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. 2024 Sep 2;20(17):e1076-e1085.
doi: 10.4244/EIJ-D-24-00339.

Outcomes of transcatheter aortic valve implantation for native aortic valve regurgitation

Robin Le Ruz  1   2 , Lionel Leroux  3 , Thibault Lhermusier  4 , Thomas Cuisset  5 , Eric Van Belle  6 , Alain Dibie  7 , Vincenzo Palermo  8 , Didier Champagnac  9 , Jean-François Obadia  10 , Emmanuel Teiger  11 , Patrick Ohlman  12 , Didier Tchétché  13 , Hervé Le Breton  14 , Christophe Saint-Etienne  15 , Pierre-Guillaume Piriou  1 , Julien Plessis  1 , Sylvain Beurtheret  16 , Florence Du Chayla  17 , Manon Leclère  17 , Thierry Lefèvre  18 , Jean-Philippe Collet  19 , Hélène Eltchaninoff  20 , Martine Gilard  21 , Bernard Iung  22 , Thibaut Manigold  1 , Vincent Letocart  1 , On Behalf Of Stop-As And France-Tavi Investigators
Affiliations

Outcomes of transcatheter aortic valve implantation for native aortic valve regurgitation

Robin Le Ruz et al. EuroIntervention. .

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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Conflict of interest statement

L. Leroux has served as a proctor for Medtronic. T. Lefèvre has served as a proctor for Edwards Lifesciences and Abbott. D. Tchétché has received honoraria or consultation fees from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. B. Iung has received consulting fees from Boehringer Ingelheim; and has received speaker fees from Edwards Lifesciences. H. Le Breton has received speaker fees from Edwards Lifesciences and Medtronic. H. Eltchaninoff has served as a proctor for and received lecture fees from Edwards Lifesciences. J.-P. Collet has received research grants from Bristol-Myers Squibb and Medtronic; and lecture fees from Bristol-Myers Squibb, Bayer, Daichii Sankyo, AstraZeneca, and Medtronic. J.-F. Obadia received consulting or speaker fees from Abbott, Delacroix-Chevalier, and Medtronic. E. Teiger has served as a proctor for Medtronic. C. Saint-Etienne has received honoraria from Abbott and Biotronik. The other authors have no conflicts of interest to declare relevant to the contents of this paper.

Figures

Figure 1
Figure 1. Technical success rates according to centre volume activity.
*Definition based on total TAVI procedures between 2010 and 2021: high-volume centre: >250 implantations/year; non-high volume centre: <250 implantations/year (average of 110/year). TAVI: transcatheter aortic valve implantation
Figure 2
Figure 2. Landmark analysis at day 30 and Kaplan-Meier estimates for the co-primary outcome comprising all-cause mortality, HFH and device-related reintervention for the whole population and according to the type of valve: self-expanding versus balloon-expandable (upper left corner).
HFH: heart failure hospitalisation
Central illustration
Central illustration. Kaplan-Meier estimates for the co-primary endpoint in patients with and without SVI.
HFH: heart failure hospitalisation; SVI: second valve implantation
See this image and copyright information in PMC

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