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TCT-621 Left atrial appendage characteristics evaluated by computed tomography following closure with Watchman device
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 68, NO. 18, SUPPL B, 2016
RESULTS Patients treated with DAPT after LAAO had higher incidence of diabetes and prior TIA or stroke, and a higher CHADS2, CHADS2-VASC and HAS-BLED score (P<0.05 for all). At a median of 36-month follow-up period, the incidence of net clinical outcomes was lower in DAPT after LAAO group than the TATT groups in spite of worse underlying comorbidities (7.41 % vs. 30.2 %, p¼0.020, hazard ratio 0.29, 95% confidence interval 0.18 - 0.38), which was driven mainly by reduction of major bleeding (3.7% vs. 12.4%, p¼0.0324, hazard ratio 0.29, 95% confidence interval 0.21 - 0.39). CONCLUSION For the patients with AF undergoing DES implantation, DAPT after LAAO was superior to TATT with respect to net clinical outcomes which was mainly driven by lower risk of bleeding. These results suggest that LAAO may be alternative treatment strategy for patients with AF undergoing DES implantation. CATEGORIES STRUCTURAL: Left Atrial Appendage Exclusion TCT-621 Left atrial appendage characteristics evaluated by computed tomography following closure with Watchman device Daniel Kupsky,1 dee dee wang,2 Marvin Eng,3 Thomas Song,4 Milan Pantelic,5 Jeffrey Nadig,6 Adam Greenbaum,7 William O’Neill8 1 Henry Ford Health System, Southfield, Michigan, United States; 2 henry ford hospital, detroit, Michigan, United States; 3University Clinic of Munich; 4MD Anderson Cancer Center Madrid; 5Henry Ford Health System, Detroit, Michigan, United States; 6Henry Ford Health System, Detroit, Michigan; 7Henry Ford Hospital, Detroit, Michigan, United States; 8Henry Ford Hospital, Detroit, Michigan, United States BACKGROUND Closure of the left atrial appendage (LAA) utilizing the Watchman device has been demonstrated to be an efficacious prophylaxis for stroke. Characterization of the LAA has been performed with both transesophageal echocardiography (TEE) and computed tomography (CT). The LAA is a dynamic, compliant structure that changes throughout the cardiac cycle. While post-closure surveillance is typically performed with TEE, using CT we characterized 45 day post-Watchman implantation LAA dimensions, compression, periWatchman leak, and presence of device thrombi. METHODS June 2015 to June 2016, patients undergoing LAA occlusion with the Watchman device at our single center institution were prospectively followed. Those who underwent pre-procedural CT, intraprocedural TEE, and post-procedural 45 day imaging were included in the analysis. Peri-procedural Watchman device deployment sizing, and follow-up device dimensions were reviewed and analyzed. RESULTS 80 patients underwent successful Watchman device implantation, 47 (59%) patients had follow-up CT imaging post-procedure. 36 of 47 patients with post-CT analysis, (77%, p<.0001) demonstrated expansion of the LAA dimensions post-device implantation, example figure 1A (pre-procedure) and 1B (post-procedure). Overall, average increase in area and circumferences was 46 mm2 (p<0.001) and 4.05 mm (p<0.001) respectively. In only patients whose LAA enlarged, the average increase in LAA area and circumference was 71.42 mm2 (p<0.001) and 6.06 mm (p<0.001) respectively. The average Watchman compression was 18.25%. Thirteen percent of patients (n¼6) had a peri-watchman leak on f/u CT 2 of which were not detected by immediate post procedure TEE. All leaks were <4.5 mm mean leak maximal diameter was 2.65 mm. One atrial sided thrombus was identified by CT and confirmed with TEE.
B253
Post-surveillance CT imaging provides valuable information regarding post LAA closure with Watchman device. CATEGORIES STRUCTURAL: Left Atrial Appendage Exclusion TCT-622 Efficay and safety of left atrial appendage closure with three different devices: peri-procedural and mid-term outcomes from a in a “real world” registry Jacopo Andrea Oreglia,1 Paolo Danna,2 Alberto Pernigotti,3 vincenzo vizzi,4 Maurizio Di Biasi,5 Alessandro Colombo,6 alberto barosi,7 simone colombo,8 Gaia Telli,9 maurizio viecca10 1 Milan, Italy; 2Unknown, Milano, Milan, Italy; 3Ospedale Luigi Sacco, Bareggio, Milan, Italy; 4Al Qassimi Hospital; 5Luigi Sacco Hospital, Milan, Italy; 6Luigi Sacco Hospital, Milan, Italy; 7Hannover Medical School; 8Singapore Heart Centre; 9Universitá degli Studi di Milano, Milano, Milan, Italy; 10Sri Venkateswaraa Medical COllege Hospital and Research Centre BACKGROUND Left atrial appendage occlusion (LAAO) is a nonpharmacological alternative for stroke prevention in high-risk patients with non-valvular atrial fibrillation. The aim of this real world retrospective registry was to obtain clinical data about procedural success, complications and mid-term outcomes. METHODS 110 consecutive patients who underwent LAA occlusion in two centers between December 2009 and March 2016 were retrospectively enrolled RESULTS Baseline and procedural data are available for all the 110 study population. Patients were at high risk of stroke (average CHA2DS2-VASc: 4.24 1.64) and high risk of bleeding (average HASBLED score: 3.14 1.2). Almost one third of the patients (28.1%) had a history of TIA or stroke, 58.1% of patients were 75 years-old or older; 55.7% of patients were deemed unsuitable for oral anticoagulation by their physician. The device was successfully deployed in 94.5% of the cases with no flow or minimal residual flow (leak < 5 m in diameter) achieved in 100% of patients. Of the 105 devices implanted 30 were Watchman (Boston Scientific), 58 were Amplatzer Cardiac Plug (St. Jude Medical) and 17 were Amulet (St Jude Medical). Nine patients experienced serious adverse events (SAEs) within 7 days of the procedure. There were no death at 30-day follow-up. Follow-up was available for 98.1% of implanted patients. Mean follow-up was 22.7 17.4 months. Overall mortality was 5.88% (1,96% cardiovascular death), stroke occurred in 3.92% of subjects, major bleeding occurred in 1.96% of patients. The observed annual rate of ischemic events and bleeding was significantly lower than what expected from CHA2DS2VASc and HAS-BLED scores (2.02 vs. 4.95 and 1.01 vs. 4.11 respectively). We finally observed an improvement in device implant success and a reduction of periprocedural SAEs during time: success rate was 92.5% in the period 2009-2011, 92.5% in the period 2012-2014 and 100% in the period 2015-2016; SAEs rate was 12.5% in the period 20122014, 7.5% in the period 2012-2014, 3.3% in the period 2015-2016 CONCLUSION Left atrial appendage occlusion has a high success rate with low peri-procedural risk, even in a high risk population. Improvements of the techniques and the operators experience have led to a reduction of peri-procedural complications previously limiting the net clinical benefit of the procedure CATEGORIES STRUCTURAL: Left Atrial Appendage Exclusion TCT-623 Predictors of MACE with the WATCHMAN device: An Intention-toTreat Analysis in a Real World Experience Mohamad Lazkani,1 shishir murarka,2 Divya Ratan Verma,3 Timothy Byrne,4 Ashish Sadhu,5 Marwan Bahu,6 Akil Loli,7 Haidar Yassin,8 Yash Pershad,9 Ashish Pershad10 1 Banner University Medical Center, Phoenix, Arizona, United States; 2 Banner University Medical Ctr, Phoenix, Arizona, United States; 3 Banner University Medical Center, Phoenix, Arizona, United States; 4 Biltmore Cardiology, Phoenix, Arizona, United States; 5Banner University Medical Center; 6Banner University Medical Center; 7 Biltmore Cardiology, Phoenix, Arizona, United States; 8Banner University Medical Center; 9Banner University Medical Center; 10 Banner University Medical Center Phoenix, Phoenix, Arizona, United States
CONCLUSION The LAA is a dynamic structure that dilates in a majority of patients post-closure. Peri-watchman leaks and atrial sided thrombi were uncommon, but CT was useful in identifying them.
BACKGROUND Left atrial appendage closure (LAAC) is an alternative to oral anticoagulation therapy for stroke prevention in patients with non-valvular atrial fibrillation. The WATCHMAN device was recently approved. This observational cohort study describes the real world
RESULTS Patients treated with DAPT after LAAO had higher incidence of diabetes and prior TIA or stroke, and a higher CHADS2, CHADS2-VASC and HAS-BLED score (P<0.05 for all). At a median of 36-month follow-up period, the incidence of net clinical outcomes was lower in DAPT after LAAO group than the TATT groups in spite of worse underlying comorbidities (7.41 % vs. 30.2 %, p¼0.020, hazard ratio 0.29, 95% confidence interval 0.18 - 0.38), which was driven mainly by reduction of major bleeding (3.7% vs. 12.4%, p¼0.0324, hazard ratio 0.29, 95% confidence interval 0.21 - 0.39). CONCLUSION For the patients with AF undergoing DES implantation, DAPT after LAAO was superior to TATT with respect to net clinical outcomes which was mainly driven by lower risk of bleeding. These results suggest that LAAO may be alternative treatment strategy for patients with AF undergoing DES implantation. CATEGORIES STRUCTURAL: Left Atrial Appendage Exclusion TCT-621 Left atrial appendage characteristics evaluated by computed tomography following closure with Watchman device Daniel Kupsky,1 dee dee wang,2 Marvin Eng,3 Thomas Song,4 Milan Pantelic,5 Jeffrey Nadig,6 Adam Greenbaum,7 William O’Neill8 1 Henry Ford Health System, Southfield, Michigan, United States; 2 henry ford hospital, detroit, Michigan, United States; 3University Clinic of Munich; 4MD Anderson Cancer Center Madrid; 5Henry Ford Health System, Detroit, Michigan, United States; 6Henry Ford Health System, Detroit, Michigan; 7Henry Ford Hospital, Detroit, Michigan, United States; 8Henry Ford Hospital, Detroit, Michigan, United States BACKGROUND Closure of the left atrial appendage (LAA) utilizing the Watchman device has been demonstrated to be an efficacious prophylaxis for stroke. Characterization of the LAA has been performed with both transesophageal echocardiography (TEE) and computed tomography (CT). The LAA is a dynamic, compliant structure that changes throughout the cardiac cycle. While post-closure surveillance is typically performed with TEE, using CT we characterized 45 day post-Watchman implantation LAA dimensions, compression, periWatchman leak, and presence of device thrombi. METHODS June 2015 to June 2016, patients undergoing LAA occlusion with the Watchman device at our single center institution were prospectively followed. Those who underwent pre-procedural CT, intraprocedural TEE, and post-procedural 45 day imaging were included in the analysis. Peri-procedural Watchman device deployment sizing, and follow-up device dimensions were reviewed and analyzed. RESULTS 80 patients underwent successful Watchman device implantation, 47 (59%) patients had follow-up CT imaging post-procedure. 36 of 47 patients with post-CT analysis, (77%, p<.0001) demonstrated expansion of the LAA dimensions post-device implantation, example figure 1A (pre-procedure) and 1B (post-procedure). Overall, average increase in area and circumferences was 46 mm2 (p<0.001) and 4.05 mm (p<0.001) respectively. In only patients whose LAA enlarged, the average increase in LAA area and circumference was 71.42 mm2 (p<0.001) and 6.06 mm (p<0.001) respectively. The average Watchman compression was 18.25%. Thirteen percent of patients (n¼6) had a peri-watchman leak on f/u CT 2 of which were not detected by immediate post procedure TEE. All leaks were <4.5 mm mean leak maximal diameter was 2.65 mm. One atrial sided thrombus was identified by CT and confirmed with TEE.
B253
Post-surveillance CT imaging provides valuable information regarding post LAA closure with Watchman device. CATEGORIES STRUCTURAL: Left Atrial Appendage Exclusion TCT-622 Efficay and safety of left atrial appendage closure with three different devices: peri-procedural and mid-term outcomes from a in a “real world” registry Jacopo Andrea Oreglia,1 Paolo Danna,2 Alberto Pernigotti,3 vincenzo vizzi,4 Maurizio Di Biasi,5 Alessandro Colombo,6 alberto barosi,7 simone colombo,8 Gaia Telli,9 maurizio viecca10 1 Milan, Italy; 2Unknown, Milano, Milan, Italy; 3Ospedale Luigi Sacco, Bareggio, Milan, Italy; 4Al Qassimi Hospital; 5Luigi Sacco Hospital, Milan, Italy; 6Luigi Sacco Hospital, Milan, Italy; 7Hannover Medical School; 8Singapore Heart Centre; 9Universitá degli Studi di Milano, Milano, Milan, Italy; 10Sri Venkateswaraa Medical COllege Hospital and Research Centre BACKGROUND Left atrial appendage occlusion (LAAO) is a nonpharmacological alternative for stroke prevention in high-risk patients with non-valvular atrial fibrillation. The aim of this real world retrospective registry was to obtain clinical data about procedural success, complications and mid-term outcomes. METHODS 110 consecutive patients who underwent LAA occlusion in two centers between December 2009 and March 2016 were retrospectively enrolled RESULTS Baseline and procedural data are available for all the 110 study population. Patients were at high risk of stroke (average CHA2DS2-VASc: 4.24 1.64) and high risk of bleeding (average HASBLED score: 3.14 1.2). Almost one third of the patients (28.1%) had a history of TIA or stroke, 58.1% of patients were 75 years-old or older; 55.7% of patients were deemed unsuitable for oral anticoagulation by their physician. The device was successfully deployed in 94.5% of the cases with no flow or minimal residual flow (leak < 5 m in diameter) achieved in 100% of patients. Of the 105 devices implanted 30 were Watchman (Boston Scientific), 58 were Amplatzer Cardiac Plug (St. Jude Medical) and 17 were Amulet (St Jude Medical). Nine patients experienced serious adverse events (SAEs) within 7 days of the procedure. There were no death at 30-day follow-up. Follow-up was available for 98.1% of implanted patients. Mean follow-up was 22.7 17.4 months. Overall mortality was 5.88% (1,96% cardiovascular death), stroke occurred in 3.92% of subjects, major bleeding occurred in 1.96% of patients. The observed annual rate of ischemic events and bleeding was significantly lower than what expected from CHA2DS2VASc and HAS-BLED scores (2.02 vs. 4.95 and 1.01 vs. 4.11 respectively). We finally observed an improvement in device implant success and a reduction of periprocedural SAEs during time: success rate was 92.5% in the period 2009-2011, 92.5% in the period 2012-2014 and 100% in the period 2015-2016; SAEs rate was 12.5% in the period 20122014, 7.5% in the period 2012-2014, 3.3% in the period 2015-2016 CONCLUSION Left atrial appendage occlusion has a high success rate with low peri-procedural risk, even in a high risk population. Improvements of the techniques and the operators experience have led to a reduction of peri-procedural complications previously limiting the net clinical benefit of the procedure CATEGORIES STRUCTURAL: Left Atrial Appendage Exclusion TCT-623 Predictors of MACE with the WATCHMAN device: An Intention-toTreat Analysis in a Real World Experience Mohamad Lazkani,1 shishir murarka,2 Divya Ratan Verma,3 Timothy Byrne,4 Ashish Sadhu,5 Marwan Bahu,6 Akil Loli,7 Haidar Yassin,8 Yash Pershad,9 Ashish Pershad10 1 Banner University Medical Center, Phoenix, Arizona, United States; 2 Banner University Medical Ctr, Phoenix, Arizona, United States; 3 Banner University Medical Center, Phoenix, Arizona, United States; 4 Biltmore Cardiology, Phoenix, Arizona, United States; 5Banner University Medical Center; 6Banner University Medical Center; 7 Biltmore Cardiology, Phoenix, Arizona, United States; 8Banner University Medical Center; 9Banner University Medical Center; 10 Banner University Medical Center Phoenix, Phoenix, Arizona, United States
CONCLUSION The LAA is a dynamic structure that dilates in a majority of patients post-closure. Peri-watchman leaks and atrial sided thrombi were uncommon, but CT was useful in identifying them.
BACKGROUND Left atrial appendage closure (LAAC) is an alternative to oral anticoagulation therapy for stroke prevention in patients with non-valvular atrial fibrillation. The WATCHMAN device was recently approved. This observational cohort study describes the real world