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2. LANDMARK comparison of early outcomes of newer-generation Myval transcatheter heart valve series with contemporary valves (Sapien and Evolut) in real-world individuals with severe symptomatic native aortic stenosis: a randomised non-inferiority trial

Author

Siqueira, Dimytri, Pinto, Ibraim, Cervone, Alberto, Assef, Jorge, Vilela, Andrea, Paladino, Antonio, Ramos, Auristela, Rezende, Mariana, Ghorayeb, Samira, Braga Silva, Tacianne Rolemberg, Gjorgjievska, Savica, Hadzibegovic, Irzal, Jurin, Ivana, Sipic, Tomislav, Pavlovic, Nikola, Rudez, Igor, Manola, Sime, GALLET DE SAINT-AURIN, Romain, BOUKANTAR, Madjid, NICOLAS, Eroan, ENNEZAT, Pierre Valdimir, URIEN, Jean Marie, Vincent, Flavien, Delhaye, Cedric, Denimal, Tom, Cosenza, Alessandro, Pamart, Thibault, Porouchani, Sina, Pontana, Francois, Montaigne, David, Balmette, Vincent, Bechiri, Mohamed, Chen, Elisabeth, Janah, Dany, Renker, Matthias, Westermann, Dirk, Valina, Christian, Ferenc, Miroslaw, Löffelhardt, Nikolaus, Rahimi, Faridun, Breitbart, Philipp, Franke, Kilian, Czerny, Martin, Diab, Nawras, Sick, Peter, Adeishvili, Medea, Mangner, Norman, Haussig, Stephan, Sveric, Krunuslav, Crusius, Lisa, Roehlig, Marie, Koliastasis, Leonidas, Drakopoulou, Maria, Katsaros, Odysseas, Ktenopoulos, Nikolaos, Ioanniadis, Andreas, Evangelou, Sotirios, Ninios, Ilias, Molnar, Levente, Papp, Roland, Arnold-Béla, Ferencz, Demeterné Kiss, Orsolya, Nagy, Andrea, Czimbalmos, Csilla, Pellegrinni, Dario, Montonati, Carolina, Pellicano, Mariano, Guagliumi, Giulio, Tespili, Maurizio, Barbara, Bellini, Filippo, Russo, Marco, Ancona, Ciro, Vella, Luca, Ferri, Eustachio, Agricola, Giacomo, Ingallina, Cannone, Gaspare, Brambilla, Nedy, Testa, Luca, Avondo, Stefano, Valvo, Roberto, Clarke, Robin, Fish, Mandy, Kosowski, Michal, Krawczyk, Magdalena, Kubler, Piotr, Kotwica, Tomasz, Teles, Rui, Gonçalves, Pedro, Raposo, Luis, Brito, Joã, Leal, Silvio, Freitas, Pedro, Ribeiras, Regina, Poliacikova, Petra, Mihailovic, Peter Marko, Terseglav, Simon, Steblovnik, Klemen, Cercek, Miha, Vitez, Luka, Sustersic, Miha, Kovac, Ana, Kogoj, Polonca, Dimitrovska, Ljupka, Arana, J.Raul Delgado, Martinez, Sandra Santos, Dieguez, Alfredo Redondo, Barrero, Alejandro, Gonzalez-Bartol, Esther, Aristizabal, Cristhian, Frutos, Ana Serrador, Luna, Juan Pablo Sanchez, Gomez, Mario Garcia, Gabella, Tania Rodriguez, Nelson, Verónica Quevedo, Medina, Jose Novoa, Ojeda, Soledad, de Lezo, Javier Suarez, Romero, Miguel, Gonzalez-Manzanares, Rafael, Alvarado, Marco, Mesa, Dolores, Perea, Jorge, Petursson, Petur, Alchay, Monér, Andréen, Sofie, Gameren, Menno Van, Heijer, Peter den, Meuwissen, Martijn, CHENG, JIN M., Vos, Jeroen, Schölzel, B.E., Simsek, C, Hubbers, S, Van den Branden, Ben J.L., Stens, NA, Versteeg, GAA, Rooijakkers, MJP, Gehlmann, HR, Verkroost, MWA, Geuzebroek, GSC, Van Wely, MH, Van Geuns, RJ, van Nunen, LX, van Garsse, LAFM, Timmers, L, ten Berg, Jurrien, Kraaijeveld, A.O., Dickinson, M.G., Dessing, T.C., Mokhles, M.M., Baumbach, Andreas, van Royen, Niels, Amat-Santos, Ignacio J, Hudec, Martin, Bunc, Matjaz, Ijsselmuiden, Alexander, Laanmets, Peep, Unic, Daniel, Merkely, Bela, Hermanides, Renicus S, Ninios, Vlasis, Protasiewicz, Marcin, Rensing, Benno J W M, Martin, Pedro L, Feres, Fausto, De Sousa Almeida, Manuel, van Belle, Eric, Linke, Axel, Ielasi, Alfonso, Montorfano, Matteo, Webster, Mark, Toutouzas, Konstantinos, Teiger, Emmanuel, Bedogni, Francesco, Voskuil, Michiel, Pan, Manuel, Angerås, Oskar, Kim, Won-Keun, Rothe, Jürgen, Kristić, Ivica, Peral, Vicente, Garg, Scot, Elzomor, Hesham, Tobe, Akihiro, Morice, Marie-Claude, Onuma, Yoshinobu, Soliman, Osama, and Serruys, Patrick W

Published
2024
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3. Left Atrial Appendage Occlusion in Patients With Anticoagulation Failure vs Anticoagulation Contraindication

Author

Aarnink, Errol W., Maarse, Moniek, Fierro, Nicolai, Mazzone, Patrizio, Beneduce, Alessandro, Tondo, Claudio, Gasperetti, Alessio, Pracon, Radoslaw, Demkow, Marcin, Zieliński, Kamil, de Backer, Ole, Korsholm, Kasper, Nielsen-Kudsk, Jens Erik, Estévez-Loureiro, Rodrigo, Caneiro-Queija, Berenice, Benito-González, Tomás, Pérez de Prado, Armando, Nombela-Franco, Luis, Salinas, Pablo, Holmes, David, Almakadma, Abdul H., Berti, Sergio, Romeo, Maria Rita, Millan, Xavier, Arzamendi, Dabit, Alla, Venkata M., Agarwal, Himanshu, Eitel, Ingo, Paitazoglou, Christina, Freixa, Xavier, Cepas-Guillén, Pedro, Chothia, Rashaad, Badejoko, Solomon O., Spoon, Daniel B., Maddux, James T., El-Chami, Mikhael, Ram, Pradhum, Branca, Luca, Adamo, Marianna, Suradi, Hussam S., Peper, Joyce, van Dijk, Vincent F., Rensing, Benno J.W.M., Swaans, Martin J., Vireca, Elisa, Bergmann, Martin W., and Boersma, Lucas V.A.

Published
2024
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6. CT-Derived Patient-Specific Computer Simulation of the Novel Self-Expanding Evolut FX Implantation: A Case Series.

Author

Hegeman, Romy R. M. J. J., van Putten, Simon E., Timmers, Leo, Rensing, Benno J. W. M., Sonker, Uday, Laengle, Severin, Andreas, Martin, Swaans, Martin J., ten Berg, Jurriën M., and Klein, Patrick

Subjects
AORTIC stenosis, COMPUTER simulation, ECHOCARDIOGRAPHY
Abstract

Background/Objectives: Paravalvular leak and permanent pacemaker implantation remain relevant issues after transcatheter aortic valve implantation (TAVI). Novel device development as well as adequate preprocedural device selection can contribute to optimal outcomes. Methods: Computed tomography-based patient-specific computer anatomical analysis and simulation were used in addition to standard preprocedural preparation in three of the first Evolut FX cases in our center. Procedural and follow-up echocardiographic outcomes are presented. Results: Computed tomography-based computer simulation of Evolut FX resulted in implantation of a different size in one of three cases. In three cases of severe aortic valve stenosis, procedural as well as follow-up outcomes were satisfactory and in line with the simulated results of the chosen strategy. Conclusions: Preprocedural patient-specific computer simulation predicts and guides decision-making in TAVI with the Evolut FX platform. The combination of advanced preprocedural technology and novel technologies continues to contribute to the optimization of TAVI outcomes. [ABSTRACT FROM AUTHOR]

Published
2024
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7. LANDMARK comparison of early outcomes of newer-generation Myval transcatheter heart valve series with contemporary valves (Sapien and Evolut) in real-world individuals with severe symptomatic native aortic stenosis: a randomised non-inferiority trial

Author

Baumbach, Andreas, primary, van Royen, Niels, additional, Amat-Santos, Ignacio J, additional, Hudec, Martin, additional, Bunc, Matjaz, additional, Ijsselmuiden, Alexander, additional, Laanmets, Peep, additional, Unic, Daniel, additional, Merkely, Bela, additional, Hermanides, Renicus S, additional, Ninios, Vlasis, additional, Protasiewicz, Marcin, additional, Rensing, Benno J W M, additional, Martin, Pedro L, additional, Feres, Fausto, additional, De Sousa Almeida, Manuel, additional, van Belle, Eric, additional, Linke, Axel, additional, Ielasi, Alfonso, additional, Montorfano, Matteo, additional, Webster, Mark, additional, Toutouzas, Konstantinos, additional, Teiger, Emmanuel, additional, Bedogni, Francesco, additional, Voskuil, Michiel, additional, Pan, Manuel, additional, Angerås, Oskar, additional, Kim, Won-Keun, additional, Rothe, Jürgen, additional, Kristić, Ivica, additional, Peral, Vicente, additional, Garg, Scot, additional, Elzomor, Hesham, additional, Tobe, Akihiro, additional, Morice, Marie-Claude, additional, Onuma, Yoshinobu, additional, Soliman, Osama, additional, Serruys, Patrick W, additional, Siqueira, Dimytri, additional, Pinto, Ibraim, additional, Cervone, Alberto, additional, Assef, Jorge, additional, Vilela, Andrea, additional, Paladino, Antonio, additional, Ramos, Auristela, additional, Rezende, Mariana, additional, Ghorayeb, Samira, additional, Braga Silva, Tacianne Rolemberg, additional, Gjorgjievska, Savica, additional, Hadzibegovic, Irzal, additional, Jurin, Ivana, additional, Sipic, Tomislav, additional, Pavlovic, Nikola, additional, Rudez, Igor, additional, Manola, Sime, additional, GALLET DE SAINT-AURIN, Romain, additional, BOUKANTAR, Madjid, additional, NICOLAS, Eroan, additional, ENNEZAT, Pierre Valdimir, additional, URIEN, Jean Marie, additional, Vincent, Flavien, additional, Delhaye, Cedric, additional, Denimal, Tom, additional, Cosenza, Alessandro, additional, Pamart, Thibault, additional, Porouchani, Sina, additional, Pontana, Francois, additional, Montaigne, David, additional, Balmette, Vincent, additional, Bechiri, Mohamed, additional, Chen, Elisabeth, additional, Janah, Dany, additional, Matthias, Renker, additional, Westermann, Dirk, additional, Valina, Christian, additional, Ferenc, Miroslaw, additional, Löffelhardt, Nikolaus, additional, Rahimi, Faridun, additional, Breitbart, Philipp, additional, Franke, Kilian, additional, Czerny, Martin, additional, Diab, Nawras, additional, Sick, Peter, additional, Adeishvili, Medea, additional, Mangner, Norman, additional, Haussig, Stephan, additional, Sveric, Krunuslav, additional, Crusius, Lisa, additional, Roehlig, Marie, additional, Koliastasis, Leonidas, additional, Drakopoulou, Maria, additional, Katsaros, Odysseas, additional, Ktenopoulos, Nikolaos, additional, Ioanniadis, Andreas, additional, Evangelou, Sotirios, additional, Ninios, Ilias, additional, Molnar, Levente, additional, Papp, Roland, additional, Arnold-Béla, Ferencz, additional, Demeterné Kiss, Orsolya, additional, Nagy, Andrea, additional, Czimbalmos, Csilla, additional, Pellegrinni, Dario, additional, Montonati, Carolina, additional, Pellicano, Mariano, additional, Guagliumi, Giulio, additional, Tespili, Maurizio, additional, Barbara, Bellini, additional, Filippo, Russo, additional, Marco, Ancona, additional, Ciro, Vella, additional, Luca, Ferri, additional, Eustachio, Agricola, additional, Giacomo, Ingallina, additional, Cannone, Gaspare, additional, Brambilla, Nedy, additional, Testa, Luca, additional, Avondo, Stefano, additional, Valvo, Roberto, additional, Clarke, Robin, additional, Fish, Mandy, additional, Kosowski, Michal, additional, Krawczyk, Magdalena, additional, Kubler, Piotr, additional, Kotwica, Tomasz, additional, Teles, Rui, additional, Gonçalves, Pedro, additional, Raposo, Luis, additional, Brito, João, additional, Leal, Silvio, additional, Freitas, Pedro, additional, Ribeiras, Regina, additional, Poliacikova, Petra, additional, Mihaolovic, Peter Marko, additional, Terseglav, Simon, additional, Steblovnik, Klemen, additional, Cercek, Miha, additional, Vitez, Luka, additional, Sustersic, Miha, additional, Kovac, Ana, additional, Kogoj, Polonca, additional, Dimitrovska, Ljupka, additional, Arana, J.Raul Delgado, additional, Martinez, Sandra Santos, additional, Dieguez, Alfredo Redondo, additional, Barrero, Alejandro, additional, Gonzalez-Bartol, Esther, additional, Aristizabal, Cristhian, additional, Frutos, Ana Serrador, additional, Luna, Juan Pablo Sanchez, additional, Gomez, Mario Garcia, additional, Gabella, Tania Rodriguez, additional, Nelson, Verónica Quevedo, additional, Medina, Jose Novoa, additional, Ojeda, Soledad, additional, de Lezo, Javier Suarez, additional, Romero, Miguel, additional, Gonzalez-Manzanares, Rafael, additional, Alvarado, Marco, additional, Mesa, Dolores, additional, Perea, Jorge, additional, Petursson, Petur, additional, Alchay, Monér, additional, Andréen, Sofie, additional, Van Gameren, Menno, additional, den Heijer, Peter, additional, Meuwissen, Martijn, additional, CHENG, JIN M., additional, Vos, Jeroen, additional, Schölzel, B.E., additional, Simsek, C, additional, Hubbers, S, additional, Stens, NA, additional, Versteeg, GAA, additional, Rooijakkers, MJP, additional, Gehlmann, HR, additional, Verkroost, MWA, additional, Geuzebroek, GSC, additional, Van Wely, MH, additional, Van Geuns, RJ, additional, van Nunen, LX, additional, van Garsse, LAFM, additional, Timmers, L, additional, ten Berg, Jurrien, additional, Kraaijeveld, A.O., additional, Dickinson, M.G., additional, Dessing, T.C., additional, and Mokhles, M.M., additional

Published
2024
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8. Left Atrial Appendage Occlusion vs Standard of Care After Ischemic Stroke Despite Anticoagulation

Author

Maarse, Moniek, Seiffge, David J., Werring, David J., Boersma, Lucas V. A., Aarnink, Errol W., Fierro, Nicolai, Mazzone, Patrizio, Beneduce, Alessandro, Tondo, Claudio, Gasperetti, Alessio, Pracon, Radoslaw, Demkow, Marcin, Zielinski, Kamil, de Backer, Ole, Korsholm, Kasper, Nielsen-Kudsk, Jens Erik, Estévez-Loureiro, Rodrigo, Caneiro-Queija, Berenice, Benito-González, Tomás, de Prado, Armando Pérez, Nombela-Franco, Luis, Salinas, Pablo, Holmes, David, Almakadma, Abdul H., Berti, Sergio, Romeo, Maria Rita, Alvarez, Xavier Millan, Arzamendi, Dabit, Alla, Venkata M., Agarwal, Himanshu, Eitel, Ingo, Paitazoglou, Christina, Freixa, Xavier, Cepas-Guillén, Pedro, Chothia, Rashaad, Badejoko, Solomon O., Bergmann, Martin W., Spoon, Daniel B., Maddux, James T., El-Chami, Mikhael, Ram, Pradhum, Branca, Luca, Adamo, Marianna, Suradi, Hussam S., van Dijk, Vincent F., Rensing, Benno J. W. M., Zietz, Annaelle, Paciaroni, Maurizio, Caso, Valeria, Koga, Masatoshi, Toyoda, Kazunori, Kallmünzer, Bernd, Cappellari, Manuel, Wilson, Duncan, Engelter, Stefan, and Swaans, Martin J.

Abstract

IMPORTANCE: Patients with atrial fibrillation (AF) who have ischemic stroke despite taking oral anticoagulation therapy (OAT) have a very high risk of recurrence. Left atrial appendage occlusion (LAAO) is a mechanical stroke prevention strategy that may provide additional protection in patients with thromboembolic events under OAT. OBJECTIVE: To compare percutaneous LAAO with continuing OAT alone regarding stroke prevention in patients with AF who had a thromboembolic event despite taking OAT. DESIGN, SETTING, AND PARTICIPANTS: This cohort study was a propensity score–matched comparison of the STR-OAC LAAO cohort, an international collaboration of 21 sites combining patients from multiple prospective registries of patients who underwent LAAO between 2010 and 2022. STR-OAC LAAO cohort patients who had follow-up longer than 3 months were propensity score–matched to a previously published control cohort comprising patients from an established international collaboration of investigator-initiated prospective studies. This control cohort included patients with nonvalvular AF, recent ischemic stroke or transient ischemic attack, and follow-up longer than 3 months who were taking OAT before the index event. Analyses were adjusted for imbalances in gender, age, hypertension, diabetes, and CHA2 DS2-VASc score. EXPOSURE: Left atrial appendage occlusion vs continuation of oral anticoagulation therapy alone (control group). MAIN OUTCOMES AND MEASURES: The primary outcome was time to first ischemic stroke. RESULTS: Four hundred thirty-three patients from the STR-OAC LAAO cohort (mean [SD] age, 72 [9] years; 171 [39%] females and 262 [61%] males; mean [SD] CHA2 DS2-VASc score, 5.0 [1.6]) were matched to 433 of 1140 patients (38%) from the control group. During 2-year follow-up, 50 patients experienced ischemic stroke: an annualized event rate of 2.8% per patient-year in the STR-OAC LAAO group vs 8.9% per patient-year in the control group. Left atrial appendage occlusion was associated with a lower risk of ischemic stroke (hazard ratio, 0.33; 95% CI, 0.19-0.58; P < .001) compared with the control group. After LAAO, OAT was discontinued in 290 patients (67%), and the remaining 143 patients (33%) continued OAT after LAAO as an adjunctive therapy. CONCLUSIONS AND RELEVANCE: In patients with nonvalvular AF and a prior thromboembolic event despite taking OAT, LAAO was associated with a lower risk of ischemic stroke compared with continued OAT alone. Randomized clinical trial data are needed to confirm that LAAO may be a promising treatment option for this population with a very high risk of stroke.

Published
2024
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9. Complications of Balloon Pulmonary Angioplasty: A Comprehensive Analysis Based on the Latest ESC Consensus Statement

Author

Circulatory Health, Team Medisch, van Leusden, Fe J., Staal, Diederik P., van Thor, Mitch C.J., Rensing, Benno J.M.W., van Kuijk, Jan Peter, Mulder, Berend M., van den Heuvel, Daniël A.F., Boerman, Sanne, Boomars, Karin A., Peper, Joyce, Mager, Johannes J., Post, Marco C., Circulatory Health, Team Medisch, van Leusden, Fe J., Staal, Diederik P., van Thor, Mitch C.J., Rensing, Benno J.M.W., van Kuijk, Jan Peter, Mulder, Berend M., van den Heuvel, Daniël A.F., Boerman, Sanne, Boomars, Karin A., Peper, Joyce, Mager, Johannes J., and Post, Marco C.

Published
2024

10. Complications of Balloon Pulmonary Angioplasty:A Comprehensive Analysis Based on the Latest ESC Consensus Statement

Author

van Leusden, Fe J., Staal, Diederik P., van Thor, Mitch C.J., Rensing, Benno J.M.W., van Kuijk, Jan Peter, Mulder, Berend M., van den Heuvel, Daniël A.F., Boerman, Sanne, Boomars, Karin A., Peper, Joyce, Mager, Johannes J., Post, Marco C., van Leusden, Fe J., Staal, Diederik P., van Thor, Mitch C.J., Rensing, Benno J.M.W., van Kuijk, Jan Peter, Mulder, Berend M., van den Heuvel, Daniël A.F., Boerman, Sanne, Boomars, Karin A., Peper, Joyce, Mager, Johannes J., and Post, Marco C.

Abstract

Background/Objectives: The literature reports high complication rates in patients with chronic thromboembolic pulmonary hypertension (CTEPH) who undergo balloon pulmonary angioplasty (BPA), especially in patients with poor pulmonary hemodynamics. Here, we describe the complications of BPA based on the new definitions. Methods: All patients with CTEPH who completed BPA treatment before 15 September 2023 were selected from the CTEPH database. Peri-procedural complications were collected and classified according to the 2023 consensus paper on BPA treatment. Complications were analyzed in subgroups of patients with pulmonary vascular resistance (PVR), ≤ or >6.6 WU, and mean pulmonary artery pressure (mPAP), ≤ or >45 mmHg, at first BPA. Results: In this analysis, 87 patients (63% women; mean age 61.1 ± 14.0 years; 62% on dual PH targeted medical therapy) underwent 426 (mean 4.9 ± 1.6 per patient) BPAs. Only non-severe complications occurred in 14% of BPA treatments and in 47% of the patients; 31% patients had a thoracic complication. The thoracic complications were mild (71%) or moderate (29%). Patients with a PVR > 6.6 WU (n = 8) underwent more BPA treatments (6.6 ± 1.5 versus 4.6 ± 1.5, p = 0.002), had more complications (88% versus 41% of patients, p = 0.020), and had more thoracic complications (17% vs. 7% of BPAs, p = 0.013) than patients with PVR ≤ 6.6 WU. Patients with mPAP > 45 mmHg (n = 13) also had more BPA treatments (6.5 ± 1.7 versus 4.6 ± 1.4, p < 0.001), more complications (77% versus 44% of patients, p = 0.027) and more thoracic complications (14% versus 8% of BPAs, p = 0.039) than patients with mPAP ≤ 45 mmHg. Conclusions: Complications occurred in 14% of BPAs and were mostly mild. Patients with severe pulmonary hemodynamics suffered more (thoracic) complications.

Published
2024

11. Complications of Balloon Pulmonary Angioplasty: A Comprehensive Analysis Based on the Latest ESC Consensus Statement.

Author

van Leusden, Fe J., Staal, Diederik P., van Thor, Mitch C. J., Rensing, Benno J. M. W., van Kuijk, Jan-Peter, Mulder, Berend M., van den Heuvel, Daniël A. F., Boerman, Sanne, Boomars, Karin A., Peper, Joyce, Mager, Johannes J., and Post, Marco C.

Subjects
TRANSLUMINAL angioplasty, PULMONARY artery, VASCULAR resistance, PULMONARY hypertension, PULMONARY embolism
Abstract

Background/Objectives: The literature reports high complication rates in patients with chronic thromboembolic pulmonary hypertension (CTEPH) who undergo balloon pulmonary angioplasty (BPA), especially in patients with poor pulmonary hemodynamics. Here, we describe the complications of BPA based on the new definitions. Methods: All patients with CTEPH who completed BPA treatment before 15 September 2023 were selected from the CTEPH database. Peri-procedural complications were collected and classified according to the 2023 consensus paper on BPA treatment. Complications were analyzed in subgroups of patients with pulmonary vascular resistance (PVR), ≤ or >6.6 WU, and mean pulmonary artery pressure (mPAP), ≤ or >45 mmHg, at first BPA. Results: In this analysis, 87 patients (63% women; mean age 61.1 ± 14.0 years; 62% on dual PH targeted medical therapy) underwent 426 (mean 4.9 ± 1.6 per patient) BPAs. Only non-severe complications occurred in 14% of BPA treatments and in 47% of the patients; 31% patients had a thoracic complication. The thoracic complications were mild (71%) or moderate (29%). Patients with a PVR > 6.6 WU (n = 8) underwent more BPA treatments (6.6 ± 1.5 versus 4.6 ± 1.5, p = 0.002), had more complications (88% versus 41% of patients, p = 0.020), and had more thoracic complications (17% vs. 7% of BPAs, p = 0.013) than patients with PVR ≤ 6.6 WU. Patients with mPAP > 45 mmHg (n = 13) also had more BPA treatments (6.5 ± 1.7 versus 4.6 ± 1.4, p < 0.001), more complications (77% versus 44% of patients, p = 0.027) and more thoracic complications (14% versus 8% of BPAs, p = 0.039) than patients with mPAP ≤ 45 mmHg. Conclusions: Complications occurred in 14% of BPAs and were mostly mild. Patients with severe pulmonary hemodynamics suffered more (thoracic) complications. [ABSTRACT FROM AUTHOR]

Published
2024
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14. The association of body mass index with long-term clinical outcomes after ticagrelor monotherapy following abbreviated dual antiplatelet therapy in patients undergoing percutaneous coronary intervention: a prespecified sub-analysis of the GLOBAL LEADERS Trial

Author

Ono, Masafumi, Chichareon, Ply, Tomaniak, Mariusz, Kawashima, Hideyuki, Takahashi, Kuniaki, Kogame, Norihiro, Modolo, Rodrigo, Hara, Hironori, Gao, Chao, Wang, Rutao, Walsh, Simon, Suryapranata, Harry, da Silva, Pedro Canas, Cotton, James, Koning, René, Akin, Ibrahim, Rensing, Benno J. W. M., Garg, Scot, Wykrzykowska, Joanna J., Piek, Jan J., Jüni, Peter, Hamm, Christian, Steg, Philippe Gabriel, Valgimigli, Marco, Windecker, Stephan, Storey, Robert F., Onuma, Yoshinobu, Vranckx, Pascal, and Serruys, Patrick W.

Published
2020
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18. Periprocedural continuation versus interruption of oral anticoagulant drugs during transcatheter aortic valve implantation: rationale and design of the POPular PAUSE TAVI trial

Author

van Ginkel, Dirk Jan, primary, Bor, Willem L., additional, Dubois, Christophe L.F., additional, Aarts, Hugo M., additional, Rooijakkers, Maxim J.P., additional, van Bergeijk, Kees H., additional, Rosseel, Liesbeth, additional, Veenstra, Leo, additional, De Backer, Ole, additional, Van Mieghem, Nicolas M., additional, van der Kley, Frank, additional, Wilgenhof, Adriaan, additional, Leonora, Remigio, additional, Halim, Jonathan, additional, Schotborgh, Carl E., additional, Barbato, Emanuele, additional, Van Der Heyden, Jan A.S., additional, Frambach, Peter, additional, Ferdinande, Bert, additional, Mylotte, Darren, additional, Fabris, Enrico, additional, Rensing, Benno J.W.M., additional, Timmers, Leo, additional, Swaans, Martin J., additional, Brouwer, Jorn, additional, Nijenhuis, Vincent J., additional, Peper, Joyce, additional, Vriesendorp, Pieter A., additional, de Laat, Bas, additional, Ninivaggi, Marisa, additional, Stragier, Hendrik, additional, Voskuil, Michiel, additional, IJsselmuiden, Alexander J.J., additional, Hermanides, Renicus S., additional, Agostoni, Pierfrancesco, additional, van 't Hof, Arnoud W.J., additional, Wykrzykowska, Joanna J., additional, van Royen, Niels, additional, Delewi, Ronak, additional, and ten Berg, Jurrien M., additional

Published
2023
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25. Effect of Adding Ticagrelor to Standard Aspirin on Saphenous Vein Graft Patency in Patients Undergoing Coronary Artery Bypass Grafting (POPular CABG): A Randomized, Double-Blind, Placebo-Controlled Trial

Author

Willemsen, Laura M., Janssen, Paul W.A., Peper, Joyce, Soliman-Hamad, Mohamed A., van Straten, Albert H.M., Klein, Patrick, Hackeng, Chris M., Sonker, Uday, Bekker, Margreet W.A., von Birgelen, Clemens, Brouwer, Marc A., van der Harst, Pim, Vlot, Eline A., Deneer, Vera H.M., Chan Pin Yin, Dean R.P.P., Gimbel, Marieke E., Beukema, Kasper F., Daeter, Edgar J., Kelder, Johannes C., Tijssen, Jan G.P., Rensing, Benno J.W.M., van Es, Hendrik W., Swaans, Martin J., and ten Berg, Jurrien M.

Published
2020
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28. Fuga paravalvular tras implante de ACURATE neo y neo2: estudio comparativo con cuantificación de calcio

Author

García Guimaraes, Marcos, Van Ginkel, Dirk-Jan, Rensing, Benno J., ten Berg, Jurriën M., Sonker, Uday, De Kroon, Thomas L., Heijmen, Robin H., Swaans, Martin J., Timmers, Leo, García Guimaraes, Marcos, Van Ginkel, Dirk-Jan, Rensing, Benno J., ten Berg, Jurriën M., Sonker, Uday, De Kroon, Thomas L., Heijmen, Robin H., Swaans, Martin J., and Timmers, Leo

Abstract

Introduction and objectives: Moderate or severe paravalvular leak (PVL) following transcatheter aortic valve implantation (TAVI) has been associated with worse outcomes. Aortic valve (AV) calcification is a strong predictor of PVL. ACURATE neo (Boston Scientific Corporation, United States) is a self-expanding transcatheter heart valve to treat degenerative aortic stenosis. We evaluated PVL after ACURATE neo and neo2 implantation, and the role of AV calcification. Methods: We analyzed patients referred for TAVI with ACURATE neo and neo2 from a large volume tertiary center. All cardiac computed tomography scans were analyzed using 3Mensio Structural Heart software (Pie Medical Imaging, The Netherlands). The volume of AV calcium was quantified using contrast-enhanced cardiac computed tomography series. The 30-day clinical and echocardiographic data were prospectively recorded. Results: We included 165 patients referred for TAVI with ACURATE (neo = 87; neo2 = 78). Median age was 82 years-old, 65% were women with a median EuroSCORE II of 4.7 [IQR, 2.4-6.1]. Patients in the neo group showed a larger amount of total AV calcium (320 mm3 vs 200 mm3; P = .0305). We found no significant inter-group differences regarding clinical outcomes both in-hospital or at 30-days. At 30-days, the rate of PVL ≥ mild (61% vs 34%; P < .001) and ≥ moderate (15.9% vs 5.4%; P = .0365) were higher in the neo group. After propensity score matching adjusted by the total amount of AV calcium, neo2 was associated with a lower risk of PVL ≥ mild (OR, 0.35, 95%CI, 0.18-0.69; P = .003), and ≥ moderate (OR, 0.16; 95%CI, 0.03-0.74; P = .019). Conclusions: TAVI with ACURATE neo2 vs neo is associated with a lower risk of any degree of PVL and a reduced risk of PVL ≥ moderate. After adjusting for AV calcium volume, ACURATE neo2 was still associated with a lower risk of PVL., Introducción y objetivos: La fuga paravalvular (FPV) moderada o grave tras el implante percutáneo de válvula aórtica (TAVI) se ha asociado a peores resultados. La calcificación de la válvula aórtica constituye un importante factor predictivo de FPV. ACURATE neo (Boston Scientific Corporation, Estados Unidos) es una válvula cardiaca transcatéter autoexpandible para el tratamiento de la estenosis aórtica degenerativa. Se evaluó la presencia de FPV tras el implante de ACURATE neo y neo2, así como el papel de la calcificación de la válvula aórtica. Métodos: Se analizaron pacientes intervenidos de TAVI con ACURATE neo y neo2 de un hospital terciario de alto volumen. Todas las tomografías computarizadas cardiacas se analizaron con el software 3Mensio Structural Heart (Pie Medical Imaging, Países Bajos). El volumen de calcio aórtico se cuantificó mediante tomografía computarizada cardiaca con contraste. Se registró prospectivamente la evolución clínica y ecocardiográfica a 30 días. Resultados: Se incluyeron 165 pacientes intervenidos de TAVI con ACURATE (neo = 87; neo2 = 78). La mediana de edad fue de 82 años, el 65% eran mujeres y la mediana de EuroSCORE II fue de 4,7 [rango intercuartílico, 2,4-6,1]. Los pacientes del grupo con neo presentaban una mayor cantidad de calcio total aórtico (320 frente a 200 mm3; p = 0,0305). No se hallaron diferencias significativas entre los grupos en cuanto a los resultados clínicos tanto durante el ingreso como a los 30 días. A los 30 días, la tasa de FPV ≥ leve (61 frente a 34%; p < 0,001) y de FPV ≥ moderada (15,9 frente a 5,4%, p = 0,0365) fue más alta en el grupo con neo. Tras el emparejamiento por puntuación de propensión ajustado por la cantidad total de calcio aórtico, neo2 se relacionó con un menor riesgo de FPV ≥ leve (odds ratio [OR] = 0,35; intervalo de confianza del 95% [IC95%], 0,18-0,69; p = 0,003) y de FPV ≥ moderada (OR = 0,16; IC95%, 0,03-0,74; p = 0,019). Conclusiones: El TAVI con ACURATE neo2, en comparación con neo, se

Published
2023

29. Periprocedural continuation versus interruption of oral anticoagulant drugs during transcatheter aortic valve implantation: rationale and design of the POPular PAUSE TAVI trial

Author

R&D Onderzoek, Arts Assistenten Cardiologie, Team Medisch, Circulatory Health, van Ginkel, Dirk-Jan, Bor, Willem L, Dubois, Christophe L F, Aarts, Hugo M, Rooijakkers, Maxim J P, van Bergeijk, Kees H, Rosseel, Liesbeth, Veenstra, Leo, De Backer, Ole, Van Mieghem, Nicolas M, van der Kley, Frank, Wilgenhof, Adriaan, Leonora, Remigio, Halim, Jonathan, Schotborgh, Carl E, Barbato, Emanuele, Van Der Heyden, Jan A S, Frambach, Peter, Ferdinande, Bert, Mylotte, Darren, Fabris, Enrico, Rensing, Benno J W M, Timmers, Leo, Swaans, Martin J, Brouwer, Jorn, Nijenhuis, Vincent J, Peper, Joyce, Vriesendorp, Pieter A, de Laat, Bas, Ninivaggi, Marisa, Stragier, Hendrik, Voskuil, Michiel, IJsselmuiden, Alexander J J, Hermanides, Renicus S, Agostoni, Pierfrancesco, van 't Hof, Arnoud W J, Wykrzykowska, Joanna J, van Royen, Niels, Delewi, Ronak, Ten Berg, Jurrien M, R&D Onderzoek, Arts Assistenten Cardiologie, Team Medisch, Circulatory Health, van Ginkel, Dirk-Jan, Bor, Willem L, Dubois, Christophe L F, Aarts, Hugo M, Rooijakkers, Maxim J P, van Bergeijk, Kees H, Rosseel, Liesbeth, Veenstra, Leo, De Backer, Ole, Van Mieghem, Nicolas M, van der Kley, Frank, Wilgenhof, Adriaan, Leonora, Remigio, Halim, Jonathan, Schotborgh, Carl E, Barbato, Emanuele, Van Der Heyden, Jan A S, Frambach, Peter, Ferdinande, Bert, Mylotte, Darren, Fabris, Enrico, Rensing, Benno J W M, Timmers, Leo, Swaans, Martin J, Brouwer, Jorn, Nijenhuis, Vincent J, Peper, Joyce, Vriesendorp, Pieter A, de Laat, Bas, Ninivaggi, Marisa, Stragier, Hendrik, Voskuil, Michiel, IJsselmuiden, Alexander J J, Hermanides, Renicus S, Agostoni, Pierfrancesco, van 't Hof, Arnoud W J, Wykrzykowska, Joanna J, van Royen, Niels, Delewi, Ronak, and Ten Berg, Jurrien M

Published
2023

33. Central arteriovenous anastomosis for the treatment of patients with uncontrolled hypertension (the ROX CONTROL HTN study): a randomised controlled trial

Author

Lobo, Melvin D, Sobotka, Paul A, Stanton, Alice, Cockcroft, John R, Sulke, Neil, Dolan, Eamon, van der Giet, Markus, Hoyer, Joachim, Furniss, Stephen S, Foran, John P, Witkowski, Adam, Januszewicz, Andrzej, Schoors, Danny, Tsioufis, Konstantinos, Rensing, Benno J, Scott, Benjamin, Ng, G André, Ott, Christian, and Schmieder, Roland E

Published
2015
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34. Rationale and Design of the Project to Look for Early Discharge in Patients Undergoing TAVR With ACURATE (POLESTAR Trial)

Author

Ooms, Joris F., primary, Cornelis, Kristoff, additional, Stella, Pieter R., additional, Rensing, Benno J., additional, Van Der Heyden, Jan, additional, Chan, Albert W., additional, Wykrzykowska, Joanna J., additional, Rosseel, Liesbeth, additional, Vandeloo, Bert, additional, Lenzen, Mattie J., additional, Cunnington, Michael S., additional, Hildick-Smith, David, additional, Wijeysundera, Harindra C., additional, and Van Mieghem, Nicolas M., additional

Published
2022
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37. Central Iliac Arteriovenous Anastomosis for Uncontrolled Hypertension: One-Year Results From the ROX CONTROL HTN Trial

Author

Lobo, Melvin D., Ott, Christian, Sobotka, Paul A., Saxena, Manish, Stanton, Alice, Cockcroft, John R., Sulke, Neil, Dolan, Eamon, van der Giet, Markus, Hoyer, Joachim, Furniss, Stephen S., Foran, John P., Witkowski, Adam, Januszewicz, Andrzej, Schoors, Danny, Tsioufis, Konstantinos, Rensing, Benno J., Scott, Benjamin, Ng, G. André, and Schmieder, Roland E.

Published
2017
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38. Diagnostic Performance of CCTA and CT-FFR for the Detection of CAD in TAVR Work-Up

Author

Peper, Joyce, primary, Becker, Leonie M., additional, van den Berg, Hans, additional, Bor, Willem L., additional, Brouwer, Jorn, additional, Nijenhuis, Vincent J., additional, van Ginkel, Dirk-Jan, additional, Rensing, Benno J.M.W., additional, ten Berg, Jurrien M., additional, Timmers, Leo, additional, Leiner, Tim, additional, and Swaans, Martin J., additional

Published
2022
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39. Rationale and Design of the Project to Look for Early Discharge in Patients Undergoing TAVR With ACURATE (POLESTAR Trial)

Author

Ooms, Joris F., Cornelis, Kristoff, Stella, Pieter R., Rensing, Benno J., Van Der Heyden, Jan, Chan, Albert W., Wykrzykowska, Joanna J., Rosseel, Liesbeth, Vandeloo, Bert, Lenzen, Mattie J., Cunnington, Michael S., Hildick-Smith, David, Wijeysundera, Harindra C., Van Mieghem, Nicolas M., Ooms, Joris F., Cornelis, Kristoff, Stella, Pieter R., Rensing, Benno J., Van Der Heyden, Jan, Chan, Albert W., Wykrzykowska, Joanna J., Rosseel, Liesbeth, Vandeloo, Bert, Lenzen, Mattie J., Cunnington, Michael S., Hildick-Smith, David, Wijeysundera, Harindra C., and Van Mieghem, Nicolas M.

Abstract

Background: Transcatheter aortic valve replacement (TAVR) is now an established treatment strategy for elderly patients with symptomatic aortic stenosis (AS) across the entire operative risk spectrum. Streamlined TAVR protocols along with reduced procedure time and expedited ambulation promote early hospital discharge. Selection of patients suitable for safe early discharge after TAVR might improve healthcare efficiency. Study design: The POLESTAR trial is an international, multi-center, prospective, observational study which aims to evaluate the safety of early discharge in selected patients who undergo TAVR with the supra-annular functioning self-expanding ACURATE Neo transcatheter heart valve (THV). A total of 250 patients will be included based on a set of baseline criteria indicating potential early discharge (within 48 h post-TAVR). Primary study endpoints include Valve Academic Research Consortium (VARC)-3 defined safety at 30 days and VARC-3 defined efficacy at 30 days and 1 year. Endpoints will be compared between early discharge and non-early discharge cohorts with a distinct landmark analysis at 48 h post-TAVR. Secondary endpoints include quality of life assessed using EQ5D-5L and Kansas City Cardiomyopathy Questionnaire (KCCQ) questionnaires and resource costs compared between discharge groups. The POLESTAR trial prospectively evaluates safety and feasibility of an early discharge protocol for TAVR using the ACURATE Neo THV.

Published
2022

40. Diagnostic Performance of CCTA and CT-FFR for the Detection of CAD in TAVR Work-Up

Author

Researchgr. Cardiovasculaire Radiologie, Cancer, MS Radiologie, Circulatory Health, Peper, Joyce, Becker, Leonie M, van den Berg, Hans, Bor, Willem L, Brouwer, Jorn, Nijenhuis, Vincent J, van Ginkel, Dirk-Jan, Rensing, Benno J M W, Ten Berg, Jurrien M, Timmers, Leo, Leiner, Tim, Swaans, Martin J, Researchgr. Cardiovasculaire Radiologie, Cancer, MS Radiologie, Circulatory Health, Peper, Joyce, Becker, Leonie M, van den Berg, Hans, Bor, Willem L, Brouwer, Jorn, Nijenhuis, Vincent J, van Ginkel, Dirk-Jan, Rensing, Benno J M W, Ten Berg, Jurrien M, Timmers, Leo, Leiner, Tim, and Swaans, Martin J

Published
2022

44. Ticagrelor Monotherapy or Dual Antiplatelet Therapy After Drug‐Eluting Stent Implantation: Per‐Protocol Analysis of the GLOBAL LEADERS Trial

Author

Gragnano, Felice, primary, Zwahlen, Marcel, additional, Vranckx, Pascal, additional, Heg, Dik, additional, Schmidlin, Kurt, additional, Hamm, Christian, additional, Steg, Philippe Gabriel, additional, Gargiulo, Giuseppe, additional, McFadden, Eugene P., additional, Onuma, Yoshinobu, additional, Chichareon, Ply, additional, Benit, Edouard, additional, Möllmann, Helge, additional, Janssens, Luc, additional, Leonardi, Sergio, additional, Zurakowski, Aleksander, additional, Arrivi, Alessio, additional, Van Geuns, Robert Jan, additional, Huber, Kurt, additional, Slagboom, Ton, additional, Calabrò, Paolo, additional, Serruys, Patrick W., additional, Jüni, Peter, additional, Valgimigli, Marco, additional, Windecker, Stephan, additional, Abdellaoui, Mohamed, additional, Adlam, David, additional, Akin, Ibrahim, additional, Gonzalez‐Trevilla, Agustin Albarran, additional, Almeida, Manuel, additional, Neto, Pedro Alves Lemos, additional, Aminian, Adel, additional, Anderson, Richard, additional, Andreae, Rick, additional, Angioi, Michael, additional, Asano, Taku, additional, Barbato, Emanuele, additional, Barlis, Peter, additional, Barraud, Pascal, additional, Bertrand, Olivier, additional, Beygui, Farzin, additional, Bolognese, Leonardo, additional, Botelho, Roberto, additional, Bouwman, Coby, additional, Bressers, Marco, additional, Brunel, Philippe, additional, Buszman, Pawel, additional, Buysschaert, Ian, additional, da Silva, Pedro Canas, additional, Carrie, Didier, additional, Cequier, Angel, additional, Chang, Chun Chin, additional, Chowdhary, Saqib, additional, Collet, Carlos, additional, Colombo, Antonio, additional, Cotton, James, additional, Ferreira, Rui Cruz, additional, Curello, Salvatore, additional, Curzen, Nick, additional, de Bot, Judith, additional, de Vreede, Tone, additional, Karth, Georg Delle, additional, Dijksma, Lynn, additional, Dominici, Marcello, additional, Édes, István, additional, Eeckhout, Eric, additional, Eitel, Ingo, additional, Faluközy, József, additional, Fath‐Ordoubadi, Farzin, additional, Ferrario, Maurizio, additional, Fontos, Geza, additional, Diaz, Jose Francisco, additional, Quintella, Edgard Freitas, additional, Frey, Bernhard, additional, Friedrich, Guy, additional, Galasko, Gavin, additional, Galuszka, Grzegorz, additional, Ribeiro, Vasco Gama, additional, Garg, Scot, additional, Geisler, Tobias, additional, Gelev, Valeri, additional, Ghandilyan, Art, additional, Goicolea, Javier, additional, Gori, Tommaso, additional, Gragnano, Felice, additional, Guimarães, Ana, additional, Haude, Michael, additional, Heijke, Pieter, additional, Antolin, Rosa Ana Hernández, additional, Hildick‐Smith, David, additional, Hillen, Dorien, additional, Hoekman, Ina, additional, Hofma, Sjoerd, additional, Holmvang, Lene, additional, Hoole, Stephen, additional, Horváth, Iván, additional, Hugense, Annemarie, additional, Ibrahim, Karim, additional, Iñiguez, Andres, additional, Isaaz, Karl, additional, Jambrik, Zoltán, additional, Jasionowicz, Pawel, additional, Jonk, Judith, additional, Jung, Werner, additional, Katagiri, Yuki, additional, Kogame, Norihiro, additional, Koh, Tian Hai, additional, Koning, René, additional, Konteva, Mariana, additional, Kőszegi, Zsolt, additional, Krackhardt, Florian, additional, Kreuger, Yvonne, additional, Kukreja, Neville, additional, Ladan, Boudijn, additional, Lantelme, Pierre, additional, Leandro, Sergio, additional, Leibundgut, Gregor, additional, Liebetrau, Christoph, additional, Lindeboom, Wietze, additional, Miguel, Carlos Macaya, additional, Mach, François, additional, Magro, Michael, additional, Maillard, Luc, additional, Manavifar, Negar, additional, Mauri, Laura, additional, McFadden, Eugene, additional, Merkely, Bela, additional, Miyazaki, Yosuke, additional, Młodziankowski, Adam, additional, Moccetti, Tiziano, additional, Modolo, Rodrigo, additional, Möllman, Helge, additional, Morelle, Jean‐François, additional, Moschovitis, Aris, additional, Ottesen, Michael Munndt, additional, Muurling, Martin, additional, Naber, Christoph Kurt, additional, Neumann, Franz‐Josef, additional, Oldroyd, Keith, additional, Ong, Paul, additional, Palsrok, Sanne, additional, Petrov, Ivo, additional, Plante, Sylvain, additional, Prokopczuk, Janusz, additional, Rademaker‐Havinga, Tessa, additional, Raffel, Christopher, additional, Rensing, Benno, additional, Roffi, Marco, additional, Royaards, Kees‐Jan, additional, Sabate, Manel, additional, Schächinger, Volker, additional, Seidler, Tim, additional, Peñaranda, Antonio Serra, additional, Serruys, Patrick, additional, Sikarulidze, Lali, additional, Soliman, Osama I, additional, Sousa, Amanda, additional, Spitzer, Ernest, additional, Stables, Rod, additional, Steg, Gabriel, additional, Steinwender, Clemens, additional, Subkovas, Eduardas, additional, Suryapranata, Harry, additional, Takahashi, Kuniaki, additional, Talwar, Suneel, additional, Teiger, Emmanuel, additional, Weele, Addy Ter, additional, Teurlings, Eva, additional, Thury, Attila, additional, Tijssen, Jan, additional, Tonev, Gincho, additional, Trendafilova‐Lazarova, Diana, additional, Tumscitz, Carlo, additional, Umans, Victor, additional, Ungi, Imre, additional, Valkov, Veselin, additional, van der Harst, Pim, additional, van Geuns, Robert Jan, additional, van Meijeren, Cokky, additional, Vassilev, Dobrin, additional, Velchev, Vasil, additional, Velthuizen, Esther, additional, Verheugt, Freek, additional, Vlcek, Natalia, additional, Dahl, Jürgen Vom, additional, Vrolix, Mathias, additional, Walsh, Simon, additional, Werner, Nikos, additional, Witsenburg, Maarten, additional, Zaman, Azfar, additional, Żmudka, Krzysztof, additional, Zrenner, Bernhard, additional, and Zweiker, Robert, additional

Published
2022
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