Search

Aims: Hospitalizations are common in patients with heart failure and are associated with high mortality, readmission and economic burden. Detecting early signs of worsening heart failure may enable earlier intervention and reduce hospitalizations. The HeartLogic algorithm is designed to predict worsening heart failure using diagnostic data from multiple device sensors. The main objective of this analysis was to evaluate the sensitivity of the HeartLogic alert calculation in predicting worsening heart failure events (HFEs). We also evaluated the false positive alert rate (FPR) and compared the incidence of HFEs occurring in a HeartLogic alert state to those occurring out of an alert state. Methods: The HINODE study enrolled 144 patients (81 ICD and 63 CRT‐D) with device sensor data transmitted via a remote monitoring system. HeartLogic alerts were then retrospectively simulated using relevant sensor data. Clinicians and patients were blinded to calculated alerts. Reported adverse events with HF symptoms were adjudicated and classified by an independent HFE committee. Sensitivity was defined as the ratio of the number of detected usable HFEs (true positives) to the total number of usable HFEs. A false positive alert was defined as an alert with no usable HFE between the alert onset date and the alert recovery date plus 30 days. The patient follow‐up period was categorized as in alert state or out of alert state. The event rate ratio was the HFE rate calculated in alert to out of alert. Results: The patient cohort was 79% male and had an average age of 68 ± 12 years. This analysis yielded 244 years of follow‐up data with 73 HFEs from 37 patients. A total of 311 HeartLogic alerts at the nominal threshold (16) occurred across 106 patients providing an alert rate of 1.27 alerts per patient‐year. The HFE rate was 8.4 times greater while in alert compared with out of alert (1.09 vs. 0.13 events per patient‐year; P < 0.001). At the nominal alert threshold, 80.8% of HFEs were detected by a HeartLogic alert [95% confidence interval (CI): 69.9%–89.1%]. The median time from first true positive alert to an adjudicated clinical HFE was 53 days. The FPR was 1.16 (95% CI: 0.98–1.38) alerts per patient‐year. Conclusions: Results suggest that signs of worsening HF can be detected successfully with remote patient follow‐up. The use of HeartLogic may predict periods of increased risk for HF or clinically significant events, allowing for early intervention and reduction of hospitalization in a vulnerable patient population. [ABSTRACT FROM AUTHOR]

Background: Pacing at sites of longest interventricular delay has been associated with greater reverse remodeling in cardiac resynchronization therapy (CRT). However, the effects of pacing at such sites on clinical outcomes is less well studied.Objective: To assess the association between interventricular delay and clinical outcomes in CRT patients implanted with quadripolar left ventricular (LV) leads.Methods: RALLY-X4 was a registry study of the Acuity X4 quadripolar LV leads. Interventricular delay was measured during unpaced basal rhythm from the right ventricular (RV) lead to the LV lead electrode (E1 to E4) chosen for CRT pacing. Patients were stratified by median RV-LV delay (80 ms) into short and long delay groups, and they were also analysed by multivariable modelling. The primary composite outcome measure was all-cause mortality and heart failure hospitalization (HFH) at 18 months.Results: There were 581 patients with complete RV-LV delay data. The mean LV ejection fraction (EF) was 27% and 73% had a typical left bundle branch block. Predictors of long RV-LV delay included female sex, LBBB and QRS duration >150ms. Survival free of the primary outcome at 18 months follow up was 87% in the long activation delay group compared with 77% in the short delay group (p=0.0042). Multivariate analysis showed that RV-LV delay was a, independent predictor of survival free of HFH (p=0.028).Conclusions: Among CRT patients with quadripolar LV pacing leads, longer baseline interventricular activation delay was significantly associated with the composite endpoint of all-cause mortality and heart failure hospitalization. [ABSTRACT FROM AUTHOR]

Aims The HINODE study aimed to analyse rates of mortality, appropriately treated ventricular arrhythmias (VA), and heart failure in Japanese patients and compared with those in Western patients. Methods and results After treatment decisions following contemporary practice in Japan, patients were prospectively enrolled into four cohorts: (i) internal cardioverter-defibrillator (ICD), (ii) cardiac resynchronization therapy (CRT) defibrillator (CRT-D), (iii) standard medical therapy (‘non-device’: ND), or (iv) pacing (indicated for CRT; received pacemaker or CRT pacing). Cohorts 1–3 required a left ventricular ejection fraction ≤35%, a history of heart failure, and a need for primary prevention of sudden cardiac death based on two to five previously identified risk factors. Endpoint outcomes were adjudicated by the independent committees. ICD and CRT-D cohorts, considered as high-voltage (HV) cohorts, were pooled for Kaplan–Meier analysis and propensity-matched to Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT) arm B and C patients. The study enrolled 354 patients followed for 19.6 ± 6.5 months, with a minimum of 12 months. Propensity-matched HV cohorts showed comparable VA (P = 0.61) and mortality rates (P = 0.29) for HINODE and MADIT-RIT. The ND cohort presented a high crossover rate to ICD therapy (6.1%, n = 7/115), and the CRT-D cohort showed elevated mortality rates. The pacing cohort revealed that patients implanted with pacemakers had higher mortality (26.0%) than those with CRT-Pacing (8.4%, P = 0.05). Conclusions The mortality and VA event rates of landmark trials are applicable to patients with primary prevention in Japan. Patients who did not receive guideline-indicated CRT devices had poor outcomes. [ABSTRACT FROM AUTHOR]

Objectives To evaluate the long-term outcome with an implantable atrial defibrillator (IAD) in patients with recurrent atrial fibrillation (AF).Background Maintenance of sinus rhythm using repeated internal cardioversion shocks has been shown to be effective and safe in short-term studies but long term follow-up is unknown.Methods Since 1995, 136 patients (30 women) with symptomatic, drug-refractory atrial fibrillation were implanted with an IAD (METRIX, InControl). This analysis was performed after a median of 40 (range 7–66) months after implantation.Results In 26 patients, the programmed mode was not documented during last follow-up, four patients had died. Of the remaining 106 patients (mean age 58±10, range 34 – 79 years), 39 were actively delivering therapy with the device, in 14 patients the device was used to monitor the arrhythmia but no shocks were delivered, and in 53 patients it was turned off or explanted. Increases in defibrillation thresholds (n=7), patient intolerance of multiple cardioversion shocks (n=15), and significant bradycardia requiring dual-chamber pacing (n=12) were the main reasons for discontinuation of therapy in addition to battery depletion (n=19). After explantation, efforts to maintain sinus rhythm were continued in 17 patients whereas rate control was attempted in 36 patients.Conclusions A strategy of maintaining sinus rhythm long-term with an IAD is feasible in a proportion of patients. However, patient selection is critical, and technical improvements (i.e. higher shock energies, dual-chamber pacing and additional preventive and anti-tachycardia pacing algorithms) are required to increase the number of patients having long term benefit, and frequent arrhythmia recurrences and patient intolerance to repeated cardioversion shocks remain a major limitation. [ABSTRACT FROM PUBLISHER]