Andrea Colli1, Laura Besola2, Stefano Salizzoni3, Dario Gregori2, Giuseppe Tarantini2, Marco Agrifoglio4, Alaide Chieffo5, Tommaso Regesta6, Davide Gabbieri7, Francesco Saia8, Corrado Tamburino9, Flavio Ribichini10, Orazio Valsecchi11, Bruno Loi12, Alessandro Iadanza13, Miroslava Stolcova14, Alessandro Minati15, Gianluca Martinelli16, Francesco Bedogni17, Anna Petronio18, Michele Dallago19, Antioco Cappai20, Augusto D'Onofrio2, Gino Gerosa2, Mauro Rinaldi3. 1. Department of Cardiology, Thoracic and Vascular Sciences, University of Padua, Padua, Italy. Electronic address: colli.andrea.bcn@gmail.com. 2. Department of Cardiology, Thoracic and Vascular Sciences, University of Padua, Padua, Italy. 3. Division of Cardiac Surgery, San Giovanni Battista Hospital 'Molinette', University of Turin, Turin, Italy. 4. Department of Clinical Sciences and Community Health, Cardiac Surgery, University of Milan, Centro Cardiologico Monzino Hospital, Milan, Italy. 5. Division of Metabolic and Cardiovascular Sciences, San Raffaele Scientific Institute, Milan, Italy. 6. Division of Cardiac Surgery, San Martino University Hospital, University of Genova, Genova, Italy. 7. Clinical Surgical Cardiology and Thoracic Vascular Department, Hesperia Hospital, Modena, Italy. 8. Department of Cardiology, Policlinico S. Orsola-Malpighi, University of Bologna, Bologna, Italy. 9. Division of Cardiology, Ferrarotto Hospital, Catania, Catania, Italy. 10. Division of Cardiology of the Department of Medicine, University of Verona, Verona, Italy. 11. Cardiovascular Department, AO Papa Giovanni XXIII, Bergamo, Italy. 12. Interventional Cardiology Unit, AO Brotzu, Cagliari, Italy. 13. Department of Cardiovascular Diseases, Le Scotte University Hospital, University of Siena, Siena, Italy. 14. Interventional Cardiology Unit, Careggi University Hospital, Florence, Italy. 15. Division of Cardiac Surgery, Azienda Ospedaliera-Universitaria, Trieste, Italy. 16. Division of Cardiac Surgery, Santa Maria Hospital, Bari, Italy. 17. Department of Cardiology, Clinical Institute S. Ambrogio, Milan, Italy. 18. Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy. 19. Division of Cardiology, S. Chiara Hospital, Trento, Italy. 20. Division of Cardiac Surgery, Humanitas Research Hospital, Milan, Italy.
Abstract
OBJECTIVE: The aim of this study was to investigate interactions among pre-procedural aortic regurgitation (AR), post-procedural paravalvular leak (PVL) and long-term clinical outcomes. METHODS AND RESULTS: We analyzed data prospectively collected in the Italian Transcatheter balloon-Expandable Registry (ITER) on aortic stenosis (AS) patients. The degree of pre-procedural AR and post-procedural PVL was stratified as: absent/trivial, mild, and moderate/severe. VARC definitions were applied to outcomes. Of 1708 patients, preoperatively, AR was absent/trivial in 40% of the patients, mild in 42%, and moderate in 18%. Postoperatively, PVL was moderate-severe in 5%, mild in 32% of patients, and absent/trivial in 63%. Clinical follow-up, median 821days (IQR 585.75), was performed in 99.7% of patients. PVL, but not preoperative AR, was a major predictor of adverse outcome (HR 1.33, CI 95% 0.9-2.05, p=0.012 for mild PVL, HR 1.36, CI 95% 0.9-2.05, p<0.001 for PVL≥moderate and OR 1.04, p=0.97 respectively). Patients with moderate-severe PVL and preoperative left ventricle (LV) dilatation (LVEDVi>75ml/m2) showed better survival than those without dilatation (HR 8.63, p=0.001). CONCLUSIONS: In patients with severe AS treated with balloon-expandable TAVI, the presence of PVL, but not pre-procedural AR, was a major predictor of adverse outcome. Preoperative LV dilatation seemed to offer some clinical advantages.
OBJECTIVE: The aim of this study was to investigate interactions among pre-procedural aortic regurgitation (AR), post-procedural paravalvular leak (PVL) and long-term clinical outcomes. METHODS AND RESULTS: We analyzed data prospectively collected in the Italian Transcatheter balloon-Expandable Registry (ITER) on aortic stenosis (AS) patients. The degree of pre-procedural AR and post-procedural PVL was stratified as: absent/trivial, mild, and moderate/severe. VARC definitions were applied to outcomes. Of 1708 patients, preoperatively, AR was absent/trivial in 40% of the patients, mild in 42%, and moderate in 18%. Postoperatively, PVL was moderate-severe in 5%, mild in 32% of patients, and absent/trivial in 63%. Clinical follow-up, median 821days (IQR 585.75), was performed in 99.7% of patients. PVL, but not preoperative AR, was a major predictor of adverse outcome (HR 1.33, CI 95% 0.9-2.05, p=0.012 for mild PVL, HR 1.36, CI 95% 0.9-2.05, p<0.001 for PVL≥moderate and OR 1.04, p=0.97 respectively). Patients with moderate-severe PVL and preoperative left ventricle (LV) dilatation (LVEDVi>75ml/m2) showed better survival than those without dilatation (HR 8.63, p=0.001). CONCLUSIONS: In patients with severe AS treated with balloon-expandable TAVI, the presence of PVL, but not pre-procedural AR, was a major predictor of adverse outcome. Preoperative LV dilatation seemed to offer some clinical advantages.