Incidental and anticipated arrhythmic diagnoses in patients with an implantable cardiac monitor.

AIMS: In this study, we investigated a cohort of unselected patients with various indications for an implantable cardiac monitor (ICM). Our main objectives were to determine the incidence of arrhythmic diagnoses, both anticipated and incidental in relation to the ICM indication, and to assess their clinical relevance. METHODS: We examined remote monitoring transmissions from patients with an ICM at four Italian sites to identify occurrences of cardiac arrhythmias. Concurrently, we collected data on medical actions taken in response to arrhythmic findings. RESULTS: The study included 119 patients, with a median follow-up period of 371 days. ICM indications were syncope/presyncope (46.2%), atrial fibrillation management (31.1%), and cryptogenic stroke (22.7%). In the atrial fibrillation management group, atrial fibrillation was the most common finding, with an incidence of 36% [95% confidence interval (CI) 22-55%] at 18 months. Rates of atrial fibrillation were not significantly different between patients with cryptogenic stroke and syncope/presyncope [17% (95% CI 7-40%) vs. 8% (95% CI 3-19%), P = 0.229].For patients with cryptogenic stroke, the incidence of asystole and bradyarrhythmias at 18 months was 23% (95% CI 11-45%) and 42% (95% CI 24-65%), respectively, similar to estimates obtained for patients implanted for syncope/presyncope (P = 0.277 vs. P = 0.836).Overall, 30 patients (25.2%) required medical intervention following ICM-detected arrhythmias, predominantly involving atrial fibrillation ablation (10.9%) and medication therapy changes (10.1%). CONCLUSION: In a real-life population with heterogeneous insertion indications, approximately 25% of patients received ICM-guided medical interventions within a short timeframe, including treatments for incidental findings. Common incidental arrhythmic diagnoses were bradyarrhythmias in patients with cryptogenic stroke and atrial fibrillation in patients with unexplained syncope.

The role of computational methods in cardiovascular medicine: a narrative review.

Background and Objective: Computational models of the cardiovascular system allow for a detailed and quantitative investigation of both physiological and pathological conditions, thanks to their ability to combine clinical-possibly patient-specific-data with physical knowledge of the processes underlying the heart function. These models have been increasingly employed in clinical practice to understand pathological mechanisms and their progression, design medical devices, support clinicians in improving therapies. Hinging upon a long-year experience in cardiovascular modeling, we have recently constructed a computational multi-physics and multi-scale integrated model of the heart for the investigation of its physiological function, the analysis of pathological conditions, and to support clinicians in both diagnosis and treatment planning. This narrative review aims to systematically discuss the role that such model had in addressing specific clinical questions, and how further impact of computational models on clinical practice are envisaged. Methods: We developed computational models of the physical processes encompassed by the heart function (electrophysiology, electrical activation, force generation, mechanics, blood flow dynamics, valve dynamics, myocardial perfusion) and of their inherently strong coupling. To solve the equations of such models, we devised advanced numerical methods, implemented in a flexible and highly efficient software library. We also developed computational procedures for clinical data post-processing-like the reconstruction of the heart geometry and motion from diagnostic images-and for their integration into computational models. Key Content and Findings: Our integrated computational model of the heart function provides non-invasive measures of indicators characterizing the heart function and dysfunctions, and sheds light on its underlying processes and their coupling. Moreover, thanks to the close collaboration with several clinical partners, we addressed specific clinical questions on pathological conditions, such as arrhythmias, ventricular dyssynchrony, hypertrophic cardiomyopathy, degeneration of prosthetic valves, and the way coronavirus disease 2019 (COVID-19) infection may affect the cardiac function. In multiple cases, we were also able to provide quantitative indications for treatment. Conclusions: Computational models provide a quantitative and detailed tool to support clinicians in patient care, which can enhance the assessment of cardiac diseases, the prediction of the development of pathological conditions, and the planning of treatments and follow-up tests.

A Nurse-Led Model of Care with Telemonitoring to Manage Patients with Heart Failure in Primary Health Care: A Mixed-Method Feasibility Study.

Purpose: To determine whether a nurse-led care model with telemonitoring in primary care for patients with stable heart failure and their caregivers is feasible and acceptable. Patients and Methods: A mixed-methods feasibility study was conducted. Patients with stable heart failure and their caregivers were consecutively enrolled from March 2021 to April 2022. Participants were managed by nurses in a community health center through education and monitoring with a mobile app. The outcomes were feasibility outcomes, self-care outcomes, and qualitative acceptability and satisfaction. Quantitative and qualitative outcomes were linked to understanding how the model of care might benefit patients. Results: Twenty-six patients and nine of their caregivers were enrolled. Ten participants used the mobile app. Nineteen patients and eight caregivers were interviewed. Participants who improved their self-care appreciated the help in finding coping strategies, being close to the clinic, and feeling cared for. Participants with fewer improvements in self-care perceived the model of care as useless and were far from the centre. Participants decided to use the app mainly for usefulness prevision, and most of them were satisfied. Conclusion: The model of care was not successful in recruiting patients, and adjustments are needed to improve the recruitment strategy and to engage people who perceive the model of care as not useful or unable to use the app.

Daily and automatic remote monitoring of implantable cardiac monitors: A descriptive analysis of transmitted episodes.

BACKGROUND: Remote Monitoring (RM) is recognized for its ability to enhance the clinical management of patients with implantable cardiac monitor (ICM). This study aims to provide a comprehensive description of the arrhythmic episodes transmitted by a daily and automatic RM system from a cohort of ICM patients. METHODS: The study retrospectively analyzed daily transmissions from consecutive patients who had been implanted with a long-sensing vector ICM (BIOMONITOR III/IIIm) at four sites. All transmitted arrhythmic recordings were evaluated to determine whether they were true positive episodes or false positives (FP). RESULTS: A total of 14,136 episodes were transmitted from 119 patients (74.8% male, median age 62 years old) during a median follow-up of 371 days. The rate of arrhythmic episodes was 14.2 per patient-year (interquartile range: 1.8-126), with 97 patients (81.5%) experiencing at least one ICM activation. Fifty-five percent of episodes were identified as FP, and 67 patients (56.3%) had at least one inappropriate activation. The FP rate was 1.4 per patient-year (0-40). The best per-episode predictive positive values were observed for bradycardia and atrial fibrillation (0.595 and 0.553, respectively). Notably, the implementation of an algorithm designed to minimize false detections significantly reduced the prevalence of atrial fibrillation FP episodes (17.6% vs. 43.5%, p = 0.008). CONCLUSION: Daily and automatic RM appears to be a reliable tool for the comprehensive remote management of ICM patients. However, the number of arrhythmic episodes requiring review is high, and further improvements are needed to reduce FP and facilitate accurate interpretation of transmissions.

Multiparametric identification of subclinical atrial fibrillation after an embolic stroke of undetermined source.

BACKGROUND: Subclinical atrial fibrillation (SCAF) may represent a cause of embolic stroke of undetermined source (ESUS) and its detection has important implications for secondary prevention with anticoagulation. Indications to implantable cardiac monitors (ICM) include SCAF detection. The aims of this study were to (1) evaluate the frequency of ICM-detected SCAF; (2) determine predictors of SCAF; and (3) identify patients who would benefit most from ICM implantation. METHODS: Between February 2017 and November 2020, all consecutive patients referred for ICM implantation after a diagnosis of ESUS and without previous history of atrial fibrillation or atrial flutter were included in this study. SCAF was diagnosed if the ICM electrogram demonstrated an episode of irregularly irregular rhythm without distinct P waves lasting > 2 min. RESULTS: We enrolled 109 patients (age 66, SD = 13 years; 36% females). During a median follow-up of 19.2 (IQR 11.0-27.5) months, SCAF episodes were detected in 36 (33%) patients. Only abnormal P wave terminal force in lead V1, left atrial end-systolic indexed volume > 34 ml/m2, and BMI > 25 kg/m2 were independently associated with an increased risk of SCAF (HR 2.44, 95% CI 1.14-5.21, p = 0.021; HR 2.39, 95% CI 1.11-5.13, p = 0.026; and HR 2.64, 95% CI 1.06-6.49, p = 0.036 respectively). The ROC curve showed that the presence of all three parameters had the best accuracy (74%) to predict SCAF detection (sensitivity 39%, specificity 91%). CONCLUSION: A multiparametric evaluation has the best accuracy to predict SCAF in ESUS patients and may help identifying those who would benefit most from ICM.

Strategic reprogramming of implantable cardiac monitors reduces the false-positive remote alert burden in a nurse-led service.

AIMS: Implantable cardiac monitors (ICMs) can generate false-positive (FP) alerts. Although these devices have an extended programmability, there are no recommendations on their optimization to reduce not-relevant activations.We tested a strategic programming optimization guide based on the type of FP and investigated the safety and feasibility of the nurse-led insertion of ICMs with a long-sensing vector. METHODS AND RESULTS: Consecutive patients implanted by trained nurses with long-sensing vector ICM were enrolled in a 1-month observational stage (Phase A). Patients who had ≥10 FP episodes underwent ICM reprogramming based on the predefined guide and were followed for an additional month (Phase B). A total of 78 patients had successful ICM insertion by nurses with a mean R wave amplitude of 0.96 ± 0.43 mV and an 86% P wave visibility. Only one patient reported a significant device-related issue, and nurse-delivered ICM was generally well accepted by the patients. During Phase A, 11 patients (14%) generated most of FP (3,627/3,849; 94%) and underwent ICM reprogramming. In the following month (Phase B), five patients (45%) were free from FP and six (55%) transmitted 57 FP alerts (98% reduction compared with Phase A). The median number of FP per patient was significantly reduced after reprogramming [195 (interquartile range, 50-311) vs. one (0-10), P = 0.0002]. CONCLUSION: A strategic reprogramming of ICM in those patients with a high FP alert burden reduces the volume of erroneous activations with potential benefits for the remote monitoring service. No concerns were raised regarding nurse-led insertion of ICMs with a long-sensing vector.

[The TeMP_cardio Model for the district management of heart failure patients: a feasibility study for the implementation of the family nurse]. / Il modello TeMP_Cardio per la gestione del paziente con scompenso cardiaco sul territorio: uno studio di fattibilità con l'introduzione dell'infermiere di famiglia e comunità.

. The TeMP_cardio Model for the district management of heart failure patients: a feasibility study for the implementation of the family nurse. INTRODUCTION: The need to enhance primary health nursing care and chronic disease management requires the development of complex and feasible models in local contexts. AIM: To test the feasibility of a complex care model, based on the introduction of the family and community nurse for patients with stable heart failure and their caregivers. METHODS: A pre-post six-month feasibility study was conducted in 2021-2022 in the Autonomous Province of Trento. Patients with stable heart failure able to access services were taken in charge with a multidisciplinary model, with the nurse as care manager, and technological and telemonitoring support. RESULTS: 26 patients out of 137 were included and nine of their caregivers. Ten participants accepted to use the mobile app. Twenty-three patients and seven caregivers completed the study, and the app was used regularly by five participants. Self-care skills improved in patients, mostly in self-monitoring, less in caregivers. One access to the emergency department for heart failure exacerbation was detected. CONCLUSIONS: The model was evaluated feasible to retain patients, with the need to build effective strategies for the recruitment, and the regular use of telemonitoring tools.

Computational electrophysiology of the coronary sinus branches based on electro-anatomical mapping for the prediction of the latest activated region.

This work dealt with the assessment of a computational tool to estimate the electrical activation in the left ventricle focusing on the latest electrically activated segment (LEAS) in patients with left bundle branch block and possible myocardial fibrosis. We considered the Eikonal-diffusion equation and to recover the electrical activation maps in the myocardium. The model was calibrated by using activation times acquired in the coronary sinus (CS) branches or in the CS solely with an electroanatomic mapping system (EAMS) during cardiac resynchronization therapy (CRT). We applied our computational tool to ten patients founding an excellent accordance with EAMS measures; in particular, the error for LEAS location was less than 4 mm. We also calibrated our model using only information in the CS, still obtaining an excellent agreement with the measured LEAS. The proposed tool was able to accurately reproduce the electrical activation maps and in particular LEAS location in the CS branches, with an almost real-time computational effort, regardless of the presence of myocardial fibrosis, even when information only at CS was used to calibrate the model. This could be useful in the clinical practice since LEAS is often used as a target site for the left lead placement during CRT. Overall picture of the computational pipeline for the estimation of LEAS.

Determinants of worse prognosis in patients with cardiac resynchronization therapy defibrillators. Are ventricular arrhythmias an adjunctive risk factor?

AIMS: Cardiac resynchronization therapy (CRT) is indicated in patients with systolic heart failure (HF), severe left ventricle (LV) dysfunction and interventricular dyssynchrony.In prospective observational research, we aimed to evaluate whether CRT-induced LV reverse remodelling and occurrence of ventricular arrhythmias (VT/VF) independently contribute to prognosis in patients with CRT defibrillators (CRT-D). METHODS: In 95 Italian cardiological centres, after a screening period of 6 months, patients were categorized according to VT/VF occurrence and CRT response, defined as LV end-systolic volume relative reduction >15% or LV ejection fraction absolute increase >5%. The main endpoint was death or HF hospitalizations. RESULTS: Among 1308 CRT-D patients (80% male, mean age 66 years), at 6 months, follow-up 71% were identified as CRT responders and 12% experienced appropriate VT/VF detections. The main endpoint was significantly and independently associated with previous myocardial infarction, New York Heart Association Class, VT/VF occurrence and with CRT response. CRT nonresponder patients who suffered VT/VF in the screening period had a risk of death or HF hospitalizations [HR = 7.82, 95% confidence interval (CI) = 3.95-15.48] significantly (P < 0.001) higher than CRT responders without VT/VF occurrence. This risk is mitigated without VT/VF occurrence (HR = 3.47, 95% CI = 2.03-5.91, P < 0.001) or in case of CRT response (HR = 3.11, 95% CI = 1.44-6.72, P = 0.004). CONCLUSION: Our data show that both CRT response and occurrence of VT/VF independently contribute to the risk of death or HF-related hospitalizations in CRT-D patients. Early VT/VF occurrence may be identified as a marker of disease severity than can be mitigated by CRT response both in terms of all-cause mortality and long-term VT/VF onset. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00147290 and NCT00617175.

Implementation of tele visit healthcare services triggered by the COVID-19 emergency: the Trentino Province experience.

AIM: In response to the SARS-CoV-2 emergency, the Competence Centre on digital health 'TrentinoSalute4.0' has developed TreC_Televisita, a tele visit solution that meets the needs of the Trentino healthcare system and maintains high-quality patient-doctor interactions while respecting social distancing. This paper highlights how 'TreC_Televisita' was integrated into the Trentino healthcare system and its potential to become a structural and durable solution for the future local healthcare service provisioning. SUBJECT AND METHODS: This paper presents the multifactorial context that TreC_Televisita has faced for its implementation and the strategies adopted for its structural integration into the healthcare system. The analysis focuses on the main issues faced for the integration of the tele visits (e.g. privacy, payments) and how the context of TrentinoSalute4.0 permitted responding quickly to its implementation during the pandemic. It also describes how TreC_Televisita fits into the healthcare continuum from the organisational and technological standpoint, the end-user perspective and the barriers that could hamper the solution scalability. RESULTS: TreC_Televisita has demonstrated to be a technological solution that can be contextualised for different clinical domains beyond SARS-CoV-2. Moreover, it has shown its potential to scale up the solution beyond the COVID-19 emergency to the whole healthcare provisioning system in the long term. CONCLUSION: Being a positive experience in the first months of its implementation, the long-term goal is to transform TreC_Televisita into a structural pillar of the Trentino healthcare system, setting the bases for a sustainable, win-win situation for all the stakeholders involved in healthcare service provisioning.

Endocavitary electrophysiological study by percutaneous antecubital vein and without X-ray for risk stratification of asymptomatic ventricular pre-excitation in young athletes.

Athletes with asymptomatic ventricular pre-excitation (VP) should undergo electrophysiological study for risk stratification. We aimed to evaluate the feasibility, efficacy, safety and tolerability of an electrophysiological study using a percutaneous antecubital vein access and without the use of X-ray (ESnoXr). Methods: We collected data from all young athletes < 18 year-old with AVP, who underwent ESnoXr from January 2000 to September 2020 for evaluation of accessory pathway refractoriness and arrhythmia inducibility using an antecubital percutaneous venous access. Endocavitary signals were used to advance the catheter in the right atrium and ventricle. Results: We included 63 consecutive young athletes (mean age 14.6 ± 1.9 years, 46% male). Feasibility of the ESnoXr technique was 87% while in 13% fluoroscopy and/or a femoral approach were needed. Specifically, fluoroscopy was used in 7 cases to position the catheter inside the heart cavities with an average exposure of 43 ± 38 s while in 2 femoral venous access was needed. The mean procedural time was 35 ± 11 min. The exam was diagnostic in all patients, there were no procedural complications and tolerability was excellent. 53% of the patients had an accessory pathway with high refractoriness and no inducible atrio-ventricular reentry tachycardia: this subgroup was considered eligible to competitive sports and no event was observed during long-term follow-up (13.6 ± 5.2 years) without drug use. The others underwent catheter ablation. Conclusion. ESnoXr has been shown to be a feasible, effective, safe and well-tolerated procedure for the assessment of arrhythmic risk in a population of young athletes with asymptomatic VP.

Impact of COVID-19 Pandemic on Remote Monitoring of Cardiac Implantable Electronic Devices in Italy: Results of a Survey Promoted by AIAC (Italian Association of Arrhythmology and Cardiac Pacing).

The COVID-19 pandemic has had a profound impact on the organisation of health care in Italy, with an acceleration in the development of telemedicine. To assess the impact of the COVID-19 pandemic on the spread of remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) in Italy, a survey addressed to cardiologists operating in all Italian CIED-implanting centres was launched. A total of 127 cardiologists from 116 Italian arrhythmia centres took part in the survey, 41.0% of all 283 CIED-implanting centres operating in Italy in 2019. All participating centres declared to use RM of CIEDs. COVID-19 pandemic resulted in an increase in the use of RM in 83 (71.6%) participating centres. In a temporal perspective, an increase in the median number of patients per centre followed up by RM was found from 2012 to 2017, followed by an exponential increase from 2017 to 2020. In 36 participating centres (31.0%) a telehealth visits service was activated as a replacement for in-person outpatient visits (in patients with or without CIED) during the COVID-19 pandemic. COVID-19 pandemic has caused an acceleration in the use of RM of CIEDs and in the use of telemedicine in the clinical practice of cardiology.

X-ray management in electrophysiology: a survey of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC).

AIMS: Radiation use in medicine has significantly increased over the last decade, and cardiologists are among the specialists most responsible for X-ray exposure. The present study investigates a broad range of aspects, from specific European Union directives to general practical principles, related to radiation management among a national cohort of cardiologists. METHODS AND RESULTS: A voluntary 31-question survey was run on the Italian Arrhythmology and Pacing Society (AIAC) website. From June 2019 to January 2020, 125 cardiologists, routinely performing interventional electrophysiology, participated in the survey. Eighty-seven (70.2%) participants are aware of the recent European Directive (Euratom 2013/59), although only 35 (28.2%) declare to have read the document in detail. Ninety-six (77.4%) participants register the dose delivered to the patient in each procedure, in 66.1% of the cases both as fluoroscopy time and dose area product. Years of exposition (P = 0.009) and working in centers performing pediatric procedures (P = 0.021) related to greater degree of X-ray equipment optimization. The majority of participants (72, 58.1%) did not recently attend radioprotection courses. The latter is related to increased awareness of techniques to reduce radiation exposure (96% vs. 81%, P = 0.022), registration of the delivered dose in each procedure (92% vs. 67%, P = 0.009), and X-ray equipment optimization (50% vs. 36%, P = 0.006). CONCLUSION: Italian interventional cardiologists show an acceptable level of radiation awareness and knowledge of updated European directives. However, there is clear space for improvement. Comparison to other health professionals, both at national and international levels, is needed to pursue proper X-ray management and protect public health.

Scheduled versus alert transmissions for remote follow-up of cardiac implantable electronic devices: Clinical relevance and resource consumption.

BACKGROUND: The remote follow-up of pacemakers and implantable cardiac defibrillators (ICDs) usually includes scheduled checks and alert transmissions. However, this results in a high volume of remote data reviews to be managed. We measured the relative contribution of scheduled and alert transmissions to the detection of relevant conditions, and the workload generated by their management. METHODS: At our center, the frequency of remote scheduled transmissions is 4/year. Moreover, all system-integrity and clinical alerts are turned on for wireless notification. We calculated the number of transmissions received from January to December 2020, and identified transmissions that necessitated in-hospital access for further assessment and transmissions that required clinical discussion with the physician. For all alert transmissions, we identified whether the alert was clinically meaningful (i.e. center was not previously aware of the condition and no action had yet been taken to treat it). RESULTS: Of 8545 transmissions received from 1697 pacemakers and ICDs, 5766 (67%) were scheduled and 2779 (33%) were alert transmissions received from 764 patients (45%); 499 (9%) scheduled transmissions required clinical discussion with the physician, but only 2 of these necessitated in-hospital visits for further assessment. Of the alert transmissions, 664 (24%) required clinical discussion, and 75 (3%) necessitated in-hospital visits. The proportion of alerts judged clinically meaningful was 7%. CONCLUSION: Scheduled transmissions generate 67% of remote data reviews for pacemakers and ICDs, but their ability to detect clinically relevant events is very low. A strategy that relies exclusively on alert transmissions could ensure continuity of patient monitoring while reducing the workload at the center.

A Divergence-Based Approach for the Identification of Atrial Fibrillation Focal Drivers From Multipolar Mapping: A Computational Study.

The expanding role of catheter ablation of atrial fibrillation (AF) has stimulated the development of novel mapping strategies to guide the procedure. We introduce a novel approach to characterize wave propagation and identify AF focal drivers from multipolar mapping data. The method reconstructs continuous activation patterns in the mapping area by a radial basis function (RBF) interpolation of multisite activation time series. Velocity vector fields are analytically determined, and the vector field divergence is used as a marker of focal drivers. The method was validated in a tissue patch cellular automaton model and in an anatomically realistic left atrial (LA) model with Courtemanche-Ramirez-Nattel ionic dynamics. Divergence analysis was effective in identifying focal drivers in a complex simulated AF pattern. Localization was reliable even with consistent reduction (47%) in the number of mapping points and in the presence of activation time misdetections (noise <10% of the cycle length). Proof-of-concept application of the method to human AF mapping data showed that divergence analysis consistently detected focal activation in the pulmonary veins and LA appendage area. These results suggest the potential of divergence analysis in combination with multipolar mapping to identify AF critical sites. Further studies on large clinical datasets may help to assess the clinical feasibility and benefit of divergence analysis for the optimization of ablation treatment.

Radiation awareness in an Italian multispecialist sample assessed with a web-based survey.

INTRODUCTION: The awareness of radiation doses and risks, also during interventional cardiology procedures, is essential today in order to apply the risk-benefit assessment and to reinforce the principles of justification and optimisation in clinical practice. METHODS: A voluntary survey with 10 questions and multiple-choice answers was run on a popular cardiology website (www.cardiolink.it) independently by a scientific publisher, in order to evaluate the contemporary level of radiation awareness in a multi-speciality sample of physicians in Italy. RESULTS: One thousand eight hundred and sixty-one physicians completed the test. The survey showed good results since both prescribers and practitioners (mostly cardiologists) working in Italy are largely aware of the cancer and non-cancer risks of medical radiation use, regardless of their subspecialty background. CONCLUSION: Physicians are largely aware of the cancer and non-cancer risks of medical radiation use, regardless of their subspecialty background. However, there is still broad space for improvement; in the future, the awareness of radiation risk is a prerequisite to create a culture of respect for radiation hazard and a commitment to minimise exposure and maximise protection.

Integration of activation maps of epicardial veins in computational cardiac electrophysiology.

In this work we address the issue of validating the monodomain equation used in combination with the Bueno-Orovio ionic model for the prediction of the activation times in cardiac electro-physiology of the left ventricle. To this aim, we consider four patients who suffered from Left Bundle Branch Block (LBBB). We use activation maps performed at the septum as input data for the model and maps at the epicardial veins for the validation. In particular, a first set (half) of the latter are used to estimate the conductivities of the patient and a second set (the remaining half) to compute the errors of the numerical simulations. We find an excellent agreement between measures and numerical results. Our validated computational tool could be used to accurately predict activation times at the epicardial veins with a short mapping, i.e. by using only a part (the most proximal) of the standard acquisition points, thus reducing the invasive procedure and exposure to radiation.