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1. Implantation of an Innovative Intracardiac Microcomputer System for Web-Based Real-Time Monitoring of Heart Failure: Usability and Patients’ Attitudes

Author

D´Ancona, Giuseppe, Murero, Monica, Feickert, Sebastian, Kaplan, Hilmi, Öner, Alper, Ortak, Jasmin, and Ince, Hueseyin

Subjects
Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

BackgroundHeart failure (HF) management guided by the measurement of intracardiac and pulmonary pressure values obtained through innovative permanent intracardiac microsensors has been recently proposed as a valid strategy to individualize treatment and anticipate hemodynamic destabilization. These sensors have potential to reduce patient hospitalization rates and optimize quality of life. ObjectiveThe aim of this study was to evaluate the usability and patients’ attitudes toward a new permanent intracardiac device implanted to remotely monitor left intra-atrial pressures (V-LAP, Vectorious Medical Technologies, Tel Aviv, Israel) in patients with chronic HF. MethodsThe V-LAP system is a miniaturized sensor implanted percutaneously across the interatrial septum. The system communicates wirelessly with a “companion device” (a wearable belt) that is placed on the patient’s chest at the time of acquisition/transmission of left heart pressure measurements. At first follow-up after implantation, the patients and health care providers were asked to fill out a questionnaire on the usability of the system, ease in performing the various required tasks (data acquisition and transmission), and overall satisfaction. Replies to the questions were mainly given using a 5-point Likert scale (1: very poor, 2: poor, 3: average, 4: good, 5: excellent). Further patient follow-ups were performed at 3, 6, and 12 months. ResultsUse and acceptance of the first 14 patients receiving the V-LAP technology worldwide and related health care providers have been analyzed to date. No periprocedural morbidity/mortality was observed. Before discharge, a tailored educational session was performed after device implantation with the patients and their health care providers. At the first follow-up, the mean score for overall comfort in technology use was 3.7 (SD 1.2) with 93% (13/14) of patients succeeding in applying and operating the system independently. For health care providers, the mean score for overall ease and comfort in use of the technology was 4.2 (SD 0.8). No significant differences were found between the patients’ and health care providers’ replies to the questionnaires. There was a general trend for higher scores in patients’ usability reports at later follow-ups, in which the score related to overall comfort with using the technology increased from 3.0 (SD 1.4) to 4.0 (SD 0.7) (P=.40) and comfort with wearing and adjusting the measuring thoracic belt increased from 2.8 (SD 1.0) to 4.2 (SD 0.4) (P=.02). ConclusionsDespite the gravity of their HF pathology and the complexity of their comorbid profile, patients are comfortable in using the V-LAP technology and, in the majority of cases, they can correctly and consistently acquire and transmit hemodynamic data. Although the overall patient/care provider satisfaction with the V-LAP system seems to be acceptable, improvements can be achieved after ameliorating the design of the measuring tools. Trial RegistrationClincalTrials.gov NCT03775161; https://clinicaltrials.gov/ct2/show/NCT03775161

Published
2021
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2. Impact of the COVID-19 Pandemic on Global TAVR Activity: The COVID-TAVI Study

Author

Armario, Xavier, Carron, Jennifer, Simpkin, Andrew J., Elhadi, Mohamed, Kennedy, Ciara, Abdel-Wahab, Mohamed, Bleiziffer, Sabine, Lefèvre, Thierry, Wolf, Alexander, Pilgrim, Thomas, Villablanca, Pedro A., Blackman, Daniel J., Van Mieghem, Nicolas M., Hengstenberg, Christian, Swaans, Martin J., Prendergast, Bernard D., Patterson, Tiffany, Barbanti, Marco, Webb, John G., Behan, Miles, Resar, Jon, Chen, Mao, Hildick-Smith, David, Spence, Mark S., Zweiker, David, Bagur, Rodrigo, Teles, Rui, Ribichini, Flavio L., Jagielak, Dariusz, Park, Duk-Woo, Kornowski, Ran, Wykrzykowska, Joanna J., Bunc, Matjaz, Estévez-Loureiro, Rodrigo, Poon, Karl, Götberg, Matthias, Jeger, Raban V., Ince, Hüseyin, Packer, Erik J.S., Angelillis, Marco, Nombela-Franco, Luis, Guo, Yingqiang, Savontaus, Mikko, Al-Moghairi, Abdulrahman M., Parasca, Catalina Andreea, Kliger, Chad, Roy, David, Molnár, Levente, Silva, Mariana, White, Jonathon, Yamamoto, Masanori, Carrilho-Ferreira, Pedro, Toggweiler, Stefan, Voudris, Vassileios, Ohno, Yohei, Rodrigues, Inês, Parma, Radosław, Ojeda, Soledad, Toutouzas, Kostas, Regueiro, Ander, Grygier, Marek, AlMerri, Khaled, Cruz-González, Ignacio, Fridrich, Viliam, de la Torre Hernández, José M., Noble, Stephane, Kala, Petr, Asmarats, Lluis, Kurt, Ibrahim Halil, Bosmans, Johan, Erglis, Martins, Casserly, Ivan, Iskandarani, Dounia, Bhindi, Ravinay, Kefer, Joelle, Yin, Wei-Hsian, Rosseel, Liesbeth, Kim, Hyo-Soo, O'Connor, Stephen, Hellig, Farrel, Sztejfman, Matias, Mendiz, Oscar, Pineda, Andres M., Seth, Ashok, Pllaha, Elton, de Brito, Fabio S., Jr., Bajoras, Vilhelmas, Balghith, Mohammed A., Lee, Michael, Eid-Lidt, Guering, Vandeloo, Bert, Vaz, Vinicius Daher, Alasnag, Mirvat, Ussia, Gian Paolo, Tay, Edgar, Mayol, Jorge, Gunasekaran, Sengottuvelu, Sardella, Gennaro, Buddhari, Wacin, Kao, Hsien-Li, Dager, Antonio, Tzikas, Apostolos, Gudmundsdottir, Ingibjörg J., Edris, Ahmad, Gutiérrez Jaikel, Luis Abel, Arias, Eduardo A., Al-Hijji, Mohammed, Ertürk, Mehmet, Conde-Vela, César, Boljević, Darko, Ferrero Guadagnoli, Adolfo, Hermlin, Toomas, ElGuindy, Ahmed M., Lima-Filho, Moysés de Oliveira, de Moura Santos, Luciano, Perez, Luis, Maluenda, Gabriel, Akyüz, Ali Rıza, Alhaddad, Imad A., Amin, Haitham, So, Chak-Yu, Al Nooryani, Arif A., Vaca, Carlos, Albistur, Juan, Nguyen, Quang Ngoc, Arzamendi, Dabit, Grube, Eberhard, Modine, Thomas, Tchétché, Didier, Hayashida, Kentaro, Latib, Azeem, Makkar, Raj R., Piazza, Nicolo, Søndergaard, Lars, McEvoy, John William, and Mylotte, Darren

Published
2024
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3. Patterns of oral anticoagulant use and outcomes in Asian patients with atrial fibrillation: a post-hoc analysis from the GLORIA-AF Registry

Author

Abban, Dzifa Wosornu, Abdul, Nasser, Abud, Atilio Marcelo, Adams, Fran, Addala, Srinivas, Adragão, Pedro, Ageno, Walter, Aggarwal, Rajesh, Agosti, Sergio, Agostoni, Piergiuseppe, Aguilar, Francisco, Linares, Julio Aguilar, Aguinaga, Luis, Ahmed, Jameel, Aiello, Allessandro, Ainsworth, Paul, Aiub, Jorge Roberto, Al-Dallow, Raed, Alderson, Lisa, Aldrete Velasco, Jorge Antonio, Alexopoulos, Dimitrios, Manterola, Fernando Alfonso, Aliyar, Pareed, Alonso, David, Alves da Costa, Fernando Augusto, Amado, José, Amara, Walid, Amelot, Mathieu, Amjadi, Nima, Ammirati, Fabrizio, Andrade, Marianna, Andrawis, Nabil, Annoni, Giorgio, Ansalone, Gerardo, Ariani, M.Kevin, Arias, Juan Carlos, Armero, Sébastien, Arora, Chander, Aslam, Muhammad Shakil, Asselman, M., Audouin, Philippe, Augenbraun, Charles, Aydin, S., Ayryanova, Ivaneta, Aziz, Emad, Backes, Luciano Marcelo, Badings, E., Bagni, Ermentina, Baker, Seth H., Bala, Richard, Baldi, Antonio, Bando, Shigenobu, Banerjee, Subhash, Bank, Alan, Esquivias, Gonzalo Barón, Barr, Craig, Bartlett, Maria, Kes, Vanja Basic, Baula, Giovanni, Behrens, Steffen, Bell, Alan, Benedetti, Raffaella, Mazuecos, Juan Benezet, Benhalima, Bouziane, Bergler-Klein, Jutta, Berneau, Jean-Baptiste, Bernstein, Richard A., Berrospi, Percy, Berti, Sergio, Berz, Andrea, Best, Elizabeth, Bettencourt, Paulo, Betzu, Robert, Bhagwat, Ravi, Bhatta, Luna, Biscione, Francesco, Bisignani, Giovanni, Black, Toby, Bloch, Michael J., Bloom, Stephen, Blumberg, Edwin, Bo, Mario, Bøhmer, Ellen, Bollmann, Andreas, Bongiorni, Maria Grazia, Boriani, Giuseppe, Boswijk, D.J., Bott, Jochen, Bottacchi, Edo, Kalan, Marica Bracic, Bradman, Drew, Brautigam, Donald, Breton, Nicolas, Brouwers, P.J.A.M., Browne, Kevin, Cortada, Jordi Bruguera, Bruni, A., Brunschwig, Claude, Buathier, Hervé, Buhl, Aurélie, Bullinga, John, Cabrera, Jose Walter, Caccavo, Alberto, Cai, Shanglang, Caine, Sarah, Calò, Leonardo, Calvi, Valeria, Sánchez, Mauricio Camarillo, Candeias, Rui, Capuano, Vincenzo, Capucci, Alessandro, Caputo, Ronald, Rizo, Tatiana Cárdenas, Cardona, Francisco, Carlos da Costa Darrieux, Francisco, Duarte Vera, Yan Carlos, Carolei, Antonio, Carreño, Susana, Carvalho, Paula, Cary, Susanna, Casu, Gavino, Cavallini, Claudio, Cayla, Guillaume, Celentano, Aldo, Cha, Tae-Joon, Cha, Kwang Soo, Chae, Jei Keon, Chalamidas, Kathrine, Challappa, Krishnan, Chand, Sunil Prakash, Chandrashekar, Harinath, Chartier, Ludovic, Chatterjee, Kausik, Chavez Ayala, Carlos Antero, Cheema, Aamir, Cheema, Amjad, Chen, Lin, Chen, Shih-Ann, Chen, Jyh Hong, Chiang, Fu-Tien, Chiarella, Francesco, Chih-Chan, Lin, Cho, Yong Keun, Choi, Jong-Il, Choi, Dong Ju, Chouinard, Guy, Hoi-Fan Chow, Danny, Chrysos, Dimitrios, Chumakova, Galina, José Roberto, Eduardo Julián, Valenzuela, Chuquiure, Nica, Nicoleta Cindea, Cislowski, David J., Clay, Anthony, Clifford, Piers, Cohen, Andrew, Cohen, Michael, Cohen, Serge, Colivicchi, Furio, Collins, Ronan, Colonna, Paolo, Compton, Steve, Connolly, Derek, Conti, Alberto, Buenostro, Gabriel Contreras, Coodley, Gregg, Cooper, Martin, Coronel, Julian, Corso, Giovanni, Sales, Juan Cosín, Cottin, Yves, Covalesky, John, Cracan, Aurel, Crea, Filippo, Crean, Peter, Crenshaw, James, Cullen, Tina, Darius, Harald, Dary, Patrick, Dascotte, Olivier, Dauber, Ira, Davalos, Vicente, Davies, Ruth, Davis, Gershan, Davy, Jean-Marc, Dayer, Mark, De Biasio, Marzia, De Bonis, Silvana, De Caterina, Raffaele, De Franceschi, Teresiano, de Groot, J.R., De Horta, José, De La Briolle, Axel, Topete, Gilberto de la Pena, Vicenzo de Paola, Angelo Amato, de Souza, Weimar, de Veer, A., De Wolf, Luc, Decoulx, Eric, Deepak, Sasalu, Defaye, Pascal, Del-Carpio Munoz, Freddy, Brkljacic, Diana Delic, Deumite, N. Joseph, Di Legge, Silvia, Diemberger, Igor, Dietz, Denise, Dionísio, Pedro, Dong, Qiang, Rossi dos Santos, Fabio, Dotcheva, Elena, Doukky, Rami, D'Souza, Anthony, Dubrey, Simon, Ducrocq, Xavier, Dupljakov, Dmitry, Duque, Mauricio, Dutta, Dipankar, Duvilla, Nathalie, Duygun, A., Dziewas, Rainer, Eaton, Charles B., Eaves, William, Ebels-Tuinbeek; Clifford Ehrlich, L.A., Eichinger-Hasenauer, Sabine, Eisenberg, Steven J., El Jabali, Adnan, El Shahawy, Mahfouz, Hernandes, Mauro Esteves, Izal, Ana Etxeberria, Evonich, Rudolph, III, Evseeva, Oksana, Ezhov, Andrey, Fahmy, Raed, Fang, Quan, Farsad, Ramin, Fauchier, Laurent, Favale, Stefano, Fayard, Maxime, Fedele, Jose Luis, Fedele, Francesco, Fedorishina, Olga, Fera, Steven R., Gomes Ferreira, Luis Gustavo, Ferreira, Jorge, Ferri, Claudio, Ferrier, Anna, Ferro, Hugo, Finsen, Alexandra, First, Brian, Fischer, Stuart, Fonseca, Catarina, Almeida, Luísa Fonseca, Forman, Steven, Frandsen, Brad, French, William, Friedman, Keith, Friese, Athena, Fruntelata, Ana Gabriela, Fujii, Shigeru, Fumagalli, Stefano, Fundamenski, Marta, Furukawa, Yutaka, Gabelmann, Matthias, Gabra, Nashwa, Gadsbøll, Niels, Galinier, Michel, Gammelgaard, Anders, Ganeshkumar, Priya, Gans, Christopher, Quintana, Antonio Garcia, Gartenlaub, Olivier, Gaspardone, Achille, Genz, Conrad, Georger, Frédéric, Georges, Jean-Louis, Georgeson, Steven, Giedrimas, Evaldas, Gierba, Mariusz, Ortega, Ignacio Gil, Gillespie, Eve, Giniger, Alberto, Giudici, Michael C., Gkotsis, Alexandros, Glotzer, Taya V., Gmehling, Joachim, Gniot, Jacek, Goethals, Peter, Goldbarg, Seth, Goldberg, Ronald, Goldmann, Britta, Golitsyn, Sergey, Gómez, Silvia, Mesa, Juan Gomez, Gonzalez, Vicente Bertomeu, Gonzalez Hermosillo, Jesus Antonio, González López, Víctor Manuel, Gorka, Hervé, Gornick, Charles, Gorog, Diana, Gottipaty, Venkat, Goube, Pascal, Goudevenos, Ioannis, Graham, Brett, Greer, G. Stephen, Gremmler, Uwe, Grena, Paul G., Grond, Martin, Gronda, Edoardo, Grönefeld, Gerian, Gu, Xiang, Torres Torres, Ivett Guadalupe, Guardigli, Gabriele, Guevara, Carolina, Guignier, Alexandre, Gulizia, Michele, Gumbley, Michael, Günther, Albrecht, Ha, Andrew, Hahalis, Georgios, Hakas, Joseph, Hall, Christian, Han, Bing, Han, Seongwook, Hargrove, Joe, Hargroves, David, Harris, Kenneth B., Haruna, Tetsuya, Hayek, Emil, Healey, Jeff, Hearne, Steven, Heffernan, Michael, Heggelund, Geir, Heijmeriks, J.A., Hemels, Maarten, Hendriks, I., Henein, Sam, Her, Sung-Ho, Hermany, Paul, Hernández Del Río, Jorge Eduardo, Higashino, Yorihiko, Hill, Michael, Hisadome, Tetsuo, Hishida, Eiji, Hoffer, Etienne, Hoghton, Matthew, Hong, Kui, Hong, Suk keun, Horbach, Stevie, Horiuchi, Masataka, Hou, Yinglong, Hsing, Jeff, Huang, Chi-Hung, Huckins, David, Hughes, kathy, Huizinga, A., Hulsman, E.L., Hung, Kuo-Chun, Hwang, Gyo-Seung, Ikpoh, Margaret, Imberti, Davide, Ince, Hüseyin, Indolfi, Ciro, Inoue, Shujiro, Irles, Didier, Iseki, Harukazu, Israel, C. Noah, Iteld, Bruce, Iyer, Venkat, Jackson-Voyzey, Ewart, Jaffrani, Naseem, Jäger, Frank, James, Martin, Jang, Sung-Won, Jaramillo, Nicolas, Jarmukli, Nabil, Jeanfreau, Robert J., Jenkins, Ronald D., Sánchez, Carlos Jerjes, Jimenez, Javier, Jobe, Robert, Joen-Jakobsen, Tomas, Jones, Nicholas, Moura Jorge, Jose Carlos, Jouve, Bernard, Jung, Byung Chun, Jung, Kyung Tae, Jung, Werner, Kachkovskiy, Mikhail, Kafkala, Krystallenia, Kalinina, Larisa, Kallmünzer, Bernd, Kamali, Farzan, Kamo, Takehiro, Kampus, Priit, Kashou, Hisham, Kastrup, Andreas, Katsivas, Apostolos, Kaufman, Elizabeth, Kawai, Kazuya, Kawajiri, Kenji, Kazmierski, John F., Keeling, P., Kerr Saraiva, José Francisco, Ketova, Galina, Khaira, Ajit Singh, Khripun, Aleksey, Kim, Doo-Il, Kim, Young Hoon, Kim, Nam Ho, Kim, Dae Kyeong, Kim, Jeong Su, Kim, June Soo, Kim, Ki Seok, Kim, Jin bae, Kinova, Elena, Klein, Alexander, Kmetzo, James J., Kneller, G. Larsen, Knezevic, Aleksandar, Angela Koh, Su Mei, Koide, Shunichi, Kollias, Anastasios, Kooistra, J.A., Koons, Jay, Koschutnik, Martin, Kostis, William J., Kovacic, Dragan, Kowalczyk, Jacek, Koziolova, Natalya, Kraft, Peter, Kragten, Johannes A., Krantz, Mori, Krause, Lars, Krenning, B.J., Krikke, F., Kromhout, Z., Krysiak, Waldemar, Kumar, Priya, Kümler, Thomas, Kuniss, Malte, Kuo, Jen-Yuan, Küppers, Achim, Karla Kurrelmeyer, Kwak, Choong Hwan, Laboulle, Bénédicte, Labovitz, Arthur, Lai, Wen Ter, Lam, Andy, Lam, Yat Yin, Zanetti, Fernando Lanas, Landau, Charles, Landini, Giancarlo, Figueiredo, Estêvão Lanna, Larsen, Torben, Lavandier, Karine, LeBlanc, Jessica, Lee, Moon Hyoung, Lee, Chang-Hoon, Lehman, John, Leitão, Ana, Lellouche, Nicolas, Lelonek, Malgorzata, Lenarczyk, Radoslaw, Lenderink, T., González, Salvador León, Leong-Sit, Peter, Leschke, Matthias, Ley, Nicolas, Li, Zhanquan, Li, Xiaodong, Li, Weihua, Li, Xiaoming, Lichy, Christhoh, Lieber, Ira, Limon Rodriguez, Ramon Horacio, Lin, Hailong, Lip, Gregory Y.H., Liu, Feng, Liu, Hengliang, Esperon, Guillermo Llamas, Navarro, Nassip Llerena, Lo, Eric, Lokshyn, Sergiy, López, Amador, López-Sendón, José Luís, Lorga Filho, Adalberto Menezes, Lorraine, Richard S., Luengas, Carlos Alberto, Luke, Robert, Luo, Ming, Lupovitch, Steven, Lyrer, Philippe, Ma, Changsheng, Ma, Genshan, Madariaga, Irene, Maeno, Koji, Magnin, Dominique, Maid, Gustavo, Mainigi, Sumeet K., Makaritsis, Konstantinos, Malhotra, Rohit, Manning, Rickey, Manolis, Athanasios, Manrique Hurtado, Helard Andres, Mantas, Ioannis, Jattin, Fernando Manzur, Maqueda, Vicky, Marchionni, Niccolo, Ortuno, Francisco Marin, Santana, Antonio Martín, Martinez, Jorge, Maskova, Petra, Hernandez, Norberto Matadamas, Matsuda, Katsuhiro, Maurer, Tillmann, Mauro, Ciro, May, Erik, Mayer, Nolan, McClure, John, McCormack, Terry, McGarity, William, McIntyre, Hugh, McLaurin, Brent, Medina Palomino, Feliz Alvaro, Melandri, Francesco, Meno, Hiroshi, Menzies, Dhananjai, Mercader, Marco, Meyer, Christian, Meyer, Beat J., Miarka, Jacek, Mibach, Frank, Michalski, Dominik, Michel, Patrik, Chreih, Rami Mihail, Mikdadi, Ghiath, Mikus, Milan, Milicic, Davor, Militaru, Constantin, Minaie, Sedi, Minescu, Bogdan, Mintale, Iveta, Mirault, Tristan, Mirro, Michael J., Mistry, Dinesh, Miu, Nicoleta Violeta, Miyamoto, Naomasa, Moccetti, Tiziano, Mohammed, Akber, Nor, Azlisham Mohd, Mollerus, Michael, Molon, Giulio, Mondillo, Sergio, Moniz, Patrícia, Mont, Lluis, Montagud, Vicente, Montaña, Oscar, Monti, Cristina, Moretti, Luciano, Mori, Kiyoo, Moriarty, Andrew, Morka, Jacek, Moschini, Luigi, Moschos, Nikitas, Mügge, Andreas, Mulhearn, Thomas J., Muresan, Carmen, Muriago, Michela, Musial, Wlodzimierz, Musser, Carl W., Musumeci, Francesco, Nageh, Thuraia, Nakagawa, Hidemitsu, Nakamura, Yuichiro, Nakayama, Toru, Nam, Gi-Byoung, Nanna, Michele, Natarajan, Indira, Nayak, Hemal M., Naydenov, Stefan, Nazlić, Jurica, Cristian Nechita, Alexandru, Nechvatal, Libor, Negron, Sandra Adela, Neiman, James, Neuenschwander, Fernando Carvalho, Neves, David, Neykova, Anna, Miguel, Ricardo Nicolás, Nijmeh, George, Nizov, Alexey, Campos, Rodrigo Noronha, Nossan, Janko, Novikova, Tatiana, Nowalany-Kozielska, Ewa, Nsah, Emmanuel, Nunez Fragoso, Juan Carlos, Nurgalieva, Svetlana, Nuyens, Dieter, Nyvad, Ole, Odin de Los Rios Ibarra, Manuel, O'Donnell, Philip, O'Donnell, Martin, Oh, Seil, Oh, Yong Seog, Oh, Dongjin, O'Hara, Gilles, Oikonomou, Kostas, Olivares, Claudia, Oliver, Richard, Ruiz, Rafael Olvera, Olympios, Christoforos, omaszuk-Kazberuk, Anna, Asensi, Joaquín Osca, Jose, eena Padayattil, Padilla Padilla, Francisco Gerardo, Rios, Victoria Padilla, Pajes, Giuseppe, Pandey, Shekhar, Paparella, Gaetano, Paris, F., Park, Hyung Wook, Park, Jong Sung, Parthenakis, Fragkiskos, Passamonti, Enrico, Patel, Rajesh J., Patel, Jaydutt, Patel, Mehool, Patrick, Janice, Jimenez, Ricardo Pavón, Paz, Analía, Pengo, Vittorio, Pentz, William, Pérez, Beatriz, Pérez Ríos, Alma Minerva, Pérez-Cabezas, Alejandro, Perlman, Richard, Persic, Viktor, Perticone, Francesco, Peters, Terri K., Petkar, Sanjiv, Pezo, Luis Felipe, Pflücke, Christian, Pham, David N., Phillips, Roland T., Phlaum, Stephen, Pieters, Denis, Pineau, Julien, Pinter, Arnold, Pinto, Fausto, Pisters, R., Pivac, Nediljko, Pocanic, Darko, Podoleanu, Cristian, Politano, Alessandro, Poljakovic, Zdravka, Pollock, Stewart, Garcéa, Jose Polo, Poppert, Holger, Porcu, Maurizio, Reino, Antonio Pose, Prasad, Neeraj, Précoma, Dalton Bertolim, Prelle, Alessandro, Prodafikas, John, Protasov, Konstantin, Pye, Maurice, Qiu, Zhaohui, Quedillac, Jean-Michel, Raev, Dimitar, Raffo Grado, Carlos Antonio, Rahimi, Sidiqullah, Raisaro, Arturo, Rama, Bhola, Ramos, Ricardo, Ranieri, Maria, Raposo, Nuno, Rashba, Eric, Rauch-Kroehnert, Ursula, Reddy, Ramakota, Renda, Giulia, Reza, Shabbir, Ria, Luigi, Richter, Dimitrios, Rickli, Hans, Rieker, Werner, Vera, Tomas Ripolil, Ritt, Luiz Eduardo, Roberts, Douglas, Briones, Ignacio Rodriguez, Rodriguez Escudero, Aldo Edwin, Pascual, Carlos Rodríguez, Roman, Mark, Romeo, Francesco, Ronner, E., Roux, Jean-Francois, Rozkova, Nadezda, Rubacek, Miroslav, Rubalcava, Frank, Russo, Andrea M., Rutgers, Matthieu Pierre, Rybak, Karin, Said, Samir, Sakamoto, Tamotsu, Salacata, Abraham, Salem, Adrien, Bodes, Rafael Salguero, Saltzman, Marco A., Salvioni, Alessandro, Vallejo, Gregorio Sanchez, Fernández, Marcelo Sanmartín, Saporito, Wladmir Faustino, Sarikonda, Kesari, Sasaoka, Taishi, Sati, Hamdi, Savelieva, Irina, Scala, Pierre-Jean, Schellinger, Peter, Scherr, Carlos, Schmitz, Lisa, Schmitz, Karl-Heinz, Schmitz, Bettina, Schnabel, Teresa, Schnupp, Steffen, Schoeniger, Peter, Schön, Norbert, Schwimmbeck, Peter, Seamark, Clare, Searles, Greg, Seidl, Karl-Heinz, Seidman, Barry, Sek, Jaroslaw, Sekaran, Lakshmanan, Serrati, Carlo, Shah, Neerav, Shah, Vinay, Shah, Anil, Shah, Shujahat, Sharma, Vijay Kumar, Shaw, Louise, Sheikh, Khalid H., Shimizu, Naruhito, Shimomura, Hideki, Shin, Dong-Gu, Shin, Eun-Seok, Shite, Junya, Sibilio, Gerolamo, Silver, Frank, Sime, Iveta, Simmers, Tim A., Singh, Narendra, Siostrzonek, Peter, Smadja, Didier, Smith, David W., Snitman, Marcelo, Filho, Dario Sobral, Soda, Hassan, Sofley, Carl, Sokal, Adam, Oi Yan, Yannie Soo, Sotolongo, Rodolfo, Ferreira de Souza, Olga, Sparby, Jon Arne, Spinar, Jindrich, Sprigings, David, Spyropoulos, Alex C., Stakos, Dimitrios, Steinwender, Clemens, Stergiou, Georgios, Stiell, Ian, Stoddard, Marcus, Stoikov, Anastas, Streb, Witold, Styliadis, Ioannis, Su, Guohai, Su, Xi, Sudnik, Wanda, Sukles, Kai, Sun, Xiaofei, Swart, H., Szavits-Nossan, Janko, Taggeselle, Jens, Takagi, Yuichiro, Singh Takhar, Amrit Pal, Tamm, Angelika, Tanaka, Katsumi, Tanawuttiwat, Tanyanan, Tang, Sherman, Tang, Aylmer, Tarsi, Giovanni, Tassinari, Tiziana, Tayal, Ashis, Tayebjee, Muzahir, Berg, J.M. ten, Tesloianu, Dan, The, Salem H.K., Thomas, Dierk, Timsit, Serge, Tobaru, Tetsuya, Tomasik, Andrzej R., Torosoff, Mikhail, Touze, Emmanuel, Trendafilova, Elina, Tsai, W. Kevin, Tse, Hung Fat, Tsutsui, Hiroshi, Tu, Tian Ming, Tuininga, Ype, Turakhia, Minang, Turk, Samir, Turner, Wayne, Tveit, Arnljot, Tytus, Richard, Valadão, C., van Bergen, P.F.M.M., van de Borne, Philippe, van den Berg, B.J., van der Zwaan, C., Van Eck, M., Vanacker, Peter, Vasilev, Dimo, Vasilikos, Vasileios, Vasilyev, Maxim, Veerareddy, Srikar, Miño; Asok Venkataraman, Mario Vega, Verdecchia, Paolo, Versaci, Francesco, Vester, Ernst Günter, Vial, Hubert, Victory, Jason, Villamil, Alejandro, Vincent, Marc, Vlastaris, Anthony, Dahl, Jürgen vom, Vora, Kishor, Vranian, Robert B., Wakefield, Paul, Wang, Ningfu, Wang, Mingsheng, Wang, Xinhua, Wang, Feng, Wang, Tian, Warner, Alberta L., Watanabe, Kouki, Wei, Jeanne, Weimar, Christian, Weiner, Stanislav, Weinrich, Renate, Wen, Ming-Shien, Wiemer, Marcus, Wiggers, Preben, Wilke, Andreas, Williams, David, Williams, Marcus L., Witzenbichler, Bernhard, Wong, Brian, Lawrence Wong, Ka Sing, Wozakowska-Kaplon, Beata, Wu, Shulin, Wu, Richard C., Wunderlich, Silke, Wyatt, Nell, Wylie, John (Jack), Xu, Yong, Xu, Xiangdong, Yamanoue, Hiroki, Yamashita, Takeshi, Bryan Yan, Ping Yen, Yang, Tianlun, Yao, Jing, Yeh, Kuo-Ho, Yin, Wei Hsian, Yotov, Yoto, Zahn, Ralf, Zarich, Stuart, Zenin, Sergei, Zeuthen, Elisabeth Louise, Zhang, Huanyi, Zhang, Donghui, Zhang, Xingwei, Zhang, Ping, Zhang, Jun, Zhao, Shui Ping, Zhao, Yujie, Zhao, Zhichen, Zheng, Yang, Zhou, Jing, Zimmermann, Sergio, Zini, Andrea, Zizzo, Steven, Zong, Wenxia, Zukerman, L. Steven, Romiti, Giulio Francesco, Corica, Bernadette, Proietti, Marco, Mei, Davide Antonio, Frydenlund, Juliane, Bisson, Arnaud, Olshansky, Brian, Chan, Yi-Hsin, Huisman, Menno V., and Chao, Tze-Fan

Published
2023
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4. Single beta-blocker or combined amiodarone therapy in implantable cardioverter-defibrillator and cardiac resynchronization therapy—defibrillator patients: Insights from the German DEVICE registry

Author

Wiedmann, Felix, Ince, Hüseyin, Stellbrink, Christoph, Kleemann, Thomas, Eckardt, Lars, Brachmann, Johannes, Gonska, Bernd-Dieter, Kääb, Stefan, Perings, Christian A., Jung, Werner, Lugenbiel, Patrick, Hochadel, Matthias, Senges, Jochen, Frey, Norbert, and Schmidt, Constanze

Published
2023
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6. The V-LAP System for Remote Left Atrial Pressure Monitoring of Patients With Heart Failure: Remote Left Atrial Pressure Monitoring

Author

Perl, Leor, Meerkin, David, D'amario, Domenico, Avraham, Binyamin Ben, Gal, Tuvia Ben, Weitsman, Tatyana, Hasin, Tal, Ince, Hüseyin, Feickert, Sebastian, D'ancona, Giuseppe, Schaefer, Ulrich, Sievert, Horst, Leyva, Francisco, Whinnett, Zachary I., Di Mario, Carlo, Jonas, Michael, Glikson, Michael, Habib, Manhal, Caspi, Oren, Koren, Oran, Abraham, William T., Kornowski, Ran, and Crea, Filippo

Published
2022
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7. Impact of Anesthesia Strategy and Valve Type on Clinical Outcomes After Transcatheter Aortic Valve Replacement

Author

Feistritzer, Hans-Josef, Kurz, Thomas, Stachel, Georg, Hartung, Philipp, Lurz, Philipp, Eitel, Ingo, Marquetand, Christoph, Nef, Holger, Doerr, Oliver, Vigelius-Rauch, Ursula, Lauten, Alexander, Landmesser, Ulf, Treskatsch, Sascha, Abdel-Wahab, Mohamed, Sandri, Marcus, Holzhey, David, Borger, Michael, Ender, Jörg, Ince, Hüseyin, Öner, Alper, Meyer-Saraei, Roza, Hambrecht, Rainer, Wienbergen, Harm, Fach, Andreas, Augenstein, Thomas, Frey, Norbert, König, Inke R., Vonthein, Reinhard, Funkat, Anne-Kathrin, Berggreen, Astrid E., Heringlake, Matthias, Desch, Steffen, de Waha-Thiele, Suzanne, and Thiele, Holger

Published
2021
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8. Comparison in Patients < 75 Years of Age - Versus – Those > 75 Years on One-year-Events With Atrial Fibrillation and Left Atrial Appendage Occluder (From the Prospective Multicenter German LAARGE Registry)

Author

Nasasra, Aref El, Brachmann, Johannes, Lewalter, Thorsten, Akin, Ibrahim, Sievert, Horst, Nienaber, Christoph A., Weiß, Christian, Pleger, Sven T., Ince, Hüseyin, Maier, Jens, Achenbach, Stephan, Sigusch, Holger H., Hochadel, Matthias, Schneider, Steffen, Senges, Jochen, and Zeymer, Uwe

Published
2020
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9. Incidence and predictors of 2-year mortality following percutaneous left atrial appendage occlusion in the EWOLUTION trial.

Author

Aarnink, Errol W, Ince, Hueseyin, Kische, Stephan, Pokushalov, Evgeny, Schmitz, Thomas, Schmidt, Boris, Gori, Tommaso, Meincke, Felix, Protopopov, Alexey Vladimir, Betts, Timothy, Mazzone, Patrizio, Grygier, Marek, Sievert, Horst, Potter, Tom De, Vireca, Elisa, Stein, Kenneth, Bergmann, Martin W, and Boersma, Lucas V A

Abstract

Aims Sufficient survival time following left atrial appendage occlusion (LAAO) is essential for ensuring the efficacy and cost-effectiveness of this strategy for stroke prevention. Understanding prognostic factors for early mortality after LAAO could optimize patient selection. In the current study, we perform an in-depth analysis of 2-year mortality after LAAO, focusing particularly on potential predictors. Methods and results The EWOLUTION registry is a real-world cohort comprising 1020 patients that underwent LAAO. Endpoint definitions were pre-specified, and death was categorized as cardiovascular, non-cardiovascular, or unknown origin. Mortality rates were calculated from Kaplan–Meier estimates. Baseline characteristics significantly associated with death in univariate Cox regression analysis were incorporated into the multivariate analysis. All multivariate predictors were included in a risk model. Two-year mortality rate was 16.4% [confidence interval (CI): 14.0–18.7%], with 50% of patients dying from a non-cardiovascular cause. Multivariate baseline predictors of 2-year mortality included age [hazard ratio (HR) 1.05, CI: 1.03–1.08, per year increase], heart failure (HR 1.73, CI: 1.24–2.41), vascular disease (HR 1.47, CI: 1.05–2.05), valvular disease (HR 1.63, CI: 1.15–2.33), abnormal liver function (HR 1.80, CI: 1.02–3.17), and abnormal renal function (HR 1.58, CI: 1.10–2.27). Mortality rate exhibited a gradual rise as the number of risk factors increased, reaching 46.1% in patients presenting with five or six risk factors. Conclusion One in six patients died within 2 years after LAAO. We identified six independent predictors of mortality. When combined, this model showed a gradual increase in mortality rate with a growing number of risk factors, which may guide appropriate patient selection for LAAO. Clinical trial registration The original EWOLUTION registry was registered at clinicaltrials.gov under identifier NCT01972282. [ABSTRACT FROM AUTHOR]

Published
2024
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12. First Report of Edge Vascular Response at 12 Months of Magmaris, A Second-Generation Drug-Eluting Resorbable Magnesium Scaffold, Assessed by Grayscale Intravascular Ultrasound, Virtual Histology, and Optical Coherence Tomography. A Biosolve-II Trial Sub-Study

Author

Hideo-Kajita, Alexandre, Garcia-Garcia, Hector M., Haude, Michael, Joner, Michael, Koolen, Jacques, Ince, Hüseyin, Abizaid, Alexandre, Toelg, Ralph, Lemos, Pedro A., von Birgelen, Clemens, Christiansen, Evald Høj, Wijns, William, Neumann, Franz-Josef, Kaiser, Christoph, Eeckhout, Eric, Teik, Lim Soo, Escaned, Javier, Azizi, Viana, Kuku, Kayode O., Ozaki, Yuichi, Dan, Kazuhiro, and Waksman, Ron

Published
2019
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15. In vivo serial invasive imaging of the second-generation drug-eluting absorbable metal scaffold (Magmaris — DREAMS 2G) in de novo coronary lesions: Insights from the BIOSOLVE-II First-In-Man Trial

Author

Garcia-Garcia, Hector M., Haude, Michael, Kuku, Kayode, Hideo-Kajita, Alexandre, Ince, Hüseyin, Abizaid, Alexandre, Tölg, Ralph, Lemos, Pedro Alves, von Birgelen, Clemens, Christiansen, Evald Høj, Wijns, William, Escaned, Javier, Dijkstra, Jouke, and Waksman, Ron

Published
2018
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18. Imaging Predictors of Left Ventricular Functional Recovery after Reperfusion Therapy of ST-Elevation Myocardial Infarction Assessed by Cardiac Magnetic Resonance

Author

Virbickiene, Agneta, primary, Lapinskas, Tomas, additional, Garlichs, Christoph D., additional, Mattecka, Stephan, additional, Tanacli, Radu, additional, Ries, Wolfgang, additional, Torzewski, Jan, additional, Heigl, Franz, additional, Pfluecke, Christian, additional, Darius, Harald, additional, Ince, Hueseyin, additional, Nordbeck, Peter, additional, Butter, Christian, additional, Schuster, Andreas, additional, Mitzner, Steffen, additional, Dobiliene, Olivija, additional, Sheriff, Ahmed, additional, and Kelle, Sebastian, additional

Published
2023
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19. Guided de-escalation of antiplatelet treatment in patients with acute coronary syndrome undergoing percutaneous coronary intervention (TROPICAL-ACS): a randomised, open-label, multicentre trial

Author

Parma, Radoslaw, Parma, Zofia, Lesiak, Maciej, Komosa, Anna, Huczek, Zenon, Koltowski, Lukasz, Kowara, Michal, Rymuza, Bartosz, Klopotowski, Mariusz, Malek, Lukasz, Aradi, Daniel, Veress, Gábor, Dézsi, András Döme, Merkely, Béla, Lux, Árpád, Kiss, Róbert Gábor, Papp, Judit, Kovács, Andrea, Dézsi, Csaba András, Amer, Sayour, Ruzsa, Zoltán, Róna, Szilárd, Komócsi, András, Ili, Renáta, Ungi, Imre, Nagy, Ferenc, Zweiker, Robert, Tóth-Gayor, Gábor, Huber, Kurt, Haller, Paul, von Scheidt, Wolfgang, Blüthgen, Andreas, Neumann, Franz-Josef, Trenk, Dietmar, Leggewie, Stefan, Kreider-Stempfle, Hans Ulrich, Remp, Thomas, Kara, Kaffer, Mügge, Andreas, Wutzler, Alexander, Fichtlscherer, Stephan, Zeiher, Andreas M., Seeger, Florian, Hinterseer, Martin, König, Andreas, Lederle, Susanne, Jacobshagen, Claudius, Czepluch, Frauke, Maier, Lars, Schillinger, Wolfgang, Sossalla, Samuel, Hummel, Astrid, Felix, Stephan, Karakas, Mahir, Sydow, Karsten, Rudolph, Tanja, Halbach, Marcel, Gori, Tommaso, Münzel, Thomas, May, Andreas, Gerstenberg, Carsten-Manuel, Pilecky, David, Rieber, Johannes, Deichstetter, Markus, Sibbing, Dirk, Mehilli, Julinda, Gross, Lisa, Kääb, Stefan, Löw, Anja, Orban, Martin, Orban, Matthias, Sattler, Stefan, Deuschl, Sabine, Teupser, Daniel, Holdt, Lesca, Mudra, Harald, Räder, Thomas, Schütz, Torsten, Vahldiek, Felix, Divchev, Dimitar, Ince, Hüseyin, Nienaber, Christoph A, Radunski, Henning, Boekstegers, Peter, Horstkotte, Jan, Mueller, Ralf, Geisler, Tobias, Müller, Karin, Schwinger, Robert, Rasp, Oliver, Aradi, Dániel, Hadamitzky, Martin, Dézsi, Csaba A, Felix, Stephan B, Schwinger, Robert H G, and Massberg, Steffen

Published
2017
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22. Safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de-novo coronary artery lesions (BIOSOLVE-II): 6 month results of a prospective, multicentre, non-randomised, first-in-man trial

Author

Haude, Michael, Ince, Hüseyin, Abizaid, Alexandre, Toelg, Ralph, Lemos, Pedro Alves, von Birgelen, Clemens, Christiansen, Evald Høj, Wijns, William, Neumann, Franz-Josef, Kaiser, Christoph, Eeckhout, Eric, Lim, Soo Teik, Escaned, Javier, Garcia-Garcia, Hector M, and Waksman, Ron

Published
2016
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23. Whither the PETTICOAT Technique

Author

Akin, Ibrahim, Rehders, Tim C., Kische, Stephan, Ince, Hüseyin, Nienaber, Christoph A., Bonser, Robert S., editor, Pagano, Domenico, editor, Haverich, Axel, editor, and Mascaro, Jorge, editor

Published
2014
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24. Evaluating Real-World Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology: Final 2-Year Outcome Data of the EWOLUTION Trial Focusing on History of Stroke and Hemorrhage

Author

Boersma, Lucas V., Ince, Hueseyin, Kische, Stephan, Pokushalov, Evgeny, Schmitz, Thomas, Schmidt, Boris, Gori, Tommaso, Meincke, Felix, Protopopov, Alexey Vladimir, Betts, Timothy, Mazzone, Patrizio, Foley, David, Grygier, Marek, Sievert, Horst, De Potter, Tom, Vireca, Elisa, Stein, Kenneth, Bergmann, Martin W., Al Nooryani, Arif, Fiedler, Thomas, Senatore, Gaetano, Brigadeau, François, Defaye, Pascal, Teiger, Emmanuel, Bonnet, Jean-Louis, Wald, Christof, Szili-Torok, Tamas, Tschishow, Wladimir, Crossland, David, Vahanian, Alec, Cruz-Gonzalez, Ignacio, Thambo, Jean-Benoit, Al Smadi, Faisal, Mudra, Harald, Molitoris, Robin, Folkeringa, Richard, Stevenhagen, Yorick, Gras, Daniel, Tamburino, Corrado, Molon, Giulio, Spence, Mark, Infante Oliveira, Eduardo, Merkulov, Evgeny, Sukiennik, Adam, Wong, Tom, Busch, Mathias, Boldt, Leif-Hendrik, Nickenig, Georg, and Neef, Martin

Published
2019
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30. Endovascular Therapy in Aortic Pathology

Author

Ince, Hüseyin, Nienaber, Christoph A., Beckmann, Joshua, Fattori, Rosella, Eagle, Kim A., editor, Baliga, Ragavendra R., editor, Isselbacher, Eric M., editor, and Nienaber, Christoph A., editor

Published
2007
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32. Prognostic value of pre-interventional cerebral oxygen saturation in transcatheter aortic valve replacement: a prespecified secondary analysis of the SOLVE–TAVI trial

Author

Feistritzer, Hans-Josef, Stachel, Georg, Hartung, Philipp, Lurz, Philipp, Eitel, Ingo, Marquetand, Christoph, Nef, Holger, Doerr, Oliver, Lauten, Alexander, Landmesser, Ulf, Abdel-Wahab, Mohamed, Sandri, Marcus, Holzhey, David, Borger, Michael, Ince, Hüseyin, Öner, Alper, Meyer-Saraei, Roza, Hambrecht, Rainer, Fach, Andreas, Augenstein, Thomas, Frey, Norbert, König, Inke R., Vonthein, Reinhard, Rückert, Yvonne, Funkat, Anne-Kathrin, Heringlake, Matthias, Berggreen, Astrid E., Baumgärtel, Romina, Kurz, Thomas, Vigelius-Rauch, Ursula, Treskatsch, Sascha, Ender, Jörg, de Waha-Thiele, Suzanne, Desch, Steffen, and Thiele, Holger

Published
2022
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34. Comparison of clinical outcomes between Magmaris and Orsiro drug eluting stent at 12 months: Pooled patient level analysis from BIOSOLVE II-III and BIOFLOW II trials

Author

BIOFLOW-II, BIOSOLVE-II and BIOSOLVE-III investigators, Hideo-Kajita, Alexandre, Garcia-Garcia, Hector M, Kolm, Paul, Azizi, Viana, Ozaki, Yuichi, Dan, Kazuhiro, Ince, Hueseyin, Kische, Stephan, Abizaid, Alexandre, Töelg, Ralph, Lemos, Pedro Alves, Van Mieghem, Nicolas M, Verheye, Stefan, von Birgelen, Clemens, Christiansen, Evald Høj, Wijns, William, Lefèvre, Thierry, Windecker, Stephan, Waksman, Ron, Haude, Michael, Clinical sciences, and Cardiology

Subjects
Target lesion, Data Analysis, Male, medicine.medical_specialty, Multivariate analysis, Time Factors, Head to head, medicine.medical_treatment, Coronary Artery Disease, 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, Primary outcome, Internal medicine, Medicine, Humans, 030212 general & internal medicine, Registries, 610 Medicine & health, Aged, 12 months follow-up, business.industry, Significant difference, Magmaris, Stent, Drug-Eluting Stents, Middle Aged, Treatment Outcome, multivariate analysis, Drug-eluting stent, Population study, Female, business, Cardiology and Cardiovascular Medicine, Orsiro, Target lesion failure
Abstract

BACKGROUND: The aim of this study was to compare the 12-month clinical outcomes of patients treated with Magmaris or Orsiro. Second generation drug-eluting absorbable metal scaffold Magmaris (Dreams 2G) has proved to be safe and effective in the BIOSOLVE-II study. Similarly, biodegradable polymer sirolimus-eluting stent, Orsiro has shown notable clinical results even in all-comer populations.METHODS: Magmaris group patients were taken from the BIOSOLVE-II and BIOSOLVE-III trials, while the patients from Orsiro group were enrolled in BIOFLOW-II trial. The primary outcome was explored using a time-to-event assessment of the unadjusted clinical outcomes for target lesion failure (TLF) at 12 months, followed by a multivariate analysis adjusting for all the significantly different covariates between the groups.RESULTS: The study population consisted of 482 patients (521 lesions), 184 patients (189 lesions) in Magmaris group and 298 patients (332 lesions) in Orsiro group. The mean age was 65.5 ± 10.8 and 62.7 ± 10.4 years in Magmaris and Orsiro groups, respectively (p = 0.005). Magmaris and Orsiro unadjusted TLF rates were 6.0 and 6.4% with no significant difference between the groups (p = 0.869). In the multivariate analysis, there were no meaningful differences between Magmaris and Orsiro groups. Finally, none of the groups presented device thrombosis cases at 12 months.CONCLUSION: At 12 months there were no significant differences between Magmaris and Orsiro groups neither in the unadjusted assessment nor in the multivariate analysis for target lesion failure. These results should be taken as hypothesis generating and may warrant a head to head comparison on a randomized fashion.

Published
2020

44. C-Reactive Protein Apheresis as Anti-inflammatory Therapy in Acute Myocardial Infarction: Results of the CAMI-1 Study

Author

Ries, Wolfgang, primary, Torzewski, Jan, additional, Heigl, Franz, additional, Pfluecke, Christian, additional, Kelle, Sebastian, additional, Darius, Harald, additional, Ince, Hueseyin, additional, Mitzner, Steffen, additional, Nordbeck, Peter, additional, Butter, Christian, additional, Skarabis, Horst, additional, Sheriff, Ahmed, additional, and Garlichs, Christoph D., additional

Published
2021
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46. Safety and Performance Outcomes of a Self-Expanding Transcatheter Aortic Heart Valve

Author

Schaefer, Ulrich, Kempfert, Jörg, Verheye, Stefan, Maisano, Francesco, Thiele, Holger, Landt, Martin, Haude, Michael, Rudolph, Tanja K, Ince, Hueseyin, Kische, Stephan, Treede, Hendrik, Tonino, Pim, Conradi, Lenard, and Clinical sciences

Subjects
Biovalve, transcatheter heart valve, Aortic stenosis, supra-annular, self-expanding, Cardiology and Cardiovascular Medicine, Transfemoral
Abstract

OBJECTIVES: The aim of this study was to assess the safety and performance of a newly introduced transfemoral self-expanding supra-annular transcatheter heart valve. BACKGROUND: Transcatheter aortic valve replacement has become an established procedure, and newer transcatheter heart valves aim to supplement the current armamentarium. METHODS: BIOVALVE-I is a prospective, single-center feasibility study enrolling 13 high-risk patients with severe aortic stenosis, and BIOVALVE-II is a multicenter pilot study enrolling a further 55 patients under the same protocol. RESULTS: Patients' mean age was 82.4 ± 5.3 years, 57.4% had concomitant coronary artery disease, 50.0% had renal insufficiency stage ≥3, 32.4% had diabetes mellitus, 29.4% had current anemia, 19.1% had chronic obstructive pulmonary disease, 19.1% were frail, and 17.6% had prior cerebrovascular events. The primary endpoint, early safety according to the Valve Academic Research Consortium-2 guidelines, was observed in 13 patients (19.1%). One patient(1.5%) died through 30 days of a noncardiac cause, and 4 patients (7.8%) died through 180 days. Disabling stroke occurred at 30 days in 1 patient (1.5%) and at 180 days in 2 patients (3.2%). New permanent pacemakers up to 30 days were implanted in 9 patients (13.4%). Two patients (3.8%) had moderate or severe paravalvular leakage at 30 days and 4 (9.1%) at 6 months, mean effective orifice area was 2.0 ± 0.4 cm2 and 1.9 ± 0.5 cm2, and mean gradient was 6.4 mm Hg at 30 days and 6 months. CONCLUSIONS: Clinical outcomes with the Biovalve self-expanding transcatheter heart valve were similar to those seen in other first-in-human studies with first-generation devices for severe aortic stenosis.

Published
2020

47. Safety and Performance Outcomes of a Self-Expanding Transcatheter Aortic Heart Valve The BIOVALVE Trials

Author

Schaefer, Ulrich, Kempfert, Joerg, Verheye, Stefan, Maisano, Francesco, Thiele, Holger, Landt, Martin, Haude, Michael, Rudolph, Tanja K., Ince, Hueseyin, Kische, Stephan, Treede, Hendrik, Tonino, Pim, Conradi, Lenard, Schaefer, Ulrich, Kempfert, Joerg, Verheye, Stefan, Maisano, Francesco, Thiele, Holger, Landt, Martin, Haude, Michael, Rudolph, Tanja K., Ince, Hueseyin, Kische, Stephan, Treede, Hendrik, Tonino, Pim, and Conradi, Lenard

Abstract

OBJECTIVES The aim of this study was to assess the safety and performance of a newly introduced transfemoral self-expanding supra-annular transcatheter heart valve. BACKGROUND Transcatheter aortic valve replacement has become an established procedure, and newer transcatheter heart valves aim to supplement the current armamentarium. METHODS BIOVALVE-I is a prospective, single-center feasibility study enrolling 13 high-risk patients with severe aortic stenosis, and BIOVALVE-II is a multicenter pilot study enrolling a further 55 patients under the same protocol. RESULTS Patients' mean age was 82.4 +/- 5.3 years, 57.4% had concomitant coronary artery disease, 50.0% had renal insufficiency stage >= 3, 32.4% had diabetes mellitus, 29.4% had current anemia, 19.1% had chronic obstructive pulmonary disease, 19.1% were frail, and 17.6% had prior cerebrovascular events. The primary endpoint, early safety according to the Valve Academic Research Consortium-2 guidelines, was observed in 13 patients (19.1%). One patient (1.5%) died through 30 days of a noncardiac cause, and 4 patients (7.8%) died through 180 days. Disabling stroke occurred at 30 days in 1 patient (1.5%) and at 180 days in 2 patients (3.2%). New permanent pacemakers up to 30 days were implanted in 9 patients (13.4%). Two patients (3.8%) had moderate or severe paravalvular leakage at 30 days and 4 (9.1%) at 6 months, mean effective orifice area was 2.0 +/- 0.4 cm(2) and 1.9 +/- 0.5 cm(2), and mean gradient was 6.4 mm Hg at 30 days and 6 months. CONCLUSIONS Clinical outcomes with the Biovalve self-expanding transcatheter heart valve were similar to those seen in other first-in-human studies with first-generation devices for severe aortic stenosis. (C) 2020 Published by Elsevier on behalf of the American College of Cardiology Foundation.

Published
2020

50. Cierre de orejuela izquierda en pacientes mayores de 85 años: seguridad y eficacia del registro EWOLUTION

Author

Cruz-González, Ignacio, primary, Ince, Hueseyin, additional, Kische, Stephan, additional, Schmitz, Thomas, additional, Schmidt, Boris, additional, Gori, Tommaso, additional, Foley, David, additional, de Potter, Tom, additional, Tschishow, Wladimir, additional, Vireca, Elisa, additional, Stein, Kenneth, additional, and Boersma, Lucas V., additional

Published
2020
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