Introduction Renal dysfunction is exceedingly common in patients with advanced heart failure. In a study of Medicare beneficiaries with end stage renal disease, 51.6% of patients who underwent LVAD therapy died during the index hospitalization. However, there are limited data on risk factors for dialysis following implantation of the contemporary centrifugal flow magnetically levitated LVAD device (CF-MagLev). The CF-MagLev is currently the only LVAD available for implantation in North America and has better outcomes compared to prior LVADs. This study aims to determine risk factors for the need for dialysis post CF-MagLev implant with regards to patient characteristics as well as intra-operative factors. Methods The study comprised 388 patients who underwent CF-MagLev implant at the University of Rochester Medical Center from November 2017 to November 2024. Patients who were dialysis dependent prior to LVAD implant were excluded. Cox proportional hazard modeling was used to assess risk factors associated with dialysis post implant within the index hospitalization. Results Out of 388 patients implanted with an LVAD during the study period, 50 required dialysis within the index hospitalization post implant. Multivariate analysis identified 6 factors that were independently associated with the need for dialysis post LVAD-implant (Table 1), including increased age (3% risk-increase per one year increment), severe RV dysfunction (2.8-fold increase), worse baseline creatinine function(2 fold increase per mg/dL), increased WBC count; lower prealbumin levels, and the length of the LVAD implant surgery (1% risk-increase per one minute increment in surgery duration). Conclusions Our findings suggest that combined assessment of underlying patient clinical, laboratory, imaging and procedural factors, can be used to assess the risk of development of need for dialysis-post CF MagLev LVAD implant. This information can be used to help patients participate in better, more data driven shared decision-making, help further understanding of appropriate patient selection as well factors that need to be taken into consideration that can predict need for dialysis.
BACKGROUND:Patients with heart failure and reduced left ventricular ejection fraction (LVEF) are at elevated risk of ventricular tachycardia or fibrillation (VT/VF), pump failure, and noncardiac death. OBJECTIVES:The purpose of this study was to evaluate the relationship between LVEF and VT/VF risk, accounting for nonarrhythmic mortality as a competing event. METHODS:We analyzed primary prevention implantable cardioverter-defibrillator (ICD) recipients from 5 major trials (MADIT-II [Multicenter Automatic Defibrillator Implantation Trial II], MADIT-CRT [Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy], MADIT-RIT [Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy], MADIT-RISK, RAID [Ranolazine in High-Risk Patients With Implanted Cardioverter-Defibrillator]), stratified by LVEF tertiles (≤20%, 21%-29%, 30%-35%). Outcomes included sustained VT/VF (primary), fast VT/VF (≥200 beats/min), appropriate ICD shocks, and all-cause mortality. Fine and Gray models were used to adjust for the competing risk of nonarrhythmic mortality. RESULTS:The study population comprised 5,168 patients. At 3 years, the cumulative incidence of sustained VT/VF was inversely correlated with increasing LVEF tertiles: 28% for LVEF ≤20%, 23% for LVEF 21%-29%, and 20% for LVEF 30%-35% (P < 0.001). In multivariable models, patients with LVEF ≤20% had a 23% higher cumulative incidence of sustained VT/VF (P = 0.004), 33% higher cumulative incidence of fast VT/VF (P = 0.001), and 31% higher cumulative incidence of ICD shocks (P = 0.003) compared with those with LVEF >20%. These associations were similar across subgroups, cardiac resynchronization therapy-defibrillator use, and cardiomyopathy etiology. Patients with LVEF ≤20% also had a 1.5-fold increased risk of all-cause mortality (P < 0.001). CONCLUSIONS:Patients with very low LVEF have higher cumulative incidence of sustained VT/VF and ICD shocks, along with an increased competing risk of death. These findings suggest that LVEF is an important factor in the shared decision-making process for a primary prevention ICD.
BACKGROUND:Cardiac resynchronization therapy with defibrillation (CRT-D) improves outcomes in heart failure. The long-term impact of CRT-D on hospitalizations remains unknown. METHODS:We analyzed the MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy) trial post hoc to assess the effects of CRT-D versus implantable cardioverter-defibrillator (ICD) on cardiovascular, heart failure (HF), and noncardiovascular hospitalizations. Hospitalization rates, length of stay, and mortality were compared during extended follow-up. RESULTS:Patients receiving CRT-D had lower rates of hospitalization compared with ICD (37.9 events per 100 patient-years versus 44.3 events per 100 patient-years, P=0.033). Rates of cardiovascular hospitalizations (20.8 versus 28.3 events per 100 patient-years; P<0.001) and heart failure hospitalizations (6.8 versus 11.6 events per 100 patient-years; P<0.001) were lower with CRT-D. There was no difference in noncardiovascular hospitalizations in the CRT-D group compared with ICD (17 versus 16 events per 100 patient-years, P=0.368). The average length of stay for cardiovascular hospitalizations was shorter in the CRT-D group versus the ICD group (6.7±0.89 versus 7.7±0.68 days; P<0.001), as was the length of stay for heart failure hospitalizations (4.2±0.79 versus 4.8±0.58 days; P<0.001). No difference was observed in the length of stay for noncardiovascular hospitalizations (8.1 versus 7.0 days; P=0.082). Hospitalization of any type was associated with a markedly increased risk of death (hazard ratio, 8.97 [95% CI, 6.17-13.05]; P<0.0001). CONCLUSIONS:Among patients in MADIT-CRT, CRT-D was associated with lower rates and shorter durations of all cardiovascular hospitalizations, including heart failure hospitalizations compared with ICD alone. Hospitalization, regardless of cause, was strongly associated with increased mortality. REGISTRATION:https://clinicaltrials.gov/study/NCT00180271.
Background Women with congenital long‐QT syndrome (LQTS) experience increased risk of cardiac events (CE) after the onset of adolescence, possibly due to the effect of sex hormones on the cardiac ion channels. We hypothesized that late menarche may affect the risk of CE in women with LQTS. Methods Beginning in 2010, information on age at menses onset was obtained from all women enrolled in the Rochester LQTS Registry. Multivariable modeling was employed to evaluate the association of age at menarche with the burden of CE (total number of syncope, aborted cardiac arrest, and LQTS‐related sudden cardiac death) during the subsequent 20 years of follow‐up. Menarche groups were defined as early (<12 years), normal (12–16 years), and late (>16 years). Results We report data on 435 genetically confirmed LQTS women, of whom 68, 346, and 21 were in the early, normal, and late‐onset groups, respectively. The mean cumulative rate of CE at 20 years of follow‐up in women with late menarche was 28% and 64% higher than in women with normal or early menarche, respectively; P<0.001 for the overall difference during follow‐up. Consistently, multivariable analysis showed that late menarche was associated with a pronounced 52% increased risk of CE compared with normal menarche (P=0.02). Conclusions Late menarche is associated with increased risk of CE in women with congenital LQTS. Further research is warranted to validate these findings and ascertain the explanatory pathophysiological pathways.
BACKGROUND:Cardiac implantable electronic devices (CIEDs) frequently detect brief, often subclinical atrial fibrillation (AF), but their value for predicting progression to persistent AF remains uncertain. Statistical and machine learning (ML) approaches may enable dynamic risk stratification using this longitudinal device data. OBJECTIVE:To develop a risk stratification model using clinical and CIED-derived AF burden measured over a rolling 6-month window to predict progression to persistent AF. METHODS:We analyzed continuous CIED data from 1985 patients without prior persistent AF implanted between 2016 and 2024 at a tertiary medical center. AF burden and clinical variables were summarized using overlapping 6-month rolling windows to estimate 1-year risk of persistent AF. Associations were evaluated using Kaplan-Meier and Cox proportional hazards models. A gradient-boosted decision tree model (XGBoost) was used to predict progression. RESULTS:During a mean follow-up of 1192 days, 874 patients (44%) developed paroxysmal AF, of whom 257 (29%) progressed to persistent AF after a mean of 813 days. Patients with no AF or < 1 h/day of AF in the prior 6 months had > 97% 1-year freedom from persistent AF, whereas those with > 8 h/day had a 63% progression rate. Higher AF burden was strongly associated with progression (maximum HR 8.66, p < 0.001). The ML model demonstrated high predictive performance (sensitivity 99.4%, specificity 95.7%). CONCLUSION:CIED-detected AF burden is strongly associated with progression to persistent AF. ML-based analysis of 6-month device data enables accurate, point-in-time risk stratification to support earlier and more targeted clinical management.
INTRODUCTION:We have previously shown an association between metabolic syndrome (MS) and heart failure (HF) outcomes in patients with implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy with defibrillator (CRT-D). However, the role of MS in predicting outcomes was not assessed in non-obese patients. We aimed to examine how the presence of MS and its components predicts the risk of HF/death in non-obese ICD or CRT-D patients. METHODS:We included obese and non-obese patients, enrolled in Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy (MADIT-CRT). Patients needed at least 2 of the 3 criteria, dyslipidaemia, diabetes, or hypertension, to be considered for having MS. Kaplan-Meier analyses were used to assess the rate of HF/death by MS. Multivariate Cox-proportional analyses were performed to assess the risk of HF/death by MS. RESULTS:From 1180 (65%) non-obese patients in MADIT-CRT, 672 (57%) presented with MS. Among non-obese patients with MS, 284 (42%) had diabetes mellitus. Non-obese MS patients had a significantly higher, 34% cumulative probability of HF/death at 3 years, as compared to the 20% of non-obese patients without MS (log-rank P < .001) (hazard ratio: 1.64, 95% CI: 1.15-2.32, P & .006). Within non-obese MS patients, those with diabetes had a significantly higher rate of HF/death with 28% vs. 20% in non-diabetics at 2.5 years (log-rank P < .001). Reverse remodelling was similar in all subgroups. CONCLUSION:MS in non-obese ICD or CRT-D patients is associated with a higher risk of HF/Death, most prominent in those with diabetes, necessitating early intervention.
Background Patients with palpitations and dizziness are typically monitored using ambulatory electrocardiographic (ECG) monitoring including Holter monitors and extended continuous ECG monitors. The KardiaMobile 6L (KM6L), a portable medical-grade ECG recorder, enables patients to initiate 6-lead ECG recordings during symptoms when needed. Objectives This study aimed to assess the comparative effectiveness in detecting clinically significant arrhythmias between ambulatory ECG monitoring modalities and 30-day use of KM6L. Methods Patients with palpitations or other arrhythmic symptoms who were referred to for standard ambulatory monitoring (either 24- or 48-hour Holter or ambulatory ECG patch) were asked to perform 1-minute, 6-lead ECG recordings with the KM6L device during symptomatic episodes over a 30-day period. Clinically significant arrhythmias were defined as atrial fibrillation/flutter, second/third-degree atrioventricular block, wide complex tachycardia, supraventricular tachycardia >100 bpm, pauses >3 seconds, or sinus tachycardia >130 bpm. Detection rates between KM6L and standard monitoring were compared using McNemar test. Results We enrolled 350 (40%, n = 140 with 24/48-hour Holter) patients who recorded 6,251 KM6L recordings (median 15 per patient). Significant arrhythmias were detected in 66 patients (18.9%) using either ambulatory ECG monitoring or KM6L. Ambulatory ECG monitoring modalities identified arrhythmias in 27 patients (7.7%), whereas KM6L detected arrhythmias in 52 patients (14.9%) (P < 0.001). Importantly, 39 arrhythmia episodes (11.1%) were detected exclusively by KM6L (P = 0.0008), most commonly atrial fibrillation (n = 23). Conclusions These findings demonstrate that patient-initiated, symptom-triggered ECG monitoring substantially enhances arrhythmia detection compared with traditional short-duration monitoring.
BACKGROUND:Women with congenital and acquired long QT syndrome (LQTS) have increased risk of adverse cardiac events after adolescence, mainly due to sex hormones modulating the KCNH2 cardiac potassium channel. We hypothesized that sex hormones may influence ventricular tachyarrhythmia risk during the menstrual cycle in women treated with QT-prolonging drugs. OBJECTIVE:To evaluate the association between repolarization dynamics and sex hormone levels during the menstrual cycle in women treated with QT-prolonging drugs. METHODS:We prospectively enrolled 41 women treated with dofetilide or sotalol (N = 20) and healthy controls (N = 21). Participants underwent three 7-day ECG recordings during their menstrual cycles, with concurrent saliva hormone measurements. Primary ECG outcomes were QT-Apex (early repolarization) and QT interval (total repolarization time), adjusted for heart rate. RESULTS:The mean age was 51 ± 11 years in the treatment group and 42 ± 12 years in controls. In women treated with QT-prolonging drugs, linear mixed-effects models (adjusted for RR interval) showed inverse correlations of QT-Apex with progesterone-to-estradiol ratio (p = 0.018) and testosterone (p = 0.026), and a direct correlation with estradiol (p = 0.004). QT interval inversely correlated with progesterone-to-estradiol ratio (p = 0.012). No significant correlations were observed in controls. CONCLUSIONS:Sex hormones are significantly associated with ventricular repolarization dynamics during the menstrual cycle in women treated with QT-prolonging drugs, suggesting a mechanism for sex-specific arrhythmia susceptibility.