Initial results from the off-label use of the SAPIEN S3 valve for percutaneous transcatheter pulmonary valve replacement: A multi-institutional experience.
Adolescent
Adult
Balloon Valvuloplasty
Cardiac Catheterization
/ adverse effects
Cardiac Surgical Procedures
/ adverse effects
Child
Female
Heart Defects, Congenital
/ physiopathology
Heart Valve Prosthesis
Heart Valve Prosthesis Implantation
/ adverse effects
Humans
Male
Postoperative Complications
/ etiology
Prosthesis Design
Pulmonary Valve
/ diagnostic imaging
Pulmonary Valve Insufficiency
/ diagnostic imaging
Recovery of Function
Retrospective Studies
Risk Factors
Time Factors
Treatment Outcome
United States
Young Adult
Sapien valve
congenital heart disease
pulmonary regurgitation
trans-catheter pulmonary valve replacement
Journal
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139
Informations de publication
Date de publication:
15 02 2019
15 02 2019
Historique:
received:
13
04
2018
revised:
15
10
2018
accepted:
19
10
2018
pubmed:
12
12
2018
medline:
18
3
2020
entrez:
12
12
2018
Statut:
ppublish
Résumé
To describe a multi-center experience of percutaneous transcatheter pulmonary valve replacement (TPVR) using the Edwards Sapien S3 Valve. Off-label use of the Sapien S3 valve can allow for TPVR in patients with congenital heart disease (CHD) and large diameter dysfunctional right ventricular outflow tract (RVOT). The initial experience at five centers with the SAPIEN S3 valve for TPVR is presented with a focus on procedural techniques, success, complications, and efficacy. A retrospective review was performed of all patients with CHD and dysfunctional RVOT who underwent TPVR using Sapien S3 valve. Imaging data, procedural elements, and clinical follow-up data were collected to evaluate acute and short-term results. A total of 50 patients underwent percutaneous placement of the Sapien S3 in the pulmonary position. Of these, 38 were placed into "native RVOTs", measuring 24-32 mm in diameter, as assessed by compliant balloon sizing. In all cases, the valve was implanted after introduction and there were no cases of valve embolization. On follow up (range 1-9 months, median 3 months), no patients had significant obstruction or regurgitation through or around the valve requiring intervention. There were no procedural deaths. Major complications included severe aortic compression (n = 1) and tricuspid valve (TV) injury related to valve placement (n = 2) and prestenting (n = 1). TPVR in patients with large diameter dysfunctional RVOTs can be effectively performed with the Sapien S3. All procedures were technically successful with no embolizations, no perivalvular leaks, and excellent short-term valve function. Tricuspid valve injury from implantation of an uncovered valve was a serious procedural complication.
Sections du résumé
OBJECTIVES
To describe a multi-center experience of percutaneous transcatheter pulmonary valve replacement (TPVR) using the Edwards Sapien S3 Valve.
BACKGROUND
Off-label use of the Sapien S3 valve can allow for TPVR in patients with congenital heart disease (CHD) and large diameter dysfunctional right ventricular outflow tract (RVOT). The initial experience at five centers with the SAPIEN S3 valve for TPVR is presented with a focus on procedural techniques, success, complications, and efficacy.
METHODS
A retrospective review was performed of all patients with CHD and dysfunctional RVOT who underwent TPVR using Sapien S3 valve. Imaging data, procedural elements, and clinical follow-up data were collected to evaluate acute and short-term results.
RESULTS
A total of 50 patients underwent percutaneous placement of the Sapien S3 in the pulmonary position. Of these, 38 were placed into "native RVOTs", measuring 24-32 mm in diameter, as assessed by compliant balloon sizing. In all cases, the valve was implanted after introduction and there were no cases of valve embolization. On follow up (range 1-9 months, median 3 months), no patients had significant obstruction or regurgitation through or around the valve requiring intervention. There were no procedural deaths. Major complications included severe aortic compression (n = 1) and tricuspid valve (TV) injury related to valve placement (n = 2) and prestenting (n = 1).
CONCLUSIONS
TPVR in patients with large diameter dysfunctional RVOTs can be effectively performed with the Sapien S3. All procedures were technically successful with no embolizations, no perivalvular leaks, and excellent short-term valve function. Tricuspid valve injury from implantation of an uncovered valve was a serious procedural complication.
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
455-463Commentaires et corrections
Type : CommentIn
Type : CommentIn
Informations de copyright
© 2018 Wiley Periodicals, Inc.