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| Name | Class |
|---|---|
| Kerstin Piayda, CardioVascular Center Frankfurt, Frankfurt, Germany | UNKNOWN |
| Kolja Sievert, CardioVascular Center Frankfurt, Frankfurt, Germany | UNKNOWN |
| Roberto Galea, Universitätsspital Bern, Bern, Switzerland |
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The investigators thought to evaluate risk factors, therapeutic approaches and outcomes after left atrial appendage occluder device embolization (LAAO, either surgical or interventional).
The global burden of atrial fibrillation (AF) is high, and AF represents a major cause of morbidity, mortality and health-care expenditure. Thromboembolic stroke may be one of the fatal complications and oral anticoagulation has been the mainstay therapy for decades to mitigate stroke risk. However, in poor candidates for long-term anticoagulation (i.e. high bleeding risk, poor drug tolerance or adherence), non- pharmacological stroke prevention with percutaneous left atrial appendage occlusion (LAAO) is a considerable treatment option.
Occluders are implanted into the left atrial appendage (LAA) but they might dislocate and therefore embolize subsequently. In this case, surgical or percutaneous removal of the device may be indicated. Depending on the patient's status, implanting another device can be an alternative to returning to anticoagulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients experiencing device embolization after left atrial appendage occlusion | Device embolization following either surgical or interventional left atrial appendage occlusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Removal or leaving of LAA occluders | Procedure | After LAA device embolization there are different approaches to dealing with the occluder dislocation. The aim is to find out which way leads to the best outcomes. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural mortality | all-cause mortality during the index procedure, any procedure-related death within 30days or during in-hospital stay for the index procedure (if>30days) | In-hospital stay, assessed up to 30 days |
| Need for cardiac surgery | In-hospital stay, assessed up to 30 days | |
| Catheter-based retrieval of LAA Occluder | peri-procedural device removal | up to 5 years (after device implantation) |
| Measure | Description | Time Frame |
|---|---|---|
| Further complications | Any other complications after device embolization (i.e., thromboembolic events, circulatory problems, CPR etc.) | up to 5 years (after device implantation) |
| Risk factors | Favoring conditions for LAAO device dislocation (e.g., anatomical risk factors, risk factors related to the initial procedure) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients after interventional or surgical left atrial appendage occlusion with device embolization
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| Name | Affiliation | Role |
|---|---|---|
| Sophie Eppinger | CardioVascular Center (CVC) Frankfurt, Seckbacher Landstraße 65, 60389 Frankfurt am Main, Hesse, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CardioVascular Center (CVC) Frankfurt | Frankfurt on the Main | Hesse | 60389 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38448258 | Derived | Eppinger S, Piayda K, Galea R, Sandri M, Maarse M, Guner A, Karabay CY, Pershad A, Ding WY, Aminian A, Akin I, Davtyan KV, Chugunov IA, Marijon E, Rosseel L, Schmidt TR, Amabile N, Korsholm K, Lund J, Guerios E, Amat-Santos IJ, Boccuzzi G, Ellis CR, Sabbag A, Ebelt H, Clapp B, Assa HV, Levi A, Ledwoch J, Lehmann S, Lee OH, Mark G, Schell W, Della Rocca DG, Natale A, de Backer O, Kefer J, Esteban PP, Abelson M, Ram P, Moceri P, Galache Osuna JG, Alvarez XM, Cruz-Gonzalez I, de Potter T, Ghassan M, Osadchiy A, Chen W, Goyal SK, Giannini F, Rivero-Ayerza M, Afzal S, Jung C, Skurk C, Langel M, Spence M, Merkulov E, Lempereur M, Shin SY, Mesnier J, McKinney HL, Schuler BT, Armero S, Gheorghe L, Ancona MBM, Santos L, Mansourati J, Nombela-Franco L, Nappi F, Kuhne M, Gaspardone A, van der Pals J, Montorfano M, Fernandez-Armenta J, Harvey JE, Rodes-Cabau J, Klein N, Sabir SA, Kim JS, Cook S, Kornowski R, Saraste A, Nielsen-Kudsk JE, Gupta D, Boersma L, Raber L, Sievert K, Sievert H, Bertog S. Embolization of percutaneous left atrial appendage closure devices: Timing, management and clinical outcomes. Cardiovasc Revasc Med. 2024 Jul;64:7-14. doi: 10.1016/j.carrev.2024.02.014. Epub 2024 Feb 28. |
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| Moniek Maarse, St. Antonius Ziekenhuis, Nieuwegein, Netherlands | UNKNOWN |
| Sheba Medical Center | OTHER_GOV |
| Andrey Osadchiy, City Hospital #40, St. Petersburg, Russia | UNKNOWN |
| Andrey Kalemberg, National Research Center, Moscow, Russia | UNKNOWN |
| Jung-Sun Kim, Yonsei University Hospital, Seoul, South Korea | UNKNOWN |
| Aarhus University Hospital | OTHER |
| Sajjad A Sabir, Cooper University Hospital, NJ, USA | UNKNOWN |
| Ashish Pershad, Banner Health, Phoenix, Arizona, USA | UNKNOWN |
| Markus Sandri, Herzzentrum Leipzig, Leipzig, Germany | UNKNOWN |
| Jens-Erik Nielsen-Kudsk, University Hospital Aarhus, Aarhus, Denmark | UNKNOWN |
| George Mark, The Heart House/Cooper University Camden, NJ, USA | UNKNOWN |
| Liverpool Heart and Chest Hospital NHS Foundation Trust | OTHER |
| Pradhum Ram, Emory University, USA | UNKNOWN |
| Rigshospitalet, Denmark | OTHER |
| Norbert Klein, Klinikum St. Georg, Leipzig, Germany | UNKNOWN |
| Josep Rodes, Laval Hospital, Quebec, Canada | UNKNOWN |
| Shazia Afzal, Heinrich-Heine University, University Hospital, Duesseldorf | UNKNOWN |
| Xavier Millán Alvarez, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain | UNKNOWN |
| James E. Harvey, WellSpan Health, York, PA, USA | UNKNOWN |
| Wern Yew Ding, University of Liverpool, Liverpool, UK | UNKNOWN |
| Adel Aminian, Centre hospitalier universitaire de Charleroi, Brussels, Belgium | UNKNOWN |
| Pamela Moceri, Hopital Pasteur 1, Nice, France | UNKNOWN |
| Ibrahim Akin, Universitätsmedizin Mannheim, Germany | UNKNOWN |
| Jacques Mansourati, Hôpital de la Cavale Blanche, Brest, France | UNKNOWN |
| Eloi Marijon, Hôpital Européen Georges-Pompidou HEGP, Paris, France | UNKNOWN |
| Ignacio Amat Santos, University Clinical Hospital of Valladolid, Valladolid, Spain | UNKNOWN |
| Hana Vaknin Assa, Beilinson Hospital, Israel | UNKNOWN |
| Thomas Robert Schmidt, Herzzentrum Dresden GmbH Universitätsklinik, Dresden, Germany | UNKNOWN |
| Ran Kornowski, Rabin Medical Center, Petah Tiqwa, Israel | UNKNOWN |
| Giacomo Boccuzzi, Ospedale san Giovanni Bosco, Torino, Italy | UNKNOWN |
| Vanderbilt University | OTHER |
| Henning Ebelt, Katholisches Krankenhaus St. Nepomuk, Erfurt, Germany | UNKNOWN |
| Guy's and St Thomas' NHS Foundation Trust | OTHER |
| Sonja Lehmann, Hôpital Fribourgeois, Freiburg, Swizerland | UNKNOWN |
| Oh-Hyun Lee, Yonsai University Hospital, Yongin, Korea | UNKNOWN |
| Wendy Schell, Cooper University Hospital, NJ, USA | UNKNOWN |
| Domenico della Rocca, St David's Medical Center, Austin, Texas, USA | UNKNOWN |
| Pablo Pinon Esteban, Hospital Universitario A Coruña, Spain | UNKNOWN |
| Jose Gabriel Galache Osuna, Miguel Servet University Hospital, Zaragoza, Spain | UNKNOWN |
| Enio Guerios, Hospital Pilar, Curitiba, Brazil | UNKNOWN |
| Nicolas Amabile, Institut Mutualiste Montsouris, Paris, France | UNKNOWN |
| Ignacio Cruz Gonzalez, University Hospital of Salamanca, Castillay Leon, Spain | UNKNOWN |
| Weita Chen, Taipei Municipal Wanfang Hospital, Taipei, Taiwan | UNKNOWN |
| Sandeep Kumar Goyal, Piedmont Heart Institute Buckhead, Atlanta, GA, USA | UNKNOWN |
| Francesco Gianni, Maria Cecilia Hospital, Cotignola, Italy | UNKNOWN |
| Máximo Rivero Ayerza, Ziekenhuis Oost Limburg, Genk, Belgium | UNKNOWN |
| Carsten Skurk, Charité, Universitätsmedizin Berlin, Berlin, Germany | UNKNOWN |
| Martin Langel, Klinikum St. Georg, Leipzig, Germany | UNKNOWN |
| Livia Gheorghe, Hospital de la Santa Creu I Santa Pau, Barcelona, Spain | UNKNOWN |
| Lino Santos, Centro Hospitalar Vila Nova de Gaia, Vila Nova de Gaia, Portugal | UNKNOWN |
| Royal Victoria Hospital, Belfast | OTHER |
| Luis Nombela-Franco, Hospital Clínico San Carlos, Madrid, Spain | UNKNOWN |
| Francesco Nappi, Centre Cardiologique du Nord de Saint-Denis, Paris, France | UNKNOWN |
| Matteo Montorfano, Ospedale San Raffaele, Segrate, Milan, Italy | UNKNOWN |
| Juan Fernández-Armenta, Hospital Universitario Puerta del Mar, Cádiz, Spain | UNKNOWN |
| Michael Kühne, Universitätsspital Basel, Basel, Swizerland | UNKNOWN |
| Jesper van der Pals, Lund University Hospital, Lund, Sweden. | UNKNOWN |
| Can Yücel Karabay, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Center, Istanbul, Turkey | UNKNOWN |
| Marco Ancona, San Raffaele Scientific Institute, Milan, Italy | UNKNOWN |
| Ghassan Moubarak, Clinique Ambroise Paré, Neuilly-sur-Seine, France | UNKNOWN |
| Tom De Potter, OLV Hospital, Aalst, Belgium | UNKNOWN |
| Mathieu Lempereur, CHU de Liège, Belgium | UNKNOWN |
| Clinton Health Access Initiative Inc. | OTHER |
| Evgeny Merkulov, Scientific Research Center, Moscow, Russia | UNKNOWN |
| Liesbeth Rosseel, ASZ Aalst, Belgium | UNKNOWN |
| Antti Saraste, Heart Center, Turku University Hospital, Turku, Finland | UNKNOWN |
| Ahmet Güner, Mehmet Akif Ersoy Hospital, Turkey | UNKNOWN |
| Achille Gaspardone, San Eugenio Hospital ASL Roma, Italy | UNKNOWN |
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| up to 30 days (after device implantation) |