Off-label use of percutaneous pulmonary valved stents in the right ventricular outflow tract: time to rewrite the label?
Catheter Cardiovasc Interv
; 81(6): 987-95, 2013 May.
Article
em En
| MEDLINE
| ID: mdl-22887796
ABSTRACT
INTRODUCTION:
Percutaneous pulmonary valve implantation is now considered feasible and safe. "Native" right ventricular outflow tract (RVOT), small diameter conduits (<16 mm) and relatively large RVOT with a dynamic outflow aneurysm are currently considered off-label uses. Extending indications creates concerns of safety, ethics, reimbursement, and liability. AIM OF STUDY To report the safety and feasibility of off-label application of percutaneous pulmonary valve implantation.DESIGN:
Retrospective analysis of prospectively collected data. PATIENTS ANDMETHODS:
Off-label indications conduit-free RVOT or patients with an existing but undersized conduit.RESULTS:
Twenty-one Melody® valves and two Sapien® valves were successfully implanted in 23 patients (16.9 years; range 6.1-80.5 years). In 22 patients, prestenting was performed 4.8 months (range 0-69.2) before valve implantation (15 covered and 13 bare stents). Stent endothelial ingrowth was allowed for at least 2 months prior to implantation of the percutaneous valve if stent stability or sealing by the covering was presumed to be insufficient. Group 1 patients (n = 8) had a "conduit-free" RVOT after transannular/infundibular patch and after prestenting underwent percutaneous pulmonary valve implantation (PPVI), with a final RVOT diameter of 21.5 mm (range 16-26 mm). Group 2 patients consisted of two elderly patients with pulmonary valve stenosis and severe RVOT calcifications. Group 3 (n = 13) had an existing conduit (nominal 15.9 ± 3.2 mm; range 10-20 mm). The conduit was augmented from 14.7 ± 3.5 to 20 ± 1.6 mm with PPVI. The RVOT preparation and valve implantations were uneventful.CONCLUSIONS:
PPVI is safe and feasible in selected patients with an off-label indication. Creating an adequate "landing zone" by prestenting makes the procedure safe and predictable. Updating the indications for PPVI should be considered.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Insuficiência da Valva Pulmonar
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Estenose da Valva Pulmonar
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Prótese Vascular
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Próteses Valvulares Cardíacas
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Cateterismo Cardíaco
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Stents
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Implante de Prótese de Valva Cardíaca
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Implante de Prótese Vascular
Tipo de estudo:
Diagnostic_studies
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Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Adolescent
/
Adult
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Aged
/
Aged80
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Child
/
Humans
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Middle aged
Idioma:
En
Revista:
Catheter Cardiovasc Interv
Assunto da revista:
CARDIOLOGIA
Ano de publicação:
2013
Tipo de documento:
Article
País de afiliação:
Bélgica