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.

Prevalence and Prognostic Implications of Mitral and Aortic Valve Calcium in Patients With Chronic Kidney Disease.

Calcium in the cardiac valves can be observed in patients with severe chronic kidney disease (CKD). However, the prevalence and prognostic implications of left-sided cardiac valve calcium in patients with stage 2 and 3 CKD (estimated glomerular filtration rate (eGFR) of 60 to 89 and 30 to 59 ml/min/1.73 m² respectively) is unknown. The present study investigates the prevalence of mitral and aortic valve calcium in patients with stage 2 and 3 CKD and evaluates its association with all-cause mortality. In patients with stage 2 and 3 CKD who underwent clinically indicated coronary computed tomography angiography, the presence of mitral and/or aortic valve calcium was assessed. Patients were divided into 2 groups according to the presence of mitral and/or aortic valve calcium on coronary computed tomography angiography. Patients were followed for the occurrence of all-cause mortality (primary end point). Of 204 stage 2 and 3 CKD patients (54% men, mean age 60 ± 10 years), 66 (32%) patients had mitral and/or aortic valve calcium. During a median follow-up of 6 years (IQR; 2, 9 years), 29 (14%) patients died. Patients with mitral and/or aortic valve calcium showed significantly higher mortality rates compared with patients without left-sided valve calcium (log-rank p = 0.009). Mitral valve calcium was independently associated with increased risk of all-cause mortality, whereas aortic valve calcium was not. In conclusion, the prevalence of left-sided valve calcium in patients with stage 2 and 3 CKD is high. Mitral valve calcium was independently associated with increased risk of all-cause mortality, whereas aortic valve calcium was not.

Left Ventricular Mechanical Dispersion and Global Longitudinal Strain and Ventricular Arrhythmias in Predialysis and Dialysis Patients.

BACKGROUND: Patients with advanced chronic kidney disease (CKD) have high risk for sudden cardiac death (SCD) and may benefit from implantable cardioverter-defibrillators (ICDs). However, the risk for ICD-related complications is also high in this population. Therefore, there is an unmet need for accurate risk stratification tools to identify patients with CKD at risk for ventricular arrhythmias (VAs), who may benefit from ICD implantation. The aim of this hypothesis-generating study was to investigate the association between left ventricular (LV) mechanical dispersion and LV global longitudinal strain (GLS) measured using two-dimensional speckle-tracking echocardiography and VA and SCD in patients with CKD. METHODS: Patients with CKD stages 3b to 5 (estimated glomerular filtration rate < 45 mL/min/1.73 m2 or on dialysis) were included and were divided into two groups according to the occurrence of VA or SCD during follow-up. LV mechanical dispersion, as a measure of the temporal heterogeneity of the LV deformation, was measured as the SD of time to peak longitudinal strain of 17 LV segments. The ability of LV mechanical dispersion, LV ejection fraction, and LV GLS to discriminate patients with VA or SCD during follow-up was evaluated using receiver operating characteristic curve analysis. RESULTS: Of 250 patients (66% men; mean age, 61 ± 14 years), 16 (6%) experienced VA or SCD during a median follow-up duration of 28 months (interquartile range, 16-53 months). Using receiver operating characteristic curve analyses, LV GLS (area under the curve = 0.79; 95% CI, 0.68-0.89) and LV mechanical dispersion (area under the curve = 0.71; 95% CI, 0.61-0.82) showed modest discrimination to identify patients at risk for VA or SCD. In contrast, LV ejection fraction showed poor discrimination (area under the curve = 0.60; 95% CI, 0.41-0.78). CONCLUSIONS: LV mechanical dispersion along with LV GLS may be an additional valuable risk marker of VA and SCD in predialysis and dialysis patients.

Prevalence of left ventricular systolic dysfunction in pre-dialysis and dialysis patients with preserved left ventricular ejection fraction.

AIMS: Patients with chronic kidney disease (CKD) have an excess of cardiovascular morbidity and mortality, with heart failure (HF) being particularly frequent. Reduced left ventricular ejection fraction (LVEF) defines left ventricular (LV) systolic dysfunction and is associated with poor prognosis. However, CKD patients may have HF symptoms with preserved LVEF. In this subgroup of patients, two-dimensional speckle tracking echocardiography can detect LV systolic dysfunction by analysing LV myocardial deformation. The present study evaluated the prevalence of impaired LV global longitudinal strain (GLS) in CKD patients with preserved LVEF and its prognostic consequences. METHODS AND RESULTS: Overall, 200 pre-dialysis and dialysis patients (65% men, mean age 60 ± 14 years) with CKD stage 3b-5 and preserved LVEF (≥50%) were evaluated. Left ventricular systolic dysfunction despite preserved LVEF was defined by LV GLS ≤15.2% (cut-off value derived from two standard deviations below the mean value of individuals without structural heart disease). Impaired LV GLS (≤15.2%) despite preserved LVEF was observed in 32% of patients. During a median follow-up of 33 months (interquartile range 17-62 months), 47% of patients underwent renal transplantation, 9% were admitted with HF, and 28% died. Patients with LV GLS ≤15.2% showed significantly worse cumulative event-free survival rates of the combined endpoint of HF hospitalization and all-cause mortality compared to patients with LV GLS >15.2% (log-rank P = 0.018). CONCLUSION: The prevalence of impaired LV GLS despite preserved LVEF in pre-dialysis and dialysis patients is relatively high. Patients with preserved LVEF but impaired LV GLS have an increased risk of HF hospitalization and all-cause mortality.

Prognostic Implications of Left Ventricular Global Longitudinal Strain in Predialysis and Dialysis Patients.

Chronic kidney disease (CKD) is a worldwide growing epidemic associated with an increased risk of cardiovascular morbidity and mortality. Left ventricular (LV) global longitudinal strain (GLS) is a measure of LV systolic function associated with prognosis in the general population. However, little is known about the association between LV GLS and survival in patients with CKD. The aim of the present study was to investigate the prognostic implications of LV GLS in predialysis and dialysis patients specifically. LV GLS was measured in a retrospective cohort of predialysis and dialysis patients (CKD stage 3b to 5) who underwent clinically indicated echocardiography between 2004 and 2015. Patients were divided into 4 groups according to quartiles of LV GLS: first quartile (LV GLS ≤10.6%, worst function), second quartile (LV GLS 10.7% to 15.1%), third quartile (LV GLS 15.2% to 17.8%), and fourth quartile (LV GLS ≥17.9%, best function). The primary end point was all-cause mortality. Of 304 patients (62 ± 14 years, 66% male), 65% were in predialysis and 35% in dialysis. During a median follow-up of 29 months (interquartile range 16 to 58 months), 34% of patients underwent renal transplantation and 36% died. Patients with LV GLS ≤10.6% showed significantly worse prognosis compared with the other groups (log-rank test, p <0.001). LV GLS ≤10.6% was significantly associated with increased risk of all-cause mortality (hazard ratio 2.18, 95% CI 1.17 to 4.06, p = 0.014) after correcting for age, gender, albumin levels, atrial fibrillation, and renal transplantation. In conclusion, in predialysis and dialysis patients, severely impaired LV GLS is independently associated with an increased risk of mortality.

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.

Short-term effects of a standardized glucose load on region-specific aortic pulse wave velocity assessed by MRI.

PURPOSE: To assess the short-term effects of a standardized oral glucose load on regional aortic pulse wave velocity (PWV) using two-directional in-plane velocity encoded MRI. MATERIALS AND METHODS: A randomized, controlled intervention was performed in 16 male subjects (mean ± standard deviation: age: 59±7 years, body mass index: 28±3 kg/m2) with impaired fasting glucose. The intervention consisted of an oral glucose load (75 grams of carbohydrates in 300 mL water) at 1 study day and water (300 mL) at the other study day. PWV was measured using multislice two-directional in-plane velocity-encoded MRI. RESULTS: PWV in the proximal aorta at 1 h post-glucose load decreased compared with PWV 1-h post-water (delta PWV: -1.0±2.6 m/s versus 0.6±2.0 m/s, P=0.02). Eight responding subjects showed a significant decrease in PWV of the proximal aorta after the glucose load and had a decreased waist circumference (P=0.037) compared with nonresponders, being one of the major criteria of the metabolic syndrome. There was no significant change in PWV of the distal aorta at 1 h post-load comparing both intervention groups. CONCLUSION: A standardized oral glucose load induces a decrease of the proximal, but not of the distal, aortic PWV. Regional response of aortic PWV may be associated with features of the metabolic syndrome.