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PANDORA-register: supra- versus intra-annulaire kleppen bij TAVR-in-TAVR

Nu transkatheter-aortaklepvervanging (TAVR) ook bij jongere, laagrisicopatiënten wordt toegepast, neemt de behoefte aan herhaalde ingrepen (TAVR-in-TAVR) toe. Het internationale PANDORA-register (172 TAVR-in-TAVR-procedures uit circa 30.000 TAVR's, mediaan interval 1.401 dagen) vergeleek combinaties van supra-annulaire (SAV) en intra-annulaire (IAV) kleppen. Structurele klepdegeneratie was de belangrijkste faaloorzaak (78%). Het technische succes (VARC-3) was 91% en het 30-dagen-device-succes 68% — beperkt door verhoogde restgradiënten (≥20 mmHg bij 13%) en een 30-dagensterfte van 7,3%. De IAV-IAV-combinatie had na één jaar de numeriek laagste overleving vrij van overlijden of hartfalenheropname. Mannelijk geslacht en CKD voorspelden sterfte. TAVR-in-TAVR is haalbaar, maar de klepcombinatie beïnvloedt de uitkomst.

Abstract (original)

BACKGROUND: As transcatheter aortic valve replacement (TAVR) expands to younger, lower-risk populations, the need for repeat procedures due to valve degeneration is expected to increase. TAVR-in-TAVR has emerged as a feasible strategy, although outcomes across supra-annular (SAV) and intra-annular (IAV) valve combinations remain unclear. The PANDORA (Supra-Annular Versus Intra-Annular Devices for TAVR-in-TAVR) international registry study assessed safety, hemodynamic performance, and clinical outcomes of TAVR-in-TAVR according to prosthetic configurations. METHODS: From an international multicenter registry (2011-2024), 172 TAVR-in-TAVR cases were identified among ≈30 000 TAVR procedures, with a median interval of 1401 days. Patients were stratified into 4 groups: SAV-IAV (n=32), SAV-SAV (n=29), IAV-SAV (n=74), and IAV-IAV (n=37). RESULTS: CoreValve/Evolut (49.4%) and Edwards SAPIEN (35.5%) were the most frequent index prostheses, whereas the second valve was mainly Edwards SAPIEN (60.5%), followed by Evolut (35.5%) and Myval/Octacor (4.0%). Structural valve deterioration was the leading failure mechanism (77.9%), while nonstructural valve deterioration dysfunction, alone or combined with structural valve deterioration, occurred in 40.7%. Overall Valve Academic Research Consortium 3 technical success was 91.3%, numerically highest in SAV-IAV and IAV-SAV (P=0.090). Thirty-day device success was 68%, also higher in SAV-IAV (75.9%, P=0.301), mainly influenced by elevated residual gradients (≥20 mm Hg in 12.7%) and the 30-day mortality rate (7.3%). At 1 year, the IAV-IAV group showed the numerically lowest freedom from death and heart failure hospitalization (76.1%, P=0.734). Male sex and chronic kidney disease independently predicted death at follow-up. CONCLUSIONS: TAVR-in-TAVR is feasible with generally favorable outcomes, although clinical and procedural profiles vary by the different prosthesis combinations. These findings highlight the need for further studies to refine device selection strategies.

Dit artikel is een samenvatting van een publicatie in Journal of the American Heart Association. Voor het volledige artikel, alle details en referenties verwijzen wij u naar de oorspronkelijke bron.

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DOI: 10.1161/JAHA.125.046180

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