The Spanish Pacemaker Registry was created with the object of establishing a record of pacemakers implanted in Spain, which would allow us to have updated information on all the aspects related to implantation, the creation of a census of patients with pacemakers (an information that makes control easier and the vigilance of these products) and the preparation of statistical analysis for the different factors collected. The first official report of the Spanish Pacemaker Registry was written in 19971 and, since then, it has been published every year and is an annual report of the data related to pacemakers implanted in Spain the previous year.2–14 The present report offers the cardiac pacing activity undertaken in 2015, in hospitals in Spain, and compares it with that carried out in previous years and with that performed in other countries of our vicinity.15

The Spanish Pacemaker Registry is supplied by information obtained from 3 sources: the European Pacemaker Patient Identification Card (EPPIC), manufacturers who distribute the devices, and the Spanish National Institute of Statistics (Instituto Nacional de Estadística [INE]).

A first aspect that should be brought to light in the analysis of data for the registry is the percentage of data lost in the different parameters studied. Although the information provided by the registry is probably representative of the pacing activity done in Spain, although it is also certain that an area for improvement could be a better implementation of the data sent to a given registry. Along these lines, we are sure that an online application could certainly result in an advance in the quality of data collection and interpretation.

The total consumption of pacemaker generators in Spain grew by 5% with respect to 2014, and the trend observed in recent years is maintained. In fact, the change is greater than that registered for 2014 (from 1.1% with regard to 2013).14 If we take into account, the constant decline of the Spanish population, the increase in the number of implants could be explained by the aging of the population, with a mean age at the time of implantation of 77.7 years. The progressive financial recovery may have influenced this growth. The number of pacemakers (excluding CRT-P) per million population also increased from 820 units/million, a rise of 36/million more than in the previous year. Concerning the countries that send data to Eucomed, Spain continues to fall below the European average (954 units/million), in accordance with the lower per capita health cost than in countries in northern and western Europe, such as, Germany, Belgium, or France.17 However, there may even be other reasons, aside from economics, to explain, the disparity in the implantation rates among different countries, as some, like the United Kingdom, Denmark, Norway, or The Netherlands, present a lower number of implants per million population than Spain, despite the larger gross national income and greater health care spending. Other causes may be the lack of a labor supply, resources, or training programs, and a lower incidence of the diseases for which implantation is indicated and low rates of referral.

Regarding the findings for CRT-T, a proposal in 2015 is an increase of 12.7% with respect to 2014 (8 units/million), which would likewise affect high- and low-energy. The ratio of CRT-D and CRT-P is 2.2, with 50 CRT-D units/million and 23 CRT-P units/million population. Despite, the increase, in CRT, Spain remains under the European average in the rate of implants (45 CRT-P units/million and 126 CRT-D units/million in the European countries evaluated in Eucomed).

We also describe, as in other years,5–14 the disparity in the incidence of implants observed in Spanish autonomous communities. The most probable causes are the variations in the mean age of each population, the distinct health structures that are implicated in the differences in the density of arrhythmia units and heart failure units, as well as the rates for patient referral, the different situations and economic managements. More pacemakers are implanted in Galicia, Principality of Asturias, and Castile and León, probably because their populations are older. In contrast, there are more CRT devices implanted in Cantabria, the Chartered Community of Navarre, the Valencian Community, and Extremadura.

There is still a larger percentage of implantation among men, possibly because they are more predominant in this group of AVB and AF with bradycardia. Somewhat more than half of the implants are performed in patients over 80 years.

With respect to the type of lead implanted, most are bipolar, both in atrial and ventricular position. Unipolar electrodes are employed to pace left ventricle via the coronary sinus, although, in general, most of the electrodes implanted for this purpose are bipolar (64.3%). The registry does not collect the increasingly widespread use of quadripolar leads in the coronary sinus, which make it possible to choose, among the multiple electronic configurations, that which will have the best electrical behavior (the best pacing threshold) and without phrenic pacing.22 The majority of the leads are for active fixation systems (81.5%), both in atrium and ventricle, making it possible to place the leads at sites alternative to the apex of the right ventricle and atrial appendage, looking for a more physiological pacing pattern. Long-term pacing in right ventricular apex has detrimental effects on ventricular function and increases the incidence of AF and heart failure.

The use of leads compatible with MRI was less significant than even a year ago, which is not explicable if it is not taken into account that most manufacturers offer this feature as a protection against radiation of this type. In the oldest patients, the use of these leads is even less widespread. It could be that the greater cost of compatible generators, usually at the high-end of the price range, also limits the use of leads compatible with this technique. The incidence of compatible generators implanted is unknown, a fact that we hope to ascertain with the introduction of the online application. The more generalized use of MRI and the progressively more advanced age of the population to benefit from studies of this type make the extensive use of systems compatible with this radiological technique necessary.23

As occurred with anterior years, the most frequent electrocardiographic alteration prior to implant continues to be AVB, mainly in detriment to third degree AVB. The most widespread pacing mode in this setting, is still synchronous with the atrium (75.9%). Pacing with DDD/R mode continues growing with respect to previous years (62.1%), and we observe that the findings for the utilization of VVI/R remain steady (24.1%), whereas the percentage of the use of VDD/R mode (13.8%) keeps on declining. Age continues to be a determining factor when the time comes to decide the pacing mode in this context. In this manner, the majority of the patients under 80 years with AVB receive DDD/R pacing, whereas 40% of those over 80 years are receiving single-chamber pacing. Likewise, VDD/R pacing mode to maintain atrioventricular synchrony is used most frequently in individuals over 80 years (18.6% vs 10.3%), although we note that it has declined in both age groups with respect to previous years.

In SSS, the pacing mode based on the atrium continues to be the most widespread approach, with predominance of DDD/R mode (71.9%), as proposed by current clinical practice guidelines.18 We observe that VVI/R mode continues to be utilized in 23.8% of all the cases of SSS, although its use continues to decline with respect to previous years. Once again, age influences the selection of the pacing mode in SSS, as well. Thus, single-chamber VVI/R is more frequent among patients over 80 years (36.3%) and in bradycardia-tachycardia type SSS (38.9%), possibly because of the risk of permanent AF in a near future or because the individual has been erroneously included in the group of patients with permanent slow-fast AF. In any case, as recommended by current guidelines, DDD/R pacing is the most recommendable mode in SSS, mainly because of its positive effect by decreasing the rate of AF and stroke, and the reduced risk of pacemaker syndrome, which can deteriorate patient quality of life. Pacing with AAI/R mode continues to decline in accordance with current clinical practice guidelines, based on the results of the DANPACE study24 and the disadvantage offered by this pacing mode, taking into account que, each year, 0.6%-1.9% of the patients with SSS develops AVB. In atrial tachyarrhythmia with a slow ventricular response, the most widespread mode is VVI/R.

In intraventricular conduction defects, DDD/R pacing is the mode most frequently utilized (56.3%), followed by VVI/R (23.2%). Age again influences the selection of pacing mode, with a greater use of DDD/R mode in patients under 80 years, 6.8% of whom receive single-chamber pacing. Pacing mode VDD/R is utilized with less frequency and with no differences related to age. Pacing with CRT-P has increased over the past year in this group of patients, becoming 14.2% of the procedures with this electrocardiographic indication, reaching 21.6% in patients under 80 years, and is much less utilized (8.8%) among those over 80 years.

For the first time, the Spanish Pacemaker Registry includes data on leadless pacemaker implants. A total of 77 units were implanted during 2015.21 We observe that those implants were performed in only 9 Spanish autonomous communities. From the point of view of the physician, there are still very few indications for the implantation of devices of this type. Moreover, the present cost of this technology is much greater than that of the conventional single-chamber pacemaker. Thus, health administrators for each autonomous community have also had to establish a series of limitations to their use. These limitations will also probably be reduced over the next few years and, we will witness a progressive growth in leadless pacemaker implantations.

Home monitoring continues to have little application in pacing units, despite the growing evidence of the benefits of this follow-up system.25 There may be organizational and economic questions that introduce limitations for its generalized use.

There is still an increase in the incidence of conventional pacemaker and CRT-P implants, despite the fact that Spain continues below the average of our neighboring countries. Age is the major factor determining the pacing mode, which is unsuitable in approximately 20% of the cases of patients with AVB and SSS. Leadless pacing is an incipient in Spain, but promising, and its efficacy and safety will require the necessary long-term studies.

None declared.