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DIRECT TRANSCATHETER AORTIC VALVE REPLACEMENT VERSUS IMPLANTATION WITH BALLOON PREDILATATION: INSIGHTS FROM THE BRAZILIAN TAVR REGISTRY
415 JACC April 5, 2016 Volume 67, Issue 13
ACC.i2 Interventional Cardiology DIRECT TRANSCATHETER AORTIC VALVE REPLACEMENT VERSUS IMPLANTATION WITH BALLOON PREDILATATION: INSIGHTS FROM THE BRAZILIAN TAVR REGISTRY Poster Contributions Poster Area, South Hall A1 Monday, April 04, 2016, 9:45 a.m.-10:30 a.m. Session Title: TAVR: Evolution of the Procedure Abstract Category: 3. ACC.i2 Interventional Cardiology: Aortic Valve Disease Presentation Number: 1255-164 Authors: Fernando Bernardi, Henrique Ribeiro, Luiz Carvalho, Rogerio Sarmento-Leite, José Mangione, Eduardo Sousa, Pedro Lemos, Eberhard Grube, Josep Rodes-Cabau, Fabio Brito, Brazilian Society of Hemodynamics and Interventional Cardiology, São Paulo, Brazil
Background: Direct transcatheter aortic valve replacement (TAVR) is regarded as having potential advantages over TAVR with balloon aortic valve predilatation (BAVP) in reducing procedural complications. However, there is few data to support this approach. The objective of the study was to compare clinical outcomes of TAVR with or without BAVP.
Methods: Patients included in the Brazilian TAVR registry with both CoreValve and Sapien-XT prosthesis were compared according to the implantation technique, with or without BAVP. Clinical outcomes and echocardiographic data were analyzed at 30 days and 1 year in the overall population and after propensity score matching.
Results: A total of 761 consecutive patients (372 in the BAVP vs. 389 in the direct-TAVR group) were included. Device success was similar between groups (BAVP=81.2% vs. direct TAVR=78.1%; p=0.3), as well as the need for postdilation (36.6% vs. 39.8%; p=0.35). No differences in clinical outcomes at 30 days and 1 year were observed, including all-cause mortality (7.6% vs. 10.0%, p=0.25 and 18.1% vs. 24.5%, p=0.07, respectively) and stroke (3.1% vs. 4%, p=0.46 and 6.5% vs. 7.4%, p=0.56, respectively). Nonetheless, TAVR with BAVP was associated with a higher rate of new onset persistent left bundle branch block (NOP-LBBB) in patients receiving a CoreValve (47.7% vs 35.1%, p=0.01 at 1-year), without any difference in the need for a permanent pacemaker at 1-year (p=0.26). Mean gradient and the incidence of moderate/severe aortic regurgitation were similar in both groups at 1 year (p=0.09 and 0.57, respectively). After propensity score matching analysis, all-cause mortality and stroke remained similar at 1-year (p=0.34 and p=0.5, respectively) in 215 pairs of patients, with a trend towards a higher rate of NOP-LBBB in the BAVP group (p=0.06). By multivariate analysis, BAVP and the use of a CoreValve were independent predictors of NOP-LBBB (both with p<0.05). Conclusions: The two TAVR strategies, with or without BAVP, provided similar clinical and echocardiographic outcomes over a mid-term follow-up, although BAVP was associated with a higher rate of NOP-LBBB, particularly in patients receiving a CoreValve.
ACC.i2 Interventional Cardiology DIRECT TRANSCATHETER AORTIC VALVE REPLACEMENT VERSUS IMPLANTATION WITH BALLOON PREDILATATION: INSIGHTS FROM THE BRAZILIAN TAVR REGISTRY Poster Contributions Poster Area, South Hall A1 Monday, April 04, 2016, 9:45 a.m.-10:30 a.m. Session Title: TAVR: Evolution of the Procedure Abstract Category: 3. ACC.i2 Interventional Cardiology: Aortic Valve Disease Presentation Number: 1255-164 Authors: Fernando Bernardi, Henrique Ribeiro, Luiz Carvalho, Rogerio Sarmento-Leite, José Mangione, Eduardo Sousa, Pedro Lemos, Eberhard Grube, Josep Rodes-Cabau, Fabio Brito, Brazilian Society of Hemodynamics and Interventional Cardiology, São Paulo, Brazil
Background: Direct transcatheter aortic valve replacement (TAVR) is regarded as having potential advantages over TAVR with balloon aortic valve predilatation (BAVP) in reducing procedural complications. However, there is few data to support this approach. The objective of the study was to compare clinical outcomes of TAVR with or without BAVP.
Methods: Patients included in the Brazilian TAVR registry with both CoreValve and Sapien-XT prosthesis were compared according to the implantation technique, with or without BAVP. Clinical outcomes and echocardiographic data were analyzed at 30 days and 1 year in the overall population and after propensity score matching.
Results: A total of 761 consecutive patients (372 in the BAVP vs. 389 in the direct-TAVR group) were included. Device success was similar between groups (BAVP=81.2% vs. direct TAVR=78.1%; p=0.3), as well as the need for postdilation (36.6% vs. 39.8%; p=0.35). No differences in clinical outcomes at 30 days and 1 year were observed, including all-cause mortality (7.6% vs. 10.0%, p=0.25 and 18.1% vs. 24.5%, p=0.07, respectively) and stroke (3.1% vs. 4%, p=0.46 and 6.5% vs. 7.4%, p=0.56, respectively). Nonetheless, TAVR with BAVP was associated with a higher rate of new onset persistent left bundle branch block (NOP-LBBB) in patients receiving a CoreValve (47.7% vs 35.1%, p=0.01 at 1-year), without any difference in the need for a permanent pacemaker at 1-year (p=0.26). Mean gradient and the incidence of moderate/severe aortic regurgitation were similar in both groups at 1 year (p=0.09 and 0.57, respectively). After propensity score matching analysis, all-cause mortality and stroke remained similar at 1-year (p=0.34 and p=0.5, respectively) in 215 pairs of patients, with a trend towards a higher rate of NOP-LBBB in the BAVP group (p=0.06). By multivariate analysis, BAVP and the use of a CoreValve were independent predictors of NOP-LBBB (both with p<0.05). Conclusions: The two TAVR strategies, with or without BAVP, provided similar clinical and echocardiographic outcomes over a mid-term follow-up, although BAVP was associated with a higher rate of NOP-LBBB, particularly in patients receiving a CoreValve.