The nationwide Finnish anticoagulation in atrial fibrillation (FinACAF): study rationale, design, and patient characteristics

Atrial fibrillation (AF) is a major cause of ischemic stroke and the number of AF patients is increasing. Thus, up-to-date multifaceted data about the characteristics of AF patients, their treatments, and outcomes are urgently needed. The Finnish anticoagulation in atrial fibrillation (FinACAF) study has collected comprehensive data on all Finnish AF patients from 1st January 2004 to 31st December 2018. The aim of this paper is to describe the study rationale, the process of integrating data from the applied resources and to define the study cohort. Using national unique personal identification number, individual patient data is linked from nationwide health care registries (primary, secondary, and tertiary care), drug purchases, education, and socio-economic status as well as places of domicile, incomes, and taxes. Six regional laboratory databases (~ 282,000, 77% of the patients) are also included. The study cohort comprises of a total of 411,000 patients. Since the introduction of the national primary care register in 2012, 9% of all AF patients were identified outside hospital care registers. The prevalence of AF in Finland—4.1% of whole population—is for the first time now established. The FinACAF study allows a unique possibility to investigate the epidemiology and socio-medico-economic impact of AF as well as the cost effectiveness of different AF management strategies in a completely unselected, nationwide population. This article provides the rationale and design of the study together with a summary of the characteristics of the cohort.

Medico-economic impact of enhanced rehabilitation after surgery: an exhaustive, nation-wide claims study

Background Study of the medico economic impact of enhanced rehabilitation after surgery (ERAS), by comparing the cost of patient care with or without ERAS, both from the point of view of the hospitals and the Social Security Health Insurance Program. Methods Retrospective longitudinal study on matched data from March 1, 2019 to December 31, 2019. The data are extracted from the French prospective payment system. We studied 12 of the most commonly performed in ERAS business segments. The primary outcome was the reduction of the average length of hospital stay and its implications on production costs and excess capacity. We also studied the impact on hospital incomes and Social Security Insurance Program expenses. The potential gain in hospital days was computed by comparing the length of stay of ERAS and non-ERAS cases. The cost reduction was estimated using the mean number of avoidable days of hospitalization, and the mean cost of the stays obtained from the national cost study. Finally, we studied an approximation of the additional expense for the Social Security Health Insurance Program on costs standardized by applying public sector rates. Results The average length of stay reduction attributed to ERAS is 1.45 (CI 95% 1.42 to 1.48) day per stay, translating to a cost reduction for the hospitals of € 1060 (CI 95% 995 to 1125) per patient and a total of €65 million (CI 95% 61 to 69). At the same time, the additional expenses for the Social Security Insurance Program can conservatively be approximated to € 1.6 million, breaking into a € 2.2 million increase partially compensated by cost savings of € 0.6 million over subsequent stays for complications. Overall, for each percent of additional ERAS activity over the scope of the study, the marginal cost reduction for the hospitals can be estimated to € 1.8 million (CI 95% 1.7 million to 2.0 million). Conclusions Associated with previously known clinical benefits for the patients, these convincing results in terms of economic gain strongly support expanding the adoption of ERAS.

A novel paclitaxel coated balloon with increased drug transfer for treatment of complex vascular lesions

Background Drug coated balloons (DCB) with paclitaxel (Ptx) dose of 2–3.5 μg/mm2 balloon surface inhibit restenosis with different effectiveness and duration of success. A clinical dose finding study is not known for any of the currently marketed products. The aim of the present preclinical trial was to investigate a novel DCB coated with 6 μg Ptx/mm2 in a porcine model. Methods and results The current study investigated a DCB with a novel, modified iopromide based matrix with 6 μg Ptx/mm2. Drug transfer to the vessel wall of peripheral arteries was compared with a dose of 3 μg Ptx/mm2 and two fully overlapping DCB with 3 μg Ptx/mm2, each. Ptx concentration in the vessel wall after drug transfer was about twice as high for balloons with 6 μg/mm2 (1957±1472 μg/g) and two overlapping DCB with 3 μg Ptx/mm2, each (1287±619 μg/g) compared to a single balloon with 3 μg Ptx/mm2, (787±738 μg/g), with statistical significant differences for 1x6 μg/mm2 vs. 1x3 μg/mm2 (p = 0.017) but not for 2x3 μg/mm2 vs. 1x3 μg/mm2 (p = 0.184) and 1x6 μg/mm2 vs. 2x3 μg/mm2 (p = 0.178). The proportion of residual Ptx on balloon after treatment was similar for all groups between 6±1% and 10±3% of dose on balloon. Conclusion The dose of 6 μg Ptx/mm2 was successfully as well as reproducibly coated on conventional balloon catheters. Increased Ptx on balloons resulted in increased drug concentration in the vessel wall. A single balloon with 6 μg Ptx/mm2 seems to provide double dose compared to 3 μg Ptx/mm2, facilitates the procedure, and may reduce medico-economic cost compared to the use of two standard DCB.

RaDiCo, the French national research program on rare disease cohorts

Background Rare diseases (RDs) affect nearly 3 million people in France and at least 26–30 million people in Europe. These diseases, which represent a major medical concern, are mainly of genetic origin, often chronic, progressive, degenerative, life threatening and disabling, accounting for more than one third of all deaths occurring during infancy. In this context, there are needs for coordinated information on RDs at national/international levels, based on high quality, interoperable and sharable data. The main objective of the RaDiCo (Rare Disease Cohorts) program, coordinated by Inserm, was the development of RD e-cohorts via a national platform. The cohort projects were selected through a national call in 2014. The e-cohorts are supported by an interoperable platform, equivalent to an infrastructure, constructed on the "cloud computing" principle and in compliance with the European General Data Protection Regulation. It is dedicated to allow a continuous monitoring of data quality and consistency, in line with the French Health Data Hub. Results Depending on cohorts, the objectives are to describe the natural history of the studied RD(s), identify the underlying disease genes, establish phenotype-genotype correlations, decipher their pathophysiology, assess their societal and medico-economic impact, and/or identify patients eligible for new therapeutic approaches. Inclusion of prevalent and incident cases started at the end of 2016. As of April 2021, 5558 patients have been included within 13 RD e-cohorts covering 67 diseases integrated in 10 European Reference Networks and contributing to the European Joint Program on RDs. Several original results have been obtained in relation with the secondary objectives of the RaDiCo cohorts. They deal with discovery of new disease genes, assessment of treatment management, deciphering the underlying pathophysiological mechanisms, diagnostic approaches, genotype–phenotype relationships, development and validation of questionnaires relative to disease burden, or methodological aspects. Conclusion RaDiCo currently hosts 13 RD e-cohorts on a sharable and interoperable platform constructed on the “cloud computing” principle. New RD e-cohorts at the European and international levels are targeted.

Increasing the medico-economic efficiency of preventive counseling for patients with arterial hypertension and behavioral risk factors for non-communicable diseases

Objective: to evaluate behavioral risk factors (BRF) in patients with arterial hypertension (AH) and to determine the ways of improvement of the approaches to preventive consulting targeted to increase medico-economic efficiency of the prevention of cardiovascular diseases (CVDs).Material and methods. A total of 107 patients aged 40–60 years old that attended health-promoting schools for patients with AH at the institutions of primary medical help in Moscow in 2017–2019 were surveyed. The authors used diagnostic criteria of the risk factors for noncommunicable diseases that have behavioral character according to the classification of the World Health Organization (WHO). Along with that, the authors reviewed the opinion of 128 top managers of the institutions of primary medical help that attended the courses of their qualification improvement “Organization of public healthcare” in 2019. The course was dedicated to the possible ways of improvement of preventive consulting of patients with AH and BRF. The methods of content analysis, synthesis, statistical analysis, comparison, etc. were applied. The authors analyzed the documentation on the prevention of CVDs, scientific publications on the subject from eLibrary, Cochrane Library, PubMed, Scopus databases, and official sites of biomedical journals.Results. The sociological survey revealed data on the presence of BRF of non-communicable diseases in patients aged 40–60 years old with verified AH based on scientifically proven criteria and WHO classification. These criteria allowed to evaluate the degree of the proneness of patients with AH to the influence of harmful risk factors (smoking, alcohol consumption, lack of physical activity, unhealthy eating habits) and their combinations. The sociological survey data obtained from the top management of institutions of primary medical help indicated the necessity of the improvement of approaches to group preventive consulting of patients with AH and BRF.Conclusion. The results of the study revealed the main areas of the systemic mistakes in the preventive consulting of patients with AH that have BRF, associated with the evaluation of individual-psychological peculiarities of a personality, and in the organizational aspects of preventive counseling.

RaDiCo, the French National Program on Rare Disease Cohorts

Background: Rare diseases (RDs) affect nearly 3 million people in France and at least 26-30 million people in Europe. These diseases, which represent a major medical concern, are mainly of genetic origin, often chronic, progressive, degenerative, life threatening and disabling, accounting for more than one third of all deaths occurring during infancy. In this context, there are needs for coordinated information on RDs at national /international levels, based on high quality, interoperable and sharable data. The main objective of the RaDiCo (Rare Disease Cohorts) program, coordinated by Inserm, was the development of RD e-cohorts via a national platform. The cohort projects were selected through a national call in 2014. The e-cohorts are supported by an interoperable platform, equivalent to an infrastructure, constructed on the "cloud computing" principle and in compliance with the European General Data Protection Regulation. It is dedicated to allow a continuous monitoring of data quality and consistency, in line with the French Health Data Hub. Results: Depending on cohorts, the objectives are to describe the natural history of the studied RD(s), establish phenotype-genotype correlations, decipher their pathophysiology, assess their societal and medico-economic impact, and/or identify patients eligible for new therapeutic approaches. Inclusion of prevalent and incident cases started at the end of 2016. As of April 2021, 5558 patients have been included within 13 RD e-cohorts covering 67 diseases integrated in 10 European Reference Networks and contributing to the European Joint Program on RDs. Several original results have been obtained in relation with the secondary objectives of the RaDiCo cohorts. They deal with discovery of new disease genes, assessment of treatment management, deciphering the underlying pathophysiological mechanisms, diagnostic approaches, genotype-phenotype relationships, development and validation of questionnaires relative to disease burden, or methodological aspects.Conclusion: RaDiCo currently hosts 13 RD e-cohorts on a sharable and interoperable platform constructed on the “cloud computing” principle. New RD e-cohorts at the European and international levels are targeted.

The Medico-economic Impacts of Marijuana Use on the Outcomes and In-hospital Mortality in Patients with Atrial Fibrillation – Nationwide Database study

Introduction Cannabinoid users are at high risk of developing atrial arrhythmias. We sought to investigate the outcomes and the economic impact of marijuana use on patients with atrial fibrillation utilizing the National Inpatient Sample. Materials and Methods Patients with atrial fibrillation were identified in the National Inpatient Sample (NIS) database between 2012 and 2014 using the International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM), who subsequently were divided into two groups, those with and without marijuana smoking. The primary outcome was all-cause in-hospital mortality in the two groups. Secondary outcomes were in-hospital morbidities, required procedures and complications. We also evaluated the length of hospital stay and the cost of hospitalization. Logistic regression model was performed to address potential confounding factors. Results: The marijuana-users group had no significant increase of in-hospital mortality (OR: 1.24; 95% CI: 0.51 - 3.01, p = 0.632). However, marijuana users were predominantly younger males and less likely to undergo cardiac surgery (OR: 0.54, 95% CI 0.37 - 0.78, p = 0.001). Moreover, marijuana users are more likely to have a lower cost of hospitalization when compared to non-users ($28,916 vs $32,303, p = 0.001). Conclusion: Cannabinoid use was not associated with an increase in mortality among patients admitted with atrial fibrillation. However, marijuana users were younger, had fewer comorbidities, and cardiac surgeries with associated lower hospitalization costs. Admittedly, given the growing popularity of these products, further large prospective studies are needed to investigate the safety and evaluate different integral associations of cannabis use with worse cardiac outcomes in atrial arrhythmias patients, particularly those with atrial fibrillation.

Early results and medico-economic evaluation of a short daily home hemodialysis program in a Private hemodialysis center

Between 2015 and 2017 there was a 40% increase in daily hemodialysis, according to the REIN database. This increase concerns 1% of patients and the private sector remains under-represented. Our retrospective study aims to describe the clinical features, the organizational and medico-economic specificities of this technique in a private hemodialysis center. Methods: We included 12 dialyzed patients trained on Nx Stage® machine from February 2020 to April 2021. Data were retrospectively obtained through review of our electronic medical records (EUCLID®). Results: Of the 12 patients trained, 11 dialyzed from home, with an average follow-up of 9 months (1-14). The average age was 45 with a sex ratio of 4/8 (M/W), and a median Charlson score of 3 (2-4). The average residual urinary output was 700 mL/24h, and 50% of patients were anuric. 100% of patients had an arteriovenous fistula and were cannulated using the buttonhole technique. 9 patients are on a transplant list. One patient needed anticoagulants. The mean training time was 35 days (28-35). 83% of patients were dialyzed 6 days a week with an average duration of 210 minutes (130-150) per session. The average volume of dialysate was 24.85 liters. One patient developed an allergy to the PUREMA® membrane. Pre-dialytic hemoglobin, serum creatinine, urea, phosphoremia and B2-microglobuline are stable at 9 months with improvement in metabolic acidosis. Conclusion: DHHD allowed a better socio-professional integration. One patient received a transplant and 3 patients resumed professional activity.

POS1237 ALGORITHM IDENTIFYING CHRONIC INFLAMMATORY DISEASES TREATED BY BIOTHERAPY AND/OR TARGETED SYNTHETIC TREATMENTS IN OUTPATIENT CARE IN FRANCE: FEASIBILITY, PRELIMINARY RESULTS, AND IMPACT OF COVID-19

Background:Discriminating chronic inflammatory diseases under biotherapy and/or targeted synthetic treatments (B/TST) using medico-administrative databases are challenging but required for medico-economic analyses focusing on these diseases.Objectives:The objective was to evaluate the feasibility of using a medication dispense data in order to identify patients with chronic inflammatory diseases under B/TST in outpatient care setting and evaluate the impact of COVID-19 in FranceMethods:LRx contains all anonymized medication dispenses prescribed in outpatient care in a representative panel of French retails pharmacies, including data of near 40 million patients. Patients having at least one B/TST delivered in 2019 were selected. An algorithm was constructed using different steps, including a machine learning step by transfer learning applied in patient classified as having a rheumatologic condition in order to differentiate rheumatoid arthritis (RA) from spondyloarthritis (SA). We numbered 190,640 patients, of which 87.8% were classified in one of the following diseases: RA, SA, psoriatic arthritis (PA), psoriasis, inflammatory bowel diseases (IBD) (extrapolated data to France). Descriptive analysis was performed. The impact of COVID-19 on biotherapy initiation was evaluated during the lockdown period (W2-W19 2020) in these different conditions.Results:Among the 167,468 patients under B/TST, 20.7%, 18.4%, 6.5%, 37.9% and 16.5% were considered as having a psoriasis, IBD, PA, RA, and SA, respectively. Female patients were more frequent in RA and PA (> 60%); younger (< 20 years) and older patients (74 years) were found in patients with IBD (5.7%) and RA (12.6%), respectively. Contrasting with IBD, SA, and RA patients were mainly under anti-TNF treatment (> 90% for IBD and SA, 73.5% for RA), psoriasis and PA patients received a range of broadly well-balanced of B/TST. Among the immunosuppressant, methotrexate was mostly prescribed in RA (58.4%), PA (34.1%), and psoriasis (14.1%), and azathioprine in IBD (19.9%). Oral corticosteroid delivered at least 4 times in 2019 were mostly found to be associated with a RA condition (28%). A significant decrease of biotherapy initiation was observed during the lockdown in France in patients with IBD (-20%, p=0.03) and psoriasis (-54%, p<0.0001), not significant decrease in patients with SA (-6%) and increase in RA patients (+23%).Conclusion:The algorithm was able to identify patients with chronic inflammatory diseases under B/TST delivered in outpatient care and will allow to follow-up its management and study the COVID-19 impact on biotherapy initiation. An external validation needs to be performedDisclosure of Interests:None declared

All you want to know about the arrhythmia: A comprehensive, nationwide registry study of atrial fibrillation in Finland

Funding Acknowledgements Type of funding sources: Public hospital(s). Main funding source(s): Helsinki and Uusimaa Hospital District Funding The Finnish Foundation for Cardiovascular Research OnBehalf FinACAF Introduction The number of atrial fibrillation (AF) patients is increasing, and thus, the socio-medico-economic impact of AF is exploding. Up-to-date, multifaceted data about the characteristics of AF patients, their treatments, and outcomes are urgently needed. Purpose The aim of the Finnish AntiCoagulation in Atrial Fibrillation (FinACAF) study is to evaluate the incidence and prevalence of AF, risk of stroke, thromboembolic complications, myocardial infarction, major bleeding events, and mortality in AF patients using comprehensive nationwide registries regulated by law. Assessment of the socio-medico-economic aspects of AF and the effect of socio-economic factors on the AF treatment play a central role in this study. Methods The FinACAF study collects data from 411 000 patients covering all Finnish AF patients from 1st January 2004 to 31st December 2018. Using national unique personal identification number, individual patient data from ten nationwide population registries and six regional laboratory databases (∼282000, 77 % of the patients) are linked together. All the register data were obtained during Q1-Q2/2020. The main results will be expected during Q1-2/2021. Results Since the introduction of the national primary care register in 2012, 9% of all AF patients were identified outside hospital care registers. The total number of AF patients on 31st December 2018 was 227 114, which translates to an AF prevalence of 4.1% in Finland (population of 5 517 900). The Table represents the registries used in the FinACAF study. Conclusions The FinACAF study records all patient contacts with the health care institutions and organizations, as well as incomes and places of domicile. Thus, the database allows a unique possibility to investigate the epidemiology and socio-medico-economic impact of AF as well as the cost effectiveness of different AF management strategies in a completely unselected, nationwide population. This data will markedly help "leading with data" when the increasing number of AF patients are treated. The registries used in the FinACAF study Register Registry Information obtained Finnish Care Register for Health Care: Primary, Hospital and Social care registries National Institute for Health and Welfare Diagnosis (ICD-10), procedure codes and date; non-hospital institutionalizations National Prescription Register, National Reimbursement Register The Social Insurance Institution of Finland Drug purchases (date, ATC codes, amount), Reimbursement decisions for chronic diseases (date, ICD-10) National Causes of Death Register, The Register of Completed Education and Degrees Statistics Finland Deaths and causes of deaths (ICD-10), Education and socio-economic status National Cancer Registry (1st Jan 1950 to 31st Dec 2018) Finnish Cancer Registry National registry of all cancer cases (e.g. date, ICD-O-3, TNM) Population Register, Tax register Population Register Center, Tax Administration Places of domicile, Income and taxes Laboratory databases (1st Jan 2010 to 31st Dec 2018) Six largest regional laboratory databases INR and other relevant laboratory measurements