[How to: Basics of programming cardiac pacemakers]. / How to: Basics der Schrittmacherprogrammierung.

Programming of implantable cardiac devices, especially dual-chamber pacemakers, can be challenging in daily clinical practice. Precise knowledge of programmable parameters is important; furthermore, one should also be familiar with the specific algorithms of each manufacturer. During programming, the patient's individual requirements should be taken into account, but out-of-the-box programming should be avoided. Another important goal of programming should be to stimulate as much as needed but as little as possible to provide the patient good exercise capacity while not being aware of the pacing. Manufacturers' algorithms can help reach these aims but need to be understood and-in case of inappropriate behavior-to be deactivated.

Novel bradycardia pacing strategies.

The adverse effects of ventricular dyssynchrony induced by right ventricular (RV) pacing has led to alternative pacing strategies, such as biventricular, His bundle (HBP), LV septal (LVSP) and left bundle branch pacing (LBBP). Given the overlap, LVSP and LBBP are also collectively referred to as left bundle branch area pacing (LBBAP). Although among these alternative pacing sites HBP is theoretically the ideal strategy as it maintains a physiological ventricular activation, its application requires more skills and is associated with the most complications. LBBAP, where the ventricular pacing lead is advanced through the interventricular septum to its left side, creates ventricular activation that is only slightly more dyssynchronous. Preliminary studies have shown that LBBAP is feasible, safe and encounters less limitations than HBP. Further studies are needed to differentiate between LVSP and LBBP with regard to acute functional and long-term clinical outcome.

Left bundle branch area pacing - restoring the natural order: A Case Report.

INTRODUCTION: Recent studies have shown that His-bundle pacing could be an alternative in patients requiring cardiac resynchronization therapy as it is comparable or better in terms of amelioration of ventricular activation, narrowing of the QRS complex, or clinical outcomes. However, in case of high threshold at the level of His-bundle or inability to correct conduction through a diseased His-Purkinje system other option should be searched like left bundle pacing. PATIENT CONCERNS: A 77-year-old man presented to the Emergency Department for dizziness and dizziness and lightheadedness due to an intermittent 2:1 atrioventricular block with a QRS complex morphology of a major left branch block. DIAGNOSIS: Given the documented symptomatic 2:1 AV block, according to the European Guideliness the patient was considered to have a class 1 indication of permanent double chamber cardiostimulation. INTERVENTIONS: A lead delivery system with a C315 His catheter and a Select Secure 3830 69 cm pacing lead were placed at the His bundle area with important narrowing of the QRS complex but with an unacceptable high threshold. The delivery system was moved towards the apex 1,5 cm and the lead screwed deep into the septum until capture of the left bundle branch was achieved with complete normalization of the conduction troubles. OUTCOMES: At 3 month follow-up the patient was asymptomatic and the pacing and sensing thresholds remained at same values as during implantation: 0.75/0.4 ms and 14 mV respectively. CONCLUSION: Left bundle-pacing represents the next step of His-Purkinje system pacing to overcome all difficulties related to His-bundle pacing.

[Syncope]. / Synkope.

Syncope is a frequent disorder, sometimes due to life-threatening causes. The uncertainty in its diagnosis requires a standardized approach. According to the 2018 European Society of Cardiology (ESC) guidelines, new aspects in evaluation and treatment include risk stratification and decision-making strategies during the initial evaluation in the emergency department, a reconsideration of diagnostic tests, algorithms for the treatment of reflex syncope, indications for an implantable cardioverter/defibrillator in high risk patients for sudden cardiac death, and organizational aspects such as interdisciplinary syncope units. The 2018 ESC guideline and the 2019 commentaries of the German Society of Cardiology (DGK) are an excellent and comprehensive instruction for safe, effective and efficient evaluation and therapy. However, some aspects require critical appraisal. The inadequate availability and reimbursement of pivotal diagnostic tests, such as tilt table testing and the implantable loop recorder is emphasized.

[Quality and performance in cardiac pacing and electrophysiology. An update to the 2010 Italian Association of Arrhythmology and Cardiac Pacing (AIAC) - Italian Federation of Cardiology (IFC) Document 'Structure and functional organization of Arrhythmology']. / Qualità e performance in Elettrostimolazione ed Elettrofisiologia. Aggiornamento al documento dell'Associazione Italiana di Aritmologia e Cardiostimolazione (AIAC) ­ Federazione Italiana di Cardiologia (FIC) 2010 "Struttura e organizzazione funzionale dell'Aritmologia".

In the last decade the field of cardiac pacing and electrophysiology underwent major advancements thanks to both new ways of arrhythmia management and technological innovations. At the same time, the clinical competence and the procedural qualitative level of Cardiac Rhythm Centers have increased significantly. In 2010 an ad hoc Committee of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) and the Italian Federation of Cardiology (FIC) published a consensus document on the organization of Cardiac Rhythm Centers and on the standards of professional practice in pacing and electrophysiology in Italy. In particular, this document focused on the minimal requirements of a Center to be qualified as suitable to perform first, second and third-level cardiac pacing and electrophysiology activities. However, most of these indicators have been overcome over time. Thus, an update of the previously published organizational model appeared necessary. In this document several new requirements and indicators about the organization and performance of both operators and Cardiac Arrhythmia Centers have been introduced. These include: (i) "structural and procedural requirements" (types of diagnostic and therapeutic procedures performed, logistic structures, healthcare staff and technologies), (ii) "activity indicators" (number of procedures performed); (iii) "appropriateness indicators" (adherence to guideline recommendations); (iv) "outcome indicators" (procedural success and complications); and (v) "quality of care indicators" (management and continuity of care levels). By applying these requirements and indicators, each center can optimize its procedures, increasing its performance and effectiveness. Finally, a new model for the organization of the Italian network of Cardiac Arrhythmia Centers is also suggested.

Optimising pacemaker therapy and medical therapy in pacemaker patients for heart failure: protocol for the OPT-PACE randomised controlled trial.

INTRODUCTION: Permanent artificial pacemaker implantation is a safe and effective treatment for bradycardia and is associated with extended longevity and improved quality of life. However, the most common long-term complication of standard pacemaker therapy is pacemaker-associated heart failure. Pacemaker follow-up is potentially an opportunity to screen for heart failure to assess and optimise patient devices and medical therapy. METHODS AND ANALYSIS: The study is a multicentre, phase-3 randomised trial. The 1200 participants will be people who have a permanent pacemaker for bradycardia for at least 12 months, randomly assigned to undergo a transthoracic echocardiogram with their pacemaker check, thereby tailoring their management directed by left ventricular function or the pacemaker check alone, continuing with routine follow-up. The primary outcome measure is time to all-cause mortality or heart failure hospitalisation. Secondary outcomes include external validation of our risk stratification model to predict onset of heart failure and quality of life assessment. ETHICS AND DISSEMINATION: The trial design and protocol have received national ethical approval (12/YH/0487). The results of this randomised trial will be published in international peer-reviewed journals, communicated to healthcare professionals and patient involvement groups and highlighted using social media campaigns. TRIAL REGISTRATION NUMBER: NCT01819662.

Prognosis after pacemaker implantation in extreme elderly.

AIMS: Significant comorbidities may limit the potential benefit of pacemaker (PM) implantation in extreme elderly. A short-term mortality risk prediction score, able to identify high-risk patients, may be a useful tool in this population. METHODS AND RESULTS: We retrospectively analyzed 538 patients aged >80 years at the time of implant who underwent PM implantation. Kaplan-Meier survival and multivariable Cox regression analyses were performed to identify patient, procedural or complication variables predictive of death. The ACP (Aging in Cardiac Pacing) Score was constructed by assigning weighted values to the variables identified by hazard ratios, combined into an additive mortality risk score equation. One, two and three-year overall mortality rate was 11%, 21% and 32% respectively. Renal failure (HR 1.63; CI 1.15-2.31; p = .006), active neoplasia (HR 1.78; CI 1.27-2.51; p = .008), connective tissue disorder (3.07; CI 1.34-7.08; p = .048), cerebrovascular disease (HR 1.75; CI 1.25-2.46; p = .001) and the use of a single lead device (HR 2.27; CI 1.6-3.24; p < .001) were independently associated with worse survival. The ACP Score showed discrete predictive ability (AUC 0,6792 CI 0,63-0,73). Kaplan-Meier survival curves comparing low vs high ACP Scores demonstrated that low ACP scores were associated with reduced mortality rates (p < .001). CONCLUSIONS: Significant comorbidities were associated with worse survival after PM implantation in extreme elderly. The ACP Score is a novel tool that may help to identify patients with high mortality risk after device implantation.

Quality assessment in Belgian arrhythmology: the Belgian heart rhythm association (BeHRA) databases.

This report presents and discusses, on behalf of the Belgian College of Cardiology, the evolution of the peer review process in arrhythmology, focussing on pacemaker implantation. Data from the last 22 years are compared. The national annual increase in implants is around 1%, clinical patient characteristics remained stable over the years while dual chamber pacing was proportionally increasing. Analyses of the normalised sick sinus and complete atrioventricular block ratios revealed a quite homogenous practice between centres and patient district with the only exception of the two more crowded districts. Battery longevity and infection rate were also assessed. With an incidence of 1/1000 device-years follow-up, Belgium remains below accepted European levels.

Inadvertent Left Ventricle Endocardial or Uncomplicated Right Ventricular Pacing: How to Differentiate in the Emergency Department.

BACKGROUND: Temporary transvenous pacemaker implantation is an important and critical procedure for emergency physicians. Traditionally, temporary pacemakers are inserted by electrocardiography (ECG) guidance in the emergency department because fluoroscopy at the bedside in an unstable patient can be limited by time and equipment availability. However, in the presence of atrial septal defect, ventricular septal defect, and patent foramen ovale, the pacemaker lead can be implanted inadvertently into the left ventricle or directly into the coronary sinus instead of right ventricle. Regular pacemaker rhythm can be achieved despite inadvertent implantation of the pacemaker lead into the left ventricle, leading to ignorance of the possibility of lead malposition. CASE REPORT: A 65-year-old female patient with hemodynamic instability and complete atrioventricular block underwent temporary pacemaker implantation via right jugular vein with ECG guidance at the emergency department. Approximately 12 h after implantation, it was noticed that the ECG revealed right bundle branch block (RBBB)-type paced QRS complexes. Diagnostic workup revealed that the lead was inadvertently located in the left ventricular apex. This case illustrates the importance of careful scrutiny of the 12-lead ECG and imaging clues in identifying lead malposition in the emergency department. WHY SHOULD AN EMERGENCY PHYSICIAN BE AWARE OF THIS?: Because inadvertent left ventricle endocardial pacing carries a high risk for systemic embolization, it is important to determine whether an RBBB pattern induced by ventricular pacing is the result of a malpositioned lead or uncomplicated transvenous right ventricular pacing.

Clinically oriented device programming in bradycardia patients: part 1 (sinus node disease). Proposals from AIAC (Italian Association of Arrhythmology and Cardiac Pacing).

: Modern pacemakers have an increasing number of programable parameters and specific algorithms designed to optimize pacing therapy in relation to the individual characteristics of patients. When choosing the most appropriate pacemaker type and programing, the following variables must be taken into account: the type of bradyarrhythmia at the time of pacemaker implantation; the cardiac chamber requiring pacing, and the percentage of pacing actually needed to correct the rhythm disorder; the possible association of multiple rhythm disturbances and conduction diseases; the evolution of conduction disorders during follow-up. The goals of device programing are to preserve or restore the heart rate response to metabolic and hemodynamic demands; to maintain physiological conduction; to maximize device longevity; to detect, prevent, and treat atrial arrhythmia. In patients with sinus node disease, the optimal pacing mode is DDDR. Based on all the available evidence, in this setting, we consider appropriate the activation of the following algorithms: rate responsive function in patients with chronotropic incompetence; algorithms to maximize intrinsic atrioventricular conduction in the absence of atrioventricular blocks; mode-switch algorithms; algorithms for autoadaptive management of the atrial pacing output; algorithms for the prevention and treatment of atrial tachyarrhythmias in the subgroup of patients with atrial tachyarrhythmias/atrial fibrillation. The purpose of this two-part consensus document is to provide specific suggestions (based on an extensive literature review) on appropriate pacemaker setting in relation to patients' clinical features.

Clinically oriented device programming in bradycardia patients: part 2 (atrioventricular blocks and neurally mediated syncope). Proposals from AIAC (Italian Association of Arrhythmology and Cardiac Pacing).

: The purpose of this two-part consensus document is to provide specific suggestions (based on an extensive literature review) on appropriate pacemaker setting in relation to patients' clinical features. In part 2, criteria for pacemaker choice and programming in atrioventricular blocks and neurally mediate syncope are proposed. The atrioventricular blocks can be paroxysmal or persistent, isolated or associated with sinus node disease. Neurally mediated syncope can be related to carotid sinus syndrome or cardioinhibitory vasovagal syncope. In sinus rhythm, with persistent atrioventricular block, we considered appropriate the activation of mode-switch algorithms, and algorithms for auto-adaptive management of the ventricular pacing output. If the atrioventricular block is paroxysmal, in addition to algorithms mentioned above, algorithms to maximize intrinsic atrioventricular conduction should be activated. When sinus node disease is associated with atrioventricular block, the activation of rate-responsive function in patients with chronotropic incompetence is appropriate. In permanent atrial fibrillation with atrioventricular block, algorithms for auto-adaptive management of the ventricular pacing output should be activated. If the atrioventricular block is persistent, the activation of rate-responsive function is appropriate. In carotid sinus syndrome, adequate rate hysteresis should be programmed. In vasovagal syncope, specialized sensing and pacing algorithms designed for reflex syncope prevention should be activated.

Use of leadless pacemakers in Europe: results of the European Heart Rhythm Association survey.

The purpose of this European Heart Rhythm Association (EHRA) survey is to provide an overview of the current use of leadless pacemakers (LLPM) across a broad range of European centres. An online questionnaire was sent to centres participating in the EHRA Electrophysiology Research Network. Questions dealt with standards of care and policies used for patient management, indications, and techniques of implantation of LLPM. In total, 52 centres participated in the survey. Most (86%) reported using LLPM, although 82% of these centres implanted <30 LLPM devices during the last 12 months. Non-availability (36%), lack of reimbursement (55%), and cost of the device (91%) were factors limiting the use of LLPM. The most commonly reported indications for LLPM were permanent atrial fibrillation (83%), a history of complicated conventional pacemaker (87%), or an anticipated difficult vascular access (91%). Implantation of LLPM is perceived as an easy-to-do and safe procedure by most implanters (64%), while difficult or risky in 28%, and comparable to conventional pacemakers by only a few (8%). Local vascular complications were the most frequently reported major problems (28%), but a significant number of respondents (36%) have never encountered any issue after LLPM implantation. Although cost and reimbursement issues strongly influence the use of LLPM, most respondents (72%) anticipate a significant increase in device utilization within next 2 years.

Permanent His bundle pacing: Recommendations from a Multicenter His Bundle Pacing Collaborative Working Group for standardization of definitions, implant measurements, and follow-up.

His bundle pacing (HBP) prevents ventricular dyssynchrony and its long-term consequences by preserving normal electrical activation of the ventricles. Since the original description of permanent HBP in 2000, the adoption of HBP has increased over the past several years. However, the reporting of procedural and clinical outcomes to date is not uniform. This article is a collaboration between several implanters with significant experience in HBP to establish a uniform set of definitions encompassing the different forms of HBP as well as define a standardized approach to gathering data end points to ensure consistency in reported outcomes.

Registro Español de Marcapasos. XIV Informe Oficial de la Sección de Estimulación Cardiaca de la Sociedad Española de Cardiología (2016) / Spanish Pacemaker Registry. 14th Official Report of the Spanish Society of Cardiology Working Group on Cardiac Pacing (2016)

Introducción y objetivos: Se describe el resultado del análisis de los dispositivos de estimulación implantados y remitidos al Registro Español de Marcapasos en 2016. Métodos: Procesado de la información que aporta la Tarjeta Europea del Paciente Portador de Marcapasos. Resultados: Se recibió información de 115 centros hospitalarios, con un total de 12.697 tarjetas, el 32,3% de la actividad estimada. El consumo de generadores convencionales y dispositivos de resincronización fue de 818 y 79 unidades por millón habitantes respectivamente. Se implantaron 200 marcapasos sin cables. La media de edad de los pacientes que recibieron un implante fue 77,8 años y un 52% de los dispositivos se implantaron en mayores de 80 años. El 74,9% de los procedimientos fueron primoimplantes y el 23,4%, recambios de generador. Los cables endocavitarios utilizados fueron bipolares, el 82,9% con sistema de fijación activa y el 16,1% compatibles con resonancia magnética. Aunque la estimulación secuencial bicameral sigue siendo mayoritaria, se estimula en modo VVI(R) al 26,7% de los pacientes con enfermedad del nódulo sinusal y el 23,8% de aquellos con bloqueo auriculoventricular pese a estar en ritmo sinusal. Conclusiones: El consumo total de generadores de marcapasos en España ha aumentado en un 1,6% con respecto a 2015. La mayoría de los cables implantados son de fijación activa y menos del 20% tiene protección para la resonancia magnética. Los factores directamente relacionados con la elección del modo de estimulación son la edad y el sexo. En alrededor del 32% de los casos podría mejorarse la elección del modo de estimulación (AU)

Introduction and objectives: This report describes the results of analysis of implanted pacemakers reported to the Spanish Pacemaker Registry. Methods: The analysis was based on information provided by the European Pacemaker Identification Card. Results: Information was received from 115 hospitals, with a total of 12 697 cards, representing 32.3% of the estimated activity. Use of conventional and resynchronization pacemakers was 818 and 79 units per million inhabitants, respectively. A total of 200 leadless pacemakers were implanted. The mean age of the patients receiving an implant was 77.8 years, and 52% of devices were implanted in persons older than 80 years. In all, 74.9% were first implants and 23.4% corresponded to generator exchange. Endocardial leads were bipolar, 82.9% with active fixation, and 16.1% had magnetic resonance imaging protection. Most patients received bicameral sequential pacing, although single chamber pacing VVI(R) was used in 26.7% of the patients with sick sinus syndrome and in 23.8% of those with atrioventricular block, despite sinus rhythm. Conclusions: Total use of pacemaker generators in Spain has increased by 1.6% compared with 2015. Most implanted leads have active fixation and less than 20% have magnetic resonance imaging protection. Age and sex directly influenced pacing mode selection, which could be improved in around 32% of patients (AU)