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Abstract Aim Remote monitoring (RM) of implantable cardiac devices has enabled continuous surveillance of atrial high rate episodes (AHREs) with well‐recognized clinical benefits. We aimed to add evidence on the role of the RM as compared to conventional follow‐up by investigating the interval from AHRE onset to physician’s evaluation and reaction time in actionable episodes. Methods and Results A total of 97 dual‐chamber pacemaker recipients were followed with RM (RM‐ON group; N = 64) or conventional in‐office visits (RM‐OFF group; N = 33) for 18 months. In‐office visits were scheduled at 1, 6, 12, and 18 months in the RM‐OFF group and at 1 and 18 months in the RM‐ON group. The overall AHRE rate was 1.98 per patient‐year (95% confidence interval [CI], 1.76–2.20) with no difference between the two groups (RM‐ON vs. RM‐OFF weighted‐HR, 0.88; CI, 0.36–2.13; p = .78). In the RM‐ON group, 100% AHREs evaluated within 11 days from onset, and within 202 days in the RM‐OFF group, with a median evaluation delay 79 days shorter in the RM‐ON group versus the RM‐OFF group (p

(1) Background: Infections are among the most frequent and life-threatening complications of cardiovascular implantable electronic device (CIED) implantation. The aim of this study is to compare the outcome and safety of a single-procedure device extraction and contralateral implantation versus the standard-of-care (SoC) two-stage replacement for infected CIEDs. (2) Methods: We retrospectively included 66 patients with CIED infections who were treated at two Italian hospitals. Of the 66 patients enrolled in the study, 27 underwent a single procedure, whereas 39 received SoC treatment. All patients were followed up for 12 months after the procedure. (3) Results: Considering those lost to follow-up, there were no differences in the mortality rates between the two cohorts, with survival rates of 81.5% in the single-procedure group and 84.6% in the SoC group (p = 0.075). (4) Conclusions: Single-procedure reimplantation associated with an active antibiofilm therapy may be a feasible and effective therapeutic option in CIED-dependent and frail patients. Further studies are warranted to define the best treatment regimen and strategies to select patients suitable for the single-procedure reimplantation.

IntroductionIn the context of randomized clinical trials, subcutaneous implantable cardiac defibrillators (S-ICDs) are non-inferior to transvenous ICDs (T-ICDs) concerning device-related complications or inappropriate shocks in patients with an indication for defibrillator therapy and not in need of pacing. We aimed at describing the clinical features of patients who underwent S-ICD implantation in our clinical practice, as well as the ICD-related complications and the inappropriate therapies among S-ICD vs. T-ICD recipients during a long-term follow-up.Materials and MethodsAll patients undergoing ICD, both S-ICD and TV-ICD, at Monaldi Hospital from January 1, 2015 to January 1, 2019 and followed up at our institution were included in the present analysis. The clinical variables associated with S-ICD implantation were evaluated by logistic regression analyses. We collected the ICD inappropriate therapies, ICD-related complications (including both pulse generator and lead-related complications), ICD-related infections, appropriate ICD therapies, and overall mortality. Kaplan-Meier (KM) analyses were performed to assess the risk of clinical outcome events between the two subgroups. A time-dependent Cox regression analysis was performed to adjust the results.ResultsTotal 607 consecutive patients (mean age 53.8 ± 16.8, male 77.8%) with both TV-ICD (n: 290, 47.8%) and S-ICD (n: 317, 52.2%), implanted and followed at our center for a mean follow-up of 1614 ± 1018 days, were included in the study. At multivariate logistic regression analysis, an independent association between S-ICD implantation and ionic channel disease [OR: 6.01 (2.26–15.87); p < 0.0001] and ischemic cardiomyopathy [OR: 0.20 (0.12–0.35); p < 0.0001] was shown. The KM analysis did not show a significantly different risk of the inappropriate ICD therapies (log rank p = 0.64) between the two subgroups; conversely, a significant increase in the risk of ICD-related complications (log rank p = 0.02) and infections (log rank p = 0.02) in TV-ICD group was shown. The adjusted risk for ICD-related infections [OR: 0.07 (0.009–0.55), p = 0.01] and complications [0.31 (0.12–0.81), p = 0.01] was significantly lower among patients with S-ICD.ConclusionsThe choice to implant S-ICD was mainly driven by younger age and the presence of ionic channel disease; conversely ischemic cardiomyopathy reduces the probability to use this technology. No significant differences in inappropriate ICD therapies were shown among S-ICD vs. TV-ICD group; moreover, S-ICD is characterized by a lower rate of infectious and non-infectious complications leading to surgical revision or extraction.

Introduction:Little is known about the clinical performance of single-chamber leadless pacemaker (LLPM) in patients without atrial fibrillation (AF) as pacing indication. The aim of this study was to describe the clinical characteristics of patients who underwent single chamber LLPM implantation at three tertiary referral centers and to compare the safety and effectiveness of the single-chamber LLPM among patients with or without AF.Materials and Methods:All the consecutive patients who underwent LLPM implantation at three referral centers were analyzed. The indications to LLPM in a real-world setting were described. The study population was divided into two groups according to AF as pacing indication. We assessed the procedure-related complications; moreover, we compared syncope, cardiac hospitalization, pacemaker syndrome, and all-cause death recurrence during the follow-up between patients with and without AF as pacing indication.Results:A total of 140 consecutive patients (mean age, 76.7 ± 11.24 years, men 64.3%) were included in the study. The indication to implantation of LLPM was permanent AF with slow ventricular response (n: 67; 47.8%), sinus node dysfunction (n: 25; 17.8%), third atrioventricular block (AVB) (n: 20; 14.2%), second-degree AVB (n: 18; 12.8%), and first degree AVB (n: 10; 7.1%). A total of 7 patients (5%) experienced perioperative complications with no differences between the AF vs. non-AF groups. During a mean follow-up of 606.5 ± 265.9 days, 10 patients (7.7%) died and 7 patients (5.4%) were reported for cardiac hospitalization; 5 patients (3.8%) experienced syncope; no patients showed pacemaker syndrome. No significant differences in the clinical events between the groups were shown. The Kaplan–Meier analysis for the combined endpoints did not show significant differences between the AF and non-AF groups [hazard ratio (HR): 0.94, 95% CI: 0.41–2.16; p = 0.88].Conclusion:Our real-world data suggest that LLPM may be considered a safe and reasonable treatment in patients without AF in need of pacing. Further studies are needed to confirm these preliminary results.

Background. Cardiac contractility modulation (CCM) is a novel device-based therapy for patients with heart failure with reduced and mild reduced ejection fraction (HFrEF/HFmrEF). CCM increases cardiac performance and produces reverse left ventricular remodeling, with improved symptoms, functional capacity, quality of life, and reduced HF-related hospitalizations. However, to date, little evidence is available on the effects of CCM on right ventricle (RV) function. Therefore, we analyzed the effects of CCM on RV systolic function and RV–pulmonary artery (PA) coupling. Methods. Twenty-one (65 ± 12.5 years) patients with NYHA class III, ejection fraction < 40% and QRS < 120 ms were assessed at baseline. During follow up, two patients had died, and so nineteen patients were evaluated six months after CCM therapy. Using echocardiography, tricuspid annular systolic excursion (TAPSE), myocardial systolic excursion velocity (RVs), and RV free-wall strain was measured. PA systolic pressure (PASP) was estimated from tricuspid regurgitation, adding the right atrial pressure estimation. The RV-PA coupling was calculated as TAPSE/PASP ratio. Results. After six months, patients who underwent CCM therapy showed a reduction in RV diameters and improved RV systolic function, as evidenced by the increase in both TAPSE (16.6 ± 4.2 mm vs. 18.5 ± 3.6 mm; p < 0.05), RVs (10.1 ± 1.8 cm/s vs. 11.3 ± 11.4 cm/s; p < 0.05), and RV strain (−13.7 ± 1.8% vs. −15.6 ± 2.3%; p < 0.05). CCM also determined a reduction in PASP (34.2 ± 9.8 mmHg vs. 28 ± 6.2 mmHg; p < 0.05) and an increase in the TAPSE/PASP ratio (0.52 ± 0.14 mm/mmHg vs. 0.66 ± 0.23 mm/mmHg; p < 0.05). Conclusions. At six months, CCM increases RV reverse remodeling and performance, reducing RV size and improving RV systolic function, PASP, and RV-PA coupling.