Publish in this journal
Journal Information
Vol. 72. Issue 12.
Pages 1054-1064 (December 2019)
Share
Share
Download PDF
More article options
Visits
Not available
Vol. 72. Issue 12.
Pages 1054-1064 (December 2019)
Special article
DOI: 10.1016/j.rec.2019.10.002
Full text access
Spanish Implantable Cardioverter-defibrillator Registry. 15th Official Report of the Spanish Society of Cardiology Electrophysiology and Arrhythmias Section (2018)
Registro Español de Desfibrilador Automático Implantable. XV Informe Oficial de la Sección de Electrofisiología y Arritmias de la Sociedad Española de Cardiología (2018)
Visits
...
Ignacio Fernández Lozanoa,
Corresponding author
iflozano@secardiologia.es

Corresponding author: Unidad de Arritmias, Hospital Universitario Puerta de Hierro Majadahonda, Manuel de Falla 1, 28222 Majadahonda, Madrid, Spain.
, Joaquín Osca Asensib, Javier Alzueta Rodríguezc
a Servicio de Cardiología, Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Madrid, Spain
b Servicio de Cardiología, Hospital La Fe, Valencia, Spain
c Servicio de Cardiología, Hospital Virgen de la Victoria, Málaga, Spain
This item has received
...
Visits
(Daily data update)
Article information
Abstract
Full Text
Bibliography
Download PDF
Statistics
Figures (8)
Show moreShow less
Tables (4)
Table 1. Implantations by Autonomous Community, Province, and Hospital
Table 2. Number of First Implantations According to Type of Heart Disease, Type of Clinical Arrhythmia, and Form of Presentation From 2014 to 2018
Table 3. Changes in the Main Indications for Implantable Cardioverter-defibrillators (Percentages of First Implantations, 2009-2018)
Table 4. Percent Distribution of Implanted Devices by Type
Show moreShow less
Abstract
Introduction and objectives

This article presents the data corresponding to automated implantable cardioverter-defibrillator (ICD) implants in Spain reported to the Spanish Registry in 2018.

Methods

The data in this registry include both primary implants and generator replacements and were gathered from a data collection sheet voluntarily completed by implantation centers.

Results

In 2018, 6421 implant sheets were received compared with 7077 reported by Eucomed (European Confederation of Medical Suppliers Associations). This represents data on 90.7% of the devices implanted in Spain. Compliance ranged between 99.6% for the field “name of the implanting hospital” and 12.4% for “population of residence”. A total of 173 hospitals reported their data to the registry, representing a slight decrease compared with hospitals participating in 2017 (n=181).

Conclusions

After the reduction in ICD implants in 2017, the number of implants increased in 2018, with the highest number of ICDs implanted in Spain. The total number of implants remains much lower than the European Union average, with substantial differences between autonomous communities.

Keywords:
Implantable cardioverter-defibrillator
Sudden cardiac death
National registry
Abbreviations:
CRT
Eucomed
ICD
SEC
Resumen
Introducción y objetivos

Se presentan los datos correspondientes a los implantes de desfibrilador automático implantable (DAI) en España comunicados al Registro Español de Desfibrilador Automático Implantable en el año 2018.

Métodos

Los datos de este registro incluyen tanto los primoimplantes como los recambios de generador y se documentan a partir de una hoja de recogida de datos que voluntariamente cumplimentan los centros implantadores.

Resultados

En el año 2018 se recibieron 6.421 hojas de implante, frente a las 7.077 comunicadas por Eucomed (European Confederation of Medical Suppliers Associations). Esto representa datos del 90,7% de los dispositivos implantados en España. El grado de cumplimiento osciló entre el 99,6% en el campo «nombre del hospital implantador» y el 12,4% en «población de residencia». Comunicaron sus datos al registro 173 hospitales, lo que supone una ligera disminución con respecto a los que participaron en 2017 (181).

Conclusiones

El Registro Español de Desfibrilador Automático Implantable del año 2018 recoge un crecimiento en el número de implantes de DAI después de la reducción observada en 2017 y es el año en que se ha implantado un mayor número de DAI en España. El número total de implantes en España sigue siendo muy inferior a la media de la Unión Europea, con importantes diferencias entre comunidades autónomas.

Palabras clave:
Desfibrilador automático implantable
Muerte súbita
Registro nacional
Full Text
INTRODUCTION

Implantable cardioverter-defibrillator (ICD) placement is a highly effective treatment for controlling ventricular arrhythmias and the most effective treatment for preventing sudden cardiac death. ICDs continually monitor cardiac rhythm and administer a shock upon detection of tachycardia meeting the established heart rate and duration criteria. Various clinical practice guidelines list the indications for ICD therapy in patients with ventricular arrhythmias or at risk of developing them and include both primary and secondary prevention measures for sudden cardiac death.1–3 Sudden cardiac death has a huge socioeconomic impact. Although its current incidence in Spain is unknown, the estimated incidence in Europe is 400 000 deaths per year,4 with 40% occurring in individuals younger than 65 years.

The Electrophysiology and Arrhythmias Section of the Spanish Society of Cardiology (SEC) has published the Spanish Implantable Cardioverter-defibrillator Registry since 2005.5–7 This report presents the data on ICD implantation corresponding to 2018. Most Spanish centers implanting ICDs have contributed to the registry. As in other years, this article reviews the patients’ indications and clinical characteristics, implantation data, device type and programming, and procedure-related complications.

METHODS

The registry is based on information voluntarily collected by the participating centers during device implantation and concerns both first implantations and replacements. The information was entered in a database by a team comprising a technician, a SEC computer scientist, and a member of the Electrophysiology and Arrhythmias Section of the SEC. Data cleaning was performed by the technician and the first author, and all authors of this article analyzed the data and are responsible for this publication.

The census data for the calculation of rates, both national and by autonomous community and province, were obtained from the Spanish National Institute of Statistics as of January 1, 2019.8 The data from the present registry were compared with those provided by the European Confederation of Medical Suppliers Associations (Eucomed).

The percentages of each of the variables analyzed were calculated by taking into account the total number of implantations with available information on the parameter. Only the most serious condition was included if various types of arrhythmias were recorded.

Statistical Analysis

Results are expressed as mean±standard deviation or median [interquartile range], depending on the distribution of the variable. Continuous quantitative variables were analyzed using analysis of variance or the Kruskal-Wallis test, while qualitative variables were analyzed using the chi-square test. Linear regression models were used to analyze the number of implantations and devices implanted per million population, the total number of implantations, and the number of implantations for primary prevention in each center.

RESULTS

A total of 6421 implantation forms were received but 7077 procedures were reported by Eucomed; hence, data were collected on 90.7% of devices implanted in Spain. Compliance ranged from 99.6% for the field name of implantation hospital to 12.4% for the variable town of residence.

Implantation Centers

In total, 173 hospitals participated, which is a slight decrease vs 2017 (181). Data from the 173 hospitals are shown in table 1; 77 were publicly-funded health centers. Figure 1 shows the total number of implantation centers, the rate per million population, and the total number of implantations per autonomous community. In 2018, 19 centers implanted ≥ 100 devices; 82, ≤ 10; and 23, only 1.

Table 1.

Implantations by Autonomous Community, Province, and Hospital

Andalusia
AlmeríaHospital Torrecárdenas  32 
Hospital Vithas Virgen del Mar 
CádizClínica Nuestra Señora de la Salud 
Hospital de Jerez  45 
Hospital Quirón Campo de Gibraltar 
Hospital San Carlos 
Hospital Universitario de Puerto Real 
Hospital Universitario Puerta del Mar  70 
CórdobaHospital de la Cruz Roja de Córdoba 
Hospital Universitario Reina Sofía de Córdoba  66 
GranadaHospital Campus de la Salud  10 
Clínica Nuestra Señora de la Salud  17 
Hospital Clínico Universitario San Cecilio 
Hospital Universitario Virgen de las Nieves  97 
HuelvaHospital Costa de la Luz 
Hospital General Juan Ramón Jiménez  48 
Jaén  Complejo Hospitalario de Jaén  44 
MálagaClínica El Ángel 
Clínica Parque San Antonio 
Hospital Internacional Xanit 
Hospital Quirón de Málaga 
Hospital Quirónsalud Marbella 
Hospital Virgen de la Victoria  238 
SevillaClínica HLA Santa Isabel 
Hospital de San Juan de Dios 
Hospital Nisa Aljarafe 
Hospital Nuestra Señora de Valme  45 
Hospital Quirónsalud Sagrado Corazón 
Hospital San Agustín 
Hospital Virgen del Rocío  93 
Hospital Virgen Macarena  62 
Aragon
ZaragozaHospital Clínico Universitario Lozano Blesa  49 
Hospital Miguel Servet  174 
Hospital Quirónsalud Zaragoza 
Principality of AsturiasHospital de Cabueñes  22 
Hospital Universitario Central de Asturias  198 
Balearic IslandsClinica Quirón Palmaplanas 
Clínica Rotger Sanitaria Balear, S.A. 
Hospital Son Llàtzer  22 
Hospital Universitari Son Espases  76 
Policlínica Miramar 
Canary Islands
Las PalmasClínica Santa Catalina 
Hospital Dr. Negrín  51 
Hospital Insular de Gran Canaria  79 
Hospital Nuestra Señora del Perpetuo Socorro 
Hospital La Paloma 
Santa Cruz de TenerifeHospital San Juan de Dios (Tenerife) 
Hospital Nuestra Señora de la Candelaria  66 
Hospital Universitario de Canarias  47 
CantabriaClínica Mompía 
Hospital Universitario Marqués de Valdecilla  130 
Castile and León
ÁvilaClínica Santa Teresa 
Hospital Nuestra Señora de Sonsoles  31 
BurgosHospital Recoletas Burgos 
Hospital Universitario de Burgos (HUBU)  60 
León  Hospital de León  62 
Salamanca  Complejo Hospitalario de Salamanca  80 
Segovia  Hospital General de Segovia 
ValladolidHospital Campo Recoletas Grande 
Hospital Clínico Universitario de Valladolid  88 
Hospital Universitario Río Hortega  17 
Castile-La Mancha
AlbaceteHospital General de Albacete  59 
Hospital Quirónsalud Albacete 
Sanatorio Santa Cristina 
Ciudad RealHospital General de Ciudad Real  56 
Quirón Ciudad Real 
Cuenca  Hospital Virgen de la Luz  15 
Guadalajara  Hospital General y Universitario de Guadalajara  32 
ToledoHospital Nuestra Señora del Prado  38 
Hospital Virgen de la Salud  116 
Catalonia
BarcelonaCentro Médico Teknon 
Clínica Delfos 
Clínica Quirónsalud Barcelona 
Hospital Clínico de Barcelona  228 
Hospital de Bellvitge  160 
Hospital de la Santa Creu i Sant Pau  141 
Hospital de Sabadell Parc Taulí  19 
Hospital del Mar  30 
Hospital El Pilar (Quirónsalud)  18 
Hospital General de Catalunya 
Hospital Germans Trias i Pujol  52 
Hospital Sant Joan de Déu 
Hospital Vall d’Hebron  129 
GironaClínica Girona 
Hospital Universitario de Girona Dr. Josep Trueta  66 
Lleida  Hospital Universitario Arnau de Vilanova  25 
TarragonaHospital de Sant Pau i Santa Tecla 
Hospital Universitario de Tarragona Joan XXIII  35 
Valencian Community
AlicanteCentro Medico Salus Baleares 
Clínica Glorieta 
Clínica Vistahermosa 
Hospital General Universitario de Alicante  168 
Hospital General Universitario de Elche 
Hospital IMED de Levante 
Hospital Mediterráneo 
Hospital Universitari Sant Joan d’Alacant  56 
Sanatorio del Perpetuo Socorro 
Castellón  Hospital General Universitari de Castelló  26 
ValenciaHospital Arnau de Vilanova de Valencia 
Hospital Clínico Universitario de Valencia  65 
Hospital de Manises  44 
Hospital Francesc de Borja de Gandía 
Hospital General Universitario de Valencia  78 
Hospital Nisa 9 de Octubre 
Hospital Quirónsalud Valencia 
Hospital Universitari de la Ribera  52 
Hospital Universitario Dr. Peset  30 
Hospital Universitario La Fe  122 
Extremadura
BadajozHospital Infanta Cristina de Badajoz  142 
Hospital Quirón Clideba 
CáceresClínica San Francisco de Cáceres 
Complejo Hospitalario de Cáceres  32 
Galicia
A CoruñaComplejo Hospitalario Universitario A Coruña  163 
Complejo Hospitalario Universitario de Santiago  105 
Hospital Modelo 
Hospital Quirónsalud A Coruña 
Lugo  Hospital Universitario Lucus Agusti  25 
Ourense  Complejo Hospitalario de Ourense  17 
PontevedraComplejo Hospitalario de Pontevedra 
Hospital Álvaro Cunqueiro (CHUVI)  89 
Hospital Montecelo 
Hospital Nuestra Señora de Fátima 
Hospital Povisa  19 
La Rioja  Hospital San Pedro  28 
Community of MadridClínica La Luz 
Clínica La Milagrosa 
Clínica Moncloa  16 
Clínica Ruber 
Clínica Universitaria de Navarra de Madrid 
Fundación Hospital Alcorcón  22 
Fundación Jiménez Díaz  73 
Grupo Hospital de Madrid  11 
Hospital 12 de Octubre  99 
Hospital Central de la Defensa  27 
Hospital Clínico San Carlos  132 
Hospital de Fuenlabrada  25 
Hospital de Torrejón  10 
Hospital del Henares 
Hospital General de Villalba 
Hospital General Universitario Gregorio Marañón  71 
Hospital Infanta Leonor  37 
Hospital Universitario La Zarzuela 
Hospital Los Madroños 
Hospital Nisa Pardo de Aravaca 
Hospital Quirón Madrid 
Hospital Quirón San Camilo 
Hospital Quirónsalud Sur Alcorcón 
Hospital Ramón y Cajal  100 
Hospital Rey Juan Carlos  19 
Hospital Ruber Internacional 
Hospital San Rafael 
Hospital Severo Ochoa  15 
Hospital Universitario de Getafe  14 
Hospital Universitario La Paz  122 
Hospital Universitario Puerta de Hierro Majadahonda  156 
Hospital Virgen de la Paloma 
Hospital Virgen del Mar 
Hospital Vithas Nuestra Señora de América 
Sanatorio San Francisco de Asís 
Region of MurciaHospital General Universitario Morales Meseguer 
Hospital General Universitario Reina Sofía Murcia  15 
Hospital General Universitario Santa Lucía  33 
Hospital La Vega-HLA 
Hospital Rafael Méndez  21 
Hospital Universitario Virgen de la Arrixaca  63 
Chartered Community of NavarreClínica Universidad de Navarra  29 
Hospital de Navarra  63 
Basque Country
Álava  Hospital Universitario de Áraba  44 
Guipúzcoa  Hospital Universitario de Donostia  150 
VizcayaHospital de Basurto  59 
Hospital de Cruces  55 
Hospital de Galdakao-Usansolo  15 
IMQ Zorrotzaurre 
Not defined    51 
Figure 1.

Distribution of implantation activity by autonomous community in 2018: number of implantation centers/rate per million population/total number of implantations. Mean rate=137 implantations/million population.

(0.2MB).
Total Number of Implantations

In 2018, the total number of implantations (first and replacements) was 6421, representing an increase vs 2017 (6273). The total number of implantations reported to the registry and those estimated by Eucomed in the last 10 years are shown in figure 2. The data for 2018 show a marked increase in the number of ICD implantations in Spain vs the previous year (7077 in 2018 and 6429 in 2017 according to Eucomed data).

Figure 2.

Total number of implantations notified and number estimated by Eucomed from 2009 to 2018. Eucomed, European Confederation of Medical Suppliers Associations; ICD, implantable cardioverter defibrillator.

(0.17MB).

The overall implantation rate was 137/million population for the registry but 152/million population according to Eucomed data. This figure is similar to that of the previous year (135/million population in 2017) but much lower than the mean ICD implantation rate in Europe (306/million population in 2018); nonetheless, the rate in Europe has fallen for the first time. Changes in the implantation rate per million population during the last 10 years according to registry and Eucomed data are shown in figure 3.

Figure 3.

Total number of implantations notified per million population and number estimated by Eucomed from 2009 to 2018. Eucomed, European Confederation of Medical Suppliers Associations; ICD, implantable cardioverter defibrillator.

(0.12MB).

The name of the hospital performing the procedure was recorded in 99.6% of forms (table 1). Most procedures (5693, 92%) were performed in publicly-funded health centers.

First Implantations vs Replacements

This information was available in 5451 forms (83%). First implantations comprised 3899, representing 71.5% of the total (71.4% in 2017, 66.8% in 2016, 71.8% in 2015, and 72.6% in 2014). The rate of first implantations per million population was 83.4 (76.5 in 2017, 65.5 in 2016, 75.1 in 2015, and 79.0 in 2014).

Age and Sex

The mean age of all patients was 62.4±13.55 (7-97) years in 2018 vs 62.6±13.4 (6-90) years in 2017, 62.7±13.4 (6-90) years in 2016, 62.8±13.3 (6-89) years in 2015, and 61.8±13.7 (7-94) years in 2014. The mean patient age was 61.2±13.3 years for first implantations. Most patients were men: they represented 82.0% of all patients and 82.4% of first implantation patients.

Underlying Heart Disease, Left Ventricular Ejection Fraction, Functional Class, and Baseline Rhythm

The most frequent underlying cardiac condition in first implantation patients was ischemic heart disease (52.9%), followed by dilated cardiomyopathy (26.1%), hypertrophy (7.1%), primary conduction abnormalities (Brugada syndrome and long QT syndrome) (2.9%), valve diseases (1.6%), and arrhythmogenic right ventricular cardiomyopathy (1.1%) (figure 4).

Figure 4.

Type of heart disease prompting implantation (first implantations). ARVC, arrhythmogenic right ventricular cardiomyopathy; Others, patients with more than 1 diagnosis.

(0.2MB).

Systolic function data were provided in 66.5% of forms. In this group, left ventricular ejection fraction was> 50% in 18.2% of patients, from 41% to 50% in 9.3%, from 36% to 40% in 9.2%, from 31% to 35% in 18.6%, and ≤ 30% in 44.8% (figure 5). The distribution was similar when it was grouped by first implantations and by replacements.

Figure 5.

Left ventricular ejection fraction of patients in the registry (total and first implantations).

(0.08MB).

The New York Heart Association (NYHA) functional class was recorded in 45.2% of forms. Most patients were in NYHA class II (55.7%), followed by NYHA III (27.9%), NYHA I (15.3%), and NYHA IV (1.1%). The distribution for this variable was also similar in the overall and first implantation groups (figure 6).

Figure 6.

New York Heart Association functional class of total and first implantation patients.

(0.06MB).

Based on data from 69.4% of forms, the baseline cardiac rhythm was primarily sinus rhythm (77.1%), followed by atrial fibrillation (18.0%) and pacemaker rhythm (4.4%). The remaining patients had other rhythms (eg, atrial flutter and other arrhythmias).

Clinical Arrhythmia Prompting Implantation, Its Form of Presentation, and the Arrhythmia Induced in the Electrophysiological Study

The clinical arrhythmia prompting device implantation was reported in 69.9% of forms submitted to the registry. For first implantations, most patients had no documented clinical arrhythmia (63.7%), while 14.5% showed sustained monomorphic ventricular tachycardia, 9.8% had nonsustained ventricular tachycardia, and 10.6% had ventricular fibrillation. In total, patients with no documented clinical arrhythmia comprised 63.7% (figure 7). The most frequent presentation in both the total implantation group and the first implantation patients (56.1% of completed responses) was asymptomatic, followed by syncope, sudden cardiac death, and other symptoms (figure 8).

Figure 7.

Distribution of the arrhythmias prompting implantation (total and first implantations). NSVT, nonsustained ventricular tachycardia; PVT, polymorphic ventricular tachycardia; SMVT, sustained monomorphic ventricular tachycardia; VF, ventricular fibrillation.

(0.07MB).
Figure 8.

Clinical presentation of the arrhythmia in the registry patients (first implantations and total). SCD, sudden cardiac death.

(0.07MB).

Information on the electrophysiological studies performed was provided in 57.5% of forms. These studies were carried out in 312 patients (8.5%), mainly those with ischemic heart disease and dilated cardiomyopathy, and in 33.5% of patients with Brugada syndrome. Sustained monomorphic ventricular tachycardia was the most common induced arrhythmia (27.6%), followed by nonsustained ventricular tachycardia (16.8%), ventricular fibrillation (14.1%), and, to a lesser extent, other arrhythmias (4.6%). No arrhythmia was induced in 36.9% of the electrophysiological studies.

Clinical History

Information on clinical history was provided in 38.6% of forms. Hypertension was present in 57% of patients, as well as hypercholesterolemia in 48%, smoking in 35%, diabetes mellitus in 30%, history of atrial fibrillation in 27%, family history of sudden cardiac death in 9%, renal failure in 15%, and history of stroke in 6%.

The QRS interval was reported for 43.5% of first implantations (mean, 124ms). In 39% of the patients, it was> 140ms, and 88.7% of these patients had a resynchronization-defibrillator device (ICD-cardiac resynchronization therapy [CRT]).

Indications

Device indications in recent years are shown in table 2. These data were provided in 62.6% of forms in 2018. Ischemic heart disease was the most frequent reason for ICD implantation, accounting for 53.8% of first implantations in 2018. Among ischemic heart disease patients, the most common indication was primary prevention (39%). The second most common reason was dilated cardiomyopathy (29% of all first implantations). For the less common heart diseases, the most frequent indication was primary prevention.

Table 2.

Number of First Implantations According to Type of Heart Disease, Type of Clinical Arrhythmia, and Form of Presentation From 2014 to 2018

  2014  2015  2016  2017  2018 
Ischemic heart disease
Aborted SCD  141 (6.7)  200 (11.9)  135 (10.4)  101 (6.5)  165 (10.6) 
SMVT with syncope  173 (10.6)  243 (14.5)  142 (10.9)  135 (8.7)  92 (5.9) 
SMVT without syncope  108 (6.6)  121 (7.2)  226 (17.3)  212 (13.7)  231 (14.9) 
Syncope without arrhythmia  70 (4.3)  174 (10.4)  31 (2.4)  61 (3.9)  62 (3.9) 
Prophylactic implantation  740 (45.5)  804 (48.9)  650 (49.9)  603 (39.0)  793 (50.8) 
Missing/unclassifiable  393 (24.8)  158 (9.4)  121 (9.3)  434 (28.0)  217 (13.9) 
Subtotal  1625  1672  1305  1546  1560 
Dilated cardiomyopathy
Aborted SCD  25 (6.8)  63 (6.5)  51 (5.9)  61 (7.3)  47 (5.6) 
SMVT with syncope  72 (8.5)  67 (6.9)  43 (5.0)  65 (7.8)  39 (4.8) 
SMVT without syncope  111 (13.4)  113 (11.7)  91 (10.5)  100 (12.0)  53 (6.6) 
Syncope without arrhythmia  37 (4.3)  66 (6.8)  59 (6.8)  30 (3.6)  26 (3.3) 
Prophylactic implantation  400 (47.0)  459 (47.6)  550 (63.5)  341 (41.0)  355 (44.2) 
Missing/unclassifiable  173 (20.3)  196 (20.3)  72 (8.3)  233 (28.7)  283 (35.2) 
Subtotal  851  964  866  830  803 
Valve disease           
Aborted SCD  11 (9.0)  19 (14.4)  12 (10.5)  5 (5.3)  9 (9.8) 
SMVT  38 (31.5)  33 (25.0)  28 (24.5)  22 (23.2)  24 (26.1) 
Syncope without arrhythmia  7 (5.7)  13 (9.9)  9 (7.9)  5 (5.3)  5 (5.4) 
Prophylactic implantation  46 (37.7)  55 (41.7)  52 (45.6)  46 (48.4)  37 (40.2) 
Missing/unclassifiable  20 (16.4)  12 (9.9)  13 (11.4)  17 (17.9)  17 (18.5) 
Subtotal  126  132  114  95  92 
Hypertrophic cardiomyopathy
Secondary prevention  62 (25.8)  60 (24.3)  49 (20.3)  49 (21.5)  48 (19.2) 
Prophylactic implantation  166 (69.2)  179 (72.5)  176 (70.3)  166 (72.8)  198 (79.2) 
Missing/unclassifiable  12 (5.0)  8 (3.2)  16 (6.6)  13 (5.7)  4 (1.6) 
Subtotal  240  247  241  228  250 
Brugada syndrome
Aborted SCD  8 (13.7)  7 (15.9)  16 (24.2)  11 (15.5)  14 (18.9) 
Prophylactic implantation in syncope  17 (29.3)  14 (31.8)  10 (15.2)  16 (22.5)  14 (18.9 
Prophylactic implantation without syncope  22 (37.9)  12 (27.3)  35 (53.0)  38 (53.5)  14 (18.9) 
Missing/unclassifiable  11 (18.9)  11 (25.0)  5 (7.6)  6 (8.4)  17 (23.0) 
Subtotal  60  47  66  71  74 
ARVC
Aborted SCD  6 (13.3)  8 (20.5)  2 (4.3)  3 (12.5)  4 (10.3) 
SMVT  16 (35.5)  17 (41.4)  25 (54.3)  7 (29.1)  16 (41.0) 
Prophylactic implantation  16 (35.5)  14 (34.1)  18 (39.1)  10 (41.6)  14 (35.9) 
Missing/unclassifiable  7 (15.5)  2 (4.8)  1 (2.2)  4 (16.6)  5 (12.8) 
Subtotal  45  41  46  24  39 
Congenital heart disease
Aborted SCD  5 (13.9)  9 (27.3)  4 (12.1)  6 (12.0)  7 (15.2) 
SMVT  7 (19.4)  9 (27.3)  10 (30.3)  10 (20.0)  14 (30.4) 
Prophylactic implantation  15 (41.7)  12 (36.4)  12 (36.4)  29 (58.0)  21 (45.6) 
Missing/unclassifiable  9 (25.0)  3 (36.4)  7 (21.2)  5 (10.0)  4 (8.7) 
Subtotal  36  33  33  50  46 
Long QT syndrome
Aborted SCD  19 (70.4)  8 (38.1)  10 (30.3)  15 (48.4)  9 (24.3) 
Prophylactic implantation  5 (18.5)  12 (54.5)  15 (45.5)  12 (38.7)  18 (48.6) 
Missing/unclassifiable  3 (11.1)  2 (9.1)  8 (24.2)  4 (12.9)  10 (27.3) 
Subtotal  26  22  33  31  37 

ARVC, arrhythmogenic right ventricular cardiomyopathy; SCD, sudden cardiac death; SMVT, sustained monomorphic ventricular tachycardia.

Data are expressed as No. (%).

The implantation indication was identified in 62.6% of forms. Most first implantations were indicated for primary prevention (65.7%), a proportion that has slowly been increasing throughout registry history (table 3).

Table 3.

Changes in the Main Indications for Implantable Cardioverter-defibrillators (Percentages of First Implantations, 2009-2018)

Year  SCD  SMVT  Syncope  Primary prevention 
2009  9.4  20.8  13.9  55.9 
2010  10.9  20.6  11.1  57.1* 
2011  10.7  15.1  14.6  59.4 
2012  12.5  10.2  19.1  58.1 
2013  13.5  11.1  22.4  53.0* 
2014  13.2  17.9  10.2  58.5* 
2015  11.2  13.6  16.9  58.2 
2016  11.8  17.0  9.9  62.0* 
2017  12.5  15.7  9.8  62.0 
2018  13.3  13.5  7.4  65.7 

SCD, sudden cardiac death; SMVT, sustained monomorphic ventricular tachycardia.

*

Significantly different (P < .02) vs 2017.

Implantation Setting and Treating Specialist

The implantation setting and specialist performing the procedure were recorded in 69.4% of forms. In total, 82.4% of procedures were performed in electrophysiology laboratories and 14.3% in operating rooms. Cardiac electrophysiologists performed 77.9% of implantations, surgeons performed 9.3%, and both together performed 8.1%. Other specialists and intensivists were involved in 2.6% and 2.1% of procedures, respectively.

Generator Placement Site

Generator placement was recorded for 70.2% of first implantations. Placement was subcutaneous in 91.8% of patients and subpectoral in the remaining 8.2%. These figures were 91.3% and 8.7%, respectively, for all devices implanted.

Device Type

The types of device implanted are shown in table 4. This information was provided in 91.6% of forms submitted to the registry. In 2018, first implantations of subcutaneous defibrillators comprised 6.0% (5.3% in 2017 and 6.4% in 2016).

Table 4.

Percent Distribution of Implanted Devices by Type

Device type  TotalFirst implantations
  2014  2015  2016  2017  2018  2014  2015  2016  2017  2018 
Subcutaneous      3.6  3.8  4.4    2.4  6.4  5.3  6.0 
Single-chamber  48.8  48.6  45.4  45.7  46.6  48.8  50.4  48.4  49.4  50.1 
Dual-chamber  17.4  14.5  13.7  15.0  15.0  17.4  13.2  13.0  14.1  13.4 
Resynchronization device  33.7  35.7  37.3  35.7  34.0  33.7  33.9  32.1  31.5  30.6 
Reasons for Device Replacement, Need for Lead Replacement, and Use of Additional Leads

The most frequent reason for replacement was battery depletion (79.3%); complications prompted 9.1% of replacements (10.5% in 2017 and 8.8% in 2016) and a change of indication prompted 11.5%. Of the 818 replacements providing this information, 2.4% were performed before 6 months.

Information was available on lead status in 56.1% of forms; 4.6% were malfunctioning (40 forms) and they were extracted in 12.5% of patients reporting this problem.

Device Programming

With data on 49.3% of implantations, the most common pacing mode was VVI (54.52%), following by DDD (28.5%), VVIR (6.3%), DDDR (4.7%), and others (6.0%).

Ventricular fibrillation induction was tested in 249 patients, 5.8% of the 4322 records providing this information (5.3% in 2017 and 4.1% in 2016). The mean number of shocks delivered was 1.1. Thus, the threshold was not calculated in most patients.

Complications

Complication data were recorded in 77.2% of forms. There were 25 complications: 10 coronary sinus dissections, 2 tamponades, 9 deaths, and 4 unspecified. The mortality rate was 0.2%, representing an increase vs the 3 previous years (0.09% in 2017 and 0.02% in 2016), although the number remains quite low.

DISCUSSION

In 2018, information was obtained on the vast majority of implantations performed in Spain, with over 90% of those being performed according to Eucomed data. This is at least partly due to the efforts of the SEC but is mainly due to the contribution of the implantation centers.

Comparison With Registries of Previous Years

The SEC excels at the publication of activity data and has systematically published registry data since 2005.5 In 2018, there was another slight uptick in the number of devices, whereas the number remained stable in Europe.9 This situation reduced, albeit slightly, the difference vs our neighboring countries. The overall implantation rate per million population was 152 in 2018 (vs 138 in 2017) while it dropped from 311 in 2017 to 306 in 2018 in Europe.

There was also a slight increase in implantations for primary prevention in 2018, which reached 65.7% (table 3); this figure also brings Spain closer (again, only slightly) to the European level.10

Finally, the percentage of subcutaneous ICDs was 6.0% in 2018; this represents a slightly increase vs 2017 (5.3%) but is still lower than that of 2016 (6.4%). This figure seems low for a therapy with so many potential advantages.11

The most frequent underlying heart disease in 2018 continued to be ischemic heart disease (52.9%), followed by dilated cardiomyopathy (26.1%). In 2018, implantations for primary prevention of dilated cardiomyopathy appeared to have slightly recovered since the marked reduction in this therapy in Spain after the publication of the DANISH study.12 This phenomenon was also seen to a greater or lesser extent in other European countries.13 In our opinion, this reduction is not justified by the available data. First, the only guidelines published after the results of the DANISH trial maintained the indication for ICD implantation for primary prevention in patients with dilated cardiomyopathy (class I, level of evidence A).3 Second, the results of the DANISH study should not be applied to patients who have no indication for cardiac resynchronization (less than half of the patients included in the study). Third, the benefit to patients younger than 70 years of age is clear in the DANISH trial, and most implantations for primary prevention are in patients younger than that age.14 Finally, the results of 2 meta-analyses again showed a benefit of ICDs in this patient population, with a 25% reduction in the relative risk of death.15,16

The 2018 data are generally consistent with those of previous years. Given the scientific evidence, the implantation rate in our country remains lower than expected. In 2010, the implantation rate per million population in Spain was about half the European rate (116 vs 248); in 2017, the gap slightly decreased to 152 vs 306 implantations per million.9 This is a positive development, but we should not forget the magnitude of the difference in implantation rates vs our neighboring countries.

There were no changes from previous registries in the epidemiological characteristics of the patients. Patients with severe ventricular dysfunction and in NYHA II and III continued to predominate. There were no changes either in the type of specialist performing the implantation.

Differences Among Autonomous Communities

As in previous years, the data from the 2018 registry showed large differences in the implantation rates of the various autonomous communities. Overall, the implantation rate in Spain in 2018 was 137 per million population according to the registry and 152 according to Eucomed data, a slight increase vs previous years. Several autonomous communities showed higher rates than the average: Cantabria (227), Principality of Asturias (214), Extremadura (168), Galicia (162), Castile-La Mancha (160), Community of Madrid (152), the Basque Country (147), Castile and León (146), Chartered Community of Navarre (142), and the Valencian Community (139). Below average were Catalonia (122), the Canary Islands (118), Andalusia (113), the Region of Murcia (97), and La Rioja (89). The analysis by autonomous community highlighted the major difference between the highest and lowest rates, which is difficult to explain in terms of a theoretically homogeneous health system. These differences are not explained by income level or population density. Also striking is the case of Andalusia, which, despite the general rise throughout Spain, failed to recover the implantation rate it had in 2016 (124).

Comparison With Other Countries

In all of the countries participating in Eucomed, the implantation rate dropped from 311 per million population in 2017 (320 in 2016) to 306 in 2018. This figure includes ICDs and ICD-CRTs. Germany continued to lead with 485 devices, whereas Spain (152 implantations/million) was the country with the lowest number of implantations. Several countries showed higher than average rates: Italy (414), the Netherlands (385), the Czech Republic (381), Denmark (359), and Poland (332). Below the average were Ireland (273), Sweden (247), Belgium (235), Finland (235), Norway (225), France (224), Switzerland (220), Portugal (219), the United Kingdom (207), Greece (186), and, in last position, Spain (152). The difference in the implantation rate in Spain from the European average was maintained in 2018 (152 vs 306 compared with 138 vs 311 in 2017, 144 vs 320 in 2016, and 138 vs 315 in 2015). We are thus still far from the nearest country in terms of rate (152 vs 186).

The ICD-CRT implantation rate in Europe was 119 per million population (124 in 2017, 119 in 2016, 126 in 2015, 119 in 2014, and 113 in 2013). Germany (195 implantations per million population) continued to be first, whereas Spain (50) had the lowest implantation rate.

The proportion of ICD-CRTs with respect to the total varied from 39% in Denmark to 87% in the Czech Republic. The European average was 58%. Above the average were France, Portugal, the Netherlands, the United Kingdom, Germany, Italy, Sweden, and the Czech Republic. Below the 58% line were Denmark, Belgium, Finland, Norway, Switzerland, Greece, Ireland, and Poland. Spain had a proportion of 49%.

Other European countries also show regional differences in the ICD implantation rate.16–18 The reasons are difficult to identify and do not seem to be economic because the rates of countries with lower income than Spain, such as Ireland and Poland, far exceed ours, even in more disadvantaged regions. Nor can these differences be explained by the prevalence of cardiovascular diseases. It seems that electrophysiologists working in Spain have not been able to convince their clinical colleagues, responsible for device indication, of the virtues of ICDs and their ability to reduce the rates of overall and sudden cardiac death in at-risk patients.

Limitations

Although the 2018 ICD registry included more than 90% of the implantations reported to Eucomed, the information was often incomplete. Data were not available for all fields of the implantation form and its completion was uneven.

In addition, data collection was limited to the periimplantation period and there are no follow-up data; thus, the complication records may underestimate the actual percentage.

Future Prospects of the Spanish Implantable Cardioverter-defibrillator Registry

During 2018, it was possible to collect information on more than 90% of the devices reported to Eucomed, a satisfactory figure but nonetheless a decrease vs 2017. Throughout 2019, a website for the online completion of the implantation form has been developed by the SEC in collaboration with the Spanish Agency for Medicines and Health Products.19 This website will allow real-time registration of both pacemakers and ICDs. We hope that this change will boost the quality of the registry and its degree of completion. We also hope that the new platform will allow us to conduct prospective studies and improve the safety of patients affected by any possible safety alerts.

CONCLUSIONS

The 2018 Spanish Implantable Cardioverter-defibrillator Registry received information on 90% of the implantations performed in Spain. In 2018, the number of devices increased and the difference vs other European countries decreased, albeit slightly. The total number of implantations in Spain is still much lower than the average for the European Union and the autonomous communities continue to show considerable variability.

CONFLICTS OF INTEREST

I. Fernández Lozano has participated in clinical studies sponsored by Medtronic, Abbott, Biotronik, and Sorin and has fellowship grants from the SEC and the Cardiovascular Research Foundation. J. Osca Asensi has participated in clinical studies sponsored by Abbott, Boston, and Biotronik. J. Alzueta Rodríguez has participated in presentations sponsored by Boston and has received fellowship grants from the FIMABIS Foundation.

References
[1]
S.G. Priori, C. Blomström-Lundqvist, A. Mazzanti, et al.
2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death.
Eur Heart J., 36 (2015), pp. 2793-2867
[2]
D.P. Zipes, A.J. Camm, M. Borggrefe, et al.
ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: A report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Com.
Europace., 8 (2006), pp. 746-837
[3]
S.M. Al-Khatib, W.G. Stevenson, M.J. Ackerman, et al.
2017 AHA/ACC/HRS Guideline for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society.
Circulation., 138 (2018), pp. e210-e271
[4]
S.P.P. Mendis, B. Norrving.
Global atlas on cardiovascular disease prevention and control.
World Health Organization, (2011),
[5]
R. Peinado, A. Arenal, F. Arribas, Spanish Implantable Cardioverter-Defibrillator Registry. First Official Report of the Spanish Society of Cardiology Working Group on Implantable Cardioverter-Defibrillators (2002-2004), et al.
Rev Esp Cardiol., 58 (2005), pp. 1435-1449
[6]
J. Alzueta, I. Fernandez-Lozano.
Spanish Implantable Cardioverter-Defibrillator Registry. 13th Official Report of the Spanish Society of Cardiology Electrophysiology and Arrhythmias Section (2016).
Rev Esp Cardiol., 70 (2017), pp. 960-970
[7]
I. Fernández Lozano, J. Osca Asensi, J. Alzueta Rodríguez.
Spanish Implantable Cardioverter-Defibrillator Registry. 14th Official Report of the Spanish Society of Cardiology Electrophysiology and Arrhythmias Section (2017).
Rev Esp Cardiol., 71 (2018), pp. 1047-1058
[8]
Instituto Nacional de Estadística. Datos poblacionales [nota de prensa 11 abril 2019]. Available at: https://www.ine.es/prensa/pad_2019_p.pdf. Accessed 15 Jun 2019.
[9]
MedTech Europe. Statistics for Cardiac Rhythm Management products, 2013-2017. Available at: http://www.medtecheurope.org/index.php/node/801. Accessed 24 Jun 2019.
[10]
A. John Camm, S. Nisam.
European utilization of the implantable defibrillator: has 10 years changed the’enigma’?.
Europace., 12 (2010), pp. 1063-1069
[12]
K.H. Haugaa, R. Tilz, S. Boveda, et al.
Implantable cardioverter defibrillator use for primary prevention in ischaemic and non-ischaemic heart disease-indications in the post-DANISH trial era: results of the European Heart Rhythm Association survey.
Europace., 19 (2017), pp. 660-664
[13]
M.B. Elming, J.C. Nielsen, J. Haarbo, et al.
Age and outcomes of primary prevention implantable cardioverter-defibrillators in patients with nonischemic systolic heart failure.
Circulation., 136 (2017), pp. 1772-1780
[14]
S.M. Al-Khatib, G.C. Fonarow, J.A. Joglar, et al.
Primary prevention implantable cardioverter defibrillators in patients with nonischemic cardiomyopathy: a meta-analysis.
JAMA Cardiol., 2 (2017), pp. 685-688
[15]
H. Golwala, N.S. Bajaj, G. Arora, P. Arora.
Implantable cardioverter-defibrillator for nonischemic cardiomyopathy: an updated meta-analysis.
Circulation., 135 (2017), pp. 201-203
[16]
A. Proclemer, M. Zecchin, A. D’Onofrio, et al.
The Pacemaker and Implantable Cardioverter-Defibrillator Registry of the Italian Association of Arrhythmology and Cardiac Pacing - Annual report 2016.
G Ital Cardiol., 19 (2018), pp. 119-131
[17]
J.V. Freeman, Y. Wang, J.P. Curtis, P.A. Heidenreich, M.A. Hlatky.
Physician procedure volume and complications of cardioverter-defibrillator implantation.
Circulation., 125 (2012), pp. 57-64
[18]
A. Lazarus, N. Biondi, J.F. Thebaut, I. Durand-Zaleski, M. Chauvin.
Implantable cardioverter-defibrillators in France: practices and regional variability.
Europace., 13 (2011), pp. 1568-1573
[19]
Agencia Española de Medicamentos y Productos Sanitarios y Sociedad Española de Cardiología. Plataforma de Registros Nacionales de Marcapasos y DAIs. Available at: http://cardiodispositivos.es. Accessed 15 Jun 2019.
Copyright © 2019. Sociedad Española de Cardiología
Idiomas
Revista Española de Cardiología (English Edition)

Subscribe to our newsletter

Article options
Tools
es en

¿Es usted profesional sanitario apto para prescribir o dispensar medicamentos?

Are you a health professional able to prescribe or dispense drugs?

es en
Política de cookies Cookies policy
Utilizamos cookies propias y de terceros para mejorar nuestros servicios y mostrarle publicidad relacionada con sus preferencias mediante el análisis de sus hábitos de navegación. Si continua navegando, consideramos que acepta su uso. Puede cambiar la configuración u obtener más información aquí. To improve our services and products, we use "cookies" (own or third parties authorized) to show advertising related to client preferences through the analyses of navigation customer behavior. Continuing navigation will be considered as acceptance of this use. You can change the settings or obtain more information by clicking here.