Implantation of contemporary transcatheter aortic valves in small aortic annuli: the international multicentre TAVI-SMALL 2 registry

DOI: 10.4244/EIJ-D-22-00843

Pier Pasquale Leone
Pier Pasquale Leone1,2,3, MD, MSc; Damiano Regazzoli3, MD; Matteo Pagnesi4, MD; Francesco Cannata2,3, MD; Antonio Mangieri3, MD; Thijmen W. Hokken5, MD; Giuliano Costa6, MD; Marco Barbanti6, MD; Rui Campante Teles7, MD; Marianna Adamo4, MD; Maurizio Taramasso8, MD, PhD; Jorg Reifart9, MD; Federico De Marco10, MD; Francesco Giannini11, MD; Faraj Kargoli1, MD; Yohei Ohno12, MD; Francesco Saia13, MD; Andrea Buono14, MD; Alfonso Ielasi15, MD; Michele Pighi16, MD; Mauro Chiarito2,3, MD; Dario Bongiovanni3, MD, PhD; Ottavia Cozzi3, MD; Giulio Stefanini2,3, MD, MSc, PhD; Flavio L. Ribichini16, MD; Diego Maffeo14, MD; Giuliano Chizzola4, MD; Francesco Bedogni11, MD; Won-Keun Kim17, MD; Francesco Maisano18, MD; Corrado Tamburino7, MD; Nicolas M. Van Mieghem5, MD, PhD; Antonio Colombo2,3, MD; Bernhard Reimers3, MD; Azeem Latib1, MB, BCh
1. Montefiore Medical Center, New York, NY, USA; 2. Department of Biomedical Sciences, Humanitas University, Pieve Emanuele-Milan, Italy; 3. Cardio Center, IRCCS Humanitas Research Hospital, Rozzano-Milan, Italy; 4. Institute of Cardiology, ASST Spedali Civili, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia, Italy; 5. Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands; 6. U.O.C. Cardiologia, Centro Alte Specialità e Trapianti, A.O.U. Policlinico “G. Rodolico-San Marco”, Catania, Italy; 7. Hospital de Santa Cruz, Centro Hospitalar de Lisboa Ocidental, Nova Medical School, CEDOC, Lisbon, Portugal; 8. HerzZentrum Hirslanden Zurich, Zurich, Switzerland and University of Zurich, Zurich, Switzerland; 9. DZHK (German Center for Cardiovascular Research), Partner Site RheinMain, Frankfurt am Main, Germany; 10. Department of Cardiology, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy; 11. GVM Care & Research, Maria Cecilia Hospital, Ravenna, Italy; 12. Department of Cardiology, Tokai University Hospital, Kanagawa, Japan; 13. Cardiology Unit, Sant’Orsola Polyclinic, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; 14. Interventional Cardiology Unit, Cardiovascular Department, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy; 15. Clinical and Interventional Unit, Sant’Ambrogio Cardio-Thoracic Center, Milan, Italy; 16. Division of Cardiology, Department of Medicine, University of Verona, Verona, Italy; 17. Department of Cardiology, Kerckhoff Heart Center, Bad Nauheim, Germany; 18. Cardio-Thoracic-Vascular Department, IRCCS Ospedale San Raffaele, Milan, Italy.Misc

Background: Treatment of aortic stenosis in patients with small annuli is challenging and can result in prosthesis-patient mismatch (PPM).

Aims: We aimed to compare the forward flow haemodynamics and clinical outcomes of contemporary transcatheter valves in patients with small annuli.

Methods: The TAVI-SMALL 2 international retrospective registry included 1,378 patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm2) treated with transfemoral self-expanding (SEV; n=1,092) and balloon-expandable valves (BEV; n=286) in 16 high-volume centres between 2011 and 2020. Analyses comparing SEV versus BEV and supra-annular (SAV; n=920) versus intra-annular valves (IAV; n=458) included inverse probability of treatment weighting (IPTW). The primary endpoints were the predischarge mean aortic gradient and incidence of severe PPM. The secondary endpoint was the incidence of more than mild paravalvular leak (PVL).

Results: The predischarge mean aortic gradient was lower after SAV versus IAV (7.8±3.9 vs 12.0±5.1; p<0.001) and SEV versus BEV implantation (8.0±4.1 vs 13.6±4.7; p<0.001). Severe PPM was more common with IAV and BEV when compared to SAV and SEV implantation, respectively, (8.8% vs 3.6%; p=0.007 and 8.7% vs 4.6%; p=0.041). At multivariable logistic regression weighted by IPTW, SAV protected from severe PPM regardless of its definition. More than mild PVL occurred more often with SEV versus BEV (11.6% vs 2.6%; p<0.001).

Conclusions: In small aortic annuli, implantation of SAV and SEV was associated with a more favourable forward haemodynamic profile than after IAV and BEV implantation, respectively. More than mild PVL was more common after SEV than BEV implantation.

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