Background Sacubitril/valsartan, the first combined angiotensin receptor-neprilysin inhibitor, has demonstrated a significant benefit compared to angiotensin inhibitor in decreasing ventricular arrhythmias and appropriate implantable cardioverter defibrillator (ICD) shocks in patients with heart failure with reduced ejection fraction (HFrEF). At present, there is no study which evaluates the effect of sacubitril/valsartan on the supraventricular arrhythmic burden in HFrEF patients with an ICD or cardiac resynchronisation therapy-defibrillator (CRT-D) and remote monitoring. Purpose To evaluate the effect of sacubitril/valsartan on the supraventricular arrhythmic burden in HFrEF patients with an ICD or CRTD and remote monitoring. Methods The SAVETHERHYTHM ((SAacubitril Valsartan rEal-world registry evaluating THE arRHYTHMia burden in HFrEF patients with implantable cardioverter defibrillator) is a multicentre, observational, prospective registry enrolling all patients with HFrEF, ICD or CRT-D actively followed through remote monitoring and starting treatment with sacubitril/valsartan. All patients are followed-up for at least one year after sacubitril/valsartan start. The primary endpoint is the mean number of sustained atrial tachycardia or atrial fibrillation (AT/AF) episodes per month. Secondary endpoints include the total burden of AT/AF (defined as the percentage of time in AT/AF per day), the mean number of premature ventricular contractions (PVC) per hour and the percentage of biventricular pacing per day (in patients with CRT-D). All primary and secondary endpoints are collected through remote monitoring. Results At the time of the first ad interim analysis, 60 patients (85.2% male, age 69±10 years) were consecutively enrolled. After treatment with sacubitril/valsartan, patients with at least one episode of AT/AF per month decreased from 32.8% to 21.3% (p=0.015). A significant decrease in number of AT/AF episodes (from 4.3 to 1.2 per year), in AT/AF burden (from 12% to 9%) and in number of PVC (from 83 to 74 per hour) were seen in patients with a previous diagnosis of paroxysmal or persistent AF (n=15; all p<0.05). Patients with permanent AF (n=7) experienced no benefits from sacubitril/valsartan therapy in terms of arrhythmic burden reduction. Patients with no previous history of AF (n=38) showed a decrease in number of AT/AF episodes (from 2.0 to 0.8 per year) and in number of PVC (from 77 to 49 per hour, all p<0.05). No new diagnosis of clinical AF was made after starting treatment with sacubitrl/valsartan, and patients with subclinical AT/AF episodes decreased from 8% to 3%. Conclusions Preliminary data suggest that therapy with sacubitril/valsartan could decrease arrhythmic burden in patients with non-permanent AF and reduce subclinical AT/AF episodes in patients with no history of AF. No positive effect has been noted in patients with permanent AF. Funding Acknowledgement Type of funding source: None
Aims To evaluate the risk of syncopal recurrences after pacemaker implantation in a population of patients with syncope of suspected bradyarrhythmic aetiology. Methods and results Prospective, multicentre, observational registry enrolling 1364 consecutive patients undergoing pacemaker implantation for syncope of bradyarrhythmic aetiology (proven or presumed). Before pacemaker implantation, all patients underwent a cardiac work-up in order to establish the bradyarrhythmic aetiology of syncope. According to the results of the diagnostic work-up, patients were divided into three groups: Group A, patients in whom a syncope-electrocardiogram (ECG) correlation was established (n = 329, 24.1%); Group B, those in whom clinically significant bradyarrhythmias were detected without a documented syncope-ECG correlation (n = 877, 64.3%); and Group C, those in whom bradyarrhythmias were not detected and the bradyarrhythmic origin of syncope remained presumptive (n = 158, 11.6%). During a median follow-up of 50 months, 213 patients (15.6%) reported at least one syncopal recurrence. Patients in Groups B and C showed a significantly higher risk of syncopal recurrences than those in Group A [hazard ratios (HRs): 1.60 and 2.66, respectively, P < 0.05]. Failure to establish a syncope-ECG correlation during diagnostic work-up before pacemaker implantation was an independent predictor of syncopal recurrence on multivariate analysis (HR: 1.90; P = 0.002). Conclusion In selecting patients with syncope of suspected bradyarrhythmic aetiology for pacemaker implantation, establishing a correlation between syncope and bradyarrhythmias maximizes the efficacy of pacing and reduces the risk of syncopal recurrences.
Subclinical atrial fibrillation (SCAF) is associated with an increased risk of clinical AF, major cardiovascular events and death. Short-term evidence on SCAF in older populations is scarce, especially in the hospital setting. We performed a cross-sectional study on 60 multimorbid older consecutive patients (aged 80+) admitted to an Internal Medicine and Geriatrics Unit for acute medical diseases with no history of AF, in order to investigate prevalence and predictors of SCAF. Portable ECG monitoring was placed on admission and ECG recording lasted for 5 days. Mean age: 85.7±4.9 years. Female prevalence: 58.3%. High burden of comorbidities: 87.9%. All enrolled patients had CHA 2 DS 2 -VASc score ≥3. SCAF was detected in 16 patients (26.7%) and 11 patients (18.4%) had at least a SCAF episode lasting 6 minutes or longer. No clinical, laboratory and echocardiographic parameters predicted SCAF. Patients with ≥2004 supraventricular ectopic beats/24h (SVEBs/24h) had a 6-fold higher prevalence of SCAF than patients with <411 SVEBs/24h (p=0.038). Time to first SCAF episode was within 3 days of ECG recording in all enrolled patients. SCAF is highly prevalent in older adults hospitalized for acute diseases. This finding may affect clinical management and prognosis. Our study could foster larger multicenter studies in similar settings.
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