Implantable cardiac monitors: artificial intelligence and signal processing reduce remote ECG review workload and preserve arrhythmia detection sensitivity.

Introduction: Implantable cardiac monitors (ICMs) provide long-term arrhythmia monitoring, but high rates of false detections increase the review burden. The new "SmartECG" algorithm filters false detections. Using large real-world data sets, we aimed to quantify the reduction in workload and any loss in sensitivity from this new algorithm. Methods: Patients with a BioMonitor IIIm and any device indication were included from three clinical projects. All subcutaneous ECGs (sECGs) transmitted via remote monitoring were classified by the algorithm as "true" or "false." We quantified the relative reduction in workload assuming "false" sECGs were ignored. The remote monitoring workload from five hospitals with established remote monitoring routines was evaluated. Loss in sensitivity was estimated by testing a sample of 2000 sECGs against a clinical board of three physicians. Results: Of our population of 368 patients, 42% had an indication for syncope or pre-syncope and 31% for cryptogenic stroke. Within 418.5 patient-years of follow-up, 143,096 remote monitoring transmissions contained 61,517 sECGs. SmartECG filtered 42.8% of all sECGs as "false," reducing the number per patient-year from 147 to 84. In five hospitals, nine trained reviewers inspected on average 105 sECGs per working hour. This results in an annual working time per patient of 83 min without SmartECG, and 48 min with SmartECG. The loss of sensitivity is estimated as 2.6%. In the majority of cases where true arrhythmias were rejected, SmartECG classified the same type of arrhythmia as "true" before or within 3 days of the falsely rejected sECG. Conclusion: SmartECG increases efficiency in long-term arrhythmia monitoring using ICMs. The reduction of workload by SmartECG is meaningful and the risk of missing a relevant arrhythmia due to incorrect filtering by the algorithm is limited.

[ANMCO Position paper: Ionizing radiation exposure and radioprotection in the cath-lab]. / Position paper ANMCO: Radioesposizione e radioprotezione nei laboratori di cardiologia interventistica.

In the last decades, because of the improvements in the percutaneous treatment of coronary heart disease, valvular heart disease, congenital heart defects, and the increasing number of cardiac resynchronization therapy and cardioverter-defibrillator implantations, the interventional cardiologists' radio-exposure has importantly risen, causing concerns for ionizing radiation-associated diseases such as cancer and neurodegenerative disorders. Consequently, the radiation exposure issue importantly affects operators' safety. However, our knowledge of this field is poor and most operators are unaware to be at risk, especially because of the absence of effective preventive measures. The aim of this ANMCO position paper is to improve the awareness of operators and identify new ways of reducing operator ionizing radiation dose and minimizing the risk.

Modern subcutaneous implantable defibrillator therapy in patients with cardiomyopathies and channelopathies: data from a large multicentre registry.

AIMS: Patients with cardiomyopathies and channelopathies are usually younger and have a predominantly arrhythmia-related prognosis; they have nearly normal life expectancy thanks to the protection against sudden cardiac death provided by the implantable cardioverter defibrillator (ICD). The subcutaneous ICD (S-ICD) is an effective alternative to the transvenous ICD and has evolved over the years. This study aimed to evaluate the rate of inappropriate shocks (IS), appropriate therapies, and device-related complications in patients with cardiomyopathies and channelopathies who underwent modern S-ICD implantation. METHODS AND RESULTS: We enrolled consecutive patients with cardiomyopathies and channelopathies who had undergone implantation of a modern S-ICD from January 2016 to December 2020 and who were followed up until December 2022. A total of 1338 S-ICD implantations were performed within the observation period. Of these patients, 628 had cardiomyopathies or channelopathies. The rate of IS at 12 months was 4.6% [95% confidence interval (CI): 2.8-6.9] in patients with cardiomyopathies and 1.1% (95% CI: 0.1-3.8) in patients with channelopathies (P = 0.032). No significant differences were noted over a median follow-up of 43 months [hazard ratio (HR): 0.76; 95% CI: 0.45-1.31; P = 0.351]. The rate of appropriate shocks at 12 months was 2.3% (95% CI: 1.1-4.1) in patients with cardiomyopathies and 2.1% (95% CI: 0.6-5.3) in patients with channelopathies (P = 1.0). The rate of device-related complications was 0.9% (95% CI: 0.3-2.3) and 3.2% (95% CI: 1.2-6.8), respectively (P = 0.074). No significant differences were noted over the entire follow-up. The need for pacing was low, occurring in 0.8% of patients. CONCLUSION: Modern S-ICDs may be a valuable alternative to transvenous ICDs in patients with cardiomyopathies and channelopathies. Our findings suggest that modern S-ICD therapy carries a low rate of IS. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov/Identifier: NCT02275637.

[ANMCO Position paper: Choosing Wisely - ANMCO proposals for 2023]. / Position paper ANMCO: Choosing Wisely ­ le proposte dell'ANMCO nel 2023.

Nowadays, a progressive and exponential increase in the use of invasive and non-invasive instrumental diagnostics and therapeutic services has been shown. Although unnecessary, instrumental examinations are often largely prescribed, replacing clinical evaluation. Their correct use, on the contrary, would address precise epidemiological and clinical contexts. Therefore identifying whether a test or procedure is appropriate or not plays a crucial role in clinical practice. Several documents from scientific societies and expert groups indicate the most appropriate cardiovascular diagnostic and therapeutic procedures. The international Choosing Wisely campaign invited the main scientific societies to identify five techniques or treatments used in their field that are often unnecessary and may potentially damage patients. The Italian Association of Hospital Cardiologists (ANMCO) joined the project identifying the five cardiological practices in our country at greater risk of inappropriateness in 2014. This list has recently been updated. Moreover, possible solutions to this problem have been proposed.

Clinical Utility of Three-Dimensional Echocardiography in the Evaluation of Mitral Valve Disease: Tips and Tricks.

Although real-time 3D echocardiography (RT3DE) has only been introduced in the last decades, its use still needs to be improved since it is a time-consuming and operator-dependent technique and acquiring a good quality data can be difficult. Moreover, the additive value of this important diagnostic tool still needs to be wholly appreciated in clinical practice. This review aims at explaining how, why, and when performing RT3DE is useful in clinical practice.

Insertable cardiac monitor with a long sensing vector: Impact of obesity on sensing quality and safety.

Background: Fat layers in obese patients can impair R-wave detection and diagnostic performance of a subcutaneous insertable cardiac monitor (ICM). We compared safety and ICM sensing quality between obese patients [body mass index (BMI) ≥ 30 kg/m2] and normal-weight controls (BMI <30 kg/m2) in terms of R-wave amplitude and time in noise mode (noise burden) detected by a long-sensing-vector ICM. Materials and methods: Patients from two multicentre, non-randomized clinical registries are included in the present analysis on January 31, 2022 (data freeze), if the follow-up period was at least 90 days after ICM insertion, including daily remote monitoring. The R-wave amplitudes and daily noise burden averaged intraindividually for days 61-90 and days 1-90, respectively, were compared between obese patients (n = 104) and unmatched (n = 268) and a nearest-neighbour propensity score (PS) matched (n = 69) normal-weight controls. Results: The average R-wave amplitude was significantly lower in obese (median 0.46 mV) than in normal-weight unmatched (0.70 mV, P < 0.0001) or PS-matched (0.60 mV, P = 0.003) patients. The median noise burden was 1.0% in obese patients, which was not significantly higher than in unmatched (0.7%; P = 0.056) or PS-matched (0.8%; P = 0.133) controls. The rate of adverse device effects during the first 90 days did not differ significantly between groups. Conclusion: Although increased BMI was associated with reduced signal amplitude, also in obese patients the median R-wave amplitude was >0.3 mV, a value which is generally accepted as the minimum level for adequate R-wave detection. The noise burden and adverse event rates did not differ significantly between obese and normal-weight patients.Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04075084 and NCT04198220.

Diagnostic yield of an insertable cardiac monitor in a large patient population.

Background: Insertable cardiac monitors (ICMs) are increasingly used for cardiac rhythm diagnosis with expanding indications. Little has been reported about their use and efficacy. Objective: The study sought to evaluate the clinical utility of a novel ICM (Biotronik BIOMONITOR III) including the time to diagnosis in unselected patients with different ICM indications. Methods: Patients from 2 prospective clinical studies were included to determine the diagnostic yield of the ICM. The primary endpoint was time to clinical diagnosis per implant indication or to the first change in atrial fibrillation (AF) therapy. Results: A total of 632 patients were included with a mean follow-up of 233 ± 168 days. Of 384 patients with (pre)syncope, 34.2% had a diagnosis at 1 year. The most frequent therapy was permanent pacemaker implantation. Of 133 patients with cryptogenic stroke, 16.6% had an AF diagnosis at 1 year, resulting in oral anticoagulation. Of 49 patients with an indication for AF monitoring, 41.0% had a relevant change in AF therapy based on ICM data at 1 year. Of 66 patients with other indications, 35.4% received a rhythm diagnosis at 1 year. Moreover, 6.5% of the cohort had additional diagnoses: 26 of 384 patients with syncope, 8 of 133 patients with cryptogenic stroke, and 7 of 49 patients with AF monitoring. Conclusion: In a large unselected patient population with heterogeneous ICM indications, the primary endpoint of rhythm diagnosis was achieved in ∼1 in 4, and additional clinically relevant findings was achieved in 6.5% of patients at short-term follow-up.

[2020 Catheter Ablation Registry of the Italian Association of Arrhythmology and Cardiac Pacing]. / Registro Italiano Ablazioni 2020. Associazione Italiana di Aritmologia e Cardiostimolazione.

BACKGROUND: This report describes the findings of the 2020 Italian Catheter Ablation Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC). METHODS: Data collection was retrospective. A standardized questionnaire was completed by each of the participating centers. RESULTS: A total of 10 378 ablation procedures were performed by 66 institutions. Most centers (70%) have an electrophysiology laboratory, and 23% a hybrid cardiac surgery laboratory. All centers have a 3D mapping system. The median number of electrophysiologists and nurses involved in the electrophysiology laboratory was 3.5 and 3, respectively. An electrophysiology technician was involved in 35% of all centers. In 88.2% of cases, catheter ablation was performed for supraventricular arrhythmias; the most frequently treated arrhythmia was atrial fibrillation (39.4%), followed by atrioventricular nodal reentrant tachycardia (18.6%), and common atrial flutter (10.6%). In 72.9% of patients, catheter ablation was performed using a 3D mapping system, with a "near-zero" fluoroscopic approach in 37.7% of all patients. CONCLUSIONS: The 2020 Italian Catheter Ablation Registry confirmed that the electrophysiology activity was markedly affected by the COVID-19 pandemic; atrial fibrillation is the most frequently treated arrhythmia with an increasing number of procedures performed with a 3D mapping system and a "near-zero" approach.

Intermuscular technique for implantation of the subcutaneous implantable defibrillator: a propensity-matched case-control study.

AIMS: 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. METHODS AND RESULTS: 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. CONCLUSION: Our data showed the superiority of the IM S-ICD generator positioning in reducing device-related complications and inappropriate shocks. CLINICAL TRIAL REGISTRATION: Clinical Trial Registration: ClinicalTrials.gov; NCT02275637.

Temporal association between drops in thoracic impedance and malignant ventricular arrhythmia: A longitudinal analysis of remote monitoring trends.

INTRODUCTION: Thoracic impedance (TI) drops measured by implantable cardioverter-defibrillators (ICDs) have been reported to correlate with ventricular tachycardia/fibrillation (VT/VF). The aim of our study was to assess the temporal association of decreasing TI trends with VT/VF episodes through a longitudinal analysis of daily remote monitoring data from ICDs and cardiac resynchronization therapy defibrillators (CRT-Ds). METHODS AND RESULTS: Retrospective data from 2384 patients were randomized 1:1 into a derivation or validation cohort. The TI decrease rate was defined as the percentage of rolling weeks with a continuously decreasing TI trend. The derivation cohort was used to determine a TI decrease rate threshold for a ≥99% specificity of arrhythmia prediction. The associated risk of VT/VF episodes was estimated in the validation cohort by dividing the available follow-up into 60-day assessment intervals. Analyses were performed separately for 1354 ICD and 1030 CRT-D patients. During a median follow-up of 2.0 years, 727 patients (30.4%) experienced 3298 confirmed VT/VF episodes. In the ICD group, a TI decrease rate of >60% was associated with a higher risk of VT/VF episode in a 60-day assessment interval (stratified hazard ratio, 1.42; 95% confidence interval (CI), 1.05-1.92; p = .023). The TI decrease preceded (40.8%) or followed (59.2%) the VT/VF episodes. In the CRT-D group, no association between TI decrease and VT/VF episodes was observed (p = .84). CONCLUSION: In our longitudinal analysis, TI decrease was associated with VT/VF episodes only in ICD patients. Preventive interventions may be difficult since episodes can occur before or after TI decrease.

Five waves of COVID-19 pandemic in Italy: results of a national survey evaluating the impact on activities related to arrhythmias, pacing, and electrophysiology promoted by AIAC (Italian Association of Arrhythmology and Cardiac Pacing).

BACKGROUND: The subsequent waves of the COVID-19 pandemic in Italy had a major impact on cardiac care. METHODS: A survey to evaluate the dynamic changes in arrhythmia care during the first five waves of COVID-19 in Italy (first: March-May 2020; second: October 2020-January 2021; third: February-May 2021; fourth: June-October 2021; fifth: November 2021-February 2022) was launched. RESULTS: A total of 127 physicians from arrhythmia centers (34% of Italian centers) took part in the survey. As compared to 2019, a reduction in 40% of elective pacemaker (PM), defibrillators (ICD), and cardiac resynchronization devices (CRT) implantations, with a 70% reduction for ablations, was reported during the first wave, with a progressive and gradual return to pre-pandemic volumes, generally during the third-fourth waves, slower for ablations. For emergency procedures (PM, ICD, CRT, and ablations), recovery from the initial 10% decline occurred in most cases during the second wave, with some variability. However, acute care for atrial fibrillation, electrical cardioversions, and evaluations for syncope showed a prolonged reduction of activity. The number of patients with devices which started remote monitoring increased by 40% during the first wave, but then the adoption of remote monitoring declined. CONCLUSIONS: The dramatic and profound derangement in arrhythmia management that characterized the first wave of the COVID-19 pandemic was followed by a progressive return to the volume of activities of the pre-pandemic periods, even if with different temporal dynamics and some heterogeneity. Remote monitoring was largely implemented during the first wave, but full implementation is needed.

Ventricular Arrhythmias and Implantable Cardioverter-Defibrillator Therapy in Women: A Propensity Score-Matched Analysis.

BACKGROUND: Causes of sex differences in incidence of sustained ventricular arrhythmias (SVAs) are poorly understood. OBJECTIVES: This study aims to investigate sex-specific risk of SVAs and device therapies by balancing sex groups in relation to several baseline characteristics with the propensity score (PS). METHODS: We used a large remote monitoring dataset from implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). Study endpoints were time to the first appropriate SVA, time to the first device therapy for SVA, and time to the first ICD shock. Results were compared between females and a PS-matched male subgroup. RESULTS: In a cohort of 2,532 patients with an ICD or CRT-D (median age, 70 years), 488 patients (19.3%) were women. After selecting 488 men PS-matched for 19 variables relative to baseline demographics, implant indications, principal comorbidities, and concomitant therapy, yet the SVA rate at the 2.1-year median follow-up was significantly lower in women than in man (adjusted HR: 0.65; 95% CI: 0.51-0.81; P < 0.001). Women also showed a reduced risk of any device therapy (HR: 0.59; 95% CI: 0.45-0.76; P < 0.001) and shocks (HR: 0.66; 95% CI: 0.47-0.94; P = 0.021). Differences in sex-specific SVA risk profile were not confirmed in CRT-D patients (HR: 0.78; 95% CI: 0.55-1.09; P = 0.14) nor in those with an ejection fraction <30% (HR: 0.80; 95% CI: 0.52-1.23; P = 0.31). CONCLUSIONS: After matching demographics, indications, principal comorbidities, and concomitant therapy, women still exhibited a lower SVA risk profile than men, except in the subgroups of CRT-D or/and ejection fraction <30%.

New-generation miniaturized insertable cardiac monitor with a long sensing vector: Insertion procedure, sensing performance, and home monitoring transmission success in a real-world population.

Background: Insertable cardiac monitors (ICMs) require an invasive procedure and are used for purely diagnostic purposes. Therefore, simplicity of the insertion procedure, low complication rate, long-term patient acceptance, sensing quality, and reliable remote monitoring are of great importance. Objective: To evaluate a novel ICM (BIOMONITOR III) regarding all these aspects. Methods: BIOMONITOR III has a miniaturized profile, long sensing vector (≈70 mm), a fast insertion tool for pocket formation and ICM placement in 1 step, and daily automatic Home Monitoring (HM) function. We evaluated the insertion procedure, complication rate, patient acceptance, sensing quality, and HM performance in 653 patients with BIOMONITOR III inserted for any ICM indication within 2 ongoing studies involving 51 sites in 11 countries. Results: The median time from skin incision to wound closure was 4.0 minutes (interquartile range, 2.3-6.2 minutes). Median follow-up period was 274 days (interquartile range, 175-342 days). Serious adverse device-related events occurred in 6 patients (0.9%). No deep infections were reported in 334 patients without antibiotic prophylaxis. The wearing comfort was good or excellent in ≈95%. The mean R-wave amplitude (0.73 mV) and HM transmission rate (≈94% of days) were stable over 1.5 years. R-wave amplitudes were larger (mean 0.80 vs 0.62 mV, P < .001) and noise burden was lower (median 3.7 vs 14.5 minutes/day, P < .001) for ICM insertions parallel to the heart's long axis (54.2%) vs parasternal (41.3%). A gross visibility of P waves was 95.1%. Conclusion: The study demonstrated fast insertion times, low complication rate, high patient acceptance, and favorable long-term sensing and HM performance of the ICM.

The Telecardiology Revolution: From Emergency Management to Daily Clinical Practice.

AIMS: Telecardiology is one of the most widespread applications of telemedicine. We aimed to report the design and development of a telecardiology system in the sanitary district of Cosenza, one of the largest in Italy, with a complex orography, and healthcare reorganization needs, for the management of the emergency network and daily clinical practice. METHODS: Our telecardiology network connects 8 hospitals, 9 first aid centers, 20 local 118-EMS stations, 1 helicopter station, 8 hospital emergency departments, 59 hospital departments, and 3 catheterization laboratories. All data are centralized on a dedicated server, accessible from any location for real-time assessment. The quality, source, and timing of the electrocardiograms transmitted were evaluated. RESULTS: From October 2015 to December 2019, a total of 389,970 ECGs were transmitted. The quality of ECGs was optimal in 52%, acceptable in 42%, and poor in 6% of the cases. The number of poor-quality ECGs was only 3% in the last 2 years. Out of the total, 145,097 (37.2%) were transmitted from the emergency departments and 5318 (1.4%) from the 118-EMS. Of interest, a sizable part of the ECG was related to routine clinical practice, comprising 110,556 (28.3%) from the cardiology department and 79,256 (20.3%) from other noncardiovascular departments. Finally, the average reporting time was significantly decreased compared to reporting times without a telecardiology system (5-10 vs. 45-90 min). CONCLUSION: Our telecardiology system provides efficient cardiology assistance for all types, settings, and phases of cardiovascular diseases.

Patient acceptance of subcutaneous versus transvenous defibrillator systems: A multi-center experience.

BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) is an effective alternative to the transvenous ICD. No study has yet compared S-ICD and transvenous ICD by assessing patient acceptance as a patient-centered outcome. OBJECTIVE: To evaluate the patient acceptance of the S-ICD and to investigate its association with clinical and implantation variables. In patients with symptomatic heart failure and reduced ejection fraction (HFrEF), the acceptance of the S-ICD was compared with a control group of patients who received a transvenous ICD. METHODS: Patient acceptance was calculated with the Florida Patient Acceptance Survey (FPAS) which measures four factors: return to function (RTF), device-related distress (DRD), positive appraisal (PA), and body image concerns (BIC). The survey was administered 12 months after implantation. RESULTS: 176 patients underwent S-ICD implantation. The total FPAS and the single factors did not differ according to gender, body habitus, or generator positioning. Patients with HFrEF had lower FPAS and RTF. Younger patients showed better RTF (75 [56-94] vs. 56 [50-81], p = .029). Patients who experienced device complications or device therapies showed higher DRD (40 [35-60] vs. 25 [10-50], p = .019). Patients with HFrEF receiving the S-ICD had comparable FPAS, RTF, DRD, and BIC to HFrEF patients implanted with the transvenous ICD while exhibited significantly better PA (88 [75-100] vs. 81 [63-94], p = .02). CONCLUSIONS: Our analysis revealed positive patient acceptance of the S-ICD, even in groups at risk of more distress such as women or patients with thinner body habitus, and regardless of the generator positioning. Among patients receiving ICDs for HFrEF, S-ICD was associated with better PA versus transvenous ICD.

[2019 Catheter Ablation Registry of the Italian Association of Arrhythmology and Cardiac Pacing]. / Registro Italiano Ablazioni 2019. Associazione Italiana di Aritmologia e Cardiostimolazione.

BACKGROUND: This report describes the findings of the 2019 Italian Catheter Ablation Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC). METHODS: Data collection was retrospective. A standardized questionnaire was completed by each of the participating centers. RESULTS: A total of 15 201 ablation procedures were performed by 91 institutions. Most (78%) of the centers has one electrophysiology laboratory, and 17% of them has a hybrid cardiac surgery laboratory. Almost all (98%) centers have a 3D mapping system. The median number of electrophysiologists and nurses involved in the electrophysiology laboratory was 3 and an electrophysiology technician was involved in 30% of all centers. In 88.4% of cases, ablations were performed for supraventricular arrhythmias, and among these the most frequently treated arrhythmia was atrial fibrillation (32.9%), followed by atrioventricular nodal reentrant tachycardia (23.9%), and common atrial flutter (11.7%). In 10 256 (67.4%) patients catheter ablation was performed by means of a 3D mapping system, with a "near-zero" fluoroscopic approach in 4626 (30.4%) of all patients. CONCLUSIONS: The 2019 Italian Catheter Ablation Registry confirmed that atrial fibrillation is the most commonly treated arrhythmia in the ablation centers with an increasing number of procedures performed with a 3D mapping system and a "near-zero" approach.