Fabrizio D'Ascenzo1, Francesco Bruno2, Luca Baldetti3, Ovidio De Filippo2, Giorgio Marengo2, Susanna Breviario2, Francesco Melillo4, Hans Gustav Hørsted Thyregod5, Holger Thiele6, Lars Sondergaard7, Jeffrey J Popma7, Susheel Kodali8, Luca Franchin2, Margherita Annaratone9, Laura Marruncheddu10, Guglielmo Gallone2, Gabriele Crimi11, Michele La Torre12, Mauro Rinaldi12, Pierluigi Omedè2, Federico Conrotto2, Stefano Salizzoni12, Gaetano Maria De Ferrari2. 1. Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza Hospital and University of Turin, Italy. Electronic address: fabrizio.dascenzo@gmail.com. 2. Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza Hospital and University of Turin, Italy. 3. Cardiac Intensive Care Unit, IRCCS San Raffaele Scientific Institute, Italy. 4. Unit of echocardiography, IRCCS San Raffaele Scientific Institute, Milan, Italy. 5. Departments of cardiothoracic and cardiology, Rigshospitalet, Copenhagen University Hospital, Denmark. 6. Heart Center Leipzig, University of Leipzig, Germany. 7. Beth Israel Deaconess Boston, United States of America. 8. Columbia University Medical Center (SKK), United States of America. 9. Politecnico di Torino, Turin, Italy. 10. Department of Clinical Internal, Anesthesiological and Cardiovascular Science, Sapienza University of Rome, Rome, Italy. 11. Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. 12. Division of Cardiosurgery, Cardiovascular and Thoracic Department, Città della Salute e della Scienza Hospital and University of Turin, Italy.
Abstract
INTRODUCTION: Recently, observational data have raised concerns about safety of selfexpandable (SE) compared to balloon-expandable (BE) valves in TAVI, although potentially limited by patient selection bias. METHODS: All Randomized Controlled Trials (RCTs) comparing BE vs. SE TAVI or/and vs. aortic valve replacement (AVR) were included and compared through Network Meta Analysis (NMA). All-cause and cardiovascular (CV) mortality were the primary endpoints, stroke, rates of permanent pacemaker implantation (PPI), moderate/severe paravalvular leak (PVL) and reintervention were the secondary endpoints. Results We obtained data from 11 RCTs, encompassing 9752 patients. After one and two years, no significant differences for allcause and CV mortality were observed. Compared to surgical bioprostheses, both BE and SE TAVI reduced the risk of acute kidney injury (OR 0.42; CI 95% 0.30-0.60 and OR 0.44; CI 95% 0.32-0.60), new-onset atrial fibrillation (OR 0.24; CI 95% 0.14-0.42 and OR 0.21; CI 95% 0.13-0.34) and major bleedings (OR 0.32; CI 95% 0.16-0.65 and OR 0.47; CI 95% 0.25-0.89). The BE prostheses reduced the risk of moderate/severe PVL at 30-day (OR 0.31; CI 95% 0.17-0.55) and of PPI both at 30-day (OR 0.51; CI 95% 0.33-0.79) and 1 year (OR 0.40; CI 95% 0.30-0.55) as compared to SE TAVI. Conclusions A TAVI strategy, independently from BE or SE prostheses, offers a midterm survival comparable to AVR. The BE prostheses are associated with a reduction of PPI and PVL compared to SE prostheses without any differences in all-cause and CV mortality during two years of follow up. PROSPERO ID CRD42020182407.
INTRODUCTION: Recently, observational data have raised concerns about safety of selfexpandable (SE) compared to balloon-expandable (BE) valves in TAVI, although potentially limited by patient selection bias. METHODS: All Randomized Controlled Trials (RCTs) comparing BE vs. SE TAVI or/and vs. aortic valve replacement (AVR) were included and compared through Network Meta Analysis (NMA). All-cause and cardiovascular (CV) mortality were the primary endpoints, stroke, rates of permanent pacemaker implantation (PPI), moderate/severe paravalvular leak (PVL) and reintervention were the secondary endpoints. Results We obtained data from 11 RCTs, encompassing 9752 patients. After one and two years, no significant differences for allcause and CV mortality were observed. Compared to surgical bioprostheses, both BE and SE TAVI reduced the risk of acute kidney injury (OR 0.42; CI 95% 0.30-0.60 and OR 0.44; CI 95% 0.32-0.60), new-onset atrial fibrillation (OR 0.24; CI 95% 0.14-0.42 and OR 0.21; CI 95% 0.13-0.34) and major bleedings (OR 0.32; CI 95% 0.16-0.65 and OR 0.47; CI 95% 0.25-0.89). The BE prostheses reduced the risk of moderate/severe PVL at 30-day (OR 0.31; CI 95% 0.17-0.55) and of PPI both at 30-day (OR 0.51; CI 95% 0.33-0.79) and 1 year (OR 0.40; CI 95% 0.30-0.55) as compared to SE TAVI. Conclusions A TAVI strategy, independently from BE or SE prostheses, offers a midterm survival comparable to AVR. The BE prostheses are associated with a reduction of PPI and PVL compared to SE prostheses without any differences in all-cause and CV mortality during two years of follow up. PROSPERO ID CRD42020182407.