Damiano Regazzoli1, Mauro Chiarito2, Francesco Cannata2, Matteo Pagnesi3, Mizuki Miura4, Francesca Ziviello5, Andrea Picci6, Jörg Reifart7, Federico De Marco8, Francesco Bedogni8, Marianna Adamo9, Salvatore Curello9, Rui Teles10, Maurizio Taramasso4, Marco Barbanti6, Corrado Tamburino6, Giulio G Stefanini2, Antonio Mangieri11, Francesco Giannini11, Paolo A Pagnotta12, Francesco Maisano4, Won-Keun Kim7, Nicolas M Van Mieghem5, Antonio Colombo11, Bernhard Reimers12, Azeem Latib13. 1. Cardio Center, Humanitas Research Hospital, Rozzano, Milan, Italy. Electronic address: damiano.regazzoli@gmail.com. 2. Cardio Center, Humanitas Research Hospital, Rozzano, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy. 3. Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy. 4. Heart Center, Zürich University Hospital, University of Zürich, Zürich, Switzerland. 5. Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. 6. Cardiologia, Centro Alte Specialità e Trapianti, Policlinico Vittorio Emanuele, Università di Catania, Catania, Italy. 7. Department of Cardiology and Cardiac Surgery, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany. 8. Department of Cardiology, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy. 9. Civil Hospital and University of Brescia, Brescia, Italy. 10. Centro Hospitalar de Lisboa Ocidental, Hospital de Santa Cruz, Lisbon, Portugal. 11. Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy; GVM Care and Research, Maria Cecilia Hospital, Ravenna, Italy. 12. Cardio Center, Humanitas Research Hospital, Rozzano, Milan, Italy. 13. Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy; Division of Cardiology, Montefiore Medical Center, Bronx, New York.
Abstract
OBJECTIVES: The aim of this study was to evaluate and compare the outcomes of transcatheter self-expandable prostheses in patients with small annuli. BACKGROUND: Transcatheter aortic heart valves appear to have better performance than surgical valves in terms of prosthesis-patient mismatch, especially in patients with aortic stenosis with small aortic annuli. METHODS: TAVI-SMALL (International Multicenter Registry to Evaluate the Performance of Self-Expandable Valves in Small Aortic Annuli) is a retrospective registry of patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm2 on computed tomography) treated with transcatheter self-expandable valves (n = 859; Evolut R, n = 397; Evolut PRO, n = 84; ACURATE, n = 201; Portico, n = 177). Primary endpoints were post-procedural mean aortic gradient, indexed effective orifice area, and rate of severe prosthesis-patient mismatch. RESULTS: Pre-discharge gradients were consistently low in every group, with a slight benefit with the Evolut R (8.1 mm Hg; 95% confidence interval [CI]: 7.7 to 8.5 mm Hg) and Evolut PRO (6.9 mm Hg; 95% CI: 6.3 to 7.6 mm Hg) compared with the ACURATE (9.6 mm Hg; 95% CI: 8.9 to 10.2 mm Hg) and Portico (8.9 mm Hg; 95% CI: 8.2 to 9.6 mm Hg) groups (p < 0.001). Mean indexed effective orifice area was 1.04 cm2/m2 (95% CI: 1.01 to 1.08 cm2/m2) with a trend toward lower values with the Portico. No significant differences were reported in terms of severe prosthesis-patient mismatch (overall rate 9.4%; p = 0.134), permanent pacemaker implantation (15.6%), and periprocedural and 1-year adverse events. Pre-discharge more than mild paravalvular leaks were significantly more common with the Portico (19.2%) and less common with the Evolut PRO (3.6%) compared with the Evolut R (11.8%) and ACURATE (9%) groups. CONCLUSIONS: Transcatheter self-expandable valves showed optimal clinical and echocardiographic results in patients with small aortic annuli, although supra-annular functioning transcatheter heart valves seemed to slightly outperform intra-annular functioning ones. The role of transcatheter aortic valve replacement with self-expandable valves for the treatment of aortic stenosis in patients with small annuli needs to be confirmed in larger trials.
OBJECTIVES: The aim of this study was to evaluate and compare the outcomes of transcatheter self-expandable prostheses in patients with small annuli. BACKGROUND: Transcatheter aortic heart valves appear to have better performance than surgical valves in terms of prosthesis-patient mismatch, especially in patients with aortic stenosis with small aortic annuli. METHODS: TAVI-SMALL (International Multicenter Registry to Evaluate the Performance of Self-Expandable Valves in Small Aortic Annuli) is a retrospective registry of patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm2 on computed tomography) treated with transcatheter self-expandable valves (n = 859; Evolut R, n = 397; Evolut PRO, n = 84; ACURATE, n = 201; Portico, n = 177). Primary endpoints were post-procedural mean aortic gradient, indexed effective orifice area, and rate of severe prosthesis-patient mismatch. RESULTS: Pre-discharge gradients were consistently low in every group, with a slight benefit with the Evolut R (8.1 mm Hg; 95% confidence interval [CI]: 7.7 to 8.5 mm Hg) and Evolut PRO (6.9 mm Hg; 95% CI: 6.3 to 7.6 mm Hg) compared with the ACURATE (9.6 mm Hg; 95% CI: 8.9 to 10.2 mm Hg) and Portico (8.9 mm Hg; 95% CI: 8.2 to 9.6 mm Hg) groups (p < 0.001). Mean indexed effective orifice area was 1.04 cm2/m2 (95% CI: 1.01 to 1.08 cm2/m2) with a trend toward lower values with the Portico. No significant differences were reported in terms of severe prosthesis-patient mismatch (overall rate 9.4%; p = 0.134), permanent pacemaker implantation (15.6%), and periprocedural and 1-year adverse events. Pre-discharge more than mild paravalvular leaks were significantly more common with the Portico (19.2%) and less common with the Evolut PRO (3.6%) compared with the Evolut R (11.8%) and ACURATE (9%) groups. CONCLUSIONS: Transcatheter self-expandable valves showed optimal clinical and echocardiographic results in patients with small aortic annuli, although supra-annular functioning transcatheter heart valves seemed to slightly outperform intra-annular functioning ones. The role of transcatheter aortic valve replacement with self-expandable valves for the treatment of aortic stenosis in patients with small annuli needs to be confirmed in larger trials.
Authors: Mauro Chiarito; Alessandro Spirito; Johny Nicolas; Alexandra Selberg; Giulio Stefanini; Antonio Colombo; Bernhard Reimers; Annapoorna Kini; Samin K Sharma; George D Dangas; Roxana Mehran Journal: J Clin Med Date: 2022-07-30 Impact factor: 4.964
Authors: Pier Pasquale Leone; Fabio Fazzari; Francesco Cannata; Jorge Sanz-Sanchez; Antonio Mangieri; Lorenzo Monti; Ottavia Cozzi; Giulio Giuseppe Stefanini; Renato Bragato; Antonio Colombo; Bernhard Reimers; Damiano Regazzoli Journal: Front Cardiovasc Med Date: 2021-06-04