Marco Barbanti1, Sergio Buccheri2, Josep Rodés-Cabau3, Simona Gulino2, Philippe Généreux4, Gerlando Pilato2, Danny Dvir5, Andrea Picci2, Giuliano Costa2, Corrado Tamburino2, Martin B Leon6, John G Webb5. 1. Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy. Electronic address: mbarbanti83@gmail.com. 2. Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy. 3. Division of Cardiology, Quebec Heart & Lung Institute, Quebec City, Québec, Canada. 4. Division of Cardiology, Hôpital du Sacré-Coeur de Montréal, Université de Montréal, Montréal, Québec, Canada. 5. Division of Cardiology, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada. 6. Division of Cardiology, Columbia University Medical Center/New York-Presbyterian Hospital, New York, USA.
Abstract
OBJECTIVE: The aim of this study was to conduct a weighted meta-analysis to determine the rates of acute (≤30days) major outcomes after (TAVR) with second-generation devices. METHODS: A comprehensive search of multiple electronic databases from January 2011 to May 2017 was conducted using predefined criteria. New-generation TAVR devices were defined as any device which received CE mark approval or is still under evaluation for CE marking after CoreValve and SAPIEN XT prostheses. RESULTS: A total of 37 studies including 10,822 patients met inclusion criteria and were included in the analysis. Devices investigated in the studies were the following: SAPIEN 3 (n=5423, 45.9%), Lotus Valve (n=3007, %), Portico (n=130, 1.1%), JenaValve (n=345, 2.9%), Symetis Acurate (n=1314, 11,1%), and Evolut R (n=1603, 13.6%). Thirty-day all-cause and cardiovascular 30-day death were 2.2% (95% CI: 1.6% to 2.8%) and 1.6% (95% CI: 0.9% to 2.3%), respectively; Any stroke and major/disabling stroke occurred at a pooled estimate rate of 2.6% (95% CI: 2.0% to 3.3%) and 0.9% (95% CI: 0.2% to 1.6%), respectively; life-threatening bleeding, 3.9% (95% CI: 2.9% to 5.0%); major vascular complications, 4.5% (95% CI: 3.7% to 5.4%); pacemaker implantation, 16.2% (95% CI: 12.7% to 19.6%); more than mild aortic regurgitation, 1.6% (95% CI: 0.9 to 2.3). CONCLUSIONS: Second-generation TAVR devices are associated with very low mortality and major complications rates at 30-day, and improved prosthesis performance with <2% of patients having more than mild post-procedural aortic regurgitation. On the other hand, the need for pacemaker implantation seems to remain an unresolved issue, and warrants further investigation.
OBJECTIVE: The aim of this study was to conduct a weighted meta-analysis to determine the rates of acute (≤30days) major outcomes after (TAVR) with second-generation devices. METHODS: A comprehensive search of multiple electronic databases from January 2011 to May 2017 was conducted using predefined criteria. New-generation TAVR devices were defined as any device which received CE mark approval or is still under evaluation for CE marking after CoreValve and SAPIEN XT prostheses. RESULTS: A total of 37 studies including 10,822 patients met inclusion criteria and were included in the analysis. Devices investigated in the studies were the following: SAPIEN 3 (n=5423, 45.9%), Lotus Valve (n=3007, %), Portico (n=130, 1.1%), JenaValve (n=345, 2.9%), Symetis Acurate (n=1314, 11,1%), and Evolut R (n=1603, 13.6%). Thirty-day all-cause and cardiovascular 30-day death were 2.2% (95% CI: 1.6% to 2.8%) and 1.6% (95% CI: 0.9% to 2.3%), respectively; Any stroke and major/disabling stroke occurred at a pooled estimate rate of 2.6% (95% CI: 2.0% to 3.3%) and 0.9% (95% CI: 0.2% to 1.6%), respectively; life-threatening bleeding, 3.9% (95% CI: 2.9% to 5.0%); major vascular complications, 4.5% (95% CI: 3.7% to 5.4%); pacemaker implantation, 16.2% (95% CI: 12.7% to 19.6%); more than mild aortic regurgitation, 1.6% (95% CI: 0.9 to 2.3). CONCLUSIONS: Second-generation TAVR devices are associated with very low mortality and major complications rates at 30-day, and improved prosthesis performance with <2% of patients having more than mild post-procedural aortic regurgitation. On the other hand, the need for pacemaker implantation seems to remain an unresolved issue, and warrants further investigation.
Authors: Declan Lloyd; Jessica G Y Luc; Ben Elias Indja; Vannessa Leung; Nelson Wang; Kevin Phan Journal: J Thorac Dis Date: 2019-01 Impact factor: 2.895
Authors: Amgad Mentias; Marwan Saad; Milind Y Desai; Phillip A Horwitz; James D Rossen; Sidakpal Panaich; Ayman Elbadawi; Abdul Qazi; Paul Sorajja; Hani Jneid; Samir Kapadia; Barry London; Mary S Vaughan Sarrazin Journal: J Am Heart Assoc Date: 2019-10-31 Impact factor: 5.501