Jörg Kempfert1, Alexander Meyer2, Won-Keun Kim3, Arnaud Van Linden1, Mani Arsalan1, Johannes Blumenstein4, Helge Möllmann4, Thomas Walther1. 1. Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim, Bad Nauheim, Germany. 2. Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim, Bad Nauheim, Germany meyer.alexander@gmail.com. 3. Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim, Bad Nauheim, Germany Department of Cardiology, Kerckhoff Clinic Bad Nauheim, Bad Nauheim, Germany. 4. Department of Cardiology, Kerckhoff Clinic Bad Nauheim, Bad Nauheim, Germany.
Abstract
OBJECTIVES: Several alternative transapical (TA) aortic prostheses for aortic valve implantation (AVI) have recently become available. Data directly comparing the performance of these different TA-AVI valves, however, are sparse. Therefore, we sought to analyse the performance of the better-established balloon-expandable SAPIEN XT™ valve system, and compare it with the recently approved self-expandable ACURATE TA™ system by means of propensity score (PS) analysis. METHODS: Samples from a total of 310 consecutive patients treated with transapical transcatheter aortic valve implantation (TAVI) were included (2010-2014). The ACURATE valve was implanted in 40% (n = 131), SAPIEN in 60% (n = 179). To adjust for baseline differences, 1:1 PS matching was used, and resulted in 103 matched pairs. In addition to demographical and clinical variables, potential anatomical confounders (calcification grade: computed tomography (CT) Agatston score; annulus diameter: CT-effective diameter) were included within the PS estimation. RESULTS: For ACURATE- versus SAPIEN-treated patients, the mean age was 83.1 ± 5.4 vs 79.8 ± 9.5 (P < 0.001). Mean Society of Thoracic Surgeon scores were 7.7 ± 4.6 vs 8.1 ± 6.0 (P = 0.56). PS matching resulted in bias reduction <0.2, indicating excellent balance and allowing for valid outcome comparison. Device success, 30-day mortality rate and 1-year survival were comparable. Pacemaker and 30-day neurological event rates were not significantly different. The need for post-ballooning was significantly higher in the self-expandable group (40% vs 9%; P < 0.001). Echocardiography upon discharge demonstrated excellent functional outcomes regarding residual paravalvular leaks (ACURATE: 3% vs SAPIEN: 4%, P = 1.0) with slightly higher mean gradients in the ACURATE group (12 ± 5 mmHg vs 10 ± 5 mmHg, P = 0.003). CONCLUSIONS: The two transapical TAVI devices demonstrated comparable haemodynamic performance and clinical outcome. The self-expandable valve required more frequent post-ballooning without affecting the safety profile.
OBJECTIVES: Several alternative transapical (TA) aortic prostheses for aortic valve implantation (AVI) have recently become available. Data directly comparing the performance of these different TA-AVI valves, however, are sparse. Therefore, we sought to analyse the performance of the better-established balloon-expandable SAPIEN XT™ valve system, and compare it with the recently approved self-expandable ACURATE TA™ system by means of propensity score (PS) analysis. METHODS: Samples from a total of 310 consecutive patients treated with transapical transcatheter aortic valve implantation (TAVI) were included (2010-2014). The ACURATE valve was implanted in 40% (n = 131), SAPIEN in 60% (n = 179). To adjust for baseline differences, 1:1 PS matching was used, and resulted in 103 matched pairs. In addition to demographical and clinical variables, potential anatomical confounders (calcification grade: computed tomography (CT) Agatston score; annulus diameter: CT-effective diameter) were included within the PS estimation. RESULTS: For ACURATE- versus SAPIEN-treated patients, the mean age was 83.1 ± 5.4 vs 79.8 ± 9.5 (P < 0.001). Mean Society of Thoracic Surgeon scores were 7.7 ± 4.6 vs 8.1 ± 6.0 (P = 0.56). PS matching resulted in bias reduction <0.2, indicating excellent balance and allowing for valid outcome comparison. Device success, 30-day mortality rate and 1-year survival were comparable. Pacemaker and 30-day neurological event rates were not significantly different. The need for post-ballooning was significantly higher in the self-expandable group (40% vs 9%; P < 0.001). Echocardiography upon discharge demonstrated excellent functional outcomes regarding residual paravalvular leaks (ACURATE: 3% vs SAPIEN: 4%, P = 1.0) with slightly higher mean gradients in the ACURATE group (12 ± 5 mmHg vs 10 ± 5 mmHg, P = 0.003). CONCLUSIONS: The two transapical TAVI devices demonstrated comparable haemodynamic performance and clinical outcome. The self-expandable valve required more frequent post-ballooning without affecting the safety profile.
Authors: Luise Gaede; Won-Keun Kim; Christoph Liebetrau; Oliver Dörr; Johannes Sperzel; Johannes Blumenstein; Alexander Berkowitsch; Thomas Walther; Christian Hamm; Albrecht Elsässer; Holger Nef; Helge Möllmann Journal: Clin Res Cardiol Date: 2017-09-29 Impact factor: 5.460
Authors: Marcin Misterski; Mateusz Puślecki; Marek Grygier; Anna Olasińska-Wiśniewska; Maciej Lesiak; Aleksander Araszkiewicz; Barłomiej Perek; Aneta Choręziak; Jacek Lindner; Anna Komosa; Piotr Buczkowski; Marcin Ligowski; Sławomir Katarzyński; Marek Jemielity Journal: Wideochir Inne Tech Maloinwazyjne Date: 2017-04-27 Impact factor: 1.195