Intra-annular self-expanding or balloon-expandable TAVI in small annuli: the NAVULTRA registry

Stefano Cannata¹^,², MD; Ibrahim Sultan³, MD; Nicolas M. Van Mieghem⁴, MD, PhD; Arturo Giordano⁵, MD; Ole De Backer⁶^,⁷, MD; Jonathan Byrne⁸, MD; Didier Tchétché⁹, MD; Sergio Buccheri¹⁰, MD; Luis Nombela-Franco¹¹, MD; Rui Campante Teles¹², MD, PhD; Marco Barbanti¹³, MD; Emanuele Barbato¹⁴, MD; Ignacio Amat Santos¹⁵^,¹⁶, MD; Daniel J. Blackman¹⁷, MD; Francesco Maisano¹⁸, MD; Roberto Lorusso²^,¹⁹, MD, PhD; Ketty La Spina¹, MD; Antonella Millin²⁰, MD; Dustin E. Kliner³, MD; Mark van den Dorpel⁴, MD; Elena Acerbi²¹, MD; Davorka Lulic⁶^,⁷, MD; Hossam Fayed⁸, MD; Chiara De Biase⁹, MD; Jorge Francisco Chavez Solsol¹¹, MD; Joao Brito¹², MD; Giuliano Costa²², MD; Matteo Casenghi¹⁴, MD; Clara Fernandez Cordon¹⁶, MD; Amanda Sherwen¹⁷, MD; Nicola Buzzatti¹⁸, MD; Salvatore Pasta¹^,²³, PhD; Marco Turrisi¹, MD; Paolo Manca¹, MD; Vincenzo Nuzzi¹, MD; Corrado Tamburino²⁴, MD; Francesco Bedogni²¹, MD; Caterina Gandolfo¹, MD; Azeem Latib²⁰, MD

1. Unit of Interventional Cardiology, Department of Cardiothoracic Surgery, IRCCS-ISMETT (Mediterranean Institute for Transplantation and Advanced Specialized Therapies), Palermo, Italy; 2. Cardiovascular Research Institute Maastricht (CARIM), Maastricht, the Netherlands; 3. Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, PA, USA and UPMC Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, USA; 4. Department of Cardiology, Thoraxcenter, Cardiovascular Institute, Erasmus University Medical Center, Rotterdam, the Netherlands; 5. Invasive Cardiology Unit, Pineta Grande Hospital, Castel Volturno, Italy; 6. Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; 7. Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark; 8. King’s College Hospital NHS Foundation Trust, London, United Kingdom; 9. Department of Cardiology, Clinique Pasteur, Toulouse, France; 10. Department of Medical Sciences, Uppsala Clinical Research Center, Uppsala University Hospital, Uppsala, Sweden; 11. Cardiovascular Institute, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria San Carlos, Madrid, Spain; 12. 12.Hospital de Santa Cruz, Centro Hospitalar de Lisboa Ocidental, Carnaxide, Portugal and Comprehensive Health Research Center (CHRC), Nova Medical School, Lisbon, Portugal; 13. Università degli Studi di Enna “Kore”, Enna, Italy; 14. Department of Clinical and Molecular Medicine, Sapienza University, Rome, Italy; 15. Centro de Investigación Biomédica en Red - Enfermedades Cardiovasculares (CIBERCV), Instituto de Salud Carlos III, Madrid, Spain; 16. Hospital Clínico Universitario de Valladolid, Valladolid, Spain; 17. Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom; 18. Division of Cardiac Surgery, San Raffaele Scientific Institute, Milan, Italy; 19. Cardio-Thoracic Surgery Department, Heart & Vascular Center, Maastricht University Medical Center, Maastricht, the Netherlands; 20. Montefiore Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA; 21. Division of Cardiology, Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Donato, San Donato Milanese, Italy; 22. Division of Cardiology, A.O.U. Policlinico “G. Rodolico-San Marco”, Catania, Italy; 23. University of Palermo, Palermo, Italy; 24. Division of Cardiology, Centro Cuore Morgagni, Pedara, Italy

Abstract

Background: Comparative data between self-expanding Navitor (NAV) and balloon-expandable SAPIEN 3 Ultra (ULTRA) transcatheter heart valves (THVs) in patients with small aortic annuli are lacking.

Aims: This study sought to evaluate outcomes of transcatheter aortic valve implantation (TAVI) using the intra-annular NAV and the ULTRA THVs in severe aortic stenosis patients with small annuli.

Methods: Patients with an aortic annulus area ≤430 mm² undergoing TAVI with either NAV or ULTRA from the NAVULTRA registry were included. Propensity-matched analysis was performed for adjustment. Primary endpoints included 1-year mortality, a composite endpoint (all-cause mortality, disabling stroke, or heart failure hospitalisation), and 30-day device-oriented outcomes (severe prosthesis-patient mismatch, moderate or greater paravalvular leak [PVL], mean gradient ≥20 mmHg).

Results: Among 1,617 patients, 524 propensity score-matched pairs were analysed. At 1 year, all-cause mortality was 8.8% with NAV versus 9.0% with ULTRA (adjusted p=0.585), and the composite endpoint occurred in 11.3% versus 11.8%, respectively (adjusted p=0.149). The device-oriented endpoint favoured NAV compared to ULTRA (6.0% vs 29.3%; adjusted p<0.01), with a lower residual transvalvular gradient (7.3 mmHg vs 12.7 mmHg; adjusted p<0.01), and reduced incidence of any prosthesis-patient mismatch (odds ratio 0.27, 95% confidence interval: 0.18-0.43; adjusted p<0.01). However, NAV was associated with higher rates of mild paravalvular leak (NAV 33.5% vs ULTRA 23.2%; adjusted p<0.05) and permanent pacemaker implantation (PPI; NAV 20.1% vs 11.9% ULTRA; adjusted p<0.01).

Conclusions: In patients with small aortic annuli, TAVI with both NAV and ULTRA provided comparable 1-year clinical outcomes, but NAV showed better haemodynamic performance at the cost of higher rates of mild PVL and PPI.

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