Since 1990, the Spanish National Pacemaker Data Bank has collected data on cardiac pacing activity in Spain and annually published this information in Revista Española de Cardiología as a report of the Spanish Pacemaker Registry.1–17 In the current document, the Cardiac Pacing Section of the Spanish Society of Cardiology reports the activity corresponding to 2019 and compares the results with those of previous years and with those reported by our neighboring countries. The information recorded includes demographic characteristics, procedure and implanted device data, and data concerning the remote monitoring of devices.

Three sources of information were used to prepare the registry: the European Pacemaker Patient Identification Card (EPPIC), the databases of the centers themselves, and the online CardioDispositivos.es platform,18 launched in January 2019 in collaboration with the Spanish Agency of Medicines and Medical Devices to centralize and homogenize the information concerning pacemakers and defibrillators, as well as to optimize the monitoring of these health care products.

Despite the abovementioned sources, data have not been obtained on 100% of the activity performed and we thus use the information provided by the device suppliers to obtain the complete data on devices implanted. In addition, this information is checked against the data published by the European Confederation of Medical Suppliers Association (Eucomed).19

Implantation rates were calculated based on the demographic data published by the Spanish National Institute of Statistics as of July 1, 2019.20

The sample obtained in the 2019 registry was larger than in previous years, with 3685 records more than in 2018, improving its representativeness and reliability. Nonetheless, this aspect shows room for improvement, and we at the Spanish Pacemaker Registry ask that implantation centers report their data via the online platform to increase the homogeneity and sample size, improve its quality, and permit the use of a single source of information. It is worth highlighting the difficulty encountered this year in the analysis and interpretation of the data because the information came from various sources.

In 2019, the number of conventional pacemakers implanted increased by 1.6%, maintaining the trend of the previous year. Nonetheless, the pacemaker rate (837/million population according to Eucomed) is still lower than the European average (963/million). As in previous years, the European rate is heavily impacted by countries with more than 1000 units/million population, such as Germany, Finland, and Italy.19 We do not know the causes of the variability in implantation rates among countries, although possible reasons include the different health system structures and management modalities found in our neighboring countries, as well as the social and demographic factors specific to each geographical area.

The CRT-T figure has increased by 11.6%, a notable increase given that its use increased by just 3.1% in 2018. This growth has mainly been due to CRT-P devices (15.1% vs 9.6% for CRT-D), which progressively represent a higher percentage of CRT-Ts, specifically 37.7% in 2019, with a CRT-D/CRT-P ratio of 1.6. Taking data from the European CRT survey, this ratio varies among European countries, with CRT-Ps reaching 88% of CRT-Ts in countries such as Bulgaria and close to 50% in Germany, Denmark, and Sweden. The CRT-P rate obtained in the present registry and according to Eucomed was 32 units/million population, lower than the European average (59/million) and only higher than that of Poland and Greece, as in previous years. The recent publication of the results in Spain of the European Society of Cardiology survey on cardiac resynchronization therapy (CRT Survey II) has shed light on the profile of CRT patients and revealed a lower proportion of patients older than 75 years and a higher proportion of patients with nonischemic dilated cardiomyopathy, in functional class II, and with electrocardiogram-documented left bundle branch block in relation to other European countries, which probably indicates a better selection of candidates for this therapy.23

Leadless pacing maintained a modest growth rate (15% this year), similar to that of previous years. It was found in 7.7% of all single-chamber devices implanted, which indicates its continuing underuse, because the percentage of potential candidates for this pacing type is much higher. Strikingly, the number of autonomous communities that do not implant leadless pacemakers has increased to 5. The recent release on the market of new leadless pacemakers capable of atrial detection will allow the indications for this pacing mode to be extended to other patient groups, suggesting a possible increase in its use in the coming years.

Regarding preimplantation electrocardiography, AVB continues to be the most frequent disorder, with 60.6% of cases, followed by SSS with 28.4%. At the time of implantation, 18.4% of patients had AF.

In 2019, information could be provided on tetrapolar leads implanted in the coronary sinus, due to their inclusion in the platform, and they represented 73.4% of leads entered into this database, a figure similar to that reported in the European survey on CRT (CRT Survey II).23 In addition, the number of magnetic resonance-compatible leads increased to 34.1% (22.9% in 2018), in all age groups, with slightly higher values for the ventricle than the atrium (37.6% vs 23.9%). The importance of the extensive use of this type of material should be highlighted, given the increasingly frequent use of this imaging technique in elderly patients.

In AVB, the percentage of pacing with AV synchrony remained stable and continues to predominate (74.3%), whereas the use of VDD/R mode in this context is clearly falling (9.4%). In general, the use of VVI/R mode remained stable at 24.2% but once again reached 40.2% of all devices in patients older than 80 years. Similarly, pacing that maintains AV synchrony reached 88.2% in patients aged ≤ 80 years, whereas it represented just 58.8% in those over 80 years, which again confirms that age is a fundamental determinant of pacing mode. The lack of data on parameters such as cognitive level, frailty, dependence, and functional class has prevented a more detailed analysis of the possible causes of this discordance between the theoretically indicated pacing mode and that implanted. VDD mode continues to be much more common in patients older than 80 years (13.7%) than in those ≤ 80 years (5.3%).

The most notable finding in IVCDs is the fall in the use of VVI/R mode, which drops to 21.8%. DDD/R mode continues to predominate (58.7%). Biventricular pacing (CRT-P) increased again after declining in 2018, reaching 20% of all implants in the group of patients younger than 80 years.

In patients with SSS in permanent atrial tachyarrhythmia, the most frequently used mode is VVI/R, representing 92.4% of all devices implanted. In patients with SSS in sinus rhythm, DDD/R mode still predominates (70.4%). Age also influences the choice of pacing mode in this group of patients, with higher use of VVI/R mode in older patients (39.8%) than in those younger than 80 years (17.1%). AAI/R mode continues to be rare, in line with the recommendations of clinical practice guidelines and as a result of the findings of the DANPACE study, which showed a 0.6% to 1.9% rate of AVB development in patients with SSS.24 Clinical practice guidelines recommend DDD/R mode in SSS patients due to its ability to reduce the incidence of AF and strokes, as well as that of pacemaker syndrome.22

Notable findings in remote monitoring include the 20.6% increase in CRT-P monitoring (41% of CRT-P devices had remote monitoring capabilities). However, the percentage of pacemakers included in such programs continues to be insufficient, given their improved early detection of events, reduction in face-to-face visits, and cost-effectiveness.25 The need to optimize resource use at the organizational level involved and more limited evidence concerning the benefits of pacemakers vs implantable cardioverter-defibrillators and CRTs may be some of the reasons for their low implementation. Regarding the distribution of remote monitoring by autonomous community (excluding the data related to the Merlin system, due to unavailability), La Rioja, the Canary Islands, and the Basque Country stand out, with more than 50% of devices implanted included in remote monitoring programs, compared with communities with poor adherence, such as the Basque Country and Cantabria, with less than 10%. In the context of the current pandemic, and given the need for health care restructuring to reduce face-to-face visits, the Cardiac Pacing Section of the Spanish Society of Cardiology champions remote monitoring as the principal follow-up method for patients with cardiac pacing devices.26

The number of pacemakers implanted increased in 2019 by 2.1%, largely due to growth in CRT-P devices (15.1%). The steady increase in leadless pacemakers continues, but huge variations are evident among autonomous communities. Sequential dual-chamber pacing predominates, and age and sex influence the choice of pacing mode. Notable findings include the low implementation of remote monitoring in the pacemaker population, the preferred follow-up approach in the current circumstances. In addition, increased use of the online platform CardioDispositivos.es is necessary to improve registry quality.

None declared.