Impact of the COVID-19 pandemic on implantation of cardiac implantable electronic devices and remote monitoring activations.

INTRODUCTION AND OBJECTIVES: Remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) is considered more reliable, efficient, and safer than conventional in-person follow-up. However, the implementation of RM is still suboptimal. This study aimed to analyze the impact of the COVID-19 pandemic on the rates of CIED implants and RM activations in Spain. METHODS: The COVID-19 RM Spain Registry was used to analyze the monthly number of all CIED implantations and RM activations from January 2018 to December 2021. A descriptive analysis was performed using aggregated data from the five major CIED manufacturers. RESULTS: A total of 205 345 CIEDs were recorded. The number of implants decreased sharply (48.2%) during the pandemic lockdown (March-June 2020) but gradually increased thereafter, compensating for the previous reduction. However, pacemakers and implantable cardiac defibrillators (ICD) showed an aggregate loss of 7% and 3%, respectively, from the annual average during 2020-2021. In contrast, cardiac resynchronization therapy defibrillators (CRT-D) increased by 17%, and pacemakers (CRT-P) by 4.5% over the 2-year period. The percentage of RM activations increased from 24.5% in 2018 to 49.0% in 2021, with a sharp increase during the lockdown. The RM activation rates consistently increased during the lockdown for all devices: pacemakers (14.4% vs 37.2%; P <.001); ICD (75.6% vs 94.2%; P <.001); CRT-D/CRT-P (68.6-44.2% vs 81.6-61%; P <.001), and implantable loop recorders (50.2% vs 68.7%; P <.001). CONCLUSIONS: The significant decline in implants during the lockdown gradually recovered, except for pacemakers and ICD. However, the COVID-19 pandemic boosted RM for all CIEDs in Spain.

Spanish pacemaker registry. 20th official report of the Heart Rhythm Association of the Spanish Society of Cardiology (2022).

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.

Spanish pacemaker registry. 19th official report of the Heart Rhythm Association of the Spanish Society of Cardiology (2021).

INTRODUCTION AND OBJECTIVES: This document includes cardiac pacing activity performed in Spain in 2021: figures for implanted devices, demographic and clinical factors, characteristics of the implanted material, and remote monitoring data. METHODS: The European Pacemaker Patient Card, the CardioDispositivos.es online platform, the centers' own databases and the data provided by the supplier companies are used as sources of information. RESULTS: 17.360 procedures were registered from 95 hospitals, which represents 43% of the activity. The implantation rates of conventional and resynchronization pacemakers were 822 and 31 units per million population, respectively. 652 leadless pacemakers were implanted. The mean age of implantation is high (78.8 years), and atrioventricular block is the most frequent electrocardiographic abnormality. Dual-chamber pacing mode predominated, nonetheless single-chamber pacing was performed in 19% of patients in sinus rhythm, mainly in the elderly. 28.5% of implanted conventional pacemakers and 56,2% of low-energy resynchronization pacemakers were included in the remote monitoring program. CONCLUSIONS: In 2021 the number of conventional pacemakers increased by 8.3% and resynchronizers by 18.9%, despite the decrease in low-energy resynchronization, probably attributable to the development of physiological pacing. Leadless pacemakers increased by 25%. The expansion of remote monitoring continued, consolidating as a fundamental follow-up method.

Spanish Pacemaker Registry. 18th Official Report of the Cardiac Pacing Section of the Spanish Society of Cardiology (2020).

INTRODUCTION AND OBJECTIVES: This report describes the cardiac pacing activity performed in Spain in 2020, including the number and type of implanted devices, demographic and clinical factors, and data on remote monitoring. METHODS: Information consisted of the European Pacemaker Patient Card, data submitted to the cardiodispositivos.es online platform, the databases of participating centers, and supplier-reported data. RESULTS: A total of 14 662 procedures were registered from 102 hospitals, representing 39.2% of the estimated activity. The implantation rates of conventional and low-energy resynchronization pacemakers were 759 and 31 units per million population, respectively. In all, 520 leadless pacemakers were implanted, 70 with atrioventricular synchrony. The mean age at implantation was high (78.8 years), and the most frequent electrocardiographic change was atrioventricular block. There was a predominance of dual-chamber pacing mode but VVI/R single-chamber pacing was used in 19% of patients in sinus rhythm, depending on age and sex. Remote monitoring capability was present in 18.5% of implanted conventional pacemakers and 45.6% of low-energy resynchronization pacemakers, although registration in this system increased by 53% in 2020. CONCLUSIONS: In 2020, in the context of the SARS-CoV-2 pandemic, the number of implanted conventional pacemakers decreased by 8% and cardiac resynchronization therapy by 4.6%. The number of leadless pacemakers increased by 16.5%. Sequential pacing was predominant, influenced by age and sex. Home monitoring played a fundamental role as a mode of follow-up in this SARS-CoV-2 pandemic year.

Spanish Pacemaker Registry. 17th Official Report of the Section on Cardiac Pacing of the Spanish Society of Cardiology (2019).

INTRODUCTION AND OBJECTIVES: This report describes Spanish cardiac pacing activity during 2019: quantities and types of devices and demographic and clinical factors. METHODS: The analysis is based on data obtained from the European Pacemaker Patient Identification Card, data submitted to the online platform cardiodispositivos.es, and supplier-reported data on the total number of implanted pacemakers. RESULTS: Information was received on 15 833 procedures from 102 implantation centers, representing 39% of the estimated total activity. The implantation rates of conventional and resynchronization pacemakers were 832 and 32 units per million population, respectively. A total of 431 leadless pacemakers were implanted. Most implantations were performed in elderly patients (mean age, 78.7 years). Most electrodes were bipolar and with active fixation and 34.1% were magnetic resonance imaging-compatible. Atrioventricular block was the most common electrocardiographic abnormality. Dual-chamber sequential pacing predominated; nonetheless, up to 20% of patients in sinus rhythm received a single-chamber ventricular pacemaker, mainly those older than 80 years of age and women. Remote monitoring capability was present in 41% of cardiac resynchronization therapy pacemakers and in 14.8% of conventional pacemakers. CONCLUSIONS: Consumption of pacing generators increased by 1.6%, mainly due to a 15.1% increase in cardiac resynchronization therapy pacemakers. Sequential pacing predominates; its use is influenced by age and sex. Remote monitoring increased by 20.6% in cardiac resynchronization therapy pacemakers and continues to be scarce in conventional pacemakers.

Spanish Pacemaker Registry. 16th Official Report of the Spanish Society of Cardiology Working Group on Cardiac Pacing (2018).

INTRODUCTION AND OBJECTIVES: This report describes the result of the analysis of the implanted pacemakers reported to the Spanish Pacemaker Registry in 2018. METHODS: The analysis is based on the information provided by the European Pacemaker Identification Card and supplier-reported data on the overall number of implanted pacemakers. RESULTS: Information was received from 90 hospitals, with a total of 12 148 cards, representing 31% of the estimated activity. Use of conventional and resynchronization pacemakers was 825 and 77 units per million people, respectively. The mean age of the patients receiving an implant was 78.3 years, and 54% of the devices were implanted in people aged> 80 years. A total of 77.1% were first implants and 21.6% corresponded to generator exchanges. Bicameral sequential pacing was the most frequent pacing mode but was less frequently used in patients aged> 80 years and in women. Single chamber VVI/R pacing was used in 28% of patients with sick sinus syndrome and in 24.7% of those with atrioventricular block, despite being in sinus rhythm. CONCLUSIONS: The total consumption of pacemaker generators in Spain increased by 1.2% compared with 2017, mainly due to an 8.7% increase in cardiac resynchronization therapy with pacemaker generators. Selection of pacing mode was directly influenced by age and sex.

Spanish Pacemaker Registry. 15th Official Report of the Spanish Society of Cardiology Working Group on Cardiac Pacing (2017).

INTRODUCTION AND OBJECTIVES: This report describes the data reported to the Spanish Pacemaker Registry concerning the activity in cardiac pacing in 2017 in Spain. METHODS: The analysis is based on the data obtained from the European Pacemaker Identification Card and the information reported by supplier companies related to global number of implanted pacemakers. RESULTS: Information was received from 106 hospitals, with a total of 12672 cards, representing the 32.1% of the total pacing activity. Conventional pacemaker and resynchronization pacemaker rate was 820 units/million and 26 units/million inhabitants respectively. A total of 333 leadless pacemakers were implanted. The mean age was 77.9 years, predominantly men (58.5%). Most electrodes were bipolar, with active fixation and only 20% had magnetic resonance protection. Atrioventricular block was the most common electrocardiographic disturb. Most patients received bicameral sequential pacing although single chamber VVIR pacing was used in up to 21.8% of patients. Patients older than 80 years benefited less from physiological pacing and resynchronization therapy. CONCLUSIONS: Total use of pacemaker generators remains stable with respect to 2016. Age is the main factor that influences pacing mode selection, which could be improved in around 22% of patients. Leadless pacing continues to rise.

Spanish Pacemaker Registry. 14th Official Report of the Spanish Society of Cardiology Working Group on Cardiac Pacing (2016).

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.

Spanish Pacemaker Registry. Thirteenth Official Report of the Spanish Society of Cardiology Working Group on Cardiac Pacing (2015).

INTRODUCTION AND OBJECTIVES: We describe the results of the analysis of the devices implanted and conveyed to the Spanish Pacemaker Registry in 2015. METHODS: The report is based on the processing of information provided by the European Pacemaker Patient Identification Card. RESULTS: We received information from 111 hospitals, with a total of 12 555 cards, representing 32.1% of all the estimated activity. The use of conventional generators and resynchronization devices was 820 and 73 units per million population, respectively. The mean age of the patients receiving an implantation was 77.7 years, and more than 50% of the devices were implanted in patients over 80 years of age. Overall, 58.6% of the implants and 58.8% of the replacements were performed in men. All of the endocardial leads employed were bipolar, 81.5% had an active fixation system, and 16.5% were compatible with magnetic resonance. Although dual chamber sequential pacing continues to be more widespread, pacing with VVI/R mode is used because up to 23.8% of the patients with sinus node disease are in sinus rhythm, as are 24.1% of those with atrioventricular block. CONCLUSIONS: The total use of pacemaker generators in Spain has increased by about 5% with respect to 2014. The majority of the leads implanted are of active fixation, and less than 20% are protected from magnetic resonance. The factors directly related to the selection of pacing mode are age and sex. In around 20% of patients, the choice of the pacing mode could be improved.

Spanish Pacemaker Registry. Twelfth Official Report of the Spanish Society of Cardiology Working Group on Cardiac Pacing (2014).

INTRODUCTION AND OBJECTIVES: This report describes the results of the analysis of pacemaker implant and replacement data submitted to the Spanish Pacemaker Registry in 2014, with special reference to pacing mode selection. METHODS: The report is based on the processing of information provided by the European Pacemaker Patient Identification Card. RESULTS: Information was received from 117 hospitals, with a total of 12 358 cards, representing 34% of estimated activity. Use of conventional generators and resynchronization devices was 784 and 64.4 units per million population, respectively. The mean age of patients receiving an implant was 77.3 years. Men received 59% of implants and 56.4% of replacements. Most patients receiving generator implants and replacements were in the age range 80 to 89 years. Most endocardial leads used were bipolar, and 84.2% had an active fixation system. Pacing was in VVI/R mode despite being in sinus rhythm in 24.7% of patients with sick sinus syndrome and 24% of those with atrioventricular block. CONCLUSIONS: The use of pacemaker generators and resynchronization devices per million population continued to increase. Most implanted leads had active fixation and approximately 20% had magnetic resonance imaging protection. Age and sex directly influenced pacing mode selection, which could have been improved in more than 20% of cases.

Spanish Pacemaker Registry. Eleventh official report of the Spanish Society of Cardiology Working Group on Cardiac Pacing (2013).

INTRODUCTION AND OBJECTIVES: The present report summarizes the analysis of pacemaker implantation and replacement data sent to the Spanish Pacemaker Registry in 2013, with specific discussion of pacing mode selection. METHODS: This study was based on information obtained from the European Pacemaker Patient Identification Card. RESULTS: Information was received on 118 hospital centers, with a total of 12 831 cards, or 35% of the estimated activity. There were 755 and 58.1 conventional and resynchronization devices per million population, respectively. The mean age of patients receiving an implant was 77.4 years. Men received 59.5% of first implantations and 56.6% of replacements. Most implantations and generator replacements were performed in patients older than 80 years. Almost all endocardial leads used were bipolar, and 78.7% of leads had an active fixation mechanism. Despite being in sinus rhythm, 24% of patients with sick sinus syndrome and 25% of those with atrioventricular block were paced in VVIR mode. CONCLUSIONS: The use of pacemaker generators and resynchronization devices per million population continues to increase in Spain. Active fixation mechanisms predominate for leads but just 20% of leads are compatible with magnetic resonance imaging. The factors influencing the correct selection of pacing mode were age and, to a lesser extent, the type of atrioventricular block, and sex. Implementation of home monitoring of pacemakers remains low.

[Progress in cardiac pacing]. / Novedades en estimulación cardiaca.

This review discusses the utility and current status of remote monitoring in patients with cardiac devices in Spain, the different anticoagulation strategies used during device implantation, the surgical replacement and maintenance of pacemakers and defibrillators, and the present and future importance of impedance sensors in cardiac pacing and heart failure management. Finally, there is a summary of the most relevant scientific articles published in the last year.

[Progress in cardiac pacing]. / Novedades en estimulación cardiaca.

This review summarizes recent scientific developments in ambulatory monitoring and its legal implications in appropriately selected patients. It also considers how new cardiac pacing devices can be used in the clinical monitoring of atrial fibrillation, sleep apnea and, in transplant patients, heart failure and transplant rejection. In addition, the system of accreditation for cardiac pacing services in Spain is outlined, with a focus on process development and quality indicators. Finally, the scientific articles on cardiac pacing that made the greatest impact in 2007 are summarized.

[Ten years' experience in continuous intravenous epoprostenol therapy in severe pulmonary arterial hypertension]. / Experiencia de 10 años en el tratamiento con epoprostenol en perfusión intravenosa continua en hipertensión pulmonar arterial grave.

INTRODUCTION: Primary pulmonary hypertension and its associated forms is a progressive and often fatal disease, the course of which has been favourably modified by prostacyclin therapy in the last decade. OBJECTIVE: The aim of this study is to analize retrospectively the efficacy of continuous intravenous epoprostenol (synthetic prostacyclin) therapy in pulmonary arterial hypertension, and to compare it with conventional therapy (anticoagulants, digoxin and diuretics). METHODS: Between 1990-2000, 31 patients with severe precapillary pulmonary hypertension in functional class III or IV went on continuous intravenous epoprostenol therapy, administered by a portable infusion pump through a Hickman catheter. We compared their survival with a group of 16 patients treated with conventional therapy alone. RESULTS: Time of follow-up was 33.25 months in the prostacyclin group and 20 months in the conventional group. The one- three- and five- year survival rates were 86%, 50% and 38% respectively for patients treated with epoprostenol compared with 40%, 40% and 8% survival rates at idetical periods for patients treated conventionally (p = 0,02). Functional class and the mean distance walked in the 6 minutes test were improved in patients treated with prostacyclin (p < 0,01). Serious complications attributable to the delivery system included 3 deaths, mainly due to infection. CONCLUSION: Continuous intravenous epoprostenol therapy improves survival and exercise capacity in patients with severe pulmonary arterial hypertension despite potentially serious complications attributable to the delivery system.