Pre-implant predictors of inappropriate shocks with the third-generation subcutaneous implantable cardioverter defibrillator.

AIMS: Despite recent improvements, inappropriate shocks emitted by implanted subcutaneous implantable cardioverter defibrillators (S-ICDs) remain a challenge in 'real-life' practice. We aimed to study the pre-implant factors associated with inappropriate shocks for the latest generation of S-ICDs. METHODS AND RESULTS: Three-hundred patients implanted with the third-generation S-ICD system for primary or secondary prevention between January 2017 and March 2020 were included in this multicentre retrospective observational study. A follow-up of at least 6 months and pre-implant screening procedure data were mandatory for inclusion. During a mean follow-up of 22.8 (±11.4) months, 37 patients (12.3%) received appropriate S-ICD shock therapy, whereas 26 patients (8.7%) experienced inappropriate shocks (incidence 4.9 per 100 patient years). The total number of inappropriate shock episodes was 48, with nine patients experiencing multiple episodes. The causes of inappropriate shocks included supraventricular arrhythmias (34.6%) and cardiac (30.7%) or extra-cardiac noise (38.4%) oversensing. Using multivariate analysis, we explored the independent factors associated with inappropriate shocks. These were the availability of less than three sensing vectors during pre-implant screening [hazard ratio (HR), 0.33; 95% confidence interval (CI), 0.11-0.93; P = 0.035], low QRS/T wave ratio in Lead I (for a threshold <3; HR, 4.79; 95% CI, 2.00-11.49; P < 0.001), history of supraventricular tachycardia (HR, 8.67; 95% CI, 2.80-26.7; P < 0.001), and being overweight (body mass index > 25; HR, 2.66; 95% CI, 1.10-6.45; P = 0.03). CONCLUSION: Automatic pre-implant screening data are a useful quantitative predictor of inappropriate shocks. Electrocardiogram features should be taken into consideration along with other clinical factors to identify patients at high risk of inappropriate shocks.

Pre-emptive treatment of heart failure exacerbations in patients managed with the HeartLogic™ algorithm.

AIMS: Heart failure (HF) is a chronic disease affecting 64 million people worldwide and places a severe burden on society because of its mortality, numerous re-hospitalizations and associated costs. HeartLogic™ is an algorithm programmed into implanted devices incorporating several biometric parameters which aims to predict HF episodes. It provides an index which can be monitored remotely, allowing pre-emptive treatment of congestion to prevent acute decompensation. We aim to assess the impact and security of pre-emptive HF management, guided by the HeartLogic™ index. METHODS AND RESULTS: The HeartLogic™ France Cohort Study is an investigator-initiated, prospective, multi-centre, non-randomized study. Three hundred ten patients with a history of HF (left ventricular ejection fraction ≤40%; or at least one episode of clinical HF with elevated NT-proBNP ≥450 ng/L) and implanted with a cardioverter defibrillator enabling HeartLogic™ index calculation will be included across 10 French centres. The HeartLogic™ index will be monitored remotely for 12 months and in the event of a HeartLogic™ index ≥16, the local investigator will contact the patient for assessment and adjust HF treatment as necessary. The primary endpoint is unscheduled hospitalization for HF. Secondary endpoints are all-cause mortality, cardiovascular death, HF-related death, unscheduled hospitalizations for ventricular or atrial arrhythmia and HeartLogic™ index evolution over time. Blood samples will be collected for biobanking, and quality of life will be assessed. Finally, the safety of a HeartLogic™-triggered strategy for initiating or increasing diuretic therapy will be assessed. A blind and independent committee will adjudicate the events. CONCLUSIONS: The HeartLogic™ France Cohort Study will provide robust real-world data in a cohort of HF patients managed with the HeartLogic™ algorithm allowing pre-emptive treatment of heart failure exacerbations.

Occurrence of significant long PR intervals in patients implanted for sinus node dysfunction and monitored with SafeR™: The PRECISE study.

BACKGROUND: Long PR intervals may increase cardiovascular complications, including atrial fibrillation. In pacemakers, the SafeR™ mode monitors PR intervals, switching from AAI to DDD when criteria for atrioventricular block are met. AIMS: The PRECISE study evaluated the incidence and predictors of long PR intervals and their association with incident atrial fibrillation after 1 year in patients implanted for sinus node dysfunction and free from significant conduction disorders at baseline. METHODS: This French, prospective, multicentre, observational trial enrolled patients implanted with a REPLY™ dual-chamber pacemaker. Pacemaker memory recorded long PR intervals (defined as first-degree atrioventricular block mode switches occurring after six consecutive PR/AR intervals≥350/450ms) and atrial fibrillation incidence (fallback mode switch>1minute/day). Predictors were identified from baseline variables (age, sex, AR and PR intervals, atrial rhythm disorder and medication) using logistic regression. RESULTS: Of 291 patients with sinus node dysfunction enrolled, 214 were free from significant conduction disorders at baseline (mean age 79±8 years; 44% men; PR/AR intervals<350/450ms). After 1 year, long PR intervals had occurred in 116 patients (54%) and atrial fibrillation in 63 patients (30%). Amiodarone was the only independent predictor of long PR interval occurrence (odds ratio 2.50, 95% confidence interval 1.20-5.21; P=0.014). There was a strong trend towards an association between long PR interval and atrial fibrillation incidence (odds ratio 1.86, 95% confidence interval 0.97-3.61; P=0.051). CONCLUSIONS: Half of the patients with pure sinus node dysfunction developed long PR intervals in the year following pacemaker implantation. Amiodarone was the only independent predictor of long PR intervals. There was a strong trend towards an association between long PR intervals and incident atrial fibrillation.