Author + information
- Received June 12, 2019
- Revision received August 1, 2019
- Accepted August 20, 2019
- Published online January 20, 2020.
- Damiano Regazzoli, MDa,∗∗ (, )
- Mauro Chiarito, MDa,b,∗,
- Francesco Cannata, MDa,b,
- Matteo Pagnesi, MDc,
- Mizuki Miura, MDd,
- Francesca Ziviello, MDe,
- Andrea Picci, MDf,
- Jörg Reifart, MDg,
- Federico De Marco, MDh,
- Francesco Bedogni, MDh,
- Marianna Adamo, MDi,
- Salvatore Curello, MDi,
- Rui Teles, MDj,
- Maurizio Taramasso, MDd,
- Marco Barbanti, MDf,
- Corrado Tamburino, MDf,
- Giulio G. Stefanini, MD, PhDa,b,
- Antonio Mangieri, MDc,k,
- Francesco Giannini, MDc,k,
- Paolo A. Pagnotta, MDa,
- Francesco Maisano, MDd,
- Won-Keun Kim, MDg,
- Nicolas M. Van Mieghem, MD, PhDe,
- Antonio Colombo, MDc,k,
- Bernhard Reimers, MDa,
- Azeem Latib, MDc,l,
- on behalf of the TAVI-SMALL Investigators
- aCardio Center, Humanitas Research Hospital, Rozzano, Milan, Italy
- bDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy
- cInterventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy
- dHeart Center, Zürich University Hospital, University of Zürich, Zürich, Switzerland
- eDepartment of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands
- fCardiologia, Centro Alte Specialità e Trapianti, Policlinico Vittorio Emanuele, Università di Catania, Catania, Italy
- gDepartment of Cardiology and Cardiac Surgery, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany
- hDepartment of Cardiology, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy
- iCivil Hospital and University of Brescia, Brescia, Italy
- jCentro Hospitalar de Lisboa Ocidental, Hospital de Santa Cruz, Lisbon, Portugal
- kGVM Care and Research, Maria Cecilia Hospital, Ravenna, Italy
- lDivision of Cardiology, Montefiore Medical Center, Bronx, New York
- ↵∗Address for correspondence:
Dr. Damiano Regazzoli, Cardio Center, Humanitas Research Hospital, Rozzano, via Manzoni 56, 20089 Milan, Italy.
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.
↵∗ Drs. Regazzoli and Chiarito contributed equally to this paper and are joint first authors.
Dr. Barbanti is a consultant for Edwards Lifesciences; and serves as an advisory board member for Biotronik. Dr. Stefanini has received a research grant (to the institution) from Boston Scientific; and has received speaking and consulting fees from B. Braun, Biosensors, and Boston Scientific. Dr. Pagnotta is a proctor for Cardia and Boston Scientific. Dr. Kim is a proctor for Boston Scientific and Abbott; and has received speaking fees from Boston Scientific, Abbott, Medtronic, and Edwards Lifesciences. Dr. Tamburino has received speaking fees from Boston Scientific and Abbott. Dr. Reimers has received speaking honoraria from Boston Scientific. Dr. Latib serves on the advisory boards of Medtronic and Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received June 12, 2019.
- Revision received August 1, 2019.
- Accepted August 20, 2019.
- 2020 American College of Cardiology Foundation
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