JACC. Cardiovascular interventions · 2018
Edwards SAPIEN Transcatheter Pulmonary Valve Implantation: Results From a French Registry.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
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Plessis Julien, Hascoët Sébastien, Baruteau Alban, Godart François, Le Gloan Laurianne, Warin Fresse Karine, Tahhan Nabil, Riou Jean-Yves, Guyomarch Béatrice, Petit Jérôme, Guérin Patrice
Аннотация
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.
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.
Предметные рубрики MeSH
AdolescentAdultAgedCardiac CatheterizationChildFemaleFranceHeart Valve ProsthesisHeart Valve Prosthesis ImplantationHumansMaleMiddle AgedPostoperative ComplicationsProspective StudiesProsthesis DesignPulmonary ValvePulmonary Valve InsufficiencyPulmonary Valve StenosisRecovery of FunctionRegistriesRisk AssessmentRisk FactorsTime FactorsTreatment OutcomeYoung Adult