Advancement in the miniaturization of high-density power sources, electronic circuits, and communication technologies enabled the construction of miniaturized electronic devices, implanted directly in the heart. These include pacing devices to prevent low heart rates or terminate heart rhythm abnormalities (‘arrhythmias’), long-term rhythm monitoring devices for arrhythmia detection in unexplained syncope cases, and heart failure (HF) hemodynamic monitoring devices, enabling the real-time monitoring of cardiac pressures to detect and alert for early fluid overload. These devices were shown to prevent HF hospitalizations and improve HF patients’ life quality. Pacing devices include permanent pacemakers (PPM) that maintain normal heart rates, defibrillators that are capable of fast detection and the termination of life-threatening arrhythmias, and cardiac re-synchronization devices that improve cardiac function and the survival of HF patients. Traditionally, these devices are implanted via the venous system (‘endovascular’) using conductors (‘endovascular leads/electrodes’) that connect the subcutaneous device battery to the appropriate cardiac chamber. These leads are a potential source of multiple problems, including lead-failure and systemic infection resulting from the lifelong exposure of these leads to bacteria within the venous system. One of the important cardiac innovations in the last decade was the development of a leadless PPM functioning without venous leads, thus circumventing most endovascular PPM-related problems. Leadless PPM’s consist of a single device, including a miniaturized power source, electronic chips, and fixating mechanism, directly implanted into the cardiac muscle. Only rare device-related problems and almost no systemic infections occur with these devices. Current leadless PPM’s sense and pace only the ventricle. However, a novel leadless device that is capable of sensing both atrium and ventricle was recently FDA approved and miniaturized devices that are designed to synchronize right and left ventricles, using novel intra-body inner-device communication technologies, are under final experiments. This review will cover these novel implantable miniaturized cardiac devices and the basic algorithms and technologies that underlie their development. Advancement in the miniaturization of high-density power sources, electronic circuits, and communication technologies enabled the construction of miniaturized electronic devices, implanted directly in the heart. These include pacing devices to prevent low heart rates or terminate heart rhythm abnormalities (‘arrhythmias’), long-term rhythm monitoring devices for arrhythmia detection in unexplained syncope cases, and heart failure (HF) hemodynamic monitoring devices, enabling the real-time monitoring of cardiac pressures to detect and alert early fluid overload. These devices were shown to prevent HF hospitalizations and improve HF patients’ life quality. Pacing devices include permanent pacemakers (PPM) that maintain normal heart rates, defibrillators that are capable of fast detection and termination of life-threatening arrhythmias, and cardiac re-synchronization devices that improve cardiac function and survival of HF patients. Traditionally, these devices are implanted via the venous system (‘endovascular’) using conductors (‘endovascular leads/electrodes’) that connect the subcutaneous device battery to the appropriate cardiac chamber. These leads are a potential source of multiple problems, including lead-failure and systemic infection that result from the lifelong exposure of these leads to bacteria within the venous system. The development of a leadless PPM functioning without venous leads was one of the important cardiac innovations in the last decade, thus circumventing most endovascular PPM-related problems. Leadless PPM’s consist of a single device, including a miniaturized power source, electronic chips, and fixating mechanism, implanted directly into the cardiac muscle. Only rare device-related problems and almost no systemic infections occur with these devices. Current leadless PPM’s sense and pace only the ventricle. However, a novel leadless device that is capable of sensing both atrium and ventricle was recently FDA approved and miniaturized devices designed to synchronize right and left ventricles, using novel intra-body inner-device communication technologies, are under final experiments. This review will cover these novel implantable miniaturized cardiac devices and the basic algorithms and technologies that underlie their development.

Lead perforation is a rare, well-known complication of cardiac implantable electronic device (CIED) implants, whose management is mostly not evidence-based. Main management strategies include conservative approach based on clinical and lead function follow-up vs. routine invasive lead revision approach. This study compared the complications of both strategies by composite endpoint, including recurrent perforation-related symptoms, recurrent pericardial effusion (PEf), lead dysfunction, and device infection during 12 month follow-up. Multicentre retrospective analysis, inquiring data from imaging studies, device interrogation, pericardiocentesis, and clinical charts of patients with suspected perforating leads between 2007 and 2014 in five hospitals. All cases were reviewed by electrophysiologist and defined as definite perforations by suggestive symptoms along with lead perforation on imaging, bloody PEf on pericardiocentesis shortly after implant, or right ventricular (RV) lead non-capture along with diaphragmatic stimulation upon bipolar pacing. Clinical outcomes associated with both management approaches were compared, with respect to the composite endpoint. The study included 48 definitive perforation cases: 22 managed conservatively and 26 via lead revision. Conservative management was associated with an increased composite endpoint compared with lead revision (8/22 vs. 1/26; P = 0.007). The dominant complication among the conservative cohort was appearance of cardiac tamponade during follow-up; 5/6 occurring in cases which presented with no or only mild PEf and were treated by antiplatelets/coagulants during or shortly after CIED implantation. A conservative management of CIED lead perforation is associated with increased complications compared with early lead revision. Lead revision may be the preferred management particularly in patients receiving antiplatelets/coagulants.

Objectives A significant proportion of COVID‐19 patients may have cardiac involvement including arrhythmias. Although arrhythmia characterization and possible predictors were previously reported, there are conflicting data regarding the exact prevalence of arrhythmias. Clinically applicable algorithms to classify COVID patients' arrhythmic risk are still lacking, and are the aim of our study. Methods We describe a single center cohort of hospitalized patients with a positive nasopharyngeal swab for COVID‐19 during the initial Israeli outbreak between 1/2/2020 –30/5/2020. The study's outcome was any documented arrhythmia during hospitalization, based on daily physical examination, routine ECG's, periodic 24‐hour Holter, and continuous monitoring. Multivariate analysis was used to find predictors for new arrhythmias and create classification trees for discriminating patients with high and low arrhythmic risk. Results Out of 390 COVID‐19 patients included, 28 (7.2%) had documented arrhythmias during hospitalization, including: 23 atrial tachyarrhythmias, combined atrial fibrillation (AF) and ventricular fibrillation, ventricular tachycardia storm, and 3 bradyarrhythmias. Only 7/28 patients had previous arrhythmias. Our study showed significant correlation between disease severity and arrhythmia prevalence (p<0.001) with a low arrhythmic prevalence among mild disease patients (2%). Multivariate analysis revealed background heart failure (CHF) and disease severity are independently associated with overall arrhythmia while age, CHF, disease severity, and arrhythmic symptoms are associated with tachyarrhythmias. A novel decision tree using age, disease severity, CHF, and troponin levels was created to stratify patients into high and low risk for developing arrhythmia. Conclusions Dominant arrhythmia among COVID‐19 patients is AF. Arrhythmia prevalence is associated with age, disease severity, CHF, and troponin levels. A novel simple Classification tree, based on these parameters, can discriminate between high and low arrhythmic risk patients.

Aims: Prior case series showed promising results for cardioneuroablation in patients with vagally induced atrioventricular blocks (VAVBs). We aimed to examine the acute procedural characteristics and intermediate-term outcomes of electroanatomical-guided cardioneuroablation (EACNA) in patients with VAVB. Methods and results: This international multicentre retrospective registry included data collected from 20 centres. Patients presenting with symptomatic paroxysmal or persistent VAVB were included in the study. All patients underwent EACNA. Procedural success was defined by the acute reversal of atrioventricular blocks (AVBs) and complete abolition of atropine response. The primary outcome was occurrence of syncope and daytime second- or advanced-degree AVB on serial prolonged electrocardiogram monitoring during follow-up. A total of 130 patients underwent EACNA. Acute procedural success was achieved in 96.2% of the cases. During a median follow-up of 300 days (150, 496), the primary outcome occurred in 17/125 (14%) cases with acute procedural success (recurrence of AVB in 9 and new syncope in 8 cases). Operator experience and use of extracardiac vagal stimulation were similar for patients with and without primary outcomes. A history of atrial fibrillation, hypertension, and coronary artery disease was associated with a higher primary outcome occurrence. Only four patients with primary outcome required pacemaker placement during follow-up. Conclusion: This is the largest multicentre study demonstrating the feasibility of EACNA with encouraging intermediate-term outcomes in selected patients with VAVB. Studies investigating the effect on burden of daytime symptoms caused by the AVB are required to confirm these findings.

Today, cardiac implantable electronic devices (CIEDs), such as pacemakers and implantable cardioverter defibrillators (ICDs), play an increasingly important role in healthcare ecosystems as patient life support devices. Physicians control, program and configure CIEDs on a regular basis using a dedicated programmer device. The programmer device is open to external connections (e.g., USB, Bluetooth, etc.), and thus it is exposed to a variety of cyber-attacks by which an attacker can manipulate the programmer device’s operations and consequently harm the patient. In this paper, we present CardiWall, a novel detection and prevention system designed to protect ICDs from cyber-attacks aimed at the programmer device. Our system has six different layers of protection, leveraging medical experts’ knowledge, statistical methods, and machine learning algorithms. We evaluated the CardiWall system extensively in two comprehensive experiments. For the evaluation, we gathered data for a period of four years and used 775 benign clinical commands that are related to hundreds of different patients (obtained from different programmer devices located at Barzilai University Medical center) and 28 malicious clinical commands (created by two cardiology experts from different hospitals). The evaluation results show that only two out of the six layers proposed in CardiWall system provided a high detection capability associated with high rates of true positive, and low rates of false positive. With the configuration that provided the best harmonic mean of sensitivity and specificity (HMSS), CardiWall achieved a high true positive rate (TPR) of 91.4% and a very low false positive rate (FPR) of 1%, with an AUC of 94.7%.

Background: Heart failure (HF) patients with wide QRS often benefit from cardiac resynchronization therapy (CRT), although QRS narrowing does not always occur. The current study investigates the incidence and predictors for QRS narrowing following CRT and its long-term impact on clinical outcomes. Methods: Among individuals undergoing clinically indicated CRT, pre-and post-implantation electrocardiographs were meticulously analyzed for QRS duration change. All-cause mortality and the composite of mortality and HF hospitalizations were retrieved. Results: For 104 patients, mean age 67 years, 25% females, QRS narrowed within days by 20.2 ± 24.7 ms. In 55/104 (53%) QRS narrowed by ≥20 ms (“acute narrowing”). Female gender and baseline QRS predicted acute narrowing. Acute narrowing persisted for 1–6 weeks in 18/20 (90%) and 3–12 months in 21/31 (68%) of patients. During the average follow-up of 41 months, 29/104 (28%) died and 50/104 (48%) met the composite outcome. In a multivariable analysis including comorbidities and cardiac history, prolonged baseline PR interval (HR 1.015, CI 1.008–1.021, p < 0.001) and acute narrowing < 20 ms (HR 3.243, CI 1.593–6.603, p = 0.001) were significant and independent predictors for the composite outcome. Conclusions: Post-CRT acute QRS narrowing ≥ 20 ms is independently associated with favorable long-term outcomes and might be considered as a novel measure for procedural success.