Health-related quality of life in in a large cohort of patients with cardiac implantable electronic devices – a registry based study 

Health-related quality of life in in a large cohort of patients with cardiac implantable electronic devices – a registry based study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Health-related quality of life in in a large cohort of patients with cardiac implantable electronic devices – a registry based study Paolo Gatti, Caroline Nymark, Fredrik Gadler This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3853538/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Aim The association of cardiac implantable electronic devices (CIED), namely pacemaker (PM), implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy with (CRT-D) or without defibrillator (CRT-P), on health-related quality of life (HRQoL) is lacking. Methods and results Data from the Swedish Pacemaker and ICD Registry together with the European Quality of Life-5 Dimension questionnaire (EQ-5D) administered before and after one year the CIED implant from January 2019 to February 2022 were used to analyze the HRQoL with the EQ-5D visual analogue scale (EQ-VAS) and the EQ-5D index. Of 1,479 who completed the EQ-5D, 80% had a PM, 10% an ICD, 5% a CRT-P and 6% a CRT-D. The median age was 77 years with a prevalence of females ranging from 38% in the PM group to 17% in the ICD group. The EQ-VAS and the EQ-5D index significantly increased in patients with PM and CRT-P (EQ-VAS +2.8, standard deviations (SD) 23 and +5.8, SD 24.9; EQ-5D index +0.019, SD 0.114 and +0.051, SD 0.125) while only the EQ-5D index increased in patients with ICD (+0.002, SD 0.104 ). After adjusting for age, sex and HRQoL at baseline, the presence of defibrillator was associated with lower EQ-VAS (-3.4, 95% confidence intervals (CI) -6.7; -0.1 and -4.8, 95% CI -8.8;-0.7) and EQ-5D index (-0.018, 95% CI -0.035; -0.0003 and -0.025 95% CI 0.046;0.004) at follow-up compared to PM. Conclusion These findings, showing the HRQoL associated with CIED, are important to support physicians' and pacemaker nurses' care after device implantation by embracing the patients’ perspectives. cardiac implantable electronic devices quality of life Figures Figure 1 Figure 2 Figure 3 Figure 4 Introduction According to the Swedish Pacemaker and implantable cardiac defibrillator Registry (annual report accessible online http://www.pacemakerregistret.se ) annually more than 10,000 pacemakers (PM), implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy device (CRT) are implanted. Despite the large use of such therapies and their survival benefit, there is a substantial lack of research focused on their impact on health-related quality of life (HRQoL) ( 1 ). HRQoL allows the measurement of the health status through patients’ experience and not only with biological parameters. Quantifying a subjective perception in a measurable quantity is challenging and has its limitations. Several disease-specific and non-disease-specific patient-reported outcome measures (PROM) have been developed. Among non-disease-specific PROM the EuroQol 5-Dimension (EQ-5D) and the Short-Form Health Survey (SF-36) are the most widely used. Trials on pacemakers’ modality of pacing, ICD to treat possible life-threatening arrhythmias and CRT to improve survival and symptoms in heart failure patients, have also shown an improvement in HRQoL ( 2 , 3 ). Several factors of medical treatment may impact the patient's perception. The level of information received about the device and the belief in the device’s capacity to cure the disease underneath, especially if a new technology is considered, greatly impacts the HRQoL ( 4 ). The level of information and amount of care varies in randomized clinical trials compared to registries and real-world scenarios ( 5 ). Overestimating the efficacy of cardiac devices may also reduce patient compliance with other therapies and health-positive preventive behaviours ( 6 ). Furthermore, sex and age may have different influences on HRQoL after device implantation ( 7 ). Our purpose, therefore, is to describe the HRQoL in our longitudinal registry-based cohort of patients who received a cardiac device. Methods Study design This was a national registry-based cohort study with patients from the Swedish Pacemaker and ICD Registry who completed a HRQoL questionnaire. Study population and registry data All the patients implanted with a cardiac device are registered in the Swedish Pacemaker and ICD Registry and are offered to complete the EuroQol 5-Dimension 3-Level (EQ-5D-3L) questionnaire and the EQ visual analogue scale (EQ-VAS) ( 8 ) at the time of PM, ICD or CRT implantation and after 1 year with an online form or at the scheduled follow-up visit. Eligible patients were patients who completed the baseline and follow-up questionnaire from January 2019 to December 2021. Data on age and sex, together with the reported bradycardic indication for PM implantation and the primary or secondary prevention indication for ICD and CRT were retrieved from the Swedish Pacemaker and ICD Registry as well as the main symptom contributing to the device’s indication that is collected at the time for device implant. EQ-5D-3L and EQ-VAS The EQ-5D-3L consists of 2 parts. Part 1 where the patients score 5 dimensions related to health aspects: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension can be labelled by the patients in grades of severity as 1: no problems, 2: some problems, 3: extreme problems. Part 2 where the patients score their HRQoL on the EQ visual analogue scale (EQ-VAS) from 0 to 100 (full health). The Swedish value set for EQ-5D-3L questionnaire, which allows summarizing the HRQoL in part 1, attaching weights to each level of each dimension, was used to determine the global “EQ-5D index” from 0 to 1 (full health) ( 9 ). If one or more of the dimension’s levels were not reported, the patient was excluded from the analysis. Statistical analysis Categorical variables were presented as absolute numbers (%) and continuous variables as mean [standard deviation (SD)] if normally distributed or medians [interquartile ranges (IQR)] if not normally distributed. Exploratory data analysis was performed using Pearson’s chi-square test and Kruskal-Wallis test or analysis of variance ANOVA for categorical and continuous variables. Wilcoxon sign rank test was used to analyze continuous not normally distributed paired variables. A multivariable regression analysis was used to compare EQ-5D index and EQ-VAS variation after 1 year from the implant adjusting for age, sex and HRQoL at baseline. All analyses were performed using Stata/IC version 16.1. The level of significance was set to 5%, two-sided. Results During 2019, 9629 patients were implanted with a cardiac device in Sweden. Of these, 1816 patients (5.3%) completed at least the EQ-5D-3L or the EQ-VAS at baseline or at follow-up, and 1479 (81%) patients completed the questionnaire both at baseline and after one year of follow-up. Of those, 1177 (79.6%) were implanted with PM, 148 (10.0%) with ICD, 67 (4.5%) with CRT without defibrillator function (CRT-P) and 87 (5.9%) with CRT with defibrillator function (CRT-D) and were included in the analysis (Fig. 1 ). Patient characteristics are shown in Table 1 . The median baseline EQ-VAS and EQ-5D index were 75 (IQR 60–85) and 0.9028 (IQR 0.8016–0.9694) respectively without significant difference between the devices group (Table 1 ). A separate table with detailed results for each single 5 dimensions by device type is reported in the supplement material with the representation of percentage variation after 1 year ( Table S1 , Figure S1 ). The dimensions exploring pain and discomfort and anxiety and depression had a larger improvement after 1 year in all devices groups. Mobility and usual activity had a consistent improvement in the CRT-P group. Table 1 Baseline characteristics by type of device Total PM ICD CRT-P CRT-D p-value N = 1,479 N = 1,177 (79%) N = 148 (10%) N = 67 (5%) N = 87 (6%) Male 974 (66%) 735 (62%) 123 (83%) 49 (73%) 67 (77%) < 0.001 Age 77 (71; 82) 78 (73; 83) 66 (56; 73) 79 (75; 83) 70 (62; 76) < 0.001 pacing modality < 0.001 AAIR 2 (0%) 2 (0%) 0 (0%) 0 (0%) 0 (0%) DDDR 1,267 (86%) 1,009 (86%) 104 (70%) 67 (100%) 87 (100%) VVIR 210 (14%) 166 (14%) 44 (30%) 0 (0%) 0 (0%) EQ-VAS at baseline 75 (60; 85) 75 (60; 85) 75 (63; 88) 70 (50; 80) 75 (60; 85) 0.09 EQ-VAS at follow-up 77 (65; 90) 80 (65; 90) 76 (65; 90) 75 (60; 85) 75 (60; 90) 0.33 EQ-VAS variation 2.6 (22.7) 2.8 (23.0) 1.8 (20.8) 5.8 (24.9) -0.7 (19.6) 0.32 EQ-5D index at baseline .9028 (.8016; .9694) .9028 (.8016; .9694) .9142 (.8131; .9694) .8797 (.7671; .9694) .9142 (.813; .9694) 0.17 EQ-5D index at follow-up .9142 (.8131; .9694) .9142 (.8131; .9694) .9349 (.8233; .9694) .9142 (.8357; .9694) .9142 (.8336; .9694) 0.78 EQ-5D index variation .0188 (.1142) .0188 (.1139) .0155 (.116) .0512 (.1253) − .0015 (.1019) 0.04 Bradycardic indication < 0.001 AV delay 55 (4%) 37 (3%) 10 (7%) 3 (4%) 5 (6%) AV-block II° 251 (17%) 235 (20%) 1 (1%) 11 (16%) 4 (5%) AV-block III° 344 (23%) 316 (27%) 3 (2%) 14 (21%) 11 (13%) SSS 443 (30%) 425 (36%) 10 (7%) 3 (4%) 5 (6%) Missing 386 (26%) 164 (14%) 124 (84%) 36 (54%) 62 (71%) Tachycardic indication < 0.001 primary prevention 159 (11%) 0 (0%) 78 (53%) 0 (0%) 81 (93%) secondary prevention 76 (5%) 0 (0%) 70 (47%) 0 (0%) 6 (7%) Missing 1,244 (84%) 1,177 (100%) 0 (0%) 67 (100%) 0 (0%) Symptom < 0.001 Dyspnea/asthenia 433 (29%) 264 (22%) 36 (24%) 56 (84%) 77 (89%) Asymptomatic 178 (12%) 95 (8%) 78 (53%) 2 (3%) 3 (3%) Palpitations 104 (7%) 88 (7%) 12 (8%) 1 (1%) 3 (3%) Syncope 455 (31%) 425 (36%) 22 (15%) 4 (6%) 4 (5%) Dizziness 309 (21%) 305 (26%) 0 (0%) 4 (6%) 0 (0%) AAIR = atrial pacing atrial sensing inhibited-response rate-adaptive, AV-block = atrioventricular block, CRT-D = cardiac resynchronization therapy with defibrillator function, CRT-P = cardiac resynchronization therapy without defibrillator function, DDDR = dual-chamber atrioventricular pacing atrioventricular sensing rate-adaptive, EQ-5D = EuroQol 5-Dimension, EQ-VAS = EuroQol visual analogue scale, ICD = implantable cardioverter defibrillator, PM = pacemaker, SSS = sick sinus syndrome, VVIR = ventricular pacing ventricular sensing inhibited-response rate-adaptive The global EQ-VAS and the EQ-5D index distributions are reported in Figure S2 . According to device type, the EQ-VAS significantly improved after 1 year in the PM group (+ 2.8 SD 23). The EQ-5D index significantly improved after 1 year in the PM and CRT-P groups (+ 0.019 SD 0.114; +0.05 SD 0.125 respectively) (Fig. 2 ) detailed values at baseline and after 1 year are reported in Table 1 . The symptoms reported as contributing to the device indication were distributed as follows: 433 (29%) dyspnea or asthenia, 178 (7%) palpitations, 455 (31%) syncope, 309 (21%) dizziness, and 178 (12%) asymptomatic. According to these symptoms, the EQ-VAS significantly improved in patients with dyspnea or asthenia, palpitation, syncope or dizziness but not in asymptomatic patients while the EQ-5D index significantly improved in all groups. (Table 2 , Fig. 3 ) Variations of the EQ-VAS and the EQ-5D index by bradycardic indication, in patients implanted with PM, and by type of arrhythmic prevention, in patients implanted with ICD or CRT-D, are reported in the supplement material ( Figure S3, Figure S4 ). Patients implanted with a pacemaker had a significant improvement of EQ-VAS and EQ-5D index after one year if the principal reported bradycardic indication was sick sinus syndrome (SSS) or atrioventricular block of third-degree (AV-block III°) while no differences were detected for first-degree atrioventricular block (AV-block I°), or missing bradycardic indication. Patients with second-degree atrioventricular block (AV-block II°) as bradycardic indication had a significant improvement in the EQ-5D index but not in the EQ-VAS. Table 2 Characteristics by symptoms at the implant Total Dyspnea/asthenia Asymptomatic Palpitations Syncope Dizziness p-value N = 1,479 N = 433 (29%) N = 178 (12%) N = 104 (7%) N = 455 (31%) N = 309 (21%) Sex 974 (66%) 298 (69%) 130 (73%) 57 (55%) 296 (65%) 193 (62%) 0.011 Age 77 (71; 82) 76 (70; 80) 73 (61; 80) 77 (71; 83) 78 (72; 83) 78 (74; 83) < 0.001 Device type < 0.001 PM 1,177 (80%) 264 (61%) 95 (53%) 88 (85%) 425 (93%) 305 (99%) ICD 148 (10%) 36 (8%) 78 (44%) 12 (12%) 22 (5%) 0 (0%) CRT-P 67 (5%) 56 (13%) 2 (1%) 1 (1%) 4 (1%) 4 (1%) CRT-D 87 (6%) 77 (18%) 3 (2%) 3 (3%) 4 (1%) 0 (0%) pacing modality 0.082 AAIR 2 (0%) 0 (0%) 0 (0%) 1 (1%) 0 (0%) 1 (0%) DDDR 1,267 (86%) 377 (87%) 143 (80%) 89 (86%) 398 (87%) 260 (84%) VVIR 210 (14%) 56 (13%) 35 (20%) 14 (13%) 57 (13%) 48 (16%) EQ-VAS at baseline 75 (60; 85) 75 (55; 85) 75 (60; 90) 75 (57; 85) 75 (56; 90) 75 (60; 85) 0.33 EQ-VAS at follow-up 77 (65; 90) 75 (60; 85) 80 (67; 90) 80 (65; 90) 77 (65; 90) 75 (65; 90) 0.36 EQ-VAS variation 2.6 (22.7) 2.3 (22.2) 2.0 (22.6) 4.4 (19.9) 2.3 (23.6) 3.3 (23.0) 0.87 EQ-5D index at baseline .9028 (.8016; .9694) .9028 (.7805; .9694) .9142 (.8336; .9694) .8797 (.7784; .9694) .9028 (.7855; .9694) .8797 (.8131; .9349) 0.25 EQ-5D index at follow-up .9142 (.8131; .9694) .9142 (.8336; .9694) .9349 (.8407; .9694) .92455 (.8336; .9694) .9142 (.8016; .9694) .9142 (.82; .9694) 0.38 EQ-5D index variation .0188 (.1142) .0215 (.1128) .0198 (.1213) .0283 (.1049) .0118 (.1105) .0213 (.1202) 0.59 CRT-D = cardiac resynchronization therapy with defibrillator function, CRT-P = cardiac resynchronization therapy without defibrillator function, EQ-5D index = EuroQol 5-Dimension index, EQ-VAS = EuroQol visual analogue scale, ICD = implantable cardioverter defibrillator, PM = pacemaker Patients with ICD or CRT-D implanted as secondary prevention had a significant improvement in the EQ-5D index after one year. After adjusting for age and sex and HRQoL and symptoms at baseline, the ICD and CRT-D group had a significantly lower EQ-5D index (-0.0215, 95% confidence intervals (CI) -0.0105; -0.0024 and − 0.0257, 95% CI -0.0482;-0.0032) after 1 year compared to the pacemaker group. Age but not sex or symptoms at the implant was associated with worse EQ-VAS and EQ-5D index after device implantation (-2.5, 95% CI -3.4;-1.5 and − 0.0153 95% CI -0.0202;-0.0103 respectively). Figure 4 Discussion Our study aims to describe the HRQoL status of patients receiving cardiac implantable electronic device (CIED) in a large national cohort using the HRQoL EQ-5D-3L questionnaire at the implant and at one year follow-up. CIED efficacy and effectiveness have a large core of evidence used by the recent European and American Guidelines on cardiac pacing to provide clinical indications ( 10 , 11 ). While the impact of CIED on HRQoL had been studied in clinical trials especially for ICD and CRT or for pacing modality (CRT and single vs dual chamber pacing) in PM ( 12 – 17 ), and since the current state of pharmacological treatment has changed the current state of the art in a real-world setting is lacking. In line with results from previous studies and metaanalyses, ( 2 , 18 , 19 ) our cohort showed an overall improvement of HRQoL at 1 year from the CIED implantation. The improvement of HRQoL was significant in patients implanted with PM or CRT-P but not for ICD and CRT-D. The presence of a defibrillator, since its preventive nature instead of physical symptomatology treatment, may not impact patients reported outcomes ( 20 ). Furthermore, the fear of inappropriate shocks, a higher rate of complication and restrictions on driving license and specific activities may have counteracted other beneficial effects perceived by the patients ( 12 , 21 , 22 ). Interestingly, the domains with greater improvement were pain or discomfort and anxiety or depression. These results show the important weight of psychological aspects in patients' perspectives. Patients with CRT-P showed a large improvement in mobility and usual activities that may reflect the device's impact on functional capacity as well as a different health status perception in the population implanted with CRT-P that are generally older with more comorbidities ( 15 ). Symptoms impact HRQoL and from the patient’s experience, may be more relevant than outcomes such as mortality or hospitalization. In our cohort, patients with symptoms correlated to the device indication, in contrast to asymptomatic patients, had a significant improvement in HRQoL. After adjusting for age, sex, and HRQoL at baseline, no significant differences were detected in HRQoL variation for any type of symptoms compared to asymptomatic patients. Hence the symptoms leading to PM implantation may affect patients’ HRQoL but further dedicated studies have to be done regarding the need for specific support after CIED implantation. The Atrioventricular (AV) -block III° or Sick sinus syndrome (SSS) indication to PM showed a significant improvement on HRQoL but not AV-block I° or the absence of reported bradycardic indication. This finding highlights the possibility that strong and clear indications may not only have a greater impact on biological outcomes but also patient perspective. Secondary prevention for ICD and CRT-D has a strong indication due to the impact on the prognosis but differences between primary and secondary prevention on HRQoL are controversial ( 23 , 24 ). Our study showed a significant improvement in HRQoL that was not replicated in the primary prevention indication. These findings may show, as reported in the European Heart Rhythm Association survey on long-term HRQoL and acceptance of implantable ICD ( 22 ), that patients who experience major arrhythmias had a larger psychological benefit from the security provided by the defibrillator who may overcome the fear of complication. After adjusting for age, sex, symptoms and the baseline HRQoL the devices with defibrillator ICD and CRT-D had a lower HRQoL compared to patients with PM. Although the effect of defibrillators on HRQoL may not be negligible, these results are mainly explained by the different cardiac conditions and the different device choices that were not accounted for in our study. In the previous European survey regarding living with CIED, older patients perceived more frequently an improvement of HRQoL connected to the device implantation independently from the type of device (PM vs ICD/CRT) ( 1 , 25 ). In our study, older age was associated with reduced HRQoL after 1 year in patients implanted with CIED. This can be explained by several factors including the different study designs (an instant survey versus a longitudinal measurement). Our study directly measured the HRQoL with the EQ-5D-3L questionnaire without specifically addressing the acceptance of the device. Younger patients may have had higher concerns about device complications and daily activity limitation but a better overall HRQoL compared to baseline. Limitations Our analysis is affected by several limitations. Important information like medical history and socio-economic status were not available in our analysis. Nevertheless, our studies aimed to provide a picture of the current situation in a large population without deriving causal implications that only randomized clinical trials can achieve. Therefore, the lack of randomization and the impossibility of adjusting for several factors that impact the HRQoL prevent causal inference and reported implications should be considered as speculative and hypothesis generator. Our results are not generalizable to other countries since all the information came from the Swedish national pacemaker and ICD registry and the adapted to Swedish population EQ-5D-3L value set was used to determine the EQ index. A selection bias due to patients' acceptance in completing the EQ-5D-3L questionnaire cannot be ruled out and may affect our results. The baseline EQ-5D-3L questionnaire was assessed at the time of the device implantation procedure which potentially increased the health problem perception leading to lower HRQoL results compared to follow-up. The exclusion of patients who did not complete the follow-up questionnaire limited the generalizability since the chance in HRQoL was not based on the entire population. However, 81% of the screened cohort completed the questionnaire both at baseline and at follow-up. Conclusion The treatment with CIED is one of the purest curative interventions. Nevertheless, accounting for patients' reported outcomes and HRQoL is fundamental. The picture provided by this large real-world cohort strengthens the importance of including the HRQoL in the decision to implement a device, and further study designs. In addition, the findings may support physicians and nurses at the pacemaker in-patient clinic in their patient education and improve the decision-making and follow-up for the patients. Declarations Ethical Approval Ethics committee of each participating hospital in the national quality registry approved data entry and collection. Individual patient consent was not required, but patients were informed of entry into national registries and allowed to opt out. Funding No funding recived Availability of data and materials Data cannot be shared for ethical/privacy reasons. Conflicts of interest P. Gatti: none declared related to this work C. Nymark: none declared related to this work F. Gadler: none declared related to this work References Haugaa KH, Potpara TS, Boveda S, Deharo JC, Chen J, Dobreanu D, et al. Patients’ knowledge and attitudes regarding living with implantable electronic devices: results of a multicentre, multinational patient survey conducted by the European Heart Rhythm Association. EP Eur. 2018;20(2):386–91. Willy K, Ellermann C, Reinke F, Rath B, Wolfes J, Eckardt L, et al. The Impact of Cardiac Devices on Patients’ Quality of Life-A Systematic Review and Meta-Analysis. J Cardiovasc Dev Dis. 2022;9(8):257. Linde C, Ellenbogen K, McAlister FA. Cardiac resynchronization therapy (CRT): Clinical trials, guidelines, and target populations. Heart Rhythm. 2012;9(8):3–13. Polikandrioti M. 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Gatti","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAyUlEQVRIiWNgGAWjYHACxgNQuvFhgwGResBaeNgYmw1J1cLAJtlAjHJz9sMHDnxgqJW3l29uq5xRwGDPT0iLZU9awsEZDMcNe9gY225uMGBInEnIKoMDOQaHeRiOMYK1PDBgSDA4QEjL+TdgLfYgLYVALfb2BLXcANtSkwjSwgh0GOMGgn6Z8QzoF4MDyT3HEpslZxhIJM4gZIs5f/LBBx8q6mzbm48//Njzx8aev4GQwyDkYRhfgpCzYFoY6girHAWjYBSMgpELAIBWQVTzaNZ7AAAAAElFTkSuQmCC","orcid":"","institution":"Karolinska Institutet","correspondingAuthor":true,"prefix":"","firstName":"Paolo","middleName":"","lastName":"Gatti","suffix":""},{"id":267107381,"identity":"9398ad10-ac43-4f60-899c-99f4ccf8cdea","order_by":1,"name":"Caroline Nymark","email":"","orcid":"","institution":"Karolinska Institutet","correspondingAuthor":false,"prefix":"","firstName":"Caroline","middleName":"","lastName":"Nymark","suffix":""},{"id":267107382,"identity":"a325edf7-77ef-4b09-8844-f5b9d06f2db8","order_by":2,"name":"Fredrik Gadler","email":"","orcid":"","institution":"Karolinska Institutet","correspondingAuthor":false,"prefix":"","firstName":"Fredrik","middleName":"","lastName":"Gadler","suffix":""}],"badges":[],"createdAt":"2024-01-11 13:14:16","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3853538/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3853538/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":49766226,"identity":"965247ae-7885-4425-ad6a-fecd1b7f4875","added_by":"auto","created_at":"2024-01-17 16:59:34","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":38533,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eType of device prevalence\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eCRT-D = cardiac resynchronization therapy with defibrillator function\u003c/p\u003e\n\u003cp\u003eCRT-P = cardiac resynchronization therapy without defibrillator function, EQ-5D-VAS = EuroQol 5-Dimension visual analogue scale, ICD = implantable cardioverter defibrillator, PM = pacemaker\u003c/p\u003e","description":"","filename":"Figure1.png","url":"https://assets-eu.researchsquare.com/files/rs-3853538/v1/a99c3b6544da8d357c7b704c.png"},{"id":49766973,"identity":"68074059-0450-4469-af10-6d4ed18c6398","added_by":"auto","created_at":"2024-01-17 17:07:34","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":476712,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eEQ-5D visual analogue scale and EQ-5D index variation after 1 year by type of device\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eCRT-D = cardiac resynchronization therapy with defibrillator function, CRT-P = cardiac resynchronization therapy without defibrillator function, EQ-5D index = EuroQol 5-Dimension index, EQ-VAS = EuroQol visual analogue scale , ICD = implantable cardioverter defibrillator, PM = pacemaker\u003c/p\u003e","description":"","filename":"Figure2.png","url":"https://assets-eu.researchsquare.com/files/rs-3853538/v1/131b38ff63c0c457ab99635c.png"},{"id":49766230,"identity":"b120ad5a-d981-4dba-957c-34503781298b","added_by":"auto","created_at":"2024-01-17 16:59:34","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":721506,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eEQ-5D visual analogue scale and EQ-5D index variation after 1 year by symptoms\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEQ-5D index = EuroQol 5-Dimension index, EQ-VAS = EuroQol visual analogue scale\u003c/p\u003e","description":"","filename":"Figure3.png","url":"https://assets-eu.researchsquare.com/files/rs-3853538/v1/cf04363850dec5c4e91239b3.png"},{"id":49766227,"identity":"793635f9-383e-4d6a-9d0e-1515f3550cd6","added_by":"auto","created_at":"2024-01-17 16:59:34","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":174004,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003ePredictors of EQ-5D visual analogue scale and EQ-5D index variation after 1 year\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eCRT-D = cardiac resynchronization therapy with defibrillator function, CRT-P = cardiac resynchronization therapy without defibrillator function, EQ-5D-VAS = EuroQol 5-Dimension visual analogue scale, ICD = implantable cardioverter defibrillator, PM = pacemaker\u003c/p\u003e","description":"","filename":"Figure4.png","url":"https://assets-eu.researchsquare.com/files/rs-3853538/v1/f35c9c05422d2f7cc8caf0bc.png"},{"id":49769031,"identity":"b4d2f9a2-bb85-4c78-a826-8e54f198a2d1","added_by":"auto","created_at":"2024-01-17 17:23:37","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1191185,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3853538/v1/7ee5af3f-f929-4b1d-8c2f-c0ade50dd8cb.pdf"},{"id":49766229,"identity":"ece9a099-47a6-4f2f-9c0d-55b6b0dc169c","added_by":"auto","created_at":"2024-01-17 16:59:34","extension":"docx","order_by":11,"title":"","display":"","copyAsset":false,"role":"supplement","size":2229544,"visible":true,"origin":"","legend":"","description":"","filename":"Supplementmaterial.docx","url":"https://assets-eu.researchsquare.com/files/rs-3853538/v1/db1e7da6089ee483c4ed3e63.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Health-related quality of life in in a large cohort of patients with cardiac implantable electronic devices – a registry based study ","fulltext":[{"header":"Introduction","content":"\u003cp\u003eAccording to the Swedish Pacemaker and implantable cardiac defibrillator Registry (annual report accessible online \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttp://www.pacemakerregistret.se\u003c/span\u003e\u003cspan address=\"http://www.pacemakerregistret.se\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e) annually more than 10,000 pacemakers (PM), implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy device (CRT) are implanted. Despite the large use of such therapies and their survival benefit, there is a substantial lack of research focused on their impact on health-related quality of life (HRQoL) (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). HRQoL allows the measurement of the health status through patients\u0026rsquo; experience and not only with biological parameters. Quantifying a subjective perception in a measurable quantity is challenging and has its limitations. Several disease-specific and non-disease-specific patient-reported outcome measures (PROM) have been developed. Among non-disease-specific PROM the EuroQol 5-Dimension (EQ-5D) and the Short-Form Health Survey (SF-36) are the most widely used. Trials on pacemakers\u0026rsquo; modality of pacing, ICD to treat possible life-threatening arrhythmias and CRT to improve survival and symptoms in heart failure patients, have also shown an improvement in HRQoL (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). Several factors of medical treatment may impact the patient's perception. The level of information received about the device and the belief in the device\u0026rsquo;s capacity to cure the disease underneath, especially if a new technology is considered, greatly impacts the HRQoL (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). The level of information and amount of care varies in randomized clinical trials compared to registries and real-world scenarios (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e). Overestimating the efficacy of cardiac devices may also reduce patient compliance with other therapies and health-positive preventive behaviours (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). Furthermore, sex and age may have different influences on HRQoL after device implantation (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e). Our purpose, therefore, is to describe the HRQoL in our longitudinal registry-based cohort of patients who received a cardiac device.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy design\u003c/h2\u003e \u003cp\u003eThis was a national registry-based cohort study with patients from the Swedish Pacemaker and ICD Registry who completed a HRQoL questionnaire.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eStudy population and registry data\u003c/h2\u003e \u003cp\u003eAll the patients implanted with a cardiac device are registered in the Swedish Pacemaker and ICD Registry and are offered to complete the EuroQol 5-Dimension 3-Level (EQ-5D-3L) questionnaire and the EQ visual analogue scale (EQ-VAS) (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) at the time of PM, ICD or CRT implantation and after 1 year with an online form or at the scheduled follow-up visit. Eligible patients were patients who completed the baseline and follow-up questionnaire from January 2019 to December 2021.\u003c/p\u003e \u003cp\u003eData on age and sex, together with the reported bradycardic indication for PM implantation and the primary or secondary prevention indication for ICD and CRT were retrieved from the Swedish Pacemaker and ICD Registry as well as the main symptom contributing to the device\u0026rsquo;s indication that is collected at the time for device implant.\u003c/p\u003e \u003cdiv id=\"Sec5\" class=\"Section3\"\u003e \u003ch2\u003eEQ-5D-3L and EQ-VAS\u003c/h2\u003e \u003cp\u003eThe EQ-5D-3L consists of 2 parts. Part 1 where the patients score 5 dimensions related to health aspects: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension can be labelled by the patients in grades of severity as 1: no problems, 2: some problems, 3: extreme problems. Part 2 where the patients score their HRQoL on the EQ visual analogue scale (EQ-VAS) from 0 to 100 (full health). The Swedish value set for EQ-5D-3L questionnaire, which allows summarizing the HRQoL in part 1, attaching weights to each level of each dimension, was used to determine the global \u0026ldquo;EQ-5D index\u0026rdquo; from 0 to 1 (full health) (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). If one or more of the dimension\u0026rsquo;s levels were not reported, the patient was excluded from the analysis.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eCategorical variables were presented as absolute numbers (%) and continuous variables as mean [standard deviation (SD)] if normally distributed or medians [interquartile ranges (IQR)] if not normally distributed. Exploratory data analysis was performed using Pearson\u0026rsquo;s chi-square test and Kruskal-Wallis test or analysis of variance ANOVA for categorical and continuous variables. Wilcoxon sign rank test was used to analyze continuous not normally distributed paired variables. A multivariable regression analysis was used to compare EQ-5D index and EQ-VAS variation after 1 year from the implant adjusting for age, sex and HRQoL at baseline.\u003c/p\u003e \u003cp\u003eAll analyses were performed using Stata/IC version 16.1. The level of significance was set to 5%, two-sided.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eDuring 2019, 9629 patients were implanted with a cardiac device in Sweden. Of these, 1816 patients (5.3%) completed at least the EQ-5D-3L or the EQ-VAS at baseline or at follow-up, and 1479 (81%) patients completed the questionnaire both at baseline and after one year of follow-up. Of those, 1177 (79.6%) were implanted with PM, 148 (10.0%) with ICD, 67 (4.5%) with CRT without defibrillator function (CRT-P) and 87 (5.9%) with CRT with defibrillator function (CRT-D) and were included in the analysis (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). Patient characteristics are shown in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. The median baseline EQ-VAS and EQ-5D index were 75 (IQR 60\u0026ndash;85) and 0.9028 (IQR 0.8016\u0026ndash;0.9694) respectively without significant difference between the devices group (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). A separate table with detailed results for each single 5 dimensions by device type is reported in the supplement material with the representation of percentage variation after 1 year (\u003cb\u003eTable \u003cspan refid=\"MOESM1\" class=\"InternalRef\"\u003eS1\u003c/span\u003e, Figure \u003cspan refid=\"MOESM1\" class=\"InternalRef\"\u003eS1\u003c/span\u003e\u003c/b\u003e). The dimensions exploring pain and discomfort and anxiety and depression had a larger improvement after 1 year in all devices groups. Mobility and usual activity had a consistent improvement in the CRT-P group.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eBaseline characteristics by type of device\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"7\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eTotal\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePM\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eICD\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eCRT-P\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eCRT-D\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;1,479\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;1,177 (79%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;148 (10%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;67 (5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;87 (6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eMale\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e974 (66%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e735 (62%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e123 (83%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e49 (73%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e67 (77%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAge\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e77 (71; 82)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e78 (73; 83)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e66 (56; 73)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e79 (75; 83)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e70 (62; 76)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003epacing modality\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAAIR\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eDDDR\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1,267 (86%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1,009 (86%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e104 (70%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e67 (100%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e87 (100%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eVVIR\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e210 (14%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e166 (14%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e44 (30%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eEQ-VAS at baseline\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e75 (60; 85)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e75 (60; 85)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e75 (63; 88)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e70 (50; 80)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e75 (60; 85)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.09\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eEQ-VAS at follow-up\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e77 (65; 90)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e80 (65; 90)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e76 (65; 90)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e75 (60; 85)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e75 (60; 90)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.33\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eEQ-VAS variation\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2.6 (22.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2.8 (23.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1.8 (20.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e5.8 (24.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e-0.7 (19.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.32\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eEQ-5D index at baseline\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e.9028 (.8016; .9694)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e.9028 (.8016; .9694)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e.9142 (.8131; .9694)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e.8797 (.7671; .9694)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e.9142 (.813; .9694)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.17\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eEQ-5D index at follow-up\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e.9142 (.8131; .9694)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e.9142 (.8131; .9694)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e.9349 (.8233; .9694)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e.9142 (.8357; .9694)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e.9142 (.8336; .9694)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.78\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eEQ-5D index variation\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e.0188 (.1142)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e.0188 (.1139)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e.0155 (.116)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e.0512 (.1253)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u0026minus;\u0026thinsp;.0015 (.1019)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.04\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eBradycardic indication\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAV delay\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e55 (4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e37 (3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e10 (7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3 (4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e5 (6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAV-block II\u0026deg;\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e251 (17%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e235 (20%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1 (1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e11 (16%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e4 (5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAV-block III\u0026deg;\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e344 (23%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e316 (27%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3 (2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e14 (21%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e11 (13%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSSS\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e443 (30%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e425 (36%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e10 (7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3 (4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e5 (6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eMissing\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e386 (26%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e164 (14%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e124 (84%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e36 (54%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e62 (71%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eTachycardic indication\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eprimary prevention\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e159 (11%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e78 (53%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e81 (93%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003esecondary prevention\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e76 (5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e70 (47%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e6 (7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eMissing\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1,244 (84%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1,177 (100%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e67 (100%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSymptom\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eDyspnea/asthenia\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e433 (29%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e264 (22%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e36 (24%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e56 (84%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e77 (89%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAsymptomatic\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e178 (12%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e95 (8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e78 (53%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2 (3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e3 (3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePalpitations\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e104 (7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e88 (7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e12 (8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1 (1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e3 (3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSyncope\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e455 (31%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e425 (36%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e22 (15%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e4 (6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e4 (5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eDizziness\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e309 (21%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e305 (26%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e4 (6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"7\"\u003e\u003cb\u003eAAIR\u0026thinsp;=\u0026thinsp;atrial pacing atrial sensing inhibited-response rate-adaptive, AV-block\u0026thinsp;=\u0026thinsp;atrioventricular block, CRT-D\u0026thinsp;=\u0026thinsp;cardiac resynchronization therapy with defibrillator function, CRT-P\u0026thinsp;=\u0026thinsp;cardiac resynchronization therapy without defibrillator function, DDDR\u0026thinsp;=\u0026thinsp;dual-chamber atrioventricular pacing atrioventricular sensing rate-adaptive, EQ-5D\u0026thinsp;=\u0026thinsp;EuroQol 5-Dimension, EQ-VAS\u0026thinsp;=\u0026thinsp;EuroQol visual analogue scale, ICD\u0026thinsp;=\u0026thinsp;implantable cardioverter defibrillator, PM\u0026thinsp;=\u0026thinsp;pacemaker, SSS\u0026thinsp;=\u0026thinsp;sick sinus syndrome, VVIR\u0026thinsp;=\u0026thinsp;ventricular pacing ventricular sensing inhibited-response rate-adaptive\u003c/b\u003e\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eThe global EQ-VAS and the EQ-5D index distributions are reported in \u003cb\u003eFigure S2\u003c/b\u003e.\u003c/p\u003e \u003cp\u003eAccording to device type, the EQ-VAS significantly improved after 1 year in the PM group (+\u0026thinsp;2.8 SD 23). The EQ-5D index significantly improved after 1 year in the PM and CRT-P groups (+\u0026thinsp;0.019 SD 0.114; +0.05 SD 0.125 respectively) (Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e2\u003c/span\u003e) detailed values at baseline and after 1 year are reported in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e \u003cp\u003eThe symptoms reported as contributing to the device indication were distributed as follows: 433 (29%) dyspnea or asthenia, 178 (7%) palpitations, 455 (31%) syncope, 309 (21%) dizziness, and 178 (12%) asymptomatic. According to these symptoms, the EQ-VAS significantly improved in patients with dyspnea or asthenia, palpitation, syncope or dizziness but not in asymptomatic patients while the EQ-5D index significantly improved in all groups. (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e, Fig.\u0026nbsp;\u003cspan refid=\"Fig5\" class=\"InternalRef\"\u003e3\u003c/span\u003e) Variations of the EQ-VAS and the EQ-5D index by bradycardic indication, in patients implanted with PM, and by type of arrhythmic prevention, in patients implanted with ICD or CRT-D, are reported in the supplement material (\u003cb\u003eFigure S3, Figure S4\u003c/b\u003e). Patients implanted with a pacemaker had a significant improvement of EQ-VAS and EQ-5D index after one year if the principal reported bradycardic indication was sick sinus syndrome (SSS) or atrioventricular block of third-degree (AV-block III\u0026deg;) while no differences were detected for first-degree atrioventricular block (AV-block I\u0026deg;), or missing bradycardic indication. Patients with second-degree atrioventricular block (AV-block II\u0026deg;) as bradycardic indication had a significant improvement in the EQ-5D index but not in the EQ-VAS.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eCharacteristics by symptoms at the implant\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"8\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eTotal\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eDyspnea/asthenia\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eAsymptomatic\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003ePalpitations\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eSyncope\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003eDizziness\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c8\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;1,479\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;433 (29%)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;178 (12%)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;104 (7%)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;455 (31%)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;309 (21%)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSex\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e974 (66%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e298 (69%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e130 (73%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e57 (55%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e296 (65%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e193 (62%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e0.011\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAge\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e77 (71; 82)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e76 (70; 80)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e73 (61; 80)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e77 (71; 83)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e78 (72; 83)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e78 (74; 83)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eDevice type\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePM\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1,177 (80%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e264 (61%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e95 (53%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e88 (85%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e425 (93%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e305 (99%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eICD\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e148 (10%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e36 (8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e78 (44%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e12 (12%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e22 (5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eCRT-P\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e67 (5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e56 (13%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2 (1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1 (1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e4 (1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e4 (1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eCRT-D\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e87 (6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e77 (18%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3 (2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3 (3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e4 (1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003epacing modality\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e0.082\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAAIR\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1 (1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e1 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eDDDR\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1,267 (86%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e377 (87%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e143 (80%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e89 (86%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e398 (87%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e260 (84%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eVVIR\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e210 (14%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e56 (13%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e35 (20%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e14 (13%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e57 (13%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e48 (16%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eEQ-VAS at baseline\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e75 (60; 85)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e75 (55; 85)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e75 (60; 90)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e75 (57; 85)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e75 (56; 90)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e75 (60; 85)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e0.33\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eEQ-VAS at follow-up\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e77 (65; 90)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e75 (60; 85)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e80 (67; 90)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e80 (65; 90)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e77 (65; 90)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e75 (65; 90)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e0.36\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eEQ-VAS variation\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2.6 (22.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2.3 (22.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2.0 (22.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e4.4 (19.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e2.3 (23.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e3.3 (23.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e0.87\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eEQ-5D index at baseline\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e.9028 (.8016; .9694)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e.9028 (.7805; .9694)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e.9142 (.8336; .9694)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e.8797 (.7784; .9694)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e.9028 (.7855; .9694)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e.8797 (.8131; .9349)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e0.25\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eEQ-5D index at follow-up\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e.9142 (.8131; .9694)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e.9142 (.8336; .9694)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e.9349 (.8407; .9694)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e.92455 (.8336; .9694)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e.9142 (.8016; .9694)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e.9142 (.82; .9694)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e0.38\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eEQ-5D index variation\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e.0188 (.1142)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e.0215 (.1128)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e.0198 (.1213)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e.0283 (.1049)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e.0118 (.1105)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e.0213 (.1202)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e0.59\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"8\"\u003e\u003cb\u003eCRT-D\u0026thinsp;=\u0026thinsp;cardiac resynchronization therapy with defibrillator function, CRT-P\u0026thinsp;=\u0026thinsp;cardiac resynchronization therapy without defibrillator function, EQ-5D index\u0026thinsp;=\u0026thinsp;EuroQol 5-Dimension index, EQ-VAS\u0026thinsp;=\u0026thinsp;EuroQol visual analogue scale, ICD\u0026thinsp;=\u0026thinsp;implantable cardioverter defibrillator, PM\u0026thinsp;=\u0026thinsp;pacemaker\u003c/b\u003e\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e\u003cp\u003ePatients with ICD or CRT-D implanted as secondary prevention had a significant improvement in the EQ-5D index after one year.\u003c/p\u003e \u003cp\u003eAfter adjusting for age and sex and HRQoL and symptoms at baseline, the ICD and CRT-D group had a significantly lower EQ-5D index (-0.0215, 95% confidence intervals (CI) -0.0105; -0.0024 and \u0026minus;\u0026thinsp;0.0257, 95% CI -0.0482;-0.0032) after 1 year compared to the pacemaker group.\u003c/p\u003e \u003cp\u003eAge but not sex or symptoms at the implant was associated with worse EQ-VAS and EQ-5D index after device implantation (-2.5, 95% CI -3.4;-1.5 and \u0026minus;\u0026thinsp;0.0153 95% CI -0.0202;-0.0103 respectively). Figure\u0026nbsp;\u003cspan refid=\"Fig8\" class=\"InternalRef\"\u003e4\u003c/span\u003e\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eOur study aims to describe the HRQoL status of patients receiving cardiac implantable electronic device (CIED) in a large national cohort using the HRQoL EQ-5D-3L questionnaire at the implant and at one year follow-up. CIED efficacy and effectiveness have a large core of evidence used by the recent European and American Guidelines on cardiac pacing to provide clinical indications (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e). While the impact of CIED on HRQoL had been studied in clinical trials especially for ICD and CRT or for pacing modality (CRT and single vs dual chamber pacing) in PM (\u003cspan additionalcitationids=\"CR13 CR14 CR15 CR16\" citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e), and since the current state of pharmacological treatment has changed the current state of the art in a real-world setting is lacking.\u003c/p\u003e \u003cp\u003eIn line with results from previous studies and metaanalyses, (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e) our cohort showed an overall improvement of HRQoL at 1 year from the CIED implantation. The improvement of HRQoL was significant in patients implanted with PM or CRT-P but not for ICD and CRT-D. The presence of a defibrillator, since its preventive nature instead of physical symptomatology treatment, may not impact patients reported outcomes (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e). Furthermore, the fear of inappropriate shocks, a higher rate of complication and restrictions on driving license and specific activities may have counteracted other beneficial effects perceived by the patients (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e, \u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eInterestingly, the domains with greater improvement were pain or discomfort and anxiety or depression. These results show the important weight of psychological aspects in patients' perspectives. Patients with CRT-P showed a large improvement in mobility and usual activities that may reflect the device's impact on functional capacity as well as a different health status perception in the population implanted with CRT-P that are generally older with more comorbidities (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eSymptoms impact HRQoL and from the patient\u0026rsquo;s experience, may be more relevant than outcomes such as mortality or hospitalization. In our cohort, patients with symptoms correlated to the device indication, in contrast to asymptomatic patients, had a significant improvement in HRQoL. After adjusting for age, sex, and HRQoL at baseline, no significant differences were detected in HRQoL variation for any type of symptoms compared to asymptomatic patients. Hence the symptoms leading to PM implantation may affect patients\u0026rsquo; HRQoL but further dedicated studies have to be done regarding the need for specific support after CIED implantation. The Atrioventricular (AV) -block III\u0026deg; or Sick sinus syndrome (SSS) indication to PM showed a significant improvement on HRQoL but not AV-block I\u0026deg; or the absence of reported bradycardic indication. This finding highlights the possibility that strong and clear indications may not only have a greater impact on biological outcomes but also patient perspective.\u003c/p\u003e \u003cp\u003eSecondary prevention for ICD and CRT-D has a strong indication due to the impact on the prognosis but differences between primary and secondary prevention on HRQoL are controversial (\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e, \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e). Our study showed a significant improvement in HRQoL that was not replicated in the primary prevention indication. These findings may show, as reported in the European Heart Rhythm Association survey on long-term HRQoL and acceptance of implantable ICD (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e), that patients who experience major arrhythmias had a larger psychological benefit from the security provided by the defibrillator who may overcome the fear of complication.\u003c/p\u003e \u003cp\u003eAfter adjusting for age, sex, symptoms and the baseline HRQoL the devices with defibrillator ICD and CRT-D had a lower HRQoL compared to patients with PM. Although the effect of defibrillators on HRQoL may not be negligible, these results are mainly explained by the different cardiac conditions and the different device choices that were not accounted for in our study.\u003c/p\u003e \u003cp\u003eIn the previous European survey regarding living with CIED, older patients perceived more frequently an improvement of HRQoL connected to the device implantation independently from the type of device (PM vs ICD/CRT) (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e). In our study, older age was associated with reduced HRQoL after 1 year in patients implanted with CIED. This can be explained by several factors including the different study designs (an instant survey versus a longitudinal measurement). Our study directly measured the HRQoL with the EQ-5D-3L questionnaire without specifically addressing the acceptance of the device. Younger patients may have had higher concerns about device complications and daily activity limitation but a better overall HRQoL compared to baseline.\u003c/p\u003e"},{"header":"Limitations","content":"\u003cp\u003eOur analysis is affected by several limitations. Important information like medical history and socio-economic status were not available in our analysis. Nevertheless, our studies aimed to provide a picture of the current situation in a large population without deriving causal implications that only randomized clinical trials can achieve. Therefore, the lack of randomization and the impossibility of adjusting for several factors that impact the HRQoL prevent causal inference and reported implications should be considered as speculative and hypothesis generator. Our results are not generalizable to other countries since all the information came from the Swedish national pacemaker and ICD registry and the adapted to Swedish population EQ-5D-3L value set was used to determine the EQ index.\u003c/p\u003e \u003cp\u003eA selection bias due to patients' acceptance in completing the EQ-5D-3L questionnaire cannot be ruled out and may affect our results. The baseline EQ-5D-3L questionnaire was assessed at the time of the device implantation procedure which potentially increased the health problem perception leading to lower HRQoL results compared to follow-up. The exclusion of patients who did not complete the follow-up questionnaire limited the generalizability since the chance in HRQoL was not based on the entire population. However, 81% of the screened cohort completed the questionnaire both at baseline and at follow-up.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThe treatment with CIED is one of the purest curative interventions. Nevertheless, accounting for patients' reported outcomes and HRQoL is fundamental. The picture provided by this large real-world cohort strengthens the importance of including the HRQoL in the decision to implement a device, and further study designs. In addition, the findings may support physicians and nurses at the pacemaker in-patient clinic in their patient education and improve the decision-making and follow-up for the patients.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthical Approval\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eEthics committee of each participating hospital in the national quality registry approved data entry and collection. Individual patient consent was not required, but patients were informed of entry into national registries and allowed to opt out.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNo funding recived\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eData cannot be shared for ethical/privacy reasons.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflicts of interest\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eP. Gatti: none declared related to this work\u003c/p\u003e\n\u003cp\u003eC. Nymark: none declared related to this work\u003c/p\u003e\n\u003cp\u003eF. Gadler: none declared related to this work\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eHaugaa KH, Potpara TS, Boveda S, Deharo JC, Chen J, Dobreanu D, et al. Patients\u0026rsquo; knowledge and attitudes regarding living with implantable electronic devices: results of a multicentre, multinational patient survey conducted by the European Heart Rhythm Association. EP Eur. 2018;20(2):386\u0026ndash;91.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWilly K, Ellermann C, Reinke F, Rath B, Wolfes J, Eckardt L, et al. The Impact of Cardiac Devices on Patients\u0026rsquo; Quality of Life-A Systematic Review and Meta-Analysis. J Cardiovasc Dev Dis. 2022;9(8):257.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLinde C, Ellenbogen K, McAlister FA. Cardiac resynchronization therapy (CRT): Clinical trials, guidelines, and target populations. Heart Rhythm. 2012;9(8):3\u0026ndash;13.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePolikandrioti M. Patient Perceptions and Quality of Life in Pacemaker Recipients. J Innov Card Rhythm Manag. 2021;12(11):4769\u0026ndash;79.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBouzalmate-Hajjaj A, Mass\u0026oacute; Guijarro P, Khan KS, Bueno-Cavanillas A, Cano-Ib\u0026aacute;\u0026ntilde;ez N. Benefits of Participation in Clinical Trials: An Umbrella Review. Int J Environ Res Public Health. 2022;19(22):15368.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHadler RA, Goldstein NE, Bekelman DB, Riegel B, Allen LA, Arnold RM, et al. Why Would I Choose Death?\u0026rsquo;: A Qualitative Study of Patient Understanding of the Role and Limitations of Cardiac Devices. J Cardiovasc Nurs. 2019;34(3):275\u0026ndash;82.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ede Barros RT, de Carvalho SMR, Silva MA, de Borges M. Evaluation of patients\u0026rsquo; quality of life aspects after cardiac pacemaker implantation. Rev Bras Cir Cardiovasc Orgao Of Soc Bras Cir Cardiovasc. 2014;29(1):37\u0026ndash;44.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001;33(5):337\u0026ndash;43.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBurstr\u0026ouml;m K, Sun S, Gerdtham UG, Henriksson M, Johannesson M, Levin L\u0026Aring;, et al. Swedish experience-based value sets for EQ-5D health states. Qual Life Res Int J Qual Life Asp Treat Care Rehabil. 2014;23(2):431\u0026ndash;42.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGlikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, et al. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Eur Pacing Arrhythm Card Electrophysiol J Work Groups Card Pacing Arrhythm Card Cell Electrophysiol Eur Soc Cardiol. 2022;24(1):71\u0026ndash;164.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKusumoto FM, Schoenfeld MH, Barrett C, Edgerton JR, Ellenbogen KA, Gold MR, et al. 2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay. J Am Coll Cardiol. 2019;74(7):e51\u0026ndash;156.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eIrvine J, Dorian P, Baker B, O\u0026rsquo;Brien BJ, Roberts R, Gent M, et al. Quality of life in the Canadian Implantable Defibrillator Study (CIDS). Am Heart J. 2002;144(2):282\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYoung JB, Abraham WT, Smith AL, Leon AR, Lieberman R, Wilkoff B, et al. Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD Trial. JAMA. 2003;289(20):2685\u0026ndash;94.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, De Marco T, et al. Cardiac-Resynchronization Therapy with or without an Implantable Defibrillator in Advanced Chronic Heart Failure. N Engl J Med. 2004;350(21):2140\u0026ndash;50.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCleland JGF, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, et al. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. 2005;352(15):1539\u0026ndash;49.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFleischmann KE, Orav EJ, Lamas GA, Mangione CM, Schron E, Lee KL, et al. Pacemaker implantation and quality of life in the Mode Selection Trial (MOST). Heart Rhythm. 2006;3(6):653\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLamas GA, Orav EJ, Stambler BS, Ellenbogen KA, Sgarbossa EB, Huang SK, et al. Quality of life and clinical outcomes in elderly patients treated with ventricular pacing as compared with dual-chamber pacing. Pacemaker Selection in the Elderly Investigators. N Engl J Med. 1998;338(16):1097\u0026ndash;104.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSu SF, Wu MS. Arrhythmia Perception and Quality of Life in Bradyarrhythmia Patients Following Permanent Pacemaker Implantation. Clin Nurs Res. 2021;30(2):183\u0026ndash;92.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMlynarska A, Mlynarski R, Golba KS. Influence of frailty on the quality of life patients qualified for pacemaker implantation. J Clin Nurs. 2018;27(3\u0026ndash;4):555\u0026ndash;60.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBundgaard JS, Thune JJ, Nielsen JC, Videb\u0026aelig;k R, Haarbo J, Bruun NE, et al. The impact of implantable cardioverter-defibrillator implantation on health-related quality of life in the DANISH trial. EP Eur. 2019;21(6):900\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSears SF, Conti JB, QUALITY OF LIFE, AND PSYCHOLOGICAL FUNCTIONING OF ICD PATIENTS. Heart. 2002;87(5):488\u0026ndash;93.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJanuszkiewicz Ł, Barra S, Providencia R, Conte G, de Asmundis C, Chun JKR, et al. Long-term quality of life and acceptance of implantable cardioverter-defibrillator therapy: results of the European Heart Rhythm Association survey. EP Eur. 2022;24(5):860\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMagnusson P, Mattsson G, Wallhagen M, Karlsson J. Health-related quality of life in patients with implantable cardioverter defibrillators in Sweden: a cross-sectional observational trial. BMJ Open. 2021;11(7):e047053.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRahmawati A, Chishaki A, Ohkusa T, Sawatari H, Tsuchihashi-Makaya M, Ohtsuka Y, et al. Influence of primary and secondary prevention indications on anxiety about the implantable cardioverter-defibrillator. J Arrhythmia. 2016;32(2):102\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFumagalli S, Pieragnoli P, Haugaa KH, Potpara TS, Rasero L, Ramacciati N, et al. The influence of age on the psychological profile of patients with cardiac implantable electronic devices: results from the Italian population in a multicenter study conducted by the European Heart Rhythm Association. Aging Clin Exp Res. 2019;31(9):1219\u0026ndash;26.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"cardiac implantable electronic devices, quality of life","lastPublishedDoi":"10.21203/rs.3.rs-3853538/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3853538/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eAim\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe association of cardiac implantable electronic devices (CIED), namely pacemaker (PM), implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy with (CRT-D) or without defibrillator (CRT-P), on health-related quality of life (HRQoL) is lacking.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods and results\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData from the Swedish Pacemaker and ICD Registry together with the European Quality of Life-5 Dimension questionnaire (EQ-5D) administered before and after one year the CIED implant from January 2019 to February 2022 were used to analyze the HRQoL with the EQ-5D visual analogue scale (EQ-VAS) and the EQ-5D index.\u003c/p\u003e\n\u003cp\u003eOf 1,479 who completed the EQ-5D, 80% had a PM, 10% an ICD, 5% a CRT-P and 6% a CRT-D. The median age was 77 years with a prevalence of females ranging from 38% in the PM group to 17% in the ICD group. The EQ-VAS and the EQ-5D index significantly increased in patients with PM and CRT-P (EQ-VAS +2.8, standard deviations (SD) 23 and +5.8, SD 24.9; EQ-5D index +0.019, SD 0.114 and +0.051, SD 0.125) while only the EQ-5D index increased in patients with ICD (+0.002, SD 0.104 ). After adjusting for age, sex and HRQoL at baseline, the presence of defibrillator was associated with lower EQ-VAS (-3.4, 95% confidence intervals (CI) -6.7; -0.1 and -4.8, 95% CI -8.8;-0.7) and EQ-5D index (-0.018, 95% CI -0.035; -0.0003 and -0.025 95% CI 0.046;0.004) at follow-up compared to PM.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThese findings, showing the HRQoL associated with CIED, are important to support physicians' and pacemaker nurses' care after device implantation by embracing the patients’ perspectives.\u003c/p\u003e","manuscriptTitle":"Health-related quality of life in in a large cohort of patients with cardiac implantable electronic devices – a registry based study ","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-01-17 16:59:29","doi":"10.21203/rs.3.rs-3853538/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"50b52c4a-9d1b-41e7-91b3-d1ea4590ebd0","owner":[],"postedDate":"January 17th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2024-01-17T16:59:32+00:00","versionOfRecord":[],"versionCreatedAt":"2024-01-17 16:59:29","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-3853538","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3853538","identity":"rs-3853538","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}