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.

Repeat cryoablation as a redo procedure for atrial fibrillation ablation: Is it a good choice?

BACKGROUND: Ablation of atrial fibrillation (AF), both cryoablation ablation (CBA) and radiofrequency catheter ablation (RFCA), have demonstrated to be safe and effective. About 1 in 3 patients may face a redo due to recurrence and the best technique is unknown. The aim of this study is to assess the efficacy of CBA as a repeat procedure in patients with prior CBA or RFCA. METHODS: A nation-wide CBA registry (RECABA) was analyzed and patients were compared who had previously undergone CBA (Prior-CB) or RFCA (Prior-RF). The primary endpoint was AF recurrence at 12 months after a 3-month blanking period. A survival analysis was performed, univariate and multivariate Cox models were also built. RESULTS: Seventy-four patients were included. Thirty-three (44.6%) were in the Prior-CB group and 41 (55.4%) in the Prior-RF. There were more reconnected pulmonary veins in the Prior-RF than in Prior-CB group (40.4% vs.16.5%, p = 0.0001). The 12-month Kaplan-Meier estimate of freedom from AF recurrence after the blanking period was 61.0% (95% confidence interval [CI] 41.4-75.8%) in the Prior-CB, and 89.2% (95% CI 73.6-95.9%) in the Prior-RF group (p = 0.002). Multivariate Cox regression pointed Prior-CB as the sole independent predictor of AF recurrence, with an adjusted HR of 2.67 (95% CI 1.05-6.79). CONCLUSIONS: Repeat CBA shows higher rates of AF recurrences compared to CBA after a previous RFCA despite presenting less reconnected veins at the procedure. These data suggest that patients with AF recurrence after CBA may benefit from other ablation techniques after a recurrence. RECABA is registered at clinicaltrials.gov with the Unique Identifier NCT02785991.

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 catheter ablation registry. 21st official report of the Heart Rhythm Association of the Spanish Society of Cardiology (2021).

INTRODUCTION AND OBJECTIVES: The results of the 2021 Spanish catheter ablation registry are presented. METHODS: Data collection was carried out retrospectively by filling in and sending a specific form by the participating centers. RESULTS: Data from 93 centers (65 public, 28 private) were analyzed. A total of 17941 ablation procedures were reported with a mean of 193 ± 133 cases per centre. Recovery of activity from SARS-CoV-2 pandemic lockdown has led to a notable increase in the number of procedures (+2772 procedures, +18%) despite a small decrease in participating centers (4 centers less than in 2020). Atrial fibrillation ablation continues to be the leading procedure, with 5848 procedures (32,6%). Together with ablation of the cavotricuspid isthmus (3766; 21%) and atrioventricular nodal reentrant tachycardia (3132; 17,5%) they constitute the 3 most frequently approached substrates. The total success rate reported (94%) is similar to previous years with a similar rate of complications (2%) and mortality (0.07). A total of 401 procedures were performed in pediatric patients (3,8%). CONCLUSIONS: The Spanish catheter ablation registry systematically and continuously collects the national activity, which has recovered significantly from the SARS-CoV-2 pandemic impact in 2020. Success rate for 2021 remains high, with a low complication rate.

[Spanish catheter ablation registry. 21st official report of the Heart Rhythm Association of the Spanish Society of Cardiology (2021)]. / Registro español de ablación con catéter. XXI informe oficial de la Asociación del Ritmo Cardiaco de la Sociedad Española de Cardiología (2021).

Introduction and objectives: The results of the 2021 Spanish catheter ablation registry are presented. Methods: Data collection was carried out retrospectively by filling in and sending a specific form by the participating centers. Results: Data from 93 centers (65 public, 28 private) were analyzed. A total of 17941 ablation procedures were reported with a mean of 193 ± 133 clases per centre. Recovery of activity from SARS-CoV-2 pandemic lockdown has led to a notable increase in the number of procedures (+2772 procedures, +18%) despite a small decrease in participating centers (4 centers less than in 2020). Atrial fibrillation ablation continues to be the leading procedure, with 5848 procedures (32,6%). Together with ablation of the cavotricuspid isthmus (3766; 21%) and atrioventricular nodal reentrant tachycardia (3132; 17,5%) they constitute the 3 most frequently approached substrates. The total success rate reported (94%) is similar to previous years with a similar rate of complications (2%) and mortality (0.07). A total of 401 procedures were performed in pediatric patients (3,8%). Conclusions: The Spanish catheter ablation registry systematically and continuously collects the national activity, which has recovered significantly from the SARS-CoV-2 pandemic impact in 2020. Success rate for 2021 remains high, with a low complication rate.

Interregional variability in the use of cardiovascular technologies (2011-2019). Correlation with economic indicators, admissions, and in-hospital mortality.

INTRODUCTION AND OBJECTIVES: Equal opportunities to access technical advances with recognized clinical value should be a priority of the publicly-funded health system. We analyzed variability among all the Spanish autonomous communities in the use of cardiovascular techniques with an established indication and its relationship with economic indicators, burden of disease, and hospital mortality. METHODS: The activity registries of various Associations of the Spanish Society of Cardiology from 2011 to 2019 were analyzed for coronary angiography, overall percutaneous coronary intervention (PCI), primary PCI, implantable cardioverter-defibrillators (ICD), cardiac resynchronization therapy, and transcatheter aortic valve replacement (TAVR). Economic indices (gross domestic product and per capita health care expenditure) were obtained from public sources and data on attendance rates and mortality from the Resources and Quality in Cardiology (RECALCAR) reports of the Spanish Society of Cardiology. We analyzed the coefficient of variation for activity and the correlation of activity with regional economic indices, attendance rates, and risk-adjusted rates of in-hospital mortality. RESULTS: We identified wide variability in the use of technologies, especially for primary PCI (18%), ICD (22%), cardiac resynchronization therapy (36%), and TAVR (42%). A certain correlation with attendance rates was seen only for overall PCI and ICD. In general, no significant correlation was found between the use of the techniques and the economic indices of wealth and expenditure. The correlation with in-hospital mortality showed no significant results, although this was the analysis with the greatest limitations because the impact of these techniques on survival is exerted more in the mid- and long-term. CONCLUSIONS: The results of this study, despite its inherent limitations, show marked variability between autonomous communities in the use of cardiovascular technologies, which is not explained by economic differences or by hospital attendance rates due to the corresponding diseases.

Spanish Catheter Ablation Registry. 20th Official Report of the Heart Rhythm Association of the Spanish Society of Cardiology (2020).

INTRODUCTION AND OBJECTIVES: This article reports the results of the 2020 Spanish Catheter Ablation Registry, a year marked by the SARS-CoV-2 pandemic. METHODS: Data were collected retrospectively through completion and return of a specific form by the participating centers. RESULTS: Data from 97 centers (67 public, 30 private) were analyzed. A total of 15 169 ablation procedures were reported with a mean of 155±117 and a median [interquartile range] of 115 [62-227]. Because of the SARS-CoV-2 pandemic, both procedures and participating centers markedly decreased (-3380 procedures,-18%) and there were 5 centers less than in 2019. The most common procedure continued to be atrial fibrillation ablation (4513; 30%), well ahead of the remaining substrates, followed by ablation of the cavotricuspid isthmus (3188; 21%), and intranodal re-entry tachycardia (2808; 18%). Ablation of these 3 substrates continued to form the bulk of the procedures. The total success rate was slightly lower than in previous years (88%) with a similar complication rate (n=309; 2%) and mortality (n=7; 0.04%). A total of 243 procedures were performed in pediatric patients (1.6%). CONCLUSIONS: The Spanish Catheter Ablation Registry systematically and continuously reflects the national trajectory, which, in 2020, was markedly affected by the SARS-CoV-2 pandemic. Although slightly lower than in previous years, the success rate remained high, with a low complication rate.

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 Catheter Ablation Registry. 20th Official Report of the Heart Rhythm Association of the Spanish Society of Cardiology (2020)]. / Registro Español de Ablación con Catéter. XX Informe Oficial de la Asociación del Ritmo Cardiaco de la Sociedad Española de Cardiología (2020).

INTRODUCTION AND OBJECTIVES: This article reports the results of the 2020 Spanish Catheter Ablation Registry, a year marked by the SARS-CoV-2 pandemic. METHODS: Data were collected retrospectively through completion and return of a specific form by the participating centers. RESULTS: Data from 97 centers (67 public, 30 private) were analyzed. A total of 15 169 ablation procedures were reported with a mean of 155 ± 117 and a median [interquartile range] of 115 [62-227]. Because of the SARS-CoV-2 pandemic, both procedures and participating centers markedly decreased (-3380 procedures, -18%) and there were 5 centers less than in 2019. The most common procedure continued to be atrial fibrillation ablation (4513; 30%), well ahead of the remaining substrates, followed by ablation of the cavotricuspid isthmus (3188; 21%), and intranodal re-entry tachycardia (2808; 18%). Ablation of these 3 substrates continued to form the bulk of the procedures. The total success rate was slightly lower than in previous years (88%) with a similar complication rate (n = 309; 2%) and mortality (n = 7; 0.04%). A total of 243 procedures were performed in pediatric patients (1.6%). CONCLUSIONS: The Spanish Catheter Ablation Registry systematically and continuously reflects the national trajectory, which, in 2020, was markedly affected by the SARS-CoV-2 pandemic. Although slightly lower than in previous years, the success rate remained high, with a low complication rate.Full English text available from:www.revespcardiol.org/en.

The RITHMI study: diagnostic ability of a heart rhythm monitor for automatic detection of atrial fibrillation.

INTRODUCTION AND OBJECTIVES: Early detection of atrial fibrillation (AF) is a priority to reduce embolic events by initiating oral anticoagulation therapy. The aim of this study was to evaluate the diagnostic ability of a wrist device designed for automatic AF detection. METHODS: RITHMI is a prospective, comparative, observational study that included 167 patients referred to a cardiology outpatient clinic for a general consultation or for electrical cardioversion. The study evaluated the ability of a wrist monitor that uses a photoplethysmography (PPG) signal and an electrocardiographic lead to automatically detect AF compared with diagnosis established by 2 cardiologists using the 12-lead electrocardiogram. RESULTS: The AF detection algorithm based on the PPG signal had a sensitivity of 91% and a specificity of 96% (diagnostic accuracy: 93%). The automatic algorithm based on the electrocardiographic signal had a sensitivity of 94% and a specificity of 96% (diagnostic accuracy: 95%). The 2 algorithms concurred in the diagnosis in 96% of the cases. Overall, the monitor had a sensitivity and specificity of 95% (diagnostic accuracy: 95% and Kappa index: 0.98). CONCLUSIONS: This study shows that automatic AF detection through the use of a heart rhythm monitor incorporating sensors and algorithms that analyze the PPG signal and the electrocardiographic signal corresponding to lead I is feasible and has high diagnostic accuracy.

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.