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1. Symptomatic vs. non-symptomatic device-related thrombus after LAAC: a sub-analysis from the multicenter EUROC-DRT registry

Author

Vij, Vivian, Cruz-González, Ignacio, Galea, Roberto, Piayda, Kerstin, Nelles, Dominik, Vogt, Lara, Gloekler, Steffen, Fürholz, Monika, Meier, Bernhard, Räber, Lorenz, O’Hara, Gilles, Arzamendi, Dabit, Agudelo, Victor, Asmarats, Lluis, Freixa, Xavier, Flores-Umanzor, Eduardo, De Backer, Ole, Sondergaard, Lars, Nombela-Franco, Luis, McInerney, Angela, Salinas, Pablo, Korsholm, Kasper, Nielsen-Kudsk, Jens Erik, Afzal, Shazia, Zeus, Tobias, Operhalski, Felix, Schmidt, Boris, Montalescot, Gilles, Guedeney, Paul, Iriart, Xavier, Miton, Noelie, Saw, Jacqueline, Gilhofer, Thomas, Fauchier, Laurent, Veliqi, Egzon, Meincke, Felix, Petri, Nils, Nordbeck, Peter, Gonzalez-Ferreiro, Rocio, Bhatt, Deepak L., Laricchia, Alessandra, Mangieri, Antonio, Omran, Heyder, Schrickel, Jan Wilko, Rodes-Cabau, Josep, Nickenig, Georg, Sievert, Horst, and Sedaghat, Alexander

Published
2023
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3. Position Statement on Cardiac Computed Tomography Following Left Atrial Appendage Occlusion

Author

Korsholm, Kasper, Iriart, Xavier, Saw, Jacqueline, Wang, Dee Dee, Berti, Sergio, Galea, Roberto, Freixa, Xavier, Arzamendi, Dabit, De Backer, Ole, Kramer, Anders, Cademartiri, Filippo, Cochet, Hubert, Odenstedt, Jacob, Aminian, Adel, Räber, Lorenz, Cruz-Gonzalez, Ignacio, Garot, Philippe, Jensen, Jesper Møller, Alkhouli, Mohamad, and Nielsen-Kudsk, Jens Erik

Published
2024
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4. Embolization of percutaneous left atrial appendage closure devices: Timing, management and clinical outcomes

Author

Eppinger, Sophie, Piayda, Kerstin, Galea, Roberto, Sandri, Marcus, Maarse, Moniek, Güner, Ahmet, Karabay, Can Y., Pershad, Ashish, Ding, Wern Y., Aminian, Adel, Akin, Ibrahim, Davtyan, Karapet V., Chugunov, Ivan A., Marijon, Eloi, Rosseel, Liesbeth, Schmidt, Thomas Robert, Amabile, Nicolas, Korsholm, Kasper, Lund, Juha, Guerios, Enio, Amat-Santos, Ignacio J., Boccuzzi, Giacomo, Ellis, Christopher R., Sabbag, Avi, Ebelt, Henning, Clapp, Brian, Assa, Hana Vaknin, Levi, Amos, Ledwoch, Jakob, Lehmann, Sonja, Lee, Oh-Hyun, Mark, George, Schell, Wendy, della Rocca, Domenico G., Natale, Andrea, de Backer, Ole, Kefer, Joelle, Esteban, Pablo P., Abelson, Mark, Ram, Pradhum, Moceri, Pamela, Galache Osuna, Jose G., Alvarez, Xavier Millán, Cruz-Gonzalez, Ignacio, de Potter, Tom, Ghassan, Moubarak, Osadchiy, Andrey, Chen, Weita, Goyal, Sandeep K., Giannini, Francesco, Rivero-Ayerza, Máximo, Afzal, Shazia, Jung, Christian, Skurk, Carsten, Langel, Martin, Spence, Mark, Merkulov, Evgeny, Lempereur, Mathieu, Shin, Seung Y., Mesnier, Jules, McKinney, Heather L., Schuler, Brian T., Armero, Sebastien, Gheorghe, Livia, Ancona, Marco B.M., Santos, Lino, Mansourati, Jacques, Nombela-Franco, Luis, Nappi, Francesco, Kühne, Michael, Gaspardone, Achille, van der Pals, Jesper, Montorfano, Matteo, Fernández-Armenta, Juan, Harvey, James E., Rodés-Cabau, Josep, Klein, Norbert, Sabir, Sajjad A., Kim, Jung-Sun, Cook, Stephane, Kornowski, Ran, Saraste, Antti, Nielsen-Kudsk, Jens E., Gupta, Dhiraj, Boersma, Lucas, Räber, Lorenz, Sievert, Kolja, Sievert, Horst, and Bertog, Stefan

Published
2024
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8. Clinical and echocardiographic risk factors for device-related thrombus after left atrial appendage closure: an analysis from the multicenter EUROC-DRT registry

Author

Vij, Vivian, Piayda, Kerstin, Nelles, Dominik, Gloekler, Steffen, Galea, Roberto, Fürholz, Monika, Meier, Bernhard, Valgimigli, Marco, O’Hara, Gilles, Arzamendi, Dabit, Agudelo, Victor, Asmarats, Lluis, Freixa, Xavier, Flores-Umanzor, Eduardo, De Backer, Ole, Sondergaard, Lars, Nombela-Franco, Luis, McInerney, Angela, Korsholm, Kasper, Nielsen-Kudsk, Jens Erik, Afzal, Shazia, Zeus, Tobias, Operhalski, Felix, Schmidt, Boris, Montalescot, Gilles, Guedeney, Paul, Iriart, Xavier, Miton, Noelie, Saw, Jacqueline, Gilhofer, Thomas, Fauchier, Laurent, Veliqi, Egzon, Meincke, Felix, Petri, Nils, Nordbeck, Peter, Ognerubov, Dmitrii, Merkulov, Evgeny, Cruz-González, Ignacio, Gonzalez-Ferreiro, Rocio, Bhatt, Deepak L., Laricchia, Alessandra, Mangieri, Antonio, Omran, Heyder, Schrickel, Jan Wilko, Rodes-Cabau, Josep, Sievert, Horst, Nickenig, Georg, and Sedaghat, Alexander

Published
2022
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9. Impact of gender in patients with device-related thrombosis after left atrial appendage closure -- a sub-analysis from the multicenter EUROC-DRT-registry

Author

Saw, Jacqueline, primary, Vij, Vivian, additional, Galea, Roberto, additional, Piayda, Kerstin, additional, Nelles, Dominik, additional, Vogt, Lara, additional, Gloekler, Steffen, additional, Fürholz, Monika, additional, Meier, Bernhard, additional, Räber, Lorenz, additional, O'Hara, Gilles, additional, Arzamendi, Dabit, additional, Agudelo, Victor, additional, Asmarats, Lluis, additional, Freixa, Xavier, additional, Flores-Umanzor, Eduardo J, additional, Backer, Ole De, additional, Sondergaard, Lars, additional, Franco, Luis Nombela, additional, Salinas, Pablo, additional, Korsholm, Kasper, additional, Nielsen-Kudsk, Jens Erik, additional, Zeus, Tobias, additional, Operhalski, Felix, additional, Schmidt, Boris, additional, Montalescot, Gilles, additional, Guedeney, Paul, additional, Iriart, Xavier, additional, Miton, Noelie, additional, Gilhofer, Thomas, additional, Fauchier, Laurent, additional, Veliqi, Egzon, additional, Meincke, Felix, additional, Petri, Nils, additional, Nordbeck, Peter, additional, Gonzalez-Ferreiro, Rocio, additional, Cruz-González, Ignacio, additional, L, Deepak Bhatt, additional, Laricchia, Alessandra, additional, Mangieri, Antonio, additional, Omran, Heyder, additional, Schrickel, Jan Wilko, additional, Beiert, Thomas, additional, Rodes-Cabau, Josep, additional, Nickenig, Georg, additional, Sievert, Horst, additional, Sedaghat, Alexander, additional, and Afzal, Shazia, additional

Published
2024
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11. Design and Rationale of the Swiss-Apero Randomized Clinical Trial: Comparison of Amplatzer Amulet vs Watchman Device in Patients Undergoing Left Atrial Appendage Closure

Author

Galea, Roberto, De Marco, Federico, Aminian, Adel, Meneveau, Nicolas, Anselme, Frederic, Gräni, Christoph, Huber, Adrian T., Teiger, Emmanuel, Iriart, Xavier, Angelillis, Marco, Brugger, Nicolas, Spirito, Alessandro, Corpataux, Noé, Franzone, Anna, Vranckx, Pascal, Fischer, Urs, Pedrazzini, Giovanni, Bedogni, Francesco, Windecker, Stephan, Räber, Lorenz, and Valgimigli, Marco

Published
2021
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15. Comparison of Mid-Term Prognosis in Intermediate-to-Low-Risk Contemporary Population with Guidelines-Oriented Age Cutoff

Author

Benenati, Stefano, primary, Gallo, Francesco, additional, Kim, Won-keun, additional, Khokhar, Arif A., additional, Zeus, Tobias, additional, Toggweiler, Stefan, additional, Galea, Roberto, additional, De Marco, Federico, additional, Mangieri, Antonio, additional, Regazzoli, Damiano, additional, Reimers, Bernhard, additional, Nombela-Franco, Luis, additional, Barbanti, Marco, additional, Regueiro, Ander, additional, Piva, Tommaso, additional, Rodes-Cabau, Josep, additional, Porto, Italo, additional, Colombo, Antonio, additional, Giannini, Francesco, additional, and Sticchi, Alessandro, additional

Published
2024
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16. Impact of gender in patients with device‐related thrombosis after left atrial appendage closure – A sub‐analysis from the multicenter EUROC‐DRT‐registry.

Author

Saw, Jacqueline, Vij, Vivian, Galea, Roberto, Piayda, Kerstin, Nelles, Dominik, Vogt, Lara, Gloekler, Steffen, Fürholz, Monika, Meier, Bernhard, Räber, Lorenz, O'Hara, Gilles, Arzamendi, Dabit, Agudelo, Victor, Asmarats, Lluis, Freixa, Xavier, Flores‐Umanzor, Eduardo, De Backer, Ole, Sondergaard, Lars, Nombela‐Franco, Luis, and Salinas, Pablo

Subjects
THROMBOSIS risk factors, RISK assessment, PROSTHETICS, ANTICOAGULANTS, SEX distribution, ARTIFICIAL implants, DESCRIPTIVE statistics, REPORTING of diseases, VITAMIN K, SURGICAL complications, KAPLAN-Meier estimator, ATRIAL fibrillation, LEFT atrial appendage closure, ADVERSE health care events, CONFIDENCE intervals, STROKE, COMORBIDITY, CHEMICAL inhibitors
Abstract

Background: Device‐related thrombosis (DRT) is a common finding after left atrial appendage closure (LAAC) and is associated with worse outcomes. As women are underrepresented in clinical studies, further understanding of sex differences in DRT patients is warranted. Methods and Results: This sub‐analysis from the EUROC‐DRT‐registry compromises 176 patients with diagnosis of DRT after LAAC. Women, who accounted for 34.7% (61/176) of patients, were older (78.0 ± 6.7 vs. 74.9 ± 9.1 years, p =.06) with lower rates of comorbidities. While DRT was detected significantly later in women (173 ± 267 vs. 127 ± 192 days, p =.01), anticoagulation therapy was escalated similarly, mainly with initiation of novel oral anticoagulant (NOAC), vitamin K antagonist (VKA) or heparin. DRT resolution was achieved in 67.5% (27/40) of women and in 75.0% (54/72) of men (p =.40). In the remaining cases, an intensification/switch of anticoagulation was conducted in 50.% (9/18) of men and in 41.7% (5/12) of women. Final resolution was achieved in 72.5% (29/40) cases in women, and in 81.9% (59/72) cases in men (p =.24). Women were followed‐up for a similar time as men (779 ± 520 vs. 908 ± 687 days, p =.51). Kaplan–Meier analysis revealed no difference in mortality rates in women (Hazard Ratio [HR]: 1.73, 95%‐Confidence interval [95%‐CI]:.68–4.37, p =.25) and no differences in stroke (HR:.83, 95%‐CI:.30–2.32, p =.72) within 2 years after LAAC. Conclusion: Evaluation of risk factors and outcome revealed no differences between men and women, with DRT in women being diagnosed significantly later. Women should be monitored closely to assess for DRT formation/resolution. Treatment strategies appear to be equally effective. [ABSTRACT FROM AUTHOR]

Published
2024
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17. Feasibility study on atrial fibrillation ablation with pulsed field ablation and concomitant occlusion of the left atrial appendage.

Author

Beney, Jennifer, Galea, Roberto, Siontis, Georgios, Gräni, Christoph, Kueffer, Thomas, Brugger, Nicolas, Reichlin, Tobias, Räber, Lorenz, and Roten, Laurent

Abstract

Aims Atrial fibrillation (AF) ablation and left atrial appendage occlusion (LAAO) are increasingly performed as individual procedures. Pulsed field ablation (PFA) has significantly reduced procedure duration and may be advantageous for the combined approach. Methods and results We have launched a programme for simultaneous AF ablation using PFA and LAAO for patients qualifying for both treatments and excluding those with a complex anatomy. We compare procedure duration and fluoroscopy time against individual procedures (either AF ablation or LAAO alone), all performed by the same operators and using consistent technologies. We performed the combined procedure in 10 patients (50% males; median age 70 years) and excluded 2 patients (17%) because of a complex left atrial appendage anatomy. No death, stroke, or major bleeding events, including pericardial effusion, occurred. For single-procedure comparison, 207 AF ablation procedures and 61 LAAO procedures were available. The total median procedure duration was 79 min (range 60–125) for the combined procedure, 71 min (25–241) for individual AF ablation (51 min without and 78 min with 3-dimensional electroanatomic mapping), and 47 min (15–162) for individual LAAO. The respective fluoroscopy times were 21 (15–26), 15 (5–44), and 10 (3–50) min. For the combined procedure, femoral vein access to last PFA application lasted 49 min (34–93) and LAAO added 20 min (15–37). Conclusion Simultaneous PFA-based AF ablation and LAAO in carefully selected patients is feasible and safe and can be executed within a short overall procedure duration. [ABSTRACT FROM AUTHOR]

Published
2024
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18. One-Year Outcomes After Amulet or Watchman Device for Percutaneous Left Atrial Appendage Closure: a Pre-Specified Analysis of the SWISS-APERO Randomized Clinical Trial

Author

Galea, Roberto, primary, Meneveau, Nicolas, additional, De Marco, Federico, additional, Aminian, Adel, additional, Heg, Dik, additional, Chalkou, Konstantina, additional, Gräni, Christoph, additional, Anselme, Frederic, additional, Franzone, Anna, additional, Vranckx, Pascal, additional, Fischer, Urs, additional, Bedogni, Francesco, additional, Räber, Lorenz, additional, and Valgimigli, Marco, additional

Published
2023
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20. Computed Tomography Scan Evidence for Left Atrial Appendage Short‐Term Remodeling Following Percutaneous Occlusion: Impact of Device Oversizing

Author

Mahmoudi, Khalil, primary, Galea, Roberto, additional, Elhadad, Simon, additional, Temperli, Fabrice, additional, Sebag, Frederic, additional, Gräni, Christoph, additional, Rezine, Zhor, additional, Roten, Laurent, additional, Landolff, Quentin, additional, Brugger, Nicolas, additional, Masri, Alaa, additional, Räber, Lorenz, additional, and Amabile, Nicolas, additional

Published
2023
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21. Symptomatic vs. non-symptomatic device-related thrombus after LAAC:a sub-analysis from the multicenter EUROC-DRT registry

Author

Vij, Vivian, Cruz-González, Ignacio, Galea, Roberto, Piayda, Kerstin, Nelles, Dominik, Vogt, Lara, Gloekler, Steffen, Fürholz, Monika, Meier, Bernhard, Räber, Lorenz, O’Hara, Gilles, Arzamendi, Dabit, Agudelo, Victor, Asmarats, Lluis, Freixa, Xavier, Flores-Umanzor, Eduardo, De Backer, Ole, Sondergaard, Lars, Nombela-Franco, Luis, McInerney, Angela, Salinas, Pablo, Korsholm, Kasper, Nielsen-Kudsk, Jens Erik, Afzal, Shazia, Zeus, Tobias, Operhalski, Felix, Schmidt, Boris, Montalescot, Gilles, Guedeney, Paul, Iriart, Xavier, Miton, Noelie, Saw, Jacqueline, Gilhofer, Thomas, Fauchier, Laurent, Veliqi, Egzon, Meincke, Felix, Petri, Nils, Nordbeck, Peter, Gonzalez-Ferreiro, Rocio, Bhatt, Deepak L., Laricchia, Alessandra, Mangieri, Antonio, Omran, Heyder, Schrickel, Jan Wilko, Rodes-Cabau, Josep, Nickenig, Georg, Sievert, Horst, Sedaghat, Alexander, Vij, Vivian, Cruz-González, Ignacio, Galea, Roberto, Piayda, Kerstin, Nelles, Dominik, Vogt, Lara, Gloekler, Steffen, Fürholz, Monika, Meier, Bernhard, Räber, Lorenz, O’Hara, Gilles, Arzamendi, Dabit, Agudelo, Victor, Asmarats, Lluis, Freixa, Xavier, Flores-Umanzor, Eduardo, De Backer, Ole, Sondergaard, Lars, Nombela-Franco, Luis, McInerney, Angela, Salinas, Pablo, Korsholm, Kasper, Nielsen-Kudsk, Jens Erik, Afzal, Shazia, Zeus, Tobias, Operhalski, Felix, Schmidt, Boris, Montalescot, Gilles, Guedeney, Paul, Iriart, Xavier, Miton, Noelie, Saw, Jacqueline, Gilhofer, Thomas, Fauchier, Laurent, Veliqi, Egzon, Meincke, Felix, Petri, Nils, Nordbeck, Peter, Gonzalez-Ferreiro, Rocio, Bhatt, Deepak L., Laricchia, Alessandra, Mangieri, Antonio, Omran, Heyder, Schrickel, Jan Wilko, Rodes-Cabau, Josep, Nickenig, Georg, Sievert, Horst, and Sedaghat, Alexander

Abstract

Background Device-related thrombus (DRT) after left atrial appendage closure (LAAC) is associated with adverse outcomes, i.e. ischemic stroke or systemic embolism (SE). Data on predictors of stroke/SE in the context of DRT are limited. Aims This study aimed to identify predisposing factors for stroke/SE in DRT patients. In addition, the temporal connection of stroke/SE to DRT diagnosis was analyzed. Methods The EUROC-DRT registry included 176 patients, in whom DRT after LAAC were diagnosed. Patients with symptomatic DRT, defined as stroke/SE in the context of DRT diagnosis, were compared against patients with non-symptomatic DRT. Baseline characteristics, anti-thrombotic regimens, device position, and timing of stroke/SE were compared. Results Stroke/SE occurred in 25/176 (14.2%) patients diagnosed with DRT (symptomatic DRT). Stroke/SE occurred after a median of 198 days (IQR 37–558) after LAAC. In 45.8% stroke/SE occurred within one month before/after DRT diagnosis (DRT-related stroke). Patients with symptomatic DRT had lower left ventricular ejection fractions (50.0 ± 9.1% vs. 54.2 ± 11.0%, p = 0.03) and higher rates of non-paroxysmal atrial fibrillation (84.0% vs. 64.9%, p = 0.06). Other baseline parameters and device positions were not different. Most ischemic events occurred among patients with single antiplatelet therapy (50%), however, stroke/SE was also observed under dual antiplatelet therapy (25%) or oral anticoagulation (20%). Conclusion Stroke/SE are documented in 14.2% and occur both in close temporal relation to the DRT finding and chronologically independently therefrom. Identification of risk factors remains cumbersome, putting all DRT patients at substantial risk for stroke/SE. Further studies are necessary to minimize the risk of DRT and ischemic events., Background: Device-related thrombus (DRT) after left atrial appendage closure (LAAC) is associated with adverse outcomes, i.e. ischemic stroke or systemic embolism (SE). Data on predictors of stroke/SE in the context of DRT are limited. Aims: This study aimed to identify predisposing factors for stroke/SE in DRT patients. In addition, the temporal connection of stroke/SE to DRT diagnosis was analyzed. Methods: The EUROC-DRT registry included 176 patients, in whom DRT after LAAC were diagnosed. Patients with symptomatic DRT, defined as stroke/SE in the context of DRT diagnosis, were compared against patients with non-symptomatic DRT. Baseline characteristics, anti-thrombotic regimens, device position, and timing of stroke/SE were compared. Results: Stroke/SE occurred in 25/176 (14.2%) patients diagnosed with DRT (symptomatic DRT). Stroke/SE occurred after a median of 198 days (IQR 37–558) after LAAC. In 45.8% stroke/SE occurred within one month before/after DRT diagnosis (DRT-related stroke). Patients with symptomatic DRT had lower left ventricular ejection fractions (50.0 ± 9.1% vs. 54.2 ± 11.0%, p = 0.03) and higher rates of non-paroxysmal atrial fibrillation (84.0% vs. 64.9%, p = 0.06). Other baseline parameters and device positions were not different. Most ischemic events occurred among patients with single antiplatelet therapy (50%), however, stroke/SE was also observed under dual antiplatelet therapy (25%) or oral anticoagulation (20%). Conclusion: Stroke/SE are documented in 14.2% and occur both in close temporal relation to the DRT finding and chronologically independently therefrom. Identification of risk factors remains cumbersome, putting all DRT patients at substantial risk for stroke/SE. Further studies are necessary to minimize the risk of DRT and ischemic events. Graphical Abstract: [Figure not available: see fulltext.]

Published
2023

22. Quality and transparency of evidence for implantable cardiovascular medical devices assessed by the CORE-MD consortium.

Author

Siontis, George C M, Coles, Bernadette, Häner, Jonas D, McGovern, Laurna, Bartkowiak, Joanna, Coughlan, J J, Spirito, Alessandro, Galea, Roberto, Haeberlin, Andreas, Praz, Fabien, Tomii, Daijiro, Melvin, Tom, Frenk, André, Byrne, Robert A, Fraser, Alan G, Windecker, Stephan, and Investigators, for the CORE-MD

Subjects
HEART valve prosthesis implantation, MEDICAL equipment, MEDICAL laws, IMPLANTABLE cardioverter-defibrillators, MITRAL valve, HEART valves
Abstract

Background and Aims The European Union Medical Device Regulation 2017/745 challenges key stakeholders to follow transparent and rigorous approaches to the clinical evaluation of medical devices. The purpose of this study is a systematic evaluation of published clinical evidence underlying selected high-risk cardiovascular medical devices before and after market access in the European Union (CE-marking) between 2000 and 2021. Methods Pre-specified strategies were applied to identify published studies of prospective design evaluating 71 high-risk cardiovascular devices in seven different classes (bioresorbable coronary scaffolds, left atrial appendage occlusion devices, transcatheter aortic valve implantation systems, transcatheter mitral valve repair/replacement systems, surgical aortic and mitral heart valves, leadless pacemakers, subcutaneous implantable cardioverter-defibrillator). The search time span covered 20 years (2000–21). Details of study design, patient population, intervention(s), and primary outcome(s) were summarized and assessed with respect to timing of the corresponding CE-mark approval. Results At least one prospective clinical trial was identified for 70% (50/71) of the pre-specified devices. Overall, 473 reports of 308 prospectively designed studies (enrolling 97 886 individuals) were deemed eligible, including 81% (251/308) prospective non-randomized clinical trials (66 186 individuals) and 19% (57/308) randomized clinical trials (31 700 individuals). Pre-registration of the study protocol was available in 49% (150/308) studies, and 16% (48/308) had a peer-reviewed publicly available protocol. Device-related adverse events were evaluated in 82% (253/308) of studies. An outcome adjudication process was reported in 39% (120/308) of the studies. Sample size was larger for randomized in comparison to non-randomized trials (median of 304 vs. 100 individuals, P <.001). No randomized clinical trial published before CE-mark approval for any of the devices was identified. Non-randomized clinical trials were predominantly published after the corresponding CE-mark approval of the device under evaluation (89%, 224/251). Sample sizes were smaller for studies published before (median of 31 individuals) than after (median of 135 individuals) CE-mark approval (P <.001). Clinical trials with larger sample sizes (>50 individuals) and those with longer recruitment periods were more likely to be published after CE-mark approval, and were more frequent during the period 2016–21. Conclusions The quantity and quality of publicly available data from prospective clinical investigations across selected categories of cardiovascular devices, before and after CE approval during the period 2000–21, were deemed insufficient. The majority of studies was non-randomized, with increased risk of bias, and performed in small populations without provision of power calculations, and none of the reviewed devices had randomized trial results published prior to CE-mark certification. [ABSTRACT FROM AUTHOR]

Published
2024
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23. Antithrombotic Therapy after Percutaneous Left Atrial Appendage Closure: Evidence, Challenges and Future Directions.

Author

Galea, Roberto and Räber, Lorenz

Abstract

Percutaneous left atrial appendage closure (LAAC) has been established in clinical practice as an attractive alternative to oral anticoagulation for preventing stroke in patients with atrial fibrillation and high bleeding risk. The devices approved in Europe and United States (US) for percutaneous LAAC contain metal and antithrombotic therapy is strongly recommended after their implantation to prevent apposition of thrombus on the atrial surface of the device during endothelialization. However, there is still uncertainty regarding the optimal antithrombotic drug regimen following device implantation in view of the incomplete understanding of the LAAC device healing process, the lack of randomized clinical trials comparing different antithrombotic agents after LAAC and the heterogeneous bleeding risk of patients undergoing LAAC. Thus, this review aims to evaluate the available evidence and the remaining challenges related to the post-LAAC antithrombotic regimens. Furthermore, common clinical scenarios associated with challenging management of antithrombotic therapy after LAAC and potential future directions, will be discussed. [ABSTRACT FROM AUTHOR]

Published
2023
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24. Prognostic Impact of Guidelines-oriented Age Cut-off in Intermediate-to-low Risk Patients Undergoing Transcatheter Aortic Valve Implantation in a Large Real-world Multicenter Registry

Author

Benenati, Stefano, primary, Gallo, Francesco, additional, Kim, Won-keun, additional, Khokhar, Arif A, additional, Zeus, Tobias, additional, Toggweiler, Stefan, additional, Galea, Roberto, additional, De Marco, Federico, additional, Mangieri, Antonio, additional, Regazzoli, Damiano, additional, Reimers, Bernhard, additional, Nombela-Franco, Luis, additional, Barbanti, Marco, additional, Regueiro, Ander, additional, Piva, Tommaso, additional, Rodes-Cabau, Josep, additional, Porto, Italo, additional, Colombo, Antonio, additional, Giannini, Francesco, additional, and Sticchi, Alessandro, additional

Published
2023
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25. PO-03-189 THROMBOEMBOLISM BEFORE VS AFTER PERCUTANEOUS CLOSURE OF PERI-DEVICE LEAKS RESULTING FROM PERCUTANEOUS LEFT ATRIAL APPENDAGE OCCLUSION

Author

Della Rocca, Domenico G., primary, Horton, Rodney P., additional, Magnocavallo, Michele, additional, King, Nicholas, additional, Turagam, Mohit, additional, Piayda, Kerstin, additional, Kramer, Anders Dahl, additional, Killu, Ammar M., additional, Galea, Roberto, additional, Jackson, Gregory, additional, Kawamura, Iwanari, additional, Kanagasundram, Arvindh N., additional, Ekanem, Emmanuel, additional, Bertog, Stefan, additional, Chierchia, Gian Battista, additional, de Asmundis, Carlo, additional, Korsholm, Kasper, additional, Sievert, Kolja, additional, Gianni, Carola, additional, Simard, Trevor, additional, Räber, Lorenz, additional, Alkhouli, Mohamad A., additional, Holmes, David R., additional, Nielsen-Kudsk, Jens Erik, additional, Sievert, Horst, additional, Reddy, Vivek Y., additional, Ellis, Christopher R., additional, and Natale, Andrea, additional

Published
2023
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30. Clinical and echocardiographic risk factors for device-related thrombus after left atrial appendage closure:an analysis from the multicenter EUROC-DRT registry

Author

Vij, Vivian, Piayda, Kerstin, Nelles, Dominik, Gloekler, Steffen, Galea, Roberto, Fürholz, Monika, Meier, Bernhard, Valgimigli, Marco, O’Hara, Gilles, Arzamendi, Dabit, Agudelo, Victor, Asmarats, Lluis, Freixa, Xavier, Flores-Umanzor, Eduardo, De Backer, Ole, Sondergaard, Lars, Nombela-Franco, Luis, McInerney, Angela, Korsholm, Kasper, Nielsen-Kudsk, Jens Erik, Afzal, Shazia, Zeus, Tobias, Operhalski, Felix, Schmidt, Boris, Montalescot, Gilles, Guedeney, Paul, Iriart, Xavier, Miton, Noelie, Saw, Jacqueline, Gilhofer, Thomas, Fauchier, Laurent, Veliqi, Egzon, Meincke, Felix, Petri, Nils, Nordbeck, Peter, Ognerubov, Dmitrii, Merkulov, Evgeny, Cruz-González, Ignacio, Gonzalez-Ferreiro, Rocío, Bhatt, Deepak L., Laricchia, Alessandra, Mangieri, Antonio, Omran, Heyder, Schrickel, Jan Wilko, Rodes-Cabau, Josep, Sievert, Horst, Nickenig, Georg, Sedaghat, Alexander, Vij, Vivian, Piayda, Kerstin, Nelles, Dominik, Gloekler, Steffen, Galea, Roberto, Fürholz, Monika, Meier, Bernhard, Valgimigli, Marco, O’Hara, Gilles, Arzamendi, Dabit, Agudelo, Victor, Asmarats, Lluis, Freixa, Xavier, Flores-Umanzor, Eduardo, De Backer, Ole, Sondergaard, Lars, Nombela-Franco, Luis, McInerney, Angela, Korsholm, Kasper, Nielsen-Kudsk, Jens Erik, Afzal, Shazia, Zeus, Tobias, Operhalski, Felix, Schmidt, Boris, Montalescot, Gilles, Guedeney, Paul, Iriart, Xavier, Miton, Noelie, Saw, Jacqueline, Gilhofer, Thomas, Fauchier, Laurent, Veliqi, Egzon, Meincke, Felix, Petri, Nils, Nordbeck, Peter, Ognerubov, Dmitrii, Merkulov, Evgeny, Cruz-González, Ignacio, Gonzalez-Ferreiro, Rocío, Bhatt, Deepak L., Laricchia, Alessandra, Mangieri, Antonio, Omran, Heyder, Schrickel, Jan Wilko, Rodes-Cabau, Josep, Sievert, Horst, Nickenig, Georg, and Sedaghat, Alexander

Abstract

Background: Data on Device-related Thrombus (DRT) after left atrial appendage closure (LAAC) remain scarce. This study aimed to investigate risk factors for DRT from centers reporting to the EUROC-DRT registry. Methods: We included 537 patients (112 with DRT and 425 without DRT) who had undergone LAAC between 12/2008 and 04/2019. Baseline and implantation characteristics, anti-thrombotic treatment and clinical outcomes were compared between both groups in uni- and multivariate analyses. Additional propensity-score matching (PSM) was conducted to focus on the role of implantation characteristics. Results: Patients with DRT showed higher rates of previous stroke/transient ischemic attack (TIA) (49.1% vs. 34.7%, p < 0.01), spontaneous echocardiographic contrast (SEC) (44.9% vs. 27.7%, p < 0.01) and lower left atrial appendage (LAA) peak emptying velocity (35.4 ± 18.5 vs. 42.4 ± 18.0 cm/s, p = 0.02). Occluders implanted in DRT patients were larger (25.5 ± 3.8 vs. 24.6 ± 3.5 mm, p = 0.03) and implanted deeper in the LAA (mean depth: 7.6 ± 4.7 vs. 5.7 ± 4.7 mm, p < 0.01). Coverage of the appendage ostium was achieved less often in DRT patients (69.5% vs. 81.5%, p < 0.01), while DRT patients were less frequently on oral anticoagulation (7.1% vs. 16.7%, p < 0.01). Multivariate analysis identified age, prior stroke/TIA and SEC as independent risk factors for DRT. After PSM, implantation depth was found to be predictive. Rates of stroke/TIA were higher in DRT patients (13.5% vs. 3.8%, Hazard Ratio: 4.21 [95%-confidence interval: 1.88–9.49], p < 0.01). Conclusions: DRT after LAAC is associated with adverse outcome and appears to be of multifactorial origin, depending on patient characteristics, anticoagulation regimen and device position. Graphical abstract: [Figure not available: see fulltext.].

Published
2022

31. Left atrial appendage closure for thrombus trapping:the international, multicentre TRAPEUR registry

Author

Sebag, Frederic A., Garot, Philippe, Galea, Roberto, De Backer, Ole, Lepillier, Antoine, De Meesteer, Antoine, Hildick-Smith, David, Armero, Sebastien, Moubarak, Ghassan, Ducrocq, Gregory, Eschalier, Romain, Aminian, Adel, Sauguet, Antoine, Lellouche, Nicolas, Mahmoudi, Khalil, Räber, Lorenz, Amabile, Nicolas, Sebag, Frederic A., Garot, Philippe, Galea, Roberto, De Backer, Ole, Lepillier, Antoine, De Meesteer, Antoine, Hildick-Smith, David, Armero, Sebastien, Moubarak, Ghassan, Ducrocq, Gregory, Eschalier, Romain, Aminian, Adel, Sauguet, Antoine, Lellouche, Nicolas, Mahmoudi, Khalil, Räber, Lorenz, and Amabile, Nicolas

Abstract

Background: Although the presence of a thrombus contraindicates left atrial appendage closure procedure (LAAC), a previous study reported the feasibility of the thrombus trapping procedure (TTP) technique to overcome this limitation. Aims: This study aimed to analyse the short-term outcomes in a series of patients who underwent LAAC using the TTP (TTP-LAAC). Methods: This retrospective series included patients who underwent TTP-LAAC between January 2018 and May 2020 in 13 European centres. Device choice, pre-interventional work-up and post-discharge antithrombotic therapy regimens were left to the discretion of the operators. The primary endpoint was the 30-day occurrence of stroke, systemic embolism or cardiovascular death. Results: During the study period, a total of 1,918 patients underwent LAAC. A thrombus was identified in 71 cases but completely disappeared in 24 patients before procedure. TTP-LAAC was finally performed in 53 cases (3%). Thrombi were identified ahead of the actual day of implantation in 47 patients (87%) and were mostly limited in size (50 cases with extension <50% of the LAA surface). The Amplatzer Amulet and WATCHMAN FLX occluders were implanted in 44 and 9 patients, respectively. A single deployment approach was applied in 70% and a cerebral embolic protection system was used in 9% of the patients. The overall success rate was 100%. Small pericardial effusion without tamponade was observed in 6% of the cases. Patients were discharged with 72% under antiplatelet therapy and 10% under short-term oral anticoagulation. The primary endpoint occurred in one patient. Conclusions: TTP-LAAC might be used in a minority of LAAC procedures but appears to be feasible and safe in the short-term, in select cases.

Published
2022

32. Left atrial appendage closure for thrombus trapping: the international, multicentre TRAPEUR registry

Author

Sebag, Frederic Sebag, primary, Garot, Philippe, additional, Galea, Roberto, additional, De Backer, Ole, additional, Lepillier, Antoine, additional, De Meesteer, Antoine, additional, Hildick-Smith, David, additional, Armero, Sebastien, additional, Moubarak, Ghassan, additional, Ducrocq, Gregory, additional, Eschalier, Romain, additional, Aminian, Adel, additional, Sauguet, Antoine, additional, Lellouche, Nicolas, additional, Mahmoudi, Khalil, additional, Räber, Lorenz, additional, and Amabile, Nicolas, additional

Published
2022
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33. Amulet or Watchman Device for Percutaneous Left Atrial Appendage Closure: Primary Results of the SWISS-APERO Randomized Clinical Trial

Author

Galea, Roberto, primary, De Marco, Federico, additional, Meneveau, Nicolas, additional, Aminian, Adel, additional, Anselme, Frédéric, additional, Gräni, Christoph, additional, Huber, Adrian T., additional, Teiger, Emmanuel, additional, Iriart, Xavier, additional, Babongo Bosombo, Flora, additional, Heg, Dik, additional, Franzone, Anna, additional, Vranckx, Pascal, additional, Fischer, Urs, additional, Pedrazzini, Giovanni, additional, Bedogni, Francesco, additional, Räber, Lorenz, additional, and Valgimigli, Marco, additional

Published
2022
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34. Watchman FLX vs. Watchman 2.5 in a Dual-Center Left Atrial Appendage Closure Cohort: the WATCH-DUAL study

Author

Galea, Roberto, primary, Mahmoudi, Khalil, additional, Gräni, Christoph, additional, Elhadad, Simon, additional, Huber, Adrian T, additional, Heg, Dik, additional, Siontis, George C M, additional, Brugger, Nicolas, additional, Sebag, Frederic, additional, Windecker, Stephan, additional, Valgimigli, Marco, additional, Landolff, Quentin, additional, Roten, Laurent, additional, Amabile, Nicolas, additional, and Räber, Lorenz, additional

Published
2022
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35. Safety and feasibility of peri-device leakage closure after LAAO: an international, multicentre collaborative study: Interventional leakage closure after LAAO

Author

Piayda, Kerstin, Sievert, Kolja, Della Rocca, Domenico, Adeola, Oluwaseun, Alkhouli, Mohamad, Yoo, David, Benito-González, Tomas, Cruz-González, Ignatio, Galea, Roberto, Skurk, Carsten, De Backer, Ole, Nielsen-Kudsk, Jens, Grygier, Marek, Beaty, Elijah, Newton, Jim, Pérez de Prado, Armando, Räber, Lorenz, Gibson, Douglas, Van Niekerk, Christoffel, Ellis, Christopher, Horton, Rodney, Natale, Andrea, Grundwald, Iris, Zeus, Tobias, and Sievert, Horst

Subjects
Clinical Research, Septal Occluder Device, Feasibility Studies, Humans
Abstract

BACKGROUND: Residual peri-device leakage (PDL) is frequent after left atrial appendage occlusion (LAAO). Little is known about management strategies, procedural aspects and outcomes of interventional PDL closure. AIMS: The aim of this study was to assess the safety and feasibility of PDL closure after LAAO. METHODS: Fifteen centres contributed data on baseline characteristics, in-hospital and follow-up outcomes of patients who underwent PDL closure after LAAO. Outcomes of interest included acute success and complication rates and long-term efficacy of the procedure. RESULTS: A total of 95 patients were included and a cumulative number of 104 leaks were closed. The majority of PDLs were detected within 90 days (range 41-231). Detachable coils were the most frequent approach (42.3%), followed by the use of the AMPLATZER Vascular Plug II (29.8%) and the AMPLATZER Duct Occluder II (17.3%). Technical success was 100% with 94.2% of devices placed successfully within the first attempt. There were no major complications requiring surgical or transcatheter interventions. During follow-up (96 days [range 49-526]), persistent leaks were found in 18 patients (18.9%), yielding a functional success rate of 82.7%, although PDLs were significantly reduced in size (pre-leak size(max): 6.1±3.6 mm vs post-leak size(max): 2.5±1.3 mm, p5 mm. Major adverse events during follow-up occurred in 5 patients (2 ischaemic strokes, 2 intracranial haemorrhages, and 1 major gastrointestinal bleeding). CONCLUSIONS: Several interventional techniques have become available to achieve PDL closure. They are associated with high technical and functional success and low complication rates.

Published
2021

37. The Impact of first wave of COVID-19 on referrals to Mtarfa Mental Health Clinic and evaluation of service response.

Author

Galea, Roberto, Apap Bologna, Martha Anne, Dimech, Catherine, and Grech, Anton

Subjects
*COVID-19 pandemic, *COVID-19, *MENTAL health services, *SOCIAL distancing, *COMMUNITY mental health services, *INFECTIOUS disease transmission
Abstract

Background The COVID-19 pandemic necessitated social distancing measures to curb the spread of disease. This disrupted daily activities and social interaction with attendant impact on mental well-being, as well as mental health service provision. Method The study aims to investigate first contact community psychiatry referrals to the Mtarfa mental health clinic before and after the onset of COVID -19 and the adequacy of the service response. Following necessary approvals an index of new case appointments was constructed from the register at Mtarfa MHC from 11 March 2019 to 31 December 2020. This was cross referenced with eMR. The imposition of social distancing on 12 March 2020 was used to separate the date into before and after the onset of COVID-19. Results A total of 236 new case appointments were identified, 92 of these records preceded the onset of COVID-19 and 144 records followed. The date of referral was available in 105 of the 136 appointments attended. The waiting time could be calculated in 77.2% of these appointments, 76.4% before the onset of COVID-19 and 77.8.% after. The mean number of new case referrals received per month increased from 7.4 before the first wave to 21.2 after, a three-fold increase. Mean waiting time was 21.6 weeks prior to the onset of COVID-19 which decreased to 7.4 weeks when a steady state was observed after the first wave. Conclusion The COVID-19 pandemic posed significant challenges to community mental health services resulting in major service restructuring. These challenges were met through staff redeployment and increased clinic frequency. The service increase successfully met a threefold increase in new case appointments at the clinic and decreased waiting time by two thirds. [ABSTRACT FROM AUTHOR]

Published
2023

38. Safety and feasibility of peri-device leakage closure after LAAO: an international, multicentre collaborative study

Author

Piayda, Kerstin, primary, Sievert, Kolja, additional, Della Rocca, Domenico G., additional, Adeola, Oluwaseun G., additional, Alkhouli, Mohamad, additional, Yoo, David, additional, Benito-González, Tomas, additional, Cruz-González, Ignatio, additional, Galea, Roberto, additional, Skurk, Carsten, additional, De Backer, Ole, additional, Nielsen-Kudsk, Jens Erik, additional, Grygier, Marek, additional, Beaty, Elijah H., additional, Newton, Jim, additional, Pérez de Prado, Armando, additional, Räber, Lorenz, additional, Gibson, Douglas, additional, Van Niekerk, Christoffel, additional, Ellis, Christopher R., additional, Horton, Rodney P., additional, Natale, Andrea, additional, Grundwald, Iris, additional, Zeus, Tobias, additional, and Sievert, Horst, additional

Published
2021
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39. Impact of clinical presentation on bleeding risk after percutaneous coronary intervention and implications for the ARC-HBR definition

Author

Gragnano, Felice, primary, Spirito, Alessandro, additional, Corpataux, Noé, additional, Vaisnora, Lukas, additional, Galea, Roberto, additional, Gargiulo, Giuseppe, additional, Siontis, George C.M., additional, Praz, Fabien, additional, Lanz, Jonas, additional, Billinger, Michael, additional, Hunziker, Lukas, additional, Stortecky, Stefan, additional, Pilgrim, Thomas, additional, Bär, Sarah, additional, Ueki, Yasushi, additional, Capodanno, Davide, additional, Urban, Philip, additional, Pocock, Stuart J., additional, Mehran, Roxana, additional, Heg, Dik, additional, Windecker, Stephan, additional, Räber, Lorenz, additional, and Valgimigli, Marco, additional

Published
2021
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41. TCT-310 Percutaneous Peridevice Leakage Closure After Insufficient Left Atrial Appendage Occlusion: Results From a Worldwide Collaborative Study

Author

Piayda, Kerstin, primary, Sievert, Kolja, additional, Della Rocca, Domenico, additional, Adeola, Oluwaseun, additional, Alkhouli, Mohamad, additional, Yoo, David, additional, Benito-González, Tomás, additional, Cruz-Gonzalez, Ignacio, additional, Galea, Roberto, additional, Skurk, Carsten, additional, De Backer, Ole, additional, Nielsen-Kudsk, Jens Erik, additional, Grygier, Marek, additional, Beaty, Elijah, additional, Newton, Jim, additional, Perez de Prado, Armando, additional, Raber, Lorenz, additional, Gibson, Douglas, additional, Van Niekerk, Christoffel, additional, Ellis, Christopher, additional, Horton, Rodney, additional, Natale, Andrea, additional, Grunwald, Iris, additional, Zeus, Tobias, additional, and Sievert, Horst, additional

Published
2021
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42. Sex‐Based Differences in Bleeding Risk After Percutaneous Coronary Intervention and Implications for the Academic Research Consortium High Bleeding Risk Criteria

Author

Spirito, Alessandro, primary, Gragnano, Felice, additional, Corpataux, Noé, additional, Vaisnora, Lukas, additional, Galea, Roberto, additional, Svab, Stefano, additional, Gargiulo, Giuseppe, additional, Siontis, George C. M., additional, Praz, Fabien, additional, Lanz, Jonas, additional, Billinger, Michael, additional, Hunziker, Lukas, additional, Stortecky, Stefan, additional, Pilgrim, Thomas, additional, Capodanno, Davide, additional, Urban, Philip, additional, Pocock, Stuart, additional, Mehran, Roxana, additional, Heg, Dik, additional, Windecker, Stephan, additional, Räber, Lorenz, additional, and Valgimigli, Marco, additional

Published
2021
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43. Device-Related Thrombus after Left Atrial Appendage Closure:Data on Thrombus Characteristics, Treatment Strategies, and Clinical Outcomes from the EUROC-DRT-Registry

Author

Sedaghat, Alexander, Vij, Vivian, Al-Kassou, Baravan, Gloekler, Steffen, Galea, Roberto, Fürholz, Monika, Meier, Bernhard, Valgimigli, Marco, O'Hara, Gilles, Arzamendi, Dabit, Agudelo, Victor, Asmarats, Lluis, Freixa, Xavier, Flores-Umanzor, Eduardo, De Backer, Ole, Søndergaard, Lars, Nombela-Franco, Luis, McInerney, Angela, Korsholm, Kaspar, Nielsen-Kudsk, Jens Erik, Afzal, Shazia, Zeus, Tobias, Operhalski, Felix, Schmidt, Boris, Montalescot, Gilles, Guedeney, Paul, Iriart, Xavier, Miton, Noelie, Saw, Jacqueline, Gilhofer, Thomas, Fauchier, Laurent, Veliqi, Egzon, Meincke, Felix, Petri, Nils, Nordbeck, Peter, Rycerz, Szymon, Ognerubov, Dmitrii, Merkulov, Evgeny, Cruz-González, Ignacio, Gonzalez-Ferreiro, Rocio, Bhatt, Deepak L., Laricchia, Alessandra, Mangieri, Antonio, Omran, Heyder, Schrickel, Jan Wilko, Rodes-Cabau, Josep, Nickenig, Georg, Sedaghat, Alexander, Vij, Vivian, Al-Kassou, Baravan, Gloekler, Steffen, Galea, Roberto, Fürholz, Monika, Meier, Bernhard, Valgimigli, Marco, O'Hara, Gilles, Arzamendi, Dabit, Agudelo, Victor, Asmarats, Lluis, Freixa, Xavier, Flores-Umanzor, Eduardo, De Backer, Ole, Søndergaard, Lars, Nombela-Franco, Luis, McInerney, Angela, Korsholm, Kaspar, Nielsen-Kudsk, Jens Erik, Afzal, Shazia, Zeus, Tobias, Operhalski, Felix, Schmidt, Boris, Montalescot, Gilles, Guedeney, Paul, Iriart, Xavier, Miton, Noelie, Saw, Jacqueline, Gilhofer, Thomas, Fauchier, Laurent, Veliqi, Egzon, Meincke, Felix, Petri, Nils, Nordbeck, Peter, Rycerz, Szymon, Ognerubov, Dmitrii, Merkulov, Evgeny, Cruz-González, Ignacio, Gonzalez-Ferreiro, Rocio, Bhatt, Deepak L., Laricchia, Alessandra, Mangieri, Antonio, Omran, Heyder, Schrickel, Jan Wilko, Rodes-Cabau, Josep, and Nickenig, Georg

Abstract

Background: Left atrial appendage closure is an established therapy in patients with atrial fibrillation. Although device-related thrombosis (DRT) is relatively rare, it is potentially linked to adverse events. As data on DRT characteristics, outcome, and treatment regimen are scarce, we aimed to assess these questions in a multicenter approach. Methods: One hundred fifty-six patients with the diagnosis of DRT after left atrial appendage closure were included in the multinational EUROC-DRT registry. Baseline characteristics included clinical and echocardiographic data. After inclusion, all patients underwent further clinical and echocardiographic follow-up to assess DRT dynamics, treatment success, and outcome. Results: DRT was detected after a median of 93 days (interquartile range, 54-161 days) with 17.9% being detected >6 months after left atrial appendage closure. Patients with DRT were at high ischemic and bleeding risk (CHA2DS2-VASc 4.5±1.7, HAS-BLED 3.3±1.2) and had nonparoxysmal atrial fibrillation (67.3%), previous stroke (53.8%), and spontaneous echo contrast (50.6%). The initial treatment regimens showed comparable resolution rates (antiplatelet monotherapy: 57.1%, dual antiplatelet therapy: 85.7%, vitamin K antagonists: 80.0%, novel oral anticoagulants: 75.0%, and heparin: 68.6%). After intensification or switch of treatment, complete DRT resolution was achieved in 79.5% of patients. Two-year follow-up revealed a high risk of mortality (20.0%) and ischemic stroke (13.8%) in patients with DRT. Patients with incomplete DRT resolution showed numerically higher stroke rates and increased mortality rates (stroke: 17.6% versus 12.3%, P=0.29; mortality: 31.3% versus 13.1%, P=0.05). Conclusions: A substantial proportion of DRT is detected >6 months after left atrial appendage closure, highlighting the need for imaging follow-up. Patients with DRT appear to be at a high risk for stroke and mortality. While DRT resolution was achieved in most patients, in

Published
2021

44. Device-Related Thrombus After Left Atrial Appendage Closure: Data on Thrombus Characteristics, Treatment Strategies, and Clinical Outcomes From the EUROC-DRT-Registry

Author

Sedaghat, Alexander, primary, Vij, Vivian, additional, Al-Kassou, Baravan, additional, Gloekler, Steffen, additional, Galea, Roberto, additional, Fürholz, Monika, additional, Meier, Bernhard, additional, Valgimigli, Marco, additional, O’Hara, Gilles, additional, Arzamendi, Dabit, additional, Agudelo, Victor, additional, Asmarats, Lluis, additional, Freixa, Xavier, additional, Flores-Umanzor, Eduardo, additional, De Backer, Ole, additional, Søndergaard, Lars, additional, Nombela-Franco, Luis, additional, McInerney, Angela, additional, Korsholm, Kaspar, additional, Nielsen-Kudsk, Jens Erik, additional, Afzal, Shazia, additional, Zeus, Tobias, additional, Operhalski, Felix, additional, Schmidt, Boris, additional, Montalescot, Gilles, additional, Guedeney, Paul, additional, Iriart, Xavier, additional, Miton, Noelie, additional, Saw, Jacqueline, additional, Gilhofer, Thomas, additional, Fauchier, Laurent, additional, Veliqi, Egzon, additional, Meincke, Felix, additional, Petri, Nils, additional, Nordbeck, Peter, additional, Rycerz, Szymon, additional, Ognerubov, Dmitrii, additional, Merkulov, Evgeny, additional, Cruz-González, Ignacio, additional, Gonzalez-Ferreiro, Rocio, additional, Bhatt, Deepak L., additional, Laricchia, Alessandra, additional, Mangieri, Antonio, additional, Omran, Heyder, additional, Schrickel, Jan Wilko, additional, Rodes-Cabau, Josep, additional, and Nickenig, Georg, additional

Published
2021
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46. Validation of high bleeding risk criteria and definition as proposed by the academic research consortium for high bleeding risk

Author

Corpataux, Noé, primary, Spirito, Alessandro, additional, Gragnano, Felice, additional, Vaisnora, Lukas, additional, Galea, Roberto, additional, Svab, Stefano, additional, Gargiulo, Giuseppe, additional, Zanchin, Thomas, additional, Zanchin, Christian, additional, Siontis, George C M, additional, Praz, Fabien, additional, Lanz, Jonas, additional, Hunziker, Lukas, additional, Stortecky, Stefan, additional, Pilgrim, Thomas, additional, Räber, Lorenz, additional, Capodanno, Davide, additional, Urban, Philip, additional, Pocock, Stuart, additional, Heg, Dik, additional, Windecker, Stephan, additional, and Valgimigli, Marco, additional

Published
2020
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47. Impact of individual stroke risk on outcome after Amplatzer left atrial appendage closure in patients with atrial fibrillation

Author

Häner, Jonas D., primary, Fürholz, Monika, additional, Kleinecke, Caroline, additional, Galea, Roberto, additional, Streit, Samuel R., additional, Fankhauser, Mate, additional, Cherni, Takwa, additional, Valgimigli, Marco, additional, Windecker, Stephan, additional, Meier, Bernhard, additional, and Gloekler, Steffen, additional

Published
2020
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49. Left atrial appendage closure versus medical therapy in patients with atrial fibrillation: the APPLY study

Author

Gloekler, Steffen, primary, Fürholz, Monika, additional, de Marchi, Stefano, additional, Kleinecke, Caroline, additional, Streit, Samuel R., additional, Buffle, Eric, additional, Fankhauser, Mate, additional, Häner, Jonas Dominik, additional, Nietlispach, Fabian, additional, Galea, Roberto, additional, Windecker, Stephan, additional, and Meier, Bernhard, additional

Published
2020
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