Registro español de marcapasos. XX informe oficial de la Asociación del Ritmo Cardiaco de la Sociedad Española de Cardiología (2022) / Spanish pacemaker registry. 20th official report of the Heart Rhythm Association of the Spanish Society of Cardiology (2022)

Introducción y objetivos: En este informe se comunica la actividad de estimulación cardiaca en 2022: número total de implantes, adherencia a la monitorización a distancia, factores demográficos y clínicos y características del material implantado. Métodos: Las fuentes de información son la plataforma CardioDispositivos, la tarjeta europea del paciente portador de marcapasos y los datos facilitados por los fabricantes. Resultados: Las tasas de marcapasos convencionales y resincronizadores de baja energía fueron de 866 y 34 unidades/millón respectivamente. Se implantaron 815 marcapasos sin cables. Se registraron 16.426 procedimientos de 82 hospitales (9.407 a través de CardioDispositivos), lo que supone un 40% de la actividad. La media de edad fue 78,6 años, con predominio de varones (60,3%). El bloqueo auriculoventricular fue el trastorno más frecuente y el 14,5% de los pacientes estaban en fibrilación auricular. Predomina el modo de estimulación DDD/R (55,6%) y la edad influye en el modo de estimulación, de forma que más de un tercio de los pacientes mayores de 80 años en ritmo sinusal recibieron estimulación monocameral en ventrículo. Se incluyeron en monitorización a distancia el 35% de los marcapasos y el 55% de los resincronizadores de baja energía. Conclusiones: Aumentan en un 5,6% el número de marcapasos convencionales, un 16% los resincronizadores de baja energía y un 25% los marcapasos sin cables. Se estabiliza la adherencia a la monitorización a distancia. Aumenta en un 11% el número de procedimientos incluidos en CardioDispositivos, aunque disminuye el volumen de muestra. El uso extensivo de la plataforma es lo que permitirá en años venideros contar con un registro de calidad.(AU)

Introduction and objectives: This article reports the cardiac pacing activity performed in 2022, including the total number of implants, adherence to remote monitoring, demographic and clinical factors, and the characteristics of the implanted devices. Methods: The information sources were the CardioDispositivos online platform, the European pacemaker patient identification card, and data provided by the manufacturers. Results: The rates of conventional pacemakers and low-energy resynchronizers were 866 and 34 units per million population, respectively. A total of 815 leadless pacemakers were implanted. In all, 16426 procedures performed in 82 hospitals were reported (9407 through CardioDispositivos), representing 40% of the activity. The mean age was 78.6 years, with a predominance of men (60.3%). The most frequent disorder was atrioventricular block, and 14.5% of the patients had atrial fibrillation. There was a predominance of the DDD/R pacing mode (55.6%), and pacing mode was influenced by age, such that more than one-third of patients older than 80 years in sinus rhythm received single-chamber ventricular pacing. The remote monitoring program included 35% of conventional pacemakers and 55% of low-energy resynchronization pacemakers. Conclusions: The number of conventional pacemakers increased by 5.6%, low-energy resynchronizers by 16%, and leadless pacemakers by 25%. Adherence to remote monitoring was stable. The number of procedures included in CardioDispositivos increased by 11%, although the sample volume decreased. In the coming years, the widespread use of the platform will likely lead to a high-quality registry.(AU)

Meta-Analysis of Transcatheter Versus Surgical Aortic Valve Replacement in Low Surgical Risk Patients.

Current guidelines recommend transcatheter aortic valve implantation (TAVI) for patients with severe aortic stenosis at elevated surgical risk, but not for patients at low surgical risk. Our objective is to compare major clinical outcomes and procedural complications with TAVI versus surgical aortic valve replacement in patients with severe aortic stenosis at low surgical risk. We conducted a systematic review and meta-analysis of randomized controlled trials, identified through a systematic search of the MEDLINE, Embase, and Cochrane databases. Count data were pooled across trials using random-effects models with inverse variance weighting to obtain relative risks (RRs) and corresponding 95% confidence intervals (CIs). Three randomized controlled trials (n = 2,629) were included. At 30 days, TAVI was associated with a substantial reduction in all-cause mortality (RR: 0.45, 95%CI: 0.20 to 0.99), atrial fibrillation (RR: 0.27, 95%CI: 0.17 to 0.41), life threatening/disabling bleeding (RR: 0.29, 95%CI: 0.12 to 0.69), and acute kidney injury (RR: 0.28, 95%CI: 0.14 to 0.57). The reduction in atrial fibrillation persisted at 12 months (RR: 0.32, 95%CI: 0.21 to 0.49). However, TAVI patients had an increased risk of permanent pacemaker implantation at both 30 days (RR: 3.13, 95%CI: 1.36 to 7.21) and 12 months (RR: 2.99, 95%CI: 1.19 to 7.51). Due to the low absolute numbers of events, results were inconclusive at 30 days and 12 months for cardiovascular mortality, stroke, transient ischemic attack, and myocardial infarction. In conclusion, while some outcomes remained inconclusive, these data suggest that TAVI should be considered as a first-line therapy for the treatment of severe aortic stenosis in low surgical risk patients.

Status of cardiac arrhythmia services in Africa in 2018: a PASCAR Sudden Cardiac Death Task Force report.

BACKGROUND: There is limited information on the availability of health services to treat cardiac arrhythmias in Africa. METHODS: The Pan-African Society of Cardiology (PASCAR) Sudden Cardiac Death Task Force conducted a survey of the burden of cardiac arrhythmias and related services over two months (15 October to 15 December) in 2017. An electronic questionnaire was completed by general cardiologists and electrophysiologists working in African countries. The questionnaire focused on availability of human resources, diagnostic tools and treatment modalities in each country. RESULTS: We received responses from physicians in 33 out of 55 (60%) African countries. Limited use of basic cardiovascular drugs such as anti-arrhythmics and anticoagulants prevails. Non-vitamin K-dependent oral anticoagulants (NOACs) are not widely used on the continent, even in North Africa. Six (18%) of the sub-Saharan African (SSA) countries do not have a registered cardiologist and about one-third do not have pacemaker services. The median pacemaker implantation rate was 2.66 per million population per country, which is 200-fold lower than in Europe. The density of pacemaker facilities and operators in Africa is quite low, with a median of 0.14 (0.03-6.36) centres and 0.10 (0.05-9.49) operators per million population. Less than half of the African countries have a functional catheter laboratory with only South Africa providing the full complement of services for cardiac arrhythmia in SSA. Overall, countries in North Africa have better coverage, leaving more than 110 million people in SSA without access to effective basic treatment for cardiac conduction disturbances. CONCLUSION: The lack of diagnostic and treatment services for cardiac arrhythmias is a common scenario in the majority of SSA countries, resulting in sub-optimal care and a subsequent high burden of premature cardiac death. There is a need to improve the standard of care by providing essential services such as cardiac pacemaker implantation.

Long-Term Outcomes Following Transvenous Lead Extraction.

BACKGROUND: Complications related to a cardiac implantable electronic device sometimes require transvenous lead extraction (TLE). We report long-term follow-up of patients undergoing TLE, particularly mortality, recurrent device infection, and need for repeat procedures. METHODS AND RESULTS: Consecutive patients undergoing TLE at a high-volume center were assessed for characteristics, indications, and outcomes. One thousand and six leads were extracted from 510 patients. Clinical success rate was 98.2% and complete procedural success was 92.2%, with one intraprocedural death. The mean follow-up was 5.5 +/- 4.9 years (range 0.2-18 years). Cumulative mortality was 3.3% at 30 days, 7.7% at 6 months, 10.0% at 1 year, and 33.0% at 10 years. Factors associated with increased long-term mortality included cardiac device infection (CDI; 33% vs 17% for non-CDI; χ² 13.8, P = 0.0003), procedural complications (43% vs 27% for no complications; χ² 4.2, P = 0.04), age (75.0 +/- 10.9 years in patients who died vs 62.7 +/- 17.2 years; P < 0.0001), and impaired renal function (creatinine 142.5 +/- 106.4 µmol/L in patients who died vs 106.3 +/- 90.7 µmol/L; P = 0.001). The rate of CDI after TLE was 3.9% (mean 11.6 months post extraction, range 0.3-84 months) and is higher in patients with retained lead fragments (13.5% vs 3.0% with complete removal; χ² 10.7, P = 0.001). CONCLUSION: Long-term mortality following TLE is high, particularly in those with systemic infection, procedural complications, advanced age, and renal impairment. Retained fragments are a risk factor for CDI post extraction.

Insuficiencia cardiaca derecha tras el implante de un marcapasos / Right heart failure after pacemaker implantation

Fundamento y objetivo: La insuficiencia tricuspídea (IT) grave secundaria a interferencia del cable del marcapasos (MCP) es una causa infrecuente de insuficiencia cardiaca (IC) derecha progresiva, que puede complicar la evolución del paciente. Material y métodos: Presentamos 3 casos clínicos de IC derecha secundaria a IT tras implantación de MCP. Resultados: En estos pacientes la clínica consiste en IC derecha, que puede aparecer de forma precoz, como en nuestra segunda paciente, o al cabo de años de la implantación del MCP, como en el primer y la tercera pacientes. El diagnóstico se confirma por ecocardiografía, siendo la más precisa la 3D, seguida de la transesofágica. La 2D transtorácica puede no detectarla, ya que tiene baja sensibilidad para la IT asociada a MCP. El tratamiento médico es siempre la primera opción, ya que cualquier otro procedimiento conlleva una morbimortalidad significativa. Conclusiones: Probablemente, esta es una patología que vamos a diagnosticar cada vez con más frecuencia, ya que cada vez hay más pacientes con dispositivos y, al mismo tiempo, están mejorando las herramientas diagnósticas (AU)

Conclusions: Severe tricuspid regurgitation (TR) secondary to interference pacemaker (PM) cable is a rare cause of progressive right heart failure (HF), which can worsen patient outcomes. This continuation/maintenance electroconvulsive therapy programme has shown to be clinically useful and to have a favourable economic impact, as well as high perceived quality. Introducción: We present 3 clinical cases of right HF secondary to TR after PM implantation. La terapia electroconvulsiva de continuación/mantenimiento ha demostrado su eficacia en la prevención de recaídas tanto en cuadros afectivos como psicóticos. Sin embargo, existen pocos estudios sobre variables de gestión clínica, costes asociados y calidad percibida. Results: In these patients the clinic is right HF, which can appear early, as in our second patient, or after years of implementation of the PM, as in the first and third patients. The diagnosis is confirmed by echocardiography, the most accurate 3D, followed by transesophageal. The 2D transthoracic can not detect it, because it has low sensitivity for TR associated with PM. Medical treatment is always the first choice, since any other procedure carries significant morbidity and mortality. Resultados: Probably this is a condition that we will diagnose with increasing frequency, because there are more and more patients with devices and, at the same time, the diagnostic tools are improving. Tras su inclusión en el programa, el 50,0% de los pacientes refirió encontrarse «mucho mejor», y el 37,5% «moderadamente mejor» en la Escala de Impresión Clínica Global-Mejoría Global. Además, una vez incluidos en el programa de terapia electroconvulsiva de continuación/mantenimiento, los pacientes tuvieron un total de 349 días de ingreso, 3 visitas a Urgencias y 2 ingresos urgentes, frente a los 690 días de ingreso (p = 0,012), 26 visitas a Urgencias (p = 0,011) y 22 ingresos urgentes (p = 0,010) en el mismo periodo, antes de su inclusión en el programa. Los costes directos asociados por estancia/día tras su inclusión en el programa se redujeron al 50,6% del coste previo, y los costes asociados a visitas a Urgencias disminuyeron al 11,5% del coste previo. Respecto a la calidad percibida, un 87,5% de los pacientes evaluaron la atención y tratamiento recibido como «muy satisfactorio», y un 12,5% como «satisfactorio» (AU)

Derrame pleural por síndrome de Dressler / No disponible

El síndrome de Dressler (SD) se caracteriza por fiebre, dolor torácico de tipo pleurítico y derrame pericárdico después de 2-3 semanas de un infarto agudo del miocardio o lesión pericárdica; suele mejorar con AAS u otro AINE; los glucocorticoides se reservan para pacientes con dolor intenso y refractario. Se presenta el caso de un varón con derrame pleural (DP) secundario a SD en paciente con antecedente de cirugía cardiaca reciente recidivante y con mala evolución, en probable relación a tratamiento con dosis bajas de antiinflamatorios y rápido descenso de los mismos de forma inicial, presentando mejoría al reintroducir tratamiento a dosis altas y de forma prolongada

Dressler’s syndrome (DS) is characterized by fever, chest pleuritic pain and pericardial effusion that may appear 2-3 weeks after an acute myocardial infarction or pericardial injury and usually improves with aspirin or other NSAIDs; glucocorticoids reserved for patients with severe and refractory pain. The case of a man with pleural effusion (PE) secondary to DS with history of recent heart surgery, which was recurrent and poor outcome, probably related to treatment with low doses of anti-inflammatory and rapid decline of the same initial presenting improvement to reintroduce treatment with high doses and for long periods

Improved access to temporary pacing in Denmark.

INTRODUCTION: The aim was to illustrate current use of temporary pacing (TP) in Denmark by replicating a questionnaire study from 1986 and to compare the results of the two studies. MATERIAL AND METHODS: The questionnaire was sent to Danish hospitals treating patients with acute myocardial infarction (AMI). To illustrate potential changes in the indications for TP, the questionnaire included two case reports also used in 1986. RESULTS: Thirty-three of 39 hospitals returned the questionnaire. Thirty-one (94%) were able to perform transcutaneous TP, and 20 (61%) had access to transvenous TP. Transcutaneous TP was preferred in five hospitals, and transvenous TP was the procedure of choice in 15. In 1986, 13 of 74 (18%) hospitals were able to perform transcutaneous TP, and 33 of 74 (45%) had access to transvenous TP. Over the two decades, the proportion of patients with AMI undergoing TP decreased from 3.7% to 0.7% (p < 0.00001). No significant difference was found with regard to the indications for TP except for patients with posterior AMI complicated with a third degree atrioventricular block in whom a higher rate of TP was found (85%) compared with the 1986 results (56%) (p < 0.05). CONCLUSION: The proportion of hospitals with TP facilities has nearly doubled since 1986. Over the same time period, the number of Danes undergoing TP in association with AMI was reduced. At present, TP is being performed in less than 1% of AMI patients. FUNDING: Not relevant. TRIAL REGISTRATION: Not relevant.

Societal views of pacemaker reutilization for those with untreated symptomatic bradycardia in underserved nations.

PURPOSE: Significant healthcare disparities exist between the developed world and low and middle income countries (LMIC), specifically in the field of cardiac electrophysiology. As a result, pacemaker reutilization has been proposed as a viable option for those in LMIC and no other means of obtaining a device. Little data exist regarding the feasibility of establishing a reuse program in addition to understanding the views of society on device reutilization. This study investigated the views of funeral directors, patients with cardiac devices, and members of the general population regarding reutilization of previously implanted pacemakers. METHODS: Ninety funeral directors in Michigan were surveyed regarding current practice as well as preferences for post-mortem device disposal. One hundred and fourteen patients with devices and 1,009 members of the general population were surveyed regarding post-mortem device handling. RESULTS: Funeral directors had an average of 21 years of experience with an annual volume of 120 deceased persons per year, with a cremation rate of 35%. When asked about disposal methods of explanted devices, the majority of devices (84%) were discarded as medical waste or stored with no intended purpose, with a total of 171 devices currently in possession at the funeral homes. Eighty-nine percent of funeral directors expressed a desire to donate devices for reuse in LMIC and 10% acknowledged previous device donation. Eighty-seven percent of device patients and 71% of the general population also expressed a desire to donate devices. CONCLUSIONS: The results of our survey show that a large percentage of funeral directors, patients with implantable devices, and members of the general population support a pacemaker reutilization initiative. This study lends further evidence that collection of devices for reuse is feasible and that establishing a framework for regional pacemaker reutilization program is warranted. If successful, the feasibility of this model should be investigated in other parts of the country in order to alleviate the burden of untreated symptomatic bradycardia in our world.

Registro Español de Marcapasos. VII Informe Oficial de la Sección de Estimulación Cardiaca de la Sociedad Española de Cardiología (2009) / Spanish Pacemaker Registry. Seventh Official Report of the Spanish Society of Cardiology Working Group on Cardiac Pacing (2009)

Introducción y objetivos. Se describe el análisis de los implantes de marcapasos remitidos al Registro Español de Marcapasos de 2009, con especial referencia a la distribución poblacional y la selección de los modos de estimulación en las diversas indicaciones electrocardiográficas. Métodos. Procesamiento de la información aportada por la Tarjeta Europea del Paciente Portador de Marcapasos en sus diversos campos empleando una aplicación informática específica. Resultados. Se recibió información de 106 centros, con un total de 11.939 tarjetas, el 35% de todos los marcapasos implantados. La media de edad del paciente que recibió el implante era 76,6 años. El 58,4% de los implantes se hicieron en varones. El mayor número de las indicaciones electrocardiográficas de los implantes fueron los bloqueos auriculoventriculares de tercer grado; los bloqueos auriculoventriculares fueron el 56%. Se estimuló en modo VVI/R al 24% de los pacientes con enfermedad del nódulo sinusal y el 23,5% de aquellos con bloqueos auriculoventriculares. Los cables utilizados fueron bipolares y más del 50% con sistema de fijación activa, el 65% en la posición auricular. Conclusiones. En 2009 persiste la tendencia al aumento del consumo de generadores de marcapasos (729/millón de habitantes), con mayor incidencia en los varones y a una edad ligeramente inferior que en las mujeres. El factor edad es más determinante que la alteración electrocardiográfica en la inadecuada selección del modo de estimulación. La elección de fijación activa de los cables supera el 50% (AU)

Introduction and objectives. This article describes the finding of an analysis of all pacemaker implants reported to the Spanish Pacemaker Registry in 2009. Particular attention is paid to patients’ demographic characteristics and to the pacing modes selected for various electrocardiographic indications. Methods. The information provided by the European Pacemaker Identification Card was analyzed using a specially developed computer program. Results. Data were received from 106 centers, covering a total of 11,939 cards and corresponding to 35% of all pacemakers implanted. The average age of patients receiving pacemakers was 76.6 years. Overall, 58.4% of pacemakers were implanted in men. The largest number of electrocardiographic indications for a pacemaker was for third-degree atrioventricular block, which comprised 56% of all atrioventricular blocks. The VVIR pacing mode was used for 24.0% of patients with sick sinus syndrome and 23.5% with atrioventricular block. Over 50% of leads employed an active fixation system, and 65% were placed in the atrium. Conclusions. The trend of increasing pacemaker use continued in 2009, reaching 729 units per million population. Pacemaker implantation was more frequent in males, who received them at a slightly younger age than women. Age was a more significant determinant of inappropriate pacing mode selection than electrocardiographic abnormalities. Active fixation of pacemaker leads was used in more than 50% of cases (AU)

Donation of explanted pacemakers for reuse in underserved nations.

Some charitable organizations and physicians are willing to assist in the compassionate donation of explanted pacemakers for reuse in medically underserved nations. However, healthcare organizations must recognize that the Food and Drug Administration (FDA), device manufacturers, professional societies and many physicians advocate return of explanted pacemakers to the manufacturer to ensure an accurate performance database promoting improved device reliability and safety for the patient.

Pacemaker reuse in a 65-year-old woman in the Philippines with severe medical need.

As disparities in healthcare between the industrialized world and low- and middle-income countries (LMIC) continue to widen, novel methods of delivering cardiovascular therapies-specifically electrophysiological devices-must be explored. Post-mortem pacemaker donation is a safe and effective method of decreasing the morbidity associated with cardiovascular disease in LMIC.

Use of a transurethral microwave thermotherapeutic device with permanent pacemakers and implantable defibrillators.

OBJECTIVE: To determine whether a device (Urologix Targis system) used for transurethral microwave treatment interferes with sensing, pacing, and arrhythmia detection by permanent pacemakers and implantable cardioverter-defibrillators (ICDs). METHODS: We tested 13 pacemakers in both bipolar and unipolar sensing configurations and 8 ICDs in vitro. Pacemakers and ICDs were programmed to their most sensitive settings. Energy outputs of the microwave device were typical of those used clinically. The probe of the microwave device was anchored 1.2 cm from the pacemaker or ICD being tested. RESULTS: No sensing, pacing, or arrhythmic interactions were noted with any ICD or any pacemaker programmed to the bipolar configuration. One pacemaker (Guidant Vigor 1230) showed intermittent tracking when programmed to the unipolar configuration. CONCLUSIONS: Most patients with permanent pacemakers or ICDs can safely undergo transurethral microwave therapy using the device tested. Pacemakers and ICDs should be programmed to the bipolar configuration (if available) during therapy. The pacemaker or ICD should be interrogated before and after therapy to determine whether programming changes occurred as a result of treatment. However, our findings suggest that this is unlikely.