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Vol. 67. Issue 11.
Pages 936-947 (November 2014)
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Vol. 67. Issue 11.
Pages 936-947 (November 2014)
Special article
DOI: 10.1016/j.rec.2014.08.001
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Spanish Implantable Cardioverter-defibrillator Registry. Tenth Official Report of the Spanish Society of Cardiology Electrophysiology and Arrhythmias Section (2013)
Registro Español de Desfibrilador Automático Implantable. X Informe Oficial de la Sección de Electrofisiología y Arritmias de la Sociedad Española de Cardiología (2013)
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Javier Alzueta
Corresponding author
jalzueta@telefonica.net

Corresponding author: Unidad de Arritmias, Servicio de Cardiología, Área del Corazón, Hospital Universitario Virgen de la Victoria, Campus de Teatinos s/n, 29010 Málaga, Spain.
, Alonso Pedrote, Ignacio Fernández Lozano
Sección de Electrofisiología y Arritmias, Sociedad Española de Cardiología, Madrid, Spain
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Tables (5)
Table 1. Implantations by Autonomous Community, Province, and Hospital
Table 2. Implantations by Autonomous Community and Province
Table 3. Number of First Implantations According to the Type of Heart Disease, Type of Clinical Arrhythmia, and Form of Presentation (2009–2013)
Table 4. Changes in the Main Indications for Implantable Cardioverter-defibrillator Placement (First Implantations, 2003-2013)
Table 5. Distribution (%) of the Types of Implantable Cardioverter-defibrillators Placed
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Abstract
Introduction and objectives

To present the findings of the Spanish Implantable Cardioverter-defibrillator Registry for 2013 compiled by the Electrophysiology and Arrhythmias Section of the Spanish Society of Cardiology.

Methods

Prospective data were voluntarily recorded on a data collection form and sent to the Spanish Society of Cardiology by each implantation team.

Results

Overall, 4772 device implantations were reported, representing 85% of the estimated total number of implantations. The reported implantation rate was 102 per million population and the estimated total implantation rate was 120 per million. The proportion of first implantations was 68.8%. Data were received from 154 hospitals (4 fewer than in 2012). Most implantable cardioverter-defibrillator recipients were men (83.3%). The mean age was 62.5 (13.4) years. Most patients had severe or moderate-to-severe ventricular dysfunction and were in New York Heart Association functional class II. The most frequent underlying cardiac condition was ischemic heart disease, followed by dilated cardiomyopathy. Indications for primary prevention accounted for 53.0% of first implantations, consolidating the decrease first observed in 2012. Overall, 79.8% of devices were implanted by cardiac electrophysiologists.

Conclusions

The 2013 Spanish Implantable Cardioverter-defibrillator Registry includes information on 85% of the devices implanted in Spain. The total number of implantations increased compared with the previous 2 years. The percentage of implantations for primary prevention indications decreased compared with the previous year.

Keywords:
Arrhythmias
Registry
Defibrillator
Abbreviations:
CRT
EUCOMED
ICD
SEC
Resumen
Introducción y objetivos

Se presentan los resultados del Registro Español de Desfibrilador Automático Implantable de 2013, elaborado por la Sección de Electrofisiología y Arritmias de la Sociedad Española de Cardiología.

Métodos

Se envió de forma prospectiva a la Sociedad Española de Cardiología la hoja de recogida de datos cumplimentada voluntariamente por cada equipo implantador.

Resultados

El número de implantes comunicados fue 4.772 (el 85% del total de implantes estimado). La tasa de implantes fue 102 por millón de habitantes y la estimada, 120. Los primoimplantes fueron el 68,8%. Se obtuvieron datos de 154 hospitales (4 menos que en 2012). La mayoría de los implantes (83,3%) se realizaron en varones. La media de edad fue 62,5±13,4 años. La mayoría de los pacientes presentaban una disfunción ventricular grave o grave-moderada y clase funcional II de la New York Heart Association. La cardiopatía más frecuente fue la isquémica, seguida de la dilatada. Las indicaciones por prevención primaria han sido el 53,0%, con lo que se consolida la disminución que se observó por primera vez el año pasado. Los implantes realizados por electrofisiólogos fueron el 79,8%.

Conclusiones

El Registro Español de Desfibrilador Automático Implantable de 2013 recoge información del 85% de los implantes realizados en España. El número total de implantes ha crecido respecto a los datos de los últimos 2 años. El porcentaje de indicación por prevención primaria ha disminuido con respecto al registro anterior.

Palabras clave:
Arritmias
Registro
Desfibrilador
Full Text

INTRODUCTION

Implantable cardioverter-defibrillators (ICD) have demonstrated usefulness in the primary and secondary prevention of sudden cardiac death. The results of several studies have allowed the main indications for ICD implantation to be defined and included in the successive clinical practice guidelines for the management of patients with ventricular arrhythmias or at risk of sudden cardiac death.1–3 However, the increased use of these devices has raised questions on their effectiveness outside the setting of clinical trials, the appropriate selection of patients for implantation in the real world, access to this treatment, and its safety and cost-effectiveness.4 Because there is Little information in the literatura on these questions and on the application of clinical guidelines in unselected patient populations, health registries can be highly useful in clarifying these issues.

This study presents the data on ICD implantation reported to the Spanish Implantable Cardioverter-defibrillator Registry in 2012. Most centers implanting ICD in Spain have collaborated with this registry. As in the case of the official reports describing the activity of previous years,5–12 this report has been prepared by members of the Electrophysiology and Arrhythmias Section of the Spanish Society of Cardiology (SEC, Sociedad Española de Cardiología).

The main aim of this registry is to identify the current use of ICDs in Spain, focusing on indications, the patients’ clinical characteristics, implantation data, types of devices and their programming, and procedural complications.

METHODS

Data for the registry were collected on a form available on the SEC web site.13 Each ICD implantation team directly and voluntarily completed the form during or after the procedure, in collaboration with technical staff at the ICD manufacturer.

The information was entered in the Spanish Implantable Cardioverter-defibrillator Registry database by a technician specifically contracted for this purpose, assisted by a computer specialist from the SEC and a member of the Electrophysiology and Arrhythmias Section, who also carried out data cleaning. The data were analysed by the authors of this article, who are responsible for this publication.

The census data used to calculate the rates per million population for Spain as a whole and for each autonomous community and province were obtained from estimates provided by the Spanish National Institute of Statistics as of 1 January 2013.14

To estimate the representativeness of the registry, the percentage of reported implantations and replacement procedures in relation to the total number of implantations and replacement procedures performed in Spain in 2013 was calculated. The total number was based on the data for 2013 reported to the European Medical Technology Industry Association (EUCOMED) by the firms marketing ICDs in Spain.15

When >1 form of clinical presentation or type of arrhythmia in the same patient was recorded on the data collection form, only the most serious condition was included in the analysis.

The percentages for each variable analyzed were calculated on the basis of the total number of reported implantations that included information on the specific variable.

Statistical Analysis

Numerical results are expressed as mean (standard deviation) or median [interquartile range], depending on the distribution of the variable. Continuous quantitative variables were compared with analysis of variance or the Kruskal-Wallis test. Qualitative variables were compared with the chi-square test. The relationships between the number of implantations and the number of implantation centers per million population and between the total number of implantations and the number of implantations for primary prevention in each center were evaluated using linear regression models.

RESULTS

The response rates for the various fields on the data collection form ranged from 99.1% for the name of the participating hospital to 18.0% for QRS width.

Participating Centers

A total of 153 centers performing ICD implantation in Spain participated in the registry (8 fewer than in 2012) (Table 1). This decrease was due to the grouping of several centers into consortia, which provided pooled data. Of the respondents, 90 were public health care centers (103 in 2012). Figure 1 shows the total number of participating centers, the implantation rate per million population, and the total number of implantations by autonomous community according to data collected by the registry. In 2013, only 14 centers implanted > 100 devices; 76 < 10 and, of these, 26 implanted only 1.

Table 1.

Implantations by Autonomous Community, Province, and Hospital

Andalusia
Almería  Hospital Torrecárdenas  17 
Cádiz  Hospital de Jerez  23 
  Clínica Nuestra Señora de la Salud 
  Hospital Universitario de Puerto Real 
  Hospital Universitario Puerta del Mar  27 
Córdoba  Hospital de la Cruz Roja de Córdoba 
  Hospital Reina Sofía de Córdoba  48 
Granada  Hospital Clínico Universitario San Cecilio 
  Hospital Universitario Virgen de las Nieves  72 
  Clínica Nuestra Señora de la Salud 
Huelva  Hospital General Juan Ramón Jiménez  35 
Jaén  Complejo Hospitalario de Jaén  17 
Málaga  Clínica El Ángel 
  Clínica Parque San Antonio 
  Clínica Santa Elena 
  Clínica Benidorm 
  Hospital Internacional Xanit  13 
  Clínica Quirón de Málaga 
  Clínica Quirón de Marbella 
  Hospital Virgen de la Victoria  188 
Seville  Clínica Sagrado Corazón, S.A. 
  Clínica de Fátima 
  Hospital Infanta Luisa (Clínica Esperanza de Triana) 
  Hospital Nisa Aljarafe 
  Clínica Santa Isabel 
  Hospital Nuestra Señora de Valme  50 
  Hospital Virgen Macarena  66 
  Hospital Virgen del Rocío  97 
Aragon
Zaragoza  Hospital Quirón Zaragoza 
  Hospital Clínico Universitario Lozano Blesa  44 
  Hospital Miguel Servet  79 
Principality of Asturias  Hospital Central de Asturias  199 
Balearic Islands  Clínica Juaneda 
  Clínica USP Palmaplanas 
  Hospital Son Llàtzer  28 
  Hospital Universitari Son Espases  47 
Canary Islands
Las Palmas  Clínica Santa Catalina, S.A. 
  Hospital Dr. Negrín  40 
  Hospital Insular de Gran Canaria  22 
  Hospital Nuestra Señora del Perpetuo Socorro 
Sta. Cruz de Tenerife  Clínica Santa Cruz 
  Hospital Nuestra Señora de la Candelaria  45 
  Hospital Universitario de Canarias  49 
Cantabria
Santander  Hospital Universitario Marqués de Valdecilla  105 
Castile and León
Ávila  Hospital Nuestra Señora de Sonsoles  23 
Burgos  Hospital Universitario de Burgos, S.A. (HUBU)  51 
Leon  Hospital de León  40 
Salamanca  Complejo Hospitalario de Salamanca  64 
Valladolid  Hospital Campo Grande 
  Hospital del Río Hortega  31 
  Hospital Clínico Universitario de Valladolid  93 
Castile-La-Mancha
Albacete  Hospital General de Albacete  40 
  Sanatorio Sta. Cristina 
Ciudad Real  Hospital General de Ciudad Real  20 
Cuenca  Hospital Virgen de la Luz  14 
Guadalajara  Hospital General y Universitario de Guadalajara  27 
Toledo  Hospital Nuestra Señora del Prado  19 
  Hospital Virgen de la Salud  113 
Catalonia
Barcelona  Centre Cardiovascular Sant Jordi, S.A. 
  Centro Médico Teknon 
  Clínica Delfos 
  Clínica Pilar Sant Jordi 
  Clínica Quirón 
  Hospital Clínic de Barcelona  199 
  Hospital de Bellvitge  96 
  Fundació de G.S. de l’Hospital de la Santa Creu i Sant Pau  139 
  Hospital del Mar  14 
  Capio Hospital General de Catalunya  18 
  Hospital Germans Trias i Pujol  51 
  Hospital Sant Joan de Déu 
  Hospital Vall d’Hebron  56 
Lleida  Hospital Universitario Arnau de Vilanova  30 
Tarragona  Hospital Universitario de Tarragona Joan XXIII  10 
Valencian Community
Alicante  Clínica Vistahermosa 
  Hospital General Universitario de Alicante  197 
  Hospital IMED de Levante 
  Hospital IMED de Elche 
  Sanatorio del Perpetuo Socorro 
  Hospital Universitari Sant Joan d’Alacant  26 
Castellón  Hospital General de Castelló  22 
Valencia  Grupo Hospitalario Quirón, S.A. 
  Hospital Clínico Universitario  102 
  Hospital de Manises 
  Hospital General Universitario  62 
  Hospital NISA 9 de Octubre 
  Hospital Quirón Valencia 
  Hospital Universitari de la Ribera  31 
  Hospital Universitario Dr. Peset  50 
  Hospital Universitario La Fe  119 
Extremadura
Badajoz  Hospital de Mérida 
  Clideba 
  Hospital Infanta Cristina de Badajoz  124 
Cáceres  Clínica San Francisco 
  Complejo Hospitalario de Cáceres  23 
  Hospital San Pedro de Alcántara 
Galicia
A Coruña  Hospital Clínico de Santiago 
  Complejo Hospitalario Universitario de Santiago  86 
  Complejo Hospitalario Universitario A Coruña  137 
  Hospital USP Santa Teresa 
  Hospital Policlínico La Rosaleda 
Lugo  Hospital Universitario Lucus Augusti 
Ourense  Centro Médico El Carmen 
  Complejo Hospitalario de Ourense 
Pontevedra  Hospital Miguel Domínguez 
  Complejo Hospitalario Universitario de Vigo (CHUVI)  98 
La Rioja  Hospital San Pedro  16 
Community of Madrid  Clínica San Camilo 
  Clínica la Luz 
  Clínica Nuestra Señora de América 
  Fundación Hospital Alcorcón  14 
  Fundación Jiménez Díaz. Clínica Nuestra Señora de la Concepción  30 
  Grupo Hospital de Madrid  11 
  Hospital 12 de Octubre  53 
  Hospital Central de la Defensa  29 
  Hospital Clínico San Carlos  102 
  Hospital de Fuenlabrada 
  Hospital de Torrejón  20 
  Hospital del Henares 
  Hospital General Universitario Gregorio Marañón  30 
  Hospital Infanta Leonor  11 
  Hospital Los Madroños 
  Hospital NISA Pardo Aravaca 
  Hospital Quirón Madrid 
  Hospital Ramón y Cajal  86 
  Hospital Rey Juan Carlos  10 
  Hospital Ruber Internacional 
  Hospital San Rafael 
  Hospital Sanitas La Moraleja 
  Hospital Severo Ochoa 
  Hospital Universitario de Getafe 
  Hospital Universitario Infanta Elena 
  Hospital Universitario la Paz  86 
  Hospital Universitario Puerta de Hierro Majadahonda  102 
  Hospital Virgen de la Paloma 
  Hospital Virgen del Mar 
  Sanatorio San Francisco de Asís 
Region of Murcia  Clínica Virgen de la Vega 
  Hospital Rafael Méndez 
  Hospital General Universitario Morales Meseguer 
  Hospital General Universitario Reina Sofía 
  Hospital General Universitario Santa Lucía 
  Hospital Universitario Virgen de la Arrixaca  105 
Chartered Community of Navarre  Hospital de Navarra  54 
  Clínica Universitaria de Navarra  34 
Basque Country
Álava  Hospital Universitario de Araba  55 
Guipúzcoa  Hospital Universitario Donostia (San Sebastián) 
  Hospital de Donostia 
Vizcaya  Hospital de Basurto  42 
  Hospital de Cruces  54 
  Hospital de Galdakao-Usansolo  23 
  IMQ Zorrotzaurre 
Figure 1.

Distribution implantation activity in 2013 by autonomous community: number of implantation centers/implantation rate per million population/total number of implantations.

(0.35MB).
Total Number of Implantations

In total, 4772 first and replacement implantations were performed in 2013, more than in 2012 (4216). According to EUCOMED data,14 this figure represents 85.6% of the total of 5573 ICD implantations carried out in 2013 in Spain. Figure 2 shows the total number of implantations reported to the registry and the number estimated by EUCOMED over the last 11 years.

Figure 2.

Total number of implantations reported to the registry and total number estimated by the European Medical Technology Industry Association (2003-2013).

(0.18MB).

The implantation rate recorded in the registry was 102,1 per million population, while the rate according to the EUCOMED data was 120 per million population. Figure 3 shows the changes occurring in the implantation rate per million population over the last 11 years according to the registry and EUCOMED data. Table 1 shows the number of implantations reported to the registry by each participating center. Table 2 lists the number of implantations performed in each province and the rate per million population for the corresponding autonomous community.

Figure 3.

Total number of implantations reported to the registry per million population and as estimated by the European Medical Technology Industry Association (2003-2013).

(0.16MB).
Table 2.

Implantations by Autonomous Community and Province

Autonomous community  Rate per 106 inhabitants  Province  Implantations (n) 
Andalusia  82.9  Almería  17 
    Cádiz  56 
    Córdoba  49 
    Granada  81 
    Huelva  35 
    Málaga  220 
    Seville  221 
Aragon  94.9  Zaragoza  127 
Principality of Asturias  186.4  Asturias  199 
Balearic Islands  71.5  Baleares  79 
Canary Islands  77.0  Las Palmas  65 
    Tenerife  97 
Cantabria  105.0  Santander  105 
Castile and León  122.7  Ávila  23 
    Burgos  51 
    Leon  40 
    Salamanca  64 
    Valladolid  131 
Castile-La-Mancha  84.3  Albacete  42 
    Ciudad Real  20 
    Cuenca  12 
    Guadalajara  27 
    Toledo  132 
Catalonia  84.6  Barcelona  593 
    Lleida  30 
    Tarragona  10 
Valencian Community  127.1  Alicante  234 
    Castellón  22 
    Valencia  374 
Extremadura  156.0  Badajoz  127 
    Cáceres  29 
Galicia  122.1  A Coruña  230 
    Lugo 
    Ourense 
    Pontevedra  105 
La Rioja  50.2  La Rioja  16 
Community of Madrid  99.1  Madrid  636 
Region of Murcia  91.0  Murcia  133 
Chartered Community of Navarre  137.7  Navarra  88 
Basque Country  85.4  Álava  55 
    Guipúzcoa  11 
    Vizcaya  120 
No data      42 

The name of the participating center was reported in 99% of the cases. Most procedures, 4398 (92%), were performed in public centers.

First Implantation vs Replacement Procedures

This information was reported in 4334 data forms sent to the SEC (91%). There were 2981 first implantations, representing 68.8% of the total (69.4% in 2012; 70.2% in 2011 and 73.8% in 2010). The rate of first implantations in 2013 was 63.8 per million population (64 per million population in 2012, equalling that in 2011).

Age and Sex

The mean age (standard deviation) [range] of patients receiving an ICD or replacement device was 62.6 (13.4) [7-90] years. In first implantations, the mean age was 61.3 (13.4) years. Most of the patients were men, representing 83.3% of all patients, and 83.7% of patients receiving a first implantation.

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

The most common underlying cardiac condition in first implantations was ischemic heart disease (53.4%), followed by dilated cardiomyopathy (28.4%), hypertrophic cardiomyopathy (7.1%), primary conduction abnormalities (Brugada syndrome, idiopathic ventricular fibrillation and long QT syndrome) (7.5%) and, in lower percentages, valvular heart disease and arrhythmogenic dysplasia (Figure 4).

Figure 4.

Type of heart disease prompting device implantation (first implantations).

(0.18MB).

Regarding left ventricular function in patients undergoing a first implantation, left ventricular ejection fraction was < 30% in 50.0%; 30%-40% in 25.6%; 41%–50% in 7.8%, and > 50% in 16.2%. The distribution was similar in patients receiving a replacement ICD (Figure 5). This information was reported in 85.5% of the data collection forms.

Figure 5.

Left ventricular ejection fraction in registry patients (all implantations and first implantations). LVEF, left ventricular ejection fraction.

(0.07MB).

Regarding New York Heart Association (NYHA) functional class, most patients were in NYHA II (47.2%), followed by NYHA III (34.3%), NYHA I (16.6%), and NYHA IV (1.9%). In this variable, the distribution between the total number of implantations and first implantations was also very similar (Figure 6). This information was reported in 75.6% of the data collection forms.

Figure 6.

New York Heart Association functional class in registry patients (all implantations and first implantations). NYHA, New York Heart Association.

(0.06MB).

The baseline cardiac rhythm, recorded in 80.5% of the patients, was mainly sinus rhythm (81.3%), followed by atrial fibrillation (16.1%) and paced rhythm (2.1%); the remaining patients had other rhythms (atrial flutter and other arrhythmias).

Clinical Arrhythmia Prompting Device Placement, Form of Presentation, and Electrical Stimulation-Induced Arrhytmias

This information was reported in 80.7% of the data collection forms. In first implantations, the largest group consisted of patients with no documented clinical arrhythmia (50.8%), followed by those with sustained monomorphic ventricular tachycardia, nonsustained ventricular tachycardia, and ventricular fibrillation (21.3%, 14.1% and 12.3%, respectively). Among the total number of implantation procedures performed, 50.8% of devices were placed in patients without documented clinical arrhythmia (Figure 7). Differences in the type of arrhythmia between patients receiving a first implantation and the overall group of patients were statistically significant for patients without arrhythmia (P<.001) and those with sustained monomorphic ventricular tachycardia (P<.001) but not for patients with nonsustained ventricular tachycardia or ventricular fibrillation. The most common clinical presentation in the overall group and the first-implantation group (62.2% and 68.9% completed responses) was asymptomatic, followed by syncope, sudden cardiac death, and “other symptoms” (Figure 8).

Figure 7.

Distribution of arrhythmias prompting device implantation (first implantations and all implantations). NSMVT, nonsustained monomorphic ventricular tachycardia; PVT, polymorphic ventricular tachycardia; SMVT, sustained monomorphic ventricular tachycardia; VF, ventricular fibrillation. *P<.001.

(0.06MB).
Figure 8.

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

(0.07MB).

Information on electrophysiological studies was available in 2244 patients receiving a first implantation (86.4%). Electrophysiological studies were conducted in only 305 patients (13.6%).The most frequently induced arrhythmia was sustained monomorphic ventricular tachycardia (47.9%), followed by ventricular fibrillation (11.8%) and, to a lesser extent, nonsustained ventricular tachycardia (10.7%), and other arrhythmias (3.7%). No arrhythmia was induced in 26.1% of electrophysiological studies, which were mainly carried out in patients with ischemic heart disease and dilated cardiomyopathy.

Clinical History

Several new fields related to the patients’ clinical history have been incorporated in the data collection form since 2011.

For patients with first implantations, between 64.5% and 80.4% of these fields were completed, with the following results: hypertension, 58.4%; hypercholesterolemia, 50.2%; smoking, 33.2%; diabetes mellitus, 29.8%; a history of atrial fibrillation, 26.4%; kidney failure, 13.8%; a history of sudden cardiac death, 8.5%, and stroke, 6.8%.

The QRS interval was documented in 47.9% of the records (mean value 124.1 [35ms]). The QRS interval was > 140ms in 31.1% of the patients. Of these, 79.6% in the first implantation group (80.2% of the overall group) had a combined resynchronization/ICD (ICD-CRT [cardiac resynchronization therapy]) device.

Indications

Table 3 shows changes in first implantations by type of heart disease and form of presentation from 2009 to 2013. This information was reported in 93% of the data collection forms. In ischemic heart disease, the most frequent indication was primary prevention (48.8%), with no increase compared with the previous year (50.5%). The main indication in dilated cardiomyopathy was also primary prevention (52.1% vs 62.3% in 2012 and 53.4% in 2010). In less common heart diseases, the most frequent indication was primary prevention of hypertrophic cardiomyopathy and Brugada syndrome and other channelopathies. In congenital heart disease and valvular heart disease, the most frequent indication was secondary prevention.

Table 3.

Number of First Implantations According to the Type of Heart Disease, Type of Clinical Arrhythmia, and Form of Presentation (2009–2013)

  2009  2010  2011  2012  2013 
Ischemic heart disease
Aborted SCD  111 (7.9)  154 (10.0)  150 (10.8)  134 (9.9)  135 (10.5) 
SMVT with syncope  117 (8.4)  132 (8.6)  199 (14.4)  110 (8.1)  160 (11.9) 
SMVT without syncope  201 (14.4)  317 (20.7)  197 (14.2)  148 (10.9)  179 (13.3) 
Syncope without arrhythmia  121 (8.7)  68 (4.4)  95 (6.8%)  77 (5.7)  43 (3.2) 
Prophylactic indication  637 (45.9)  642 (42.0)  623 (45.0)  682 (50.5)  657 (48.9) 
Missing/unclassifiable  202 (14.5)  212 (13.9)  120 (8.7)  200 (14.8)  169 (12.6) 
Subtotal  1389  1525  1348  1.351  1343 
Dilated cardiomyopathy
Aborted SCD  53 (5.5)  49 (6)  47 (5.9)  50 (6.6)  46 (6.0) 
SMVT with syncope  61 (6.4)  58 (7.1)  57 (7.1)  44 (5.8)  79 (10.4) 
SMVT without syncope  69 (7.2)  136 (16.8)  157 (19.6)  46 (6.0)  81 (10.7) 
Syncope without arrhythmia  102 (10.7)  34 (4.2)  37 (4.6)  38 (5.0)  49 (6.5) 
Prophylactic indication  440 (46.1)  393 (48.7)  427 (53.4)  473 (62.3)  395 (52.1) 
Missing/unclassifiable  228 (23.9)  136 (16.8)  74 (9.3)  108 (14.2)  108 (14.2) 
Subtotal  953  806  799  759  758 
Valvular heart disease
Aborted SCD  8 (9.3)  9 (8.3)  16 (10.8)  15 (13.4)  11 (10.2) 
SMVT  27 (31.3)  29 (26.8)  47 (31.8)  24 (21.6)  41 (37.9) 
Syncope without arrhythmias  8 (9.3)  4 (3.7)  5 (3.4)  12 (10.8)  4 (3.7) 
Prophylactic indication  28 (23.5)  50 (46.2)  66 (44.6)  48 (43.2)  38 (35.2) 
Missing/unclassifiable  15 (17.4)  16 (14.8)  14 (9.6)  12 (10.8)  14 (12.9) 
Subtotal  86  108  148  111  108 
Hypertrophic cardiomyopathy
Secondary prevention  24 (14.9)  90 (54.5)  52 (27.9)  53 (26)  58 (29.9) 
Prophylactic indication  97 (60.2)  53 (32.1)  127 (68.8)  140 (68.6)  131 (67.5) 
Missing/unclassifiable  40 (24.8)  22 (13.2)  7 (3.8)  11 (5.3)  5 (2.8) 
Subtotal  161  165  186  204  194 
Brugada syndrome
Aborted SCD  11 (8.4)  17 (24.6)  7 (13.5)  11 (14.1)  9 (13.6) 
Prophylactic implantation in syncope  36 (27.6)  18 (26.6)  25 (40.8)  22 (28.2)  28 (42.4) 
Prophylactic implantation without syncope  52 (40.0)  23 (33.3)  15 (28.8)  42 (53.8)  18 (27.2) 
Missing/unclassifiable  31 (23.8)  11 (15.9)  5 (9.6)  3 (3.8)  11 (16.7) 
Subtotal  130  69  52  78  66 
ARVC
Aborted SCD  1 (3.8)  4 (15.9)  2 (4.6)  1 (3.3)  5 (12.2) 
SMVT  16 (61.2)  23 (71.8)  21 (48.8)  11 (33.3)  14 (34.5) 
Prophylactic implantation  5 (19.2)  4 (12.5)  17 (39.5)  13 (39.4)  14 (34.5) 
Missing/unclassifiable  4 (15.3)  1 (3.1)  3 (6.9)  8 (24.4)  8 (19.5) 
Subtotal  26  32  43  33  41 
Congenital heart disease
Aborted SCD  4 (19.0)  3 (8.1)  4 (12.5)  6 (20.0)  4 (17.4) 
SMVT  1 (4.7)  15 (40.5)  8 (25.0)  7 (23.3)  6 (26.1) 
Prophylactic implantation  9 (42.8)  16 (43.2)  15 (46.8)  12 (40.0)  10 (43.5) 
Missing/unclassifiable  7 (33.3)  3 (8.1)  5 (15.4)  5 (16.6)  3 (13.4) 
Subtotal  21  37  32  30  23 
Long QT syndrome
Aborted SCD  9 (50.0)  18 (60.0)  11 (50.0)  10 (41.6)  19 (48.7) 
Prophylactic implantation  3 (16.6)  6 (20.0)  9 (40.9)  10 (41.6)  18 (46.1) 
Missing/unclassifiable  6 (33.3)  6 (20.0)  2 (9.1)  4 (16.6)  2 (5.3) 
Subtotal  18  30  22  24  39 

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

Data are expressed as No. (%).

The indication for implantation was reported in 82.1% of the data collection forms. Most first implantations were indicated for primary prevention (53.0%); this was the second year that the number of implantations decreased for this indication. This trend has been increasing and was statistically significant (P<.01) until 2008, between 2009 and 2010, and became significant again in 2013 (Table 4).

Table 4.

Changes in the Main Indications for Implantable Cardioverter-defibrillator Placement (First Implantations, 2003-2013)

Year  SCD  SMVT  Syncope  Primary prevention 
2003  13.7  42.8  14.0  29.0 
2004  14.8  37.0  16.0  32.2* 
2005  11.1  34.8  14.6  39.5* 
2006  9.5  27.0  13.2  50.3* 
2007  9.9  25.0  14.1  50.7* 
2008  9.3  21.4  12.3  57.0* 
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* 

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

*Significant difference compared with the previous year (P<.001).

Implantation Setting and Attending Specialist

Information on these items was reported in 82.5% of the data collection forms. Implantations were mainly (79.8%) carried out in the electrophysiology laboratory (81.4% in 2012, 76.4% in 2011), followed by the operating room (18.4%). The procedure was carried out by electrophysiologists in 80.7% of implantations (81.0% in 2012, 78.4% in 2011), surgeons in 13.8% (14.0% in 2012, 15.5% in 2011), both specialists in 2.0%, and other specialists and intensivists in 2.0% and 1.6%, respectively.

Generator Implantation Site

Information on the generator implantation site in first implantations was reported in 2575 (28.8%) data collection forms. The generator was placed subcutaneously in 94.6% of procedures and in a subpectoral position in the remaining 5.4%. Among the total number of devices implanted, these percentages were 93.5% and 6.5%, respectively.

Type of Device

This information was reported in 91.4% of the data collection forms and is summarized in Table 5. Single/chamber ICDs were implanted in 48.2% (49.4% in 2012 and 46.7% in 2011). Dual-chambers were implanted in 18.9% (18.0% in 2012 and 18.4% in 2011) and ICD-CRT were implanted in 32.9% (32.5% in 2012 and 34.9% in 2011).

Table 5.

Distribution (%) of the Types of Implantable Cardioverter-defibrillators Placed

  2010, total  2011, total  2012, total  2012, first implantations  2013, total  2013, first implantations 
Single-chamber  50.3  46.7  49.4  52.5  48.2  50.9 
Dual-chamber  20.2  18.4  18.0  17.7  18.9  19.5 
Resynchronizer  28.2  34.9  32.5  30.0  32.9  29.5 

In patients with ischemic heart disease, 74.8% of the devices were single- or dual-chamber devices (72.3% in 2012) and 25.5% were ICD-CRT (27.7% in 2012). In patients with dilated cardiomyopathy, 51.7% of the devices were ICD-CRTs (56.5% in 2012 and 59.7% in 2011).

Reasons for Device Replacement, Need for Replacement, and Use of Additional Leads

Among 1,353 replacement procedures, information was available for 1,035 (86.9%). The most common reason was battery depletion in 86.9%, followed by complications in 7.9% and change of indication in 5.1%. Of the 69 cases of early replacement procedures reported, 11.6% were carried out within 6 months of the implantation procedure.

In 65% of the replacement reports, information was provided on the status of the leads; 9.3% (82 records) were malfunctioning. Among cases in which malfunctioning was reported, lead extraction was performed in 46%.

Implantable Cardioverter-defibrillator Programming

Information on this ítem was reported in 73.5% of the data collection forms. The most commonly used pacing was VVI mode (56.6%), followed by DDD mode (29.3%), VVIR mode (7.0%), DDDR mode (4.9%), and other pacing modes, mainly preventive algorithms for ventricular pacing (2.2%)

Information on induction of ventricular fibrillation was reported in 3850 data collection forms and 197 patients (5.1%) underwent this procedure (6.7% in 2012). The mean threshold was 20.4 (6.5) (20.5 [7.1] in 2012) and the mean number of shocks delivered was 1.3.

Complications

Information on complications was provided in 79.4% of the data collection forms. In total, 26 complications were described: 6 coronary sinus dissections, 3 pneumothorax, 2 deaths, 2 cases of tamponade, and 13 cases of unspecified complications. The mortality rate was 0.05%, similar to that reported for the previous year (0. 08%).

DISCUSSION

The results of the 2013 Spanish Implantable Cardioverter-defibrillator Registry continue to show an acceptable level of representativeness. The information provided is reliable regarding the number of implantations, the type of device, indications, and the patients’ clinical characteristics.

Comparison With Registries for Previous Years

The first Spanish Implantable Cardioverter-defibrillator Registry was published in 2005 and presented the results for the period 2002-2004.4 The number of ICDs implanted increased each year until 2010,5–10 and decreased in 2011 and 2012. This decrease was observed in the total number of devices implanted in Spain, both in the registry data,11,12 and in the results reported by EUCOMED. In 2013, the number of implantations increased again, exceeding the number reported to the registry in 2010. In Europe, a slight increase has been maintained, both in the number of ICD implantations and in ICD-CRTs.14

Despite the increase in the number of devices implanted, for the second consecutive year, the number of implantations indicated for primary prevention decreased compared with 201212 (53.0% vs 58.1%).

The percentage of ICD-CRT implantations reached a plateau (32.9% vs 32.5% in 2012), as did the percentage of single-chamber ICD implantations (48.2% vs 49.4% in 2012). There was practically no change in the use of dual-chamber ICDs (18.9% vs 18.0%). The rate of ICD-CRT implantation seems to have become stabilized within ICD therapy, and no major changes are expected, unless produced by potential new indications. These data may also be modified in future registries by the arrival of subcutaneous ICDs.

The most common indication for ICD implantation continued to be ischemic heart disease (53.4%), followed by dilated cardiomyopathy (28.2%). As in previous years,12 more than half of the implantations in patients with dilated cardiomyopathy were ICD-CRTs (51.6%), whereas the percentage was lower in patients with ischemic heart disease (25.1%).

The progressive increase in the number of ICD implantations came to a halt in 2011 and 2012. The results of 2013 show a certain recovery: the total number of implantations slightly exceeded the rate per million population for 2010 (102 vs 100).15 In the last few years, no new studies have been published that would modify the indications for ICD implantation. The Multicenter Automatic Defibrillator Implantation Trial II16 was published in 2002, and the Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure trial17 and the Sudden Cardiac Death in Heart Failure Trial18 in 2005 and 2006, respectively, which laid down the current indications in primary prevention and cardiac resynchronization and led to a progressive rise in the number of implantations during that decade. The indications for ICD and CRT implantation are well supported by clinical practice guidelines.19–22 However, the implantation rate per million population does not correspond to the rate that could be expected from the clinical evidence, either in Spain or in neighboring countries,23 and this tendency has become more marked over time, both in Spain and elsewhere in Europe.

As in previous registries, there are differences in the number of implantations recorded in the present registry and the EUCOMED data, although these differences decreased in 2013 (85.0% vs 80.4% in 2012), despite a slight reduction in the number of participating centers. Most hospitals implanting ICDs send data to the registry, but the rate has not yet reached 100% of implanting centers. Moreover, some data are lost while being sent and processed. All these reasons may explain the differences between the present registry and the EUCOMED data.

The number of participating centers decreased slightly compared with 2012, mainly due to the grouping of several hospitals, which submitted pooled data. None of the hospitals reported an implantation rate > 200; 14 hospitals (8 in 2012 and 11 in 2011) reported > 100 implantations, and 72 centers—mostly private centers—reported < 10 implantations. Some studies show a relationship between implantation volume and the number of complications,24 with a higher implantation volume being associated with a lower complications rate.

There were no significant changes in the patients’ epidemiologic characteristics compared with previous registries. Patients with severe ventricular dysfunction and those in NYHA functional class II or III continued to predominate and a plateau was reached in the growing tendency in the number of implantations carried out in the electrophysiology laboratory (79.8% vs 81.4% in 2012 and 76.4% in 2011) and in those performed by electrophysiologists (80.7% vs 81% in 2012 and 78.4% in 2011).

Differences Among Autonomous Communities

The differences in ICD implantation rates among the various autonomous communities held steady. The implantation rate was 102 per million population according to the registry and was 120 per million population according to EUCOMED data, with both figures showing an increase compared with 2012 (91.2 and 113.0, respectively). Several autonomous communities showed rates above the average: Principality of Asturias (186), Extremadura (156), Chartered Community of Navarre (137), Valencian Community (127), Galicia (122), Castile and León (122) and Cantabria (105). The autonomous communities with activity below the average included the Community of Madrid (99), Aragon (94), Region of Murcia (91), the Basque Country(85), Castile-La-Mancha (84), Catalonia (84), Andalusia (82), The Canary Islands (77) and the Balearic Islands (71). The difference between the communities with the highest and lowest implantation rates is currently more than double and has increased compared with previous registries (186 vs 71). In general, the percentage of implantations per million population increased in practically all the autonomous communities and decreased only in the Canary Islands.

The data for 2013 show a widespread increase in Spain, which was more marked in the autonomous communities with ICD implantation rates above the average. No association was found between the gross domestic product of each region and the number of implantations. Curiously, most of the regions with higher per capita incomes had below-average implantation rates. The regions with higher-than-average rates were the least densely populated, except for the Valencian Community. Equally, there was no association between implantation rates and the incidence of ischemic heart disease and heart failure in the distinct regions. These differences could be explained by other reasons, such as the organization of the health system in each region, the number of arrhythmia units, and the distribution of referrals.

Comparison With Other Countries

The implantation rate in countries participating in the EUCOMED was 289 per million population (273 in 2012), including ICD and ICD-CRT. Germany, with 541 devices, continued to be the country with the highest number of implantations. Spain (120 implantations per million) was the country with the lowest number of implantations. The countries with above-average implantation rates were the Netherlands (388), Italy (381), Denmark (322), and the Czech Republic (351). Countries with below-average implantation rates were Poland (276), Austria (253), Ireland (250), Belgium (237), Sweden (223), Norway (219), France (202), Switzerland (196), Finland (182), the United Kingdom (164), Portugal (148), Greece (141), and Spain (120). The difference in the implantation rate in Spain compared with the mean continued to increase (120 vs 289 in 2013 and 113 vs 269 in 2012). Likewise, the difference between Spain and the next-ranking country also increased (120 vs 141).

The ICD implantation rate was 176 per million population in 2013 (167 in 2012). The country with the highest number of implantations was Germany (331) and that with the lowest was Spain (80).

The ICD-CRT implantation rate was 113 per million population (106 in 2012). The rate continued to be highest in Germany (210 implantations) and lowest in Spain (40).

The proportion of ICD-CRT with respect to the total number of implantations ranged from 26% in Poland and 45% in Italy. The percentages were above 40% in the Czech Republic, France, Switzerland, Ireland, and Italy and were <30% in Norway and Poland. The proportion was in Spain was 33%.

The 2013 data show that implantation rates increased in Europe. The differences in Spain compared with the European mean continued to increase.

Other European countries showed the same regional differences25,26 found in our registry and there is no clear explanation for this finding. A possible explanation involves the number of available arrhythmia units but the relationship is far from clear, at least in Spain, where the regions with the highest number of available units had the lowest implantation rates. Other explanations, such as per capita income, also fail to elucidate these differences; the ICD implantation rate was much higher in countries such as Ireland, the Czech Republic and Poland than in Spain. Other factors that could be related to the implantation rate and its variability in Spain are the prevalence of cardiovascular diseases, access to the health system and its organization, and the degree of acceptance and adherence to clinical practice guidelines.

Limitations

According to the EUCOMED data, the registry included 85.6% of the implantations performed in Spain. This percentage is higher than those for 2012 (80.8%) and 2011 (83.6%). The number of implantations reported to the registry decreased after 2007, when 90% of implantations were notified, but has risen again and the number reported is still representative of the situation in Spain. The number of participating centers has slightly declined in the last 2 years, mainly because amalgamation among hospitals led to data pooling.

In some hospitals, the true number of implantations differed from the number notified. Some data collection forms were not received or properly registered, since data can be sent and received in several ways. We continue to hope that next year's data will be gathered through the online data collection form, which could improve the results and narrow the gap between the data received and those provided by EUCOMED.

There was excessive variability in the response rate to distinct items on the ICD data collection form, oscillating between 99.0% for the item on the implanting hospital to 47.9% for that on QRS width. Lastly, the percentage of complications reported to the registry does not reflect the true situation, given that the data were completed during or immediately after implantation. Consequently, there was no record of most subacute complications.

Future Prospects of the Spanish Implantable Cardioverter-defibrillator Registry

The current registry is the X official report of this activity in Spain. All members of the Electrophysiology and Arrhythmias Section of the SEC who participate in this registry can feel proud of its continued existence. Its progressive modernization will allow more and better information to be collected with less effort on the part of all the staff involved in its maintenance. Its future computerization may allow the inclusion of more ambitious clinical objectives and parameters such as mortality, shocks delivered, complications, etc., which will provide important clinical information and represent a substantial improvement.

CONCLUSIONS

The 2013 Spanish Implantable Cardioverter-defibrillator Registry is a compilation of 85.6% of the implantations carried out in Spain and continues to be representative of the activity and current indications for this treatment in our environment. After 2 consecutive years with a decreasing number of implantations, this trend was reversed, with 102 implantations per million population. As in previous years, the number of implantations in Spain continues to be much lower than the average for the European Union. This difference continues to increase and considerable differences persist among the autonomous communities.

CONFLICTS OF INTEREST

J. Alzueta has participated in research projects with St. Jude Medical, Medtronic, Boston Scientific, Biotronik and the Sorin Group. I. Fernández Lozano has participated in round tables sponsored by Medtronic, St. Jude Medical, Boston, Biotronik and the Sorin Group and holds a research grant from Boston Scientific.

Acknowledgments

We would like to express our appreciation to all the health care professionals involved in ICD implantation in Spain, who have voluntarily and generously contributed to the success of the registry. We also extend our thanks to José María Fernández, who holds a grant from the SEC for maintaining the Spanish Implantable Cardioverter-defibrillator Registry database, for his enthusiasm in maintaining the data and participating in its compilation. We also thank the staff at the ICD manufacturers (Medtronic, Boston Scientific, St, Jude Medical, Biotronik, and the Sorin Group) for their help in collecting and sending data to the SEC on the majority of implantations. Finally, we wish to thank the SEC for its excellent work in data collection and entry, and in particular Gonzalo Justes and José María Naranjo.

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