Author + information
- Received January 10, 2018
- Revision received May 14, 2018
- Accepted May 22, 2018
- Published online October 1, 2018.
- Julien Plessis, MDa,∗ (, )
- Sébastien Hascoët, MDb,c,
- Alban Baruteau, MD, PhDa,d,e,
- François Godart, MD, PhDf,
- Laurianne Le Gloan, MDa,
- Karine Warin Fresse, MDa,
- Nabil Tahhan, MDb,
- Jean-Yves Riou, MDb,
- Béatrice Guyomarch, MSa,
- Jérôme Petit, MDb and
- Patrice Guérin, MD, PhDa
- aCentre Hospitalier Universitaire de Nantes, Institut du Thorax, Fédération des Cardiopathies Congénitales, Service de Cardiologie, Nantes, France
- bMarie-Lannelongue, Pole de Chirurgie des Cardiopathies Congénitales, M3C- Centre de Reference Malformations Cardiaques Congénitales Complexes, Université Paris-Sud, Paris, France
- cInserm UMR-S999, Hôpital Marie Lannelongue, Université Paris-Sud, Université Paris-Saclay, Le Kremlin-Bicêtre, France
- dINSERM, CNRS, Universitaire de Nantes, l’Institut du Thorax, Nantes, France
- eEvelina London Children’s Hospital, Guy’s and St. Thomas’s NHS Foundation Trust, London, United Kingdom
- fDepartment of Pediatric and Congenital Heart Disease, University of Lille-Nord de France, Lille, France
- ↵∗Address for correspondence:
Dr. Julien Plessis, Service de Cardiologie, Centre Hospitalier Universitaire de Nantes, Hôpital Nord-Laennec, Boulevard Jacques Monod, 44093 Nantes Cedex, France.
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.
- congenital heart disease
- Edwards SAPIEN pulmonic valve
- percutaneous pulmonary valve implantation
- pulmonary regurgitation
- pulmonary stenosis
The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received January 10, 2018.
- Revision received May 14, 2018.
- Accepted May 22, 2018.
- 2018 American College of Cardiology Foundation