Device Embolisation, Left Atrial Appendage Occluder, Risk Factors, Therapy Strategies
Conditions
Keywords
left atrial appendage occluder, device embolization, therapy strategy, risk factors
Brief summary
The investigators thought to evaluate risk factors, therapeutic approaches and outcomes after left atrial appendage occluder device embolization (LAAO, either surgical or interventional).
Detailed description
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.
Interventions
PROCEDURERemoval or leaving of LAA occluders
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.
Sponsors
Kerstin Piayda, CardioVascular Center Frankfurt, Frankfurt, Germany
Kolja Sievert, CardioVascular Center Frankfurt, Frankfurt, Germany
Roberto Galea, Universitätsspital Bern, Bern, Switzerland
Moniek Maarse, St. Antonius Ziekenhuis, Nieuwegein, Netherlands
Sheba Medical Center
Andrey Osadchiy, City Hospital #40, St. Petersburg, Russia
Andrey Kalemberg, National Research Center, Moscow, Russia
Jung-Sun Kim, Yonsei University Hospital, Seoul, South Korea
Aarhus University Hospital
Sajjad A Sabir, Cooper University Hospital, NJ, USA
Ashish Pershad, Banner Health, Phoenix, Arizona, USA
Markus Sandri, Herzzentrum Leipzig, Leipzig, Germany
Jens-Erik Nielsen-Kudsk, University Hospital Aarhus, Aarhus, Denmark
George Mark, The Heart House/Cooper University Camden, NJ, USA
Dhiraj Gupta, Liverpool Heart and Chest Hospital, Liverpool, UK
Pradhum Ram, Emory University, USA
Ole de Backer, Rigshospitalet Copenhagen, Denmark
Norbert Klein, Klinikum St. Georg, Leipzig, Germany
Josep Rodes, Laval Hospital, Quebec, Canada
Shazia Afzal, Heinrich-Heine University, University Hospital, Duesseldorf
Xavier Millán Alvarez, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
James E. Harvey, WellSpan Health, York, PA, USA
Wern Yew Ding, University of Liverpool, Liverpool, UK
Adel Aminian, Centre hospitalier universitaire de Charleroi, Brussels, Belgium
Pamela Moceri, Hopital Pasteur 1, Nice, France
Ibrahim Akin, Universitätsmedizin Mannheim, Germany
Jacques Mansourati, Hôpital de la Cavale Blanche, Brest, France
Eloi Marijon, Hôpital Européen Georges-Pompidou HEGP, Paris, France
Ignacio Amat Santos, University Clinical Hospital of Valladolid, Valladolid, Spain
Hana Vaknin Assa, Beilinson Hospital, Israel
Thomas Robert Schmidt, Herzzentrum Dresden GmbH Universitätsklinik, Dresden, Germany
Ran Kornowski, Rabin Medical Center, Petah Tiqwa, Israel
Giacomo Boccuzzi, Ospedale san Giovanni Bosco, Torino, Italy
Christopher R. Ellis, Vanderbilt University, Nashville, TN, USA
Henning Ebelt, Katholisches Krankenhaus St. Nepomuk, Erfurt, Germany
Guy's and St Thomas' NHS Foundation Trust
Sonja Lehmann, Hôpital Fribourgeois, Freiburg, Swizerland
Oh-Hyun Lee, Yonsai University Hospital, Yongin, Korea
Wendy Schell, Cooper University Hospital, NJ, USA
Domenico della Rocca, St David's Medical Center, Austin, Texas, USA
Pablo Pinon Esteban, Hospital Universitario A Coruña, Spain
Jose Gabriel Galache Osuna, Miguel Servet University Hospital, Zaragoza, Spain
Enio Guerios, Hospital Pilar, Curitiba, Brazil
Nicolas Amabile, Institut Mutualiste Montsouris, Paris, France
Ignacio Cruz Gonzalez, University Hospital of Salamanca, Castillay Leon, Spain
Weita Chen, Taipei Municipal Wanfang Hospital, Taipei, Taiwan
Sandeep Kumar Goyal, Piedmont Heart Institute Buckhead, Atlanta, GA, USA
Francesco Gianni, Maria Cecilia Hospital, Cotignola, Italy
Máximo Rivero Ayerza, Ziekenhuis Oost Limburg, Genk, Belgium
Carsten Skurk, Charité, Universitätsmedizin Berlin, Berlin, Germany
Martin Langel, Klinikum St. Georg, Leipzig, Germany
Livia Gheorghe, Hospital de la Santa Creu I Santa Pau, Barcelona, Spain
Lino Santos, Centro Hospitalar Vila Nova de Gaia, Vila Nova de Gaia, Portugal
Royal Victoria Hospital, Belfast
Luis Nombela-Franco, Hospital Clínico San Carlos, Madrid, Spain
Francesco Nappi, Centre Cardiologique du Nord de Saint-Denis, Paris, France
Matteo Montorfano, Ospedale San Raffaele, Segrate, Milan, Italy
Juan Fernández-Armenta, Hospital Universitario Puerta del Mar, Cádiz, Spain
Michael Kühne, Universitätsspital Basel, Basel, Swizerland
Jesper van der Pals, Lund University Hospital, Lund, Sweden.
Can Yücel Karabay, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Center, Istanbul, Turkey
Marco Ancona, San Raffaele Scientific Institute, Milan, Italy
Ghassan Moubarak, Clinique Ambroise Paré, Neuilly-sur-Seine, France
Tom De Potter, OLV Hospital, Aalst, Belgium
Mathieu Lempereur, CHU de Liège, Belgium
Clinton Health Access Initiative Inc.
Evgeny Merkulov, Scientific Research Center, Moscow, Russia
Liesbeth Rosseel, ASZ Aalst, Belgium
Antti Saraste, Heart Center, Turku University Hospital, Turku, Finland
Ahmet Güner, Mehmet Akif Ersoy Hospital, Turkey
Achille Gaspardone, San Eugenio Hospital ASL Roma, Italy
Cardiovascular Center Frankfurt
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patients after interventional or surgical left atrial appendage occlusion with device embolization
Exclusion criteria
* n/a
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural mortality | In-hospital stay, assessed up to 30 days | all-cause mortality during the index procedure, any procedure-related death within 30days or during in-hospital stay for the index procedure (if\>30days) |
| Need for cardiac surgery | In-hospital stay, assessed up to 30 days | — |
| Catheter-based retrieval of LAA Occluder | up to 5 years (after device implantation) | peri-procedural device removal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Further complications | up to 5 years (after device implantation) | Any other complications after device embolization (i.e., thromboembolic events, circulatory problems, CPR etc.) |
| Risk factors | up to 30 days (after device implantation) | Favoring conditions for LAAO device dislocation (e.g., anatomical risk factors, risk factors related to the initial procedure) |
Countries
Germany
Outcome results
None listed