The national pacemaker data bank was created in 1990 to record cardiac pacing activity in Spain. The registry provides updated information on all aspects related to pacemaker implantation in order to take a census of patients with pacemakers and to statistically analyze various factors. The activity data of the previous year are published annually in Revista Española de Cardiología.1–16 The current report provides information on the pacemakers implanted in 2017, the profiles of the patients with such devices, and the trends and compares the results with those of neighboring countries

This report was prepared by the Spanish Pacemaker Registry based on the information provided by the European Pacemaker Patient Identification Card (EPPIC) submitted by the implantation centers. Because cards are not received for all implanted devices, the device suppliers also report the total numbers of generators implanted (pacemaker generators and high-energy [CRT-D] and low-energy [CRT-P] cardiac resynchronization therapy [CRT] devices), both in Spain as a whole and by autonomous community). This information is checked against that of Eucomed (European Confederation of Medical Suppliers Association)17 and the annual report published by the EHRA (European Heart Rhythm Association) on implantable electronic devices.18

The population data of the Spanish National Institute of Statistics on July 1, 2017 were used to calculate the rates per million population.19

This work includes cards corresponding to 12 672 procedures from 106 centers, with a total of 12 634 implanted generators (Table 1). According to the information provided by the industry, this number accounts for 32.1% of all devices in 2017, a figure similar to that of previous years.

As in previous years, the quality of the sample continues to show room for improvement, given that only 106 centers provided EPPIC data (fewer than in previous years) and that a considerable percentage of data is lost or missing from the cards. For this reason, implementation of the smartphone application designed in conjunction with the Spanish Agency of Medicines and Medical Devices is important, as well as its extensive use in implantation centers, which would increase the size of the sample, as well as its reliability and representativeness.

During 2017, the use of pacemaker generators was practically unchanged vs 201616 (–0.3% according to Eucomed and+0.4% according to the Spanish Pacemaker Registry), which breaks with the upward trend of previous years. However, the increase in the number of implanted devices had already slowed down in 2016, after a 5% increase in generator implantation in 2015. This lack of growth affected both conventional pacemakers and CRT-P devices. The implantation rate recorded by the Spanish Pacemaker Registry was 820 units/million population, lower than the European average (949 units/million population). Nonetheless, this European average is affected by the high rate of implantations in countries such as Germany, Belgium, Italy, and Finland, which exceed 1000 units/million population. The economic factor cannot be considered the sole determinant of this difference because some countries with lower implantation rates have higher per capita income and higher spending on health, such as the United Kingdom, the Netherlands, Norway, and Switzerland, whereas countries such as Greece and Portugal, with lower per capita income, have rates close to 900 and 1000 implantations/million population.17 The differences among countries may be influenced by differences in health management, availability of human resources, training programs, and even the type of funding, considering the copayment system found in some countries. It should also be noted that, after several years of progressive growth, the European average has experienced a fall vs 2016 (965 implantations/million population).

The number of CRT-T devices decreased by 4.7% vs 2016, and the rate also fell from 79 units/million population to 75. This decrease affected both CRT-P and CRT-D devices, particularly the latter (–1.1% and –6.5% in the number of devices, respectively), giving a CRT-D/CRT-P ratio of 1.9/1. CRT-P devices constituted 34.6% of cardiac resynchronization activity in Spain in 2017, and the rate has practically remained constant vs the previous year (26 units/million population). This figure is still clearly lower than the European average (53 units/million population) and is one of the lowest of the countries reporting their data to Eucomed, only exceeding Greece and Poland with 9 and 20 units/million population, respectively. Denmark, Sweden, France, and Switzerland are the countries with the highest implantation rates.17 Again, the economic factor is not the only reason for the low implantation rate in Spain because countries such as Portugal, with a lower gross domestic product and health expenditure than Spain, have a higher implantation rate (36 units/million population). Nor can the number of CRT implantation centers explain the low rate, given that Spain had an average of 2.7 centers/million population in 2016, similar to that of neighboring countries such as France, Sweden, and Portugal.18 One possible cause is an indication defect due to a lack of arrhythmia/heart failure units that act as referral centers. The SEC-Excellence project of the Spanish Society of Cardiology includes a heart failure process whose objective is to define standards for both the clinical management of patients with heart failure and the heart failure units managed by cardiology services.21 The lack of adherence to clinical guidelines may also have influenced the low rate of CRT-P device implantations.22 Age continues to be an important factor at the time of CRT-P device implantation in patients with IVCD. Although the elderly population was poorly represented in the large clinical trials that evaluated the benefit of CRT, more and more studies report a clinical benefit and improved echocardiographic parameters in octogenarian patients, with survival rates similar to or only slightly lower than the same-aged population not receiving this therapy.23

For distribution by autonomous community, those with the highest pacemaker implantation rates were Galicia, Castile and León, and Aragon (>1000 units/million population), probably because they have an older population. La Rioja is still the community with the lowest number of implantations and the Region of Murcia returns to figures before 2016 (around 600 units/million population) after a rebound last year. For CRT-P devices, as in 2016, Cantabria and the Chartered Community of Navarre stand out, with more than 50 units/million population. The differences in resynchronization rates are probably influenced by factors such as the economic climate, population age, and health system structure and organization.

Men predominate in the use of devices (58.5%), both in primary implants and in replacements, and pacemaker use continue to be a condition and a therapy characteristic of advanced age, with more than 50% of the implantations performed in elderly patients older than 80 years.

The most common electrocardiographic abnormality prior to implantation remains AVB (54.1%), particularly third-degree AVB, at 38.7%. SSS was the second most common indication, at 18.4% of all indications. Slow or blocked AF also represented a significant percentage of implantations (18.4%). Bundle branch block remains the least frequent abnormality (5.6%).

Regarding the leads implanted, practically all were bipolar, both in the atrium and in the ventricle, and also in the coronary sinus, where monopolar leads predominated until 2 years ago. The use of tetrapolar leads, already common in clinical practice because of their advantages in terms of the various electronic configurations offered, is not considered in the cards because it is possible to choose the configuration with the best electrical behavior and without phrenic stimulation. Neither is there information on multipoint pacing. Studies published in recent years have revealed the acute hemodynamic benefits of this therapy, as well as the mid- to long-term improvement in the echocardiographic parameters of asynchrony.24 Regarding the type of fixation, most implantations involved active fixation leads, both in the atrium and in the ventricle, and in all age groups. Their advantages in terms of the possibility of implantation in alternative sites, both in the atrium and in the ventricle, and their optimal electrical behavior have probably contributed to their widespread use. The use of MRI-compatible leads25 is still suboptimal, although a slight increase was observed vs 2016 (19.4% vs 16.1%). We do not know the percentage of MRI-compatible generators, but their higher cost may have resulted in low implementation.

Leadless pacing continued to grow, with 333 units in 2017, representing a 67% increase vs 2016. However, in 5 autonomous communities, this type of device is not implanted and most are implanted in just 3 (58% in Catalonia, Galicia, and the Valencian Community). Although these pacemakers are still more expensive than conventional VVI/R pacemakers, the progressive increase in the number of such implantations is due to the long-term advantages of the absence of leads in the vascular space, the greater availability of this technology, and the scientific evidence corroborating their effectiveness and mid-term safety.26

For the first time in the registry, information on pacing in the pediatric population has been provided. A total of 43 implantations were recorded in patients younger than 14 years. More than three-quarters were performed during the first year of life.

Atrial synchronous pacing continues to be the most used approach in patients with AVB, but age still determines the pacing mode in this setting.

The DDD/R mode continues to predominate in SSS, although the VVI/R mode is still used in 27.2% of cases, slightly more than in the previous year, and age is still a fundamental factor when the pacing mode is being chosen for these patients. Thus, single-chamber VVI/R pacing is more frequent in patients older than 80 years and with bradycardia-tachycardia-like SSS, possibly due to the risk of a near-future fall in those with permanent AF or because patients with slow-fast permanent AF have been mistakenly included in this group. In any case, as recommended by the current guidelines, the DDD/R mode is the most suitable for SSS, mainly due to its ability to reduce the incidence of AF and stroke and the risk of pacemaker syndrome that can impair patients’ quality of life. AAI/R pacing mode has declined again, in accordance with the current clinical practice guidelines, based on the results of the DANPACE trial27 and the drawbacks of this pacing mode, given that 0.6% to 1.9% of patients with SSS develop AVB each year. In atrial tachyarrhythmia with a slow ventricular response, the predominant mode is still VVI/R.

During 2017, 12.4% of conventional pacemakers and 24% of CRT-P pacemakers were included in a remote monitoring program. These percentages are similar to those reported the previous year but lower than those of the last EHRA report on the implementation and financing of remote monitoring in Europe (22% of conventional pacemakers and 69% of CRT-Ts).28 Funding is the main limitation perceived by implantation centers surveyed on the implementation of remote monitoring. Taking into account the demonstrated benefit of remote monitoring in terms of the detection and early treatment of clinical and technical events in patients with devices, the application of this technological advance in Spain should be considered insufficient.

During 2017, the number of implanted pacemakers remained stable, with a slight decrease in the total number of CRT-P devices. More than 50% of implantations performed in patients older than 80 years, precisely those patients who receive a less physiological mode of pacing and with a lower rate of CRT-Ps. The use of leadless pacemakers continues to rise and these devices are consolidated as an effective and safe technique in the medium term, and the application of remote monitoring for device follow-up remains constant, despite the proven advantages. The quality of the sample needs to be improved to enable a more reliable interpretation of Spanish Pacemaker Registry data.

None declared.