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.
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.
LV mechanical dispersion along with LV GLS may be an additional valuable risk marker of VA and SCD 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.
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 m 2 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.
ESRD patients with AF show more advanced changes in the LA substrate than ESRD patients without AF.
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 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
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