Outcomes of transcatheter pulmonary SAPIEN 3 valve implantation: an international registry

Author:

Hascoët Sebastien123ORCID,Bentham James R4,Giugno Luca5ORCID,Betrián-Blasco Pedro6ORCID,Kempny Aleksander2ORCID,Houeijeh Ali7ORCID,Baho Haysam8,Sharma Shiv-Raj2,Jones Matthew I9ORCID,Biernacka Elżbieta Katarzyna10ORCID,Combes Nicolas111ORCID,Georgiev Stanimir12ORCID,Bouvaist Hélène13ORCID,Martins Jose Diogo14ORCID,Kantzis Marinos15ORCID,Turner Mark16,Schubert Stephan17ORCID,Jalal Zakaria1819ORCID,Butera Gianfranco20ORCID,Malekzadeh-Milani Sophie21ORCID,Valdeolmillos Estibaliz13ORCID,Karsenty Clement22ORCID,Ödemiş Ender23ORCID,Aldebert Philippe24ORCID,Haas Nikolaus A25ORCID,Khatib Ihab2627,Wåhlander Håkan28ORCID,Gaio Gianpiero29ORCID,Mendoza Alberto30ORCID,Arif Sayqa31,Castaldi Biagio32ORCID,Dohlen Gaute33ORCID,Carere Ronald G34ORCID,Del Cerro-Marin Maria Jesus35ORCID,Kitzmüller Erwin36ORCID,Hermuzi Antony37ORCID,Carminati Mario5ORCID,Guérin Patrice38ORCID,Tengler Anja25ORCID,Fraisse Alain2ORCID,Aaberge Lars,Akodad Mariama,Alvarez-Fuente Maria,Batteux Clément,Bautista Carles,Bedair Radwa,Bianco Lisa,Bonnet Damien,Bosser Gilles,Chessa Massimo,Demkow Marcin,Eicken Andreas,Ewert Peter,Gatzoulis Michael,Giordano Mario,Godart Francois,Grohmann Jochen,Gudnason Janus Freyr,Haddad Raymond,Kizilkaya Mete Han,Helal Abdelmonem,Hermuzi Anthony,Herrera Dolores,Kim Wan Cheol,Ruz Robin Le,Li Wei,Loureiro Petra,Lunde Ketil,Ly Reaksmei,Marti-Aguasca Gerard,Nygren Anders,Ordonez Maria Victoria,Petit Jerome,Plessis Julien,Piccinelli Enrico,Pilati Mara,Qureshi Shakeel,Ratsimandresy Miarisoa,Rebonato Micol,Rosenthal Eric,Riahi Mounir,Rużyłło Witold,Sarnago Fernando,Sousa Lidia,Thambo Jean-Benoit,Toledano-Navarro Maria,Velasco Daniel,Ystgaard Martin Bogale,

Affiliation:

1. Hôpital Marie Lannelongue, Groupe Hospitalier Paris Saint Joseph, Faculté de médecine Paris-Saclay, Université Paris-Saclay, BME laboratory , 133 avenue de la résistance , 92350 Le Plessis Robinson, France

2. Royal Brompton Hospital , Sydney Street, London , Greater London SW3 6NP, UK

3. Inserm UMR-S 999, Marie Lannelongue hospital, Paris-Saclay university , 133 avenue de la résistance, 92350 Le Plessis Robinson , France

4. Leeds Teaching Hospitals NHS Trust, Yorkshire Heart Centre , Leeds , UK

5. Department of Paediatric Cardiology and Adults with congenital heart diseases, IRCCS-Policlinico San Donato , Via Morandi, 30 , 20097 San Donato, Milan, Italy

6. Hospital Universitario Vall d’Hebron , Department of Paediatric Cardiology and Adults with Congenital Heart Diseases, Passeig de la Vall d'Hebron, 119 , 08035 Barcelona, Spain

7. Centre Hospitalier Universitaire de Lille , Department of Paediatric Cardiology and Adults with Congenital Heart Diseases, 2 Av. Oscar Lambret , 59000 Lille, France

8. King Faisal Specialist Hospital , Department of Paediatric Cardiology and Adults with congenital heart diseases, Jeddah , Saudi Arabia

9. Evelina London Children's Hospital & St Thomas’ Hospital , Departement of Paediatric Cardiology and Adults with Congenital Heart Diseases, Westminster Bridge Rd , London SE1 7EH, United Kingdom

10. Cardinal Stefan Wyszyński Institute of Cardiology , Department of Congenital Heart Diseases, Alpejska 42 , 04-628 Warsaw, Poland

11. Clinique Pasteur , Department of Cardiology, 31000 Toulouse , France

12. Department of Congenital Heart Disease and Pediatric Cardiogy, German Heart Centre Munich, Technical University of Munich , Munich , Germany

13. Service de Cardiologie, CHU Grenoble Alpes , Grenoble , France

14. Paediatric Cardiology Department, Hospital de Santa Marta, Centro Hospitalar Universitário de Lisboa Central-EPE , Lisbon , Portugal

15. Glenfield Hosp , Department of Paediatric Cardiology and Adults with Congenital Heart Diseases, Leicester , United Kingdom

16. Bristol Heart Institute, University Hospitals Bristol & Weston NHS Foundation Trust , Bristol , United Kingdom

17. Centre for Congenital Heart Defects, Heart and Diabetes Centre Universitario North Rhine Westphalia, Department for Congenital Heart Defects, Ruhr University Bochum , 32545 Bad Oeynhausen , Germany

18. Pediatric and congenital heart diseases department, Bordeaux University Hospital , Pessac , France

19. IHU LIRYC, Electrophysiology and Heart Modeling Institute, CRCTB INSERM U1045 , Bordeaux , France

20. Cardiology, Cardiac Surgery and Heart Lung transplantation, ERN GUARD HEART: Bambino Gesù Hospital and Research Institute, IRCCS , Rome , Italy

21. M3C-Necker, Hôpital Universitaire Necker-Enfants malades, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP) , Paris , France

22. CHU Hôpital des enfants , Department of Paediatric Cardiology, Toulouse , France

23. Koç University Hospital , Department of Paediatric Cardiology and Adults with Congenital Heart Diseases, Davutpaşa Cd , 34010 Istanbul, Turkey

24. CHU Timone, Assistance Publique des Hôpitaux de Marseille , 278 rue Saint-Pierre , 13385 Marseille, France

25. Department of Pediatric Cardiology and Intensive Care, Medical Hospital of the University of Munich, LMU Ludwig Maximilian University of Munich , Campus Grosshadern, Marchioninistrasse 15 , D-81377 Munich, Germany

26. Department of Paediatric Cardiology and Congenital Heart Disease in Adults, Rambam Healthcare Campus, Haifa , Israel

27. Department of Paediatric Cardiology and Congenital Heart Disease in Adults, Sheba Medical Center, Tel HaShomer Hospital, Ramat Gan , Israël

28. Paediatric Heart Centre, Queen Silvia Children's Hospital, Sahlgrenska University Hospital and Department of Paediatrics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg , Gothenburg , Sweden

29. Paediatric Cardiology, Ospedali dei Colli, Luigi Vanvitelli University of Campania , Str. Vicinale Reggente, 66/82 , 80131 Naples, Italy

30. Instituto Pediátrico del Corazón, Hospital Universitario 12 de Octubre , Av de Cordoba s/n , 28041 Madrid, Spain

31. University Hospital Birmingham NHS Trust , Department of Paediatric Cardiology and Adults with Congenital Heart Diseases, Mindelsohn Way , Birmingham B15 2GW, United Kingdom

32. Paediatric Cardiology Unit, Department of Child and Woman's Health, University of Padua , Via VIII Febbraio, 2 , 35122 Padua, Italy

33. University hospital , Department of Paediatric Cardiology and Adults with Congenital Heart Diseases, Oslo , Norway

34. St Paul's Hospital , Department of Paediatric Cardiology and Adults with Congenital Heart Diseases, 1081 Burrard St , Vancouver, British Columbia V6Z 1Y6, Canada

35. Department of Paediatric Cardiology and Adults Congenital Heart Disease, H. Ramón y Cajal University Hospital , Madrid , Spain

36. Vienna General Hospital (AKH), Vienna Medical University , Vienna , Austria

37. The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital Newcastle upon Tyne , Newcastle , United Kingdom

38. Centre Hospitalier Universitaire de Nantes , Department of Cardiology, 1 Pl. Alexis-Ricordeau , 44093 Nantes, France

Abstract

Abstract Background and Aims Transcatheter pulmonary valve implantation (TPVI) is indicated to treat right-ventricular outflow tract (RVOT) dysfunction related to congenital heart disease (CHD). Outcomes of TPVI with the SAPIEN 3 valve that are insufficiently documented were investigated in the EUROPULMS3 registry of SAPIEN 3-TPVI. Methods Patient-related, procedural, and follow-up outcome data were retrospectively assessed in this observational cohort from 35 centres in 15 countries. Results Data for 840 consecutive patients treated in 2014–2021 at a median age of 29.2 (19.0–41.6) years were obtained. The most common diagnosis was conotruncal defect (70.5%), with a native or patched RVOT in 50.7% of all patients. Valve sizes were 20, 23, 26, and 29 mm in 0.4%, 25.5%, 32.1%, and 42.0% of patients, respectively. Valve implantation was successful in 98.5% [95% confidence interval (CI), 97.4%–99.2%] of patients. Median follow-up was 20.3 (7.1–38.4) months. Eight patients experienced infective endocarditis; 11 required pulmonary valve replacement, with a lower incidence for larger valves (P = .009), and four experienced pulmonary valve thrombosis, including one who died and three who recovered with anticoagulation. Cumulative incidences (95%CI) 1, 3, and 6 years after TPVI were as follows: infective endocarditis, 0.5% (0.0%–1.0%), 0.9% (0.2%–1.6%), and 3.8% (0.0%–8.4%); pulmonary valve replacement, 0.4% (0.0%–0.8%), 1.3% (0.2%–2.4%), and 8.0% (1.2%–14.8%); and pulmonary valve thrombosis, 0.4% (0.0%–0.9%), 0.7% (0.0%–1.3%), and 0.7% (0.0%–1.3%), respectively. Conclusions Outcomes of SAPIEN 3 TPVI were favourable in patients with CHD, half of whom had native or patched RVOTs.

Funder

Department of Research and Innovation

Marie Lannelongue Hospital

Groupe Hospitalier Paris-Saint Joseph

Publisher

Oxford University Press (OUP)

Subject

Cardiology and Cardiovascular Medicine

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