Article, 2024

One-year clinical outcomes of transcatheter aortic valve implantation with the latest iteration of self-expanding or balloonexpandable devices: insights from the OPERA-TAVI registry.

EuroIntervention, ISSN 1774-024X, 1969-6213, Volume 20, 1, Pages 95-103, 10.4244/eij-d-23-00720

Contributors

Costa, Giuliano [1] Saia, Francesco 0000-0001-9969-2649 [2] [3] Pilgrim, Thomas [4] Abdel-Wahab, Mohamed [5] Garot, Philippe 0009-0001-8960-7006 [6] Sammartino, Sofia [1] Gandolfo, Caterina 0000-0001-6049-8961 [7] Branca, Luca [8] Latib, Azeem Mohamed 0000-0001-9035-343X [9] [10] Amat-Santos, Ignacio Jesús 0000-0002-2311-4129 [11] Mylotte, Darren M 0000-0001-7824-2577 [12] De Marco, Federico 0000-0003-3554-6938 [13] De Backer, Ole 0000-0002-9674-0278 [14] Nombela-Franco, L N F 0000-0003-3438-8907 [15] Akodad, Mariama 0000-0002-2957-5655 [6] [16] [17] Ribichini, Flavio Luciano 0000-0002-6662-0304 [18] Bedogni, Francesco 0000-0002-4975-6605 [19] Mazzapicchi, Alessandro [2] [3] Tomii, Daijiro 0000-0002-4488-1335 [4] Laforgia, Pietro Leonida [6] Cannata, Stefano 0000-0002-0559-7833 [7] Fiorina, Claudia 0000-0001-7868-1617 [8] Scotti, Andrea 0000-0003-4731-4384 [9] [10] Fezzi, Simone 0000-0003-2755-2094 [12] Criscione, Enrico 0000-0002-1550-8531 [19] Poletti, Enrico 0000-0002-3605-505X [19] Mazzucca, Mattia [19] Lunardi, Mattia 0000-0001-8344-6048 [18] Mainardi, Andrea [18] Andreaggi, Stefano 0009-0007-6115-5822 [18] Quagliana, Angelo 0000-0001-7024-3452 [14] Montarello, Nicholas J [14] Hennessey, Breda 0000-0002-0420-943X [15] Mon-Noboa, Matias [15] Meier, David 0000-0002-5524-5844 [16] [17] Adamo, Marianna [8] Sgroi, Carmelo [1] Reddavid, Claudia Maria [1] Strazzieri, Orazio 0000-0003-2971-363X [1] Crescenzia Motta, Silvia [1] Frittitta, Valentina [1] Dipietro, Elena [1] Comis, Alessandro [1] Melfa, Chiara [1] Calì, Mariachiara [1] Laterra, Giulia 0000-0001-8932-9045 [20] Thiele, Holger 0000-0002-0169-998X [5] Webb, John Graydon [16] [17] Sondergaard, Lars [14] [21] Tamburino, Corrado [1] Barbanti, Marco 0000-0002-4903-5437 [22]

Affiliations

  1. [1] Division of Cardiology, A.O.U. Policlinico "G. Rodolico-San Marco", Catania, Italy.
    2. [NORA names: Italy; Europe, EU; OECD];
  2. [2] Policlinico S.Orsola-Malpighi
    3. [NORA names: Italy; Europe, EU; OECD];
  3. [3] University of Bologna
    4. [NORA names: Italy; Europe, EU; OECD];
  4. [4] University Hospital of Bern
    5. [NORA names: Switzerland; Europe, Non-EU; OECD];
  5. [5] Leipzig University
    6. [NORA names: Germany; Europe, EU; OECD];

Abstract

BACKGROUND: Midterm comparative analyses of the latest iterations of the most used Evolut and SAPIEN platforms for transcatheter aortic valve implantation (TAVI) are lacking. AIMS: We aimed to compare 1-year clinical outcomes of TAVI patients receiving Evolut PRO/PRO+ (PRO) or SAPIEN 3 Ultra (ULTRA) devices in current real-world practice. METHODS: Among patients enrolled in the OPERA-TAVI registry, patients with complete 1-year follow-up were considered for the purpose of this analysis. One-to-one propensity score matching was used to compare TAVI patients receiving PRO or ULTRA devices. The primary endpoint was a composite of 1-year all-cause death, disabling stroke and rehospitalisation for heart failure. Five prespecified subgroups of patients were considered according to leaflet and left ventricular outflow tract calcifications, annulus dimensions and angulation, and leaflet morphology. RESULTS: Among a total of 1,897 patients, 587 matched pairs of patients with similar clinical and anatomical characteristics were compared. The primary composite endpoint did not differ between patients receiving PRO or ULTRA devices (Kaplan-Meier [KM] estimates 14.0% vs 11.9%; log-rank p=0.27). Patients receiving PRO devices had higher rates of 1-year disabling stroke (KM estimates 2.6% vs 0.4%; log-rank p=0.001), predominantly occurring within 30 days after TAVI (1.4% vs 0.0%; p=0.004). Outcomes were consistent across all the prespecified subsets of anatomical scenarios (all pinteraction>0.10). CONCLUSIONS: One-year clinical outcomes of patients undergoing transfemoral TAVI and receiving PRO or ULTRA devices in the current clinical practice were similar, but PRO patients had higher rates of disabling stroke. Outcomes did not differ across the different anatomical subsets of the aortic root.

Keywords

One-to-one propensity score matching, SAPIEN 3 Ultra, TAVI patients, Ultra, analysis, anatomic subsets, anatomical characteristics, anatomical scenarios, angulation, annulus, annulus dimensions, aortic root, aortic valve implantation, calcification, characteristics, clinical outcomes, clinical outcomes of patients, clinical outcomes of transcatheter aortic valve implantation, clinical practice, comparative analysis, compare 1-year clinical outcomes, composite endpoint, composition, days, devices, dimensions, endpoint, evolution, failure, follow-up, heart, heart failure, implantation, iteration, leaflet, leaflet morphology, left ventricular outflow tract calcification, matching, morphology, one-to-one, one-year clinical outcomes, one-year clinical outcomes of patients, outcomes, outcomes of patients, outcomes of transcatheter aortic valve implantation, pairs, pairs of patients, patients, platform, practice, primary composite endpoint, primary endpoint, propensity score matching, rate, rate of disabling stroke, real-world practice, registry, rehospitalisation, root, sapiens, scenarios, score matching, self-expanding, stroke, subgroup of patients, subgroups, subsets, transcatheter, transcatheter aortic valve implantation, transcatheter aortic valve implantation patients, transfemoral transcatheter aortic valve implantation, valve implantation

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