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1. P475 RECURRENT CORONARY ARTERY VASOSPASM COMPLICATED BY CARDIAC ARRESTS IN HEART TRANSPLANT RECIPIENT: AN UNUSUAL ENEMY

Author: A Tedeschi, M Palazzini, P Gentile, N Conti, U Ianni, E Perna, L D'Angelo, G Masciocco, G Foti, E Ammirati, A Verde, and A Garascia
Subjects: Cardiology and Cardiovascular Medicine
Abstract: Even if coronary vasospasm (CV) is considered a rare phenomenon in heart transplant (HT) recipients, during routine coronary angiography asymptomatic CV may be observed. We report the case of a 30–year–old male who underwent HT in 2007 for dilatative cardiomyopathy. He was maintained on tacrolimus and mycophenolate mofetil and had no significant rejection or coronary allograft vasculopathy (CAV) demonstration. In December 2020 patient presented with cardiac arrest preceded by angina. Coronary angiography demonstrated diffuse spasm of the right coronary artery (RCA) with resolution after intracoronary nitrate administration. An endomyocardial biopsy (EBM) revealed no signs of cellular rejection whilst cardiac magnetic resonance showed signs of acute rejection (Fig.1). Moreover, two major histocompatibility complex (MHC) Class 2 donor–specific antibodies (DSAs) were positive with a high title. Treatment for antibody–mediated rejection (AMR) was initiated with steroids and plasmapheresis, followed by immunoglobulin infusion. Cardiac defibrillator was implanted before discharge. In August 2021, patient experienced a second cardiac arrest. Left heart catheterization found diffuse CV and after nitrates administration, proximal critical stenosis of RCA was pointed out and treated with stent insertion (Fig. 2–3). EMB and DSAs assessment were both negative. The patient was discharged after medical therapy optimization for CV prevention including the switch from mycophenolate to everolimus. After two more episodes of ACS with angiography finding of CV we decided to empirically treat the patient with weekly photopheresis sessions. Despite aggressive AMR management, a third ACC occurred in March 2022. The patient was finally reintroduced to the HT waiting list. Most CV episodes run without any symptoms due to the denervated heart post–transplant so probably re–innervation occurred in our patient. Calcium channel blockers, nitrates, and beta–blockers failed in CV prevention, suggesting ineffectiveness in HT recipients because of a different pathogenetic mechanism when compared to healthy subjects. Furthermore, documentation of coronary disease progression after the second ACC supports the hypothesis that CV could be the first manifestation of CAV. An intriguing hypothesis would be the presence of pathological vasoreactivity in the donor‘s heart, ascribable to an “inherited” endothelial dysfunction that could last be exacerbated by multiple factors, including AMR.
Published: 2023
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2. A multicentric observational study of patients affected by advanced heart failure with implantable cardioverter defibrillator and left ventricular assist devices

Author: L Pignalosa, M Casula, R Rordorf, E Perna, M Baroni, A Garascia, S Guida, F Gazzoli, D Pini, F Cannata, M Pellegrino, P Vergara, P Della Bella, and S Gulletta
Subjects: Physiology (medical), Cardiology and Cardiovascular Medicine
Abstract: Funding Acknowledgements Type of funding sources: None. Background Left ventricular assist device (LVAD) implantation is increasingly used in patients with end-stage heart failure. Most patients already have an implantable defibrillator (ICD) at the time of L-VAD implantation. Studies on this patient population are limited by the small sample size and the short duration of follow-up. Purpose The aim of this study was to retrospectively describe the real-world management of patients implanted with both ICD and LVAD. The main objective was to evaluate the incidence and predictors of appropriate and inappropriate therapies of the ICD and the incidence and predictors of ICD related complications. Methods 212 patients were enrolled in four Centers in the period between July 2006 and November 2020. The inclusion criteria were age> 18 years, advanced heart failure, patients with ICD and concomitant or subsequent continuous flow LVAD implantation. ICD therapy was defined as antitachycardia pacing therapy or shock. The data available at the last visit with a median follow up of 21 months were analyzed. Outcome predictors were assessed by univariate logistic regression and the variables of interest included in a multivariate model. Results The rate of appropriate ICD therapies was 29.7%, while the incidence of inappropriate therapies was 10.4%; in the multivariate analysis the presence of a zone therapy with low detection rate (VT zone with median detection rate of 164.5 bpm) was found to be an independent predictor of the composite of appropriate and inappropriate therapies (OR = 19.05; CI = 2.19-165.21; p = 0.007). Interference between ICD and LVAD occurred in 7.5% of cases; the incidence of infectious complications related to the ICD was 7.1% and bleeding complications of 5.2%; in the multivariate analysis, ICD generator replacement was an independent predictor of total complications related to the ICD (interference, infectious and bleeding; OR = 4.45; IC = 1.60-12.36; p = 0.004). 103 patients had CRT defibrillator (48,6%). At follow up there was no statistically significant difference in the incidence of appropriate therapies between those who had CRT-on (n=74) and those who had CRT-off (n=29; p = 0.61). Conclusions Patients with LVAD implanted with an ICD experience a high rate of appropriate and inappropriate ICD therapies. An active VT zone at low heart rate was found to be an independent predictor of ICD therapies. Of more, ICD generator replacement was found to be an independent predictor of total complications related to the ICD. Our findings suggest the importance of tailoring device programming in order to minimize the incidence of ICD therapies, thus sparing the need for generator replacement in this population.
Published: 2022
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3. P217 SACUBITRIL/VALSARTAN IN ADVANCED HEART FAILURE: SAFETY AND EFFECTS ON HAEMODYNAMIC PARAMETERS

Author: P Gentile, R Cantone, E Perna, E Ammirati, M Varrenti, L D‘Angelo, A Verde, G Foti, G Masciocco, A Garascia, M Frigerio, and M Cipriani
Subjects: Cardiology and Cardiovascular Medicine
Abstract: Aims The angiotensin–II receptor neprilysin inhibitor (ARNI), sacubitril/valsartan has been shown to be effective in treatment of patients with heart failure (HF), but limited data is available in patients with advanced disease. This retrospective observational study assessed the effects of ARNI treatment in patients with advanced HF. Methods We reviewed medical records of all advanced HF patients evaluated at our center for unconventional therapies from September 2016 to January 2019. We studied 44 patients who started ARNI therapy and who had a hemodynamic assessment before beginning ARNI and after 6 ± 2 months. The primary endpoint was variation in pulmonary pressures and filling pressures at 6 months after starting ARNI therapy. Results Mean patient age was 51.6±7.4 years; 84% were male. At 6±2 months after starting ARNI, there was significant reduction of systolic pulmonary artery pressure (PAP) (32 mmHg, IQR 27–45 vs 25 mmHg, IQR 22.3–36.5; p Conclusions Sacubitril/valsartan is effective in reducing filling pressures and pulmonary pressures in patients with advanced HF. The absence of adverse events during follow–up suggests that sacubitril/valsartan is safe and well–tolerated in this cohort of patients.
Published: 2022
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4. Empagliflozin in the treatment of heart failure with reduced ejection fraction in addition to background therapies and therapeutic combinations (EMPEROR-Reduced): a post-hoc analysis of a randomised, double-blind trial

Author: Subodh Verma, Nitish K Dhingra, Javed Butler, Stefan D Anker, Joao Pedro Ferreira, Gerasimos Filippatos, James L Januzzi, Carolyn S P Lam, Naveed Sattar, Barbara Peil, Matias Nordaby, Martina Brueckmann, Stuart J Pocock, Faiez Zannad, Milton Packer, M Packer, S Anker, J Butler, G Filippatos, S Pocock, F Zannad, JP Ferreira, M Brueckmann, J George, W Jamal, FK Welty, M Palmer, T Clayton, KG Parhofer, TR Pedersen, B Greenberg, MA Konstam, KR Lees, P Carson, W Doehner, A Miller, M Haas, S Pehrson, M Komajda, I Anand, J Teerlink, A Rabinstein, T Steiner, H Kamel, G Tsivgoulis, J Lewis, J Freston, N Kaplowitz, J Mann, J Petrie, S Perrone, S Nicholls, S Janssens, E Bocchi, N Giannetti, S Verma, J Zhang, J Spinar, M-F Seronde, M Boehm, B Merkely, V Chopra, M Senni, S Taddi, H Tsutsui, D-J Choi, E Chuquiure, HPB La Rocca, P Ponikowski, JRG Juanatey, I Squire, J Januzzi, I Pina, R Bernstein, A Cheung, J Green, S Kaul, C Lam, G Lip, N Marx, P McCullough, C Mehta, J Rosenstock, N Sattar, B Scirica, S Shah, C Wanner, D Aizenberg, L Cartasegna, F Colombo Berra, H Colombo, M Fernandez Moutin, J Glenny, C Alvarez Lorio, D Anauch, R Campos, A Facta, A Fernandez, R Ahuad Guerrero, L Lobo Márquez, RA Leon de la Fuente, M Mansilla, M Hominal, E Hasbani, M Najenson, G Moises Azize, H Luquez, L Guzman, H Sessa, M Amuchástegui, O Salomone, E Perna, D Piskorz, M Sicer, D Perez de Arenaza, C Zaidman, S Nani, C Poy, J Resk, R Villarreal, C Majul, T Smith Casabella, S Sassone, A Liberman, G Carnero, A Caccavo, M Berli, N Budassi, J Bono, A Alvarisqueta, J Amerena, K Kostner, A Hamilton, A Begg, J Beltrame, D Colquhoun, G Gordon, A Sverdlov, G Vaddadi, J Wong, J Coller, D Prior, A Friart, A Leone, G Vervoort, P Timmermans, P Troisfontaines, C Franssen, T Sarens, H Vandekerckhove, P Van De Borne, F Chenot, J De Sutter, E De Vuyst, P Debonnaire, M Dupont, O Pereira Dutra, LH Canani, MdC Vieira Moreira, W de Souza, LM Backes, L Maia, B De Souza Paolino, ER Manenti, W Saporito, F Villaça Guimarães Filho, T Franco Hirakawa, LA Saliba, FC Neuenschwander, CA de Freitas Zerbini, G Gonçalves, Y Gonçalves Mello, J Ascenção de Souza, L Beck da Silva Neto, EA Bocchi, J Da Silveira, JB de Moura Xavier Moraes Junior, JD de Souza Neto, M Hernandes, HC Finimundi, CR Sampaio, E Vasconcellos, FJ Neves Mancuso, MM Noya Rabelo, M Rodrigues Bacci, F Santos, M Vidotti, MV Simões, FL Gomes, C Vieira Nascimento, D Precoma, FA Helfenstein Fonseca, JA Ribas Fortes, PE Leães, D Campos de Albuquerque, JF Kerr Saraiva, S Rassi, FA Alves da Costa, G Reis, S Zieroth, D Dion, D Savard, R Bourgeois, C Constance, K Anderson, M-H Leblanc, D Yung, E Swiggum, L Pliamm, Y Pesant, B Tyrrell, T Huynh, J Spiegelman, J-P Lavoie, M Hartleib, R Bhargava, L Straatman, S Virani, A Costa-Vitali, L Hill, M Heffernan, Y Khaykin, J Ricci, M Senaratne, A Zhai, B Lubelsky, M Toma, L Yao, R McKelvie, L Noronha, M Babapulle, A Pandey, G Curnew, A Lavoie, J Berlingieri, S Kouz, E Lonn, R Chehayeb, Y Zheng, Y Sun, H Cui, Z Fan, X Han, X Jiang, Q Tang, J Zhou, Z Zheng, X Zhang, N Zhang, Y Zhang, A Shen, J Yu, J Ye, Y Yao, J Yan, X Xu, Z Wang, J Ma, Y Li, S Li, S Lu, X Kong, Y Song, G Yang, Z Yao, Y Pan, X Guo, Z Sun, Y Dong, J Zhu, D Peng, Z Yuan, J Lin, Y Yin, O Jerabek, H Burianova, T Fiala, J Hubac, O Ludka, Z Monhart, P Vodnansky, K Zeman, D Foldyna, J Krupicka, I Podpera, L Busak, M Radvan, Z Vomacka, R Prosecky, R Cifkova, V Durdil, J Vesely, J Vaclavik, P Cervinka, A Linhart, T Brabec, R Miklik, H Bourhaial, H-G Olbrich, S Genth-Zotz, E Kemala, B Lemke, M Böhm, S Schellong, W Rieker, T Heitzer, H Ince, M Faghih, A Birkenfeld, A Begemann, A Ghanem, A Ujeyl, S von Haehling, T Dorsel, J Bauersachs, M Prull, F Weidemann, H Darius, G Nickenig, A Wilke, J Sauter, U Rauch-Kroehnert, N Frey, CP Schulze, W König, L Maier, F Menzel, N Proskynitopoulos, H-H Ebert, H-E Sarnighausen, H-D Düngen, M Licka, C Stellbrink, B Winkelmann, N Menck, JL López-Sendón, L de la Fuente Galán, JF Delgado Jiménez, N Manito Lorite, M Pérez de Juan Romero, E Galve Basilio, F Cereto Castro, JR González Juanatey, JJ Gómez, M Sanmartín Fernández, X Garcia-Moll Marimon, D Pascual Figal, R Bover Freire, E Bonnefoy Cudraz, A Jobbe Duval, D Tomasevic, G Habib, R Isnard, F Picard, P Khanoyan, J-L Dubois-Rande, M Galinier, F Roubille, J Alexandre, D Babuty, N Delarche, J-B Berneau, N Girerd, M Saxena, G Rosano, Z Yousef, C Clifford, C Arden, A Bakhai, C Boos, G Jenkins, C Travill, D Price, L Koenyves, F Lakatos, A Matoltsy, E Noori, Z Zilahi, P Andrassy, S Kancz, G Simon, T Sydo, A Vorobcsuk, RG Kiss, K Toth, I Szakal, L Nagy, T Barany, A Nagy, E Szolnoki, VK Chopra, S Mandal, V Rastogi, B Shah, A Mullasari, J Shankar, V Mehta, A Oomman, U Kaul, S Komarlu, D Kahali, A Bhagwat, V Vijan, NK Ghaisas, A Mehta, J Kashyap, Y Kothari, S TaddeI, M Scherillo, V Zacà, S Genovese, A Salvioni, A Fucili, F Fedele, F Cosmi, M Volpe, C Mazzone, G Esposito, M Doi, H Yamamoto, S Sakagami, S Oishi, Y Yasaka, H Tsuboi, Y Fujino, S Matsuoka, Y Watanabe, T Himi, T Ide, M Ichikawa, Y Kijima, T Koga, S Yuda, K Fukui, T Kubota, M Manita, H Fujinaga, T Matsumura, Y Fukumoto, R Kato, Y Kawai, G Hiasa, Y Kazatani, M Mori, A Ogimoto, M Inoko, M Oguri, M Kinoshita, K Okuhara, N Watanabe, Y Ono, K Otomo, Y Sato, T Matsunaga, A Takaishi, N Miyagi, H Uehara, H Takaishi, H Urata, T Kataoka, H Matsubara, T Matsumoto, T Suzuki, N Takahashi, M Imamaki, T Yoshitama, T Saito, H Sekino, Y Furutani, M Koda, T Shinozaki, K Hirabayashi, R Tsunoda, K Yonezawa, H Hori, M Yagi, M Arikawa, T Hashizume, R Ishiki, T Koizumi, K Nakayama, S Taguchi, M Nanasato, Y Yoshida, S Tsujiyama, T Nakamura, K Oku, M Shimizu, M Suwa, Y Momiyama, H Sugiyama, K Kobayashi, S Inoue, T Kadokami, K Maeno, K Kawamitsu, Y Maruyama, A Nakata, T Shibata, A Wada, H-J Cho, JO Na, B-S Yoo, J-O Choi, SK Hong, J-H Shin, M-C Cho, SH Han, J-O Jeong, J-J Kim, SM Kang, D-S Kim, MH Kim, G Llamas Esperon, J Illescas Díaz, P Fajardo Campos, J Almeida Alvarado, A Bazzoni Ruiz, J Echeverri Rico, I Lopez Alcocer, L Valle Molina, C Hernandez Herrera, C Calvo Vargas, FG Padilla Padilla, I Rodriguez Briones, EJJR Chuquiure Valenzuela, ME Aguilera Real, J Carrillo Calvillo, M Alpizar Salazar, JL Cervantes Escárcega, R Velasco Sanchez, N Al - Windy, L van Heerebeek, L Bellersen, H-P Brunner-La Rocca, J Post, GCM Linssen, M van de Wetering, R Peters, R van Stralen, R Groutars, P Smits, A Yilmaz, WEM Kok, P Van der Meer, P Dijkmans, R Troquay, AP van Alem, R Van de Wal, L Handoko, ICD Westendorp, PFMM van Bergen, BJWM Rensing, P Hoogslag, B Kietselaer, JA Kragten, FR den Hartog, A Alings, L Danilowicz-Szymanowicz, G Raczak, W Piesiewicz, W Zmuda, W Kus, P Podolec, W Musial, G Drelich, G Kania, P Miekus, S Mazur, A Janik, J Spyra, J Peruga, P Balsam, B Krakowiak, J Szachniewicz, M Ginel, J Grzybowski, W Chrustowski, P Wojewoda, A Kalinka, A Zurakowski, R Koc, M Debinski, W Fil, M Kujawiak, J Forys, M Kasprzak, M Krol, P Michalski, E Mirek-Bryniarska, K Radwan, G Skonieczny, K Stania, G Skoczylas, A Madej, J Jurowiecki, B Firek, B Wozakowska-Kaplon, K Cymerman, J Neutel, K Adams, P Balfour, A Deswal, A Djamson, P Duncan, M Hong, C Murray, D Rinde-Hoffman, S Woodhouse, R MacNevin, B Rama, C Broome-Webster, S Kindsvater, D Abramov, M Barettella, S Pinney, J Herre, A Cohen, K Vora, K Challappa, S West, S Baum, J Cox, S Jani, A Karim, A Akhtar, O Quintana, L Paukman, R Goldberg, Z Bhatti, M Budoff, E Bush, A Potler, R Delgado, B Ellis, J Dy, J Fialkow, R Sangrigoli, K Ferdinand, C East, S Falkowski, S Donahoe, R Ebrahimi, G Kline, B Harris, R Khouzam, N Jaffrani, N Jarmukli, N Kazemi, M Koren, K Friedman, W Herzog, J Silva Enciso, D Cheung, M Grover-McKay, P Hauptman, D Mikhalkova, V Hegde, J Hodsden, S Khouri, F McGrew, R Littlefield, P Bradley, B McLaurin, S Lupovitch, I Labin, V Rao, M Leithe, M Lesko, N Lewis, D Lombardo, S Mahal, V Malhotra, I Dauber, A Banerjee, J Needell, G Miller, L Paladino, K Munuswamy, M Nanna, E McMillan, M Mumma, M Napoli, W Nelson, T O'Brien, A Adlakha, A Onwuanyi, H Serota, J Schmedtje, A Paraschos, R Potu, C Sai-Sudhakar, M Saltzberg, A Sauer, P Shah, H Skopicki, H Bui, K Carr, G Stevens, N Tahirkheli, J Tallaj, K Yousuf, B Trichon, J Welker, P Tolerico, A Vest, R Vivo, X Wang, R Abadier, S Dunlap, N Weintraub, A Malik, P Kotha, V Zaha, G Kim, N Uriel, T Greene, A Salacata, R Arora, R Gazmuri, J Kobayashi, B Iteld, R Vijayakrishnan, R Dab, Z Mirza, V Marques, M Nallasivan, D Bensimhon, B Peart, H Saint-Jacques, K Barringhaus, J Contreras, A Gupta, S Koneru, V Nguyen, Verma, S, Dhingra, N, Butler, J, Anker, S, Ferreira, J, Filippatos, G, Januzzi, J, Lam, C, Sattar, N, Peil, B, Nordaby, M, Brueckmann, M, Pocock, S, Zannad, F, Packer, M, George, J, Jamal, W, Welty, F, Palmer, M, Clayton, T, Parhofer, K, Pedersen, T, Greenberg, B, Konstam, M, Lees, K, Carson, P, Doehner, W, Miller, A, Haas, M, Pehrson, S, Komajda, M, Anand, I, Teerlink, J, Rabinstein, A, Steiner, T, Kamel, H, Tsivgoulis, G, Lewis, J, Freston, J, Kaplowitz, N, Mann, J, Petrie, J, Perrone, S, Nicholls, S, Janssens, S, Bocchi, E, Giannetti, N, Zhang, J, Spinar, J, Seronde, M, Boehm, M, Merkely, B, Chopra, V, Senni, M, Taddi, S, Tsutsui, H, Choi, D, Chuquiure, E, La Rocca, H, Ponikowski, P, Juanatey, J, Squire, I, Pina, I, Bernstein, R, Cheung, A, Green, J, Kaul, S, Lip, G, Marx, N, Mccullough, P, Mehta, C, Rosenstock, J, Scirica, B, Shah, S, Wanner, C, Aizenberg, D, Cartasegna, L, Colombo Berra, F, Colombo, H, Fernandez Moutin, M, Glenny, J, Alvarez Lorio, C, Anauch, D, Campos, R, Facta, A, Fernandez, A, Ahuad Guerrero, R, Lobo Marquez, L, Leon de la Fuente, R, Mansilla, M, Hominal, M, Hasbani, E, Najenson, M, Moises Azize, G, Luquez, H, Guzman, L, Sessa, H, Amuchastegui, M, Salomone, O, Perna, E, Piskorz, D, Sicer, M, Perez de Arenaza, D, Zaidman, C, Nani, S, Poy, C, Resk, J, Villarreal, R, Majul, C, Smith Casabella, T, Sassone, S, Liberman, A, Carnero, G, Caccavo, A, Berli, M, Budassi, N, Bono, J, Alvarisqueta, A, Amerena, J, Kostner, K, Hamilton, A, Begg, A, Beltrame, J, Colquhoun, D, Gordon, G, Sverdlov, A, Vaddadi, G, Wong, J, Coller, J, Prior, D, Friart, A, Leone, A, Vervoort, G, Timmermans, P, Troisfontaines, P, Franssen, C, Sarens, T, Vandekerckhove, H, Van De Borne, P, Chenot, F, De Sutter, J, De Vuyst, E, Debonnaire, P, Dupont, M, Pereira Dutra, O, Canani, L, Vieira Moreira, M, de Souza, W, Backes, L, Maia, L, De Souza Paolino, B, Manenti, E, Saporito, W, Villaca Guimaraes Filho, F, Franco Hirakawa, T, Saliba, L, Neuenschwander, F, de Freitas Zerbini, C, Goncalves, G, Goncalves Mello, Y, Ascencao de Souza, J, Beck da Silva Neto, L, Da Silveira, J, de Moura Xavier Moraes Junior, J, de Souza Neto, J, Hernandes, M, Finimundi, H, Sampaio, C, Vasconcellos, E, Neves Mancuso, F, Noya Rabelo, M, Rodrigues Bacci, M, Santos, F, Vidotti, M, Simoes, M, Gomes, F, Vieira Nascimento, C, Precoma, D, Helfenstein Fonseca, F, Ribas Fortes, J, Leaes, P, Campos de Albuquerque, D, Kerr Saraiva, J, Rassi, S, Alves da Costa, F, Reis, G, Zieroth, S, Dion, D, Savard, D, Bourgeois, R, Constance, C, Anderson, K, Leblanc, M, Yung, D, Swiggum, E, Pliamm, L, Pesant, Y, Tyrrell, B, Huynh, T, Spiegelman, J, Lavoie, J, Hartleib, M, Bhargava, R, Straatman, L, Virani, S, Costa-Vitali, A, Hill, L, Heffernan, M, Khaykin, Y, Ricci, J, Senaratne, M, Zhai, A, Lubelsky, B, Toma, M, Yao, L, Mckelvie, R, Noronha, L, Babapulle, M, Pandey, A, Curnew, G, Lavoie, A, Berlingieri, J, Kouz, S, Lonn, E, Chehayeb, R, Zheng, Y, Sun, Y, Cui, H, Fan, Z, Han, X, Jiang, X, Tang, Q, Zhou, J, Zheng, Z, Zhang, X, Zhang, N, Zhang, Y, Shen, A, Yu, J, Ye, J, Yao, Y, Yan, J, Xu, X, Wang, Z, Ma, J, Li, Y, Li, S, Lu, S, Kong, X, Song, Y, Yang, G, Yao, Z, Pan, Y, Guo, X, Sun, Z, Dong, Y, Zhu, J, Peng, D, Yuan, Z, Lin, J, Yin, Y, Jerabek, O, Burianova, H, Fiala, T, Hubac, J, Ludka, O, Monhart, Z, Vodnansky, P, Zeman, K, Foldyna, D, Krupicka, J, Podpera, I, Busak, L, Radvan, M, Vomacka, Z, Prosecky, R, Cifkova, R, Durdil, V, Vesely, J, Vaclavik, J, Cervinka, P, Linhart, A, Brabec, T, Miklik, R, Bourhaial, H, Olbrich, H, Genth-Zotz, S, Kemala, E, Lemke, B, Bohm, M, Schellong, S, Rieker, W, Heitzer, T, Ince, H, Faghih, M, Birkenfeld, A, Begemann, A, Ghanem, A, Ujeyl, A, von Haehling, S, Dorsel, T, Bauersachs, J, Prull, M, Weidemann, F, Darius, H, Nickenig, G, Wilke, A, Sauter, J, Rauch-Kroehnert, U, Frey, N, Schulze, C, Konig, W, Maier, L, Menzel, F, Proskynitopoulos, N, Ebert, H, Sarnighausen, H, Dungen, H, Licka, M, Stellbrink, C, Winkelmann, B, Menck, N, Lopez-Sendon, J, de la Fuente Galan, L, Delgado Jimenez, J, Manito Lorite, N, Perez de Juan Romero, M, Galve Basilio, E, Cereto Castro, F, Gonzalez Juanatey, J, Gomez, J, Sanmartin Fernandez, M, Garcia-Moll Marimon, X, Pascual Figal, D, Bover Freire, R, Bonnefoy Cudraz, E, Jobbe Duval, A, Tomasevic, D, Habib, G, Isnard, R, Picard, F, Khanoyan, P, Dubois-Rande, J, Galinier, M, Roubille, F, Alexandre, J, Babuty, D, Delarche, N, Berneau, J, Girerd, N, Saxena, M, Rosano, G, Yousef, Z, Clifford, C, Arden, C, Bakhai, A, Boos, C, Jenkins, G, Travill, C, Price, D, Koenyves, L, Lakatos, F, Matoltsy, A, Noori, E, Zilahi, Z, Andrassy, P, Kancz, S, Simon, G, Sydo, T, Vorobcsuk, A, Kiss, R, Toth, K, Szakal, I, Nagy, L, Barany, T, Nagy, A, Szolnoki, E, Mandal, S, Rastogi, V, Shah, B, Mullasari, A, Shankar, J, Mehta, V, Oomman, A, Kaul, U, Komarlu, S, Kahali, D, Bhagwat, A, Vijan, V, Ghaisas, N, Mehta, A, Kashyap, J, Kothari, Y, Taddei, S, Scherillo, M, Zaca, V, Genovese, S, Salvioni, A, Fucili, A, Fedele, F, Cosmi, F, Volpe, M, Mazzone, C, Esposito, G, Doi, M, Yamamoto, H, Sakagami, S, Oishi, S, Yasaka, Y, Tsuboi, H, Fujino, Y, Matsuoka, S, Watanabe, Y, Himi, T, Ide, T, Ichikawa, M, Kijima, Y, Koga, T, Yuda, S, Fukui, K, Kubota, T, Manita, M, Fujinaga, H, Matsumura, T, Fukumoto, Y, Kato, R, Kawai, Y, Hiasa, G, Kazatani, Y, Mori, M, Ogimoto, A, Inoko, M, Oguri, M, Kinoshita, M, Okuhara, K, Watanabe, N, Ono, Y, Otomo, K, Sato, Y, Matsunaga, T, Takaishi, A, Miyagi, N, Uehara, H, Takaishi, H, Urata, H, Kataoka, T, Matsubara, H, Matsumoto, T, Suzuki, T, Takahashi, N, Imamaki, M, Yoshitama, T, Saito, T, Sekino, H, Furutani, Y, Koda, M, Shinozaki, T, Hirabayashi, K, Tsunoda, R, Yonezawa, K, Hori, H, Yagi, M, Arikawa, M, Hashizume, T, Ishiki, R, Koizumi, T, Nakayama, K, Taguchi, S, Nanasato, M, Yoshida, Y, Tsujiyama, S, Nakamura, T, Oku, K, Shimizu, M, Suwa, M, Momiyama, Y, Sugiyama, H, Kobayashi, K, Inoue, S, Kadokami, T, Maeno, K, Kawamitsu, K, Maruyama, Y, Nakata, A, Shibata, T, Wada, A, Cho, H, Na, J, Yoo, B, Choi, J, Hong, S, Shin, J, Cho, M, Han, S, Jeong, J, Kim, J, Kang, S, Kim, D, Kim, M, Llamas Esperon, G, Illescas Diaz, J, Fajardo Campos, P, Almeida Alvarado, J, Bazzoni Ruiz, A, Echeverri Rico, J, Lopez Alcocer, I, Valle Molina, L, Hernandez Herrera, C, Calvo Vargas, C, Padilla Padilla, F, Rodriguez Briones, I, Chuquiure Valenzuela, E, Aguilera Real, M, Carrillo Calvillo, J, Alpizar Salazar, M, Cervantes Escarcega, J, Velasco Sanchez, R, Al - Windy, N, van Heerebeek, L, Bellersen, L, Brunner-La Rocca, H, Post, J, Linssen, G, van de Wetering, M, Peters, R, van Stralen, R, Groutars, R, Smits, P, Yilmaz, A, Kok, W, Van der Meer, P, Dijkmans, P, Troquay, R, van Alem, A, Van de Wal, R, Handoko, L, Westendorp, I, van Bergen, P, Rensing, B, Hoogslag, P, Kietselaer, B, Kragten, J, den Hartog, F, Alings, A, Danilowicz-Szymanowicz, L, Raczak, G, Piesiewicz, W, Zmuda, W, Kus, W, Podolec, P, Musial, W, Drelich, G, Kania, G, Miekus, P, Mazur, S, Janik, A, Spyra, J, Peruga, J, Balsam, P, Krakowiak, B, Szachniewicz, J, Ginel, M, Grzybowski, J, Chrustowski, W, Wojewoda, P, Kalinka, A, Zurakowski, A, Koc, R, Debinski, M, Fil, W, Kujawiak, M, Forys, J, Kasprzak, M, Krol, M, Michalski, P, Mirek-Bryniarska, E, Radwan, K, Skonieczny, G, Stania, K, Skoczylas, G, Madej, A, Jurowiecki, J, Firek, B, Wozakowska-Kaplon, B, Cymerman, K, Neutel, J, Adams, K, Balfour, P, Deswal, A, Djamson, A, Duncan, P, Hong, M, Murray, C, Rinde-Hoffman, D, Woodhouse, S, Macnevin, R, Rama, B, Broome-Webster, C, Kindsvater, S, Abramov, D, Barettella, M, Pinney, S, Herre, J, Cohen, A, Vora, K, Challappa, K, West, S, Baum, S, Cox, J, Jani, S, Karim, A, Akhtar, A, Quintana, O, Paukman, L, Goldberg, R, Bhatti, Z, Budoff, M, Bush, E, Potler, A, Delgado, R, Ellis, B, Dy, J, Fialkow, J, Sangrigoli, R, Ferdinand, K, East, C, Falkowski, S, Donahoe, S, Ebrahimi, R, Kline, G, Harris, B, Khouzam, R, Jaffrani, N, Jarmukli, N, Kazemi, N, Koren, M, Friedman, K, Herzog, W, Silva Enciso, J, Cheung, D, Grover-McKay, M, Hauptman, P, Mikhalkova, D, Hegde, V, Hodsden, J, Khouri, S, Mcgrew, F, Littlefield, R, Bradley, P, Mclaurin, B, Lupovitch, S, Labin, I, Rao, V, Leithe, M, Lesko, M, Lewis, N, Lombardo, D, Mahal, S, Malhotra, V, Dauber, I, Banerjee, A, Needell, J, Miller, G, Paladino, L, Munuswamy, K, Nanna, M, Mcmillan, E, Mumma, M, Napoli, M, Nelson, W, O'Brien, T, Adlakha, A, Onwuanyi, A, Serota, H, Schmedtje, J, Paraschos, A, Potu, R, Sai-Sudhakar, C, Saltzberg, M, Sauer, A, Shah, P, Skopicki, H, Bui, H, Carr, K, Stevens, G, Tahirkheli, N, Tallaj, J, Yousuf, K, Trichon, B, Welker, J, Tolerico, P, Vest, A, Vivo, R, Wang, X, Abadier, R, Dunlap, S, Weintraub, N, Malik, A, Kotha, P, Zaha, V, Kim, G, Uriel, N, Greene, T, Salacata, A, Arora, R, Gazmuri, R, Kobayashi, J, Iteld, B, Vijayakrishnan, R, Dab, R, Mirza, Z, Marques, V, Nallasivan, M, Bensimhon, D, Peart, B, Saint-Jacques, H, Barringhaus, K, Contreras, J, Gupta, A, Koneru, S, Nguyen, V, Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), and Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)
Subjects: Male, medicine.medical_specialty, Angiotensin receptor, Glucoside, Endocrinology, Diabetes and Metabolism, [SDV]Life Sciences [q-bio], Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], Adrenergic beta-Antagonists, Angiotensin-Converting Enzyme Inhibitors, 030204 cardiovascular system & hematology, Placebo, 03 medical and health sciences, Angiotensin Receptor Antagonists, 0302 clinical medicine, Endocrinology, Mineralocorticoid receptor, Glucosides, Double-Blind Method, Internal medicine, Post-hoc analysis, Internal Medicine, medicine, Empagliflozin, Humans, 030212 general & internal medicine, Benzhydryl Compounds, ComputingMilieux_MISCELLANEOUS, Aged, Benzhydryl Compound, Heart Failure, Ejection fraction, business.industry, Angiotensin Receptor Antagonist, Adrenergic beta-Antagonist, Angiotensin-Converting Enzyme Inhibitor, Stroke Volume, medicine.disease, 3. Good health, Heart failure, ACE inhibitor, Female, Hypotension, business, medicine.drug, Human
Abstract: Contains fulltext : 249977.pdf (Publisher’s version ) (Closed access) BACKGROUND: It is important to evaluate whether a new treatment for heart failure with reduced ejection fraction (HFrEF) provides additive benefit to background foundational treatments. As such, we aimed to evaluate the efficacy and safety of empagliflozin in patients with HFrEF in addition to baseline treatment with specific doses and combinations of disease-modifying therapies. METHODS: We performed a post-hoc analysis of the EMPEROR-Reduced randomised, double-blind, parallel-group trial, which took place in 520 centres (hospitals and medical clinics) in 20 countries in Asia, Australia, Europe, North America, and South America. Patients with New York Heart Association (NYHA) classification II-IV with an ejection fraction of 40% or less were randomly assigned (1:1) to receive the addition of either oral empagliflozin 10 mg per day or placebo to background therapy. The primary composite outcome was cardiovascular death and heart failure hospitalisation; the secondary outcome was total heart failure hospital admissions. An extended composite outcome consisted of inpatient and outpatient HFrEF events was also evaluated. Outcomes were analysed according to background use of angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs) or angiotensin receptor neprilysin inhibitors (ARNIs), as well as β blockers and mineralocorticoid receptor antagonists (MRAs) at less than 50% or 50% or more of target doses and in various combinations. This study is registered with ClinicalTrials.gov, NCT03057977. FINDINGS: In this post-hoc analysis of 3730 patients (mean age 66·8 years [SD 11·0], 893 [23·9%] women; 1863 [49·9%] in the empagliflozin group, 1867 [50·1%] in the placebo group) assessed between March 6, 2017, and May 28, 2020, empagliflozin reduced the risk of the primary outcome (361 in 1863 participants in the empagliflozin group and 462 of 1867 in the placebo group; HR 0·75 [95% CI 0·65-0·86]) regardless of background therapy or its target doses for ACE inhibitors or ARBs at doses of less than 50% of the target dose (HR 0·85 [0·69-1·06]) and for doses of 50% or more of the target dose (HR 0·67 [0·52-0·88]; p(interaction)=0·18). A similar result was seen for β blockers at doses of less than 50% of the target dose (HR 0·66 [0·54-0·80]) and for doses of 50% or more of the target dose (HR 0·81 [0·66-1·00]; p(interaction)=0·15). Empagliflozin also reduced the risk of the primary outcome irrespective of background use of triple therapy with an ACE inhibitor, ARB, or ARNI plus β blocker plus MRA (given combination HR 0·73 [0·61-0·88]; not given combination HR 0·76 [0·62-0·94]; p(interaction)=0·77). Similar patterns of benefit were observed for the secondary and extended composite outcomes. Empagliflozin was well tolerated and rates of hypotension, symptomatic hypotension, and hyperkalaemia were similar across all subgroups. INTERPRETATION: Empagliflozin reduced serious heart failure outcomes across doses and combinations of disease-modifying therapies for HFrEF. Clinically, these data suggest that empagliflozin might be considered as a foundational therapy in patients with HFrEF regardless of their existing background therapy. FUNDING: Boehringer Ingelheim and Eli Lilly and Company.
Published: 2022
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5. Extrapolating Long-term Event-Free and Overall Survival With Dapagliflozin in Patients With Heart Failure and Reduced Ejection Fraction: An Exploratory Analysis of a Phase 3 Randomized Clinical Trial

Author: M Nishino, T Shinozaki, J Lash, N Takahashi, H Kokane, Béla Merkely, F Guimaraes, T Arakawa, C Zaidman, V Bugan, A Arouni, D Precoma, L Ermoshkina, A Pandey, D Kucera, I Efremov, L Younis, H Nagashima, C Chiang, M Ogunniyi, R Nilk, D Wang, T Haddad, M Zacharias, R Nischik, S Leslie, Mikhail Kosiborod, J Castriz, K Saito, I Weigmann, A Schabauer, A Kiyosue, M Hernandes, Charlotta Ljungman, Subodh Verma, Marc S. Sabatine, Y Khaykin, C Ince, S Iskander, Mark C. Petrie, G Drelich, R Lee, J Slaby, A Nikfarjam, M Kanwar, R Smik, Y Onishi, M Gadkari, M Suzuki, A Viera, S Matsuoka, F Poór, K Egstrup, M Bennett, Y Gu, L Maia, T Lewis, D Sinha, Jonathan G. Howlett, Andrej Dukát, J Shih, L Wu, O Montaña, D Peng, V Mehta, S Higashiue, S Rassi, Junbo Ge, S Mansour, H Nguyen, J Dong, E O’Meara, S Joseph, G Cursack, L Køber, G Reis, A Naik, M Schou, R Ahuad Guerrero, V Kostenko, Silvio E. Inzucchi, Scott D. Solomon, R Robles De Medina, E Vishneva, Y Didenko, D García Brasca, A Sosa Liprandi, M Bernstein, A Hedman, K Kuwahara, A Hirohata, Y Li, Michael Böhm, D Karageorgiev, B Al-Joundi, Jan Belohlavek, P Hajek, E Noori, J Spinar, S Sinha, M Milanova, B Groenemeijer, T Hashimoto, M Najenson, M Higuchi, C Brown, V Macek, S Mahal, B Merkely, K Lindmark, F Nasser-Sharif, N Botushanov, A Costard-Jäckle, S Hiroi, D Raev, L Lin, S Suzuki, N Toursarkissian, Rudolf A. de Boer, J Hove, W Huang, O Akinboboye, T Kadokami, Y Ivanova, N Koziolova, L Kantaros, L Pawłowicz, R Kuchar, K Chang, G Hamroff, C Staniloae, K Appel, L Spinarova, N Runev, J Lampart, N Jaffrani, Dapa-Hf Investigators, S Emani, L Antalik, Y Okumura, A Pereira, K Fujii, Y Hisamatsu, N Iliev, M Sandhu, S Vizel, M Pursley, Y Momiyama, A Ezhov, R Sawant, Z Zheng, M Hominal, S Mehta, B Han, K Shah, R Ściborski, J Saraiva, R Kawamura, R Witek, A Wada, C Majul, U Stephan, L Fu, David L. DeMets, M Tokmakova, D Martinez, L Jamriskova, Tzvetana Katova, E Schmidt, X Li, Eileen O'Meara, O Mayer, W Tseng, K Fujimoto, L Bellersen, C Wu, A Japp, J Sala, Mirta Diez, F Arantes, Kieran F. Docherty, Anna Maria Langkilde, R Cheng, H Chang, M Böhm, J Londono, J Walsh, Chern-En Chiang, R Mariankowski, A Mihov, Colin J. Petrie, M Mahapekar, Y Noguchi, Y Yasaka, Robert S. McKelvie, J Albisu, D Gupta, K Seki, Pardeep S. Jhund, C Király, A Al-Zoebi, H Ueno, I Malek, M Jardula, A Kazakov, I Lieber, F Franchi, D Avino, S Pereiro Gonzalez, P Wakefield, P Pimentel, T Kasai, E Fruehling, Olof Bengtsson, P Kopylov, S Uchikawa, X Guo, J Borges, S Tereschenko, F Azzari, J Selecky, S Sassone, J Vyselaar, S Lederman, J Howlett, Committees, E Vasconcellos, J Kostis, A Czigány, G Masszi, J Izzo, Z Járai, F Neuenschwander, L Tomasova, Mikaela Sjöstrand, C De Nooijer, Felipe Martinez, H Tsutsui, I Uchida, J Patel, A Arif, W Takahashi, M Nassif, K Moritani, M Mohri, J Shilko, Tereshchenko Sn, B Paolino, Z Wang, S Tanaka, João Pedro Ferreira, Y Takagi, H Jiang, A Maltcev, Piotr Ponikowski, V Bhargava, N Komiyama, W Dong, S Verma, S Weiss, L Busak, R Sotolongo, B Foley, C Hsia, John J.V. McMurray, T Mooe, R Gardner, N Cluigt, H Swart, N Spasova, Clare Murphy, K Harada, S Srivastava, P Olexa, B Bertolet, P Andrássy, M Petrie, Inder S. Anand, L Levinson, D Rupka, N Fujimoto, S Aksentiev, Y Hata, L Krylova, N Dzhaiani, R Korzeniak, T.Z. Maung, G Hickey, F Colombo Berra, X Zhang, Q Zhao, B Chompalova, D Avramov, M Asakura, A Hershson, G Mercau, N Takeyasu, J Menon, D Pevzner, T Nunohiro, T Katova, F Syed, W French, P Rossi, C Constance, Z Paltsman, K Tsukahara, A Gogov, M Liu, K Ilieva, I Majercak, Y Zhou, Vijay K. Chopra, T Anzai, F Mody, P Jhund, V Kothiwale, M Hartleib, S Zoet Nugteren, Z Li, J Drożdż, E Krcova, Lars Køber, A Galyavich, A Dincheva, R García Durán, D Hotchkiss, V Chopra, R Manshadi, T Greene, J Taborda, A Fernandez, E Lo, Pham Nguyen Vinh, G Gislason, K Sumii, G Lewis, L Nagy, S Genth-Zotz, J Liu, A Clark, P Leaes, A Wilke, Y Hayashi, J Belohlavek, Y Liang, S Szynal, M Van Hessen, T Kakuta, T Dalcoquio, J Skopek, S Karna, Q Tang, R Vijayaraghavan, K Fukui, X Lin, J Teel, S Nani, P Liu, D Vinanska, C Ljungman, Morten Schou, P Fulop, Y Katayama, D Song, L Yao, A Kimura, M Babapulle, D Kollarova, D Ho, E Fairman, S Deleon, V Pham, C Lindholm, T Kuramochi, S Boldueva, T Cimato, Y Ueda, T Shibasaki, H Takase, S Inoue, E MirekBryniarska, J Huang, D Aizenberg, R Chehayeb, J Van Eck, Y Pesant, Brian Claggett, H Do, I Hsieh, B Mikłaszewicz, R De Boer, Y Tomobuchi, J Carda, P Fong, N Kazemi, E Manenti, Y Komura, D Singal, Jarosław Drożdż, J Cha, T Nguyen, M Berk, E Hattori, B Kolomanov, Á Motyovszki, P Miękus, V Florea, T Lin, H Meno, G Simonis, L Videbæk, Y Dong, P Poirier, C Venugopal, D Tschöpe, M Deshpande, M Kellerer, L Chandra, K Ramanathan, C Lang, D Phaneuf, S Vladeva, H Kamiya, J Javier, Masahumi Kitakaze, M Talavera, Jose C. Nicolau, J Prokopczuk, B Truong, E Perna, W Sudnik, A Paraschos, H Sugino, S Banerjee, Akshay S. Desai, A Chernyavsky, H Luquez, P Nierop, P Udgire, G Caruso, M Slovenska, and H Iseki
Subjects: Male, medicine.medical_specialty, Time Factors, medicine.medical_treatment, Placebo, Global Health, Ventricular Function, Left, law.invention, chemistry.chemical_compound, Randomized controlled trial, Double-Blind Method, Glucosides, law, Internal medicine, Cause of Death, medicine, Humans, Prospective Studies, Dapagliflozin, Benzhydryl Compounds, Sodium-Glucose Transporter 2 Inhibitors, Original Investigation, Aged, Heart Failure, Ejection fraction, Dose-Response Relationship, Drug, business.industry, Stroke Volume, Middle Aged, medicine.disease, New York Heart Association Functional Classification, Clinical trial, Survival Rate, chemistry, Intravenous therapy, Heart failure, Female, Cardiology and Cardiovascular Medicine, business, Follow-Up Studies
Abstract: Importance: Sodium glucose cotransporter 2 inhibitors reduce morbidity and mortality in patients with heart failure and reduced ejection fraction (HFrEF). Clinicians may find estimates of the projected long-term benefits of sodium glucose cotransporter 2 inhibitors a helpful addition to clinical trial results when communicating the benefits of this class of drug to patients. Objective: To estimate the projected long-term treatment effects of dapagliflozin in patients with HFrEF over the duration of a patient’s lifetime. Design, Setting, and Participants: Exploratory analysis was performed of Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure (DAPA-HF), a phase 3 randomized, placebo-controlled clinical trial conducted at 410 sites in 20 countries. Patients with an ejection fraction less than or equal to 40% in New York Heart Association functional classification II to IV and elevated plasma levels of N-terminal pro B-type natriuretic peptide were enrolled between February 15, 2017, and August 17, 2018, with final follow-up on June 6, 2019. Mean (SD) duration of follow-up was 17.6 (5.2) months. Interventions: Dapagliflozin, 10 mg, once daily vs placebo in addition to standard therapy. Main Outcomes and Measures: The primary composite outcome was time to first hospitalization for heart failure, urgent heart failure visit requiring intravenous therapy, or cardiovascular death. The trial results were extrapolated to estimate the projected long-term treatment effects of dapagliflozin over the duration of a patient’s lifetime for the primary outcome and the secondary outcome of death from any cause. Results: A total of 4744 patients (1109 women [23.4%]; 3635 men [76.6%]) were randomized in DAPA-HF, with a mean (SD) age of 66.3 (10.9) years. The extrapolated mean event-free survival for an individual aged 65 years from a primary composite end point event was 6.2 years for placebo and 8.3 years for dapagliflozin, representing an event-free survival time gain of 2.1 years (95% CI, 0.8-3.3 years; P = .002). When considering death from any cause, mean extrapolated life expectancy for an individual aged 65 years was 9.1 years for placebo and 10.8 years for dapagliflozin, with a gain in survival of 1.7 years (95% CI, 0.1-3.3; P = .03) with dapagliflozin. Similar results were seen when extrapolated across the age range studied. In analyses of subgroups of patients in DAPA-HF, consistent benefits were seen with dapagliflozin on both event-free and overall survival. Conclusions and Relevance: These findings indicate that dapagliflozin provides clinically meaningful gains in extrapolated event-free and overall survival. These findings may be helpful in communicating the benefits of this treatment to patients with HFrEF. Trial registration: ClinicalTrials.gov Identifier: NCT03036124.
Published: 2021

6. Effects of Chronic Heart Failure Unconventional Therapies on Endothelial Function

Author: Ilaria Bassi, Cristina Giannattasio, Marisa Varrenti, J. Zanoni, Francesco Pansera, S. Castelnuovo, G. Masciocco, Lucia Occhi, Enrico Piccinelli, E. Perna, Maria Frigerio, Alessandro Maloberti, Manlio Cipriani, P. Vallerio, Giannattasio, C, Maloberti, A, Piccinelli, E, Zanoni, J, Castelnuovo, S, Vallerio, P, Bassi, I, Pansera, F, Occhi, L, Varrenti, M, Masciocco, G, Perna, E, Cipriani, M, Frigerio, M, Zannoni, J, and Pansera, G
Subjects: Heart transplantation, medicine.medical_specialty, Physiology, business.industry, medicine.medical_treatment, chronic heart failure, unconventional therapies, endothelial function, medicine.disease, Peripheral, Chronic Heart Failure Unconventional Therapies, Endothelial Function, Ventricular assist device, Internal medicine, Heart failure, cardiovascular system, Internal Medicine, medicine, Cardiology, cardiovascular diseases, Endothelial dysfunction, Cardiology and Cardiovascular Medicine, business
Abstract: Introduction: Endothelial dysfunction (ED) of peripheral arteries in chronic heart failure (CHF) subjects has been demonstrated. We assessed endothelial function in subjects undergoing unconventional treatments for CHF, namely heart transplantation (HTX), continuous-flow left ventricular assist device implantation (LVAD), and repeated levosimendan infusions (r-LEVO). Methods: Twenty HTX recipients (median time from HTX 21 months), 20 patients supported with LVAD (median time from implant 39 months), and 20 patients receiving monthly Levosimendan infusions (median time on treatment 28 months) were enrolled and compared to a group of 20 healthy subjects. ED was evaluated with ultrasound assessment of the diameter before and after ischemic stress at the brachial artery level. The difference between the two diameters normalized for the baseline value (flow mediated dilation–FMD) has been used for the analysis. All the patients were stable at the time of FMD assessment, with those on r-LEVO being evaluated prior to infusion. Results: FMD was significantly lower in HTX and LVAD groups with respect to controls (9.8 ± 7.4, 9.3 ± 5.7, and 15.6 ± 6.4% respectively, p = 0.01), but not in r-LEVO group (12.5 ± 6.9%). When patients were analysed according to time from the operation or on treatment, (
Published: 2019

7. Effects of Chronic Heart Failure Unconventional Therapies on Endothelial Function

Author: Giannattasio, C, Maloberti, A, Piccinelli, E, Zanoni, J, Castelnuovo, S, Vallerio, P, Bassi, I, Pansera, F, Occhi, L, Varrenti, M, Masciocco, G, Perna, E, Cipriani, M, Frigerio, M, C. Giannattasio, A. Maloberti, E. Piccinelli, J. Zanoni, S. Castelnuovo, P. Vallerio, I. Bassi, F. Pansera, L. Occhi, M. Varrenti, G. Masciocco, E. Perna, M. Cipriani, M. Frigerio, Giannattasio, C, Maloberti, A, Piccinelli, E, Zanoni, J, Castelnuovo, S, Vallerio, P, Bassi, I, Pansera, F, Occhi, L, Varrenti, M, Masciocco, G, Perna, E, Cipriani, M, Frigerio, M, C. Giannattasio, A. Maloberti, E. Piccinelli, J. Zanoni, S. Castelnuovo, P. Vallerio, I. Bassi, F. Pansera, L. Occhi, M. Varrenti, G. Masciocco, E. Perna, M. Cipriani, and M. Frigerio
Published: 2019

8. Next Generation Molecular Diagnosis of Hereditary Spastic Paraplegias: An Italian Cross-Sectional Study

Author: D'Amore, A. Tessa, A. Casali, C. Dotti, M.T. Filla, A. Silvestri, G. Antenora, A. Astrea, G. Barghigiani, M. Battini, R. Battisti, C. Bruno, I. Cereda, C. Dato, C. Di Iorio, G. Donadio, V. Felicori, M. Fini, N. Fiorillo, C. Gallone, S. Gemignani, F. Gigli, G.L. Graziano, C. Guerrini, R. Gurrieri, F. Kariminejad, A. Lieto, M. Marques LourenḈo, C. Malandrini, A. Mandich, P. Marcotulli, C. Mari, F. Massacesi, L. Melone, M.A.B. Mignarri, A. Milone, R. Musumeci, O. Pegoraro, E. Perna, A. Petrucci, A. Pini, A. Pochiero, F. Pons, M.R. Ricca, I. Rossi, S. Seri, M. Stanzial, F. Tinelli, F. Toscano, A. Valente, M. Federico, A. Rubegni, A. Santorelli, F.M.
Abstract: Hereditary spastic paraplegia (HSP) refers to a group of genetically heterogeneous neurodegenerative motor neuron disorders characterized by progressive age-dependent loss of corticospinal motor tract function, lower limb spasticity, and weakness. Recent clinical use of next generation sequencing (NGS) methodologies suggests that they facilitate the diagnostic approach to HSP, but the power of NGS as a first-tier diagnostic procedure is unclear. The larger-than-expected genetic heterogeneity—there are over 80 potential disease-associated genes—and frequent overlap with other clinical conditions affecting the motor system make a molecular diagnosis in HSP cumbersome and time consuming. In a single-center, cross-sectional study, spanning 4 years, 239 subjects with a clinical diagnosis of HSP underwent molecular screening of a large set of genes, using two different customized NGS panels. The latest version of our targeted sequencing panel (SpastiSure3.0) comprises 118 genes known to be associated with HSP. Using an in-house validated bioinformatics pipeline and several in silico tools to predict mutation pathogenicity, we obtained a positive diagnostic yield of 29% (70/239), whereas variants of unknown significance (VUS) were found in 86 patients (36%), and 83 cases remained unsolved. This study is among the largest screenings of consecutive HSP index cases enrolled in real-life clinical-diagnostic settings. Its results corroborate NGS as a modern, first-step procedure for molecular diagnosis of HSP. It also disclosed a significant number of new mutations in ultra-rare genes, expanding the clinical spectrum, and genetic landscape of HSP, at least in Italy. © Copyright © 2018 D'Amore, Tessa, Casali, Dotti, Filla, Silvestri, Antenora, Astrea, Barghigiani, Battini, Battisti, Bruno, Cereda, Dato, Di Iorio, Donadio, Felicori, Fini, Fiorillo, Gallone, Gemignani, Gigli, Graziano, Guerrini, Gurrieri, Kariminejad, Lieto, Marques LourenḈo, Malandrini, Mandich, Marcotulli, Mari, Massacesi, Melone, Mignarri, Milone, Musumeci, Pegoraro, Perna, Petrucci, Pini, Pochiero, Pons, Ricca, Rossi, Seri, Stanzial, Tinelli, Toscano, Valente, Federico, Rubegni and Santorelli.
Published: 2018

9. Between Scylla and Charybdis: Difficult Balance between Anticoagulation and Bleeding in the Management of LVAD Thrombosis: A Case Report

Author: M.P. Gagliardone, E. Ammirati, Garascia A, M. Frigerio, Filippo Milazzo, Manlio Cipriani, D’Angelo L, E. Perna, Claudio Russo, Macera F, and De Marco F
Subjects: medicine.medical_specialty, Subsequent Relapse, business.industry, medicine.medical_treatment, General Medicine, Tirofiban, medicine.disease, Haemolysis, Thrombosis, Surgery, Ventricular assist device, Antithrombotic, medicine, Thrombus, business, Major bleeding, medicine.drug
Abstract: Case: The patient was a 67 years old male. The patient experienced an episode of LVAD thrombosis. Device replacement was not possible due to high surgical risk. Pharmacological strategy was adopted with intraventricular fibrinolysis+intravenous Tirofiban infusion. Outcome: Despite thrombosis resolution, two episodes of bleeding occurred. Thus we lowered antithrombotic drugs dose with subsequent relapse risk. At the end, a successful therapeutic strategy was achieved. Conclusion: Our case report shows how the balance between anticoagulation and bleeding is a tricky feature of LVAD thrombosis management. When device replacement is not an option, trying to remove the clot soon with aggressive antithrombotic therapy can be a winning strategy and can quickly stop the haemolysis. Unfortunately, it can produce major bleeding events, harmful and potentially life-threatening. To be aware of potential cause of bleeding and looking for the appropriate dosage of antithrombotic drugs can be useful to manage these complications
Published: 2016
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10. Implantation Strategies and Outcomes of Patients Treated with Left Ventricular Assist Devices Awaiting for Heart Transplant in Europe and United States: Data from the TransAtlantic Registry on VAD and Transplant (TRAVIATA)

Author: Cynthia Partida, V. Pretorius, Eric Adler, Claudio Russo, Davor Miličić, E. Ammirati, Yan K. Gernhofer, L. Bogar, E. Perna, Maja Čikeš, M. Frigerio, Manlio Cipriani, Grunde Gjesdal, C M Van De Heyning, B. Quan, Liviu Klein, D. De Bock, M. Kassemos, Nina Jakus, Palak Shah, Michela Brambatti, Oscar Ö. Braun, Jonathan Minto, and Johan Nilsson
Subjects: Pulmonary and Respiratory Medicine, Transplantation, medicine.medical_specialty, business.industry, Emergency medicine, Medicine, Surgery, Cardiology and Cardiovascular Medicine, business
Published: 2018
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11. Which 'Roadmap' in Patients With Advanced or Refractory Heart Failure, Eligible for LVAD and Heart Transplantation?

Author: Andrea Garascia, Manlio Cipriani, A.F. Giglio, Enrico Ammirati, M.P. Gagliardone, Claudio Russo, E. Perna, Marisa Varrenti, Maria Frigerio, L. D'Angelo, Francesca Macera, Letizia Bertoldi, Paolo G. Camici, S. Nonini, and A. Costetti
Subjects: Pulmonary and Respiratory Medicine, Heart transplantation, Transplantation, medicine.medical_specialty, business.industry, medicine.medical_treatment, Internal medicine, medicine, Cardiology, Surgery, In patient, Cardiology and Cardiovascular Medicine, business, Refractory heart failure
Published: 2018
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12. Correction

Author: Cristina Quintavalle, Giuseppina Roscigno, F. De Micco, Chiara Viviani Anselmi, Laura Papa, Amelia Focaccio, Gianluigi Condorelli, Bruno Golia, Gabriella Visconti, E. Perna, Carlo Briguori, Bruno Ricciardelli, and Elvira Donnarumma
Subjects: Neutrophil gelatinase-associated lipocalin, Pathology, medicine.medical_specialty, business.industry, Immunology, Acute kidney injury, Medicine, Cardiology and Cardiovascular Medicine, business, medicine.disease
Published: 2015
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13. Repeated Levosimendan Infusions in Refractory Heart Failure. Single Center Experience

Author: E. Perna, E. Ammirati, F.M. Turazza, M. Cipriani, L. D’Angelo, G. Foti, A. Garascia, F. Macera, G. Masciocco, and M. Frigerio. A.
Subjects: Pulmonary and Respiratory Medicine, Transplantation, business.industry, Anesthesia, Medicine, Surgery, Levosimendan, Cardiology and Cardiovascular Medicine, business, Single Center, Refractory heart failure, medicine.drug
Published: 2016
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14. Blood letting therapy in HCV-related iron overload - Part 2: Evaluation of HFE genetic mutation, HCV genotype and viral load

Author: M. D'Onofrio, L. Paesano, C. Viola, E. D'Agostino, E. Perna, M. Piazza, S. Formisano, GENTILE, Ivan, BORGIA, GUGLIELMO, M., D'Onofrio, L., Paesano, Gentile, Ivan, C., Viola, E., D'Agostino, E., Perna, M., Piazza, Borgia, Guglielmo, and S., Formisano
Published: 2007

15. Blood letting therapy in HCV-related iron overload - Part 1: Evaluation of clinical, hematological and hepatic parameters

Author: L. Paesano, M. D'Onofrio, C. Viola, E. D'Agostino, E. Perna, M. Piazza, S. Formisano, GENTILE, Ivan, BORGIA, GUGLIELMO, L., Paesano, M., D'Onofrio, Gentile, Ivan, C., Viola, E., D'Agostino, E., Perna, M., Piazza, Borgia, Guglielmo, and S., Formisano
Published: 2007

16. Between Scylla and Charybdis: Difficult Balance between Anticoagulation and Bleeding in the Management of LVAD Thrombosis: A Case Report

Author: E, Perna, primary, MG, Cipriani, additional, Marco F, De, additional, F, Macera, additional, and F, Milazzo, additional
Published: 2016
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17. CAD-BASED SURFACE FITTING FROM RANGE DATA

Author: O. D. Isselmou, D. Vandorpe, B. Shariat, and E. Perna
Subjects: Surface (mathematics), business.industry, Applied Mathematics, ComputingMethodologies_IMAGEPROCESSINGANDCOMPUTERVISION, Conformal map, CAD, Computer Science Applications, Set (abstract data type), Range (mathematics), Computer Science::Graphics, Tensor product, Modeling and Simulation, Segmentation, Computer vision, Geometry and Topology, Computer Vision and Pattern Recognition, Artificial intelligence, business, Algorithm, Software, ComputingMethodologies_COMPUTERGRAPHICS, Mathematics, Subdivision
Abstract: In this paper, we present a methodology permitting the conversion of the range data into free-form surface models using patches that are common in current CAD packages, namely rectangular Beziers or NURBS. Our aim is to fit a set of tensor product surface patches globally G1 or G2, of arbitrary topological type, to structured or unorganized range data. In this method the range data is first segmented. Then each subdivision is independently modelled. The three key points of this approach are segmentation, parameterisation of each subdivision (patch) and approximation of the surface model of each patch, and the joining of different calculated patches. To overcome the limitations of classical parameterisation methods, we propose a new and efficient methodology derived from conformal mapping techniques. A surface joining method is also presented. The segmentation is not detailed in this paper.
Published: 1998
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18. Characterization of a CubeSat compatible magnetically levitated thrust balance for electrospray propulsion systems

Author: Chase S. Coffman, Fernando M. Hicks, Louis E. Perna, and Paulo C. Lozano
Subjects: Difficult problem, Power processing unit, Electrospray, Engineering, ComputingMethodologies_SIMULATIONANDMODELING, business.industry, Measure (physics), ComputerApplications_COMPUTERSINOTHERSYSTEMS, Thrust, ComputerSystemsOrganization_PROCESSORARCHITECTURES, Propulsion, Characterization (materials science), CubeSat, Aerospace engineering, business
Abstract: Thrust estimates from an ion Electrospray Propulsion System [1] can be inferred by measuring the electrical current consumed by the device. However, it is very challenging to directly measure the microNewton thrust these thrusters generate. A thrust balance was designed, constructed, and characterized to tackle this difficult problem and measure thrust directly. A complete electrospray power processing unit used for the thrust stand will also be described.
Published: 2013
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19. Progress Toward Demonstration of Remote, Autonomous Attitude Control of a CubeSat Using Ion Electrospray Propulsion Systems

Author: Louis E. Perna, Hanqing Li, Paulo C. Lozano, Fernando M. Hicks, and Chase S. Coman
Subjects: Engineering, Spacecraft propulsion, business.industry, Testbed, Thrust, Propulsion, Grid, law.invention, Attitude control, law, CubeSat, Aerospace engineering, business, Remote control
Abstract: As a solution to the problem of scalable propulsion in small satellite architectures, the microfabricated ion Electrospray Propulsion System (iEPS) developed by MIT’s Space Propulsion Laboratory has progressed to a point where it is ready to be characterized on a realistic testbed. In this paper, developments in the iEPS thruster design and testing equipment are outlined. Design changes address the performance and testing issues encountered with the rst version. These changes include features to mitigate the formation of liquid current paths and ease grid-to-tip alignment and grid removal. Additionally, a 1-DOF free-oating CubeSat testbed with an integrated autonomous remote control system and high-voltage PPU has been developed and tested for use as a thrust balance and attitude control demonstrator.
Published: 2012
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20. Near Final Height after GnRH Agonist Treatment in Central Precocious Puberty

Author: N. Gasparini, L. Pisaturo, M Micillo, E Perna, M. Salerno, S. Di Maio, A. Officioso, M., Micillo, Salerno, Mariacarolina, A., Officioso, E., Perna, N., Gasparini, L., Pisaturo, and S. Di M. a. i., O.
Subjects: Agonist, medicine.medical_specialty, Bone development, medicine.drug_class, Endocrinology, Diabetes and Metabolism, Central precocious puberty, Puberty, Precocious, Gonadotropin-Releasing Hormone, Endocrinology, Internal medicine, medicine, Humans, Child, Brain Diseases, Bone Development, Triptorelin Pamoate, business.industry, Final height, GnRH agonist, Near final height, Precocious puberty, Bone age, Long term results, Triptorelin, Body Height, Adult height, Pediatrics, Perinatology and Child Health, Female, Leuprolide, business, medicine.drug
Abstract: The impact of treatment of central precocious puberty (CPP) with gonadotropin-releasing hormone agonists (GnRHa) on final height remains controversial. We analyzed the long term results of 23 girls with CPP treated with triptorelin or leuprolide. Their "near final height" (NFH) assessed at a bone age of at least 14 years and expressed as SDS, was compared either with predicted height before treatment (PAH) or with parental height (TH). We also compared NFH of 12 girls treated before 8 years of age (7.0 +/- 0.5 yr) with NFH of 11 girls treated after 8 years old (8.5 +/- 0.3 yr). The NFH of the 23 girls (-0.9 +/- 1.0 SDS) was not different either from PAH (-0.85 +/- 1.5 SDS) or from TH (-0.5 +/0.6 SDS). Earlier treated girls reached a NFH (-0.97 +/- 1.0 SDS) not different from later treated girls (-0.91 +/- 1.0 SDS; p = ns) and both groups reached parental height (NFH - TH = -0.44 +/- 1 and -0.09 +/- 0.83 SDS, respectively). In conclusion, our patients, treated either earlier or later, reached a near final height comparable to predicted height and familial target; however, these results might still improve further because the girls have not yet reached their final adult height.
Published: 2000
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21. Failure and post failure conditions of a landslide involving weathered and degraded rocks

Author: Loredana Antronico, Luigi Aceto, M Cilento, O Terranova, E Perna, D Niceforo, and Giovanni Gullà
Subjects: Mining engineering, Post failure, Geotechnical engineering, Landslide, Geology
Published: 2004
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22. [Impact of a screening program on the surgical treatment of breast carcinoma]

Author: M, Braga, D, Pinelli, L, Filippini, F, Ragni, P I, Piccini, D, Pezzola, A M, Bianchi, and E, Perna
Subjects: Biopsy, Age Factors, Breast Neoplasms, Middle Aged, Mastectomy, Segmental, Mastectomy, Modified Radical, Italy, Lymphatic Metastasis, Humans, Lymph Node Excision, Mass Screening, Female, Breast, Mastectomy, Radical, Mastectomy, Aged, Mammography
Abstract: Results are presented concerning the first two cycles of a breast cancer screening program carried out by USSL 41 (the local social health center). 38,000 women were examined in a period ranging from 1987 to 1993 and more than 250 early stage tumors were diagnosed. Early detection by screening is confirmed by tumor size and nodal involvement. Overall, this program carried out in Brescia met requirements set by international and national scientific committees. Good results were obtained as far as quality standards are concerned. The importance of screening is evaluated concerning surgical treatment undergone by the patients. The study of surgical treatment clearly shows the gradual progression of conservative surgery deviating from more destructive operations.
Published: 1996

23. [Conservative surgery in the environment of a screening program for breast carcinoma: evaluation of the results in terms of local recurrence]

Author: D, Pinelli, A M, Bianchi, L, Filippini, E, Perna, F, Barbera, P, Frata, L, Vassalli, E, Simoncini, and M, Braga
Subjects: Time Factors, Breast Neoplasms, Radiotherapy Dosage, Middle Aged, Mastectomy, Segmental, Mastectomy, Modified Radical, Evaluation Studies as Topic, Humans, Lymph Node Excision, Mass Screening, Female, Neoplasm Recurrence, Local, Mastectomy, Follow-Up Studies
Abstract: This report evaluates the results of conservative surgery plus radiotherapy (QUART) in a group of 123 patients from the screening programme of the District Health Board USSL 41 in Brescia, Italy (over 250 tumours diagnosed in two screening rounds, between 1987 and 1993). To date no recurrence of neoplasms in the operated breast have been diagnosed in either of the two QUART groups (64 patients from the first round, average follow-up 28 months, median 66 months; 59 patients from the second round, average follow-up 28 months, median 30 months). A new carcinoma in the contralateral breast occurred in 3 patients (2 from the first and 1 from the second round), while in 3 cases there was a recurrence in another site (2 from the first and 1 from the second round). These results confirm both the proven effectiveness of conservative treatment in the local control of breast tumours, and the importance of the correct choice of conservative treatment in optimising aesthetic and therapeutic results.
Published: 1996

24. 3D Reconstruction Software

Author: O. D. Isselmou, D. Vandorpe, E. Perna, and B. Shariat
Subjects: Software, business.industry, Computer science, Computer graphics (images), 3D reconstruction, business
Published: 1994
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25. 645 CORRELATES AND PROGNOSTIC VALUE OF HEPATITIS C VIRUS CORE ANTIGEN SERUM LEVELS DURING CHRONIC INFECTION AND TREATMENT

Author: Domenico Iossa, E. Durante-Mangoni, Riccardo Utili, G. Portella, E. Perna, U. Malgeri, R. Andini, and L. Vallefuoco
Subjects: Chronic infection, Hepatology, business.industry, Medicine, Hepatitis C virus core Antigen, business, Virology, Value (mathematics)
Published: 2010
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26. Serum B2-microglobulin and human immunodeficiency virus infection in intravenous drug users: a cross-sectional study

Author: R, De Mercato, G, Rezza, M, Giuliani, E, Perna, V, Iovinella, A, Bassi, and R, Tagliaferro
Subjects: Male, Cross-Sectional Studies, Italy, HIV Seroprevalence, Predictive Value of Tests, Humans, HIV Infections, Substance Abuse, Intravenous, beta 2-Microglobulin, Sensitivity and Specificity, Biomarkers
Abstract: Beta 2-microglobulin level has been evaluated in 183 male intravenous drug users and 50 apparently healthy blood donors. The aim of the study was to assess the possible association between high values of the peptide and both HIV infection and disease progression in intravenous drug users. Beta 2-microglobulin values were found significantly higher in AIDS patients and other symptomatic subjects than in asymptomatic, both seropositive and seronegative, intravenous drug users. Among asymptomatic drug users, no significant difference in the values was found.
Published: 1990

27. [The serum beta-2-microglobulin values in drug addicts with persistent generalized lymphadenopathy]

Author: R, De Mercato, E, Perna, G, Oriani, V, Siciliano, V, Iovinella, R, Ciampi, A, Bassi, and R, Tagliaferro
Subjects: Adult, Male, Acquired Immunodeficiency Syndrome, Analysis of Variance, Chi-Square Distribution, Adolescent, AIDS-Related Complex, Carrier State, HIV Seropositivity, Humans, Substance Abuse, Intravenous, beta 2-Microglobulin
Abstract: Serum beta 2-microglobulin levels (beta-2-M) were studied in 150 drug addicts, 50 of them asymptomatic carriers of anti HIV-1 antibodies, 50 symptomatic carriers with persistent generalized lymphadenopathy (P.G.L.) and 50 serum negative patients who had been living in a closed community for at least 2 years. The results showed increased beta-2-M in 24 P.G.L. patients (48%), in 6 of the asymptomatic serum positive cases (12%) and in 3 of the serum negative subjects (6%). No such increase was found in the selected control group. Statistical analysis using the chi-square test and one-way variance analysis gave a significant result. The data suggest that increased serum beta-2-M is essentially linked to the presence of P.G.L.
Published: 1990

28. REDUCED SYSTOLIC PERFOMANCE BY TISSUE DOPPLER IN PATIENTS WITH PRESERVED AND ABNORMAL EJECTION FRACTION: NEW INSIGHTS IN CHRONIC HEART FAILURE

Author: P. Ariel, O. Ricardo, E. H. Garcia, P. Jorge, A. Marcelo, M. Stella, T. Eduardo, R. Leonardo., E. Perna, and F. Eduardo
Subjects: medicine.medical_specialty, Ejection fraction, Receiver operating characteristic, business.industry, Diastolic heart failure, Diastole, medicine.disease, Doppler imaging, Internal medicine, Heart failure, medicine, Cardiology, Radiology, Nuclear Medicine and imaging, In patient, Wall motion, Cardiology and Cardiovascular Medicine, business
Abstract: Background: Tissue Doppler imaging (TDI) is a new tool in the evaluation of the systolic and diastolic function. We sought to compare TDI findings in patients with chronic heart failure (CHF) due to systolic and diastolic dysfunction as well as to assess its usefulness for diagnosing diastolic CHF. Methods and Results: One hundred and ten outpatients with CHF and 68 controls were prospectively included. Ejection fraction (EF) was obtained by two-dimensional echocardiography and systolic and diastolic wall motion velocities were recorded for basal septum. Patients without CHF were classified as Group A (controls); those with CHF were classified according to EF in Group B1: > 45% and B2: £ 45%. In groups A, B1, and B2 the mean peak S was 7.74; 5.45 and 4.89 cm/sec (p < 0.001); the mean peak E was 8.56; 5.72, and 6.1 cm/sec (p < 0.001); and the mean A peak was 10.2; 7.3 and 5.3 cm/sec (p < 0.001). Control and CHF groups were different in all terms except E/A ratio (p = 0.001), the E peak and IVRT among groups with CHF were comparable (p = ns). The most useful parameters for identifying diastolic CHF were IVRT and S peak, with area under ROC curves of 0.93 and 0.89. The cut-off of 115 msec for IVRT and 5.8 cm/sec for S peak showed a sensitivity of 94% and 97%, with a specificity of 82% and 73%, respectively. Table TABLE. Parameter Group A (n = 68) Group B1 (n = 37) Group B2 (n = 73) p value EF (%) 66.1 ± 7.9 57 ± 7.8 28.8 ± 9.7 0.001 E peak 8.56 ± 2.4 5.72 ± 2.2 6.1 ± 1.9 0.001 A peak 10.2 ± 1.9 7.3 ± 2.9 5.3 ± 2.8 0.001 S peak 7.74 ± 1.4 5.45 ± 1.6 4.89 ± 1.2 0.001 E/A ratio 0.87 ± 0.3 0.96 ± 0.6 1.7 ± 1.5 0.001 IVTR 98 ± 26 166 ± 38 153 ± 42 0.001 IVTC 67 ± 18 110 ± 34 132 ± 47 0.001 Conclusion: TDI velocities were reduced in CHF compared with normal subjects, there were not differences among CHF with preserved or reduced EF in E peak and IVRT. In addition, the systolic velocity as well as IVRT were useful to diagnose CHF with preserved EF. These findings suggest that impairment of left ventricular systolic function is present even in those with diastolic heart failure, and that abnormalities may have an important role to identify that condition.
Published: 2004
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29. P3253 Ongoing myocardial damage is a powerful tool in chronic heart failure: usefulness of cardiac troponin T monitoring to identifying high-risk patients

Author: E Perna
Subjects: medicine.medical_specialty, High risk patients, Cardiac troponin, business.industry, Internal medicine, Heart failure, medicine, Cardiology, Cardiology and Cardiovascular Medicine, business, medicine.disease
Published: 2003
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30. Alfa-interferon (A-IFN) treatment could induce antinuclear antibodies (ANA) development in virus chronic hepatitis (CH)

Author: Gabriele Mazzacca, G. Ambrogio, E. Perna, C. Cristodoro, and D. Mattera
Subjects: Hepatology, Chronic hepatitis, Anti-nuclear antibody, business.industry, Interferon, Medicine, business, Virology, Virus, medicine.drug
Published: 1990
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31. Tetraplegia from trauma of the cervical spine in the absence of fractures and luxations

Author: E, Perna, G, Petrone, R, Liguori, D, Serino, G, De Rosa, and A, Calabrò
Subjects: Spinal Injuries, Cervical Vertebrae, Humans, Quadriplegia, Intervertebral Disc Displacement, Myelography, Spinal Cord Injuries
Abstract: Spinal cord lesions are not infrequent in cervical traumas in absence of fractures and/or luxations. In hyperextension traumas conservative treatment is normally sufficient. In hyperflexion and unknowm mechanism traumas neurosurgical treatment is often necessary due to the frequency of a discal herniation. Myelography is indispensable for correct and complete diagnosis and for this reason its use is strongly recommended.
Published: 1975

32. Primary intraorbital meningiomas (presentation of 3 cases)

Author: R, Liguori, G, Petrone, E, Perna, and G, Palisi
Subjects: Adult, Male, Radiography, Humans, Orbital Neoplasms, Female, Middle Aged, Child, Meningioma
Published: 1974

33. [Stomatologic pathology in HIV infection. Preliminary data]

Author: R, De Mercato, V, Siciliano, S, Noce, C, D'Ambrosio, G, Rovito, E, Perna, V, Iovinella, and A, Bassi
Subjects: Adult, Male, Acquired Immunodeficiency Syndrome, Adolescent, AIDS-Related Complex, Risk Factors, HIV Seropositivity, Humans, Middle Aged, Mouth Diseases
Abstract: In order to investigate the clinical oral manifestations associated with Acquired Immunodeficiency Syndrome (AIDS) and AIDS-related conditions, 922 male subjects were studied in a closed community (inmates). 669 were drug-abusers, 24 homosexual or bisexual men, 86 drug-abusers and homosexual or bisexual men, 143 without risk behaviour. Only 120 patients had antibodies to human immunodeficiency virus type I. All were throughly examined for evidence of oral disorders. The major finding was that almost all with AIDS and AIDS-related complex had oral manifestations one AIDS-patient was affected with hairy leukoplakia.
Published: 1989

34. [Prevention of the transmission of HIV infections in an odontosmatological environment. Study in a closed community]

Author: R, De Mercato, F, Rossano, S, Noce, C, D'Ambrosio, V, Siciliano, E, Perna, V, Iovinella, and A, Bassi
Subjects: Adult, Male, Acquired Immunodeficiency Syndrome, Italy, Dentistry, Prisoners, Sexual Behavior, HIV Seropositivity, Humans, Middle Aged
Published: 1988

35. [Study using replicas of the structure of the dental surface in periodontal disease, with normal and elevated blood sugar]

Author: E, Perna
Subjects: Blood Glucose, Hyperglycemia, Humans, Dental Caries, Dental Enamel, Models, Biological, Periodontal Diseases
Published: 1970

36. [The surface of human impacted and erupted teeth]

Author: E, Perna
Subjects: Tooth, Impacted, Humans, Dental Enamel
Published: 1970

37. 2 cases of surgical replacement of a vertebral body with osseous heteroplastic graft

Author: M R, Liguori, G, Petrone, and E, Perna
Subjects: Adult, Male, Radiography, Fracture Fixation, Internal, Fractures, Bone, Bone Transplantation, Fracture Fixation, Spinal Injuries, Transplantation, Heterologous, Cervical Vertebrae, Joint Dislocations, Humans, Middle Aged
Published: 1971

38. Baseline characteristics of patients in the Reduction of Events with Darbepoetin alfa in Heart Failure trial (RED-HF)

Author: McMurray, J.J.V., Anand, I. S., Diaz, R., Maggioni, A. P., O'Connor, C., Pfeffer, M. A., Solomon, S. D., Tendera, M., van Veldhuisen, D. J., Albizem, M., Cheng, S., Scarlata, D., Swedberg, K., Young, J. B., Amuchastegui, M., Belziti, C., Bluguermann, J., Caccavo, M., Cartasegna, L., Colque, R., Cuneo, C., Fernandez, A., Gabito, A., Goicochea, R., Gonzalez, M., Gorosito, V., Grinfeld, L., Hominal, M., Kevorkian, R., Litvak Bruno, M., Llanos, J., Mackinnon, I., Manuale, O., Marzetti, E., Nul, D., Perna, E., Riccitelli, M., Sanchez, A., Santos, D., Schygiel, P., Toblli, J., Vogel, D., Aggarwal, A., Amerena, J., De Looze, F., Fletcher, P., Hare, D., Ireland, M., Krum, H., Lattimore, J., Marwick, T., Sindone, A., Thompson, P., Waites, J., Altenberger, J., Ebner, C., Lenz, K., Pacher, R., Poelzl, G., Charlier, F., de Ceuninck, M., De Keulenaer, G., Dendale, P., Marechal, P., Mullens, W., Thoeng, J., Vanderheyden, M., Vanhaecke, J., Weytjens, C., Wollaert, B., Albuquerque, D., Almeida, D., Aspe y Rosas, J., Bocchi, E., Bordignon, S., Clausell, N., Kaiser, S., Leaes, P., Martins Alves, S., Montera, M., Moura, L., Pereira de Castro, R., Rassi, S., Reis, A., Saraiva, J., Simoes, M., Souza Neto, J., Teixeira, M., Benov, H., Chompalova, B., Donova, T., Georgiev, P., Gotchev, D., Goudev, A., Grigorov, M., Guenova, D., Hergeldjieva, V., Ivanov, D., Kostova, E., Manolova, A., Marchev, S., Nikolov, F., Popov, A., Raev, D., Tzekova, M., Czarnecki, W., Giannetti, N., Haddad, H., Heath, J., Huynh, T., Lepage, S., Liu, P., Lonn, E., Ma, P., Manyari, D., Moe, G., Parker, J., Pesant, Y., Rajda, M., Ricci, J., Roth, S., Sestier, F., Sluzar, V., Sussex, B., Vizel, S., Antezana, G., Bugueno, C., Castro, P., Conejeros, C., Manriquez, L., Martinez, D., Potthoff, S., Stockins, B., Vukasovic, J., Gregor, P., Herold, M., Jerabek, O., Jirmar, R., Kuchar, R., Linhart, A., Podzemska, B., Soucek, M., Spac, J., Spacek, R., Vodnansky, P., Bronnum-Schou, J., Clemmensen, K., Egstrup, K., Jensen, G., Kjoller-Hansen, L., Kober, L., Markenvard, J., Rokkedal, J., Skagen, K., Torp-Pedersen, C., Tuxen, C., Videbak, L., Laks, T., Vahula, V., Harjola, V., Kettunen, R., Kotila, M., Bauer, F., Cohen Solal, A., Coisne, D., Davy, J., De Groote, P., Dos Santos, P., Funck, F., Galinier, M., Gibelin, P., Isnard, R., Neuder, Y., Roul, G., Sabatier, R., Trochu, J., Anker, S., Denny, S., Dreykluft, T., Flesch, M., Genth-Zotz, S., Hambrecht, R., Hein, J., Jeserich, M., John, M., Kreider-Stempfle, H., Laufs, U., Muellerleile, K., Natour, M., Sandri, M., Schaufele, T., von Hodenberg, E., Weyland, K., Winkelmann, B., Tse, H., Yan, B., Barsi, B., Csikasz, J., Dezsi, C., Edes, I., Forster, T., Karpati, P., Kerekes, C., Kis, E., Kosa, I., Lupkovics, G., Nagy, A., Preda, I., Ronaszeki, A., Tomcsanyi, J., Zamolyi, K., Agarwal, D., Bahl, V., Bordoloi, A., Chockalingam, K., Chopda, M., Chopra, V., Dugal, J., Ghaisas, N., Ghosh, S., Grant, P., Hiremath, S., Iyengar, S., Jagadeesa Subramania, B., Jain, P., Joshi, A., Khan, A., Mullasari, A., Naik, S., Oomman, A., Pai, V., Pareppally Gopal, R., Parikh, K., Patel, T., Prakash, V., Sastry, B., Sathe, S., Sinha, N., Srikanthan, V., Subburamakrishnan, P., Thacker, H., Wander, G., Admon, D., Katz, A., Klainman, E., Lewis, B., Marmor, A., Moriel, M., Mosseri, M., Shotan, A., Weinstein, J., Zimlichman, R., Agostoni, P., Albanese, M., Alunni, G., Bini, R., Boccanelli, A., Bolognese, L., Campana, C., Carbonieri, E., Carpino, C., Checco, L., Cosmi, F., D'Angelo, G., De Cristofaro, M., Floresta, A., Fucili, A., Galvani, M., Ivleva, A., Marra, S., Musca, G., Peccerillo, N., Perrone Filardi, P., Picchio, E., Russo, T., Scelsi, L., Senni, M., Tavazzi, L., Erglis, A., Jasinkevica, I., Kakurina, N., Veze, I., Volans, E., Bagdonas, A., Berukstis, E., Celutkiene, J., Dambrauskaite, A., Jarasuniene, D., Luksiene, D., Rudys, A., Sakalyte, G., Sliaziene, S., Aguilar-Romero, R., Cardona-Munoz, E., Castro-Jimenez, J., Chavez-Herrera, J., Chuquiure Valenzuela, E., De la Pena, G., Herrera, E., Leiva-Pons, J., Lopez Alvarado, A., Mendez Machado, G., Ramos-Lopez, G., Basart, D., Buijs, E., Cornel, J., de Leeuw, M., Dijkgraaf, R., Dunselman, P., Freericks, M., Hamraoui, K., Lenderlink, T., Linssen, G., Lodewick, P., Lodewijks, C., Lok, D., Nierop, P., Ronner, E., Somsen, A., van Dantzig, J., van der Burgh, P., van Kempen, L., van Vlies, B., Voors, A., Wardeh, A., Willems, F., Dickstein, K., Gundersen, T., Hole, T., Thalamus, J., Westheim, A., Dabrowski, M., Gorski, J., Korewicki, J., Kuc, K., Miekus, P., Musial, W., Niegowska, J., Piotrowski, W., Podolec, P., Polonski, L., Ponikowski, P., Rynkiewicz, A., Szelemej, R., Trusz-Gluza, M., Ujda, M., Wojciechowski, D., Wysokinski, A., Camacho, A., Fonseca, C., Monteiro, P., Apetrei, E., Bruckner, I., Carasca, E., Coman, I., Datcu, M., Dragulescu, S., Ionescu, P., Iordachescu-Petica, D., Manitiu, I., Popa, V., Pop-Moldovan, A., Radoi, M., Stamate, S., Tomescu, M., Vita, I., Aroutiounov, G., Ballyuzek, M., Bart, B., Churina, S., Glezer, M., Goloshchekin, B., Kobalava, Z., Kostenko, V., Lopatin, Y., Martynov, A., Orlov, V., Semernin, E., Shogenov, Z., Sidorenko, B., Skvortsov, A., Storzhakov, G., Sulimov, V., Talibov, O., Tereshenko, S., Tsyrline, V., Zadionchenko, V., Zateyshchikov, D., Dzupina, A., Hranai, M., Kmec, J., Micko, K., Murin, J., Pella, D., Sojka, G., Spisak, V., Vahala, P., Vinanska, D., Badat, A., Bayat, J., Dawood, S., Delport, E., Ellis, G., Garda, R., Klug, E., Mabin, T., Naidoo, D., Pretorius, M., Ranjith, N., Van Zyl, L., Weich, H., Anguita, M., Berrazueta, J., Bruguera i Cortada, J., de Teresa, E., Gomez Sanchez, M., Gonzalez Juanatey, J., Gonzalez-Maqueda, I., Jordana, R., Lupon, J., Manzano, L., Pascual Figal, D., Pulpon, L., Recio, J., Ridocci Soriano, F., Rodriguez Lambert, J., Roig Minguell, E., Romero, J., Valdovinos, P., Klintberg, L., Kronvall, T., Lycksell, M., Morner, S., Rydberg, E., Timberg, I., Wikstrom, G., Moccetti, T., Ashok, J., Banerjee, P., Carr-White, G., Cleland, J., Connolly, E., Francis, M., Greenbaum, R., Kadr, H., Lindsay, S., McMurray, J., Megarry, S., Memon, A., Murdoch, D., Senior, R., Squire, I., Tan, L., Witte, K., Adams, K., Adamson, P., Adler, A., Altschul, L., Altschuller, A., Amirani, H., Anand, I., Andreou, C., Ansari, M., Antonishen, M., Banchs, H., Banerjee, S., Banish, D., Bank, A., Barbagelata, A., Barnard, D., Bellinger, R., Benn, A., Berk, M., Berry, B., Bethala, V., Bilazarian, S., Bisognano, J., Bleyer, F., Blum, M., Boehmer, J., Bouchard, A., Boyle, A., Bozkurt, B., Brown, C., Burlew, B., Burnham, K., Butler, J., Call, J., Cambier, P., Cappola, T., Carlson, R., Chandler, B., Chandra, R., Chandraratna, P., Chernick, R., Colan, D., Colfer, H., Colucci, W., Connelly, T., Costantini, O., Dadkhah, S., Dauber, I., Davis, J., Davis, S., Denning, S., Drazner, M., Dunlap, S., Egbujiobi, L., Elkayam, U., Elliott, J., El-Shahawy, M., Essandoh, L., Ewald, G., Fang, J., Farhoud, H., Felker, G., Fernandez, J., Festin, R., Fishbein, G., Florea, V., Flores, E., Floro, J., Gabris, M., Garg, M., Gatewood, R., Geller, M., Ghali, J., Ghumman, W., Gibbs, G., Gillespie, E., Gilmore, R., Gogia, H., Goldberg, L., Gradus-Pizlo, I., Grainger, T., Gudmundsson, G., Gunawardena, D., Gupta, D., Hack, T., Hall, S., Hamroff, G., Hankins, S., Hanna, M., Hargrove, J., Haught, W., Hauptman, P., Hazelrigg, M., Herzog, C., Heywood, J., Hill, T., Hilton, T., Hirsch, H., Hunter, J., Ibrahim, H., Imburgia, M., Iteld, B., Jackson, B., Jaffrani, N., Jain, D., Jain, A., James, M., Jimenez, J., Johnson, E., Kale, P., Kaneshige, A., Kapadia, S., Karia, D., Karlsberg, R., Katholi, R., Kerut, E., Khoury, W., Kipperman, R., Klapholz, M., Kosinski, E., Kozinn, M., Kraus, D., Krueger, S., Kumar, S., Lader, E., Lee, C., Levy, W., Lewis, E., Light-McGroary, K., Loh, I., Lombardi, W., Machado, C., Maislos, F., Mancini, D., Markus, T., Mather, P., McCants, K., McGrew, F., McLaurin, B., McMillan, E., McNamara, D., Meyer, T., Meymandi, S., Miller, A., Minami, E., Modi, M., Mody, F., Mohanty, P., Moscoso, R., Moskowitz, R., Moustafa, M., Mullen, M., Naz, T., Noonan, T., O'Brien, T., Oellerich, W., Oren, R., Pamboukian, S., Pereira, N., Pitt, W., Porter, C., Prabhu, S., Promisloff, S., Ratkovec, R., Richardson, R., Ross, A., Saleh, N., Saltzberg, M., Sarkar, S., Schmedtje, J., Schneider, R., Schuyler, G., Shanes, J., Sharma, A., Siegel, C., Siegel, R., Silber, D., Singh, V., Singh, N., Singh, J., Sklar, J., Small, R., Smith, A., Smith, E., Smull, D., Sotolongo, R., Staniloae, C., Stapleton, D., Steele, P., Stehlik, J., Stein, M., Tang, W., Thadani, U., Torre-Amoine, G., Trichon, B., Tsai, C., Tummala, R., Van Bakel, A., Vicari, R., Vijay, N., Vijayaraghavan, K., Vittorio, T., Vossler, M., Wagoner, L., Wallis, D., Ward, N., Widmer, M., Wight, J., Wilkins, C., Williams, C., Williams, G., Winchester, M., Winkel, E., Wittmer, B., Wood, D., Wormer, D., Wright, R., Xu, Z., Yasin, M., Zolty, R., J. J. V., Mcmurray, I. S., Anand, R., Diaz, A. P., Maggioni, C., O'Connor, M. A., Pfeffer, S. D., Solomon, M., Tendera, D. J., van Veldhuisen, M., Albizem, S., Cheng, D., Scarlata, K., Swedberg, J. B., Young, M., Amuchastegui, C., Belziti, J., Bluguermann, M., Caccavo, L., Cartasegna, R., Colque, C., Cuneo, A., Fernandez, A., Gabito, R., Goicochea, M., Gonzalez, V., Gorosito, L., Grinfeld, M., Hominal, R., Kevorkian, M., Litvak Bruno, J., Llano, I., Mackinnon, O., Manuale, E., Marzetti, D., Nul, E., Perna, M., Riccitelli, A., Sanchez, D., Santo, P., Schygiel, J., Toblli, D., Vogel, A., Aggarwal, J., Amerena, F., De Looze, P., Fletcher, D., Hare, M., Ireland, H., Krum, J., Lattimore, T., Marwick, A., Sindone, P., Thompson, J., Waite, J., Altenberger, C., Ebner, K., Lenz, R., Pacher, G., Poelzl, F., Charlier, M., de Ceuninck, G., De Keulenaer, P., Dendale, P., Marechal, W., Mullen, J., Thoeng, M., Vanderheyden, J., Vanhaecke, C., Weytjen, B., Wollaert, D., Albuquerque, D., Almeida, J. Aspe y., Rosa, E., Bocchi, S., Bordignon, N., Clausell, S., Kaiser, P., Leae, S., Martins Alve, M., Montera, L., Moura, R., Pereira de Castro, S., Rassi, A., Rei, J., Saraiva, M., Simoe, J., Souza Neto, M., Teixeira, H., Benov, B., Chompalova, T., Donova, P., Georgiev, D., Gotchev, A., Goudev, M., Grigorov, D., Guenova, V., Hergeldjieva, D., Ivanov, E., Kostova, A., Manolova, S., Marchev, F., Nikolov, A., Popov, D., Raev, M., Tzekova, W., Czarnecki, N., Giannetti, H., Haddad, J., Heath, T., Huynh, S., Lepage, P., Liu, E., Lonn, P., Ma, D., Manyari, G., Moe, J., Parker, Y., Pesant, M., Rajda, J., Ricci, S., Roth, F., Sestier, V., Sluzar, B., Sussex, S., Vizel, G., Antezana, C., Bugueno, P., Castro, C., Conejero, L., Manriquez, D., Martinez, S., Potthoff, B., Stockin, J., Vukasovic, P., Gregor, M., Herold, O., Jerabek, R., Jirmar, R., Kuchar, A., Linhart, B., Podzemska, M., Soucek, J., Spac, R., Spacek, P., Vodnansky, J., Bronnum Schou, K., Clemmensen, K., Egstrup, G., Jensen, L., Kjoller Hansen, L., Kober, J., Markenvard, J., Rokkedal, K., Skagen, C., Torp Pedersen, C., Tuxen, L., Videbak, T., Lak, V., Vahula, V., Harjola, R., Kettunen, M., Kotila, F., Bauer, A., Cohen Solal, D., Coisne, J., Davy, P., De Groote, P., Dos Santo, F., Funck, M., Galinier, P., Gibelin, R., Isnard, Y., Neuder, G., Roul, R., Sabatier, J., Trochu, S., Anker, S., Denny, T., Dreykluft, M., Flesch, S., Genth Zotz, R., Hambrecht, J., Hein, M., Jeserich, M., John, H., Kreider Stempfle, U., Lauf, K., Muellerleile, M., Natour, M., Sandri, T., Schaufele, E., von Hodenberg, K., Weyland, B., Winkelmann, H., Tse, B., Yan, B., Barsi, J., Csikasz, C., Dezsi, I., Ede, T., Forster, P., Karpati, C., Kereke, E., Ki, I., Kosa, G., Lupkovic, A., Nagy, I., Preda, A., Ronaszeki, J., Tomcsanyi, K., Zamolyi, D., Agarwal, V., Bahl, A., Bordoloi, K., Chockalingam, M., Chopda, V., Chopra, J., Dugal, N., Ghaisa, S., Ghosh, P., Grant, S., Hiremath, S., Iyengar, B., Jagadeesa Subramania, P., Jain, A., Joshi, A., Khan, A., Mullasari, S., Naik, A., Oomman, V., Pai, R., Pareppally Gopal, K., Parikh, T., Patel, V., Prakash, B., Sastry, S., Sathe, N., Sinha, V., Srikanthan, P., Subburamakrishnan, H., Thacker, G., Wander, D., Admon, A., Katz, E., Klainman, B., Lewi, A., Marmor, M., Moriel, M., Mosseri, A., Shotan, J., Weinstein, R., Zimlichman, P., Agostoni, M., Albanese, G., Alunni, R., Bini, A., Boccanelli, L., Bolognese, C., Campana, E., Carbonieri, C., Carpino, L., Checco, F., Cosmi, G., D'Angelo, M., De Cristofaro, A., Floresta, A., Fucili, M., Galvani, A., Ivleva, S., Marra, G., Musca, N., Peccerillo, PERRONE FILARDI, Pasquale, E., Picchio, T., Russo, L., Scelsi, M., Senni, L., Tavazzi, A., Ergli, I., Jasinkevica, N., Kakurina, I., Veze, E., Volan, A., Bagdona, E., Beruksti, J., Celutkiene, A., Dambrauskaite, D., Jarasuniene, D., Luksiene, A., Rudy, G., Sakalyte, S., Sliaziene, R., Aguilar Romero, E., Cardona Munoz, J., Castro Jimenez, J., Chavez Herrera, E., Chuquiure Valenzuela, G., De la Pena, E., Herrera, J., Leiva Pon, A., Lopez Alvarado, G., Mendez Machado, G., Ramos Lopez, D., Basart, E., Buij, J., Cornel, M., de Leeuw, R., Dijkgraaf, P., Dunselman, M., Freerick, K., Hamraoui, T., Lenderlink, G., Linssen, P., Lodewick, C., Lodewijk, D., Lok, P., Nierop, E., Ronner, A., Somsen, J., van Dantzig, P., van der Burgh, L., van Kempen, B., van Vlie, A., Voor, A., Wardeh, F., Willem, K., Dickstein, T., Gundersen, T., Hole, J., Thalamu, A., Westheim, M., Dabrowski, J., Gorski, J., Korewicki, K., Kuc, P., Mieku, W., Musial, J., Niegowska, W., Piotrowski, P., Podolec, L., Polonski, P., Ponikowski, A., Rynkiewicz, R., Szelemej, M., Trusz Gluza, M., Ujda, D., Wojciechowski, A., Wysokinski, A., Camacho, C., Fonseca, P., Monteiro, E., Apetrei, I., Bruckner, E., Carasca, I., Coman, M., Datcu, S., Dragulescu, P., Ionescu, D., Iordachescu Petica, I., Manitiu, V., Popa, A., Pop Moldovan, M., Radoi, S., Stamate, M., Tomescu, I., Vita, G., Aroutiounov, M., Ballyuzek, B., Bart, S., Churina, M., Glezer, B., Goloshchekin, Z., Kobalava, V., Kostenko, Y., Lopatin, A., Martynov, V., Orlov, E., Semernin, Z., Shogenov, B., Sidorenko, A., Skvortsov, G., Storzhakov, V., Sulimov, O., Talibov, S., Tereshenko, V., Tsyrline, V., Zadionchenko, D., Zateyshchikov, A., Dzupina, M., Hranai, J., Kmec, K., Micko, J., Murin, D., Pella, G., Sojka, V., Spisak, P., Vahala, D., Vinanska, A., Badat, J., Bayat, S., Dawood, E., Delport, G., Elli, R., Garda, E., Klug, T., Mabin, D., Naidoo, M., Pretoriu, N., Ranjith, L., Van Zyl, H., Weich, M., Anguita, J., Berrazueta, J. Bruguera i., Cortada, E., de Teresa, M., Gomez Sanchez, J., Gonzalez Juanatey, I., Gonzalez Maqueda, R., Jordana, J., Lupon, L., Manzano, D., Pascual Figal, L., Pulpon, J., Recio, F., Ridocci Soriano, J., Rodriguez Lambert, E., Roig Minguell, J., Romero, P., Valdovino, L., Klintberg, T., Kronvall, M., Lycksell, S., Morner, E., Rydberg, I., Timberg, G., Wikstrom, T., Moccetti, J., Ashok, P., Banerjee, G., Carr White, J., Cleland, E., Connolly, M., Franci, R., Greenbaum, H., Kadr, S., Lindsay, J., Mcmurray, S., Megarry, A., Memon, D., Murdoch, R., Senior, I., Squire, L., Tan, K., Witte, K., Adam, P., Adamson, A., Adler, L., Altschul, A., Altschuller, H., Amirani, I., Anand, C., Andreou, M., Ansari, M., Antonishen, H., Banch, S., Banerjee, D., Banish, A., Bank, A., Barbagelata, D., Barnard, R., Bellinger, A., Benn, M., Berk, B., Berry, V., Bethala, S., Bilazarian, J., Bisognano, F., Bleyer, M., Blum, J., Boehmer, A., Bouchard, A., Boyle, B., Bozkurt, C., Brown, B., Burlew, K., Burnham, J., Butler, J., Call, P., Cambier, T., Cappola, R., Carlson, B., Chandler, R., Chandra, P., Chandraratna, R., Chernick, D., Colan, H., Colfer, W., Colucci, T., Connelly, O., Costantini, S., Dadkhah, I., Dauber, J., Davi, S., Davi, S., Denning, M., Drazner, S., Dunlap, L., Egbujiobi, U., Elkayam, J., Elliott, M., El Shahawy, L., Essandoh, G., Ewald, J., Fang, H., Farhoud, G., Felker, J., Fernandez, R., Festin, G., Fishbein, V., Florea, E., Flore, J., Floro, M., Gabri, M., Garg, R., Gatewood, M., Geller, J., Ghali, W., Ghumman, G., Gibb, E., Gillespie, R., Gilmore, H., Gogia, L., Goldberg, I., Gradus Pizlo, T., Grainger, G., Gudmundsson, D., Gunawardena, D., Gupta, T., Hack, S., Hall, G., Hamroff, S., Hankin, M., Hanna, J., Hargrove, W., Haught, P., Hauptman, M., Hazelrigg, C., Herzog, J., Heywood, T., Hill, T., Hilton, H., Hirsch, J., Hunter, H., Ibrahim, M., Imburgia, B., Iteld, B., Jackson, N., Jaffrani, D., Jain, A., Jain, M., Jame, J., Jimenez, E., Johnson, P., Kale, A., Kaneshige, S., Kapadia, D., Karia, R., Karlsberg, R., Katholi, E., Kerut, W., Khoury, R., Kipperman, M., Klapholz, E., Kosinski, M., Kozinn, D., Krau, S., Krueger, S., Kumar, E., Lader, C., Lee, W., Levy, E., Lewi, K., Light McGroary, I., Loh, W., Lombardi, C., Machado, F., Maislo, D., Mancini, T., Marku, P., Mather, K., Mccant, F., Mcgrew, B., Mclaurin, E., Mcmillan, D., Mcnamara, T., Meyer, S., Meymandi, A., Miller, E., Minami, M., Modi, F., Mody, P., Mohanty, R., Moscoso, R., Moskowitz, M., Moustafa, M., Mullen, T., Naz, T., Noonan, T., O'Brien, W., Oellerich, R., Oren, S., Pamboukian, N., Pereira, W., Pitt, C., Porter, S., Prabhu, S., Promisloff, R., Ratkovec, R., Richardson, A., Ro, N., Saleh, M., Saltzberg, S., Sarkar, J., Schmedtje, R., Schneider, G., Schuyler, J., Shane, A., Sharma, C., Siegel, R., Siegel, D., Silber, V., Singh, N., Singh, J., Singh, J., Sklar, R., Small, A., Smith, E., Smith, D., Smull, R., Sotolongo, C., Staniloae, D., Stapleton, P., Steele, J., Stehlik, M., Stein, W., Tang, U., Thadani, G., Torre Amoine, B., Trichon, C., Tsai, R., Tummala, A., Van Bakel, R., Vicari, N., Vijay, K., Vijayaraghavan, T., Vittorio, M., Vossler, L., Wagoner, D., Walli, N., Ward, M., Widmer, J., Wight, C., Wilkin, C., William, G., William, M., Winchester, E., Winkel, B., Wittmer, D., Wood, D., Wormer, R., Wright, Z., Xu, M., Yasin, R., Zolty, Faculteit Medische Wetenschappen/UMCG, and Cardiovascular Centre (CVC)
Subjects: Male, CHRONIC KIDNEY-DISEASE, Darbepoetin alfa, medicine.medical_treatment, heart failure, Ciencias de la Salud, Comorbidity, Severity of Illness Index, law.invention, DOUBLE-BLIND, Randomized controlled trial, law, Interquartile range, Cause of Death, Medicine, Cause of death, Aged, 80 and over, Clinical Trials as Topic, CARDIAC-RESYNCHRONIZATION THERAPY, HEALTH-STATUS, Ética Médica, Middle Aged, RANDOMIZED CONTROLLED-TRIAL, Hospitalization, IRON-DEFICIENCY, Treatment Outcome, purl.org/becyt/ford/3 [https], Female, TREATMENT OPTIONS, Cardiology and Cardiovascular Medicine, medicine.drug, medicine.medical_specialty, CIENCIAS MÉDICAS Y DE LA SALUD, Anemia, Cardiac resynchronization therapy, Heart failure, Anaemia, purl.org/becyt/ford/3.3 [https], Double-Blind Method, Internal medicine, Humans, Clinical Trials, ANEMIA, Erythropoietin, Aged, Demography, anaemia, business.industry, MORTALITY, medicine.disease, MORBIDITY CHARM PROGRAM, Clinical trial, Hematinics, Physical therapy, CAUSA DA MORTE, business
Abstract: AIMS: This report describes the baseline characteristics of patients in the Reduction of Events with Darbepoetin alfa in Heart Failure trial (RED-HF) which is testing the hypothesis that anaemia correction with darbepoetin alfa will reduce the composite endpoint of death from any cause or hospital admission for worsening heart failure, and improve other outcomes. METHODS AND RESULTS: Key demographic, clinical, and laboratory findings, along with baseline treatment, are reported and compared with those of patients in other recent clinical trials in heart failure. Compared with other recent trials, RED-HF enrolled more elderly [mean age 70 (SD 11.4) years], female (41%), and black (9%) patients. RED-HF patients more often had diabetes (46%) and renal impairment (72% had an estimated glomerular filtration rate < 60 mL/min/1.73 m2). Patients in RED-HF had heart failure of longer duration [5.3 (5.4) years], worse NYHA class (35% II, 63% III, and 2% IV), and more signs of congestion. Mean EF was 30% (6.8%). RED-HF patients were well treated at randomization, and pharmacological therapy at baseline was broadly similar to that of other recent trials, taking account of study-specific inclusion/exclusion criteria. Median (interquartile range) haemoglobin at baseline was 112 (106-117) g/L. CONCLUSION: The anaemic patients enrolled in RED-HF were older, moderately to markedly symptomatic, and had extensive co-morbidity. Fil: McMurray, John J. V.. University of Glasgow; Reino Unido Fil: Anand, Inder S.. University of Minnesota; Estados Unidos Fil: Diaz, Rafael. Estudios Clínicos Latinoamérica; Argentina Fil: Maggioni, Aldo P.. Associazione Nazionale Medici Cardiologi Ospedalieri; Italia Fil: O'Connor, Christopher. University of Duke; Estados Unidos Fil: Pfeffer, Marc A.. Brigham and Women’s Hospita; Estados Unidos Fil: Solomon, Scott D.. Brigham and Women’s Hospital; Estados Unidos Fil: Tendera, Micha. Medical University of Silesia; Polonia Fil: van Veldhuisen, Dirk J.. University of Groningen; Países Bajos Fil: Moetaz, Albizem. Amgen Inc.; Estados Unidos Fil: Cheng, Sunfa. Amgen Inc.; Estados Unidos Fil: Scarlata, Debra. Amgen Inc.; Estados Unidos Fil: Swedberg, Karl. University of Gothenburg; Suecia Fil: Young, James B.. Cleveland Clinic. Endocrinology and Metabolism Institute; Estados Unidos Fil: Toblli, Jorge Eduardo. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina Fil: RED-HF Committees Investigators. No especifíca
Published: 2013
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39. The chronic heart failure evolutions: Different fates and routes.

Author: Agostoni P, Chiesa M, Salvioni E, Emdin M, Piepoli M, Sinagra G, Senni M, Bonomi A, Adamopoulos S, Miliopoulos D, Mapelli M, Campodonico J, Attanasio U, Apostolo A, Pestrin E, Rossoni A, Magrì D, Paolillo S, Corrà U, Raimondo R, Cittadini A, Iorio A, Salzano A, Lagioia R, Vignati C, Badagliacca R, Filardi PP, Correale M, Perna E, Metra M, Cattadori G, Guazzi M, Limongelli G, Parati G, De Martino F, Matassini MV, Bandera F, Bussotti M, Re F, Lombardi CM, Scardovi AB, Sciomer S, Passantino A, Santolamazza C, Girola D, Passino C, Karsten M, Nodari S, and Pompilio G
Abstract: Aims: Individual prognostic assessment and disease evolution pathways are undefined in chronic heart failure (HF). The application of unsupervised learning methodologies could help to identify patient phenotypes and the progression in each phenotype as well as to assess adverse event risk., Methods and Results: From a bulk of 7948 HF patients included in the MECKI registry, we selected patients with a minimum 2-year follow-up. We implemented a topological data analysis (TDA), based on 43 variables derived from clinical, biochemical, cardiac ultrasound, and exercise evaluations, to identify several patients' clusters. Thereafter, we used the trajectory analysis to describe the evolution of HF states, which is able to identify bifurcation points, characterized by different follow-up paths, as well as specific end-stages conditions of the disease. Finally, we conducted a 5-year survival analysis (composite of cardiovascular death, left ventricular assist device, or urgent heart transplant). Findings were validated on internal (n = 527) and external (n = 777) populations. We analyzed 4876 patients (age = 63 [53-71], male gender n = 3973 (81.5%), NYHA class I-II n = 3576 (73.3%), III-IV n = 1300 (26.7%), LVEF = 33 [25.5-39.9], atrial fibrillation n = 791 (16.2%), peak VO 2 % pred = 54.8 [43.8-67.2]), with a minimum 2-year follow-up. Nineteen patient clusters were identified by TDA. Trajectory analysis revealed a path characterized by 3 bifurcation and 4 end-stage points. Clusters survival rate varied from 44% to 100% at 2 years and from 20% to 100% at 5 years, respectively. The event frequency at 5-year follow-up for each study cohort cluster was successfully compared with those in the validation cohorts (R = 0.94 and R = 0.84, P < 0.001, for internal and external cohort, respectively). Finally, we conducted a 5-year survival analysis (composite of cardiovascular death, left ventricular assist device, or urgent heart transplant observed in 22% of cases)., Conclusions: Each HF phenotype has a specific disease progression and prognosis. These findings allow to individualize HF patient evolutions and to tailor assessment., (© 2024 The Author(s). ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)
Published: 2024
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40. A matter of sex-persistent predictive value of MECKI score prognostic power in men and women with heart failure and reduced ejection fraction: a multicenter study.

Author: Grilli G, Salvioni E, Moscucci F, Bonomi A, Sinagra G, Schaeffer M, Campodonico J, Mapelli M, Rossi M, Carriere C, Emdin M, Piepoli M, Paolillo S, Senni M, Passino C, Apostolo A, Re F, Santolamazza C, Magrì D, Lombardi CM, Corrà U, Raimondo R, Cittadini A, Iorio A, Salzano A, Lagioia R, Vignati C, Badagliacca R, Passantino A, Filardi PP, Correale M, Perna E, Girola D, Metra M, Cattadori G, Guazzi M, Limongelli G, Parati G, De Martino F, Matassini MV, Bandera F, Bussotti M, Scardovi AB, Sciomer S, and Agostoni P
Abstract: Background: A sex-based evaluation of prognosis in heart failure (HF) is lacking., Methods and Results: We analyzed the Metabolic Exercise test data combined with Cardiac and Kidney Indexes (MECKI) score registry, which includes HF with reduced ejection fraction (HFrEF) patients. A cross-validation procedure was performed to estimate weights separately for men and women of all MECKI score parameters: left ventricular ejection fraction (LVEF), hemoglobin, kidney function assessed by Modification of Diet in Renal Disease, blood sodium level, ventilation vs. carbon dioxide production slope, and peak oxygen consumption (peakVO 2 ). The primary outcomes were the composite of all-cause mortality, urgent heart transplant, and implant of a left ventricle assist device. The difference in predictive ability between the native and sex recalibrated MECKI (S-MECKI) was calculated using a receiver operating characteristic (ROC) curve at 2 years and a calibration plot. We retrospectively analyzed 7,900 HFrEF patients included in the MECKI score registry (mean age 61 ± 13 years, 6,456 men/1,444 women, mean LVEF 33% ± 10%, mean peakVO 2 56.2% ± 17.6% of predicted) with a median follow-up of 4.05 years (range 1.72-7.47). Our results revealed an unadjusted risk of events that was doubled in men compared to women (9.7 vs. 4.1) and a significant difference in weight between the sexes of most of the parameters included in the MECKI score. S-MECKI showed improved risk classification and accuracy (area under the ROC curve: 0.7893 vs. 0.7799, p = 0.02) due to prognostication improvement in the high-risk settings in both sexes (MECKI score >10 in men and >5 in women)., Conclusions: S-MECKI, i.e., the recalibrated MECKI according to sex-specific differences, constitutes a further step in the prognostic assessment of patients with severe HFrEF., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The handling editor RDP declared a past co-authorship with the author GP. The authors declared that they were an editorial board member of Frontiers at the time of submission. This had no impact on the peer review process and the final decision., (© 2024 Grilli, Salvioni, Moscucci, Bonomi, Sinagra, Schaeffer, Campodonico, Mapelli, Rossi, Carriere, Emdin, Piepoli, Paolillo, Senni, Passino, Apostolo, Re, Santolamazza, Magri, Lombardi, Corrá, Raimondo, Cittadini, Iorio, Salzano, Lagioia, Vignati, Badagliacca, Passantino, Filardi, Correale, Perna, Girola, Metra, Cattadori, Guazzi, Limongelli, Parati, De Martino, Matassini, Bandera, Bussotti, Scardovi, Sciomer, Agostoni and MECKI Score Research Group.)
Published: 2024
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41. Semaglutide and NT-proBNP in Obesity-Related HFpEF: Insights From the STEP-HFpEF Program.

Author: Petrie MC, Borlaug BA, Butler J, Davies MJ, Kitzman DW, Shah SJ, Verma S, Jensen TJ, Einfeldt MN, Liisberg K, Perna E, Sharma K, Ezekowitz JA, Fu M, Melenovský V, Ito H, Lelonek M, and Kosiborod MN
Subjects: Humans, Male, Female, Double-Blind Method, Aged, Middle Aged, Treatment Outcome, Natriuretic Peptide, Brain blood, Heart Failure drug therapy, Heart Failure blood, Heart Failure physiopathology, Peptide Fragments blood, Glucagon-Like Peptides therapeutic use, Obesity blood, Obesity complications, Obesity drug therapy, Stroke Volume drug effects, Stroke Volume physiology
Abstract: Background: The glucagon-like peptide-1 receptor agonist, semaglutide, improved health status and reduced body weight in patients with obesity-related heart failure (HF) with preserved ejection fraction (HFpEF) in the STEP-HFpEF (Semaglutide Treatment Effect in People with Obesity and HFpEF) program. Whether benefits were due to mechanical unloading or effects on HF pathobiology is uncertain., Objectives: This study sought to determine if semaglutide 2.4 mg reduced N-terminal pro-B-type natriuretic peptide (NT-proBNP) in patients with obesity-related HFpEF and compare treatment responses by baseline NT-proBNP., Methods: This was a prespecified secondary analysis of pooled data from 2 double-blind, placebo-controlled, randomized trials (STEP-HFpEF [Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity] and STEP-HFpEF DM [Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes]) testing effects of semaglutide in patients with obesity-related HFpEF. The main outcomes were change in NT-proBNP at 52 weeks and change in the dual primary endpoints of Kansas City Cardiomyopathy Questionnaire Clinical Summary Score and body weight by baseline NT-proBNP., Results: In total, 1,145 patients were randomized. Semaglutide compared with placebo reduced NT-proBNP at 52 weeks (estimated treatment ratio: 0.82; 95% CI: 0.74-0.91; P = 0.0002). Improvements in health status were more pronounced in those with higher vs lower baseline NT-proBNP (estimated difference: tertile 1: 4.5 points, 95% CI: 0.8-8.2; tertile 2: 6.2 points, 95% CI: 2.4-10.0; tertile 3: 11.9 points, 95% CI: 8.1-15.7; P interaction = 0.02; baseline NT-proBNP as a continuous variable: P interaction = 0.004). Reductions in body weight were consistent across baseline NT-proBNP levels (P interaction = 0.21)., Conclusions: In patients with obesity-related HFpEF, semaglutide reduced NT-proBNP. Participants with higher baseline NT-proBNP had a similar degree of weight loss but experienced larger reductions in HF-related symptoms and physical limitations with semaglutide than those with lower NT-proBNP., Competing Interests: Funding Support and Author Disclosures The STEP-HFpEF program was funded by Novo Nordisk. Dr Petrie has received grants from the British Heart Foundation Centre of Research Excellence Grant RE/18/6/34217; has received research funding from AstraZeneca, Boehringer Ingelheim, Boston Scientific, Medtronic, Novo Nordisk, Novartis, Pharmacosmos, Roche, and SQ Innovations; and has served on committees or consulted for AbbVie, Akero, AnaCardio, Applied Therapeutics, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Cardiorentis, Corvia, Eli Lilly, Horizon Therapeutics, LIB Therapeutics, Moderna, New Amsterdam, Novartis, Novo Nordisk, Pharmacosmos, Siemens, SQ Innovations, Takeda, Teikoku, and Vifor. Dr Borlaug has received grants from the National Institutes of Health (NIH), the United States Department of Defense, AstraZeneca, Axon, GlaxoSmithKline, Medtronic, Mesoblast, Novo Nordisk, Rivus, and Tenax Therapeutics; has received consulting fees from Actelion, Amgen, Aria, Axon Therapies, BD, Boehringer Ingelheim, Cytokinetics, Edwards Lifesciences, Eli Lilly, Imbria, Janssen, Merck, NGM, Novo Nordisk, NXT, and VADovations; and has been named inventor (U.S. patent no. 10,307,179) for the tools and approach for a minimally invasive pericardial modification procedure to treat heart failure. Dr Butler has received consulting fees from Abbott, American Regent, Amgen, Applied Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Cardiac Dimension, Cardior, CVRx, Cytokinetics, Daxor, Edwards Lifesciences, Element Science, Innolife, Impulse Dynamics, Imbria, Inventiva, Lexicon, Lilly, LivaNova, Janssen, Medtronics, Merck, Occlutech, Owkin, Novartis, Novo Nordisk, Pfizer, Pharmacosmos, PharmaIN, Prolaio, Roche, Secretome, Sequana, SQ Innovation, Tenex, and Vifor. Dr Davies has received consulting fees from, been an advisory board member for, and has been speaker for Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Sanofi; has been an advisory board member and speaker for AstraZeneca; has been an advisory board member for Medtronic, Pfizer, and ShouTi Pharma; has been a speaker for Amgen, Novartis, and Sanofi; and has received grants as an investigator in support of investigator-initiated trials from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Novo Nordisk, and Sanofi. Dr Kitzman has received grants from the Kermit Glenn Phillips II Chair in Cardiovascular Medicine, NIH grants U01AG076928, R01AG078153, R01AG045551, R01AG18915, P30AG021332, U24AG059624, and U01HL160272; has received honoraria as a consultant for AstraZeneca, Bayer, Boehringer Ingelheim, Corvia Medical, Ketyo, Novartis, Novo Nordisk, Pfizer, and Rivus; has received grant funding from AstraZeneca, Bayer, Novartis, Novo Nordisk, Pfizer, and Rivus; and has stock ownership in Gilead Sciences. Dr Shah has received grants from AstraZeneca, Corvia, Pfizer, the National Heart, Lung, and Blood Institute (U54 HL160273, R01 HL107577, R01 HL127028, R01 HL140731, and R01 HL149423); and has received consulting fees from Abbott, Alleviant, Amgen, Aria CV, AstraZeneca, Axon Therapies, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cyclerion, Cytokinetics, Edwards Lifesciences, Eidos, Imara, Impulse Dynamics, Intellia, Ionis, Lilly, Merck, MyoKardia, Novartis, Novo Nordisk, Pfizer, Prothena, ReCor, Regeneron, Rivus, Sardocor, Shifamed, Tenax, Tenaya, and Ultromics. Dr Verma has received speaking honoraria and/or consulting fees from Abbott, Amarin, AstraZeneca, Bayer, Boehringer Ingelheim, Canadian Medical and Surgical Knowledge Translation Research Group, Eli Lilly, HLS Therapeutics, Janssen, Merck, Novartis, Novo Nordisk, Pfizer, PhaseBio, and TIMI. Drs Jensen and Einfeldt and Ms Liisberg are employees of Novo Nordisk A/S and shareholders. Dr Perna has received honoraria from Novo Nordisk. Dr Sharma has been an advisory board member for and has received consulting fees from Alleviant, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Cytokinetics, Janssen, Novartis, Novo Nordisk, and Rivus. Dr Ezekowitz has received research support for trial leadership from American Regent, Applied Therapeutics, Bayer, Cytokinetics, Merck, and Novo Nordisk; has received consulting fees from AstraZeneca, Bayer, Boehringer Ingelheim, Novartis, Novo Nordisk, and Otsuka; and has served as an advisor to US2.ai. Dr Melenovský has received consulting fees from Bayer, Merck Sharp & Dohme, and Novo Nordisk; has received research grants from Regeneron; and has received research support from the National Institute for Research on Metabolic and Cardiovascular Diseases (Programme EXCELES, ID Project No. LX22NPO5104), funded by the European Union – Next Generation EU. Dr Ito has received honoraria and/or consulting fees from AstraZeneca, Bayer, Boehringer Ingelheim, Daiichi-Sankyo, Mochida, Novartis, and Novo Nordisk. Dr Lelonek has received honoraria and/or consulting fees from AstraZeneca, Bayer, Boehringer Ingelheim, Ewopharma, Gedeon Richter, Novartis, Novo Nordisk, Roche, and Servier. Dr Kosiborod has received consulting or advisory board fees from 35Pharma, Alnylam, Amgen, Applied Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Dexcom, Eli Lilly, Esperion Therapeutics, Imbria Pharmaceuticals, Janssen, Lexicon Pharmaceuticals, Merck (Diabetes and Cardiovascular), Novo Nordisk, Pharmacosmos, Pfizer, Sanofi, scPharmaceuticals, Structure Therapeutics, Vifor Pharma, and Youngene Therapeutics; has received research grants from AstraZeneca, Boehringer Ingelheim, and Pfizer; holds stocks in Artera Health and Saghmos Therapeutics; has received honoraria from AstraZeneca, Boehringer Ingelheim, and Novo Nordisk; and has received other research support from AstraZeneca. Dr Fu has reported that he has no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
Published: 2024
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42. Real-world data of patients affected by advanced heart failure treated with implantable cardioverter defibrillator and left ventricular assist device: Results of a multicenter observational study.

Author: Rordorf R, Pignalosa L, Casula M, Perna E, Baroni M, Garascia A, Guida S, Gazzoli F, Pini D, Cannata F, Pellegrino M, Vittori C, De Filippo P, Malanchini G, Vergara P, Della Bella P, and Gulletta S
Subjects: Female, Humans, Male, Arrhythmias, Cardiac etiology, Retrospective Studies, Treatment Outcome, Middle Aged, Defibrillators, Implantable adverse effects, Heart Failure surgery, Heart Failure etiology, Heart-Assist Devices adverse effects, Tachycardia, Ventricular etiology
Abstract: Background: Left ventricular assist device (L-VAD) implantation is increasingly used in patients with heart failure (HF) and most patients also have an implantable cardioverter defibrillator (ICD). Limited data are available on the incidence of ICD therapies and complications in this special setting. The aim of this study was to analyze the real-world incidence and predictors of ICD therapies, complications and interactions between ICD and L-VAD., Methods: We conducted a multicenter retrospective observational study in patients with advanced HF implanted with ICD and a continuous-flow L-VAD, followed-up in five advanced HF centers in Northern Italy., Results: A total of 234 patients (89.7% male, median age 59, 48.3% with ischemic etiology) were enrolled. After a median follow-up of 21 months, 66 patients (28.2%) experienced an appropriate ICD therapy, 22 patients (9.4%) an inappropriate ICD therapy, and 17 patients (7.3%) suffered from an interaction between ICD and L-VAD. The composite outcome of all ICD-related complications was reported in 41 patients (17.5%), and 121 (51.7%) experienced an L-VAD-related complication. At multivariable analysis, an active ventricular tachycardia (VT) zone and a prior ICD generator replacement were independent predictors of ICD therapies and of total ICD-related complications, respectively., Conclusions: Real-world patients with both L-VAD and ICD experience a high rate of ICD therapies and complications. Our findings suggest the importance of tailoring device programming in order to minimize the incidence of unnecessary ICD therapies, thus sparing the need for ICD generator replacement, a procedure associated to a high risk of complications., (© 2024 The Authors. Artificial Organs published by International Center for Artificial Organ and Transplantation (ICAOT) and Wiley Periodicals LLC.)
Published: 2024
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43. Semaglutide versus placebo in people with obesity-related heart failure with preserved ejection fraction: a pooled analysis of the STEP-HFpEF and STEP-HFpEF DM randomised trials.

Author: Butler J, Shah SJ, Petrie MC, Borlaug BA, Abildstrøm SZ, Davies MJ, Hovingh GK, Kitzman DW, Møller DV, Verma S, Einfeldt MN, Lindegaard ML, Rasmussen S, Abhayaratna W, Ahmed FZ, Ben-Gal T, Chopra V, Ezekowitz JA, Fu M, Ito H, Lelonek M, Melenovský V, Merkely B, Núñez J, Perna E, Schou M, Senni M, Sharma K, van der Meer P, Von Lewinski D, Wolf D, and Kosiborod MN
Subjects: Humans, Male, Female, Aged, Middle Aged, Double-Blind Method, Treatment Outcome, Randomized Controlled Trials as Topic, Heart Failure drug therapy, Glucagon-Like Peptides therapeutic use, Glucagon-Like Peptides administration & dosage, Stroke Volume drug effects, Obesity complications, Obesity drug therapy
Abstract: Background: In the STEP-HFpEF (NCT04788511) and STEP-HFpEF DM (NCT04916470) trials, the GLP-1 receptor agonist semaglutide improved symptoms, physical limitations, bodyweight, and exercise function in people with obesity-related heart failure with preserved ejection fraction. In this prespecified pooled analysis of the STEP-HFpEF and STEP-HFpEF DM trials, we aimed to provide a more definitive assessment of the effects of semaglutide across a range of outcomes and to test whether these effects were consistent across key patient subgroups., Methods: We conducted a prespecified pooled analysis of individual patient data from STEP-HFpEF and STEP-HFpEF DM, randomised, double-blind, placebo-controlled trials at 129 clinical research sites in 18 countries. In both trials, eligible participants were aged 18 years or older, had heart failure with a left ventricular ejection fraction of at least 45%, a BMI of at least 30 kg/m 2 , New York Heart Association class II-IV symptoms, and a Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS; a measure of heart failure-related symptoms and physical limitations) of less than 90 points. In STEP-HFpEF, people with diabetes or glycated haemoglobin A 1c concentrations of at least 6·5% were excluded, whereas for inclusion in STEP-HFpEF DM participants had to have been diagnosed with type 2 diabetes at least 90 days before screening and to have an HbA 1c of 10% or lower. In both trials, participants were randomly assigned to either 2·4 mg semaglutide once weekly or matched placebo for 52 weeks. The dual primary endpoints were change from baseline to week 52 in KCCQ-CSS and bodyweight in all randomly assigned participants. Confirmatory secondary endpoints included change from baseline to week 52 in 6-min walk distance, a hierarchical composite endpoint (all-cause death, heart failure events, and differences in changes in KCCQ-CSS and 6-min walk distance); and C-reactive protein (CRP) concentrations. Heterogeneity in treatment effects was assessed across subgroups of interest. We assessed safety in all participants who received at least one dose of study drug., Findings: Between March 19, 2021 and March 9, 2022, 529 people were randomly assigned in STEP-HFpEF, and between June 27, 2021 and Sept 2, 2022, 616 were randomly assigned in STEP-HFpEF DM. Overall, 1145 were included in our pooled analysis, 573 in the semaglutide group and 572 in the placebo group. Improvements in KCCQ-CSS and reductions in bodyweight between baseline and week 52 were significantly greater in the semaglutide group than in the placebo group (mean between-group difference for the change from baseline to week 52 in KCCQ-CSS 7·5 points [95% CI 5·3 to 9·8]; p<0·0001; mean between-group difference in bodyweight at week 52 -8·4% [-9·2 to -7·5]; p<0·0001). For the confirmatory secondary endpoints, 6-min walk distance (mean between-group difference at week 52 17·1 metres [9·2 to 25·0]) and the hierarchical composite endpoint (win ratio 1·65 [1·42 to 1·91]) were significantly improved, and CRP concentrations (treatment ratio 0·64 [0·56 to 0·72]) were significantly reduced, in the semaglutide group compared with the placebo group (p<0·0001 for all comparisons). For the dual primary endpoints, the efficacy of semaglutide was largely consistent across multiple subgroups, including those defined by age, race, sex, BMI, systolic blood pressure, baseline CRP, and left ventricular ejection fraction. 161 serious adverse events were reported in the semaglutide group compared with 301 in the placebo group., Interpretation: In this prespecified pooled analysis of the STEP-HFpEF and STEP-HFpEF DM trials, semaglutide was superior to placebo in improving heart failure-related symptoms and physical limitations, and reducing bodyweight in participants with obesity-related heart failure with preserved ejection fraction. These effects were largely consistent across patient demographic and clinical characteristics. Semaglutide was well tolerated., Funding: Novo Nordisk., Competing Interests: Declaration of interests JB is a paid consultant to Abbott, American Regent, Amgen, Applied Therapeutic, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Cardiac Dimension, Cardior, CVRx, Cytokinetics, Daxor Edwards, Element Science, Innolife, Impulse Dynamics, Imbria, Inventiva, Lexicon, Lilly, LivaNova, Janssen, Medtronics, Merck, Occlutech, Owkin, Novartis, Novo Nordisk, Pfizer, Pharmacosmos, Pharmain, Prolaio, Roche, Secretome, Sequana, SQ Innovation, Tenex, and Vifor. SJS has received research grants from AstraZeneca, Corvia, and Pfizer, and consulting fees from Abbott, Alleviant, AstraZeneca, Amgen, Aria CV, Axon Therapies, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cyclerion, Cytokinetics, Edwards Lifesciences, Eidos, Imara, Impulse Dynamics, Intellia, Ionis, Lilly, Merck, MyoKardia, Novartis, Novo Nordisk, Pfizer, Prothena, ReCor, Regeneron, Rivus, Sardocor, Shifamed, Tenax, Tenaya, and Ultromics. MCP has received research funding from AstraZeneca, Boehringer Ingelheim, Boston Scientific, Medtronic, Novo Nordisk, Novartis, Pharmacosmos, Roche, and SQ Innovations, and has served on committees or consulted for AbbVie, Akero, AnaCardio, Applied Therapeutics, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Cardiorentis, Corvia, Eli Lilly, Horizon Therapeutics, LIB Therapeutics, Moderna, New Amsterdam, Novartis, Novo Nordisk, Pharmacosmos, Siemens, SQ Innovations, Takeda, Teikoku, and Vifor. BAB has received research funding from AstraZeneca, Axon, GlaxoSmithKline, Medtronic, Mesoblast, Novo Nordisk, Rivus, and Tenax Therapeutics, has served as a paid consultant for Actelion, Amgen, Aria, Axon Therapies, BD, Boehringer Ingelheim, Cytokinetics, Edwards Lifesciences, Eli Lilly, Imbria, Janssen, Merck, NGM, Novo Nordisk, NXT, and VADovations, and is named inventor (US patent number 10 307 179) for the tools and approach for a minimally invasive pericardial modification procedure to treat heart failure. SZA, GKH, DVM, MNE, MLL, and SR are employees of, and shareholders in, Novo Nordisk. MJD has acted as paid consultant, advisory board member, and speaker for Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Sanofi, a paid advisory board member and speaker for AstraZeneca, a paid advisory board member for Medtronic, Pfizer, and ShouTi Pharma, and a paid speaker for Amgen, Novartis, and Sanofi, and has received grants as an investigator in support of investigator-initiated trials from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Novo Nordisk, and Sanofi-Aventis. DWK reports receiving honoraria as a consultant for AstraZeneca, Bayer, Boehringer Ingelheim, Corvia Medical, Ketyo, Novartis, Novo Nordisk, Pfizer, and Rivus, has received grant funding from AstraZeneca, Bayer, Novartis, Novo Nordisk, Pfizer, and Rivus, and owns stock in Gilead. SV reports speaking honoraria or consulting fees from Abbott, Amarin, AstraZeneca, Bayer, Boehringer Ingelheim, Canadian Medical and Surgical Knowledge Translation Research Group, Eli Lilly, HLS Therapeutics, Janssen, Merck, Novartis, Novo Nordisk, Pfizer, PhaseBio, and TIMI. WA reports honoraria or consulting fees from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Novartis, and Novo Nordisk. FZA reports honoraria or consulting fees from Abbott, AstraZeneca, Medtronic, Novo Nordisk, Occlutech, Pharmacosmos, and Vifor. VC reports speaker fees from AstraZeneca, Boehringer Ingelheim, Cipla, Dr Reddy's, Lupin, Novartis, Novo Nordisk, Mankind, Pfizer, Sanofi, Sun Pharma, and Torrent. JAE reports research support for trial leadership from American Regent, Applied Therapeutics, Bayer, Cytokinetics, Merck, and Novo Nordisk, reports honoraria for consultancy from AstraZeneca, Bayer, Boehringer Ingelheim, Novartis, Novo Nordisk, and Otsuka, and serves as an advisor to US2.ai. HI reports honoraria or consulting fees from AstraZeneca, Bayer, Boehringer Ingelheim, Daiichi-Sankyo, Mochida, Novartis, and Novo Nordisk. ML reports honoraria or consulting fees from AstraZeneca, Bayer, Boehringer Ingelheim, Ewopharma, Gedeon Richter, Novartis, Novo Nordisk, Roche, and Servier. VM reports consulting fees from Bayer, Merck Sharp & Dohme, and Novo Nordisk and research grants from Regeneron. BM reports speaker fees or research payments from Abbott, AstraZeneca, Biotronik, Boehringer Ingelheim, CSL Behring, Daiichi-Sankyo, DUKE Clinical Institute, Medtronic, and Novartis, and institutional grants from Abbott, AstraZeneca, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, CSL Behring, Daiichi-Sankyo, DUKE Clinical Institute, Eli Lilly, Medtronic, Novartis, Terumo, and Vifor. JN reports honoraria or consulting fees from Alleviant, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Pfizer, Novartis, Novo Nordisk, Rovi, and Vifor. EP reports honoraria from Novo Nordisk. MSc reports speaker fees from AstraZeneca, Boehringer Ingelheim, Novartis, and Novo Nordisk. MSe reports honoraria or consulting fees from Abbott, AstraZeneca, Bayer, Boehringer Ingelheim, Merck, Merck Sharp & Dohme, Novartis, Novo Nordisk, and Vifor. KS received honoraria for serving as an advisory board member and consultant for Alleviant, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Cytokinetics, Janssen, Novartis, Novo Nordisk, and Rivus. PvdM reports institutional payments for consultancy fees or grants from AstraZeneca, Boehringer Ingelheim, BridgeBio, Ionis, Novartis, Novo Nordisk, Pfizer, Pharmacosmos, Pharma Nord, and Vifor. DVL reports honoraria or consulting fees from AstraZeneca, Bayer, Boehringer Ingelheim, Merck Sharp & Dohme, Novartis, Novo Nordisk, Recardio, Sanofi, Sanova, and Vaxxinity. DW reports consultancy fees from Novo Nordisk. MNK served as a paid consultant or advisory board member for 35Pharma, Alnylam, Amgen, Applied Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Dexcom, Eli Lilly, Esperion Therapeutics, Imbria Pharmaceuticals, Janssen, Lexicon Pharmaceuticals, Merck (Diabetes and Cardiovascular), Novo Nordisk, Pharmacosmos, Pfizer, Sanofi, scPharmaceuticals, Structure Therapeutics, Vifor, and Youngene Therapeutics, has received research grants from AstraZeneca, Boehringer Ingelheim, and Pfizer, holds stocks in Artera Health and Saghmos Therapeutics, has received honoraria from AstraZeneca, Boehringer Ingelheim, and Novo Nordisk, and has received other research support from AstraZeneca. TB-G and MF report no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved.)
Published: 2024
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44. Semaglutide in Patients with Obesity-Related Heart Failure and Type 2 Diabetes.

Author: Kosiborod MN, Petrie MC, Borlaug BA, Butler J, Davies MJ, Hovingh GK, Kitzman DW, Møller DV, Treppendahl MB, Verma S, Jensen TJ, Liisberg K, Lindegaard ML, Abhayaratna W, Ahmed FZ, Ben-Gal T, Chopra V, Ezekowitz JA, Fu M, Ito H, Lelonek M, Melenovský V, Merkely B, Núñez J, Perna E, Schou M, Senni M, Sharma K, van der Meer P, Von Lewinski D, Wolf D, and Shah SJ
Subjects: Humans, Double-Blind Method, Stroke Volume, Diabetes Mellitus, Type 2 drug therapy, Diabetes Mellitus, Type 2 etiology, Glucagon-Like Peptides administration & dosage, Glucagon-Like Peptides adverse effects, Glucagon-Like Peptides therapeutic use, Heart Failure drug therapy, Heart Failure etiology, Obesity complications, Obesity drug therapy, Glucagon-Like Peptide-1 Receptor Agonists administration & dosage, Glucagon-Like Peptide-1 Receptor Agonists adverse effects, Glucagon-Like Peptide-1 Receptor Agonists therapeutic use
Abstract: Background: Obesity and type 2 diabetes are prevalent in patients with heart failure with preserved ejection fraction and are characterized by a high symptom burden. No approved therapies specifically target obesity-related heart failure with preserved ejection fraction in persons with type 2 diabetes., Methods: We randomly assigned patients who had heart failure with preserved ejection fraction, a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 or more, and type 2 diabetes to receive once-weekly semaglutide (2.4 mg) or placebo for 52 weeks. The primary end points were the change from baseline in the Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS; scores range from 0 to 100, with higher scores indicating fewer symptoms and physical limitations) and the change in body weight. Confirmatory secondary end points included the change in 6-minute walk distance; a hierarchical composite end point that included death, heart failure events, and differences in the change in the KCCQ-CSS and 6-minute walk distance; and the change in the C-reactive protein (CRP) level., Results: A total of 616 participants underwent randomization. The mean change in the KCCQ-CSS was 13.7 points with semaglutide and 6.4 points with placebo (estimated difference, 7.3 points; 95% confidence interval [CI], 4.1 to 10.4; P<0.001), and the mean percentage change in body weight was -9.8% with semaglutide and -3.4% with placebo (estimated difference, -6.4 percentage points; 95% CI, -7.6 to -5.2; P<0.001). The results for the confirmatory secondary end points favored semaglutide over placebo (estimated between-group difference in change in 6-minute walk distance, 14.3 m [95% CI, 3.7 to 24.9; P = 0.008]; win ratio for hierarchical composite end point, 1.58 [95% CI, 1.29 to 1.94; P<0.001]; and estimated treatment ratio for change in CRP level, 0.67 [95% CI, 0.55 to 0.80; P<0.001]). Serious adverse events were reported in 55 participants (17.7%) in the semaglutide group and 88 (28.8%) in the placebo group., Conclusions: Among patients with obesity-related heart failure with preserved ejection fraction and type 2 diabetes, semaglutide led to larger reductions in heart failure-related symptoms and physical limitations and greater weight loss than placebo at 1 year. (Funded by Novo Nordisk; STEP-HFpEF DM ClinicalTrials.gov number, NCT04916470.)., (Copyright © 2024 Massachusetts Medical Society.)
Published: 2024
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45. Estimation of Right Atrial Pressure by Ultrasound-Assessed Jugular Vein Distensibility in Patients With Heart Failure.

Author: Ammirati E, Marchetti D, Colombo G, Pellicori P, Gentile P, D'Angelo L, Masciocco G, Verde A, Macera F, Brunelli D, Occhi L, Musca F, Perna E, Bernasconi DP, Moreo A, Camici PG, Metra M, Oliva F, and Garascia A
Subjects: Humans, Atrial Pressure, Cardiac Catheterization, Catheterization, Swan-Ganz, Jugular Veins diagnostic imaging, Pulmonary Wedge Pressure, Stroke Volume, Heart Failure diagnostic imaging, Heart Failure therapy
Abstract: Background: Clinical evaluation of central venous pressure is difficult, depends on experience, and is often inaccurate in patients with chronic advanced heart failure. We assessed the ultrasound-assessed internal jugular vein (JV) distensibility by ultrasound as a noninvasive tool to identify patients with normal right atrial pressure (RAP ≤7 mm Hg) in this population., Methods: We measured JV distensibility as the Valsalva-to-rest ratio of the vein diameter in a calibration cohort (N=100) and a validation cohort (N=101) of consecutive patients with chronic heart failure with reduced ejection fraction who underwent pulmonary artery catheterization for advanced heart failure therapies workup., Results: A JV distensibility threshold of 1.6 was identified as the most accurate to discriminate between patients with RAP ≤7 versus >7 mm Hg (area under the receiver operating characteristic curve, 0.74 [95% CI, 0.64-0.84]) and confirmed in the validation cohort (receiver operating characteristic, 0.82 [95% CI, 0.73-0.92]). A JV distensibility ratio >1.6 had predictive positive values of 0.86 and 0.94, respectively, to identify patients with RAP ≤7 mm Hg in the calibration and validation cohorts. Compared with patients from the calibration cohort with a high JV distensibility ratio (>1.6; n=42; median RAP, 4 mm Hg; pulmonary capillary wedge pressure, 11 mm Hg), those with a low JV distensibility ratio (≤1.6; n=58; median RAP, 8 mm Hg; pulmonary capillary wedge pressure, 22 mm Hg; P <0.0001 for both) were more likely to die or undergo a left ventricular assist device implant or heart transplantation (event rate at 2 years: 42.7% versus 18.2%; log-rank P =0.034)., Conclusions: Ultrasound-assessed JV distensibility identifies patients with chronic advanced heart failure with normal RAP and better outcomes., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03874312., Competing Interests: Disclosures The authors disclose that Dr Ammirati received a grant from the Italian Ministry of Health (GR-2019-12368506) and a grant from the NextGenerationEU (M6C2/2.1 PNRR-MAD-2022-12376225—CUP H43C21000140006) and served as a consultant for Kiniksa Pharmaceuticals, Cytokinetics, and AstraZeneca. Dr Pellicori has received consultancy honoraria and sponsorship support from Boehringer Ingelheim, Pharmacosmos, Novartis, Vifor, AstraZeneca, and Caption Health and research support from Bristol Myers Squibb in the past 5 years, not connected with this article. Prof Metra is the outgoing Editor-in-Chief of the European Journal of Heart Failure. The other authors report no conflicts.
Published: 2024
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46. Exploring the Prognostic Performance of MECKI Score in Heart Failure Patients with Non-Valvular Atrial Fibrillation Treated with Edoxaban.

Author: Mapelli M, Mattavelli I, Salvioni E, Capra N, Bonomi A, Cattadori G, Pezzuto B, Campodonico J, Piotti A, Nava A, Piepoli M, Magrì D, Paolillo S, Corrà U, Raimondo R, Lagioia R, Vignati C, Badagliacca R, Perrone Filardi P, Senni M, Correale M, Cicoira M, Metra M, Guazzi M, Limongelli G, Parati G, De Martino F, Bandera F, Bussotti M, Re F, Lombardi CM, Scardovi AB, Sciomer S, Passantino A, Emdin M, Santolamazza C, Perna E, Passino C, Sinagra G, and Agostoni P
Abstract: Introduction: Risk stratification in heart failure (HF) is essential for clinical and therapeutic management. The Metabolic Exercise test data combined with Cardiac and Kidney Indexes (MECKI) score is a validated prognostic model for assessing cardiovascular risk in HF patients with reduced ejection fraction (HFrEF). From the validation of the score, the prevalence of HF patients treated with direct oral anticoagulants (DOACs), such as edoxaban, for non-valvular atrial fibrillation (NVAF) has been increasing in recent years. This study aims to evaluate the reliability of the MECKI score in HFrEF patients treated with edoxaban for NVAF., Materials and Methods: This study included consecutive outpatients with HF and NVAF treated with edoxaban ( n = 83) who underwent a cardiopulmonary exercise test (CPET). They were matched by propensity score with a retrospective group of HFrEF patients with NVAF treated with vitamin K antagonists (VKAs) from the MECKI score registry ( n = 844). The study endpoint was the risk of cardiovascular mortality, urgent heart transplantation, or Left Ventricle Assist Device (LVAD) implantation., Results: Edoxaban patients were treated with a more optimized HF therapy and had different clinical characteristics, with a similar MECKI score. After propensity score, 77 patients treated with edoxaban were successfully matched with the MECKI-VKA control cohort. In both groups, MECKI accurately predicted the composite endpoint with similar area under the curves (AUC = 0.757 vs. 0.829 in the MECKI-VKA vs. edoxaban-treated group, respectively, p = 0.452). The two populations' survival appeared non-significantly different at the 2-year follow-up., Conclusions: this study confirms the prognostic accuracy of the MECKI score in HFrEF patients with NVAF treated with edoxaban, showing improved predictive power compared to VKA-treated patients.
Published: 2023
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47. Semaglutide in Patients With Obesity and Heart Failure Across Mildly Reduced or Preserved Ejection Fraction.

Author: Butler J, Abildstrøm SZ, Borlaug BA, Davies MJ, Kitzman DW, Petrie MC, Shah SJ, Verma S, Abhayaratna WP, Chopra V, Ezekowitz JA, Fu M, Ito H, Lelonek M, Núñez J, Perna E, Schou M, Senni M, van der Meer P, von Lewinski D, Wolf D, Altschul RL, Rasmussen S, and Kosiborod MN
Subjects: Humans, Stroke Volume, Ventricular Function, Left, Obesity complications, Obesity drug therapy, Heart Failure
Abstract: Background: Many therapies for heart failure (HF) have shown differential impact across the spectrum of left ventricular ejection fraction (LVEF)., Objectives: In this prespecified analysis, the authors assessed the effects of semaglutide across the baseline LVEF strata in patients with the obesity phenotype of HF with preserved ejection fraction (HFpEF) in the STEP-HFpEF (Semaglutide Treatment Effect in People with obesity and HFpEF) trial., Methods: STEP-HFpEF randomized 529 patients (263 semaglutide; 266 placebo). For this prespecified analysis, patients were categorized into 3 groups based on LVEF: 45% to 49% (n = 85), 50% to 59% (n = 215), and ≥60% (n = 229)., Results: At 52 weeks, semaglutide improved the dual primary endpoints of Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (estimated treatment difference: EF [ejection fraction] 45%-49%: 5.0 points [95% CI: -2.7 to 12.8 points], EF 50%-59%: 9.8 points [95% CI: 5.0 to 14.6 points], and EF ≥60%: 7.4 points [95% CI: 2.8 to 12.0 points]; P interaction = 0.56) and body weight (EF: 45%-49%: -7.6 [95% CI: -10.7 to -4.4], EF 50%-59%: -10.6 [95% CI: -12.6 to -8.6] and EF ≥60%: -11.9 [95% CI: -13.8 to -9.9]; P interaction = 0.08), to a similar extent across LVEF categories. Likewise, LVEF did not influence the benefit of semaglutide on confirmatory secondary endpoints: 6-minute walk distance (P interaction = 0.19), hierarchal composite endpoint (P interaction = 0.43), and high-sensitivity C-reactive protein (P interaction = 0.26); or exploratory endpoint of N-terminal pro-brain natriuretic peptide (P interaction = 0.96). Semaglutide was well-tolerated across LVEF categories., Conclusions: In patients with HFpEF and obesity, semaglutide 2.4 mg improved symptoms, physical limitations, and exercise function, and reduced inflammation and body weight to a similar extent across LVEF categories. These data support treatment with semaglutide in patients with the obesity phenotype of HFpEF regardless of LVEF. (Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity [STEP-HFpEF]; NCT04788511)., Competing Interests: Funding Support and Author Disclosures The STEP-HFpEF trial was funded by Novo Nordisk A/S. Dr Butler is a consultant to 3live, Abbott, American Regent, Amgen, Applied Therapeutic, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Cardiac Dimension, Cardior, CVRx, Cytokinetics, Edwards, Element Science, Innolife, Impulse Dynamics, Imbria, Inventiva, Lexicon, Lilly, LivaNova, Janssen, Medtronic, Merck, Occlutech, Novartis, Novo Nordisk, Pfizer, Pharmacosmos, Pharmain, Roche, Sequana, SQ Innovation, and Vifor. Dr Borlaug has received research support from the National Institutes of Health and the U.S. Department of Defense; has received research grant funding from AstraZeneca, Axon, GlaxoSmithKline, Medtronic, Mesoblast, Novo Nordisk, Rivus, and Tenax Therapeutics; has served as a consultant for Actelion, Amgen, Aria, Axon Therapies, BD, Boehringer Ingelheim, Cytokinetics, Edwards Lifesciences, Eli Lilly, Imbria, Janssen, Merck, Novo Nordisk, NGM, NXT, and VADovations; and is a named inventor (U.S. Patent number 10,307,179) for the tools and approach for a minimally invasive pericardial modification procedure to treat heart failure. Dr Davies has acted as a consultant, advisory board member, and speaker for Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Sanofi; has served as an advisory board member and speaker for AstraZeneca; has served as an advisory board member for Medtronic, Pfizer, and ShouTi Pharma; has served as a speaker for Amgen, Novartis, and Sanofi; and has received grants in support of investigator and investigator-initiated trials from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Novo Nordisk, and Sanofi. Dr Kitzman was supported in part by the Kermit Glenn Phillips II Chair in Cardiovascular Medicine and National Institutes of Health grants U01AG076928, R01AG078153, R01AG045551, R01AG18915, and U01HL160272; has received honoraria as a consultant for AstraZeneca, Bayer, Boehringer Ingelheim, Corvia Medical, Ketyo, Novartis, Novo Nordisk, Pfizer, and Rivus; has received grant funding from AstraZeneca, Bayer, Novartis, Novo Nordisk, Pfizer, and Rivus; and has stock ownership in Gilead Sciences. Dr Petrie has received research funding from AstraZeneca, Boehringer Ingelheim, Boston Scientific, Medtronic, Novartis, Novo Nordisk, Pharmacosmos, Roche, and SQ Innovations; and has received consultancy and committee payments for AbbVie, Akero, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Cardiorentis, Horizon Therapeutics, New Amsterdam, Novartis, Novo Nordisk, Pharmacosmos, Siemens, Takeda, Teikoku, and Vifor. Dr Shah has received consulting fees from Abbott, Amgen, Aria CV, AstraZeneca, Axon Therapies, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cyclerion, Cytokinetics, Edwards Lifesciences, Eidos, Imara, Impulse Dynamics, Intellia, Ionis, Lilly, Merck, Metabolic Flux, MyoKardia, NGM Biopharmaceuticals, Novartis, Novo Nordisk, Pfizer, Prothena, Regeneron, Rivus, Sardocor, Shifamed, Tenax, Tenaya, and United Therapeutics. Dr Verma has received research grants or consultancy fees from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Napp Pharmaceuticals, Novartis, Novo Nordisk, Pharmacosmos, Roche, and SQ Innovations; has served on committees for AbbVie, Akero, Alnylam, AstraZeneca, Bayer, Boehringer Ingelheim, GlaxoSmithKline, New Amsterdam, Novo Nordisk, Resverlogix, and Teikoku; and is Director of Global Clinical Trial Partners (GCTP). Dr Abhayaratna has received honoraria and/or consulting fees from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Novartis, and Novo Nordisk. Dr Chopra has received speaker fees from AstraZeneca, Boehringer Ingelheim, Cipla, Dr Reddy’s, Lupin, Mankind, Novartis, Novo Nordisk, Pfizer, Sanofi, Sun Pharma, and Torrent. Dr Ezekowitz has received research support for trial leadership from American Regent, Applied Therapeutics, Bayer, Cytokinetics, Merck, and Novo Nordisk; has received honoraria for consultancy from AstraZeneca, Bayer, Boehringer Ingelheim, Novartis, Novo Nordisk, and Otsuka; and serves as an advisor to US2.ai. Dr Ito has received honoraria and/or consulting fees from AstraZeneca, Bayer, Boehringer Ingelheim, Daiichi-Sankyo, Mochida, Novartis, and Novo Nordisk. Dr Lelonek has received honoraria and/or consulting fees from AstraZeneca, Bayer, Boehringer Ingelheim, Ewopharma, Gedeon Richter, Novartis, Novo Nordisk, Roche, and Servier. Dr Núñez has received honoraria and/or consulting fees from Alleviant, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Novartis, Novo Nordisk, Pfizer, Rovi, and Vifor. Dr Perna has received honoraria from Novo Nordisk. Dr Schou has received speaker fees from AstraZeneca, Boehringer Ingelheim, Novartis, and Novo Nordisk. Dr Senni has received honoraria and/or consulting fees from Abbott, AstraZeneca, Bayer, Boehringer Ingelheim, Merck, MSD, Novartis, Novo Nordisk, and Vifor. Dr van der Meer has received institutional payments for consultancy fees and/or grants from AstraZeneca, Boehringer Ingelheim, BridgeBio, Ionis, Novartis, Novo Nordisk, Pfizer, Pharmacosmos, Pharma Nord, and Vifor. Dr von Lewinski has received honoraria and/or consulting fees from AstraZeneca, Bayer, Boehringer Ingelheim, MSD, Novartis, Novo Nordisk, Recardio, Sanofi, Sanova, and Vaxxinity. Dr Wolf is a member of SFB1425, funded by the Deutsche Forschungsgemeinschaft (German Research Foundation); and has received consultancy fees from Novo Nordisk and Novartis. Drs Abildstrøm, Altschul, and Rasmussen are employees of and hold shares in Novo Nordisk. Dr Kosiborod has served as a consultant or on an advisory board for 35Pharma, Alnylam, Amgen, Applied Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Dexcom, Eli Lilly, Esperion Therapeutics, Janssen, Lexicon Pharmaceuticals, Merck (Diabetes and Cardiovascular), Novo Nordisk, Pfizer, Pharmacosmos, Sanofi, scPharmaceuticals, Structure Therapeutics, Vifor Pharma, and Youngene Therapeutics; has received research grants from AstraZeneca, Boehringer Ingelheim, and Pfizer; holds stocks in Artera Health and Saghmos Therapeutics; has received honoraria from AstraZeneca, Boehringer Ingelheim, and Novo Nordisk; and has received other research support from AstraZeneca. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)
Published: 2023
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48. Heart failure patients with improved ejection fraction: Insights from the MECKI score database.

Author: Agostoni P, Pluchinotta FR, Salvioni E, Mapelli M, Galotta A, Bonomi A, Magrì D, Perna E, Paolillo S, Corrà U, Raimondo R, Lagioia R, Badagliacca R, Perrone Filardi P, Apostolo A, Senni M, Iorio A, Correale M, Campodonico J, Palermo P, Cicoira M, Metra M, Guazzi M, Limongelli G, Contini M, Pezzuto B, Sinagra G, Parati G, Cattadori G, Carriere C, Cittar M, Matassini MV, Salzano A, Cittadini A, Masè M, Bandera F, Bussotti M, Mattavelli I, Re F, Vignati C, Lombardi C, Scardovi AB, Sciomer S, Passantino A, Emdin M, Di Lenarda A, Passino C, Santolamazza C, Moscucci F, Zaffalon D, and Piepoli M
Subjects: Humans, Stroke Volume, Ventricular Function, Left, Exercise Test methods, Follow-Up Studies, Prognosis, Kidney, Heart Failure
Abstract: Aims: Improvement of left ventricular ejection fraction is a major goal of heart failure (HF) treatment. However, data on clinical characteristics, exercise performance and prognosis in HF patients who improved ejection fraction (HFimpEF) are scarce. The study aimed to determine whether HFimpEF patients have a distinct clinical phenotype, biology and prognosis than HF patients with persistently reduced ejection fraction (pHFrEF)., Methods and Results: A total of 7948 patients enrolled in the Metabolic Exercise Cardiac Kidney Indexes (MECKI) score database were evaluated (median follow-up of 1490 days). We analysed clinical, laboratory, electrocardiographic, echocardiographic, exercise, and survival data from HFimpEF (n = 1504) and pHFrEF (n = 6017) patients. The primary endpoint of the study was the composite of cardiovascular death, left ventricular assist device implantation, and urgent heart transplantation. HFimpEF patients had lower HF severity: left ventricular ejection fraction 44.0 [41.0-47.0] versus 29.7 [24.1-34.5]%, B-type natriuretic peptide 122 [65-296] versus 373 [152-888] pg/ml, haemoglobin 13.5 [12.2-14.6] versus 13.7 [12.5-14.7] g/dl, renal function by the Modification of Diet in Renal Disease equation 72.0 [56.7-89.3] versus 70.4 [54.5-85.3] ml/min, peak oxygen uptake 62.2 [50.7-74.1] versus 52.6 [41.8-64.3]% predicted, minute ventilation-to-carbon dioxide output slope 30.0 [26.9-34.4] versus 32.1 [28.0-38.0] in HFimpEF and pHFrEF, respectively (p < 0.001 for all). Cardiovascular mortality rates were 26.6 and 46.9 per 1000 person-years for HFimpEF and pHFrEF, respectively (p < 0.001). Kaplan-Meier analysis showed that HFimpEF had better a long-term prognosis compared with pHFrEF patients. After adjustment for variables differentiating HFimpEF from pHFrEF, except echocardiographic parameters, the Kaplan-Meier curves showed the same prognosis., Conclusions: Heart failure with improved ejection fraction represents a peculiar group of HF patients whose clinical, laboratory, electrocardiographic, echocardiographic, and exercise characteristics parallel the recovery of systolic function. Nonetheless, these patients remain at risk for adverse outcome., (© 2023 European Society of Cardiology.)
Published: 2023
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49. Latin-American Registry of Cardiovascular Disease and COVID-19: Final Results.

Author: Gomez-Mesa JE, Galindo S, Escalante-Forero M, Rodas Y, Valencia A, Perna E, Romero A, Mendoza I, Wyss F, Barisani JL, Speranza M, Alarco W, and Flórez NA
Subjects: Female, Humans, Male, Middle Aged, Aftercare, Intensive Care Units, Patient Discharge, Prospective Studies, SARS-CoV-2, Multicenter Studies as Topic, Observational Studies as Topic, Cardiovascular Diseases epidemiology, COVID-19 epidemiology
Abstract: Background: Socioeconomic factors contribute to a more severe impact of COVID-19 in Latin American and Caribbean (LA&C) countries than in developed countries. Patients with a severe or critical illness can develop respiratory and cardiovascular complications., Objective: To describe a LA&C population with COVID-19 to provide information related to this disease, in-hospital cardiovascular complications, and in-hospital mortality., Methods: The CARDIO COVID-19-20 Registry is an observational, multicenter, prospective, and hospital-based registry of patients with confirmed COVID-19 infection that required in-hospital treatment in LA&C. Enrollment of patients started on May 01, 2020, and ended on June 30, 2021., Results: The CARDIO COVID-19-20 Registry included 3260 patients from 44 institutions of 14 LA&C countries. 63.2% patients were male and median age was 61.0 years old. Most common comorbidities were overweight/obesity (49.7%), hypertension (49.0%), and diabetes mellitus (26.7%). Most frequent cardiovascular complications during hospitalization or reported at discharge were cardiac arrhythmia (9.1%), decompensated heart failure (8.5%), and pulmonary embolism (3.9%). The number of patients admitted to the Intensive Care Unit (ICU) was 1745 (53.5%), and median length of their stay at the ICU was 10.0 days. Support required in ICU included invasive mechanical ventilation (34.2%), vasopressors (27.6%), inotropics (10.3%), and vasodilators (3.7%). Rehospitalization after 30-day post discharge was 7.3%. In-hospital mortality and 30-day post discharge were 25.5% and 2.6%, respectively., Conclusions: According to our findings, more than half of the LA&C population with COVID-19 assessed required management in ICU, with higher requirement of invasive mechanical ventilation and vasoactive support, resulting in a high in-hospital mortality and a considerable high 30-day post discharge rehospitalization and mortality., Competing Interests: The authors have no competing interests to declare., (Copyright: © 2023 The Author(s).)
Published: 2023
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50. Intravenous continuous home inotropic therapy in advanced heart failure: Insights from an observational retrospective study.

Author: Gentile P, Masciocco G, Palazzini M, Tedeschi A, Ruzzenenti G, Conti N, D'Angelo L, Foti G, Perna E, Verde A, Ammirati E, Sinagra G, Oliva F, and Garascia A
Subjects: Humans, Retrospective Studies, Cardiotonic Agents therapeutic use, Quality of Life, Heart Failure drug therapy, Heart Transplantation
Abstract: Introduction: Intravenous inotropic support represents an important therapeutic option in advanced heart failure (HF) as bridge to heart transplantation, bridge to mechanical circulatory support, bridge to candidacy or as palliative therapy. Nevertheless, evidence regarding risks and benefits of its use is lacking., Methods: we conducted a retrospective single center study, analysing the effect of inotropic therapies in an outpatient cohort, evaluating the burden of hospitalizations, the improvement in quality of life, the incidence of adverse events and the evolution of organ damage., Results: twenty-seven patients with advanced HF were treated in our Day Hospital service from 2014 to 2021. Nine patients were treated as bridge to heart transplant while eighteen as palliation. Comparing data regarding the year before and after the beginning of inotropic infusion, we observed a reduction of hospitalization (46 vs 25, p<0,001), an improvement of natriuretic peptides, renal and hepatic function since the first month (p<0,001) and a better quality of life in 53% of the population treated. Two hospitalizations for arrhythmias and seven hospitalizations for catheter-related complications were registered., Conclusions: in a selected population of advanced HF patients, continuous home inotropic infusion were able to reduce hospitalizations, improving end organ damage and quality of life. We provide a practical guidance on starting and maintaining home inotropic infusion while monitoring a challenging group of patients., Competing Interests: Declaration of Competing Interest None of the authors have conflict of interest., (Copyright © 2023. Published by Elsevier B.V.)
Published: 2023
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