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Early outcomes of percutaneous pulmonary valve implantation using the Edwards SAPIEN 3 transcatheter heart valve system


Hascoet, Sebastien; Dalla Pozza, Robert; Bentham, Jamie; Carere, Ronald Giacomo; Kanaan, Majed; Ewert, Peter; Biernacka, Elzbieta Katarzyna; Kretschmar, Oliver; Deutsch, Cornelia; Lecerf, Florence; Lehner, Anja; Kantzis, Marinos; Kurucova, Jana; Thoenes, Martin; Bramlage, Peter; Haas, Nikolaus A (2019). Early outcomes of percutaneous pulmonary valve implantation using the Edwards SAPIEN 3 transcatheter heart valve system. EuroIntervention, 14(13):1378-1385.

Abstract

AIMS Multiple surgical revisions are often necessary in individuals with congenital heart defects affecting the RVOT or pulmonary valve. There are no multicentre data on the feasibility and safety of percutaneous pulmonary valve implantation using the SAPIEN 3 (S3) transcatheter heart valve.
METHODS AND RESULTS Pulmonic S3 is an observational registry of patients undergoing PPVI with the S3 valve across centres in Europe and Canada. Data for 82 patients (mean age 27.3 years) was obtained. The most common underlying diagnosis was Tetralogy of Fallot (ToF) (58.5%), with 16.0% of patients having native RVOT anatomy. 90.2% received pre-stenting. Prosthesis dislodgement occurred in one patient and conduit perforation in another. Both were successfully resolved without need for open surgery. Peak systolic gradient over the RVOT fell from 46.3 mmHg to 17.2 mmHg, moderate/severe pulmonary regurgitation from 86.3% to 0.0% and NYHA ≥II from 86.0% to 15.2%. During follow-up valve-thrombosis was observed in two patients which resolved with adequate anticoagulation. No other procedural complications, endocarditis, stent fracture or death were reported within two years.
CONCLUSIONS PPVI with the S3 valve appears feasible and safe in a wide range of patients with congenital heart defects, with good short-term haemodynamic and functional outcomes.

Abstract

AIMS Multiple surgical revisions are often necessary in individuals with congenital heart defects affecting the RVOT or pulmonary valve. There are no multicentre data on the feasibility and safety of percutaneous pulmonary valve implantation using the SAPIEN 3 (S3) transcatheter heart valve.
METHODS AND RESULTS Pulmonic S3 is an observational registry of patients undergoing PPVI with the S3 valve across centres in Europe and Canada. Data for 82 patients (mean age 27.3 years) was obtained. The most common underlying diagnosis was Tetralogy of Fallot (ToF) (58.5%), with 16.0% of patients having native RVOT anatomy. 90.2% received pre-stenting. Prosthesis dislodgement occurred in one patient and conduit perforation in another. Both were successfully resolved without need for open surgery. Peak systolic gradient over the RVOT fell from 46.3 mmHg to 17.2 mmHg, moderate/severe pulmonary regurgitation from 86.3% to 0.0% and NYHA ≥II from 86.0% to 15.2%. During follow-up valve-thrombosis was observed in two patients which resolved with adequate anticoagulation. No other procedural complications, endocarditis, stent fracture or death were reported within two years.
CONCLUSIONS PPVI with the S3 valve appears feasible and safe in a wide range of patients with congenital heart defects, with good short-term haemodynamic and functional outcomes.

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Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Children's Hospital Zurich > Medical Clinic
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:1 January 2019
Deposited On:14 Mar 2019 16:40
Last Modified:14 Mar 2019 16:41
Publisher:Europa Digital and Publishing
ISSN:1774-024X
OA Status:Closed
Free access at:Publisher DOI. An embargo period may apply.
Publisher DOI:https://doi.org/10.4244/EIJ-D-18-01035
PubMed ID:30418156

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