up was 28 ± 16 months, 80% male, 70 ± 8 years old. A total of 428 episodes of AF were monitored in 14 patients. AF onset was more frequent on the days of haemodialysis (HD) (p0.001) and specifically increased during the dialysis procedure itself (p=0.04). Patients with AF had a larger left atrium (p0.001) and a higher systolic blood pressure before and after HD (p0.001).This study provides insight in the exact timing of AF onset in relation to the dialysis procedure itself. In HD patients, AF occurred significantly more often on a dialysis day and especially during HD. These findings might help to elucidate some aspects of the pathophysiology of AF in dialysis patients and could facilitate early detection of AF in these high-risk patients.

Background Transvenous implantable cardioverter-defibrillators (TV-ICDs) improve survival in patients at risk for sudden cardiac death, but complications remain an important drawback. The subcutaneous ICD (S-ICD) was developed to overcome lead-related complications. Comparison of clinical outcomes of both device types in previous studies was hampered by dissimilar patient characteristics. Objectives This retrospective study compares long-term clinical outcomes of S-ICD and TV-ICD therapy in a propensity-matched cohort. Methods The authors analyzed 1,160 patients who underwent S-ICD or TV-ICD implantation in 2 high-volume hospitals in the Netherlands. Propensity matching for 16 baseline characteristics, including diagnosis, yielded 140 matched pairs. Clinical outcomes were device-related complications requiring surgical intervention, appropriate and inappropriate ICD therapy, and were reported as 5-year Kaplan-Meier rate estimates. Results All 16 baseline characteristics were balanced in the matched cohort of 140 patients with S-ICDs and 140 patients with TV-ICDs (median age 41 years [interquartile range: 30 to 52 years] and 40% women). The complication rate was 13.7% in the S-ICD group versus 18.0% in the TV-ICD group (p = 0.80). The infection rate was 4.1% versus 3.6% in the TV-ICD groups (p = 0.36). Lead complications were lower in the S-ICD arm compared with the TV-ICD arm, 0.8% versus 11.5%, respectively (p = 0.03). S-ICD patients had more nonlead-related complications than TV-ICD patients, 9.9% versus 2.2%, respectively (p = 0.047). Appropriate ICD intervention (antitachycardia pacing and shocks) occurred more often in the TV-ICD group (hazard ratio [HR]: 2.42; p = 0.01). The incidence of appropriate (TV-ICD HR: 1.46; p = 0.36) and inappropriate shocks (TV-ICD HR: 0.85; p = 0.64) was similar. Conclusions The complication rate in patients implanted with an S-ICD or TV-ICD was similar, but their nature differed. The S-ICD reduced lead-related complications significantly, at the cost of nonlead-related complications. Rates of appropriate and inappropriate shocks were similar between the 2 groups.

Prevention of sudden cardiac death (SCD) is an important target for improving survival in various patient groups and many prevention options have been evaluated. In the past decade several trials have documented beneficial effects for implantable cardioverter-defibrillator (ICD) implantation in patients surviving out-of-hospital cardiac arrest (secondary prevention) and in patients with diminished left ventricular function (primary prevention).1 However, within these patient groups a variety of comorbidities is present which might influence the benefit conferred by prophylactic ICD implantation. One of these comorbidities is chronic kidney disease (CKD), a condition that is highly prevalent among patients with a current ICD indication. CKD is of particular interest since this condition is associated with a substantial risk for non-arrhythmic death and this might negatively influence the beneficial effects of prophylactic ICD implantation. Accordingly this raises the question whether ICD implantation in these patients is appropriate for prevention of SCD or whether other more conservative treatment strategies are preferred with regard to safety and cost effectiveness. The mechanisms that underlie SCD in patients with CKD are complex and many factors have been associated with increasing the risk for SCD. Beside coronary artery disease (CAD), present in 80% of the patients dying from SCD, many other factors are believed to contribute to the development of SCD in patients with CKD which also might form therapeutic targets for preventing SCD in these patients. The key factors in the development of SCD, including CAD, will be discussed below and are summarised in table 1. View this table: Table 1 Mechanisms associated with sudden cardiac death in patients with chronic kidney disease ### Ischaemic heart disease CAD is highly prevalent among patients with CKD and is more severe compared to …

Prevention of sudden cardiac death (SCD) is an important target for improving survival in various patient groups and many prevention options have been evaluated. In the past decade several trials have documented beneficial effects for implantable cardioverter-defibrillator (ICD) implantation in patients surviving out-of-hospital cardiac arrest (secondary prevention) and in patients with diminished left ventricular function (primary prevention).1 However, within these patient groups a variety of comorbidities is present which might influence the benefit conferred by prophylactic ICD implantation. One of these comorbidities is chronic kidney disease (CKD), a condition that is highly prevalent among patients with a current ICD indication. CKD is of particular interest since this condition is associated with a substantial risk for non-arrhythmic death and this might negatively influence the beneficial effects of prophylactic ICD implantation. Accordingly this raises the question whether ICD implantation in these patients is appropriate for prevention of SCD or whether other more conservative treatment strategies are preferred with regard to safety and cost effectiveness. The mechanisms that underlie SCD in patients with CKD are complex and many factors have been associated with increasing the risk for SCD. Beside coronary artery disease (CAD), present in 80% of the patients dying from SCD, many other factors are believed to contribute to the development of SCD in patients with CKD which also might form therapeutic targets for preventing SCD in these patients. The key factors in the development of SCD, including CAD, will be discussed below and are summarised in table 1. View this table: Table 1 Mechanisms associated with sudden cardiac death in patients with chronic kidney disease ### Ischaemic heart disease CAD is highly prevalent among patients with CKD and is more severe compared to …

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.

Background Large randomized trials demonstrated the beneficial effect of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy–defibrillator (CRT-D) treatments in selected patients. Data on long-term follow-up of patients outside the setting of clinical trials are scarce. Objective The aim of this study was to evaluate the long-term outcome of ICD and CRT-D recipients. Methods All patients who underwent ICD (n = 1729 [57%]) or CRT-D (n = 1326 [43%]) implantation at the Leiden University Medical Center since 1996 were evaluated. Follow-up visits were performed every 3–6 months, and events were registered. Cumulative incidence curves of device therapy and device-related complications were adjusted for the competing risk of all-cause mortality. Results After a median follow-up of 5.1 years (25th–75th percentile 3.1–7.8 years), 842 patients (28%) died. The cumulative incidence of all-cause mortality was 49% (95% confidence interval [CI] 45%–54%) in ICD recipients after 12 years of follow-up and 55% (95% CI 52%–58%) in CRT-D recipients after 8 years of follow-up. A total of 1081 patients (35%) received appropriate defibrillator therapy. The cumulative incidence of appropriate therapy in ICD patients was 58% (95% CI 54%–62%) after 12 years of follow-up and 39% (95% CI 35%–43%) in CRT-D patients after 8 years of follow-up. Twelve-year cumulative incidences of adverse events were 20% (95% CI 18%–22%) for inappropriate shock, 6% (95% CI 5%–8%) for device-related infection, and 17% (95% CI 14%–21%) for lead failure. Conclusion After long-term follow-up of ICD (12 years) and CRT-D (8 years) recipients, 49% of ICD recipients and 55% of CRT-D recipients had died. Appropriate ICD therapy was received by the majority (58%) of ICD recipients and by almost 40% of CRT-D recipients.

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

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.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 GFR30 mL/min/1.73 m(2) . Registered complications were pocket hematoma, pneumothorax, lead complications, and device infection.In 3,147 device recipients, 236 patients (7.5%) suffered from at least 1 complication. Patients with a GFR30 (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; P0.05). After correcting for these risk factors, hematoma remained independently associated with a GFR30 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 GFR30 mL/min/1.73 m(2) .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.

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

Coronary artery disease (CAD) is common in asymptomatic chronic dialysis patients and plays an important role in their poor survival. Early identification of these high-risk patients could improve treatment and reduce mortality. Abdominal aortic calcification (AAC) has previously been associated with CAD in autopsy studies. Since the AAC can be quantified easily using a lateral lumbar X-ray we hypothesized that the extent of AAC as assessed on a lateral lumbar X-ray might be predictive of the presence of significant CAD in dialysis patients. All patients currently enrolled in the ICD2 trial without a history of CABG or a PCI with stent implantation were included in this study. All patients underwent CT-angiography (CTA) and a lateral X-ray of the abdomen. AAC on X-ray was quantified using a previously validated scoring system whereupon the association between AAC and the presence of significant CAD was assessed. A total of 90 patients were included in this study (71% male, 67 ± 7 years old). Forty-six patients were found to have significant CAD. AAC-score was significantly higher in patients with CAD (10.1 ± 4.9 vs 6.3 ± 4.6 (p