Europace (2023) 25, 1–9 EHRA SURVEY https://doi.org/10.1093/europace/euad110 Regional disparity on patient characteristics and perceptions after implantable cardioverter-defibrillator implantation: results from an EHRA patient survey Łukasz Januszkiewicz 1*, Sérgio Barra 2, Rui Providencia 3,4 , Julian K. R. Chun 5, Giulio Conte 6,7, Michał M. Farkowski 8 , Jose M. Guerra 9, Eloi Marijon 10,11,12, Carlo de Asmundis 13 , and Serge Boveda 14,13,12 1 1st Department of Cardiology, Medical University of Warsaw, Banacha 1a, 02-097 Warsaw, Poland; 2Cardiology Department, Hospital da Luz Arrabida, V. N. Gaia, Portugal; 3Barts Heart Centre, St. Bartholomew’s Hospital, London, UK; 4Institute of Health Informatics Research, University College London, London, UK; 5CCB, Cardiology, Med. Klinik III, Markuskrankenhaus, Frankfurt, Germany; 6Division of Cardiology, Cardiocentro Ticino Institute, Lugano, Switzerland; 7Università della Svizzera italiana, Lugano, Switzerland; 82nd Department of Heart Arrhythmia, National Institute of Cardiology, Warsaw, Poland; 9Department of Cardiology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, IIB SANT PAU, CIBERCV, Barcelona, Spain; 10University of Paris, Paris, France; 11Cardiology Department, European Georges Pompidou Hospital, Paris, France; 12Paris Cardiovascular Research Center, INSERM Unit 970, Paris, France; 13Heart Rhythm Management Centre, Universitair Ziekenhuis Brussel—Vrije Universiteit Brussel, Brussels, Belgium; and 14Department of Heart Rhythm, Clinique Pasteur, 31076 Toulouse, France Received 20 December 2022; accepted after revision 3 April 2023 Aims The aim of this study was to identify potential regional disparities in characteristics of implantable cardioverter-defibrillator (ICD) recipients, patient perceptions and perspectives after implantation and level of information provided to patients. ................................................................................................................................................... Methods The prospective, multicentre, and multinational European Heart Rhythm Association patient Survey ‘Living with an ICD’ and results included patients already implanted with an ICD (median ICD dwell time – 5 years, interquartile range 2–10). An online questionnaire was filled-in by patients invited from 10 European countries. A total of 1809 patients (the majority in their 40s to 70s, 65.5% men) were enrolled, with 877 (48.5%) from Western Europe (group 1), followed by 563 from Central/Eastern Europe (group 2, 31.1%), and 369 from Southern Europe (group 3, 20.4%). A total of 52.9% of Central/ Eastern Europe patients reported increased satisfaction after ICD placement compared with 46.6% from Western and 33.1% from Southern Europe (1 vs. 2 P = 0.047, 1 vs. 3 P < 0.001, 2 vs. 3 P < 0.001). About 79.2% of Central/Eastern and 76.0% of Southern Europe patients felt optimally informed at the time of device implantation compared with just 64.6% from Western Europe (1 vs. 2 P < 0.001, 1 vs. 3 P < 0.001, 2 vs. 3 P = ns). ................................................................................................................................................... Conclusions While physicians in Southern Europe should address the patients’ concerns about the impact of the ICD on quality of life, phy­ sicians from Western Europe should focus on improving the quality of information provided to their prospective ICD patients. Novel strategies to address regional differences in patients’ quality of life and provision of information are warranted. * Corresponding author. Tel: +48 22 599 29 58. E-mail address: lukasz.jan.januszkiewicz@gmail.com © The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com 2 Ł. Januszkiewicz et al. Graphical Abstract EHRA patient survey ‘Living with an ICD’ 25-item questionnaire Western Europe – 48.5% = 1809 Central/Eastern Europe – 31.1% Southern Europe – 20.4% median ICD dwell time – 5 years ICD Quality of life after ICD implantation Improved Unchanged Worsened I am not sure 100% 80% 60% 40% 20% 0% Western Central/Eastern Southern Western Central/Eastern Southern Western Central/Eastern Southern Europe Europe Europe Europe Europe Europe Europe Europe Europe ICD S-ICD CRT-D ............................................................................................................................................................................................. Keywords Geographical differences • Outcome • Registry of ICD recipients, patient perceptions and perspectives after ICD im­ Introduction plantation, level of information provided to patients, and their needs The implantable cardioverter-defibrillator (ICD) is one of the main thera­ regarding education. peutic options for primary and secondary prevention of sudden cardiac death.1 The European Society of Cardiology (ESC) guidelines recommend the use of an ICD in symptomatic heart failure patients with an ejection Methods fraction ≤35% and in those who recovered from a ventricular arrhythmia In the prospective, multicentre, and multinational EHRA patient Survey causing haemodynamic instability. Despite uniform guidelines in Europe, ‘Living with an ICD’, we included patients already implanted with an ICD. there is considerable variability in guideline adherence and ICD implant­ The study design was previously described.11 In brief, the EHRA Scientific ation rates across the continent, i.e. from 5.9 ICDs per million people in Initiatives Committee created the questionnaire (see Supplementary Belarus to 408.5 ICDs per million people in Germany.2–4 Moreover, differ­ Material 1), consisting of 25 questions translated to patients’ native lan­ guages. The questionnaire covered the relevant aspects of ICD patients’ ences in patient characteristics and management across countries are ap­ perceptions and perspectives on the ICD and living with the ICD, as well parent.5 This geographical variability is often multifactorial and includes as information provision before the implantation procedure. The study socioeconomic, demographic, and healthcare system-related causes. was conducted within many countries belonging to the EHRA Scientific The ESC guidelines clearly state that patients’ involvement in the Network, categorized according to the EuroVoc classification: France, decision-making process and information about specific implications for Germany, UK (Western Europe), Croatia, Poland, Serbia (Central/ life with an ICD is a matter of great importance.1,6 In a previous report, Eastern Europe), Italy, Portugal, Spain (Southern Europe), and Latvia we identified major gaps regarding patients’ knowledge and empower­ (Northern Europe). Due to underrepresentation of Northern Europe, ment in this process.7 Most of the research on European regional differ­ we arbitrarily added the Latvian responses to Central/Eastern Europe. ences in ICD therapy focused on implantation rates and predictors of The questionnaire was posted on an electronic platform, and the link was sent to the EHRA Research Network centres, national arrhythmia working ICD underutilization.8–10 However, data on differences in quality of life, pa­ groups, and patient associations working in each participating country tient engagement, and information provided are scarce. whenever possible. Patients were asked to personally enter their replies dir­ In this analysis of the ‘Living with an ICD’ patient survey, initiated ectly via the electronic form or in paper form. They were encouraged to and carried out by the European Heart Rhythm Association answer the survey autonomously whenever possible in order to reduce (EHRA), we assessed potential regional differences in characteristics any potential bias arising from medical staff. The local ethics committee Regional disparity on patient characteristics and perceptions 3 Western Europe Central/Eastern Europe Southern Europe 83 4.6% 79 410 4.4% 248 22.7% 13.7% 550 30.4% 20 1.1% 50 2.8% 138 7.6% 228 3 12.6% 0.2% Figure 1 Number of patients according to country. approval was obtained where needed according to the local policy. The Fisher’s exact test, as appropriate. Continuous data were compared study was conducted between 12 April 2021 and 5 July 2021. using Student’s t-test or the Kruskal–Wallis and Mann–Whitney U test, as appropriate. The normal distribution of data was tested using the Kolmogorov–Smirnov test. The association between specific vari­ ables and patients’ perceptions and perspectives on the ICD was eval­ Statistical analysis uated using binary logistic regression and expressed as odds ratios with Values are expressed as numbers or percentages for categorical data or 95% confidence intervals. Factors significantly associated with improved median (25th to 75th percentile) for continuous data. Distributions of patient satisfaction and ICD acceptance in univariate analysis were in­ categorical data were examined by the Pearson’s chi-squared test or cluded in a backward stepwise multivariate binary logistic regression. 4 Ł. Januszkiewicz et al. Table 1 Demographic data and device history according to region N (%) Or median, IQR Whole cohort Western Central/ Southern P-value P-value P-value 1809 (100) Europe (1) 877 Eastern Europe Europe (3) 369 (1) vs. (2) (1) vs. (3) (2) vs. (3) (48.5) (2) 563 (31.1) (20.4) .............................................................................................................................................. Age <0.001 <0.001 <0.001 0–20 7 (0.4) 2 (0.2) 2 (0.4) 3 (0.8) 21–40 271 (15.0) 98 (11.2) 109 (19.4) 64 (17.3) 41–60 682 (37.7) 318 (36.3) 169 (30.0) 195 (52.8) 61–80 784 (43.3) 432 (49.3) 256 (45.5) 96 (26.0) ≥81 65 (3.6) 27 (3.1) 27 (4.8) 11 (3.0) Sex (% female) 624 (34.5) 300 (34.2) 208 (36.9) 116 (31.4) ns ns ns Education level <0.001 0.001 <0.001 Primary school 147 (8.1) 52 (5.9) 54 (9.6) 41 (11.1) Secondary school 608 (33.6) 238 (27.1) 293 (52.0) 77 (20.9) College 381 (21.1) 202 (23.0) 79 (14.0) 100 (27.1) University 673 (37.2) 385 (43.9) 137 (24.3) 151 (40.9) Employment status ns <0.001 <0.001 Student 21 (1.2) 7 (0.8) 5 (0.9) 9 (2.4) Employed 715 (39.5) 311 (35.5) 212 (37.7) 192 (52.0) Not employed 186 (10.3) 90 (10.3) 60 (10.7) 36 (9.8) Retired 887 (49.0) 469 (53.5) 286 (50.8) 132 (35.8) Marital status <0.001 ns 0.023 Married or living with a partner 1351 (74.7) 636 (72.5) 433 (76.9) 282 (76.4) Single 320 (17.7) 192 (21.9) 66 (11.7) 62 (16.8) Widower or widow 87 (4.8) 27 (3.1) 46 (8.2) 14 (3.8) Living at home (as a child) 8 (0.4) 2 (0.2) 3 (0.5) 3 (0.8) Living alone with children 43 (2.4) 20 (2.3) 15 (2.7) 8 (2.2) Time from first ICD implantation 5 (2–10) 6 (2–11) 5 (2–8) 4 (1–8) <0.001 <0.001 0.042 Patients with ICD shocks 704 (38.9) 349 (39.8) 233 (41.4) 122 (33.1) ns 0.025 0.010 Device type ICD-VR, ICD-DR 829 (45.8) 392 (44.7) 283 (50.3) 154 (41.7) 0.001 ns 0.011 S-ICD 563 (31.1) 297 (33.9) 145 (25.8) 121 (32.8) CRT-D 281 (15.5) 134 (15.3) 80 (14.2) 67 (18.2) Do not know 136 (7.5) 54 (6.2) 55 (9.8) 27 (7.3) Remote monitoring <0.001 <0.001 <0.001 Yes 1021 (56.4) 611 (69.7) 175 (31.1) 235 (63.7) No 675 (37.3) 256 (29.2) 303 (53.8) 116 (31.4) Do not know 113 (6.2) 10 (1.1) 85 (15.1) 18 (4.9) ICD indication Post-cardiac arrest (secondary 583 (32.2) 321 (36.6) 170 (30.2) 92 (24.9) 0.012 <0.001 ns prevention) Prevention of sudden death 808 (44.7) 401 (45.7) 207 (36.8) 200 (54.2) 0.001 0.006 <0.001 Heart failure symptoms 665 (36.8) 297 (33.9) 272 (48.3) 96 (26.0) <0.001 0.006 <0.001 Do not know 54 (3.0) 16 (1.8) 17 (3.0) 21 (5.7) ns <0.001 0.044 Complications None 1404 (77.6) 655 (74.7) 431 (76.6) 318 (86.2) ns <0.001 <0.001 Inappropriate shocks 209 (11.6) 106 (12.1) 77 (13.7) 26 (7.0) ns 0.008 0.002 Malfunctioning lead 204 (11.3) 121 (13.8) 61 (10.8) 22 (6.0) ns <0.001 0.011 Unplanned re-operations 128 (7.1) 79 (9.0) 35 (6.2) 14 (3.8) ns 0.001 ns CRT-D, cardiac resynchronization therapy with defibrillator; ICD, implantable cardioverter-defibrillator; ICD-DR, dual chamber implantable cardioverter-defibrillator; ICD-VR, single chamber implantable cardioverter-defibrillator; IQR, interquartile range; S-ICD, subcutaneous implantable cardioverter-defibrillator. Regional disparity on patient characteristics and perceptions 5 Quality of life after ICD implantation Improved Unchanged Worsened I am not sure 100% 2.5 3.0 4.6 3.9 4.8 7.4 7.7 9.1 9.7 3.8 11.0 10.4 8.3 11.9 7.1 3.7 14.3 16.5 20.0 80% 18.7 35.3 40.0 37.3 42.8 60% 36.2 57.1 44.6 40% 73.8 67.9 49.1 46.9 47.8 20% 42.1 42.4 28.6 29.8 0% Western Central/Eastern Southern Western Central/Eastern Southern Western Central/Eastern Southern Europe Europe Europe Europe Europe Europe Europe Europe Europe ICD S-ICD CRT-D Figure 2 Quality of life after ICD implantation according to region and device type. CRT-D, cardiac resynchronization therapy with defibrillator; ICD, implantable cardioverter-defibrillator; S-ICD, subcutaneous implantable cardioverter-defibrillator. A value of P < 0.05 was considered statistically significant. The statistical vs. 3 P < 0.001, group 2 vs. 3 P < 0.001). Similarly, Central/Eastern analysis was performed using SPSS software, version 23.0 (IBM Europe patients were more frequently unaware of their device type Corporation, Armonk, NY, USA). (group 1 vs. 2 P < 0.001, group 1 vs. 3 P = ns, group 2 vs. 3 P < 0.001). Respondents from Southern Europe experienced complica­ tions less frequently than in Western and Central/Eastern Europe Results (13.8%, 25.3%, 23.4%, respectively, group 1 vs. 2 P = ns, group 1 vs. 3 P < 0.001, group 2 vs. 3 P < 0.001). Patient population A total of 1809 patients were enrolled, with the majority recruited from Western Europe (group 1, n = 877, 48.5%), followed by Patients’ perceptions and perspectives Central/Eastern Europe (group 2, n = 563, 31.1%), and Southern More than a half of Central/Eastern Europe patients (52.9%) experienced a Europe (group 3, n = 369, 20.4%) (Figure 1). The study population relevant improvement in their quality of life compared with 46.6% from and device data have been described previously.11 Briefly, the final Western and only 33.1% from Southern Europe (group 1 vs. 2 P = population in the ‘Living with an ICD’ survey included 1809 patients 0.047, group 1 vs. 3 P < 0.001, group 2 vs. 3 P < 0.001). This difference (1185 men, 65.5%) with an ICD implanted on average 5 years prior was still present after stratifying patients according to device type to enrollment (median 5 years, interquartile range 2–10). The baseline (Figure 2). After stratifying patients according to ICD dwell time, we ob­ characteristics of patients according to European region are summar­ served incremental percentages of respondents with increased satisfaction ized in Table 1. Southern Europe patients were younger and more often and acceptance of life with an ICD (<2 years—35.7%, 2–5 years—44.6%, employed than in other regions (both P < 0.001). Central/Eastern >5 years—50.7%, <2 vs. 2–5 P = 0.006, <2 vs. >5 P < 0.001, 2–5 vs. >5 Europe patients reported a lower level of education than Western P = 0.022). In multivariate analysis, region was one of the independent pre­ and Southern patients (both P < 0.001). Subcutaneous ICDs were dictors of increased satisfaction (Table 2). Other independent predictors used more extensively in Western and Southern Europe compared of increased satisfaction and ICD acceptance included age >80 years old, with Central/Eastern countries (33.9%, 32.8%, 25.8%, group 1 vs. 2 P primary education as the highest education level, longer ICD dwell time, < 0.001, group 1 vs. 3 P = ns, group 2 vs. 3 P = 0.011), whilst cardiac re­ feeling of being well informed before ICD implantation, and cardiac resyn­ synchronization therapy rate was similar (group 1—15.3%, group 2— chronization therapy. Furthermore, the Southern Europe cohort ex­ 14.2%, group 3—18.2%, respectively). Remote monitoring was twice as pressed a lower degree of acceptance of the ICD limitations and the frequent in Western and Southern Europe than in Central/Eastern necessary lifestyle changes (61.1% vs. 70.3% in Western and 72.6% in Europe (69.7%, 63,7%, 31.1%, group 1 vs. 2 P < 0.001, group 1 vs. 3 Central/Eastern Europe, group 1 vs. 2 P = ns, group 1 vs. 3 P = 0.003, group P < 0.001, group 2 vs. 3 P < 0.001). Moreover, 15.1% of respondents 2 vs. 3 P < 0.001). The ICDs made more participants feel safer in Western from Central/Eastern Europe did not know whether their device was and Central/Eastern Europe than in Southern Europe (82.3% vs. 82.1% vs. controlled remotely (compared with just 1.1% and 4.9% in Western 72.6% respectively, group 1 vs. 2 P = ns, group 1 vs. 3 P < 0.001, group 2 vs. and Southern Europe, respectively, group 1 vs. 2 P < 0.001, group 1 3 P = 0.001). However, the percentage of patients regretting their decision 6 Ł. Januszkiewicz et al. 17.9% in Western Europe and 12.2% in Southern Europe, group 1 vs. Table 2 Univariate and multivariate logistic regression of factors 2 P < 0.001, group 1 vs. 3 P = 0.013, group 2 vs. 3 P < 0.001). associated with improved quality of life Additionally, patient knowledge was related to age and education sta­ Univariate analysis Odds 95% CI P tus. Older patients declared having sufficient information about the ratio ICD more often than their younger counterparts (35.2% of 61 to .................................................................. 80-year-old patients vs. 17.3% of 18 to 40-year-old patients, P < Age >80 years old 2.1 1.2–3.5 0.005 0.001). A total of 38.1% of patients with primary education as their Sex male vs. female 1.3 1.1–1.6 0.004 highest education level had sufficient information about ICD compared Region Western vs. Southern 1.8 1.4–2.3 <0.001 with just 26.2% of patients with a licentiate or upper degree (P = 0.004). Treatment discussion before ICD implantation and the patients’ partici­ Region Central/Eastern vs. Southern 2.3 1.7–3.0 <0.001 pation in the decision about ICD implantation varied substantially across Education secondary vs. primary 0.6 0.4–0.9 0.008 Europe. Full explanation of the available treatment options was given to Education college vs. primary 0.5 0.3–0.8 0.001 only 57.0% of Western European patients, compared with 76.7% from Education university vs. primary 0.5 0.3–0.8 <0.001 Central/Eastern Europe and 75.7% from Southern Europe (group 1 vs. 2 P < 0.001, group 1 vs. 3 P < 0.001, group 2 vs. 3 P = ns, Figure 4A). A simi­ No complications 1.0 0.8–1.3 0.684 lar pattern was observed for patients’ active involvement in the ICD im­ ICD dwell time 1.03 1.01–1.04 <0.001 plantation decision-making process—Western Europe 48.0%, Central/ Remote monitoring 1.2 1.0–1.5 0.056 Eastern Europe 56.1%, Southern Europe 60.1%, group 1 vs. 2 P < 0.001, Feeling of being well informed before ICD 2.5 2.0–3.2 <0.001 group 1 vs. 3 P = 0.001, group 2 vs. 3 P = 0.017, Figure 4B). CRT 2.5 1.9–3.3 <0.001 Multivariate analysis Age >80 years old 1.9 1.1–3.3 0.031 Discussion Region Western vs. Southern 2.1 1.6–2.8 <0.001 In this analysis from a large EHRA multinational patient survey, we pro­ Region Central/Eastern vs. Southern 2.5 1.8–3.5 <0.001 vide the first general overview of regional European differences in char­ Education secondary vs. primary 0.6 0.4–0.9 0.011 acteristics of ICD recipients, patients’ perceptions and perspectives on Education college vs. primary 0.6 0.4–0.9 <0.001 the ICD and life with an ICD, level of information provided to patients prior to and after implantation, and patient needs regarding education Education university vs. primary 0.5 0.3–0.7 <0.001 on living with an ICD. We found significant differences between regions ICD dwell time 1.03 1.01–1.05 <0.001 in (i) patient characteristics (age, education, and employment status), Feeling of being well informed before ICD 2.5 2.0–3.2 <0.001 type of device and remote monitoring, (ii) patient knowledge on their CRT 3.2 2.3–4.3 <0.001 type of device, use of remote monitoring, driving restrictions, travelling with an ICD and life expectancy, (iii) provision of detailed information CI, confidence interval; CRT, cardiac resynchronization therapy; ICD, implantable on the ICD prior to and after device implantation, and (iv) ICD impact cardioverter-defibrillator. on quality of life metrics, patient perceptions and perspectives, accept­ ance of the ICD limitations, and associated lifestyle changes. While pa­ tients from Western Europe felt in general less well informed about the about ICD implantation was low and similar in all cohorts (4.8% in ICD and available treatment options and had the highest need for add­ Western, 6.0% in Central/Eastern, 6.5% in Southern Europe, group 1 vs. itional information, those from Southern Europe had the lowest im­ 2 P = ns, group 1 vs. 3 P = ns, group 2 vs. 3 P = ns). provement in quality of life and degree of acceptance of the ICD limitations and the necessary lifestyle changes. Information provided to patients before Although this study could at first suggest that the quality of informa­ tion provision prior to ICD implantation does not associate with pa­ implantation tient satisfaction after having the ICD, this is not necessarily the case, Even though the vast majority of patients reported knowing the reason and the observed differences between European regions in quality of their ICD was implanted (group 1—95.8%, group 2—97.9%, group 3— life and ICD acceptance should be interpreted with caution. The 98.4%, respectively; group 1 vs. 2 P = 0.043, group 1 vs. 3 P = 0.028, group Southern European cohort was younger than the Western and 2 vs. 3 P = ns), there was great variability in the level of information pro­ Central/Eastern European ones, while the period between ICD im­ vided across Europe (Figure 3, Supplementary material 2). In general, plantation and study enrollment was shorter. This may help explain Western Europe patients received less information than Central/Eastern why patients from Southern Europe had the lowest degree of satisfac­ and Southern Europe patients. Indeed, 79.2% of Central/Eastern Europe tion and ICD acceptance despite being better informed in general and patients and 76.0% of Southern Europe patients felt optimally informed having the lowest rate of complications. Younger patients may find it at the time of device implantation compared with just 64.6% from more difficult to accept a device, which has the potential to negatively Western Europe (group 1 vs. 2 P < 0.001, group 1 vs. 3 P < 0.001, group impact on their lifestyle and professional life, and to commit to the ne­ 2 vs. 3 P = ns). Patients from Southern Europe patients were better in­ cessary lifestyle changes. However, it is noteworthy that multivariate formed than patients from other regions regarding driving restrictions, analysis identified region as an independent predictor of increased pa­ travelling with an ICD, and life expectancy of ICD patients. tient satisfaction. Also, it is possible that patients who had had an ICD The disparity in the quality of information provided to patients influ­ for a longer period of time were more likely to have already learned enced their need for further information. Western Europe patients de­ how to live with it and accept its limitations. Living with an ICD requires clared having the highest need for information regarding most aspects a period of adaptation, and this may vary according to the patient’s age of ICD function compared with Central/Eastern and Southern and lifestyle. In addition, age and level of education may influence pa­ European patients (see Supplementary material 3). Remote monitoring tients’ perceptions and perspectives on life with an ICD (understanding of the ICD was the only aspect about which Central/Eastern European of ICD capabilities). The type and density of information provided to patients were the most likely to wish to know more about (25.9% vs. prospective ICD patients may require adaptation according to the Regional disparity on patient characteristics and perceptions 7 Before ICD implantation, I was informed about: 100% 80% 60% 40% 20% 0% IC for w ICD e re sut ling In ork n I do t o ll er he ith en liv ck el tio ng io d an fe ta st l d D to an po a an ef e re ould th at an de ho fe pl rt gic ct y li pl b t w liv if t w h ric vi en IC ty D ks ac be ov e ge , e CD W atio re W sho s a an er is ns ns cy tio - of in a n tti son d ea ly g ow m ur st Dri s d e te ili , w th ca pl D e pe M im ppo olo or im ed el sh nt ou d (s cal Wh al e in ra .) n tra a ck ha ICD ed ac Po n e de o a ul th th va sib an d h m IC e lif d ne tc ge ea D rm I f ng ry ue llin d if co rts wi t I su ch ow IC t to s ic co ible n ve t to po ly a R IC fo l, tte eq y tI pl H Ps re ex ha ba fr ad s W D h le Pos i ow t W H de i ys ph th Western Europe Central/Eastern Europe Southern Europe Figure 3 Quality of information provided before ICD implantation according to region. ICD, implantable cardioverter-defibrillator. A How would you describe the treatment B How would you describe your participation in the discussion before the ICD implantation? decision about the ICD implantation? Available treatment options were not explained to me Available treatment options were somewhat explained to me I was actively involved I was somewhat involved Available treatment options were fully explained to me I was not at all involved 100% 100% 10.4 5.8 7.5 13.4 17.8 22.4 17.5 16.8 80% 80% 32.6 30.5 22.1 29.6 60% 60% 40% 76.7 40% 75.7 57.0 56.1 60.1 48.0 20% 20% 0% 0% Western Central/Eastern Southern Western Central/Eastern Southern Europe Europe Europe Europe Europe Europe Figure 4 (A) Treatment discussion before ICD implantation according to region. (B) Participation in the decision about ICD implantation according to region. ICD, implantable cardioverter-defibrillator. 8 Ł. Januszkiewicz et al. patient’s age and the anticipated impact the ICD may have on their life­ populations were numerically unbalanced due to variable questionnaire style and profession. distribution. Significant differences in the basal characteristics of the three This ICD survey provides unique data on regional differences in in­ populations may also have driven the results; however, such differences formation provided to patients before ICD implantation and treatment exist and certainly reflect real life. Since this survey questionnaire was discussion. As shown in the multivariate analysis, age, educational level, shared with patients only, more advanced or detailed clinical or centre- as well as region and other factors independently influenced quality of based data were unavailable for analysis. These include data such as ICD life. Also, less information is provided to patients in Western Europe. programming, heart failure aetiology, or the number of ICD implants in These patients are given less information on treatment options and each participating centre, which could have helped interpret our results. are less likely to participate in the decision-making process, which ex­ Additionally, we did not retrieve data on specific programs (if any) aimed plains their higher need for better education about the ICD. The rea­ to inform patients about the ICD, specific information provided in the sons for these observed regional inequalities are unclear. The informed consent documents, or how follow-ups (frequency of inhospi­ Western cohort had a higher mean age and longer time since ICD im­ tal appointments and remote monitoring) was organized. plantation. It is possible that older patients may feel less need of detailed information since the device may not interfere in daily life as significantly as in younger subjects who, in general, live more actively. Furthermore, Conclusion patients’ empowerment in decision making may have been less com­ mon in earlier years since there were less data available on ICD implica­ Regional European differences in patients’ quality of life after ICD im­ tions, benefits, and risks. Communication should be improved and plantation and the level of information provision before and after adapted to each individual patient situation (individual level), but at ICD implantation were detected by this patient survey, and novel strat­ the same time, it would be important to make patient information egies to address these issues are warranted. While physicians in more homogeneous across European countries (transnational level). Southern Europe should address the concerns of a younger ICD popu­ The latter can only be achieved through international guidelines and re­ lation about the impact of the device on quality of life, physicians from commendations (which are currently lacking). Western Europe should focus on improving the quality of information Healthcare system factors may play an additional non-negligible role provided to their ICD patients. in explaining these regional disparities. Although Western countries have a higher mean gross domestic product and larger current health expenditure represented as percentage of gross domestic product, Supplementary material they have fewer cardiologists per million inhabitants than Central/ Supplementary material is available at Europace online. Eastern and Southern Europe.2 Notwithstanding, physicians in Western Europe may need to reassess the way they interact with pro­ spective ICD patients and develop novel strategies to improve the qual­ Acknowledgements ity of information provided to patients prior to ICD implantation. The authors acknowledge Axel Verstrael, Patient from the ESC Patient Forum Candidates for the ICD must be thoroughly explained the implications, who consulted the questionnaire. The authors would like to thank Vanessa Meyen for her considerable support in coordinating the project. The authors benefits, and risks of the device, the impact it may have on their quality acknowledge EHRA Research Network centres for their participation in this of life, and the likelihood that the device may save their lives, in order to survey. The authors acknowledge the European Heart Network and its mem­ improve their acceptance of the device. In our previous paper,7 we re­ bers for the dissemination and promotion of the survey. The authors acknow­ ported that most ICD patients would have liked to receive information ledge Sylwester Rogula for his assistance in figures creation. Graphical abstract about living with the device during face-to-face appointments, through and Figure 1 were created with BioRender.com. Internet content or printed material. Patient associations and support We acknowledge the Patient Associations: APODEC—Association de groups for ICD recipients provide aid and information about cardiac im­ POrteurs de Dispositifs Electriques Cardiaques and DAIPP from France, plantable electronic devices, and we have shown that patients find these Arrhythmia Alliance from UK, ICDefibrylatorzy—Stowarzyszenie na rzecz activities helpful.11 Decision-aids used in the shared-decision-making pro­ osób ze wszczepionymi urządzeniami kardiologicznymi from Poland, cess when considering ICD implantation for primary prevention of sud­ Defibrillator (ICD) Deutschland e.V., The Irish Heart Foundation, The Lithuaninan Heart Association, The German Heart Foundation (Deutsche den cardiac death may increase the subjective feeling of being well Herzstiftung), The Swiss Heart Foundation (Schweizerische Herzstiftung), informed.12 Recently, modern technological solutions, such as virtual The Spanish Heart Foundation (Fundación Española del Corazón), The reality videos, have been shown to provide better information and re­ Finnish Heart Association (Suomen Sydänliitto), Fondazione Italiana per il duce anxiety in patients submitted to atrial fibrillation ablation.13 Cuore and Conacuore ODV Coordinamento Nazionale Associazioni Del Similar technologies could be adapted to ICD patients. Cuore from Italy. The production of this document is under the responsibility of the Scientific Initiatives Committee of the European Heart Rhythm Association: Serge Boveda (Chair), Giulio Conte (Co-Chair), Ante Anic, Limitations Sergio Barra, Julian K.R. Chun, Carlo de Asmundis, Nikolaos Dagres, Michal M. Farkowski, Jose Guerra, Konstantinos E. Iliodromitis, Kristine The main limitation of this study is its observational nature based on Jubele, Jedrzej Kosiuk, Eloi Marijon, Rui Providencia, and Frits Prinzen. voluntary participation of patients from ten European countries. Significant inclusion bias should be considered, but it is unclear which way this may have affected our results. The proportion of respondents Funding compared with the volume of implanted patients is different from None declared country to country (between 0.73% and 8.83%, Supplementary Material 4), which makes national comparisons impossible. In order Conflict of interest: Ł.J. has received speaker/consultant fees from Biotronik, Medtronic. G.C. has received research grants from the Swiss to empower this analysis, we have therefore gathered many countries National Foundation and research grants and speaker fees from Boston into three regions on a geographical basis. Our division of countries into Scientific. M.M.F. has received speaker/proctoring fees from Abbott three groups (Western, Central/Eastern, and Southern), and Latvia in­ Medical Poland and Medtronic Poland. J.M.G. has served as consultant for clusion in Central/Eastern Europe due to underrepresentation of Boston-Scientific, Abbott and ZOLL, received speaker fees from Northern Europe, while reasonable from economic and geographical Boston-Scientific, Microport, Abbott and ZOLL, and received research points of view, may be questionable. Also, analysed geographical grants from Medtronic and Abbott. E.M. has served as a consultant for Regional disparity on patient characteristics and perceptions 9 Boston Scientific, Medtronic and Abbott and received research grants from 6. Aktaa S, Tzeis S, Gale CP, Ackerman MJ, Arbelo E, Behr ER et al. European Society of Boston Scientific, Medtronic, Abbott, Biotronik, and Microport. S.B. has Cardiology quality indicators for the management of patients with ventricular arrhythmias served as consultant for Medtronic, Boston Scientific, Microport, and and the prevention of sudden cardiac death: developed in collaboration with the European Zoll. All the other authors have no conflict of interest to declare. heart rhythm association of the European society of cardiology. Europace 2023;25:199–210. 7. Januszkiewicz Ł, Barra S, Marijon E, Providencia R, de Asmundis C, Chun JKR et al. Major Data availability gaps in the information provided to patients before implantation of cardioverter defi­ brillators: a prospective patient European evaluation. Europace 2023;25:1144–51. The data underlying this article will be shared on reasonable request to 8. Pedersen SB, Farkas DK, Hjortshøj SP, Bøtker HE, Johansen JB, Philbert BT et al. the corresponding author with permission of EHRA Scientific Initiatives Significant regional variation in use of implantable cardioverter-defibrillators in Committee. Denmark. Eur Heart J Qual Care Clin Outcomes 2019;5:352–60. 9. Schrage B, Lund LH, Benson L, Dahlström U, Shadman R, Linde C et al. Predictors of References primary prevention implantable cardioverter-defibrillator use in heart failure with re­ 1. Zeppenfeld K, Tfelt-Hansen J, de Riva M, Winkel BG, Behr ER, Blom NA et al. 2022 ESC duced ejection fraction: impact of the predicted risk of sudden cardiac death and all- guidelines for the management of patients with ventricular arrhythmias and the preven­ cause mortality. Eur J Heart Fail 2022;24:1212–22. tion of sudden cardiac death. Eur Heart J 2022;43:3997–4126. 10. 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