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3. Congenital heart disease in the ESC EORP Registry of Pregnancy and Cardiac disease (ROPAC)

Author

Hall, Roger, Roos-Hesselink, Jolien, Stein, Joerg, Parsonage, William Anthony, Budts, Werner, De Backer, Julie, Grewal, Jasmin, Marelli, Ariane, Kaemmerer, Harald, Jondeau, Guillaume, Johnson, Mark, Maggioni, Aldo P., Tavazzi, Luigi, Thilen, Ulf, Elkayam, Uri, Otto, Catherine, Sliwa, Karen, Aquieri, A., Saad, A., Vega, H. Ruda, Hojman, J., Caparros, J.M., Blanco, M. Vazquez, Arstall, M., Chung, C.M., Mahadavan, G., Aldridge, E., Wittwer, M., Chow, Y.Y., Parsonage, W.A., Lust, K., Collins, N., Warner, G., Hatton, R., Gordon, A., Nyman, E., Stein, J., Donhauser, E., Gabriel, H., Bahshaliyev, A., Guliyev, F., Hasanova, I., Jahangirov, T., Gasimov, Z., Salim, A., Ahmed, C.M., Begum, F., Hoque, M.H., Mahmood, M., Islam, M.N., Haque, P.P., Banerjee, S.K., Parveen, T., Morissens, M., De Backer, J., Demulier, L., de Hosson, M., Budts, W., Beckx, M., Kozic, M., Lovric, M., Kovacevic-Preradovic, T., Chilingirova, N., Kratunkov, P., Wahab, N., McLean, S., Gordon, E., Walter, L., Marelli, A., Montesclaros, A.R., Monsalve, G., Rodriguez, C., Balthazar, F., Quintero, V., Palacio, W., Cadavid, L.A. Mejía, Ortiz, E. Munoz, Hoyos, F. Fortich, Guerrero, E. Arevalo, Ricardo, J. Gandara, Penagos, J. Velasquez, Vavera, Z., Prague, Popelova, J., Vejlstrup, N., Grønbeck, L., Johansen, M., Ersboll, A., Elrakshy, Y., Eltamawy, K., Abd-El Aziz, M. Gamal, El Nagar, A., Ebaid, H., Elenin, H. Abo, Saed, M., Farag, S., Makled, W., Sorour, K., Ashour, Z., El-Sayed, G., Meguid Mahdy, M. Abdel, Taha, N., Dardeer, A., Shabaan, M., Ali, M., Moceri, P., Duthoit, G., Gouton, M., Nizard, J., Baris, L., Cohen, S., Ladouceur, M., Khimoud, D., Iung, B., Berger, F., Olsson, A., Gembruch, U., Merz, W.M., Reinert, E., Clade, S., Kliesch, Y., Wald, C., Sinning, C., Kozlik-Feldmann, R., Blankenberg, S., Zengin-Sahm, E., Mueller, G., Hillebrand, M., Hauck, P., von Kodolitsch, Y., Zarniko, N., Baumgartner, Muenster H., Schmidt, R., Hellige, A., Tutarel, O., Kaemmerer, H., Kuschel, B., Nagdyman, N., Motz, R., Maisuradze, D., Frogoudaki, A., Iliodromitis, E., Anastasiou-Nana, M., Marousi, Triantafyllis, D., Bekiaris, G., Karvounis, H., Giannakoulas, G., Ntiloudi, D., Mouratoglou, S.A., Temesvari, A., Balint, H., Kohalmi, D., Merkely, B., Liptai, C., Nemes, A., Forster, T., Kalapos, A., Berek, K., Havasi, K., Ambrus, N., Shelke, A., Kawade, R., Patil, S., Martanto, E., Aprami, T.M., Purnomowati, A., Cool, C.J., Hasan, M., Akbar, R., Hidayat, S., Dewi, T.I., Permadi, W., Soedarsono, D.A., Ansari-Ramandi, M.M., Samiei, N., Tabib, A., Kashfi, F., Ansari-Ramandi, S., Rezaei, S., Farhan, H. Ali, Al-Hussein, A., Al-Saedi, G., Mahmood, G., Yaseen, I.F., Al-Yousuf, L., AlBayati, M., Mahmood, S., Raheem, S., AlHaidari, T., Dakhil, Z., Thornton, P., Donnelly, J., Bowen, M., Blatt, A., Elbaz-Greener, G., Shotan, A., Yalonetsky, S., Goland, S., Biener, M., Assenza, G. Egidy, Bonvicini, M., Donti, A., Bulgarelli, A., Prandstraller, D., Romeo, C., Crepaz, R., Sciatti, E., Metra, M., Orabona, R., Ali, L. Ait, Festa, P., Fesslova, V., Bonanomi, C., Calcagnino, M., Lombardi, F., Colli, A.M., Ossola, M.W., Gobbi, C., Gherbesi, E., Tondi, L., Schiavone, M., Squillace, M., Carmina, M.G., Maina, A., Macchi, C., Gollo, E., Comoglio, F.M., Montali, N., Re, P., Bordese, R., Todros, T., Donvito, V., Marra, W. Grosso, Sinagra, G., D'Agata Mottolese, B., Bobbo, M., Gesuete, V., Rakar, S., Ramani, F., Niwa, K., Mekebekova, D., Mussagaliyeva, A., Lee, T., Mirrakhimov, E., Abilova, S., Bektasheva, E., Neronova, K., Lunegova, O., Žaliūnas, R., Jonkaitienė, R., Petrauskaitė, J., Laucevicius, A., Jancauskaite, D., Lauciuviene, L., Gumbiene, L., Lankutiene, L., Glaveckaite, S., Laukyte, M., Solovjova, S., Rudiene, V., Chee, K.H., Yim, C.C.-W., Ang, H.L., Kuppusamy, R., Watson, T., Caruana, M., Estensen, M.-E., Kayani, M.G.A. Mahmood, Munir, R., Tomaszuk-Kazberuk, A., Sobkowicz, B., Przepiesc, J., Lesniak-Sobelga, A., Tomkiewicz-Pajak, L., Komar, M., Olszowska, M., Podolec, P., Wisniowska-Smialek, S., Lelonek, M., Faflik, U., Cichocka-Radwan, A., Plaskota, K., Trojnarska, O., Guerra, N., de Sousa, L., Cruz, C., Ribeiro, V., Jovanova, S., Petrescu, V., Jurcut, R., Ginghina, C., Coman, I. Mircea, Musteata, M., Osipova, O., Golivets, T., Khamnagadaev, I., Golovchenko, O., Nagibina, A., Ropatko, I., Gaisin, I.R., Shilina, L. Valeryevna, Sharashkina, N., Shlyakhto, E., Irtyuga, O., Moiseeva, O., Karelkina, E., Zazerskaya, I., Kozlenok, A., Sukhova, I., Jovovic, L., Prokšelj, K., Koželj, M., Askar, A.O., Abdilaahi, A.A., Mohamed, M.H., Dirir, A.M., Sliwa, K., Manga, P., Pijuan-Domenech, A., Galian-Gay, L., Tornos, P., Subirana, M.T., T, M., Subirana, Oliver, J.M., Garcia-Aranda Dominguez, B., Gonzalez, I. Hernandez, Jimenez, J.F. Delgado, Subias, P. Escribano, Murga, N., Elbushi, A., Suliman, A., Jazzar, K., Murtada, M., Ahamed, N., Dellborg, M., Furenas, E., Jinesjo, M., Skoglund, K., Eriksson, P., Gilljam, T., Thilen, U., Tobler, D., Wustmann, K., Schwitz, F., Schwerzmann, M., Rutz, T., Bouchardy, J., Greutmann, M., Lopes, B.M. Santos, Meier, L., Arrigo, M., de Boer, K., Konings, T., Wajon, E., Wagenaar, L.J., Polak, P., Pieper, E.P.G., Roos-Hesselink, J., van Hagen, I., Duvekot, H., Cornette, J.M.J., De Groot, C., van Oppen, C., Sarac, L., Esen, O. Batukan, Enar, S. Catirli, Mondo, C., Ingabire, P., Nalwanga, B., Semu, T., Salih, B.T., Almahmeed, W.A.R., Wani, S., Farook, F.S. Mohamed, Ain, Al, Gerges, F., Komaranchath, A.M., Al bakshi, F., Al Mulla, A., Yusufali, A.H., Al Hatou, E.I., Bazargani, N., Hussain, F., Hudsmith, L., Thompson, P., Thorne, S., Bowater, S., Money-Kyrle, A., Clifford, P., Ramrakha, P., Firoozan, S., Chaplin, J., Bowers, N., Adamson, D., Schroeder, F., Wendler, R., Hammond, S., Nihoyannopoulos, P., Norfolk, Norwich, Hall, R., Freeman, L., Veldtman, G., Kerr, J., Tellett, L., Scott, N., Bhatt, A.B., DeFaria Yeh, D., Youniss, M.A., Wood, M., Sarma, A.A., Tsiaras, S., Stefanescu, A., Duran, J.M., Stone, L., Majdalany, D.S., Chapa, J., Chintala, K., Gupta, P., Botti, J., Ting, J., Davidson, W.R., Wells, G., Sparks, D., Paruchuri, V., Marzo, K., Patel, D., Wagner, W., Ahanya, S.N., Colicchia, L., Jentink, T., Han, K., Loichinger, M., Parker, M., Longtin, C., Yetman, A., Erickson, K., Cramer, J., Tsai, S., Fletcher, B., Warta, S., Cohen, C., Lindblade, C., Puntel, R., Nagaran, K., Croft, N., Gurvitz, M., Otto, C., Talluto, C., Murphy, D., Perlroth, M.G., Ramlakhan, Karishma P., Johnson, Mark R., Lelonek, Malgorzata, Saad, Aly, Gasimov, Zaur, Sharashkina, Natalia V., Thornton, Patrick, Arstall, Margaret, and Roos-Hesselink, Jolien W.

Published
2021
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5. Adults with congenital heart disease and pulmonary arterial hypertension: Quantitative assessment of haemodynamic parameters under disease targeting therapy - A retrospective multicentre analysis

Author

Von Stein, P, primary, D'alto, M, additional, Diller, G, additional, Orwat, S, additional, Dumitrescu, D, additional, Giannakoulas, G, additional, Arvanitaki, A, additional, Momcilovic, D, additional, Hohmann, C, additional, and Rosenkranz, S, additional

Published
2023
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7. Cardiopulmonary exercise testing and echocardiography in the follow-up after acute pulmonary embolism

Author

Farmakis, I, primary, Valerio, L, additional, Barco, S, additional, Alsheimer, E, additional, Ewert, R, additional, Giannakoulas, G, additional, Hobohm, L, additional, Keller, K, additional, Mavromanoli, A C, additional, Rosenkranz, S, additional, Morris, T A, additional, Held, M, additional, Dumitrescu, D, additional, and Konstantinides, S, additional

Published
2023
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8. Prognostic significance of thyroid disease in atrial fibrillation

Author

Vasilopoulou, A, primary, Bekiaridou, A, additional, Papazoglou, A, additional, Patsiou, V, additional, Zergioti, M, additional, Lambropoulou, C, additional, Kostakakis, D, additional, Kyriakideli, M, additional, Spacho, M, additional, Samaras, A, additional, Moysidis, D, additional, Kartas, A, additional, Ziakas, A, additional, Zanos, S, additional, and Giannakoulas, G, additional

Published
2023
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9. Epidemiology and management of patients with pulmonary arterial hypertension associated with congenital heart disease: data from the hellenic pulmonary hypertension registry (HOPE)

Author

Arvanitaki, A, primary, Farmakis, I, additional, Demerouti, E, additional, Anthi, A, additional, Naka, A, additional, Brili, S, additional, Gourgiotis, P, additional, Papadopoulos, G, additional, Apostolopoulou, S, additional, Stamatopoulou, V, additional, Frogoudaki, A, additional, Frantzeskaki, F, additional, Karyofyllis, P, additional, Manginas, A, additional, and Giannakoulas, G, additional

Published
2023
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10. Serum magnesium and phosphorus values are lower among patients with paroxysmal atrial fibrillation: insights from the PLACEBO study

Author

Boulmpou, A, primary, Tsarouchas, A, additional, Papadopoulos, C E, additional, Pagourelias, E, additional, Patoulias, D, additional, Konstantinidis, K, additional, Terzidis, P, additional, Meletidou, M, additional, Kotzadamis, D, additional, Siskos, F, additional, Giannakoulas, G, additional, and Vassilikos, V, additional

Published
2023
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12. Acute myocardial infarction in patients without standard modifiable risk factors - preliminary data on clinical and laboratory biomarkers from the beyond-smurfs study

Author

Moysidis, D, primary, Papazoglou, A, additional, Anastasiou, V, additional, Daios, S, additional, Liatsos, A, additional, Kartas, A, additional, Karagiannidis, E, additional, Makedou, K, additional, Savvopoulos, C, additional, Kamperidis, V, additional, Ziakas, A, additional, Giannakoulas, G, additional, Vassilikos, V, additional, and Giannopoulos, G, additional

Published
2023
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14. Safety and efficacy of apixaban for the prevention of thromboembolism in adults with congenital heart disease and atrial arrhythmias: a prospective cohort study with historical control comparison

Author

Kartas, A, primary, Papazoglou, A, additional, Moysidis, D, additional, Kosmidis, D, additional, Baroutidou, A, additional, Despotopoulos, S, additional, Doundoulakis, I, additional, Koutssakis, A, additional, Liori, S, additional, Apostolopoulou, S, additional, Frogoudaki, A, additional, Tzifa, A, additional, Karvounis, H, additional, Ziakas, A, additional, and Giannakoulas, G, additional

Published
2023
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20. Recovery of right ventricular function after intermediate-risk pulmonary embolism: results from the multicentre Pulmonary Embolism International Trial (PEITHO)-2

Author

Mavromanoli, A.C., Barco, S., Ageno, W., Bouvaist, H., Brodmann, M., Cuccia, C., Couturaud, F., Dellas, C., Dimopoulos, K., Duerschmied, D., Empen, K., Faggiano, P., Ferrari, E., Galie, N., Galvani, M., Ghuysen, A., Giannakoulas, G., Huisman, M.V., Jimenez, D., Kozak, M., Lang, I.M., Meneveau, N., Munzel, T., Palazzini, M., Petris, A.O., Piovaccari, G., Salvi, A., Schellong, S., Schmidt, K.H., Verschuren, F., Schmidtmann, I., Toenges, G., Klok, F.A., Konstantinides, S.V., and PEITHO-2 Investigators

Subjects
Science & Technology, Cardiac & Cardiovascular Systems, Pulmonary embolism, WORKING GROUP, General Medicine, ASSOCIATION, GUIDELINES, EUROPEAN-SOCIETY, DYSFUNCTION, Echocardiography, Dysfunction, Cardiovascular System & Cardiology, MANAGEMENT, HEART, Right ventricle, Intermediate-risk, Cardiology and Cardiovascular Medicine, FOLLOW-UP, Life Sciences & Biomedicine, CARDIOLOGY
Abstract

Background Right ventricular (RV) function plays a critical role in the pathophysiology and acute prognosis of pulmonary embolism (PE). We analyzed the temporal changes of RV function in the cohort of a prospective multicentre study investigating if an early switch to oral anticoagulation in patients with intermediate-risk PE is effective and safe. Methods Echocardiographic and laboratory examinations were performed at baseline (PE diagnosis), 6 days and 6 months. Echocardiographic parameters were classified into categories representing RV size, RV free wall/tricuspid annulus motion, RV pressure overload and right atrial (RA)/central venous pressure. Results RV dysfunction based on any abnormal echocardiographic parameter was present in 84% of patients at baseline. RV dilatation was the most frequently abnormal finding (40.6%), followed by increased RA/central venous pressure (34.6%), RV pressure overload (32.1%), and reduced RV free wall/tricuspid annulus motion (20.9%). As early as day 6, RV size remained normal or improved in 260 patients (64.7%), RV free wall/tricuspid annulus motion in 301 (74.9%), RV pressure overload in 297 (73.9%), and RA/central venous pressure in 254 (63.2%). At day 180, the frequencies slightly increased. The median NT-proBNP level decreased from 1448 pg/ml at baseline to 256.5 on day 6 and 127 on day 180. Conclusion In the majority of patients with acute intermediate-risk PE switched early to a direct oral anticoagulant, echocardiographic parameters of RV function normalised within 6 days and remained normal throughout the first 6 months. Almost one in four patients, however, continued to have evidence of RV dysfunction over the long term. Graphical Abstract

Published
2022

21. Expanding the phenotype of TAB2 variants and literature review

Author

Woods, E., Marson, I., Coci, E., Spiller, M., Kumar, A., Brady, A., Homfray, T., Fisher, R., Turnpenny, P., Rankin, J., Kanani, F., Platzer, K., Ververi, A., Emmanouilidou, E., Bourboun, N., Giannakoulas, G., and Balasubramanian, M.

Abstract

TAB2 is a gene located on chromosome 6q25.1 and plays a key role in development of the heart. Existing literature describes congenital heart disease as a common recognized phenotype of TAB2 gene variants, with evidence of a distinct syndromic phenotype also existing beyond this. Here we describe 14 newly identified individuals with nine novel, pathogenic TAB2 variants. The majority of individuals were identified through the Deciphering Developmental Disorders study through trio whole exome sequencing. Eight individuals had de novo variants, the other six individuals were found to have maternally inherited, or likely maternally inherited, variants. Five individuals from the same family were identified following cardiac disease gene panel in the proband and subsequent targeted familial gene sequencing. The clinical features of this cohort were compared to the existing literature. Common clinical features include distinctive facial features, growth abnormalities, joint hypermobility, hypotonia, and developmental delay. Newly identified features included feeding difficulties, sleep problems, visual problems, genitourinary abnormality, and other anatomical variations. Here we report 14 new individuals, including novel TAB2 variants, in order to expand the emerging syndromic clinical phenotype and provide further genotype–phenotype correlation.

Published
2022

24. Mortality related to pulmonary embolism in the United States before and during the COVID-19 pandemic: an analysis of the CDC Multiple Cause of Death database

Author

Farmakis, I, primary, Valerio, L, additional, Mavromanoli, A C, additional, Bikdeli, B, additional, Connors, J M, additional, Giannakoulas, G, additional, Goldhaber, S Z, additional, Hobohm, L, additional, Hunt, B J, additional, Keller, K, additional, Klok, F A, additional, Spyropoulos, A C, additional, Kucher, N, additional, Konstantinides, S, additional, and Barco, S, additional

Published
2022
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29. Repetitive use of levosimendan for treatment of chronic advanced heart failure: Clinical evidence, practical considerations, and perspectives: An expert panel consensus

Author

Nieminen, M.S., Altenberger, J., Ben-Gal, T., Böhmer, A., Comin-Colet, J., Dickstein, K., Édes, I., Fedele, F., Fonseca, C., García-González, M.J., Giannakoulas, G., Iakobishvili, Z., Jääskeläinen, P., Karavidas, A., Kettner, J., Kivikko, M., Lund, L.H., Matskeplishvili, S.T., Metra, M., Morandi, F., Oliva, F., Parkhomenko, A., Parissis, J., Pollesello, P., Pölzl, G., Schwinger, R.H.G., Segovia, J., Seidel, M., Vrtovec, B., and Wikström, G.

Published
2014
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31. Rationale, design and methodology of APPROACH-IS II: International study of patient-reported outcomes and frailty phenotyping in adults with congenital heart disease.

Author

Van Bulck, L, Kovacs, AH, Goossens, E, Luyckx, K, Zaidi, A, Wang, J-K, Yadeta, D, Windram, J, Van De Bruaene, A, Thomet, C, Thambo, J-B, Taunton, M, Sasikumar, N, Sandberg, C, Saidi, A, Rutz, T, Ortiz, L, Mwita, JC, Moon, JR, Menahem, S, Mattsson, E, Mandalenakis, Z, Mahadevan, VS, Lykkeberg, B, Leye, M, Leong, MC, Ladouceur, M, Ladak, LA, Kim, Y, Khairy, P, Kaneva, A, Johansson, B, Jackson, JL, Giannakoulas, G, Gabriel, H, Fernandes, SM, Enomoto, J, Demir, F, de Hosson, M, Constantine, A, Coats, L, Christersson, C, Cedars, A, Caruana, M, Callus, E, Brainard, S, Bouchardy, J, Boer, A, Baraona Reyes, F, Areias, ME, Araujo, JJ, Andresen, B, Amedro, P, Ambassa, J-C, Amaral, F, Alday, L, Moons, P, APPROACH-IS II consortium, on behalf of the International Society for Adults Congenital Heart Disease (ISACHD), Van Bulck, L, Kovacs, AH, Goossens, E, Luyckx, K, Zaidi, A, Wang, J-K, Yadeta, D, Windram, J, Van De Bruaene, A, Thomet, C, Thambo, J-B, Taunton, M, Sasikumar, N, Sandberg, C, Saidi, A, Rutz, T, Ortiz, L, Mwita, JC, Moon, JR, Menahem, S, Mattsson, E, Mandalenakis, Z, Mahadevan, VS, Lykkeberg, B, Leye, M, Leong, MC, Ladouceur, M, Ladak, LA, Kim, Y, Khairy, P, Kaneva, A, Johansson, B, Jackson, JL, Giannakoulas, G, Gabriel, H, Fernandes, SM, Enomoto, J, Demir, F, de Hosson, M, Constantine, A, Coats, L, Christersson, C, Cedars, A, Caruana, M, Callus, E, Brainard, S, Bouchardy, J, Boer, A, Baraona Reyes, F, Areias, ME, Araujo, JJ, Andresen, B, Amedro, P, Ambassa, J-C, Amaral, F, Alday, L, Moons, P, and APPROACH-IS II consortium, on behalf of the International Society for Adults Congenital Heart Disease (ISACHD)

Abstract

BACKGROUND: In recent years, patient-reported outcomes (PROs) have received increasing prominence in cardiovascular research and clinical care. An understanding of the variability and global experience of PROs in adults with congenital heart disease (CHD), however, is still lacking. Moreover, information on epidemiological characteristics and the frailty phenotype of older adults with CHD is minimal. The APPROACH-IS II study was established to address these knowledge gaps. This paper presents the design and methodology of APPROACH-IS II. METHODS/DESIGN: APPROACH-IS II is a cross-sectional global multicentric study that includes Part 1 (assessing PROs) and Part 2 (investigating the frailty phenotype of older adults). With 53 participating centers, located in 32 countries across six continents, the aim is to enroll 8000 patients with CHD. In Part 1, self-report surveys are used to collect data on PROs (e.g., quality of life, perceived health, depressive symptoms, autonomy support), and explanatory variables (e.g., social support, stigma, illness identity, empowerment). In Part 2, the cognitive functioning and frailty phenotype of older adults are measured using validated assessments. DISCUSSION: APPROACH-IS II will generate a rich dataset representing the international experience of individuals in adult CHD care. The results of this project will provide a global view of PROs and the frailty phenotype of adults with CHD and will thereby address important knowledge gaps. Undoubtedly, the project will contribute to the overarching aim of improving optimal living and care provision for adults with CHD.

Published
2022

32. Elevated red cell distribution width and cardiovascular mortality in ASCVD risk cohorts: National Health and Nutrition Examination Survey (NHANES III)

Author

Katamreddy, A. Kokkinidis, D.G. Miles, J. Siasos, G. Giannakoulas, G. Faillace, R.T.

Abstract

Background: Although red cell distribution width (RDW) is associated with increased cardiovascular mortality, the relationship between an elevated RDW and cardiovascular mortality among various ASCVD risk groups is unknown. Methods: We utilized the National Health and Nutrition Examination Survey (NHANES) III, which uses a complex, multistage, clustered design to represent the civilian, community-based US population. Out of 30,818 subjects whose data were entered during the 1988-1994 period, 8884 subjects over 40 years of age, representing a weighted sample of 85,323,902 patients, were selected after excluding missing variables. The ACC/AHA pooled cohort equation (PCE) was used to calculate atherosclerotic cardiovascular disease (ASCVD) risk, and low (20%) risk groups were created. The primary endpoint was cardiovascular mortality. A multivariate proportional hazard regression was performed using the Fine and Gray (sub-distribution) method. Red cell distribution (RDW), C-reactive protein (CRP), age, sex, race, diabetes, smoking status, high-density lipoprotein (HDL), and chronic kidney disease (CKD) were used as covariates in each of the ACC/AHA pooled cohort risk groups. Results: The adjusted hazard ratios for RDW >14 (Normal range 12.5-14.5 %) as compared to 14 vs.

Published
2022

33. Glycemic control and atrial fibrillation: an intricate relationship, yet under investigation

Author

Papazoglou, A.S. Kartas, A. Moysidis, D.V. Tsagkaris, C. Papadakos, S.P. Bekiaridou, A. Samaras, A. Karagiannidis, E. Papadakis, M. Giannakoulas, G.

Abstract

Atrial fibrillation (AF) and diabetes mellitus (DM) constitute two major closely inter-related chronic cardiovascular disorders whose concurrent prevalence rates are steadily increasing. Although, the pathogenic mechanisms behind the AF and DM comorbidity are still vague, it is now clear that DM precipitates AF occurrence. DM also affects the clinical course of established AF; it is associated with significant increase in the incidence of stroke, AF recurrence, and cardiovascular mortality. The impact of DM on AF management and prognosis has been adequately investigated. However, evidence on the relative impact of glycemic control using glycated hemoglobin levels is scarce. This review assesses up-to-date literature on the association between DM and AF. It also highlights the usefulness of glycated hemoglobin measurement for the prediction of AF and AF-related adverse events. Additionally, this review evaluates current anti-hyperglycemic treatment in the context of AF, and discusses AF-related decision-making in comorbid DM. Finally, it quotes significant remaining questions and sets some future strategies with the potential to effectively deal with this prevalent comorbidity. © 2022, The Author(s).

Published
2022

34. Balloon Pulmonary Angioplasty in Patients with Chronic Thromboembolic Pulmonary Hypertension in Greece: Data from the Hellenic Pulmonary Hypertension Registry

Author

Karyofyllis, P. Demerouti, E. Giannakoulas, G. Anthi, A. Arvanitaki, A. Athanassopoulos, G. Feloukidis, C. Iakovou, I. Kostelidou, T. Mitrouska, I. Mouratoglou, S.-A. Orfanos, S.E. Pappas, C. Pitsiou, G. Tsetika, E.-G. Tsiapras, D. Voudris, V. Manginas, A.

Abstract

Balloon pulmonary angioplasty (BPA) is a novel and promising treatment option for patients with chronic thromboembolic pulmonary hypertension (CTEPH) who are ineligible for pulmonary endarterectomy (PEA) and for those with persistent or recurrent pulmonary hypertension after PEA. We present the results of BPA procedures in CTEPH patients included in the Greek Pulmonary Hypertension Registry, evaluating the real-life efficacy and safety. We analyzed data from 180 BPA procedures (2–17/patient, mean 8 ± 4/patient, 1248 dilated vessels, 0–18/session). Significant improvements were observed in mean pulmonary arterial pressure (a reduction by 44%, p < 0.001), pulmonary vascular resistance (reduction by 60%, p < 0.001), and NT-proBNP (decrease by >70%, p: 0.003), while cardiac index improved modestly (9% increase, p = 0.143). We had 37 BPA-related non-fatal complications (20.6% in all interventions), predominantly including hemoptysis. Overall survival was 91%, 75% and 62% at 3, 4 and 5 years, respectively. Therefore, BPA may be a promising therapeutic option in patients with CTEPH in Greece. © 2022 by the authors. Licensee MDPI, Basel, Switzerland.

Published
2022

35. Angiotensin receptor-neprilysin inhibition in patients with acute decompensated heart failure: an expert consensus position paper

Author

Ntalianis, A. Chrysohoou, C. Giannakoulas, G. Giamouzis, G. Karavidas, A. Naka, A. Papadopoulos, C.H. Patsilinakos, S. Parissis, J. Tziakas, D. Kanakakis, J.

Abstract

The short-term mortality and rehospitalization rates after admission for acute heart failure (AHF) remain high, despite the high level of adherence to contemporary practice guidelines. Observational data from non-randomized studies in AHF strongly support the in-hospital administration of oral evidence-based modifying chronic heart failure (HF) medications (i.e., b-blockers, ACE inhibitors, mineralocorticoid receptor antagonists) to reduce morbidity and mortality. Interestingly, a well-designed prospective randomized multicenter study (PIONEER-HF) showed an improved clinical outcome and stress/injury biomarker profile after in-hospital administration of sacubitril/valsartan (sac/val) as compared to enalapril, in hemodynamically stable patients with AHF. However, sac/val implementation during hospitalization remains suboptimal due to the lack of an integrated individualized plan or well-defined appropriateness criteria for transition to oral therapies, an absence of specific guidelines regarding dose selection and the up-titration process, and uncertainty regarding patient eligibility. In the present expert consensus position paper, clinical practical recommendations are proposed, together with an action plan algorithm, to encourage and facilitate sac/val administration during hospitalization after an AHF episode with the aim of improving efficiencies of care and resource utilization. © 2021, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

Published
2022

36. Advances in treatment of chronic thromboembolic pulmonary hypertension

Author

Tzoumas, A. Peppas, S. Sagris, M. Papanastasiou, C.A. Barakakis, P.A. Bakoyiannis, C. Taleb, A. Kokkinidis, D.G. Giannakoulas, G.

Subjects
food and beverages
Abstract

Chronic Thromboembolic Pulmonary Hypertension (CTEPH) is a progressive pulmonary vascular disease which can lead to right heart failure and death, if left untreated. CTEPH is caused by persistent obstruction of large, middle-sized, or distal pulmonary arteries due to limited thromboembolic resolution in the pulmonary vascular arterial tree. Every patient with CTEPH should undergo evaluation for Pulmonary Endarterectomy (PEA) after referral to institutions with an experienced multidisciplinary CTEPH team. Although management of distal thromboembolic lesions with PEA remains a challenge due to their difficult accessibility, limited distal CTEPH is not considered an absolute contraindication for PEA, as more expertise surgical teams operate on them successfully. Furthermore, in up to 30–50% of patients who undergo PEA, curative treatment is not achieved due to incomplete thrombi removal or extensive pulmonary microvascular disease. Medical therapies that target the underlying pulmonary microvascular disease can offer symptomatic and hemodynamic benefits, although they do not deal with the core mechanism of the disease which is the removal of thromboembolic material from pulmonary vasculature. Recent research has provided evidence suggesting balloon pulmonary angioplasty (BPA) is a reasonable treatment option for inoperable CTEPH and recurrent/persistent pulmonary hypertension after PEA. Advancements in diagnostic modalities and refinements of BPA technique have decreased the complication rate and increased its beneficial effects in hemodynamics, symptoms, right ventricular function and long-term survival. Ongoing trials and future prospective cohorts will provide evidence regarding the optimal selection of patients and lesions prone to BPA treatment along with hybrid therapeutic strategies combining pharmacological therapy, PEA and BPA, which can potentially change the standard of care in CTEPH. © 2022 Elsevier Ltd

Published
2022

37. Treatment with a fixed dose combination for cardiovascular disease-more than a health benefit?

Author

Dima, I, primary, Andrikopoulos, G, additional, Demerouti, E, additional, Giannakoulas, G, additional, Kartalis, A, additional, Lambropoulos, K, additional, Marketou, M, additional, Papadopoulos, C, additional, Poulimenos, L, additional, Stalikas, D, additional, Stougiannos, P, additional, Tsiafoutis, I, additional, Tsioufis, K, additional, and Vlachopoulos, C, additional

Published
2021
Full Text
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38. Right ventricular myocardial work characterisation in patients with pulmonary hypertension: association with invasive haemodynamic parameters

Author

Butcher, S C, primary, Feloukidis, C, additional, Kamperidis, V, additional, Stassen, J, additional, Fortuni, F, additional, Vrana, E, additional, Mouratoglou, S A, additional, Boutou, A, additional, Giannakoulas, G, additional, Playford, D, additional, Ajmone Marsan, N, additional, Bax, J J, additional, and Delgado, V, additional

Published
2021
Full Text
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40. Predictors of all-cause mortality within and beyond 1 year after an acute coronary syndrome

Author

Zafeiropoulos, S, primary, Farmakis, IT, additional, Kartas, A, additional, Psarakis, G, additional, Kourti, O, additional, Tsolakidis, C, additional, Konstantas, O, additional, Touriki, A, additional, Baroutidou, A, additional, Vrana, E, additional, Graidis, S, additional, Psathas, T, additional, Miyara, SJ, additional, Karvounis, H, additional, and Giannakoulas, G, additional

Published
2021
Full Text
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41. Predictive role of platelet indices on hospital admission and discharge in the long-term prognosis of acute coronary syndrome: Platelets do count

Author

Psarakis, G, primary, Farmakis, I, additional, Zafeiropoulos, S, additional, Tsolakidis, C, additional, Konstantas, O, additional, Kourti, O, additional, Touriki, AB, additional, Psathas, T, additional, Vrana, E, additional, Graidis, S, additional, Spyridaki, K, additional, Daniilidou, A, additional, Baroutidou, A, additional, Karvounis, H, additional, and Giannakoulas, G, additional

Published
2021
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42. Polypharmacy and major adverse events in atrial fibrillation

Author

Tsagkaris, C, primary, Kartas, A, additional, Samaras, A, additional, Papazoglou, A, additional, Moysidis, D, additional, Vrana, E, additional, Vouloagkas, I, additional, Papanastasiou, A, additional, Kotzampasis, G, additional, Baroutidou, A, additional, Karagiannidis, E, additional, Louka, A-M, additional, Matiashova, L, additional, Tzikas, A, additional, and Giannakoulas, G, additional

Published
2021
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43. Prognostic significance of diabetes mellitus in patients with atrial fibrillation

Author

Papazoglou, A, primary, Kartas, A, additional, Samaras, A, additional, Vouloagkas, I, additional, Vrana, E, additional, Moysidis, D, additional, Akrivos, E, additional, Kotzampasis, G, additional, Papanastasiou, A, additional, Baroutidou, A, additional, Botis, M, additional, Tsagkaris, C, additional, Karagiannidis, E, additional, Tzikas, A, additional, and Giannakoulas, G, additional

Published
2021
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44. Digoxin and association with mortality in patients discharged from hospital with atrial fibrillation, with or without heart failure

Author

Mpotis, M, primary, Kartas, A, additional, Samaras, A, additional, Akrivos, E, additional, Vrana, E, additional, Liampas, E, additional, Papazoglou, A, additional, Moysidis, D, additional, Papanastasiou, A, additional, Baroutidou, A, additional, Karvounis, H, additional, Tzikas, A, additional, and Giannakoulas, G, additional

Published
2021
Full Text
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45. Riociguat treatment in patients with pulmonary arterial hypertension: Final safety data from the EXPERT registry

Author

Hoeper, M.M. Gomez Sanchez, M.-A. Humbert, M. Pittrow, D. Simonneau, G. Gall, H. Grünig, E. Klose, H. Halank, M. Langleben, D. Snijder, R.J. Escribano Subias, P. Mielniczuk, L.M. Lange, T.J. Vachiéry, J.-L. Wirtz, H. Helmersen, D.S. Tsangaris, I. Barberà, J.A. Pepke-Zaba, J. Boonstra, A. Rosenkranz, S. Ulrich, S. Steringer-Mascherbauer, R. Delcroix, M. Jansa, P. Šimková, I. Giannakoulas, G. Klotsche, J. Williams, E. Meier, C. Ghofrani, H.-A.

Abstract

Objective: The soluble guanylate cyclase stimulator riociguat is approved for the treatment of adult patients with pulmonary arterial hypertension (PAH) and inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension following Phase 3 randomized trials. The EXPosurE Registry RiociguaT in patients with pulmonary hypertension (EXPERT) study was designed to monitor the long-term safety of riociguat in clinical practice. Methods: EXPERT was an international, multicenter, prospective, uncontrolled, non-interventional cohort study of patients treated with riociguat. Patients were followed for at least 1 year and up to 4 years from enrollment or until 30 days after stopping riociguat treatment. Primary safety outcomes were adverse events (AEs) and serious adverse events (SAEs) coded using Medical Dictionary for Regulatory Activities preferred terms and System Organ Classes version 21.0, collected during routine clinic visits (usually every 3–6 months) and collated via case report forms. Results: In total, 326 patients with PAH were included in the analysis. The most common AEs in these patients were dizziness (11.7%), right ventricular (RV)/cardiac failure (10.7%), edema/peripheral edema (10.7%), diarrhea (8.6%), dyspnea (8.0%), and cough (7.7%). The most common SAEs were RV/cardiac failure (10.1%), pneumonia (6.1%), dyspnea (4.0%), and syncope (3.4%). The exposure-adjusted rate of hemoptysis/pulmonary hemorrhage was 2.5 events per 100 patient-years. Conclusion: Final data from EXPERT show that in patients with PAH, the safety of riociguat in clinical practice was consistent with clinical trials, with no new safety concerns identified and a lower exposure-adjusted rate of hemoptysis/pulmonary hemorrhage than in the long-term extension of the Phase 3 trial in PAH. © 2020 The Author(s)

Published
2021

46. Riociguat treatment in patients with chronic thromboembolic pulmonary hypertension: Final safety data from the EXPERT registry

Author

Ghofrani, H.-A. Gomez Sanchez, M.-A. Humbert, M. Pittrow, D. Simonneau, G. Gall, H. Grünig, E. Klose, H. Halank, M. Langleben, D. Snijder, R.J. Escribano Subias, P. Mielniczuk, L.M. Lange, T.J. Vachiéry, J.-L. Wirtz, H. Helmersen, D.S. Tsangaris, I. Barberá, J.A. Pepke-Zaba, J. Boonstra, A. Rosenkranz, S. Ulrich, S. Steringer-Mascherbauer, R. Delcroix, M. Jansa, P. Šimková, I. Giannakoulas, G. Klotsche, J. Williams, E. Meier, C. Hoeper, M.M. Caneva, J. Tuhay, G. Diez, M. Talavera, M.L. Acosta, A. Vulcano, N. Bosio, M. Maldonado, L. Deleo, S. Melatini, L. Keogh, A. Kotlyar, E. Feenstra, J. Dwyer, N. Adams, H. Stevens, W. Steele, P. Proudman, S. Minson, R. Reeves, G. Lavender, M. Ng, B. Mackenzie, M. Barry, L. Gruenberger, M. Huber, C. Lang, I. Tilea, I. Sadushi-Kolici, R. Löffler-Ragg, J. Feistmantl, L.-T. Evrard, P. Louis, R. Guiot, J. Naldi, M. De Pauw, M. Mehta, S. Camacho, R.C. Tovar, P.P. Londoño, A. Campo, F. Garcia, P. Lema, C. Orozco-Levi, M. Martinez, W. Gomez, J.E. Nielsen-Kudsk, J.E. Mellemkjaer, S. Anton, L. Altraja, A. Vihinen, T. Vasankari, T. Sitbon, O. Cottin, V. Têtu, L. Noël-Savina, E. Shearman, N. Tayler, S. Olzik, I. Kulka, C. Grimminger, J. Simon, M. Nolde, A. Oqueka, T. Harbaum, L. Egenlauf, B. Ewert, R. Schulz, C. Regotta, S. Kramer, T. Knoop-Busch, S. Gerhardt, F. Konstantinides, S. Pitsiou, G. Stanopoulos, I. Sourla, E. Mouratoglou, S. Karvounis, H. Pappas, A. Georgopoulos, D. Fanaridis, M. Mitrouska, I. Michalis, L. Pappas, K. Kotsia, A. Gaine, S. Vizza, C.D. Manzi, G. Poscia, R. Badagliacca, R. Agostoni, P. Bruno, N. Farina, S. D'Alto, M. Argiento, P. Correra, A. Di Marco, G.M. Cresci, C. Vannucchi, V. Torricelli, E. Garcea, A. Pesci, A. Sardella, L. Paciocco, G. Pane, F. D'Armini, A.M. Pin, M. Grazioli, V. Massola, G. Sciortino, A. Prediletto, R. Bauleo, C. Airò, E. Ndreu, R. Pavlickova, I. Lunardi, C. Mulè, M. Farruggio, S. Costa, S. Galgano, G. Petruzzi, M. De Luca, A. Lombardi, F. Roncon, L. Conte, L. Picariello, C. Wirtz, G. Alexandre, M. Vonk-Noordegraaf, A. Boogaard, H. Mager, J. Reesink, H. van den Toorn, L.M. Boomars, K. Andreassen, A.K. Castro, G. Tania, G. Baptista, R. Marinho, A. Shiang, T. Oliveira, A. Coutinho, D. Sousa, J. Loureiro, M.J. Repolho, D. Martins Jesus, S.M. Capinha, M. Agostinho, J. Cardoso, T. Rocha, A. Espinha, M. Ivanov, K.I. Alexeeva, D.E. Batalina, M.V. Hegya, D.V. Zvereva, T.N. Avdeev, S.N. Tsareva, N.A. Galyavich, A.S. Nikolaevich, B.A. Filippov, E.V. Yakovleva, O.E. Pavlova, O.B. Skripkina, E.S. Martynyuk, T.V. Bukatova, I.F. Tregubova, A.V. Platonov, D.Y. Kolomeytseva, T.M. Al Dalaan, A. Abdelsayed, A.A. Weheba, I. Saleemi, S. Sakkijha, H. Bohacekova, M. Valkovicova, T. Farkasova, I. Quezada, C.A. Piccari, L. Blanco, I. Sebastian, L. Roman, A. Lopez, M. Otero, R. Elias, T. Jara, L. Asencio, I. Arjona, J.J. Almagro, R.M. Cárdenas, S.L. García, S.A. Rodríguez, P.V. Lopez, R. Garcia, A. Avilés, F.F. De La Pava, S. Yotti, R. Peñate, G.P. Marrero, F.L. Cifrián Martínez, J.M. Martinez-Meñaca, A. Alonso, L.P. Rozas, S.F. Fernandez, D.I. Cuesta, V.M. Söderberg, S. Bartfay, S.-E. Rundqvist, B. Alfetlawi, M. Wodlin, P. Schwarz, E.I. Speich, R. Lador, F. Rochat, T. Gasche-Soccal, P. Hsu, C.-H. Lin, T.-H. Su, H.-M. Lai, W.-T. Chu, C.Y. Hsu, P.-C. Voon, W.-C. Yen, H.-W. Yih-Jer Wu, J. Wu, S.-H. Huang, W.-P. Fong, M.-C. Huang, C.-L. Kuo, P.-H. Lin, Y.-H. Lin, J.-L. Hung, C.-S. Wu, C.-K. Sung, S.-H. Huang, W.-C. Cheng, C.-C. Kuo, S.-H. Wang, W.-H. Ho, W.-J. Hsu, T.-S. Mutlu, B. Atas, H. Ongen, G. Un, Z. Okumus, G. Hanta, I. Corris, P. Peacock, A. Church, C. Toshner, M. Newnham, M. NEW COLLABORATORS LIST

Abstract

Objective: The soluble guanylate cyclase stimulator riociguat is approved for the treatment of adult patients with pulmonary arterial hypertension (PAH) and inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) following Phase 3 randomized trials. The EXPosurE Registry RiociguaT in patients with pulmonary hypertension (EXPERT) study was designed to monitor the long-term safety of riociguat in clinical practice. Methods: EXPERT was an international, multicenter, prospective, uncontrolled, non-interventional cohort study of patients treated with riociguat. Patients were followed for at least 1 year and up to 4 years from enrollment or until 30 days after stopping riociguat treatment. Primary safety outcomes were adverse events (AEs) and serious adverse events (SAEs) coded using Medical Dictionary for Regulatory Activities preferred terms and System Organ Classes version 21.0, collected during routine clinic visits and collated via case report forms. Results: In total, 956 patients with CTEPH were included in the analysis. The most common AEs in these patients were peripheral edema/edema (11.7%), dizziness (7.5%), right ventricular (RV)/cardiac failure (7.7%), and pneumonia (5.0%). The most common SAEs were RV/cardiac failure (7.4%), pneumonia (4.1%), dyspnea (3.6%), and syncope (2.5%). Exposure-adjusted rates of hemoptysis/pulmonary hemorrhage and hypotension were low and comparable to those in the long-term extension study of riociguat (Chronic Thromboembolic Pulmonary Hypertension Soluble Guanylate Cyclase–Stimulator Trial [CHEST-2]). Conclusion: Data from EXPERT show that in patients with CTEPH, the safety of riociguat in routine practice was consistent with the known safety profile of the drug, and no new safety concerns were identified. © 2020 The Authors

Published
2021

47. Venous thromboembolism in the era of COVID-19

Author

Kyriakoulis, K.G. Kokkinidis, D.G. Kyprianou, I.A. Papanastasiou, C.A. Archontakis-Barakakis, P. Doundoulakis, I. Bakoyiannis, C. Giannakoulas, G. Palaiodimos, L.

Abstract

Coronavirus disease 2019 (COVID-19) does not only affect the respiratory system but appears to be a systemic disease. Venous thromboembolism is a common manifestation in hospitalized patients with COVID-19 with a reported incidence that is significantly higher compared to other acute viral infections. The pathophysiology mechanisms have not been fully explored and autopsy studies might enhance our understanding on this topic. Microthrombi formation occurs mainly in the pulmonary vasculature but can also occur in other organs. The high inflammatory burden related to COVID-19 seems to be associated with the coexisting coagulopathy. Concomitant manifestations of COVID-19, such as severe pneumonia, which has similar clinical presentation with pulmonary embolism (PE), and barriers related to strict isolation protocols are the two main reasons why PE diagnosis might be more challenging in patients with COVID-19. Medical societies have published guidance reports suggesting the administration of prophylactic anticoagulant therapy in hospitalized patients with COVID-19, but several questions regarding the optimal acute and long-term treatment of these patients remain unanswered. © The Author(s) 2020.

Published
2021

48. The management of atrial fibrillation in heart failure: an expert panel consensus

Author

Farmakis, D. Chrysohoou, C. Giamouzis, G. Giannakoulas, G. Hamilos, M. Naka, K. Tzeis, S. Xydonas, S. Karavidas, A. Parissis, J.

Abstract

Heart failure (HF) and atrial fibrillation (AF) often coexist, being closely interrelated as the one increases the prevalence and incidence and worsens the prognosis of the other. Their frequent coexistence raises several challenges, including under-diagnosis of HF with preserved ejection fraction in AF and of AF in HF, characterization and diagnosis of atrial cardiomyopathy, target and impact of rate control therapy on outcomes, optimal rhythm control strategy in the era of catheter ablation, HF-related thromboembolic risk and management of anticoagulation in patients with comorbidities, such as chronic kidney disease or transient renal function worsening, coronary artery disease or acute coronary syndromes, valvular or structural heart disease interventions and cancer. In the present document, derived by an expert panel meeting, we sought to focus on the above challenging issues, outlining the existing evidence and identifying gaps in knowledge that need to be addressed. © 2020, Springer Science+Business Media, LLC, part of Springer Nature.

Published
2021

49. Riociguat treatment in patients with chronic thromboembolic pulmonary hypertension: Final safety data from the EXPERT registry

Author

Ghofrani, H.A., Gomez Sanchez, M.-A. (Miguel-Angel), Humbert, M., Pittrow, D. (David), Simonneau, G. (Gérald), Gall, H. (Henning), Grünig, E. (Ekkehard), Klose, H. (Hans), Halank, M. (Michael), Langleben, D. (David), Snijder, R., Escribano Subías, P. (Pilar), Mielniczuk, L.M. (Lisa M.), Lange, T.J. (Tobias J.), Vachiéry, J.-L. (Jean-Luc), Wirtz, H. (Hubert), Helmersen, D.S. (Douglas S.), Tsangaris, I. (Iraklis), Barberá, J.A. (Joan A.), Pepke-Zaba, J. (Joanna), Boonstra, A. (Anco), Rosenkranz, S. (Stephan), Ulrich, S. (Silvia), Steringer-Mascherbauer, R. (Regina), Delcroix, M. (Marion), Jansa, P. (Pavel), Šimková, I. (Iveta), Giannakoulas, G. (George), Klotsche, J. (Jens), Williams, E. (Evgenia), Meier, C. (Christian), Hoeper, M.M. (Marius M.), Caneva, J. (Jorge), Tuhay, G. (Graciela), Diez, M. (Mirta), Talavera, M.L. (Maria Lujan), Acosta, A. (Adriana), Vulcano, N. (Norberto), Bosio, M. (Martin), Maldonado, L. (Lorena), Deleo, S. (Sabino), Melatini, L. (Luciano), Keogh, A. (Anne), Kotlyar, E. (Eugene), Feenstra, J. (John), Dwyer, N. (Nathan), Adams, H. (Heath), Stevens, W. (Wendy), Steele, P. (Peter), Proudman, S. (Susanna), Minson, R. (Robert), Reeves, G. (Glenn), Lavender, M. (Melanie), Ng, B. (Benjamin), Mackenzie, M. (Michele), Barry, L. (Lisa), Gruenberger, M. (Margarethe), Huber, C. (Charlotte), Lang, I. (Irene), Tilea, I. (Ioana), Sadushi-Kolici, R. (Roela), Löffler-Ragg, J. (Judith), Feistmantl, L.-T. (Lisa-Theresa), Evrard, P. (Patrick), Louis, R. (Renaud), Guiot, J. (Julien), Naldi, M. (Marco), De Pauw, M. (Michel), Mehta, S. (Sanjay), Camacho, R.C. (Rafael Conde), Tovar, P.P. (Patricia Parada), Londoño, A. (Alejandro), Campo, F. (Felipe), Garcia, P. (Paula), Lema, C. (Camila), Orozco-Levi, M. (Mauricio), Martinez, W. (William), Gomez, J.E. (Juan Esteban), Nielsen-Kudsk, J.E. (Jens Erik), Mellemkjaer, S. (Soren), Anton, L. (Ly), Altraja, A. (Alan), Vihinen, T. (Tapani), Vasankari, T. (Tuija), Sitbon, O. (Olivier), Cottin, V. (Vincent), Têtu, L. (Laurent), Noël-Savina, E. (Elise), Shearman, N. (Nicole), Tayler, S. (Susanne), Olzik, I. (Ilona), Kulka, C. (Christine), Grimminger, J. (Jan), Simon, M. (Marcel), Nolde, A. (Anna), Oqueka, T. (Tim), Harbaum, L. (Lars), Egenlauf, B. (Benjamin), Ewert, R. (Ralf), Schulz, C. (Christian), Regotta, S. (Sabine), Kramer, T. (Tilmann), Knoop-Busch, S. (Susanne), Gerhardt, F. (Felix), Konstantinides, S. (Stavros), Pitsiou, G. (Georgia), Stanopoulos, I. (Ioannis), Sourla, E. (Evdokia), Mouratoglou, S. (Sofia), Karvounis, H.I., Pappas, A. (Athanasios), Georgopoulos, D. (Dimitrios), Fanaridis, M. (Michail), Mitrouska, I. (Ioanna), Michalis, L.K. (Lampros), Pappas, K. (Konstantinos), Kotsia, A. (Anna), Gaine, S. (Sean), Vizza, C.D. (Carmine Dario), Manzi, G. (Giovanna), Poscia, R. (Roberto), Badagliacca, R. (Roberto), Agostoni, P. (Piergiuseppe), Bruno, N. (Noemi), Farina, S. (Stefania), D'Alto, M. (Michele), Argiento, P. (Paola), Correra, A. (Anna), Di Marco, G.M. (Giovanni Maria), Cresci, C. (Chiara), Vannucchi, V. (Vieri), Torricelli, E. (Elena), Garcea, A. (Alessio), Pesci, A. (Alberto), Sardella, L. (Luca), Paciocco, G. (Giuseppe), Pane, F. (Federico), D'Armini, A.M. (Andrea Maria), Pin, M. (Maurizio), Grazioli, V. (Valentina), Massola, G. (Giulia), Sciortino, A. (Antonio), Prediletto, R. (Renato), Bauleo, C. (Carolina), Airò, E. (Edoardo), Ndreu, R. (Rudina), Pavlickova, I. (Ivana), Lunardi, C. (Claudio), Mulè, M. (Massimiliano), Farruggio, S. (Silvia), Costa, S. (Serena), Galgano, G. (Giuseppe), Petruzzi, M. (Mario), De Luca, A. (Anna), Lombardi, F. (Francesco), Roncon, L. (Loris), Conte, L. (Luca), Picariello, C. (Claudio), Wirtz, G. (Gil), Alexandre, M. (Myriam), Vonk Noordegraaf, A. (Anton), Boogaard, H. (H.), Mager, J. (J.), Reesink, H.J. (Herre), Toorn, L.M. (Leon) van den, Boomars, K.A.T. (Karin), Andreassen, A.K. (Arne K.), Castro, G. (Graça), Tania, G. (Gonçalves), Baptista, R. (Rui), Marinho, A. (António), Shiang, T. (Teresa), Oliveira, A. (Ana), Coutinho, D. (Daniel), Sousa, J. (Joana), Loureiro, M.J. (Maria José), Repolho, D. (Débora), Martins Jesus, S.M. (Susana Maria), Capinha, M. (Marta), Agostinho, J. (João), Cardoso, T. (Tania), Rocha, A. (Andreia), Espinha, M. (Mafalda), Ivanov, K.I. (Kyundyul Ivanovich), Alexeeva, D.E. (Dalyana Eduardovna), Batalina, M.V. (Marina Vadimovna), Hegya, D.V. (Daria Viktorovna), Zvereva, T.N. (Tatyana Nikolaevna), Avdeev, S.N. (Sergey Nikolaevich), Tsareva, N.A. (Natalia Anatolievna), Galyavich, A.S. (Albert Sarvatovich), Nikolaevich, B.A. (Bykov Aleksander), Filippov, E.V. (Evgeny Vladimirovich), Yakovleva, O.E. (Olga Eduardovna), Pavlova, O.B. (Olga Borisovna), Skripkina, E.S. (Elena Sergeevna), Martynyuk, T.V. (Tamila Vitalievna), Bukatova, I.F. (Irina Fedorovna), Tregubova, A.V. (Anna Viktorovna), Platonov, D.Y. (Dmitry Yurievich), Kolomeytseva, T.M. (Tatyana Mikhaylovna), Al Dalaan, A. (Abdullah), Abdelsayed, A.A. (Abeer Abeer), Weheba, I. (Ihab), Saleemi, S. (Sarferaz), Sakkijha, H. (Hussam), Bohacekova, M. (Marcela), Valkovicova, T. (Tatiana), Farkasova, I. (Iveta), Quezada, C.A. (Carlos Andres), Piccari, L. (Lucilla), Blanco, I. (Isabel), Sebastian, L. (Laura), Roman, A. (Antonio), Lopez, M. (Manuel), Otero, R. (Remedios), Elias, T. (Teresa), Jara, L. (Luis), Asencio, I. (Isabel), Arjona, J.J. (Josefa Jiménez), Almagro, R.M. (Raúl Menor), Cárdenas, S.L. (Salvador López), García, S.A. (Salvador Alcaraz), Rodríguez, P.V. (Patricia Villanueva), Lopez, R. (Raquel), Garcia, A. (Alberto), Avilés, F.F. (Francisco Fernandez), De La Pava, S. (Sebastian), Yotti, R. (Raquel), Peñate, G.P. (Gregorio Pérez), Marrero, F.L. (Fernando León), Cifrián Martínez, J.M. (José Manuel), Martinez-Meñaca, A. (Amaya), Alonso, L.P. (Lecue Pilar), Rozas, S.F. (Sonia Fernandez), Fernandez, D.I. (David Iturbe), Cuesta, V.M. (Victor Mora), Söderberg, S. (Stefan), Bartfay, S.-E. (Sven-Erik), Rundqvist, B. (Bengt), Alfetlawi, M. (Monthir), Wodlin, P. (Peter), Schwarz, E.I. (Esther Irene), Speich, R. (Rudolf), Lador, F. (Frédéric), Rochat, T. (Thierry), Gasche-Soccal, P. (Paola), Hsu, C.-H. (Chih-Hsin), Lin, T.-H. (Tsung-Hsien), Su, H.-M. (Ho-Ming), Lai, W.-T. (Wen-Ter), Chu, C.Y. (Chun Yuan), Hsu, P.-C. (Po-Chao), Voon, W.-C. (Wen-Chol), Yen, H.-W. (Hsueh-Wei), Yih-Jer Wu, J. (Jacob), Wu, S.-H. (Shu-Hao), Huang, W.-P. (Wen-Pin), Fong, M.-C. (Man-Cai), Huang, C.-L. (Chien-Lung), Kuo, P.-H. (Ping-Hung), Lin, Y.-H. (Yen-Hung), Lin, J.-L. (Jiunn-Lee), Hung, C.-S. (Chi-Sheng), Wu, C.-K. (Cho-Kai), Sung, S.-H. (Shih-Hsien), Huang, W.-C. (Wei-Chun), Cheng, C.-C. (Chin-Chang), Kuo, S.-H. (Shu-Hung), Wang, W.-H. (Wen-Hwa), Ho, W.-J. (Wan-Jing), Hsu, T.-S. (Tsu-Shiu), Mutlu, B. (Bülent), Atas, H. (Halil), Ongen, G. (Gul), Un, Z. (Zeynep), Okumus, G. (Gulfer), Hanta, I. (Ismail), Corris, P. (Paul), Peacock, A. (Andrew), Church, C. (Colin), Toshner, M. (Mark), Newnham, M. (Michael), Ghofrani, H.A., Gomez Sanchez, M.-A. (Miguel-Angel), Humbert, M., Pittrow, D. (David), Simonneau, G. (Gérald), Gall, H. (Henning), Grünig, E. (Ekkehard), Klose, H. (Hans), Halank, M. (Michael), Langleben, D. (David), Snijder, R., Escribano Subías, P. (Pilar), Mielniczuk, L.M. (Lisa M.), Lange, T.J. (Tobias J.), Vachiéry, J.-L. (Jean-Luc), Wirtz, H. (Hubert), Helmersen, D.S. (Douglas S.), Tsangaris, I. (Iraklis), Barberá, J.A. (Joan A.), Pepke-Zaba, J. (Joanna), Boonstra, A. (Anco), Rosenkranz, S. (Stephan), Ulrich, S. (Silvia), Steringer-Mascherbauer, R. (Regina), Delcroix, M. (Marion), Jansa, P. (Pavel), Šimková, I. (Iveta), Giannakoulas, G. (George), Klotsche, J. (Jens), Williams, E. (Evgenia), Meier, C. (Christian), Hoeper, M.M. (Marius M.), Caneva, J. (Jorge), Tuhay, G. (Graciela), Diez, M. (Mirta), Talavera, M.L. (Maria Lujan), Acosta, A. (Adriana), Vulcano, N. (Norberto), Bosio, M. (Martin), Maldonado, L. (Lorena), Deleo, S. (Sabino), Melatini, L. (Luciano), Keogh, A. (Anne), Kotlyar, E. (Eugene), Feenstra, J. (John), Dwyer, N. (Nathan), Adams, H. (Heath), Stevens, W. (Wendy), Steele, P. (Peter), Proudman, S. (Susanna), Minson, R. (Robert), Reeves, G. (Glenn), Lavender, M. (Melanie), Ng, B. (Benjamin), Mackenzie, M. (Michele), Barry, L. (Lisa), Gruenberger, M. (Margarethe), Huber, C. (Charlotte), Lang, I. (Irene), Tilea, I. (Ioana), Sadushi-Kolici, R. (Roela), Löffler-Ragg, J. (Judith), Feistmantl, L.-T. (Lisa-Theresa), Evrard, P. (Patrick), Louis, R. (Renaud), Guiot, J. (Julien), Naldi, M. (Marco), De Pauw, M. (Michel), Mehta, S. (Sanjay), Camacho, R.C. (Rafael Conde), Tovar, P.P. (Patricia Parada), Londoño, A. (Alejandro), Campo, F. (Felipe), Garcia, P. (Paula), Lema, C. (Camila), Orozco-Levi, M. (Mauricio), Martinez, W. (William), Gomez, J.E. (Juan Esteban), Nielsen-Kudsk, J.E. (Jens Erik), Mellemkjaer, S. (Soren), Anton, L. (Ly), Altraja, A. (Alan), Vihinen, T. (Tapani), Vasankari, T. (Tuija), Sitbon, O. (Olivier), Cottin, V. (Vincent), Têtu, L. (Laurent), Noël-Savina, E. (Elise), Shearman, N. (Nicole), Tayler, S. (Susanne), Olzik, I. (Ilona), Kulka, C. (Christine), Grimminger, J. (Jan), Simon, M. (Marcel), Nolde, A. (Anna), Oqueka, T. (Tim), Harbaum, L. (Lars), Egenlauf, B. (Benjamin), Ewert, R. (Ralf), Schulz, C. (Christian), Regotta, S. (Sabine), Kramer, T. (Tilmann), Knoop-Busch, S. (Susanne), Gerhardt, F. (Felix), Konstantinides, S. (Stavros), Pitsiou, G. (Georgia), Stanopoulos, I. (Ioannis), Sourla, E. (Evdokia), Mouratoglou, S. (Sofia), Karvounis, H.I., Pappas, A. (Athanasios), Georgopoulos, D. (Dimitrios), Fanaridis, M. (Michail), Mitrouska, I. (Ioanna), Michalis, L.K. (Lampros), Pappas, K. (Konstantinos), Kotsia, A. (Anna), Gaine, S. (Sean), Vizza, C.D. (Carmine Dario), Manzi, G. (Giovanna), Poscia, R. (Roberto), Badagliacca, R. (Roberto), Agostoni, P. (Piergiuseppe), Bruno, N. (Noemi), Farina, S. (Stefania), D'Alto, M. (Michele), Argiento, P. (Paola), Correra, A. (Anna), Di Marco, G.M. (Giovanni Maria), Cresci, C. (Chiara), Vannucchi, V. (Vieri), Torricelli, E. (Elena), Garcea, A. (Alessio), Pesci, A. (Alberto), Sardella, L. (Luca), Paciocco, G. (Giuseppe), Pane, F. (Federico), D'Armini, A.M. (Andrea Maria), Pin, M. (Maurizio), Grazioli, V. (Valentina), Massola, G. (Giulia), Sciortino, A. (Antonio), Prediletto, R. (Renato), Bauleo, C. (Carolina), Airò, E. (Edoardo), Ndreu, R. (Rudina), Pavlickova, I. (Ivana), Lunardi, C. (Claudio), Mulè, M. (Massimiliano), Farruggio, S. (Silvia), Costa, S. (Serena), Galgano, G. (Giuseppe), Petruzzi, M. (Mario), De Luca, A. (Anna), Lombardi, F. (Francesco), Roncon, L. (Loris), Conte, L. (Luca), Picariello, C. (Claudio), Wirtz, G. (Gil), Alexandre, M. (Myriam), Vonk Noordegraaf, A. (Anton), Boogaard, H. (H.), Mager, J. (J.), Reesink, H.J. (Herre), Toorn, L.M. (Leon) van den, Boomars, K.A.T. (Karin), Andreassen, A.K. (Arne K.), Castro, G. (Graça), Tania, G. (Gonçalves), Baptista, R. (Rui), Marinho, A. (António), Shiang, T. (Teresa), Oliveira, A. (Ana), Coutinho, D. (Daniel), Sousa, J. (Joana), Loureiro, M.J. (Maria José), Repolho, D. (Débora), Martins Jesus, S.M. (Susana Maria), Capinha, M. (Marta), Agostinho, J. (João), Cardoso, T. (Tania), Rocha, A. (Andreia), Espinha, M. (Mafalda), Ivanov, K.I. (Kyundyul Ivanovich), Alexeeva, D.E. (Dalyana Eduardovna), Batalina, M.V. (Marina Vadimovna), Hegya, D.V. (Daria Viktorovna), Zvereva, T.N. (Tatyana Nikolaevna), Avdeev, S.N. (Sergey Nikolaevich), Tsareva, N.A. (Natalia Anatolievna), Galyavich, A.S. (Albert Sarvatovich), Nikolaevich, B.A. (Bykov Aleksander), Filippov, E.V. (Evgeny Vladimirovich), Yakovleva, O.E. (Olga Eduardovna), Pavlova, O.B. (Olga Borisovna), Skripkina, E.S. (Elena Sergeevna), Martynyuk, T.V. (Tamila Vitalievna), Bukatova, I.F. (Irina Fedorovna), Tregubova, A.V. (Anna Viktorovna), Platonov, D.Y. (Dmitry Yurievich), Kolomeytseva, T.M. (Tatyana Mikhaylovna), Al Dalaan, A. (Abdullah), Abdelsayed, A.A. (Abeer Abeer), Weheba, I. (Ihab), Saleemi, S. (Sarferaz), Sakkijha, H. (Hussam), Bohacekova, M. (Marcela), Valkovicova, T. (Tatiana), Farkasova, I. (Iveta), Quezada, C.A. (Carlos Andres), Piccari, L. (Lucilla), Blanco, I. (Isabel), Sebastian, L. (Laura), Roman, A. (Antonio), Lopez, M. (Manuel), Otero, R. (Remedios), Elias, T. (Teresa), Jara, L. (Luis), Asencio, I. (Isabel), Arjona, J.J. (Josefa Jiménez), Almagro, R.M. (Raúl Menor), Cárdenas, S.L. (Salvador López), García, S.A. (Salvador Alcaraz), Rodríguez, P.V. (Patricia Villanueva), Lopez, R. (Raquel), Garcia, A. (Alberto), Avilés, F.F. (Francisco Fernandez), De La Pava, S. (Sebastian), Yotti, R. (Raquel), Peñate, G.P. (Gregorio Pérez), Marrero, F.L. (Fernando León), Cifrián Martínez, J.M. (José Manuel), Martinez-Meñaca, A. (Amaya), Alonso, L.P. (Lecue Pilar), Rozas, S.F. (Sonia Fernandez), Fernandez, D.I. (David Iturbe), Cuesta, V.M. (Victor Mora), Söderberg, S. (Stefan), Bartfay, S.-E. (Sven-Erik), Rundqvist, B. (Bengt), Alfetlawi, M. (Monthir), Wodlin, P. (Peter), Schwarz, E.I. (Esther Irene), Speich, R. (Rudolf), Lador, F. (Frédéric), Rochat, T. (Thierry), Gasche-Soccal, P. (Paola), Hsu, C.-H. (Chih-Hsin), Lin, T.-H. (Tsung-Hsien), Su, H.-M. (Ho-Ming), Lai, W.-T. (Wen-Ter), Chu, C.Y. (Chun Yuan), Hsu, P.-C. (Po-Chao), Voon, W.-C. (Wen-Chol), Yen, H.-W. (Hsueh-Wei), Yih-Jer Wu, J. (Jacob), Wu, S.-H. (Shu-Hao), Huang, W.-P. (Wen-Pin), Fong, M.-C. (Man-Cai), Huang, C.-L. (Chien-Lung), Kuo, P.-H. (Ping-Hung), Lin, Y.-H. (Yen-Hung), Lin, J.-L. (Jiunn-Lee), Hung, C.-S. (Chi-Sheng), Wu, C.-K. (Cho-Kai), Sung, S.-H. (Shih-Hsien), Huang, W.-C. (Wei-Chun), Cheng, C.-C. (Chin-Chang), Kuo, S.-H. (Shu-Hung), Wang, W.-H. (Wen-Hwa), Ho, W.-J. (Wan-Jing), Hsu, T.-S. (Tsu-Shiu), Mutlu, B. (Bülent), Atas, H. (Halil), Ongen, G. (Gul), Un, Z. (Zeynep), Okumus, G. (Gulfer), Hanta, I. (Ismail), Corris, P. (Paul), Peacock, A. (Andrew), Church, C. (Colin), Toshner, M. (Mark), and Newnham, M. (Michael)

Abstract

Objective: The soluble guanylate cyclase stimulator riociguat is approved for the treatment of adult patients with pulmonary arterial hypertension (PAH) and inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) following Phase 3

Published
2021
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50. Riociguat treatment in patients with chronic thromboembolic pulmonary hypertension: Final safety data from the EXPERT registry.

Author

Ghofrani, H-A, Gomez Sanchez, M-A, Humbert, M, Pittrow, D, Simonneau, G, Gall, H, Grünig, E, Klose, H, Halank, M, Langleben, D, Snijder, RJ, Escribano Subias, P, Mielniczuk, LM, Lange, TJ, Vachiéry, J-L, Wirtz, H, Helmersen, DS, Tsangaris, I, Barberá, JA, Pepke-Zaba, J, Boonstra, A, Rosenkranz, S, Ulrich, S, Steringer-Mascherbauer, R, Delcroix, M, Jansa, P, Šimková, I, Giannakoulas, G, Klotsche, J, Williams, E, Meier, C, Hoeper, MM, NEW COLLABORATORS LIST, Ghofrani, H-A, Gomez Sanchez, M-A, Humbert, M, Pittrow, D, Simonneau, G, Gall, H, Grünig, E, Klose, H, Halank, M, Langleben, D, Snijder, RJ, Escribano Subias, P, Mielniczuk, LM, Lange, TJ, Vachiéry, J-L, Wirtz, H, Helmersen, DS, Tsangaris, I, Barberá, JA, Pepke-Zaba, J, Boonstra, A, Rosenkranz, S, Ulrich, S, Steringer-Mascherbauer, R, Delcroix, M, Jansa, P, Šimková, I, Giannakoulas, G, Klotsche, J, Williams, E, Meier, C, Hoeper, MM, and NEW COLLABORATORS LIST

Abstract

OBJECTIVE: The soluble guanylate cyclase stimulator riociguat is approved for the treatment of adult patients with pulmonary arterial hypertension (PAH) and inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) following Phase 3 randomized trials. The EXPosurE Registry RiociguaT in patients with pulmonary hypertension (EXPERT) study was designed to monitor the long-term safety of riociguat in clinical practice. METHODS: EXPERT was an international, multicenter, prospective, uncontrolled, non-interventional cohort study of patients treated with riociguat. Patients were followed for at least 1 year and up to 4 years from enrollment or until 30 days after stopping riociguat treatment. Primary safety outcomes were adverse events (AEs) and serious adverse events (SAEs) coded using Medical Dictionary for Regulatory Activities preferred terms and System Organ Classes version 21.0, collected during routine clinic visits and collated via case report forms. RESULTS: In total, 956 patients with CTEPH were included in the analysis. The most common AEs in these patients were peripheral edema/edema (11.7%), dizziness (7.5%), right ventricular (RV)/cardiac failure (7.7%), and pneumonia (5.0%). The most common SAEs were RV/cardiac failure (7.4%), pneumonia (4.1%), dyspnea (3.6%), and syncope (2.5%). Exposure-adjusted rates of hemoptysis/pulmonary hemorrhage and hypotension were low and comparable to those in the long-term extension study of riociguat (Chronic Thromboembolic Pulmonary Hypertension Soluble Guanylate Cyclase-Stimulator Trial [CHEST-2]). CONCLUSION: Data from EXPERT show that in patients with CTEPH, the safety of riociguat in routine practice was consistent with the known safety profile of the drug, and no new safety concerns were identified.

Published
2021

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