Alpha-1 Antitrypsin Deficiency in Romania : where are we and where are we need to be?
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1 Alpha-1 Antitrypsin Deficiency in Romania : where are we and where are we need to be? Ruxandra Ulmeanu Visiting Professor, Habil, MD, PhD,FCCP Ruxandra Ulmeanu, Lavinia Davidescu, Ana Zaharie, President of the Romanian Society of Pneumology Simona Olteanu, Iulia Oita National representative GOLD,GINA,Central- Eastern European Alpha-1 Antitrypsin Network Head of Pneumology Department Faculty of Medicine Oradea Institute of Pneumology"Marius Nasta Bucharest Romania
2 RARE DISEASES a challenging activity for physicians
3 ALPHA-1 ANTITRIPSIN DEFICIENCY one of the most challenging activity for chest physicians
4 AATD - a disease slowly investigated Time between first symptoms and diagnosis 7.2 years ± 8.3 years Before the diagnosis is established at least 3 doctors evaluation Peter J. Barnes, Chronic Obstructive Pulmonary Disease, N Engl J Med 2000; 343:
5 AATD in other countries represents an iceberg 5% of patients diagnosed 1. K. Stoller, A Review of a1-antitrypsin Deficiency, Am J Respir Crit Care Med Vol 185, Iss. 3, pp , Feb 1, Darren N. Saunders, A Novel SERPINA1 Mutation Causing Serum Alpha 1 -Antitrypsin Deficiency, PLoS One. 2012; 7(12): e Ruxandra Ulmeanu et al, Epidemiology of AADT in Central-Eastern Europe where are we now?,first CEE -AATD Network Conference,Warsaw,19 th April
6 before 2012 AATD in Romania frozen frozen diagnosis lake we just know that it exists Ruxandra Ulmeanu et al, Epidemiology of AADT in Central-Eastern Europe where are we now?,first CEE -AATD Network Conference,Warsaw,19 th April
7 before 2012 AATD in Romania The disease was usually identified only by the plasmatic values Genetic testing - only in the private practice with samples worked abroad and costs fully covered by the patient. Ruxandra Ulmeanu et al, Epidemiology of AADT in Central-Eastern Europe where are we now?,first CEE -AATD Network Conference,Warsaw,19 th April 2013
8 Genetic Screening for AATD in Romania We start to introduce the standards of the best medical practice for AATD patients in Romania since 2012
9 It was a complex and extremely helpful activity for Romanian team Trainings for doctors (6) biochemists (1) nurses (1) physiotherapists (1) in hospitals and laboratories from Warsaw, Hanover, Vilnius, Leiden
10 Still in Romania Genetic testing only in the private practice costs fully covered by the patient.
11 Genetic Screening for AATD in Romania goes on!!!. although Leonardo project came to an end with the support of The National Institute of Lung Diseases - Warsaw Joanna Chorostowska-Wynimko Head of Central-Eastern European Alpha-1 Antitrypsin Network
12 AATD in Romania? Certainly AATD in Romania is an under-diagnosed pathology in patients with COPD Ruxandra Ulmeanu,Ana Nebunoiu et al, Alpha 1 antitrypsin deficiency in Romania: preliminary results from the genetic screening ,unpublished data
13 Preliminary results of Genetic Screening Romania
14 Protocol October 2012-present Dry blood spots Testing in Warsaw The National Institute of Lung Diseases: Plasmatic value Isoelectric focusing Genotyping Sequencing (rare cases)
15 Ruxandra Ulmeanu, Ana Zaharie et al, Alpha 1 antitrypsin deficiency in Romania: preliminary results from the genetic screening ,unpublished data Gender distribution N=679 patients with available results October 2012 March 2017 More than 700 DBS have been tested (697 unique patients) 285; 40% Men 411; 60% Women AATD suspicion is higher among men Sex ratio: 1.44:1
16 Ruxandra Ulmeanu, Ana Zaharie et al, Alpha 1 antitrypsin deficiency in Romania: preliminary results from the genetic screening ,unpublished data Reason for testing N= The main reason for testing COPD (61%), emphysema (37%) or bronchiectasis (18%) followed by asthma, siblings, other in accordance with ERS / ATS guidelines COPD Emphysema Bronchiectasis Asthma Pneumothorax Siblings Other * * Other: association of: lung cancer, pulmonary fibrosis, autoimmune cirrhosis, neonatal hepatitis syndrome history, ACOS
17 7.5 % of screened patients were identified to have genetic modification heterozygous, more rarely homozygous Ruxandra Ulmeanu, Ana Zaharie et al, Alpha 1 antitrypsin deficiency in Romania: preliminary results from the genetic screening ,unpublished data N=679 available results October 2012 March 2017 Normal genotype: 92.50% Modified genotype: 7.50% heterozygote c.1033g>t p.val321phe Classical mutations (80.39%) Rare mutations (19.61%)
18 Age distribution Minimum: The 5 average years age for testing fluctuated around 50 years, Maximum: 85 years in accordance with the decade Median: ±16.20 when years commonly Average: AATD is years symptomatic and diagnosed N= October 2012 March years Ruxandra Ulmeanu, Ana Zaharie et al, Alpha 1 antitrypsin deficiency in Romania: preliminary results from the genetic screening 2012-
19 Ruxandra Ulmeanu, Ana Zaharie et al, Alpha 1 antitrypsin deficiency in Romania: preliminary results from the genetic screening ,unpublished data Rare genotypes % of mutations it may be a feature for this zone of Europe Genotype Number Percent (%) Median AAT level (mg/dl) SD (mg/dl) Average AAT level (mg/dl) M wurzburg M IM IZ P lowell Z undetectable plasma levels - - P lowell M heterozygote c.1033g>t p.val321phe
20 Ruxandra Ulmeanu, Ana Zaharie et al, Alpha 1 antitrypsin deficiency in Romania: preliminary results from the genetic screening ,unpublished data Reason for testing of modified genotype N= COPD is the main indication COPD Siblings Bronchiectasis 2 Asthma 2 COPD+bronchiectasis ACOS COPD+emphysema Emphysema+pneumothorax COPD+cirrhosis Others * *Others: Chronic bronchitis, interstitial fibrosis, neonatal hepatitis syndrome history
21 Ruxandra Ulmeanu, Ana Zaharie et al, Alpha 1 antitrypsin deficiency in Romania: preliminary results from the genetic screening ,unpublished data COPD remains the main indication for testing at patients with modified genotype screening of first-degree relatives in 2nd bronchiectasis ranks in 3rd place refractory asthma ACOS COPD+cirrhosis until now 4.30% of patients with COPD are carriers of a modified gene
22 Ruxandra Ulmeanu, Ana Zaharie et al, Alpha 1 antitrypsin deficiency in Romania: preliminary results from the genetic screening ,unpublished data The median FEV1 is 60% with large variations between 20% and 122% Fortunately, from the identified genome homozygotes 2 are children - their lung function is still in the normal range N=51 Characteristics of group with modified Parameter Median SD Minimum Maximum Age (years) FEV1 (%) AAT plasmatic value (mg/dl)* Below the 186 sensitivity *NB: NV: mg/dl
23 What else have we done for AATD in Romania?
24 AATD Working Group of Romanian Society of Pneumology Fouded in founding members June 17 th Sibiu Dr.Lavinia Davidescu Coordinator
25 We kept increasing the AATD awareness in Romanian medical community
26 We have the guideline for the diagnosis and management of AATD the version in Romanian language
27 Lavinia Davidescu Coordinator of AATD Working Group of the Romanian Society of Pneumology Ruxandra Ulmeanu National representative Central- Eastern European Alpha-1 Antitrypsin Network
28 Joanna Chorostowska-Wynimko Scientific Director National Institute of Tuberculosis & Lung Diseases, Warsaw, Poland Head of Central-Eastern European Alpha-1 Antitrypsin Network
29 Overview of the preliminary data for AATD screening for Romania in 2015
30 over 400 participants
31 Experts from 9 medical specialties
32 An exceptional involvement of young specialists, residents, students
33 Accession to the European AATD organizations
34 Romania become founding member of AATD Network of Central Eastern Europe
35 The presence of Romanian team
36
37 The presence of Romanian team
38 Relevant publications The incidence of severe alpha-1-antitrypsin (AAT) deficiency alleles in COPD patients Preliminary results from Central Eastern European (CEE) AAT NETWORK Joanna Chorostowska-Wynimko, Anna Kubincova, Nikolay Yanev, Ruxandra Ulmeanu, Radoslaw Struniawski, Pavol Pobeha, Nikolay Kyuchukov, Oana Deleanu, Beata Poplawska, Ruzena Tkacova, Yavor Ivanov, Florin Dumitru Mihaltan, Arunas Valiulis, ERJ September 1, 2013 vol. 42 no. Suppl 57 P541 The incidence of severe alpha-1-antitrypsin (AAT) deficiency alleles in COPD patients Update from Central Eastern European (CEE) AAT Network Joanna Chorostowska-Wynimko, Anna Kubincova, Nikolay Yanev, Ruxandra Ulmeanu, Radoslaw Struniawski, Pavol Pobeha, Nikolay Kyuchukov, Oana Deleanu, Beata Poplawska-Wisniewska, Ruzena Tkacova, Yavor Ivanov, Florin Mihaltan, Arunas Valiulis, ERJ September 2014 vol. 44 no. Suppl ;
39 Relevant publications Alpha-1 Antitrypsin Deficiency in Romania First Steps (Results of First Three Years of Screening) R. Ulmeanu, A.-M. Zaharie, J. Chorostowska Wynimko, O.C. Deleanu, F.D. Mihaltan, American Journal of Respiratory and Critical Care Medicine 2016;193:A1574 Alpha-1 antitrypsin deficiency do we really understand it? Case presentations. Ana-Maria Zaharie, Florin Dumitru Mihaltan, Cristian Popa, Oana Claudia Deleanu, Ruxandra Ulmeanu, American Journal of Respiratory and Critical Care Medicine 2016;193:A1576
40 Relevant publications Journal of Romanian Society of Pneumology
41 and starting with 2015 Romania was repesented at The Biennial Alpha-1 Global Patient Congress and International Research Conference 2015,2016,2017 Simona Olteanu Romanian patients representative Lavinia Davidescu Coordinator of Romanian AATD Working Group The Romanian stand Hillegonda Guttierez Alpha 1 Global Director
42 Alpha -1 Global website Romanian page Bine ati venit la Pagina Romaniei Deficitul de Alfa 1 Antitripsina
43 First flyer with information about AATD for romanian patients I have to mention the special activity of Mrs. Simona Olteanu
44 Simona Olteanu a lovely lady a powerful and unique mother a wonderful partner in patient-physician team The author of informative materials for patients
45 The official Romanian website for Alpha-1 Antitrypsin Deficiency Was founded in 2016 with the support of the Romanian Society of Pneumology
46 The National Register of Alpha-1 Antitrypsin Deficiency Dr. Ana Zaharie an exceptional young pneumologist Coordinator of AATD screening Was founded in 2016 with the support of the Romanian Society of Pneumology
47 The National Register of Alpha-1 Antitrypsin Deficiency a unique code, date of birth, sex, age, county
48 The National Register of Alpha-1 Antitrypsin Deficiency the menu for the first data - the reason for testing, other members tested, spirometry, phenotype and plasma value
49 The National Register of Alpha-1 Antitrypsin Deficiency 1st evaluation, last evaluation, current evaluation
50 The National Register of Alpha-1 Antitrypsin Deficiency spirometry and plethysmography - successive assessments
51 The National Register of Alpha-1 Antitrypsin Deficiency other important clinical data arterial blood gases, 6 minutes walking test
52 Novelties Interactive Session with Patients Associations
53 Novelties Interactive Session with Patients Associations Frank Willersinn Alpha-1 Global & Alpha-1 Foundation Bruxelles, Belgium
54 Interactive session title was Saturday October 8th, 2016
55 Alpha 1 Global - guest of honor of Romanian Society of Pneumology Indeed Alpha 1 Global is a model to follow we hope that this model will be essential for alpha patients from Romania
56 We must say that there is a significant problem in Romania Still does not exist associations for patients with lung diseases due to excessive bureaucracy fear of the authorities the feeling of hopelessness patients with chronic lung diseases older than 50 years lived under communism when these mentalities were dominant
57 Romanian Society of Pneumology attended for the 1 st time the International Conference of Patients with Rare Diseases organized by Romanian Patients Alliance For Rare Diseases 8 th February 2017
58 Romanian Society of Pneumology attended the International Conference of Patients with Rare Diseases It is hopeful that this year our Society discussed for the first time the huge problem represented by rare lung diseases in Romania, especially AATD and IPF
59 Patients Alliance For Rare Diseases Romania accepted the invitation to be partner of The 2nd National Conference of Rare Lung Diseases October 2017 Oradea Romania
60 Summarizing
61 More than 700 patients screened Mostly heterozygotes Rare genotypes Mostly in COPD patients
62 establishing a national reference laboratory Screening for AATD creating a national database for patients in Romania goes on! identified with AATD
63 We'll do more two powerful ladies two wonderful partners in patient-physician team Simona Olteanu Iulia Oita
64 Thank you for your invitation and for the opportunity to talk about the problems of alpha patients from Romania
65 At the same time we will be happy and honored if Alpha-1 global will accept our invitation to be partner of The 2nd National Conference of Rare Lung Diseases October 2017 Oradea, Romania
66 The Network of AATD in Central and Eastern Europe
67
68
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