Abstract 764 Treatment strategies and outcome in patients with device-related thrombus – Results of the multi-center EUROC-DRT registry

BACKGROUND

Left atrial appendage closure (LAAc) is a feasible alternative in stroke prevention, however device-related thrombosis (DRT) is a common finding potentially linked to an increased rate of adverse events. As the dynamics of DRT are still not well understood and treatment regimens are non-standardized, there is an unmet need for studies on this topic. In this registry, including 22 centers (EUROC-DRT), we aimed to describe DRT dynamics and treatment strategies.

METHODS AND RESULTS

In this analysis, only patients with documented DRT were included. Clinical and echocardiographic parameters and post-procedural treatment regimens were available in all patients. Overall, 149 patients with post-procedurally detected DRT after LAAc were identified. Patients presented with an increased mean CHA2DS2-VASC-Score of 4.5 ± 1.8 and increased mean HASBLED-Score of 3.3 ± 1.2. The majority of patients were treated with AMPLATZER (64.2%) and WATCHMAN (29.1%) devices, while other devices were used in 6.8%. After LAAc, temporary oral anticoagulation (OAC) was initiated in 12.6%, triple therapy in 0.7% and DAPT in 55.2% of patients. The remaining patients were treated with aspirin monotherapy (17.5%), other antiplatelet drugs (7.7%) or low-molecular weight heparin/Enoxaparin (4.8%). No therapy was given in 1.4% of patients.

Overall, DRT were detected after a median of 92 (interquartile range [IQR]: 45-75) days after LAAc. Hereof 82.3% were detected within the first 6 months after LAAc (median: 83 days; IQR: 48-103 days) while 17.7% were detected later (Figure 1). The mean size of DRT was 11 ± 7 mm x 15 ± 13 mm. DRT was localized centrally on the occluder in 52.3%, in a notch between occluder and left upper pulmonary vein in 38.5% and on the valvular side of the occluder in 9.2% (Figure 2). Regarding therapy regimens, a change in anticoagulation therapy was initiated in 77.3% of patients. Hereby, therapy with vitamin K antagonists (VKA) was given in 25.4%, while novel oral anticoagulants (NOAC) were prescribed in 20.3% and heparin/Enoxaparin (either as a monotherapy or in addition to ASS/DAPT) was commenced in 28.0%. Out of 108/149 patients (72.4%) with imaging FU after DRT detection, DRT resolution was observed in 78.7% after a median of 98 (IQR: 50-218) days after detection, while residual DRT were still seen in the remaining 21.3%.

Patients without DRT resolution showed lower baseline ejection fraction (49.4 ± 11.6 vs. 54.4 ± 10.2%, p = 0.05) and higher CHA2DS2-VASC-Score (5.1 ± 1.9 vs. 4.6 ± 1.7, p = 0.29). Of note, changes in anticoagulation therapy resulted in higher rates of DRT resolution than in patients without changes (81.7% vs. 69.2%, p = 0.30). No differences were seen in the rate of DRT resolution between treatment regimens (VKA: 79.2%, NOAC: 83.3%, heparin/Enoxaparin: 77.8%, p = 0.98). Kaplan-Meier analysis revealed a stroke rate of 12.7% within 2 years. Bleeding events were observed in 14.9% after DRT detection, however showed no differences in anticoagulation regimens (p = 0.43).

DISCUSSION

DRT is a common finding after LAAc often resulting in a change of anticoagulation therapy. A significant amount of DRT is detected later than 6 months, underlining the need for long-term echocardiographic FU. Treatment of DRT varies from addition of heparin to NOAC/OAC and leads to resolution in approximately 80% of cases. Randomized prospective studies are warranted to evaluate the optimal regimens for prevention and treatment of DRT.


Treatment strategies and outcome in patients with device-related thrombus – Results of the multi-center EUROC-DRT registry
A. Sedaghat¹, V. O. Vij¹, J. W. Schrickel¹, B. Al-Kassou², H. Omran³, I. Cruz Gonzalez⁴, S. Gloekler⁵, S. Rycerz⁵, D. Arzamendi⁶, V. Agudelo⁶, X. Freixa⁷, E. Flores-Umanzor⁷, K. Korsholm⁸, J. Nielsen-Kudsk⁸, X. Iriart⁹, N. Miton⁹, F. K. Operhalski¹⁰, B. Schmidt¹¹, L. Nombela-Franco¹², A. McInerney¹², E. Veliqi¹³, F. Meincke¹³, O. De Backer¹⁴, L. Sondergaard¹⁴, G. Montalescot¹⁵, P. Guedeney¹⁵, J. Saw¹⁶, T. Gilhofer¹⁷, S. S. Afzal¹⁸, T. Zeus¹⁸, M. Fürholzu¹⁹, L. Fauchier²⁰, D. Ognerubov²¹, E. V. Merkulov²¹, A. Mangieri²², A. Laricchia²², N. Petri²³, L. Asmarats⁶, J. Rodes-Cabau²⁴, G. Nickenig¹
¹Medizinische Klinik und Poliklinik II, Universitätsklinikum Bonn, Bonn; ²Med. Klinik II Intensivstation, Universitätsklinikum Bonn, Bonn; ³Innere Medizin, St. Marien-Hospital, Bonn; ⁴Salamanca University Hospital, Salamanca, ES; ⁵Klinik für Innere Medizin III: Kardiologie und Intensivmedizin, Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH, Villingen-Schwenningen; ⁶Hospital de la Santa Creu i Sant Pau Barcelona, Barcelona, ES; ⁷Hospital Clinic Barcelona, Barcelona, ES; ⁸Aarhus University Hospital, Aarhuis, DK; ⁹Bordeaux University Hospital, Bordeaux, FR; ¹⁰Herzschrittmacher-Centrum, CCB am AGAPLESION BETHANIEN KRANKENHAUS, Frankfurt am Main; ¹¹Medizinische Klinik III, CCB am AGAPLESION BETHANIEN KRANKENHAUS, Frankfurt am Main; ¹²Hospital Clinico San Carlos Madrid, Madrid, ES; ¹³Kardiologie, Asklepios Klinik St. Georg, Hamburg; ¹⁴Rigshospitalet Kopenhagen, Kopenhagen, DK; ¹⁵Hôpital de la Salpêtrière Paris, Paris, FR; ¹⁶Vancouver General Hospital, Vancouver, CA; ¹⁷Kardiologie, Stadtspital Triemli Zürich, Zürich, CH; ¹⁸Klinik für Kardiologie, Pneumologie und Angiologie, Universitätsklinikum Düsseldorf, Düsseldorf; ¹⁹Klinik und Poliklinik für Kardiologie, Inselspital - Universitätsspital Bern, Bern, CH; ²⁰University Hospital Tours, Malakoff, FR; ²¹Russian Cardiology Research and Production Complex, Moskau, RU; ²²Maria Cecilia Hospital Cotignola, Cotignola, IT; ²³Medizinische Klinik und Poliklinik I, Universitätsklinikum Würzburg, Würzburg; ²⁴Laval University Hospital, Quebec, CA;
BACKGROUND Left atrial appendage closure (LAAc) is a feasible alternative in stroke prevention, however device-related thrombosis (DRT) is a common finding potentially linked to an increased rate of adverse events. As the dynamics of DRT are still not well understood and treatment regimens are non-standardized, there is an unmet need for studies on this topic. In this registry, including 22 centers (EUROC-DRT), we aimed to describe DRT dynamics and treatment strategies. METHODS AND RESULTS In this analysis, only patients with documented DRT were included. Clinical and echocardiographic parameters and post-procedural treatment regimens were available in all patients. Overall, 149 patients with post-procedurally detected DRT after LAAc were identified. Patients presented with an increased mean CHA2DS2-VASC-Score of 4.5 ± 1.8 and increased mean HASBLED-Score of 3.3 ± 1.2. The majority of patients were treated with AMPLATZER (64.2%) and WATCHMAN (29.1%) devices, while other devices were used in 6.8%. After LAAc, temporary oral anticoagulation (OAC) was initiated in 12.6%, triple therapy in 0.7% and DAPT in 55.2% of patients. The remaining patients were treated with aspirin monotherapy (17.5%), other antiplatelet drugs (7.7%) or low-molecular weight heparin/Enoxaparin (4.8%). No therapy was given in 1.4% of patients. Overall, DRT were detected after a median of 92 (interquartile range [IQR]: 45-75) days after LAAc. Hereof 82.3% were detected within the first 6 months after LAAc (median: 83 days; IQR: 48-103 days) while 17.7% were detected later (Figure 1). The mean size of DRT was 11 ± 7 mm x 15 ± 13 mm. DRT was localized centrally on the occluder in 52.3%, in a notch between occluder and left upper pulmonary vein in 38.5% and on the valvular side of the occluder in 9.2% (Figure 2). Regarding therapy regimens, a change in anticoagulation therapy was initiated in 77.3% of patients. Hereby, therapy with vitamin K antagonists (VKA) was given in 25.4%, while novel oral anticoagulants (NOAC) were prescribed in 20.3% and heparin/Enoxaparin (either as a monotherapy or in addition to ASS/DAPT) was commenced in 28.0%. Out of 108/149 patients (72.4%) with imaging FU after DRT detection, DRT resolution was observed in 78.7% after a median of 98 (IQR: 50-218) days after detection, while residual DRT were still seen in the remaining 21.3%. Patients without DRT resolution showed lower baseline ejection fraction (49.4 ± 11.6 vs. 54.4 ± 10.2%, p = 0.05) and higher CHA2DS2-VASC-Score (5.1 ± 1.9 vs. 4.6 ± 1.7, p = 0.29). Of note, changes in anticoagulation therapy resulted in higher rates of DRT resolution than in patients without changes (81.7% vs. 69.2%, p = 0.30). No differences were seen in the rate of DRT resolution between treatment regimens (VKA: 79.2%, NOAC: 83.3%, heparin/Enoxaparin: 77.8%, p = 0.98). Kaplan-Meier analysis revealed a stroke rate of 12.7% within 2 years. Bleeding events were observed in 14.9% after DRT detection, however showed no differences in anticoagulation regimens (p = 0.43). DISCUSSION DRT is a common finding after LAAc often resulting in a change of anticoagulation therapy. A significant amount of DRT is detected later than 6 months, underlining the need for long-term echocardiographic FU. Treatment of DRT varies from addition of heparin to NOAC/OAC and leads to resolution in approximately 80% of cases. Randomized prospective studies are warranted to evaluate the optimal regimens for prevention and treatment of DRT.
/V525.htm