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Multicenter Study
. 2024 Mar 18;20(6):e363-e375.
doi: 10.4244/EIJ-D-23-00779.

Comparison of two self-expanding transcatheter heart valves for degenerated surgical bioprostheses: the AVENGER multicentre registry

Won-Keun Kim  1   2   3 , Moritz Seiffert  4 , Andreas Rück  5 , David M Leistner  6   7 , Henryk Dreger  7   8 , Hendrik Wienemann  9 , Matti Adam  9 , Helge Möllmann  10 , Johannes Blumenstein  10   11 , Clemens Eckel  10   11 , Andrea Buono  12 , Diego Maffeo  12 , Antonio Messina  13 , Andreas Holzamer  14 , Samuel Sossalla  1   3 , Giuliano Costa  15 , Marco Barbanti  16 , Silvia Motta  15 , Corrado Tamburino  15 , Ina von der Heide  4 , Julius Glasmacher  7   8 , Mohammad Sherif  7   8 , Philipp Seppelt  6 , Stephan Fichtlscherer  6 , Thomas Walther  6 , Fausto Castriota  17 , Roberto Nerla  17 , Christian Frerker  18 , Tobias Schmidt  18 , Alexander Wolf  19 , Martin M Adamaszek  19 , Francesco Giannini  20 , Maarten Vanhaverbeke  21 , Stefaan Van de Walle  21 , Francis Stammen  21 , Stefan Toggweiler  22 , Stephanie Brunner  22 , Antonio Mangieri  23 , Mauro Gitto  24 , Gerrit Kaleschke  25 , Vlasis Ninios  26 , Ilias Ninios  26 , Judith Hübner  27 , Erion Xhepa  27 , Matthias Renker  1   2 , Efstratios I Charitos  2 , Michael Joner  27 , Tobias Rheude  27
Affiliations
Multicenter Study

Comparison of two self-expanding transcatheter heart valves for degenerated surgical bioprostheses: the AVENGER multicentre registry

Won-Keun Kim et al. EuroIntervention. .

Abstract

Background: There is a lack of comparative data on transcatheter aortic valve implantation (TAVI) in degenerated surgical prostheses (valve-in-valve [ViV]).

Aims: We sought to compare outcomes of using two self-expanding transcatheter heart valve (THV) systems for ViV.

Methods: In this retrospective multicentre registry, we included consecutive patients undergoing transfemoral ViV using either the ACURATE neo/neo2 (ACURATE group) or the Evolut R/PRO/PRO+ (EVOLUT group). The primary outcome measure was technical success according to Valve Academic Research Consortium (VARC)-3. Secondary outcomes were 30-day all-cause mortality, device success (VARC-3), coronary obstruction (CO) requiring intervention, rates of severe prosthesis-patient mismatch (PPM), and aortic regurgitation (AR) ≥moderate. Comparisons were made after 1:1 propensity score matching.

Results: The study cohort comprised 835 patients from 20 centres (ACURATE n=251; EVOLUT n=584). In the matched cohort (n=468), technical success (ACURATE 92.7% vs EVOLUT 88.9%; p=0.20) and device success (69.7% vs 73.9%; p=0.36) as well as 30-day mortality (2.8% vs 1.6%; p=0.392) were similar between the two groups. The mean gradients and rates of severe PPM, AR ≥moderate, or CO did not differ between the groups. Technical and device success were higher for the ACURATE platform among patients with a true inner diameter (ID) >19 mm, whereas a true ID ≤19 mm was associated with higher device success - but not technical success - among Evolut recipients.

Conclusions: ViV TAVI using either ACURATE or Evolut THVs showed similar procedural outcomes. However, a true ID >19 mm was associated with higher device success among ACURATE recipients, whereas in patients with a true ID ≤19 mm, device success was higher when using Evolut.

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Conflict of interest statement

W. Kim reports personal fees from Abbott, Boston Scientific, Edwards Lifesciences, Meril Life Sciences, Shockwave Medical, and HiD Imaging. M. Seiffert received speaker or advisory fees from Abbott, Abiomed, Amgen, AstraZeneca, Boston Scientific, Bristol-Myers Squibb, Daichii Sankyo, Edwards Lifesciences, Inari Medical, Medtronic, Pfizer, Shockwave Medical, and Siemens Healthineers; and a research grant from Boston Scientific - all unrelated to the submitted work. A. Rück has received grants from Boston Scientific; and personal fees from Boston Scientific and Edwards Lifesciences. D. Leistner reports personal fees and non-financial support from Abbott; personal fees from Boston Scientific; and grants from DZHK (German Center for Cardiovascular Research). H. Dreger is on the advisory board and received speaker fees from Abbott and Edwards Lifesciences; and is a proctor for and received research funding from Abbott. M. Adam reports personal fees/speaker honoraria from Abbott, Boston Scientific, Edwards Lifesciences, JenaValve, and Medtronic. H Möllmann reports proctor fees and/or speaker honoraria from Abbott, Biotronik, Edwards Lifesciences, Medtronic, SMT, and Boston Scientific. J. Blumenstein reports proctor fees from Boston Scientific. A. Holzamer reports proctoring for Boston Scientific. M. Barbanti is a consultant for Medtronic, Edwards Lifesciences, and Boston Scientific. C. Tamburino is a consultant for Medtronic. F. Castriota is a proctor for Boston Scientific, Medtronic, Abbott, and Terumo. R. Nerla is a proctor for Medtronic. C. Frerker received travel support and lecture honoraria from Medtronic and Boston Scientific. T. Schmidt received travel support and lecture honoraria from Medtronic and Boston Scientific. A. Wolf is a proctor for Medtronic, Boston Scientific, and Edwards Lifesciences. S. Toggweiler has served as a consultant for Medtronic, Boston Scientific, Edwards Lifesciences, Medira, Shockwave Medical, Teleflex, AtHeart Medical, Veosource, Polares Medical, and Biosensors; has served as a proctor for Medtronic, Boston Scientific, Edwards Lifesciences, Biosensors, and Abbott; has received institutional research grants from Boston Scientific, Biosensors, Fumedica, and Novartis; and holds equity in Hi-D Imaging. A. Mangieri received speaker honoraria from Boston Scientific and Abbott; received fees and speaker honoraria from Concept Medical; has received institutional grants from Boston Scientific, Abbott, and Kardia; and serves as proctor for Kardia. G. Kaleschke received speaker fees and travel grants from Edwards Lifesciences. E. Charitos reports proctor fees from Boston Scientific. M. Joner reports institutional grant support from Boston Scientific, Cardiac Dimensions, Edwards Lifesciences, and Infraredx; consulting fees from Biotronik, TriCares, Veryan, and Shockwave Medical; speaker fees from Abbott, AstraZeneca, Biotronik, Boston Scientific, Cardiac Dimensions, Edwards Lifesciences, ReCor Medical, and Shockwave Medical; reports participation on the steering committees of Biotronik and Edwards Lifesciences; travel support from Boston Scientific, Cardiac Dimensions, Edwards Lifesciences, and SIS Medical. M. Vanhaverbeke is a consultant for Boston Scientific. M. Renker received proctor fees from Boston Scientific. T. Rheude received lecture fees from Abbott, AstraZeneca, SIS Medical AG and Translumina. The other authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1. Implantation depth measurements.
A) ACURATE and B) EVOLUT. The double-headed arrows denote the implantation depth at the non-coronary cusp. ACURATE: ACURATE neo/neo2 group; EVOLUT: Evolut R/PRO/PRO+ group
Figure 2
Figure 2. Projected and measured indexed effective orifice area.
Projected and measured indexed effective orifice area (iEAO) in the unmatched (A) and matched (B) cohorts.ACURATE: ACURATE neo/neo2 group; EVOLUT: Evolut R/PRO/PRO+ group
Figure 3
Figure 3. Subgroup analyses in the total cohort comparing ACURATE vs Evolut platforms for technical and device success.
A) Technical success was more likely when using the ACURATE platform in cases with a true inner diameter (true ID) >19 mm and when the mode of failure was aortic regurgitation (the odds ratio was not calculated due to a 100% success rate for ACURATE vs 85.3% for Evolut). B) Among patients with a true ID ≤19 mm, device success was higher for Evolut, whereas among patients with a true ID >19 mm, device success was higher for ACURATE. ACURATE: ACURATE neo/neo2 group; CI: confidence interval; EVOLUT: Evolut R/PRO/PRO+ group; ID: inner diameter; OR: odds ratio; PPM: prosthesis-patient mismatch; THV: transcatheter heart valve
Figure 4
Figure 4. Coronary occlusion rates according to risk categories in the unmatched cohort.
Across the different risk categories, coronary occlusion rates were similar between ACURATE and EVOLUT groups. ACURATE: ACURATE neo/neo2 group; EVOLUT: Evolut R/PRO/PRO+ group
Figure 5
Figure 5. Kaplan-Meier survival curves.
Survival curves are stratified according to the type of transcatheter prosthesis. At 24 months, there was no difference in all-cause mortality between ACURATE and Evolut THVs both in the unmatched (A) and matched (B) cohorts. ACURATE: ACURATE neo/neo2 group; EVOLUT: Evolut R/PRO/PRO+ group
Central illustration
Central illustration. Main outcomes comparing ACURATE versus Evolut for ViV.
The Central illustration provides an overview of the main outcomes after propensity score matching. Technical success, device success, rates of severe prosthesis-patient mismatch (PPM), aortic regurgitation (AR) ≥moderate, coronary obstruction, and permanent pacemaker implantation were similar between the ACURATE and EVOLUT groups. ACURATE: ACURATE neo/neo2 group; EVOLUT: Evolut R/PRO/PRO+ group; VARC: Valve Academic Research Consortium; ViV: valve-in-valve
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