Robin Le Ruz; Lionel Leroux; Thibault Lhermusier; Thomas Cuisset; Eric Van Belle; Alain Dibie; Vincenzo Palermo; Didier Champagnac; Jean-François Obadia; Emmanuel Teiger; Patrick Ohlman; Didier Tchétché; Herve Le Breton; Christophe Saint-Etienne; Pierre-Guillaume Piriou; Julien Plessis; Sylvain Beurtheret; Florence Du  Chayla; Manon Leclère; Thierry Lefèvre; Jean-Philippe Collet; Hélène Eltchaninoff; Martine Gilard; Bernard Iung; Thibaut Manigold; Vincent Letocart; on of STOP-AS and FRANCE-TAVI investigators

doi:10.4244/EIJ-D-24-00339

Outcomes of transcatheter aortic valve implantation for native aortic valve regurgitation

Robin Le Ruz¹^,², MD; Lionel Leroux³, MD; Thibault Lhermusier⁴, MD, PhD; Thomas Cuisset⁵, MD, PhD; Eric Van Belle⁶, MD, PhD; Alain Dibie⁷, MD, PhD; Vincenzo Palermo⁸, MD; Didier Champagnac⁹, MD; Jean-François Obadia¹⁰, MD, PhD; Emmanuel Teiger¹¹, MD, PhD; Patrick Ohlman¹², MD, PhD; Didier Tchétché¹³, MD; Hervé Le Breton¹⁴, MD, PhD; Christophe Saint-Etienne¹⁵, MD; Pierre-Guillaume Piriou¹, MD; Julien Plessis¹, MD; Sylvain Beurtheret¹⁶, MD; Florence Du Chayla¹⁷, PhD; Manon Leclère¹⁷, PhD; Thierry Lefèvre¹⁸, MD; Jean-Philippe Collet¹⁹, MD, PhD; Hélène Eltchaninoff²⁰, MD, PhD; Martine Gilard²¹, MD, PhD; Bernard Iung²², MD, PhD; Thibaut Manigold¹, MD; Vincent Letocart¹, MD; on behalf of STOP-AS and FRANCE-TAVI investigators

1. Interventional Cardiology Department, Nantes Université, CHU Nantes, L’institut du thorax, Nantes, France; 2. Nantes Université, CHU Nantes, CNRS, INSERM, L’institut du thorax, Nantes, France; 3. Department of Cardiology and Cardiovascular Surgery, Hôpital Cardiologique de Haut-Lévêque, Pessac, France; 4. Department of Cardiology, Rangueil University Hospital, Toulouse, France; 5. Centre for Cardiovascular and Nutrition Research, Aix Marseille Université, Marseille, France; 6. University of Lille, INSERM, Centre Hospitalier Universitaire Lille, Institut Pasteur de Lille, Lille, France; 7. Institut Mutualiste Montsouris, Paris, France; 8. Hôpital Marie-Lannelongue (groupe hospitalier Paris Saint-Joseph), Le Plessis-Robinson, France; 9. Médipôle Lyon-Villeurbanne, Villeurbanne, France; 10. Clinical Investigation Center & Heart Failure Department, Hôpital Cardiovasculaire Louis Pradel, INSERM 1407, Hospices Civils de Lyon and Claude Bernard University, Lyon, France; 11. Department of Cardiology, APHP, Henri-Mondor University Hospital, Créteil, France; 12. Department of Cardiology, University Hospital of Strasbourg, Strasbourg, France; 13. Clinique Pasteur, Toulouse, France; 14. Department of Cardiology, University of Rennes, CHU Rennes, INSERM, LTSI – UMR 1099, Rennes, France; 15. Centre Hospitalier Régional Universitaire Tours, Tours, France; 16. Saint-Joseph Hospital, Marseille, France; 17. Clinityx, Paris, France; 18. Institut Cardiovasculaire Paris Sud, Hôpital privé Jacques Cartier, Ramsay Santé, Massy, France; 19. ACTION Study Group, Sorbonne Université, UMRS 1166, Institut de Cardiologie, Pitié-Salpêtrière Hospital (AP-HP), Paris, France; 20. Department of Cardiology, University Rouen Normandie, INSERM U1096, CHU Rouen, Rouen, France; 21. Department of Cardiology, Brest University Hospital, Brest, France; 22. Department of Cardiology, Université Paris-Cité, Paris, France and Assistance Publique-Hôpitaux de Paris (AP-HP), Bichat Hospital, Paris, France

Abstract

BACKGROUND: Large datasets of transcatheter aortic valve implantation (TAVI) for pure aortic valve regurgitation (PAVR) are scarce.

AIMS: We aimed to report procedural safety and long-term clinical events (CE) in a contemporary cohort of PAVR patients treated with new-generation devices (NGD).

METHODS: Patients with grade III/IV PAVR enrolled in the FRANCE-TAVI Registry were selected. The primary safety endpoint was technical success (TS) according to Valve Academic Research Consortium 3 criteria. The co-primary endpoint was defined as a composite of mortality, heart failure hospitalisation and valve reintervention at last follow-up.

Results: From 2015 to 2021, 227 individuals (64.3% males, median age 81.0 [interquartile range {IQR} 73.5-85.0] years, with EuroSCORE II 6.0% [IQR 4.0-10.9]) from 41 centres underwent TAVI with NGD, using either self-expanding (55.1%) or balloon-expandable valves (44.9%; p=0.50). TS was 85.5%, with a non-significant trend towards increased TS in high-volume activity centres. A second valve implantation (SVI) was needed in 8.8% of patients, independent of valve type (p=0.82). Device size was ≥29 mm in 73.0% of patients, post-procedure grade ≥III residual aortic regurgitation was rare (1.2%), and the permanent pacemaker implantation (PPI) rate was 36.0%. At 30 days, the incidences of mortality and reintervention were 8.4% and 3.5%, respectively. The co-primary endpoint reached 41.6% (IQR 34.4-49.6) at 1 year, increased up to 61.8% (IQR 52.4-71.2) at 4 years, and was independently predicted by TS, with a hazard ratio of 0.45 (95% confidence interval: 0.27-0.76); p=0.003.

CONCLUSIONS: TAVI with NGD in PAVR patients is efficient and reasonably safe. Preventing the need for an SVI embodies the major technical challenge. Larger implanted valves may have limited this complication, outweighing the increased risk of PPI. Despite successful TAVI, PAVR patients experience frequent CE at long-term follow-up.

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