Stephan Staubach1, Leonhard Schlatterbeck2, Moritz Mörtl1, Henning Strohm1, Petra Hoppmann2, Karl-Ludwig Laugwitz2, Harald Mudra1, Jakob Ledwoch3. 1. Klinik für Kardiologie, Pneumologie und Internistische Intensivmedizin, München Klinik Neuperlach, Munich, Germany. 2. Klinik und Poliklinik für Innere Medizin I, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany. 3. Klinik für Kardiologie, Pneumologie und Internistische Intensivmedizin, München Klinik Neuperlach, Munich, Germany; Klinik und Poliklinik für Innere Medizin I, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany. Electronic address: jakobledwoch@yahoo.de.
Abstract
BACKGROUND: Peri-device leaks and device thrombi are assumed to lead to ischemic events after percutaneous left atrial appendage occlusion (LAAO). While these device-related complications are well assessed until 12 months after LAAO, no data are available beyond this period. OBJECTIVE: The purpose of this study was to assess device-related complications beyond 12 months after LAAO. METHODS: All patients who underwent successful percutaneous LAAO ≥12 months ago in the 2 participating centers were screened for eligibility. After inclusion, structured transesophageal echocardiography (TEE) was performed to assess peri-device leaks, device thrombus, and other device-related complications. RESULTS: A total of 63 patients were enrolled in the present prospective, 2-center, nonrandomized, single-arm trial. The median time from implantation until long-term TEE was 3.1 years (interquartile range 2.0-5.1 years), ranging from 1.0 to 7.5 years. The number of patients without a detectable leak increased significantly at long-term TEE compared with 6-week follow-up (P = .04). Major peri-device leaks (>5 mm) were detected in 2 patients (3%). Device thrombus was found in 8 patients (13%). Patients with device thrombus at long-term follow-up had larger peri-device leaks at 6-week follow-up than did those without thrombus formation (3.0 [interquartile range 2.7-3.5] vs 1.4 [interquartile range 0.0-2.6]; P = .04). Of those who suffered an ischemic stroke during long-term follow-up (n = 5), 1 patient showed a peri-device leak >5 mm. None of the patients with detected device thrombus had a stroke. CONCLUSION: Peri-device leaks and device thrombi continue to occur during long-term follow-up after LAAO. The clinical impact of these late occluder complications requires further evaluation in larger prospective trials.
BACKGROUND: Peri-device leaks and device thrombi are assumed to lead to ischemic events after percutaneous left atrial appendage occlusion (LAAO). While these device-related complications are well assessed until 12 months after LAAO, no data are available beyond this period. OBJECTIVE: The purpose of this study was to assess device-related complications beyond 12 months after LAAO. METHODS: All patients who underwent successful percutaneous LAAO ≥12 months ago in the 2 participating centers were screened for eligibility. After inclusion, structured transesophageal echocardiography (TEE) was performed to assess peri-device leaks, device thrombus, and other device-related complications. RESULTS: A total of 63 patients were enrolled in the present prospective, 2-center, nonrandomized, single-arm trial. The median time from implantation until long-term TEE was 3.1 years (interquartile range 2.0-5.1 years), ranging from 1.0 to 7.5 years. The number of patients without a detectable leak increased significantly at long-term TEE compared with 6-week follow-up (P = .04). Major peri-device leaks (>5 mm) were detected in 2 patients (3%). Device thrombus was found in 8 patients (13%). Patients with device thrombus at long-term follow-up had larger peri-device leaks at 6-week follow-up than did those without thrombus formation (3.0 [interquartile range 2.7-3.5] vs 1.4 [interquartile range 0.0-2.6]; P = .04). Of those who suffered an ischemic stroke during long-term follow-up (n = 5), 1 patient showed a peri-device leak >5 mm. None of the patients with detected device thrombus had a stroke. CONCLUSION: Peri-device leaks and device thrombi continue to occur during long-term follow-up after LAAO. The clinical impact of these late occluder complications requires further evaluation in larger prospective trials.