Comparison of two self-expanding transcatheter heart valves for degenerated surgical bioprostheses: the AVENGER multicentre registry | PCRonline (2024)

Selected in EuroInterventionbyL. Koliastasis, N. Ryan

This trial sought to compare the procedural and clinical outcomes of ACURATE neo/neo2 and EVOLUT R/PRO/Pro+ valves for ViV procedures.

Our Comment

Why this study – the rationale/objective?

Surgical bioprostheses can degenerate and fail over time, while previously the only treatment option was re-do surgery with the associated increased risks. Transcatheter aortic valve implantation (TAVI) has emerged as an established treatment option for severe structural valve degeneration (referred to as valve-in-valve, ViV). Self-expanding (SE) valves have been associated with better outcomes than balloon-expandable for ViV procedures, however direct comparison between SE valves is lacking. This trial sought to compare the procedural and clinical outcomes of ACURATE neo/neo2 and EVOLUT R/PRO/Pro+ valves for ViV procedures.

How was it executed – the methodology?

The AVENGER study included consecutive patients undergoing transfemoral ViV TAVI procedures from 2012 to 2023 in 20 European centres. In total 835 patients underwent ViV TAVI, 251 treated with ACURATE valves and 584 with EVOLUT valves. To account for differing baseline characteristics 1:1 propensity matching was performed creating 2 groups of 234 patients.

• The primary outcome measure was technical success based on Valve Academic Consortium (VARC) 3 criteria.
• Secondary outcome measures were 30-day all-cause mortality and device success at 30 days
• Subgroup analysis included each valve performance and outcomes regarding the true inner prosthetic valve diameter (ID) (>19mm vs ≤19mm).
• The risk of coronary occlusion for each valve was based on predefined risk stratification (low, intermediate and high risk).

What is the main result?

The population's average age was 79 years and 46.5% were female. Baseline characteristics were similar between the groups, however distance to the coronary arteries was smaller for the unmatched ACURATE group. The majority of degenerated surgical valves were stented with internal leaflets with the mode of failure being stenosis in half and mixed in one-third of them.

• Technical success was similar between valve types ACURATE 91.2% vs EVOLUT 89.2%, p=0.375 unmatched (matched 92.7% vs. 88.9% p=0.200).
• 30-day all-cause mortality was similar in both unmatched (ACURATE 2.9% vs. EVOLUT 1.9%, p=0.429) and matched cohorts (ACURATE 2.8% vs. EVOLUT 1.6%, p=0.392).
• Device success (unmatched 68.1% vs 68.8%, p=0.840, matched 69.7% vs. 73.9% p=0,355) and permanent pacemaker implantation (unmatched 0.8% vs. 2.9%, p=0.060, matched 0.9% vs. 2.6%, p=0.285) were similar.
• Effective orifice area (EOA) was smaller in the unmatched ACURATE group (ACURATE 1.5 [IQR 1.3; 1.7] vs EVOLUT 1.5 [IQR 1.3; 1.9] cm2; p=0.021) and remained smaller after matching (1.5 [1.4;2.0] vs 1.5 [1.3;1.7] cm2; p=0.022).
• Coronary occlusion occurred in 37 cases (4.4%) with similar rates in all risk categories before and after propensity matching (matched p=0.491, unmatched p=0.820).
• The subgroup analysis showed that true ID>19mm was associated with higher rates of technical and device success for the ACURATE group, whereas when ID≤19mm EVOLUT demonstrated higher rates of device success.

Critical reading and the relevance for clinical practice

This large real-world registry demonstrated that ViV TAVI using EVOLUT or ACURATE platforms had similar procedural and clinical outcomes. These findings add to the limited data in the treatment of degenerated surgical bioprostheses.

This data compares two similar but different self-expanding supra-annular valves. The higher opening radial force with the ability to retrieve and reposition the EVOLUT platform versus the top-to-down deployment, one-shot, with low pacemaker incidence ACURATE valve. Clinical endpoints were comparable between the two valves. Interestingly aortic regurgitation ≥ moderate (which is included in the VARC-3 device success definition) was similar even though the ACURATE neo platform was associated with high rates of regurgitation in the SCOPE trials^2,3. As expected in ViV procedures, pacemaker rates were similarly low with only two implantations in the ACURATE arm. Concerning hemodynamics, the median numerical EOA were identical (1.5cm2) for both valves; however, the statistical analysis fell in favour of the EVOLUT platform in the unmatched and matched cohorts though there was more missing data in the Evolut group.

A major consideration for ViV procedures is the possibility of coronary occlusion and in this study, it was thoroughly examined. Patients were stratified in low, intermediate and high risk of coronary obstruction based on the surgical valve characteristics and the distance of the coronary ostia. Coronary protection with commissural alignment, BASILICA device or wire-stent protection was more common in the ACURATE group. Coronary obstruction rates were similar between the two groups; nevertheless, the definition included prophylactic stent deployment even with adequate coronary flow and left to the operators’ discretion.

In the subgroup analysis of ID, the study showed a possible advantage in true ID≤19mm for the EVOLUT platform, whereas the opposite was evident with true ID>19mm in favour of the ACURATE neo. The limitations of the study include the retrospective nature without prespecified endpoints, no core-lab evaluation and no independent adjudication of the events.

Overall, these findings support that the SE EVOLUT and ACURATE valves demonstrate similar outcomes for ViV procedures, with ID≤19mm favouring the EVOLUT and ID>19mm favouring the ACURATE neo.

References

1. Kim W-K, Seiffert M, Ruck A, Leistner D M, Dreger H, Wienemann H, Adam M, Mollmann H, Blumenstein J, Eckel C, Buono A, Maffeo A, Messina A, Holzamer A, Sossalla S, Costa G, Barbanti M, Motta S, Tamburino C, von der Heide I, Glasmacher J, Sherif M, Seppelt P, Fischtlscherer S, Walther T, Castriota F, Nerla R, Frerker C, Schmidt T, Wolf A, Adamaszek M, Giannini F, Vanhaverbeke M, Van de Walle S, Stammen F, Toggweiler S, Brunner S, Mangieri A, Gitto M, Kaleschke G, Ninios V, Ninios I, Hubner J, Xhepa E, Renker M, Charitos E, Joner M, Rheude T. Comparison of two self-expanding transcatheter heart valves for degenerated surgical bioprostheses: the AVENGER multicentre registry; Eurointervention. 2024 Mar 18;20:e363-e375. doi: 10.4244/EIJ-D-23-00779
2. Lanz J, Kim WK, Walther T, Burgdorf C, Möllmann H, Linke A, Redwood S, Thilo C, Hilker M, Joner M, Thiele H, Conzelmann L, Conradi L, Kerber S, Schymik G, Prendergast B, Husser O, Stortecky S, Heg D, Jüni P, Windecker S, Pilgrim T; SCOPE I investigators. Safety and efficacy of a self-expanding versus a balloon-expandable bioprosthesis for transcatheter aortic valve replacement in patients with symptomatic severe aortic stenosis: a randomised non-inferiority trial. Lancet. 2019 Nov 2;394(10209):1619-1628. doi: 10.1016/S0140-6736(19)32220-2
3. Tamburino C, Bleiziffer S, Thiele H, Scholtz S, Hildick-Smith D, Cunnington M, Wolf A, Barbanti M, Tchetchè D, Garot P, Pagnotta P, Gilard M, Bedogni F, Van Belle E, Vasa-Nicotera M, Chieffo A, Deutsch O, Kempfert J, Søndergaard L, Butter C, Trillo-Nouche R, Lotfi S, Möllmann H, Joner M, Abdel-Wahab M, Bogaerts K, Hengstenberg C, Capodanno D. Comparison of Self-Expanding Bioprostheses for Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis: SCOPE 2 Randomized Clinical Trial. Circulation. 2020 Dec 22;142(25):2431-2442. doi: 10.1161/CIRCULATIONAHA.120.051547