Abstract

Cardiac resynchronization therapy (CRT) is a highly efficient treatment modality for patients with severe congestive heart failure and intraventricular dyssynchrony. However, the high individual cost and technical complexity of the implantation may limit its widespread utilization. The European Heart Rhythm Association (EHRA) launched a project to assess treatment of arrhythmias in all European Society of Cardiology member countries in order to have a platform for a progressive harmonization of arrhythmia treatment. As a result, two EHRA White Books have been published in 2008 and 2009 based on governmental, insurance, and professional society data. Our aim was to analyse the local differences in the utilization of CRT, based on these surveys. A total of 41 countries provided enough data to analyse years 2006–2008. Significant differences were found in the overall number of implantations and the growth rate between 2006 and 2008. Other contributing factors include local reimbursement of CRT, the existence of national guidelines, and a high number of conventional implantable cardioverter-defibrillator implantations, while GDP or healthcare spending has less effect. Focusing on improving these factors may increase the availability of CRT in countries where it is currently underutilized.

Introduction

The increasing incidence of congestive heart failure (CHF) is one of the major causes for the growing healthcare costs in industrialized countries. The overall CHF prevalence is ∼2%, which increases to 6–10% in the elderly population (age >65 years). The lifetime risk of developing CHF is ∼20%, regardless of gender, 1 while the age-adjusted incidence of CHF remained stable over the past 20 years in Europe. 2 , 3 Despite the advances of medical therapy, mortality is still high and quality of life is severely impaired in advanced stages. 4 Using different measurements, the prevalence of mechanical dyssynchrony can reach 70% in patients with severe CHF. 5

Cardiac resynchronization therapy (CRT) with atriobiventricular pacing (CRT-P) was introduced in the mid-90s and became increasingly popular after the promising results of the early trials. 6 , 7 From the year 2000 onwards, implantable cardioverter-defibrillators capable of atriobiventricular stimulation became available (CRT-D). The convincing results first of large clinical trials and subsequently of meta-analyses formed the basis of evidence-based practice guidelines, published by professional societies, such as the European Society of Cardiology (ESC), European Heart Rhythm Association (EHRA), American Heart Association, American College of Cardiology, and the Heart Rhythm Society. 8–11

Survey- and registry-based data regarding local pacing and electrophysiological practice, from several European countries are available 12 , 13 and the EHRA launched a project to assess the treatment of arrhythmias in all ESC member countries in order to have a platform for a progressive harmonization of arrhythmia treatment. As a result, two EHRA White Books were published in 2008 and 2009 based on governmental, insurance, and professional society data. 14 , 15

Methods

Data gathering

Data were gathered from the EHRA White Book publications. 14 , 15 A total of 41 countries provided comprehensive data and were included in the analysis ( Figure  1 ). It should be noted that demographic or economical data were dated a few years earlier in a few cases, but did not exceed 3 years. Implantation data from 2006, 2007, and 2008 have been analysed.

Figure 1

The 41 countries included in this analysis are Armenia, Austria, Belarus, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Latvia, Lebanon, Lithuania, Luxembourg, FYROM, Netherlands, Norway, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Tunisia, Turkey, and UK (coloured in dark blue).

Figure 1

The 41 countries included in this analysis are Armenia, Austria, Belarus, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Latvia, Lebanon, Lithuania, Luxembourg, FYROM, Netherlands, Norway, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Tunisia, Turkey, and UK (coloured in dark blue).

To gather data on the specific items a questionnaire was prepared. The questionnaire was presented and explained to the individual national representatives during the annual Spring Summit of the European Heart Rhythm Association in Nice 2007 and 2008. Each chairperson of the national working group of arrhythmias and/or pacing or president of the national society of arrhythmias was asked to provide data for each item. In many of the countries, national registry data, e.g. Spanish registry for catheter ablation were used as data source. In other countries, the president conducted a national survey or used reasonable estimates, if no exact data were available. Whenever estimates were used they were clearly indicated as such. Furthermore, data on ICD and pacemaker implantation were provided in parallel by EUCOMED (European Confederation of Medical Devices Association) for a number of countries. Data from EUCOMED were only used for entry into the White Book if the national chairman authorized the correctness of data for his country and only served as an additional source. In case no valid data were available, the data were not presented. For the presentation of the data of 2007, the most recent updated data were used from the 2009 edition. The same procedure was used both for the 2008 and 2009 edition. After the publication of the White Book, the national chairmen were asked to verify the data and to indicate mistakes. Only two mistakes were found and were immediately corrected in the published web version. The data collection and entry was performed by a Task Force of EHRA consisting of MBA students, EHRA staff, and members of the National Societies Committee.

Statistical analysis

For comparison, data are shown as mean ± standard deviation. Correlation analysis was performed by calculating Pearson's r . Stepwise multiple regression analysis was performed to identify independent factors that affect the number of CRT implantations per capita. The variables included were local CRT reimbursement, number of CRT centres per capita, availability of electrophysiology subspecialty, adherence to national or international CRT implantation guidelines, and healthcare spending per capita.

Results

Number of implantations

The number of CRT implantations per million capita for each country is shown in Figure  2 . Table  1 lists the number of pacemaker, CRT, and ICD implantations in 2008 and the changes from 2006.

Table 1

Pacemaker, ICD, and CRT implantation data 2006–2008

 PM/mil pop 2008 Change 2006–2008, PM/mil pop DDD PM 2007 (%) CRT/mil pop 2008 Change 2006–2008, CRT/mil pop CRT-D% 2008 ICD/mil pop 2008 Change 2006–2008, ICD/mil pop 
Armenia 100.4 10.1 n.a. 11.5 4.7 85 34.7 18.5 
Austria 922.5 32.2 64 96.9 28.3 70 134.1 25.0 
Belarus 161.5 −1.6 n.a. 5.2 3.1 50 4.1 3.6 
Belgium  833.1 a  −224.1 a n.a. n.a. n.a. n.a. 153.8 28.8 
Bulgaria 335.6  32.2 a 16 10.6  6.1 a 19 1.2  0.0 a 
Croatia 482.2 57.4 n.a. 5.1 0.2 18.5 6.7 
Cyprus 378.5 n.a. n.a. n.a. n.a. n.a. 44.2 n.a. 
Czech Republic 821.9 −27.6 55 113.6  35.4 a 58 196.9 70.7 
Denmark 737.9 −1.3 63 66.2 −11.1 61 228.8 125.8 
Egypt 26.9 n.a. n.a. 1.3 n.a. 31 0.2 n.a. 
Estonia 851.2 142.2 71 14.5 −5.4 13.8 2.3 
Finland 803.5 154.2 n.a. 36.6 13.5 63 31.5 −50.0 
France 983.5 46.1 75 84.0 15.1 61 128.0 62.6 
Georgia 60.0 12.7 29 1.3 0.4 100 2.4 1.5 
Germany 1 193.4 16.9 67 114.6 30.0 89 262.2 69.5 
Greece 711.3 70.8 n.a 33.8 13.2 75 93.1 55.0 
Hungary 470.7 20.6 53 52.5 15.2 42 54.3 16.8 
Iceland 896.9 n.a. n.a. 26.3 n.a. 38 141.3 n.a. 
Ireland  441.8 a  −104.7 a 48 n.a. n.a. n.a.  79.2 a  −45.5 a 
Israel 456.8 105.9 41 115.6 59.2 85 108.1 23.3 
Italy 1 054.3 108.3 n.a  163.4 b  60.2 b  100 b 309.6 79.1 
Latvia 487.2 126.0 n.a. 42.3 33.8 43 16.9 9.4 
Lebanon 93.2 17.6 n.a. 25.2 −7.6 90 27.7 −2.5 
Lithuania 561.8 157.9 74 16.0 10.9 14.3 9.8 
Luxembourg 191.4 63.8 n.a. 20.6 4.1 40 84.4 22.6 
FYROM 108.7 18.9 n.a. 5.8 −6.3 17 1.5 −1.9 
Netherlands 648.8 62.2 n.a. 88.6 32.4 89 194.5 87.7 
Norway  587.8 a  162.3 a 68  51.2 a  5.0 a  43 a  126.8 a  56.4 a 
Poland 707.8 240.3 37 34.8 23.6 61 91.2 56.2 
Portugal 739.6 69.8 55 41.8 10.4 74 68.1 23.9 
Romania 105.5 15.9 19 4.5 1.3 24 4.8 1.8 
Russia  145.0 a  36.6 a 32  2.3 a  1.2 a  6 a  2.3 a  1.1 a 
Serbia 461.3 2.7 n.a. 30.6 5.7 30 31.3 12.4 
Slovakia 490.3 29.5 30 37.6 23.3 80 103.4 64.2 
Slovenia 547.9 27.9 n.a. 27.9 14.9 34 47.8 9.0 
Spain 790.3 80.5 53 43.1 10.3 71 86.1 30.1 
Sweden 917.6 37.7 70 94.0 26.3 41 75.2 34.2 
Switzerland 710.7 45.5 64 56.6 14.8 69 155.5 98.4 
Tunisia 134.8 37.6 58 7.9 5.5 33 6.1 2.2 
Turkey  69.5 a  0.0 a n.a.  6.3 a  1.4 a  33 a  12.5 a  1.4 a 
UK 631.7 55.8 n.a. 77.1 20.5 60 73.8 11.5 
 PM/mil pop 2008 Change 2006–2008, PM/mil pop DDD PM 2007 (%) CRT/mil pop 2008 Change 2006–2008, CRT/mil pop CRT-D% 2008 ICD/mil pop 2008 Change 2006–2008, ICD/mil pop 
Armenia 100.4 10.1 n.a. 11.5 4.7 85 34.7 18.5 
Austria 922.5 32.2 64 96.9 28.3 70 134.1 25.0 
Belarus 161.5 −1.6 n.a. 5.2 3.1 50 4.1 3.6 
Belgium  833.1 a  −224.1 a n.a. n.a. n.a. n.a. 153.8 28.8 
Bulgaria 335.6  32.2 a 16 10.6  6.1 a 19 1.2  0.0 a 
Croatia 482.2 57.4 n.a. 5.1 0.2 18.5 6.7 
Cyprus 378.5 n.a. n.a. n.a. n.a. n.a. 44.2 n.a. 
Czech Republic 821.9 −27.6 55 113.6  35.4 a 58 196.9 70.7 
Denmark 737.9 −1.3 63 66.2 −11.1 61 228.8 125.8 
Egypt 26.9 n.a. n.a. 1.3 n.a. 31 0.2 n.a. 
Estonia 851.2 142.2 71 14.5 −5.4 13.8 2.3 
Finland 803.5 154.2 n.a. 36.6 13.5 63 31.5 −50.0 
France 983.5 46.1 75 84.0 15.1 61 128.0 62.6 
Georgia 60.0 12.7 29 1.3 0.4 100 2.4 1.5 
Germany 1 193.4 16.9 67 114.6 30.0 89 262.2 69.5 
Greece 711.3 70.8 n.a 33.8 13.2 75 93.1 55.0 
Hungary 470.7 20.6 53 52.5 15.2 42 54.3 16.8 
Iceland 896.9 n.a. n.a. 26.3 n.a. 38 141.3 n.a. 
Ireland  441.8 a  −104.7 a 48 n.a. n.a. n.a.  79.2 a  −45.5 a 
Israel 456.8 105.9 41 115.6 59.2 85 108.1 23.3 
Italy 1 054.3 108.3 n.a  163.4 b  60.2 b  100 b 309.6 79.1 
Latvia 487.2 126.0 n.a. 42.3 33.8 43 16.9 9.4 
Lebanon 93.2 17.6 n.a. 25.2 −7.6 90 27.7 −2.5 
Lithuania 561.8 157.9 74 16.0 10.9 14.3 9.8 
Luxembourg 191.4 63.8 n.a. 20.6 4.1 40 84.4 22.6 
FYROM 108.7 18.9 n.a. 5.8 −6.3 17 1.5 −1.9 
Netherlands 648.8 62.2 n.a. 88.6 32.4 89 194.5 87.7 
Norway  587.8 a  162.3 a 68  51.2 a  5.0 a  43 a  126.8 a  56.4 a 
Poland 707.8 240.3 37 34.8 23.6 61 91.2 56.2 
Portugal 739.6 69.8 55 41.8 10.4 74 68.1 23.9 
Romania 105.5 15.9 19 4.5 1.3 24 4.8 1.8 
Russia  145.0 a  36.6 a 32  2.3 a  1.2 a  6 a  2.3 a  1.1 a 
Serbia 461.3 2.7 n.a. 30.6 5.7 30 31.3 12.4 
Slovakia 490.3 29.5 30 37.6 23.3 80 103.4 64.2 
Slovenia 547.9 27.9 n.a. 27.9 14.9 34 47.8 9.0 
Spain 790.3 80.5 53 43.1 10.3 71 86.1 30.1 
Sweden 917.6 37.7 70 94.0 26.3 41 75.2 34.2 
Switzerland 710.7 45.5 64 56.6 14.8 69 155.5 98.4 
Tunisia 134.8 37.6 58 7.9 5.5 33 6.1 2.2 
Turkey  69.5 a  0.0 a n.a.  6.3 a  1.4 a  33 a  12.5 a  1.4 a 
UK 631.7 55.8 n.a. 77.1 20.5 60 73.8 11.5 

n.a., no data available.

a Data from 2007.

b CRT-D only, no data for CRT-P.

Figure 2

Number of CRT implantations between 2006 and 2008.

Figure 2

Number of CRT implantations between 2006 and 2008.

Between 2006 and 2008, a comparison between the number of implantations for conventional pacemakers showed a relatively small increase. Only a few countries were able to significantly increase the rate by more than 100/million capita, namely Estonia, Finland, Israel, Italy, Latvia, Lithuania, Norway, and Poland. The ratio of dual-chamber pacemaker devices shows a great variation from as low as 16% in Bulgaria to as high as 75% in France.

The number of ICD implantations in 2008 also showed great variability: the highest was 310/capita in Italy. The increase in the number of implantations between 2006 and 2008 was more dramatic than for pacemakers, most prominently in Belgium, the Czech Republic, Denmark, Germany, Italy, the Netherlands, and Switzerland.

The highest CRT implantation rate in 2008 was in Italy with 163 CRT devices/million capita (CRT-D only, data on CRT-P are unavailable). The number of implantations grew most dramatically in Italy and Israel: an increase of 60 and 59 implantations/million capita in 2008 compared with 2006. The ratio of CRT-D to total CRT shows great variability between countries. The ratio was 100% only in Georgia, however, the total number of procedures was very low, just 0.4/million capita in 2008 (six implants in total). The ratio in most countries was <60%. The average number of CRT implantations/million capita for the 31 ESC countries which had data for all 3 year was 53 in 2006, 65 in 2007, and 76 in 2008, a 43.4% increase in just 2 years (population 518 million, excluded countries: Belgium, Bulgaria, Cyprus, Czech Republic, Egypt, Iceland, Ireland, Norway, Russia, and Turkey). Taking all 41 countries into account, using the last available year, if data from 2008 were missing, the total number of implantations was 42/million capita, total population 782 million, only Belgium excluded. In 2008, 70.9% of implanted devices were CRT-D and 29.1% CRT-P.

Economical, reimbursement, and medical-professional differences

Table  2 summarizes the gross demographic, economical, and insurance data. The health expenditure generally ranges between 7 and 10% of each country's income, the lowest ratio is in Armenia (4.7%), while the highest is in Switzerland (11.3%). The per capita healthcare expenditure shows great variability, mostly depending on the nation's per capita GDP: the lowest is in Egypt, 133 Euro/capita, the highest is in Luxembourg: 8499 Euro/capita. The proportion of the public insurance for the healthcare costs is generally between 60 and 80%, with several examples on both extremes: Croatia, the Czech Republic, Denmark, Iceland, Luxembourg, the Netherlands, Norway, Sweden, and the UK above 80%, while Armenia, Cyprus, Egypt, Georgia, Greece, Lebanon, and Tunisia significantly below 60%. The availability of general public insurance also shows significant variation. Only a few countries had no reimbursement for pacemakers, ICD, and CRT in 2008: Bulgaria, Croatia, Cyprus, Denmark, Egypt, Iceland, and the Former Yugoslav Republic of Macedonia (FYROM).

Table 2

Demographic, economical, and insurance data

 Pop, million 2008 GDP, Euro/capita Health expenditure, Euro/capita Government health expenditure (%) Public insurance (%) CRT reimbursement 
Armenia 2 968 586 3401 160 41.2 35 Yes 
Austria 8 205 533 52 159 5164 77 83 Yes 
Belarus 9 658 768 6058 388 74.9 100 Yes 
Belgium 10 403 951 49 430 4696 71.1 90 Yes 
Bulgaria 7 262 675 6849 473 59.8 63 No 
Croatia 4 491 543 14 414 1081 80.1 90 No 
Cyprus 792 604 32 195 2028 44.8 70 No 
Czech Republic 10 220 911 21 041 1431 87.9 100 Yes 
Denmark 5 484 723 67 387 6402 84 100 No 
Egypt 81 713 517 2109 133 40.7 54 No 
Estonia 1 307 605 18 810 940 74.2 99 Yes 
Finland 5 244 749 54 578 4148 78.5 76 Yes 
France 64 057 790 48 012 5329 79.7 100 Yes 
Georgia 4 630 841 3061 257 21.5 25 Yes 
Germany 82 369 548 49 499 5148 76.6 90 Yes 
Greece 10 722 816 33 434 3310 42.5 89 Yes 
Hungary 9 930 915 16 343 1242 70.8 100 Yes 
Iceland 304 367 60 122 5591 83.1 100 No 
Ireland 4 156 119 64 660 4849 78.3 32 Yes 
Israel 7 112 359 26 536 2070 65.3 94 Yes 
Italy 58 145 321 40 450 3640 77.1 100 Yes 
Latvia 2 245 423 14 930 896 63.2 90 Yes 
Lebanon 3 971 941 7376 656 46.8 60 Yes 
Lithuania 3 565 205 14 456 896 70 100 Yes 
Luxembourg 486 006 118045 8499 90.6 100 Yes 
FYROM 2 061 315 4683 384 71.6 90 No 
Netherlands 16 645 313 54 445 5063 81.8 65 Yes 
Norway 4 644 457 102525 8920 83.6 100 Yes 
Poland 38 500 696 14 893 923 69.9 90 Yes 
Portugal 10 676 910 24 031 2403 71.8 85 Yes 
Romania 22 246 862 9953 567 71 57 Yes 
Russia 140 702 094 12 579 667 63.2 Yes 
Serbia 7 413 882 7054 536 71 100 Yes 
Slovakia 5 455 407 18 585 1301 73.9 75 Yes 
Slovenia 2 007 711 28 328 2380 73 85 Yes 
Spain 40 491 051 36 970 2995 72.5 100 Yes 
Sweden 9 045 389 55 624 4951 81.2 100 Yes 
Switzerland 7 581 520 67 379 7614 60.3 34 Yes 
Tunisia 10 383 577 4032 214 43.7 80 Yes 
Turkey 71 892 807 9629 741 72.3 95 Yes 
UK 60 943 912 45 681 3837 87.4 90 Yes 
 Pop, million 2008 GDP, Euro/capita Health expenditure, Euro/capita Government health expenditure (%) Public insurance (%) CRT reimbursement 
Armenia 2 968 586 3401 160 41.2 35 Yes 
Austria 8 205 533 52 159 5164 77 83 Yes 
Belarus 9 658 768 6058 388 74.9 100 Yes 
Belgium 10 403 951 49 430 4696 71.1 90 Yes 
Bulgaria 7 262 675 6849 473 59.8 63 No 
Croatia 4 491 543 14 414 1081 80.1 90 No 
Cyprus 792 604 32 195 2028 44.8 70 No 
Czech Republic 10 220 911 21 041 1431 87.9 100 Yes 
Denmark 5 484 723 67 387 6402 84 100 No 
Egypt 81 713 517 2109 133 40.7 54 No 
Estonia 1 307 605 18 810 940 74.2 99 Yes 
Finland 5 244 749 54 578 4148 78.5 76 Yes 
France 64 057 790 48 012 5329 79.7 100 Yes 
Georgia 4 630 841 3061 257 21.5 25 Yes 
Germany 82 369 548 49 499 5148 76.6 90 Yes 
Greece 10 722 816 33 434 3310 42.5 89 Yes 
Hungary 9 930 915 16 343 1242 70.8 100 Yes 
Iceland 304 367 60 122 5591 83.1 100 No 
Ireland 4 156 119 64 660 4849 78.3 32 Yes 
Israel 7 112 359 26 536 2070 65.3 94 Yes 
Italy 58 145 321 40 450 3640 77.1 100 Yes 
Latvia 2 245 423 14 930 896 63.2 90 Yes 
Lebanon 3 971 941 7376 656 46.8 60 Yes 
Lithuania 3 565 205 14 456 896 70 100 Yes 
Luxembourg 486 006 118045 8499 90.6 100 Yes 
FYROM 2 061 315 4683 384 71.6 90 No 
Netherlands 16 645 313 54 445 5063 81.8 65 Yes 
Norway 4 644 457 102525 8920 83.6 100 Yes 
Poland 38 500 696 14 893 923 69.9 90 Yes 
Portugal 10 676 910 24 031 2403 71.8 85 Yes 
Romania 22 246 862 9953 567 71 57 Yes 
Russia 140 702 094 12 579 667 63.2 Yes 
Serbia 7 413 882 7054 536 71 100 Yes 
Slovakia 5 455 407 18 585 1301 73.9 75 Yes 
Slovenia 2 007 711 28 328 2380 73 85 Yes 
Spain 40 491 051 36 970 2995 72.5 100 Yes 
Sweden 9 045 389 55 624 4951 81.2 100 Yes 
Switzerland 7 581 520 67 379 7614 60.3 34 Yes 
Tunisia 10 383 577 4032 214 43.7 80 Yes 
Turkey 71 892 807 9629 741 72.3 95 Yes 
UK 60 943 912 45 681 3837 87.4 90 Yes 

The local differences in cardiac electrophysiological practice are significant ( Table  3 ). Only Belarus, the Czech Republic, Egypt, Hungary, Latvia, the Netherlands, Poland, Portugal, Russia, Slovakia, Spain, and Tunisia recognized this field as an individual subspecialty. The number of CRT centres per capita is highest in Austria, 7.9/million capita, while most countries have between 1 and 2. The average number of CRT implantations per year for a centre is usually low, only the Czech Republic, Denmark, France, Israel, the Netherlands, Russia, Serbia, and the UK have more than 50 patients implanted per year. Most implants are now performed by cardiologists. Almost each country developed national PM/ICD guidelines and/or adheres to European or American guidelines, with the exception of Israel as of 2008.

Table 3

Local practices in device therapy

 EP subspec CRT centres/mil pop, 2008 Average CRT/centre/-year CRT implantation by cardiologists (%) National PM/ICD guidelines US/Euro PM/ICD guidelines 
Armenia No 0.3 34.0 100 No Yes 
Austria No 7.9 12.2 35 No Yes 
Belarus Yes 0.2 25.0 Yes Yes 
Belgium No 3.4 n.a. 95 Yes Yes 
Bulgaria No 0.8 12.8 87.5 No Yes 
Croatia No 0.9 5.8 80 No Yes 
Cyprus No 2.5 n.a. 100 No Yes 
Czech Republic Yes 1.5 77.4 80 Yes No 
Denmark No 1.3 51.9 100 Yes No 
Egypt Yes 0.1 18.0 50 Yes Yes 
Estonia No 1.5 9.5 76 No Yes 
Finland No 1.5 24.0 95 Yes Yes 
France No 1.3 63.3 100 Yes Yes 
Georgia No 0.6 2.0 100 No Yes 
Germany No  4.0 a  28.4 a 45 Yes Yes 
Greece No 1.3 25.9 99 No Yes 
Hungary Yes 1.2 43.4 93 Yes Yes 
Iceland No 3.3 8.0 50 No Yes 
Ireland No n.a. n.a. n.a. Yes Yes 
Israel No 1.7 68.5 95 No No 
Italy No  6.9 a  23.8 a 99 Yes Yes 
Latvia Yes 0.9 47.5 60 Yes Yes 
Lebanon No 2.5 10.0 100 No Yes 
Lithuania No 0.8 19.0 100 No Yes 
Luxembourg No 2.1 10.0 100 No Yes 
FYROM No 0.5 12.0 100 No Yes 
Netherlands Yes 1.0 86.8 99 Yes Yes 
Norway No  2.6 a  19.8 a 100 No Yes 
Poland Yes 1.4 25.7 99 No Yes 
Portugal Yes 2.0 21.2 99 No Yes 
Romania No 0.4 9.9 100 No Yes 
Russia Yes 0.0 53.3 70 Yes Yes 
Serbia No 0.5 56.8 100 No Yes 
Slovakia Yes 1.1 34.2 100 Yes Yes 
Slovenia No 1.0 28.0 95 No Yes 
Spain Yes 0.9 47.1 98 Yes Yes 
Sweden No 2.4 38.6 98 Yes Yes 
Switzerland No 2.9 19.5 99 Yes Yes 
Tunisia Yes 0.8 10.3 100 No Yes 
Turkey No 0.3 18.0 100 No Yes 
UK No 0.9 88.7 100 Yes No 
 EP subspec CRT centres/mil pop, 2008 Average CRT/centre/-year CRT implantation by cardiologists (%) National PM/ICD guidelines US/Euro PM/ICD guidelines 
Armenia No 0.3 34.0 100 No Yes 
Austria No 7.9 12.2 35 No Yes 
Belarus Yes 0.2 25.0 Yes Yes 
Belgium No 3.4 n.a. 95 Yes Yes 
Bulgaria No 0.8 12.8 87.5 No Yes 
Croatia No 0.9 5.8 80 No Yes 
Cyprus No 2.5 n.a. 100 No Yes 
Czech Republic Yes 1.5 77.4 80 Yes No 
Denmark No 1.3 51.9 100 Yes No 
Egypt Yes 0.1 18.0 50 Yes Yes 
Estonia No 1.5 9.5 76 No Yes 
Finland No 1.5 24.0 95 Yes Yes 
France No 1.3 63.3 100 Yes Yes 
Georgia No 0.6 2.0 100 No Yes 
Germany No  4.0 a  28.4 a 45 Yes Yes 
Greece No 1.3 25.9 99 No Yes 
Hungary Yes 1.2 43.4 93 Yes Yes 
Iceland No 3.3 8.0 50 No Yes 
Ireland No n.a. n.a. n.a. Yes Yes 
Israel No 1.7 68.5 95 No No 
Italy No  6.9 a  23.8 a 99 Yes Yes 
Latvia Yes 0.9 47.5 60 Yes Yes 
Lebanon No 2.5 10.0 100 No Yes 
Lithuania No 0.8 19.0 100 No Yes 
Luxembourg No 2.1 10.0 100 No Yes 
FYROM No 0.5 12.0 100 No Yes 
Netherlands Yes 1.0 86.8 99 Yes Yes 
Norway No  2.6 a  19.8 a 100 No Yes 
Poland Yes 1.4 25.7 99 No Yes 
Portugal Yes 2.0 21.2 99 No Yes 
Romania No 0.4 9.9 100 No Yes 
Russia Yes 0.0 53.3 70 Yes Yes 
Serbia No 0.5 56.8 100 No Yes 
Slovakia Yes 1.1 34.2 100 Yes Yes 
Slovenia No 1.0 28.0 95 No Yes 
Spain Yes 0.9 47.1 98 Yes Yes 
Sweden No 2.4 38.6 98 Yes Yes 
Switzerland No 2.9 19.5 99 Yes Yes 
Tunisia Yes 0.8 10.3 100 No Yes 
Turkey No 0.3 18.0 100 No Yes 
UK No 0.9 88.7 100 Yes No 

The two right columns indicate adherence to local or international device guidelines. In case of missing data the field was left blank.

a Data from 2007.

Factors affecting the number of CRT implantations

The number of CRT implantations and the growth between 2006 and 2008 is higher in countries, where the devices are reimbursed or who adhere to a national guideline ( Table  4 ).

Table 4

Analysis of factors affecting CRT implantations

 CRT/mil pop 2008 Change 2006–2008, CRT/mil pop CRT-D of total CRT, 2008 
CRT reimbursement    
 Yes 48.5 ± 41.2 48.0 ± 80.8 56.6 ± 27.2% 
 No 19.2 ± 24.6 26.8 ± 24.6 29.0 ± 18.8% 
EP subspeciality    
 Yes 39.3 ± 34.6 61.3 ± 72.4 53.2% ± 23.8% 
 No 46.0 ± 43.1 39.4 ± 79.1 51.8% ± 29.9% 
National guideline    
 Yes 63.5 ± 43.8 25.6 ± 85.2 59.6 ± 23.4% 
 No 28.0 ± 29.5 63.9 ± 65.5 46.2 ± 30.1% 
European or US guideline    
 Yes 38.1 ± 37.8 47.2 ± 79.3 50.6 ± 28.7% 
 No 93.1 ± 25.2 33.2 ± 59.7 65.9 ± 12.9% 
% DDD PM r = 0.457  r = 0.165  r = −0.023  
ICD/mil pop r = 0.843  r = −0.082  r = 0.569  
GDP/capita r = 0.410  r = 0.028  r = 0.188  
Health/capita r = 0.468  r = −0.013  r = 0.257  
Gov cost (%) r = 0.427  r = 0.049  r = −0.186  
Publ ins (%) r = 0.350  r = 0.220  r = −0.100  
CRTcentre/mil pop r = 0.657  r = 0.016  r = 0.401  
Avg impl/CRT centre r = 0.517  r = −0.101  r = 0.238  
CRT by cardiologist r = 0.023  r = 0.093  r = 0.111  
 CRT/mil pop 2008 Change 2006–2008, CRT/mil pop CRT-D of total CRT, 2008 
CRT reimbursement    
 Yes 48.5 ± 41.2 48.0 ± 80.8 56.6 ± 27.2% 
 No 19.2 ± 24.6 26.8 ± 24.6 29.0 ± 18.8% 
EP subspeciality    
 Yes 39.3 ± 34.6 61.3 ± 72.4 53.2% ± 23.8% 
 No 46.0 ± 43.1 39.4 ± 79.1 51.8% ± 29.9% 
National guideline    
 Yes 63.5 ± 43.8 25.6 ± 85.2 59.6 ± 23.4% 
 No 28.0 ± 29.5 63.9 ± 65.5 46.2 ± 30.1% 
European or US guideline    
 Yes 38.1 ± 37.8 47.2 ± 79.3 50.6 ± 28.7% 
 No 93.1 ± 25.2 33.2 ± 59.7 65.9 ± 12.9% 
% DDD PM r = 0.457  r = 0.165  r = −0.023  
ICD/mil pop r = 0.843  r = −0.082  r = 0.569  
GDP/capita r = 0.410  r = 0.028  r = 0.188  
Health/capita r = 0.468  r = −0.013  r = 0.257  
Gov cost (%) r = 0.427  r = 0.049  r = −0.186  
Publ ins (%) r = 0.350  r = 0.220  r = −0.100  
CRTcentre/mil pop r = 0.657  r = 0.016  r = 0.401  
Avg impl/CRT centre r = 0.517  r = −0.101  r = 0.238  
CRT by cardiologist r = 0.023  r = 0.093  r = 0.111  

Data for dichotomous variables are shown as mean ± standard deviation. Pearson's correlation coefficient ( r ) was calculated for scale variables.

While countries with higher GDP or healthcare spending per capita generally had a higher number of implantations, due to large variations the correlation between these factors and the number of CRT implantations was weak. There is stronger correlation between per capita CRT implantations and the number of ICD implantations ( Figure  3 , Table  4 ). Similarly, the ratio of dual-chamber pacemaker implantations, the general availability of governmental or public insurance, or cardiologist-performed procedures have minimal or no correlation with the number of CRT implantations. Both the growth of CRT implantations and the higher ratio of CRT-D correlated mostly with the number of ICD implantations ( Table  4 ).

Figure 3

The number of CRT implantations correlates well with the number of ICD implantations (top), but not with total GDP (middle) or healthcare spending (bottom). All numbers are per capita. GDP and healthcare spending is in Euro.

Figure 3

The number of CRT implantations correlates well with the number of ICD implantations (top), but not with total GDP (middle) or healthcare spending (bottom). All numbers are per capita. GDP and healthcare spending is in Euro.

Multiple regression analysis showed that the number of CRT implantations per capita was significantly affected by local CRT reimbursement ( P = 0.023), number of CRT centres per capita ( P < 0.001), adherence to national guidelines ( P = 0.002), and adherence to European or US guidelines (negative effect, P < 0.001). Accredited electrophysiology subspecialty and healthcare spending per capita were not significant factors ( P = 0.668 and P = 0.899, respectively). As of note, only a very few countries, each one with a high implantation rate, indicated that they follow national guidelines only (Czech Republic, Denmark, UK; Israel denied both).

Discussion

Cardiac resynchronization therapy with or without a defibrillator is a class I recommendation with a level of evidence ‘A’ for patients with left ventricular systolic dysfunction (ejection fraction <35%), symptomatic heart failure despite optimal medical therapy, and a QRS duration of ≥120 ms, in order to improve survival and reduce morbidity. 10 Based on the great difference in the number of implantations between the countries, it is likely that many patients who would potentially benefit from device therapy do not receive it. On the other hand, there are data that some patients who receive a CRT do not fulfil all the guideline criteria. 16 As guidelines do not necessarily conform strictly to the entry criteria for clinical trials (for instance, the ESC guidelines do not exclude patients with atrial fibrillation), substantial variations in implantation routines may exist, based on economical factors or individual experience. The EHRA and the Heart Failure Association initiated the European CRT survey in 2009 to describe the current European practice and routines associated with CRT implantations-based sampling in 13 countries. The survey analysed demographics and clinical characteristics, diagnostic criteria, implantation routines and techniques, short-term outcomes, adverse experience, and assessment of adherence to guideline recommendations. 17 It has showed that approximately one-fourth (23%) of the patients had atrial fibrillation and one-fourth of them (26%) had had a device implanted previously. Thirty-one percent of the patients were older than 75 years. Altogether 22% of the patients were in NYHA functional class I or II. In conclusion, the survey data showed that general practice do not adhere to the guidelines strictly and there are major differences with regard to the proportion of elderly patients, presence of atrial fibrillation, or a previous device as compared with the randomized clinical trials. However, long-term data are needed to evaluate the response to the therapy in this patient population.

There is no easy way to tell what number of CRT implantations would be optimal. With current implantation indications, up to 30% of patients are non-responders, while other patients, who could potentially benefit, may not be included. The surveys initiated by ESC and its associated organizations will provide detailed data on the epidemiology of CHF and potentially eligible patients.

Clarification of the indications is the subject of several ongoing or recently finished trials. 18 , 19 The MADIT-CRT trial has shown the effect of CRT in NYHA I, II class patients. 20 Recent publications suggest that patients with a left ventricular ejection fraction of up to 40% and with few or no symptoms may also benefit from CRT. 21 The deleterious effects of chronic right ventricular stimulation have long been identified. 22 Currently a large number of patients with bradycardia indications receive conventional pacemakers and are at risk of developing pacing-induced dyssynchrony and CHF. Initial data are promising that a ‘CRT upgrade’ in this population can be similarly effective as with patients with conventional CRT indications. 23 The BIOPACE clinical trial investigates the use of CRT in high-degree AV block in a general population. 24 In the case of a positive outcome, the number of patients eligible for CRT may increase significantly, similar to the sudden increase in ICD implantations when the results of primary prevention trials were incorporated into guidelines. However, in addition to the cost, the high complexity of CRT implantation and the relatively low number of procedures per centre, with lack of experience (possibly also because of the low number of EP subspecialists) may also limit the number of implantations.

The issue of cost-efficiency of CRT has been addressed in several papers. 18 , 19 CRT-P appears a highly cost-effective addition to medical therapy among eligible patients. CRT-D is cost-effective when there is a reasonable life expectancy at the time of implantation. CRT was shown to be cost-effective even in the ninth decade. 19 The question whether CRT-D or CRT-P will be more cost-efficient in a given patient group will need to be determined in future studies. Cost-efficiency data are essential to convince the local healthcare insurers to reimburse CRT, and this seems to be a major factor describing the differences between European countries.

Implantation of a transvenous CRT device is a technically demanding task which requires significant expertise and may require new invasive methods to apply. 25 All the large randomized clinical trials (COMPANION, CARE-HF, REVERSE) showed a failure rate to implant the device of 5–10%. 26–28 European data show that having an accredited electrophysiology subspecialty only has a very modest effect on the number of CRT implantations. This may be due to different requirements for certification or high number of implantations performed by non-electrophysiologists even when such a subspecialty exists in a country. More studies will be needed to investigate this finding.

In addition, the number of CRT devices implanted per centre may highly influence the success rate. Beyond reimbursement, the fact that the number of CRT implantations have a better correlation with ICD implantations than with financial indicators like GDP or healthcare spending, may suggest that the limitations for widespread utilization of CRT are mainly technical and not economical (physicians who can perform ICD implantations may also consider implanting CRT-D when indicated). Therefore, the education of device therapy treatment and the implantation procedure has to be focused upon to increase the number of implantations. European standards such as the EHRA individual accreditation in Cardiac Pacing and ICDs (and CRT) may help this process. The aim is to ensure an equal access to this highly efficient and cost-effective treatment and to have CRT devices implanted by qualified electrophysiologists in all European countries.

Limitations

The EHRA White Book survey was not able to provide complete data for all 51 ESC countries. The data represent a reasonable percentage of the actual procedures but certainly not the absolute reality, since even the best national or international registries do not cover 100% of the interventions. However, the correctness of data were authorized by each national chair or president and in case of estimates, they are very close to what can be expected. Benchmarking testing had not been conducted. There has been no negative feedback over the last 2 years after publication of the White Book, although there is open access to the data. There were no indications of mistakes or changes by national societies during the last 2 years, which makes us confident that the data represent each country's reality at best.

Conclusion

The joint effort of the ESC and EHRA highlighted the significant variation in local utilization of CRT. These differences might not only be explained by the unequal financial realities of the countries, but also by variations in reimbursement and guideline adherence.

Funding

The whole EHRA White Book project was made possible by an unrestricted educational grant from Biotronik GMBH, Berlin, Germany. The article has been granted an unrestricted educational grant of TÁMOP (Social Renewal Operative Program) 4.2.2.-08/1/KMR (National Development Agency, Hungary).

Conflict of interest: Biotronik GMBH provided funding for the project.

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