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1. Supplemental Material - GEospatial aNalysis of ExtRacorporeal membrane oxygenATion in Europe (GENERATE)

Author

Gillon, Stuart, Zheng, Chunyu, Feng, Zhiqiang, Fleig, Marcel, Scquizzato, Tommaso, Belohlavek, Jan, Lorusso, Roberto, Lone, Nazir, and Swol, Justyna

Subjects
FOS: Clinical medicine, Cardiology, 110323 Surgery
Abstract

Supplemental Material for GEospatial aNalysis of ExtRacorporeal membrane oxygenATion in Europe (GENERATE) by Stuart Gillon, Chunyu Zheng, Zhiqiang Feng, Marcelcel Fleig, Tommaso Scquizzato, Jan Belohlavek, Roberto Lorusso, Nazir Lone, and Justyna Swol in Perfusion

Published
2023
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2. sj-pdf-2-prf-10.1177_02676591211042563 – Supplemental material for International survey of neuromonitoring and neurodevelopmental outcome in children and adults supported on extracorporeal membrane oxygenation in Europe

Author

Cvetkovic, Mirjana, Chiarini, Giovanni, Belliato, Mirko, Delnoij, Thijs, Zanatta, Paolo, Taccone, Fabio Silvio, Miranda, Dinis dos Reis, Davidson, Mark, Matta, Nashwa, Davis, Carl, IJsselstijn, Hanneke, Schmidt, Matthieu, Broman, Lars Mikael, Donker, Dirk W, Vlasselaers, Dirk, David, Piero, Di Nardo, Matteo, Muellenbach, Ralf M, Mueller, Thomas, Barrett, Nicholas A, Lorusso, Roberto, Belohlavek, Jan, and Hoskote, Aparna

Subjects
FOS: Clinical medicine, Cardiology, 110323 Surgery
Abstract

Supplemental material, sj-pdf-2-prf-10.1177_02676591211042563 for International survey of neuromonitoring and neurodevelopmental outcome in children and adults supported on extracorporeal membrane oxygenation in Europe by Mirjana Cvetkovic, Giovanni Chiarini, Mirko Belliato, Thijs Delnoij, Paolo Zanatta, Fabio Silvio Taccone, Dinis dos Reis Miranda, Mark Davidson, Nashwa Matta, Carl Davis, Hanneke IJsselstijn, Matthieu Schmidt, Lars Mikael Broman, Dirk W Donker, Dirk Vlasselaers, Piero David, Matteo Di Nardo, Ralf M Muellenbach, Thomas Mueller, Nicholas A Barrett, Roberto Lorusso, Jan Belohlavek and Aparna Hoskote in Perfusion

Published
2021
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3. sj-pdf-1-prf-10.1177_02676591211042563 – Supplemental material for International survey of neuromonitoring and neurodevelopmental outcome in children and adults supported on extracorporeal membrane oxygenation in Europe

Author

Cvetkovic, Mirjana, Chiarini, Giovanni, Belliato, Mirko, Delnoij, Thijs, Zanatta, Paolo, Taccone, Fabio Silvio, Miranda, Dinis dos Reis, Davidson, Mark, Matta, Nashwa, Davis, Carl, IJsselstijn, Hanneke, Schmidt, Matthieu, Broman, Lars Mikael, Donker, Dirk W, Vlasselaers, Dirk, David, Piero, Di Nardo, Matteo, Muellenbach, Ralf M, Mueller, Thomas, Barrett, Nicholas A, Lorusso, Roberto, Belohlavek, Jan, and Hoskote, Aparna

Subjects
FOS: Clinical medicine, Cardiology, 110323 Surgery
Abstract

Supplemental material, sj-pdf-1-prf-10.1177_02676591211042563 for International survey of neuromonitoring and neurodevelopmental outcome in children and adults supported on extracorporeal membrane oxygenation in Europe by Mirjana Cvetkovic, Giovanni Chiarini, Mirko Belliato, Thijs Delnoij, Paolo Zanatta, Fabio Silvio Taccone, Dinis dos Reis Miranda, Mark Davidson, Nashwa Matta, Carl Davis, Hanneke IJsselstijn, Matthieu Schmidt, Lars Mikael Broman, Dirk W Donker, Dirk Vlasselaers, Piero David, Matteo Di Nardo, Ralf M Muellenbach, Thomas Mueller, Nicholas A Barrett, Roberto Lorusso, Jan Belohlavek and Aparna Hoskote in Perfusion

Published
2021
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4. Effects of a Novel Nitroxyl Donor in Acute Heart Failure: The STAND-UP AHF Study

Author

Felker, G Michael, Mcmurray, John J V, Cleland, John G, O'Connor, Christopher M, Teerlink, John R, Voors, Adriaan A, Belohlavek, Jan, Böhm, Michael, Borentain, Maria, Bueno, Hector, Cole, Robert T, Desouza, Mary M, Ezekowitz, Justin A, Filippatos, Gerasimos, Lang, Ninian N, Kessler, Paul D, Martinez, Felipe A, Mebazaa, Alex, Metra, Marco, Mosterd, Arend, Pang, Peter S, Ponikowski, Piotr, Sato, Naoki, Seiffert, Dietmar, and June, Ye

Subjects
Heart Failure, clinical trials, Treatment Outcome, nitroxyl, Double-Blind Method, acute heart failure, drug therapy, Acute Disease, Humans, Nitrogen Oxides, Stroke Volume, Ventricular Function, Left
Abstract

The primary objective was to identify well-tolerated doses of cimlanod in patients with acute heart failure (AHF). Secondary objectives were to identify signals of efficacy, including biomarkers, symptoms, and clinical events.Nitroxyl (HNO) donors have vasodilator, inotropic and lusitropic effects. Bristol-Myers Squibb-986231 (cimlanod) is an HNO donor being developed for acute heart failure (AHF).This was a phase IIb, double-blind, randomized, placebo-controlled trial of 48-h treatment with cimlanod compared with placebo in patients with left ventricular ejection fraction ≤40% hospitalized for AHF. In part I, patients were randomized in a 1:1 ratio to escalating doses of cimlanod or matching placebo. In part II, patients were randomized in a 1:1:1 ratio to either of the 2 highest tolerated doses of cimlanod from part I or placebo. The primary endpoint was the rate of clinically relevant hypotension (systolic blood pressure 90 mm Hg or patients became symptomatic).In part I (n = 100), clinically relevant hypotension was more common with cimlanod than placebo (20% vs. 8%; relative risk [RR]: 2.45; 95% confidence interval [CI]: 0.83 to 14.53). In part II (n = 222), the incidence of clinically relevant hypotension was 18% for placebo, 21% for cimlanod 6 μg/kg/min (RR: 1.15; 95% CI: 0.58 to 2.43), and 35% for cimlanod 12 μg/kg/min (RR: 1.9; 95% CI: 1.04 to 3.59). N-terminal pro-B-type natriuretic peptide and bilirubin decreased during infusion of cimlanod treatment compared with placebo, but these differences did not persist after treatment discontinuation.Cimlanod at a dose of 6 μg/kg/min was reasonably well-tolerated compared with placebo. Cimlanod reduced markers of congestion, but this did not persist beyond the treatment period. (Evaluate the Safety and Efficacy of 48-Hour Infusions of HNO (Nitroxyl) Donor in Hospitalized Patients With Heart Failure [STANDUP AHF]; NCT03016325).

Published
2020

5. Supplemental_digital_file – Supplemental material for Pressure and flow properties of dual-lumen cannulae for extracorporeal membrane oxygenation

Author

Broman, Lars Mikael, C Jerker Westlund, Gilbers, Martijn, Câmara, Luisa Perry Da, Wittberg, Lisa Prahl, Taccone, Fabio Silvio, Malfertheiner, Maximilian V, Nardo, Matteo Di, Swol, Justyna, Vercaemst, Leen, Barrett, Nicholas A, Pappalardo, Federico, Belohlavek, Jan, Belliato, Mirko, and Lorusso, Roberto

Subjects
FOS: Clinical medicine, Cardiology, 110323 Surgery
Abstract

Supplemental material, Supplemental_digital_file for Pressure and flow properties of dual-lumen cannulae for extracorporeal membrane oxygenation by Lars Mikael Broman, C Jerker Westlund, Martijn Gilbers, Luisa Perry da Câmara, Lisa Prahl Wittberg, Fabio Silvio Taccone, Maximilian V Malfertheiner, Matteo Di Nardo, Justyna Swol, Leen Vercaemst, Nicholas A Barrett, Federico Pappalardo, Jan Belohlavek, Mirko Belliato and Roberto Lorusso in Perfusion

Published
2020
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6. Effect of aliskiren on post-discharge outcomes among diabetic and non-diabetic patients hospitalized for heart failure: insights from the ASTRONAUT trial

Author

Maggioni, Aldo P., Greene, Stephen J., Fonarow, Gregg C., Böhm, Michael, Zannad, Faiez, Solomon, Scott D., Lewis, Eldrin F., Baschiera, Fabio, Hua, Tsushung A., Gimpelewicz, Claudio R., Lesogor, Anastasia, Gheorghiade, Mihai, Ramos, Silvina, Luna, Alejandra, Miriuka, Santiago, Diez, Mirta, Perna, Eduardo, Luquez, Hugo, Pinna, Jorge Garcia, Castagnino, Jorge, Alvarenga, Pablo, Ibañez, Julio, Blumberg, Eduardo Salmon, Dizeo, Claudio, Guerrero, Rodolfo Ahuad, Schygiel, Pablo, Milesi, Rodolfo, Sosa, Carlos, Hominal, Miguel, Marquez, Lilia Lobo, Poy, Carlos, Hasbani, Eduardo, Vico, Marisa, Fernandez, Alberto, Vita, Nestor, Vanhaecke, Johan, De Keulenaer, Gilles, Striekwold, Harry, Vervoort, Geert, Vrolix, Mathias, Henry, Philippe, Dendale, Paul, Smolders, Walter, Marechal, Patrick, Vandekerckhove, Hans, Oliveira, Mucio, Neuenschwande, Fernando, Reis, Gilmar, Saraiva, Jose, Bodanese, Luiz, Canesin, Manoel, Greco, Oswaldo, Bassan, Roberto, Marino, Roberto Luis, Giannetti, Nadia, Moe, Gordon, Sussex, Bruce, Sheppard, Richard, Huynh, Thao, Stewart, Robert, Haddad, Haissam, Echeverria, Luis, Quintero, Adalberto, Torres, Adriana, Jaramillo, Mónica, Lopez, Mónica, Mendoza, Fernan, Florez, Noel, Cotes, Carlos, Garcia, Magali, Belohlavek, Jan, Hradec, Jaromir, Peterka, Martin, Gregor, Pavel, Monhart, Zdenek, Jansky, Petr, Kettner, Jiri, Reichert, Petr, Spinar, Jindrich, Brabec, Tomas, Hutyra, Martin, Solar, Miroslav, Pietilä, Mikko, Nyman, Kai, Pajari, Risto, Cohen, Ariel, Galinier, Michel, Gosse, Philippe, Livarek, Bernard, Neuder, Yannick, Jourdain, Patrick, Picard, François, Isnard, Richard, Hoppe, Uta, Kaeaeb, Stefan, Rosocha, Stefan, Prondzinsky, Roland, Felix, Stephan, Duengen, Hans-Dirk, Figulla, Hans-Reiner, Fischer, Sven, Behrens, Steffen, Stawowy, Philipp, Kruells-Muench, Juergen, Knebel, Fabian, Nienaber, Christoph, Werner, Dierk, Aron, Wilma, Remppis, Bjoern, Hambrecht, Rainer, Kisters, Klaus, Werner, Nikos, Hoffmann, Stefan, Rossol, Siegbert, Geiss, Ernst, Graf, Kristof, Hamann, Frank, von Scheidt, Wolfgang, Schwinger, Robert, Tebbe, Ulrich, Costard-Jaeckle, Angelika, Lueders, Stephan, Heitzer, Thomas, Leutermann-Oei, Marie-Louise, Braun-Dullaeus, Ruediger, Roehnisch, Jens-Uwe, Muth, Gerhard, Goette, Andreas, Rotter, Achim, Ebelt, Henning, Olbrich, Hans-Georg, Mitrovic, Veselin, Hengstenberg, Christian, Schellong, Sebastian, Zamolyi, Karoly, Vertes, Andras, Matoltsy, Andras, Palinkas, Attila, Herczeg, Bela, Apro, Dezso, Lupkovics, Geza, Tomcsanyi, Janos, Toth, Kalman, Mathur, Atul, Banker, Darshan, Bharani, Anil, Arneja, Jaspal, Khan, Aziz, Gadkari, Milind, Hiremath, Jagdish, Patki, Nitin, Kumbla, Makund, Santosh, M.J., Ravikishore, A.G., Abhaichand, Rajpal, Maniyal, Vijayakukmar, Nanjappa, Manjunath, Reddy, P. Naveen, Chockalingam, Kulasekaran, Premchand, Rajendra, Mahajan, Vijay, Lewis, Basil, Wexler, Dov, Shochat, Michael, Keren, Andre, Omary, Muhamad, Katz, Amos, Marmor, Alon, Lembo, Giuseppe, Di Somma, Salvatore, Boccanelli, Alessandro, Barbiero, Mario, Pajes, Giuseppe, De Servi, Stefano, Greco, Dott Cosimo, De Santis, Fernando, Floresta, Agata, Visconti, Luigi Oltrona, Piovaccari, Giancarlo, Cavallini, Claudio, Di Biase, Matteo, Masini, Dott Franco, Vassanelli, Corrado, Viecca, Maurizio, Cangemi, Dott Francesco, Pirelli, Salvatore, Borghi, Claudio, Volpe, Massimo, Branzi, Angelo, Percoco, Dott Giovanni, Severi, Silvia, Santini, Alberto, De Lorenzi, Ettore, Metra, Marco, Zacà, Valerio, Mortara, Andrea, Tranquilino, Francisco P., Babilonia, Noe A., Ferrolino, Arthur M., Manlutac, Benjamin, Dluzniewski, Miroslaw, Dzielinska, Zofia, Nowalany-Kozie, Ewa, Mazurek, Walentyna, Wierzchowiecki, Jerzy, Wysokinski, Andrzej, Szachniewicz, Joanna, Romanowski, Witold, Krauze-Wielicka, Magdalena, Jankowski, Piotr, Berkowski, Piotr, Szelemej, Roman, Kleinrok, Andrzej, Kornacewicz-Jac, Zdzislawa, Vintila, Marius, Vladoianu, Mircea, Militaru, Constantin, Dan, Gheorghe, Dorobantu, Maria, Dragulescu, Stefan, Kostenko, Victor, Vishnevsky, Alexandr, Goloschekin, Boris, Tyrenko, Vadim, Gordienko, Alexander, Kislyak, Oxana, Martsevich, Sergey, Kuchmin, Alexey, Karpov, Yurii, Fomin, Igor, Shvarts, Yury, Orlikova, Olga, Ershova, Olga, Berkovich, Olga, Sitnikova, Maria, Pakhomova, Inna, Boldueva, Svetlana, Tyurina, Tatiana, Simanenkov, Vladimir, Boyarkin, Mikhail, Novikova, Nina, Tereschenko, Sergey, Zadionchenko, Vladimir, Shogenov, Zaur, Gordeev, Ivan, Moiseev, Valentin, Wong, Raymond, Ong, Hean Yee, Le Tan, Ju, Goncalvesova, Eva, Kovar, Frantisek, Skalina, Ivan, Kasperova, Viera, Hojerova, Silvia, Szentivanyi, Miroslav, Stancak, Branislav, Babcak, Marian, Kycina, Peter, Poliacik, Pavol, Toth, Peter, Sirotiakova, Jana, de Sa, Esteban Lopez, Bueno, Manuel Gomez, Selles, Manuel Martinez, Cabrera, Jose Angel, Freire, Ramon Bover, Gonzalez Juanatey, Jose Ramon, Comin, Josep, Soriano, FranciscoRidocci, Lopez, Alejandro, Vicho, Raul, Lama, Manuel Geraldia, Schaufelberger, Maria, Brunotte, Richard, Ullman, Bengt, Hagerman, Inger, Cizinsky, Stella, Cherng, Wen-Jin, Yu, Wen-Chung, Kuo, Chi-Tai, Chang, Kuan-Cheng, Lai, Wen-Ter, Kuo, Jen-Yuan, Ural, Dilek, Badak, Ozer, Akin, Mustafa, Yigit, Zerrin, Yokusoglu, Mehmet, Yilmaz, Mehmet, Abaci, Adnan, Ebinc, Haksun, Perlman, Richard, Parish, David, Bergin, James, Burnham, Kenneth, Brown, Christopher, Lundbye, Justin, Williams, Celeste, Eisen, Howard, Juneman, Elizabeth, Joseph, Susan, Peberdy, Mary Ann, Peura, Jennifer, Gupta, Vishal, Habet, Kalim, French, William, Mody, Freny, Graham, Susan, Hazelrigg, Monica, Chung, Eugene, Dunlap, Stephanie, Nikolaidis, Lazaros, Najjar, Samer, Katz, Richard, Murali, Srinivas, Izzo, Joseph L., Callister, Tracy, Phillips, Roland, Lippolis, Nicholas, Winterton, John, Meymandi, Sheba, Heilman, Karl, Oren, Ron, Zolty, Ronald, Brottman, Michael, Gunawardena, D.R., Adams, Kirkwood, Barnard, Denise, Klapholz, Marc, Fulmer, James, Maggioni AP, Greene SJ, Fonarow GC, Böhm M, Zannad F, Solomon SD, Lewis EF, Baschiera F, Hua TA, Gimpelewicz CR, Lesogor A, Gheorghiade M, Ramos S, Luna A, Miriuka S, Diez M, Perna E, Luquez H, Pinna JG, Castagnino J, Alvarenga P, Ibañez J, Blumberg ES, Dizeo C, Guerrero RA, Schygiel P, Milesi R, Sosa C, Hominal M, Marquez LL, Poy C, Hasbani E, Vico M, Fernandez A, Vita N, Vanhaecke J, De Keulenaer G, Striekwold H, Vervoort G, Vrolix M, Henry P, Dendale P, Smolders W, Marechal P, Vandekerckhove H, Oliveira M, Neuenschwande F, Reis G, Saraiva J, Bodanese L, Canesin M, Greco O, Bassan R, Marino RL, Giannetti N, Moe G, Sussex B, Sheppard R, Huynh T, Stewart R, Haddad H, Echeverria L, Quintero A, Torres A, Jaramillo M, Lopez M, Mendoza F, Florez N, Cotes C, Garcia M, Belohlavek J, Hradec J, Peterka M, Gregor P, Monhart Z, Jansky P, Kettner J, Reichert P, Spinar J, Brabec T, Hutyra M, Solar M, Pietilä M, Nyman K, Pajari R, Cohen A, Galinier M, Gosse P, Livarek B, Neuder Y, Jourdain P, Picard F, Isnard R, Hoppe U, Kaeaeb S, Rosocha S, Prondzinsky R, Felix S, Duengen HD, Figulla HR, Fischer S, Behrens S, Stawowy P, Kruells-Muench J, Knebel F, Nienaber C, Werner D, Aron W, Remppis B, Hambrecht R, Kisters K, Werner N, Hoffmann S, Rossol S, Geiss E, Graf K, Hamann F, von Scheidt W, Schwinger R, Tebbe U, Costard-Jaeckle A, Lueders S, Heitzer T, Leutermann-Oei ML, Braun-Dullaeus R, Roehnisch JU, Muth G, Goette A, Rotter A, Ebelt H, Olbrich HG, Mitrovic V, Hengstenberg C, Schellong S, Zamolyi K, Vertes A, Matoltsy A, Palinkas A, Herczeg B, Apro D, Lupkovics G, Tomcsanyi J, Toth K, Mathur A, Banker D, Bharani A, Arneja J, Khan A, Gadkari M, Hiremath J, Patki N, Kumbla M, Santosh MJ, Ravikishore AG, Abhaichand R, Maniyal V, Nanjappa M, Reddy PN, Chockalingam K, Premchand R, Mahajan V, Lewis B, Wexler D, Shochat M, Keren A, Omary M, Katz A, Marmor A, Lembo G, Di Somma S, Boccanelli A, Barbiero M, Pajes G, De Servi S, Greco DC, De Santis F, Floresta A, Visconti LO, Piovaccari G, Cavallini C, Di Biase M, Masini DF, Vassanelli C, Viecca M, Cangemi DF, Pirelli S, Borghi C, Volpe M, Branzi A, Percoco DG, Severi S, Santini A, De Lorenzi E, Metra M, Zacà V, Mortara A, Tranquilino FP, Babilonia NA, Ferrolino AM, Manlutac B, Dluzniewski M, Dzielinska Z, Nowalany-Kozie E, Mazurek W, Wierzchowiecki J, Wysokinski A, Szachniewicz J, Romanowski W, Krauze-Wielicka M, Jankowski P, Berkowski P, Szelemej R, Kleinrok A, Kornacewicz-Jac Z, Vintila M, Vladoianu M, Militaru C, Dan G, Dorobantu M, Dragulescu S, Kostenko V, Vishnevsky A, Goloschekin B, Tyrenko V, Gordienko A, Kislyak O, Martsevich S, Kuchmin A, Karpov Y, Fomin I, Shvarts Y, Orlikova O, Ershova O, Berkovich O, Sitnikova M, Pakhomova I, Boldueva S, Tyurina T, Simanenkov V, Boyarkin M, Novikova N, Tereschenko S, Zadionchenko V, Shogenov Z, Gordeev I, Moiseev V, Wong R, Ong HY, Le Tan J, Goncalvesova E, Kovar F, Skalina I, Kasperova V, Hojerova S, Szentivanyi M, Stancak B, Babcak M, Kycina P, Poliacik P, Toth P, Sirotiakova J, Lopez de Sa E, Bueno MG, Selles MM, Cabrera JA, Freire RB, Gonzalez Juanatey JR, Comin J, Soriano F, Lopez A, Vicho R, Lama MG, Schaufelberger M, Brunotte R, Ullman B, Hagerman I, Cizinsky S, Cherng WJ, Yu WC, Kuo CT, Chang KC, Lai WT, Kuo JY, Ural D, Badak O, Akin M, Yigit Z, Yokusoglu M, Yilmaz M, Abaci A, Ebinc H, Perlman R, Parish D, Bergin J, Burnham K, Brown C, Lundbye J, Williams C, Eisen H, Juneman E, Joseph S, Peberdy MA, Peura J, Gupta V, Habet K, French W, Mody F, Graham S, Hazelrigg M, Chung E, Dunlap S, Nikolaidis L, Najjar S, Katz R, Murali S, Izzo JL, Callister T, Phillips R, Lippolis N, Winterton J, Meymandi S, Heilman K, Oren R, Zolty R, Brottman M, Gunawardena DR, Adams K, Barnard D, Klapholz M, and Fulmer J

Subjects
Male, medicine.medical_specialty, Cardiotonic Agents, ASTRONAUT, Diabetic Cardiomyopathies, Administration, Oral, Kaplan-Meier Estimate, Placebo, Diabete, chemistry.chemical_compound, Double-Blind Method, Fumarates, Internal medicine, Diabetes mellitus, Troponin I, Renin, Clinical endpoint, medicine, Humans, Prospective Studies, Heart Failure, Ejection fraction, business.industry, Surrogate endpoint, Aliskiren, Middle Aged, medicine.disease, Amides, Hospitalization, Endocrinology, Death, Sudden, Cardiac, Treatment Outcome, chemistry, Heart failure, Female, Cardiology and Cardiovascular Medicine, business, aliskiren
Abstract

Aims The objective of the Aliskiren Trial on Acute Heart Failure Outcomes (ASTRONAUT) was to determine whether alis- kiren, a direct renin inhibitor, would improve post-discharge outcomes in patients with hospitalization for heart failure (HHF) with reduced ejection fraction. Pre-specified subgroup analyses suggested potential heterogeneity in post- discharge outcomes with aliskiren in patients with and without baseline diabetes mellitus (DM). Methods and results ASTRONAUT included 953 patients without DM (aliskiren 489; placebo 464) and 662 patients with DM (aliskiren 319; placebo 343) (as reported by study investigators). Study endpoints included the first occurrence of cardiovascular death or HHF within 6 and 12 months, all-cause death within 6 and 12 months, and change from baseline in N-terminal pro-B- type natriuretic peptide (NT-proBNP) at 1, 6, and 12 months. Data regarding risk of hyperkalaemia, renal impairment, and hypotension, and changes in additional serum biomarkers were collected. The effect of aliskiren on cardiovascular death or HHF within 6 months (primary endpoint) did not significantly differ by baseline DM status (P ¼ 0.08 for interaction), but reached statistical significance at 12 months (non-DM: HR: 0.80, 95% CI: 0.64-0.99; DM: HR: 1.16, 95% CI: 0.91-1.47; P ¼ 0.03 for interaction). Risk of 12-month all-cause death with aliskiren significantly differed by the presence of baseline DM (non-DM: HR: 0.69, 95% CI: 0.50-0.94; DM: HR: 1.64, 95% CI: 1.15-2.33; P , 0.01 for interaction). Among non-diabetics, aliskiren significantly reduced NT-proBNP through 6 months and plasma troponin I and aldosterone through 12 months, as compared to placebo. Among diabetic patients, aliskiren reduced plasma troponin I and aldoster- one relative to placebo through 1 month only. There was a trend towards differing risk of post-baseline potassium ≥6 mmol/L with aliskiren by underlying DM status (non-DM: HR: 1.17, 95% CI: 0.71-1.93; DM: HR: 2.39, 95% CI: 1.30-4.42; P ¼ 0.07 for interaction). Conclusion This pre-specified subgroup analysis from the ASTRONAUT trial generates the hypothesis that the addition of aliskiren to standard HHF therapy in non-diabetic patients is generally well-tolerated and improves post-discharge outcomes and biomarker profiles. In contrast, diabetic patients receiving aliskiren appear to have worse post-discharge outcomes. Future prospective investigations are needed to confirm potential benefits of renin inhibition in a large cohort of HHF patients without DM.

Published
2013

9. Carotid intima-media thickness in young survivors of acute myocardial infarction

Author

Linhart, Ales, Dostalova, Gabriela, Belohlavek, Jan, Vitek, Libor, Karetova, Debora, Ingrischova, Michaela, Bojanovska, Kristina, Polacek, Pavel, Votavova, Regina, and Renata Cífková

Subjects
Clinical Cardiology: Original Article
Abstract

Carotid intima-media thickness (CIMT) is considered to be a useful surrogate marker of coronary atherosclerosis. However, it is unclear whether this applies to young patients with acute myocardial infarction (AMI), in whom most cases are attributable to the destabilization of focal atheroma.To assess CIMT in patients experiencing AMI at a young age.CIMT was investigated in young survivors of AMI (78 male and 20 female) occurring before 45 years of age in men and before 50 years of age in women. CIMT values were compared with those of a sex-, age- and smoking status-matched sample selected from participants of a large epidemiological survey (115 men and 144 women). CIMT was measured on the anterior and posterior walls of the distal common carotid artery.In post-AMI male patients, the mean average CIMT, comprised of measurements of both the near and far walls on both sides, was significantly increased compared with controls (0.67±0.10 mm versus 0.60±0.09 mm; P0.001), while it did not differ in post-AMI female patients (0.60±0.07 mm versus 0.60±0.10 mm). Mean maximum CIMT was greater in both male and female post-AMI patients (0.94±0.15 mm versus 0.81±0.13 mm; P0.001 in men and 0.89±0.14 mm versus 0.80±0.11 mm; P=0.001 in women).In young AMI survivors, CIMT appeared to be significantly increased to a greater extent in men than in women. Although most patients had single- or double-vessel coronary disease, the overall increase in CIMT suggests that their coronary events were not due to destabilization of a single focal atheroma but may have reflected a generalized atherosclerotic process.

12. A narrative review of the technical standards for extracorporeal life support devices (pumps and oxygenators) in Europe

Author

Leen Vercaemst, Jan Belohlavek, Matteo Di Nardo, Fabio Silvio Taccone, Nicholas Barret, Federico Pappalardo, Roberto Lorusso, Lars Mikael Broman, Maximilian V. Malfertheiner, Thomas Mueller, Mirko Belliato, Justyna Swol, Margherita Lonero, Di Nardo, Matteo, Vercaemst, Leen, Swol, Justyna, Barret, Nichola, Taccone, Fabio S., Malfertheiner, Maximilian V., Broman, Lars M., Pappalardo, Federico, Belohlavek, Jan, Mueller, Thoma, Lorusso, Roberto, Lonero, Margherita, and Belliato, Mirko

Subjects
Radiology, Nuclear Medicine and Imaging, oxygenators, Oxygenators, medicine.medical_treatment, Technical standard, Certification, 030204 cardiovascular system & hematology, Extracorporeal, 03 medical and health sciences, 0302 clinical medicine, Extracorporeal Membrane Oxygenation, Extracorporeal membrane oxygenation, Medicine, ISO, Humans, Radiology, Nuclear Medicine and imaging, DP3, Heart-Assist Devices, ECLS, Advanced and Specialized Nursing, business.industry, General Medicine, centrifugal pump, Europe, Engineering management, oxygenator, 030228 respiratory system, Life support, centrifugal pumps, Narrative review, ECMO, business, Cardiology and Cardiovascular Medicine, Safety Research
Abstract

This review summarizes the European rules to control the market when introducing new products. In particular, it shows all the steps to achieve the European Conformity (CE Mark), a certification that all new medical products must achieve before being used in Europe. Extracorporeal membrane oxygenation (ECMO) devices are exposed to the same procedures. Hereby, we present some regulatory issues regarding pumps and oxygenators, providing technical details as released by the manufacturers on their websites and information charts.

Published
2018

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