Biotronik (BIOTRONIK SE & Co. KG; Biotronik Worldwide) is a limited partnership multi-national cardiovascular biomedical research and technology company, headquartered in Berlin, Germany.The company offers equipment for diagnosis, treatment, and therapy support in the areas of cardiac rhythm management, electrophysiology, and vascular intervention. In the area of cardiac rhythm management, Biotronik Home Monitoring uses tele-monitoring technology to provide doctors with up-to-date information for implant patients.Biotronik employs more than 9,000 people worldwide in over 100 countries, with research and development activities in Europe, North America, and Singapore. It produces all critical components of its products in-house. One in every five employees at its Berlin headquarters works in research and development (R&D).
BackgroundAs remote monitoring has become the standard of care for follow-up of cardiac implantable cardiac devices, extensions of remote monitoring can provide greater efficiency for the patient, caregiver, and industry representatives. To accomplish greater efficiency and flexibility of remote monitoring, and as an interim step toward "true" remote monitoring, LiveSupport was introduced as an innovative programmer and software solution that allows for remote programming of all current and most legacy BIOTRONIK devices.ObjectiveTo determine the utilization and efficacy of LiveSupport as an extension of remote monitoring and the level of satisfaction with this modality. Methods Analysis of the USA dataset of LiveSupport utilization from 04/01/2022 to 04/30/2025 was completed. In addition, satisfaction with LiveSupport was assessed with a total of 159 surveys of patients, remote caregivers, and industry representative.ResultsA total of 38,943 total LiveSupport sessions, from 2831 unique Renamic Neo Programmers, and 555 unique users were successfully completed. LiveSupport utilization increased substantially over time, peaking at 2,295 sessions per month. Survey results were consistent with high levels of satisfaction for patients, remote caregivers, and industry representatives. It was estimated that LiveSupport saved more than 60 min per patient in 78% of the sessions.ConclusionLiveSupport as an extension of remote monitoring is safe and effective with marked advantages for patients, remote caregivers, and industry representatives. This technical solution is an important step toward "true" remote monitoring of cardiac electronic implantable devices.
Closed-Loop Stimulation (CLS) adjusts pacing rate based on beat-to-beat impedance changes reflecting myocardial contractility and autonomic tone. While early studies focused on right ventricular apical leads, conduction system pacing, particularly left bundle branch area pacing (LBBAP) offers a more physiologic approach. The effect of septal lead position on CLS performance remains unclear. To investigate the impact of LBBAP versus alternative right ventricular lead positions on CLS performance. We conducted a retrospective cohort study using the CERTITUDE registry, which includes longitudinal remote monitoring data from over 55,000 U.S. patients with Biotronik devices. Patients with dual-chamber pacemakers implanted starting January 1, 2021, with ≥ 1 year of follow-up were included, excluding those who were > 110 years old at implant, with ≥ 20
This study examined whether objective physiological arousal predicts patient-triggered recordings (PTRs) in patients with an implantable loop recorder (ILR), to clarify how normative autonomic activation and clinically meaningful rhythm disturbances relate to symptom-triggered monitoring behavior during long-term surveillance. Data were drawn from 2,266 ILR patients enrolled in the CERTITUDE registry between 2019 and 2025; analyses were restricted to the 878 individuals who used the PTR function at least once. Day-level ILR data from the first 12 months following implantation were analyzed. Daily physical activity percent per day (PA), weekly variability in PA, and counts of device-detected atrial fibrillation, bradycardia, and asystole were modeled as predictors of daily PTR counts using within-person repeated-measures correlations and linear mixed-effects models. Subgroup analyses were conducted by primary clinical indication. Daily PA showed near-zero within-person associations with PTR behavior (overall r = − .018), and mixed-effects models yielded very small coefficients. Weekly PA variability was not associated with PTR activation. Device-detected arrhythmic events accounted for only marginal additional variance in PTR counts, and asystole was not associated with PTR use. Patterns were consistent across ILR indications. Overall, objective physiological arousal explained little of the observed variation in PTR behavior. PTR behavior during long-term ILR monitoring appears to be shaped largely by interpretive and decisional processes, rather than by direct detection of physiological events alone. Conceptualizing PTRs as behavioral responses to ambiguity in bodily sensations highlights the importance of patient education, contextualized physiological feedback, and attention to symptom appraisal in the clinical management of ILR patients.
BACKGROUND:Transvenous lead conductors are subject to fatigue fracture from repetitive bending stresses, which are proportional to alternating curvature. A prerequisite for developing a valid preclinical lead-testing standard is knowledge of the stresses on implanted leads - their fatigue environment, but little is known about it. OBJECTIVE:The Human Use Condition Study (HUCS) quantified this fatigue environment, including the relationship between lead stiffness and alternating curvature. METHODS:HUCS was a prospective, observational, multicenter clinical study. Leads from 4 manufacturers were chosen to span the range of stiffness in clinical use. They were imaged using biplane cinefluoroscopy during cardiac motion and in the shoulder region during arm motion. In each image, the lead was traced, and its curvature was calculated as a function of time. RESULTS:Images were analyzed for 109 subjects. In each region of the lead analyzed, maximum alternating curvature was determined primarily by between-patient differences, not differences in lead stiffness. Across regions, maximum alternating curvature was greatest in the extravenous region (P = .001). In this region, the length of the highly stressed portion of the lead correlated inversely with lead stiffness (P < .001). CONCLUSION:HUCS is the first study to measure alternating in vivo stresses applied to leads from multiple manufacturers that spanned a range of stiffnesses and thereby enable the development of an evidence-based lead-testing standard. The greatest alternating stress occurs in the extravenous region. There, lead stiffness predicts how much of the lead is highly stressed but does not predict maximum alternating curvature.
