Summary
Background
An ageing population and the extension of indications will in all probability result in an increasing number of cardiac device implantations.
Methods
Patients implanted in 2008 and 2009 were identified by means of the French National Hospital Discharge database to establish the implantation rate and the National Health Insurance (NHI) Information System database for patient profiles (76% of the population).
Results
Of the 64,306 pacemaker implantations (1003.7 per million inhabitants [pmi]) in 2009, 21.4% were single chamber, 75.4% double chamber and 3.2% triple chamber (CRT-P). Of the 9028 cardioverter-defibrillator implantations (140.8 pmi) in 2009, 30.1% were single chamber, 27.5% double chamber and 42.5% triple chamber (CRT-D), accounting for 65% of cardiac resynchronization therapy (CRT) implants. Among NHI beneficiaries, 58.6% of cardioverter-defibrillators were implanted for primary prevention. Between 2008 and 2009, CRT-P implantations increased by 8.8% and CRT-D implantations by 29.3%. Regional variations in implantation rates were observed regarding single-chamber pacemakers (15–33%) and CRT-D among CRT (46.2–73.8%). Pacemaker implantations cost €158.4 million overall, 4.5% of which was for CRT-P; cardioverter-defibrillator implantations cost €96 million, 49% of which was for CRT-D. For NHI beneficiaries, 11.9% of CRT-P patients and 6.5% of CRT-D patients already had a device of the same type implanted in the 3 preceding years.
Conclusion
The results confirm the increase in cardioverter-defibrillator implantations in France. The implantation rate remains lower than that in the USA but falls within the European average. Reasons behind significant regional variations in implantation rates need further study.
Résumé
Justification
L’implantation de dispositifs cardiaques est susceptible d’augmenter fortement face au vieillissement de la population et à l’élargissement des indications.
Méthode
Les malades ont été identifiés à l’aide du PMSI en 2008 et 2009 pour le calcul des taux nationaux d’implantation, puis les bénéficiaires du régime général (76 % de la population) ont été retenus pour l’étude des caractéristiques des patients implantés.
Résultats
Parmi les 64 306 implantations de stimulateurs (1003,7 par million d’habitant [pmh]) en 2009, 21,4 % concernaient des simple chambre (214,5 pmh), 75,4 % des double (756,7 pmh) et 3,2 % des triple (CRT-P, 32,7 pmh). En 2009, 9028 défibrillateurs ont été implantés (140,8 pmh) dont 30,1 % en simple chambre (42,3 pmh), 27,5 % en double (38,6 pmh) et 42,5 % en triple (CRT-D, 59,8 pmh). Ces derniers totalisaient 65 % des resynchronisateurs. Entre 2008 et 2009, la pose de CRT-P a augmenté de 8,8% et celle de CRT-D de 29,3%. Il existait des variations régionales des taux d’implantation et de la proportion de simple chambre parmi les stimulateurs (15–33 %), des triple chambre parmi les défibrillateurs (14,9–59,2 %) et de ces derniers parmi les resynchronisateur (46,2–73,8 %). Le coût global était de 158,4 millions d’euros pour les stimulateurs, dont 4,5 % pour les CRT-P, et de 96 millions pour les défibrillateurs, dont 49 % pour les CRT-D. Pour les bénéficiaires du régime général, 58,6 % des défibrillateurs ont été implantés en prévention primaire; concernant les resynchronisateurs, 11,9 % des malades avec CRT-P avaient eu une implantation d’un appareil du même type les trois années précédentes et 6,5 % pour les CRT-D.
Conclusion
En France, l’augmentation de l’implantation de défibrillateurs se confirme. Le taux reste inférieur à celui des États-Unis, mais dans la moyenne européenne. Les fortes disparités régionales d’implantation restent à explorer, comme dans d’autres pays, ainsi que le taux de réimplantation.
Introduction
Implantable cardiac devices can be distinguished by two main types: pacemakers for treatment of bradycardia and cardioverter-defibrillators for additional treatment of ventricular arrhythmias. There are single- or dual-chamber devices, according to the number of chambers stimulated with pacing leads. Cardiac resynchronization therapy (CRT) directly stimulates three of the heart chambers with either a triple-chamber pacemaker (CRT-P) or a triple-chamber cardioverter-defibrillator (CRT-D). Excepting possible variations in the prevalence of cardiac diseases treated by these devices, the ageing of the French population implies a regular increase in the number of target individuals. In addition, recommended indications for CRT and defibrillation have been extended.
CRT with the addition of left ventricular pacing through coronary sinus lead insertion was previously reserved for patients with severe heart failure with left ventricular systolic dysfunction and electrical ventricular asynchronism (wide QRS complex). It has now been sufficiently demonstrated that implanting these patients in the earlier phases of the disease significantly limits its progression . Similarly, in the past 10 years, the systematic implantation of cardioverter-defibrillators has no longer been exclusively limited to secondary prevention (i.e. cases of serious ventricular tachycardia or cardiac arrest) but has evolved to include primary prevention . As heart failure is a major cause of ventricular arrhythmias, the combination of defibrillator implantation with CRT is frequently debated . However, no randomized controlled clinical trials designed to specifically compare implantations of multisite pacemakers and multisite defibrillators (CRT-P vs. CRT-D) have been carried out among patients with heart failure . Thus, recent national data concerning these devices exist in a continuously evolving context; nevertheless, the data are sparse .
The aim of this study is to determine implantation rates in patients between 2008 and 2009 in France and, using the National Health Insurance (NHI) Information System database, patient profiles and associated medications.
Methods
Data sources
The NHI Information System Database (SNIIRAM) contains anonymous, exhaustive, personal data on all healthcare expenditure claims by beneficiaries for the past 2 years plus the current year . Other information, such as patients’ area of residence or co-payment exonerations for patients covered by the long-term illness scheme ( affection de longue durée [ALD]) are also available. These data can be matched to French National Hospital Discharge database ( Programme de médicalisation du système d’information [PMSI]) data through a unique anonymous number allocated to each individual. Medical diagnoses and listed long-term chronic diseases (ALD scheme) are coded according to the International Classification of Diseases (10th revision with some extensions introduced by the Technical Hospitalization Information Agency, www.atih.sante.fr; [ICD10]).
Population
The PMSI database enabled the use of the whole population as a sample base. It provided the annual number of implantations and the rate of implanted patients in France together with regional variations. The study of patient characteristics concentrated on NHI beneficiaries, covering 76% of the French population in 2008 (around 48 million inhabitants). In 2009, 74,482 pacemaker and cardioverter defibrillator implantations were identified through the PMSI database for 73,826 valid hospital stays, excluding those with an invalid patient number or with distinct devices. After selecting the last admission with device implantation (the most recent stay if the patient was hospitalized several times), 73,334 hospitalizations or patients were included in the study. In 2008, 70,409 implantations corresponding to 69,181 valid hospitalizations were identified and 68,756 hospitalizations or patients were retained after the selected admission.
Variables analysed
The implantation of a cardiac device was identified through specific billing data for public and private hospitals. Billing data permits the identification of the specific types of pacemaker or defibrillator implanted (single-chamber, dual-chamber or triple-chamber, according to the number of chambers stimulated, i.e. the number of pacing leads used) coded by means of the products and services list (LPP).
The existence of heart disease and the nature of this disease were identified through the list of chronic long-term diseases eligible for coverage under the ALD scheme, and by means of medical diagnosis codes for the selected admission and all hospitalizations occurring in the 36 months prior to implantation. The following disease groups were established: valvular heart disease (ICD10 codes I05 to I08, I34 to I39), ischaemic cardiomyopathy (I20 to I25), cardiomyopathy (I42 and I43) and heart failure (I50). Subgroups were specifically added for electrocardiographic disorders, from the ICD10 codes: sinoatrial blocks (I495), atrioventricular blocks (I440 to I443, I458 and I459), bundle branch blocks (I444 to I455), cardiac arrest (I460, I461 and I469), ventricular tachycardia (I470, I472, I490 and I493), supraventricular tachycardia (I471, I479, I48, I491 and I492), and the category ‘other’, which included the remaining codes (mostly non-disease-specified). Cardiac surgical interventions other than device implantations (valvular surgery, coronary artery bypass graft) and coronary angioplasties were searched for during the 36 months prior to the selected admission.
Prescription drugs administered for heart conditions were searched for during the 6 months preceding the selected admission and during the 6 months after. For each of these two periods, the reimbursement claims for at least 3 months of treatment were tested for each class of prescription drug identified by its Anatomical Therapeutic Chemical Classification code: beta-blockers; other antiarrhythmic agents (Vaughan-Williams classification–class I: quinidine, lidocaine, flecainide, etc.; class III: amiodarone and sotalol; class IV: calcium channel blockers); angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers; diuretics; cardiotonic digitalis; antiplatelet agents; and oral anticoagulants.
Comorbidity was identified as follows: the presence of cancer was identified through patients qualified for ALD scheme coverage starting at last 2 years before the selected admission and/or hospitalized with a cancer principal diagnosis code and/or radiotherapy or chemotherapy delivered during the course of the year. Alzheimer’s disease was identified through tracer drug prescriptions on at least two different dates and/or disease-specific ALD coverage and/or a specific hospitalization. Parkinson’s disease was identified through disease-specific ALD coverage and/or tracer drugs prescribed on three different dates. Asthma and chronic obstructive pulmonary disease, diabetes and depression were identified through the delivery of disease-specific drugs at least three times during the course of the year. End-stage renal disease was identified by means of disease-specific ALD coverage, delivery of regular dialyses and reimbursement claims for immunosuppressors associated with a kidney transplant. Symptoms of inflammation were defined by the existence of at least nine reimbursement dates for anti-inflammatory drugs during the course of the year. Chronic hepatic disease and psychotic disorder were identified through disease-specific ALD coverage.
Statistical analysis
Implantation rates were standardized by sex and age for regional comparisons using the estimated French population on 1 January 2008 supplied by the National Institute for Statistics and Economic Research ( http://www.insee.fr ). Regional analyses were performed using the area of residence, not the place where the implantation was performed. Patient profiles and treatment characteristics were compared for the different types of implantable cardiac devices using the Chi 2 test and the Wilcoxon test. For comparisons between the periods before and after the selected admission, only patients still on record 6 months after the implantation date were included. Analyses were done using SAS software (version 9.1.3, SAS Inc., Cary, NC, USA).
Results
Types of device and implantation rates
The baseline characteristics and primary reason for hospitalization are shown in Table 1 . In 2009, pacemakers accounted for 88% of patients with a cardiac device implantation. The national rate was 1003.7 per million inhabitants (pmi), of which 21.4% were single chamber, 75.4% dual chamber and 3.2% CRT-P. Between 2008 and 2009, the number of patients implanted with a pacemaker increased by 5.0% and, more particularly, by 4.3% for single-chamber pacemakers and 8.8% for CRT-P.
| Implantable cardiac device | 2008 | 2009 | Evolution | ||||
|---|---|---|---|---|---|---|---|
| N | % | Rates a | N | % | Rates* | % | |
| Pacemaker, single chamber | 13,175 | 21.5 | 205.7 | 13,739 | 21.4 | 214.5 | 4.3 |
| Pacemaker, dual chamber | 46,161 | 75.4 | 720.2 | 48,484 | 75.4 | 756.7 | 5.0 |
| CRT-P | 1915 | 3.1 | 30.0 | 2083 | 3.2 | 32.7 | 8.8 |
| Total pacemakers | 61,251 | 100.0 | 955.7 | 64,306 | 100.0 | 1003.7 | 5.0 |
| Cardioverter-defibrillator, single chamber | 2320 | 30.9 | 36.1 | 2714 | 30.1 | 42.3 | 17.0 |
| Cardioverter-defibrillator, dual chamber | 2221 | 29.6 | 34.7 | 2481 | 27.5 | 38.6 | 11.7 |
| CRT-D | 2964 | 39.5 | 46.2 | 3825 | 42.5 | 59.8 | 29.3 |
| Total cardioverter-defibrillators | 7505 | 100.0 | 116.9 | 9028 | 100.0 | 140.8 | 20.3 |
| Cardiac resynchronization (CRT-P and CRT-D) | 4879 | 76.1 | 5908 | 92.4 | 21.1 | ||
| Total | 68,756 | 1072.6 | 73,334 | 1144.5 | 6.7 | ||
In 2009, 9028 patients (140.8 pmi) were implanted with cardioverter-defibrillators, of which 30.1% were single chamber, 27.5% dual chamber and 42.5% CRT-D. Between 2008 and 2009, there was a global increase of 20.3% in the number of patients with a cardioverter-defibrillator implantation, and, in particular, an increase of 29.3% in CRT-D. Concerning CRT, 5908 patients were implanted (92.4 pmi), of whom 64.8% received CRT-D.
Regional variations in implantation rates for each device type
In 2009, after standardization of age and sex, marked regional disparities in patient implantation rates for each of the three main types of device were found ( Table 2 ). For pacemaker implantations, regional rates were below 550 pmi outside metropolitan France and ranged between 764 pmi (Auvergne) and 1168 pmi (Lorraine) in metropolitan France. After adjustment for age and sex, the percentage of single-chamber pacemaker implantations varied from 15.4% in Île-de-France to 33.4% in Champagne-Ardenne ( Fig. 1 ). The highest regional implantation rates for all types of pacemaker were recorded in the west and south-west regions and also in the north-east.
| Pacemakers | Cardioverter-defibrillators | Cardiac resynchronization therapy | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| N | Rates (pmi) a | p b | Single chamber c (%) | p b | N | Rates (pmi) a | p b | CRT-D c (%) | p b | N | Rates (pmi) a | p b | CRT-D c (%) | p b | |
| Réunion | 187 | 526 | – | 20 | 109 | 207 | + | 55 | * | 75 | 177 | + | 70 | ||
| Auvergne | 1273 | 764 | – | 33 | *** | 298 | 194 | + | 44 | 176 | 118 | + | 68 | ||
| Rhône-Alpes | 5017 | 854 | – | 25 | *** | 1132 | 190 | + | 44 | 694 | 125 | + | 74 | ** | |
| Languedoc-Roussillon | 2836 | 923 | – | 21 | 522 | 183 | + | 37 | 281 | 100 | 68 | ||||
| Aquitaine | 4252 | 1121 | + | 19 | *** | 642 | 182 | + | 59 | *** | 550 | 162 | + | 71 | |
| Provence Alpes Côte d’Azur | 5538 | 970 | 17 | *** | 934 | 173 | + | 44 | 620 | 119 | + | 74 | ** | ||
| Nord Pas de Calais | 3521 | 1039 | + | 23 | 602 | 167 | + | 30 | *** | 251 | 76 | – | 68 | ||
| Centre | 2697 | 926 | – | 22 | 435 | 159 | + | 44 | 315 | 119 | + | 62 | |||
| Midi-Pyrénées | 3365 | 994 | 22 | 416 | 136 | 38 | 277 | 92 | 57 | ||||||
| Guyane | 20 | 343 | – | 17 | 11 | 136 | 27 | 3 | 45 | 84 | |||||
| Champagne-Ardenne | 1475 | 1091 | + | 33 | *** | 181 | 133 | 34 | 84 | 66 | – | 69 | |||
| Bourgogne | 1898 | 940 | 27 | *** | 244 | 132 | 42 | 166 | 92 | 65 | |||||
| Corse | 319 | 887 | 18 | 47 | 129 | 50 | 38 | 111 | 62 | ||||||
| Haute-Normandie | 1561 | 911 | – | 24 | * | 226 | 128 | 41 | 114 | 69 | – | 72 | |||
| Franche-Comté | 943 | 796 | – | 26 | ** | 153 | 127 | 22 | *** | 57 | 50 | – | 60 | ||
| Limousin | 1233 | 1167 | + | 30 | *** | 106 | 118 | 45 | 75 | 84 | 63 | ||||
| Ile de France | 9699 | 1096 | + | 15 | *** | 1145 | 118 | – | 53 | *** | 923 | 107 | + | 65 | |
| Lorraine | 2641 | 1168 | + | 23 | 280 | 117 | – | 39 | 192 | 86 | 54 | * | |||
| Pays de la Loire | 3177 | 874 | – | 18 | *** | 415 | 117 | – | 40 | 379 | 112 | + | 46 | *** | |
| Poitou-Charentes | 2504 | 1119 | + | 26 | *** | 226 | 115 | – | 40 | 148 | 75 | – | 59 | ||
| Picardie | 1576 | 922 | – | 23 | 207 | 113 | – | 36 | 97 | 58 | – | 66 | |||
| Alsace | 1689 | 1045 | + | 27 | *** | 190 | 105 | – | 15 | *** | 48 | 29 | – | 54 | |
| Bretagne | 2806 | 812 | – | 29 | *** | 315 | 96 | – | 38 | 221 | 69 | – | 49 | ** | |
| Basse-Normandie | 1566 | 949 | 22 | 125 | 80 | – | 43 | 99 | 65 | – | 53 | ||||
| Martinique | 182 | 546 | – | 18 | 29 | 78 | – | 24 | 14 | 44 | – | 52 | |||
| Guadeloupe | 141 | 445 | – | 33 | ** | 13 | 37 | – | 55 | 10 | 34 | – | 63 | ||
| France | 62,116 | 971 | 22 | 9003 | 141 | 42 | 5907 | 92 | 67 | ||||||
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