Background: The HeartLogic algorithm combines multiple implantable cardioverter-defibrillator sensors to identify patients at risk of heart failure (HF) events. We sought to evaluate the risk stratification ability of this algorithm in clinical practice. We also analyzed the alert management strategies adopted in the study group and their association with the occurrence of HF events. Methods: The HeartLogic feature was activated in 366 implantable cardioverter-defibrillator and cardiac resynchronization therapy implantable cardioverter-defibrillator patients at 22 centers. The median follow-up was 11 months [25th–75th percentile: 6–16]. The HeartLogic algorithm calculates a daily HF index and identifies periods IN alert state on the basis of a configurable threshold. Results: The HeartLogic index crossed the threshold value 273 times (0.76 alerts/patient-year) in 150 patients. The time IN alert state was 11% of the total observation period. Patients experienced 36 HF hospitalizations, and 8 patients died of HF during the observation period. Thirty-five events were associated with the IN alert state (0.92 events/patient-year versus 0.03 events/patient-year in the OUT of alert state). The hazard ratio in the IN/OUT of alert state comparison was (hazard ratio, 24.53 [95% CI, 8.55–70.38], P <0.001), after adjustment for baseline clinical confounders. Alerts followed by clinical actions were associated with less HF events (hazard ratio, 0.37 [95% CI, 0.14–0.99], P =0.047). No differences in event rates were observed between in-office and remote alert management. Conclusions: This multiparametric algorithm identifies patients during periods of significantly increased risk of HF events. The rate of HF events seemed lower when clinical actions were undertaken in response to alerts. Extra in-office visits did not seem to be required to effectively manage HeartLogic alerts. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02275637.

Infections resulting from cardiac implantable electronic device (CIED) implantation are severely impacting on patients’ and on health care systems. The use of TYRX^TM absorbable antibiotic-eluting envelope has proven to decrease major CIED infections within 12 months of CIED surgery. The aim is to evaluate the impact of the envelope use on infection-related clinical events in a real-world contemporary patient population. Data on patients undergoing CIED surgery were collected prospectively by participating centers of the One Hospital ClinicalService project. Patients were divided into two groups according to whether TYRX^TM absorbable antibiotic-eluting envelope was used or not. Out of 1819 patients, 872 (47.9%) were implanted with an absorbable antibiotic-eluting envelope and included in the Envelope group and 947 (52.1%) patients who did not receive an envelope were included in the Control group. Compared to control, patients in the Envelope group had higher thrombo-embolic or hemorrhagic risk, higher BMI, lower LVEF and more comorbidities. During a mean follow-up of 1.4 years, the incidence of infection-related events was significantly higher in the control compared to the Envelope group (2.4% vs. 0.8%, P = 0.007). The five-year cumulative incidence of infection-related events was 8.1% in the control and 2.1% in the Envelope group (HR: 0.34, 95%CI: 0.14–0.80, P = 0.010). In our analysis, the use of an absorbable antibiotic-eluting envelope in the general CIED population was associated with a lower risk of systemic and pocket infection.

A previous randomized study demonstrated that the subcutaneous implantable cardioverter defibrillator (S-ICD) was noninferior to transvenous ICD with respect to device-related complications and inappropriate shocks. However, that was performed prior to the widespread adoption of pulse generator implantation in the intermuscular (IM) space instead of the traditional subcutaneous (SC) pocket. The aim of this analysis was to compare survival from device-related complications and inappropriate shocks between patients who underwent S-ICD implantation with the generator positioned in an IM position in comparison with an SC pocket. We analysed 1577 consecutive patients who had undergone S-ICD implantation from 2013 to 2021 and were followed up until December 2021. Subcutaneous patients (n = 290) were propensity matched with patients of the IM group (n = 290), and their outcomes were compared. : During a median follow-up of 28 months, device-related complications were reported in 28 (4.8%) patients and inappropriate shocks were reported in 37 (6.4%) patients. The risk of complication was lower in the matched IM group than in the SC group [hazard ratio 0.41, 95% confidence interval (CI) 0.17–0.99, P = 0.041], as well as the composite of complications and inappropriate shocks (hazard ratio 0.50, 95% CI 0.30–0.86, P = 0.013). The risk of appropriate shocks was similar between groups (hazard ratio 0.90, 95% CI 0.50–1.61, P = 0.721). There was no significant interaction between generator positioning and variables such as gender, age, body mass index, and ejection fraction. Our data showed the superiority of the IM S-ICD generator positioning in reducing device-related complications and inappropriate shocks. Clinical Trial Registration: ClinicalTrials.gov; NCT02275637.

Aims: Prolonged right ventricular pacing (RVP) increases the risk of cardiomyopathy, atrial fibrillation, heart failure (HF), and mortality. This registry-based trial compared left bundle branch area pacing (LBBAP) with RVP in patients younger than 65 years. Methods and results: Using the ConTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing (TREEBEARD) registry (NCT06324682), patients were randomized 1:1 to LBBAP or RVP. The primary endpoint was a composite of cardiovascular (CV) death and HF hospitalization (HFH); secondary endpoints included individual components and all-cause mortality. A total of 344 patients (mean age 58.5 years, 215 males, 172 per arm) were included. At 2 years, the primary composite endpoint occurred in 6.3% of LBBAP vs. 12.7% of RVP patients (HR, 0.78; 95% CI, 0.59–0.87), representing a 22% risk reduction. Subgroup analyses aligned with primary findings. Left bundle branch area pacing significantly reduced HFH risk (HR, 0.79; 95% CI, 0.63–0.86) but showed no difference in CV mortality (HR, 1.02; 95% CI, 0.79–1.32) or all-cause mortality (HR, 1.00; 95% CI, 0.72–1.38). Conclusion: Left bundle branch area pacing significantly lowered the 2-year composite of CV death and HFH compared to RVP in patients aged <65 years old. However, it did not reduce CV or all-cause mortality individually compared to RVP. Clinical Trial Registration: TREEBEARD (NCT06324682)