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Edwards SAPIEN Transcatheter Pulmonary Valve Implantation: Results From a French Registry.
JACC Cardiovasc Interv. 2018 10 08; 11(19):1909-1916.JC

Abstract

OBJECTIVES

The aim of this study was to describe and analyze data from patients treated in France with the Edwards SAPIEN transcatheter heart valve (Edwards Lifesciences LLC, Irvine, California) in the pulmonary position.

BACKGROUND

The Edwards SAPIEN valve has recently been introduced for percutaneous pulmonary valve implantation (PPVI).

METHODS

From April 2011 to May 2017, 71 patients undergoing PPVI were consecutively included.

RESULTS

The median age at PPVI was 26.8 years (range 12.8 to 70.1 years). Primary underlying diagnoses were conotruncal malformations (common arterial trunk, tetralogy of Fallot and variants; n = 45), Ross procedure (n = 18), and other diagnoses (n = 8). PPVI indication was pure stenosis in 33.8% of patients, pure regurgitation in 28.1%, and mixed lesions in 38.1%. PPVI was successfully implemented in 68 patients (95.8%). Pre-stenting of the right ventricular outflow tract was performed in 70 patients (98.6%). Early major complications occurred in 4 subjects (5.6%), including 1 death, 1 coronary compression, and 2 pulmonary valve embolizations. Three of the 4 major complications occurred in the first 15 operated patients. No significant regurgitation was recorded after the procedure. Transpulmonary gradient was significantly reduced from 34.5 to 10.5 mm Hg (p < 0.0001). No patient died during a 1-month follow-up period. At 1-year follow-up, the death rate was 2.9%, and 3 patients had undergone surgical reintervention (44%).

CONCLUSIONS

Early results with the Edwards SAPIEN valve in the pulmonary position demonstrate an ongoing high rate of procedural success.

Authors+Show Affiliations

Centre Hospitalier Universitaire de Nantes, Institut du Thorax, Fédération des Cardiopathies Congénitales, Service de Cardiologie, Nantes, France. Electronic address: julien.plessis@chu-nantes.fr.Marie-Lannelongue, Pole de Chirurgie des Cardiopathies Congénitales, M3C- Centre de Reference Malformations Cardiaques Congénitales Complexes, Université Paris-Sud, Paris, France; Inserm UMR-S999, Hôpital Marie Lannelongue, Université Paris-Sud, Université Paris-Saclay, Le Kremlin-Bicêtre, France.Centre Hospitalier Universitaire de Nantes, Institut du Thorax, Fédération des Cardiopathies Congénitales, Service de Cardiologie, Nantes, France; INSERM, CNRS, Universitaire de Nantes, l'Institut du Thorax, Nantes, France; Evelina London Children's Hospital, Guy's and St. Thomas's NHS Foundation Trust, London, United Kingdom.Department of Pediatric and Congenital Heart Disease, University of Lille-Nord de France, Lille, France.Centre Hospitalier Universitaire de Nantes, Institut du Thorax, Fédération des Cardiopathies Congénitales, Service de Cardiologie, Nantes, France.Centre Hospitalier Universitaire de Nantes, Institut du Thorax, Fédération des Cardiopathies Congénitales, Service de Cardiologie, Nantes, France.Marie-Lannelongue, Pole de Chirurgie des Cardiopathies Congénitales, M3C- Centre de Reference Malformations Cardiaques Congénitales Complexes, Université Paris-Sud, Paris, France.Marie-Lannelongue, Pole de Chirurgie des Cardiopathies Congénitales, M3C- Centre de Reference Malformations Cardiaques Congénitales Complexes, Université Paris-Sud, Paris, France.Centre Hospitalier Universitaire de Nantes, Institut du Thorax, Fédération des Cardiopathies Congénitales, Service de Cardiologie, Nantes, France.Marie-Lannelongue, Pole de Chirurgie des Cardiopathies Congénitales, M3C- Centre de Reference Malformations Cardiaques Congénitales Complexes, Université Paris-Sud, Paris, France.Centre Hospitalier Universitaire de Nantes, Institut du Thorax, Fédération des Cardiopathies Congénitales, Service de Cardiologie, Nantes, France.

Pub Type(s)

Journal Article
Multicenter Study
Observational Study

Language

eng

PubMed ID

30219326

Citation

Plessis, Julien, et al. "Edwards SAPIEN Transcatheter Pulmonary Valve Implantation: Results From a French Registry." JACC. Cardiovascular Interventions, vol. 11, no. 19, 2018, pp. 1909-1916.
Plessis J, Hascoët S, Baruteau A, et al. Edwards SAPIEN Transcatheter Pulmonary Valve Implantation: Results From a French Registry. JACC Cardiovasc Interv. 2018;11(19):1909-1916.
Plessis, J., Hascoët, S., Baruteau, A., Godart, F., Le Gloan, L., Warin Fresse, K., Tahhan, N., Riou, J. Y., Guyomarch, B., Petit, J., & Guérin, P. (2018). Edwards SAPIEN Transcatheter Pulmonary Valve Implantation: Results From a French Registry. JACC. Cardiovascular Interventions, 11(19), 1909-1916. https://doi.org/10.1016/j.jcin.2018.05.050
Plessis J, et al. Edwards SAPIEN Transcatheter Pulmonary Valve Implantation: Results From a French Registry. JACC Cardiovasc Interv. 2018 10 8;11(19):1909-1916. PubMed PMID: 30219326.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Edwards SAPIEN Transcatheter Pulmonary Valve Implantation: Results From a French Registry. AU - Plessis,Julien, AU - Hascoët,Sébastien, AU - Baruteau,Alban, AU - Godart,François, AU - Le Gloan,Laurianne, AU - Warin Fresse,Karine, AU - Tahhan,Nabil, AU - Riou,Jean-Yves, AU - Guyomarch,Béatrice, AU - Petit,Jérôme, AU - Guérin,Patrice, Y1 - 2018/09/12/ PY - 2018/01/10/received PY - 2018/05/14/revised PY - 2018/05/22/accepted PY - 2018/9/17/pubmed PY - 2019/11/27/medline PY - 2018/9/17/entrez KW - Edwards SAPIEN pulmonic valve KW - congenital heart disease KW - percutaneous pulmonary valve implantation KW - pulmonary regurgitation KW - pulmonary stenosis SP - 1909 EP - 1916 JF - JACC. Cardiovascular interventions JO - JACC Cardiovasc Interv VL - 11 IS - 19 N2 - OBJECTIVES: The aim of this study was to describe and analyze data from patients treated in France with the Edwards SAPIEN transcatheter heart valve (Edwards Lifesciences LLC, Irvine, California) in the pulmonary position. BACKGROUND: The Edwards SAPIEN valve has recently been introduced for percutaneous pulmonary valve implantation (PPVI). METHODS: From April 2011 to May 2017, 71 patients undergoing PPVI were consecutively included. RESULTS: The median age at PPVI was 26.8 years (range 12.8 to 70.1 years). Primary underlying diagnoses were conotruncal malformations (common arterial trunk, tetralogy of Fallot and variants; n = 45), Ross procedure (n = 18), and other diagnoses (n = 8). PPVI indication was pure stenosis in 33.8% of patients, pure regurgitation in 28.1%, and mixed lesions in 38.1%. PPVI was successfully implemented in 68 patients (95.8%). Pre-stenting of the right ventricular outflow tract was performed in 70 patients (98.6%). Early major complications occurred in 4 subjects (5.6%), including 1 death, 1 coronary compression, and 2 pulmonary valve embolizations. Three of the 4 major complications occurred in the first 15 operated patients. No significant regurgitation was recorded after the procedure. Transpulmonary gradient was significantly reduced from 34.5 to 10.5 mm Hg (p < 0.0001). No patient died during a 1-month follow-up period. At 1-year follow-up, the death rate was 2.9%, and 3 patients had undergone surgical reintervention (44%). CONCLUSIONS: Early results with the Edwards SAPIEN valve in the pulmonary position demonstrate an ongoing high rate of procedural success. SN - 1876-7605 UR - https://www.unboundmedicine.com/medline/citation/30219326/Edwards_SAPIEN_Transcatheter_Pulmonary_Valve_Implantation:_Results_From_a_French_Registry_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1936-8798(18)31286-X DB - PRIME DP - Unbound Medicine ER -