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Off-label use of percutaneous pulmonary valved stents in the right ventricular outflow tract: time to rewrite the label?
Catheter Cardiovasc Interv. 2013 May; 81(6):987-95.CC

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 AND METHODS

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.

Authors+Show Affiliations

Paediatric and Adult Congenital Heart Unit, University Hospitals KU Leuven and UC Louvain, Belgium.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22887796

Citation

Boshoff, Derize E., et al. "Off-label Use of Percutaneous Pulmonary Valved Stents in the Right Ventricular Outflow Tract: Time to Rewrite the Label?" Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions, vol. 81, no. 6, 2013, pp. 987-95.
Boshoff DE, Cools BL, Heying R, et al. Off-label use of percutaneous pulmonary valved stents in the right ventricular outflow tract: time to rewrite the label? Catheter Cardiovasc Interv. 2013;81(6):987-95.
Boshoff, D. E., Cools, B. L., Heying, R., Troost, E., Kefer, J., Budts, W., & Gewillig, M. (2013). Off-label use of percutaneous pulmonary valved stents in the right ventricular outflow tract: time to rewrite the label? Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions, 81(6), 987-95. https://doi.org/10.1002/ccd.24594
Boshoff DE, et al. Off-label Use of Percutaneous Pulmonary Valved Stents in the Right Ventricular Outflow Tract: Time to Rewrite the Label. Catheter Cardiovasc Interv. 2013;81(6):987-95. PubMed PMID: 22887796.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Off-label use of percutaneous pulmonary valved stents in the right ventricular outflow tract: time to rewrite the label? AU - Boshoff,Derize E, AU - Cools,Bjorn L M, AU - Heying,Ruth, AU - Troost,Els, AU - Kefer,Joelle, AU - Budts,Werner, AU - Gewillig,Marc, Y1 - 2013/02/12/ PY - 2012/04/04/received PY - 2012/07/28/accepted PY - 2012/8/14/entrez PY - 2012/8/14/pubmed PY - 2013/10/29/medline SP - 987 EP - 95 JF - Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions JO - Catheter Cardiovasc Interv VL - 81 IS - 6 N2 - 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 AND METHODS: 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. SN - 1522-726X UR - https://www.unboundmedicine.com/medline/citation/22887796/Off_label_use_of_percutaneous_pulmonary_valved_stents_in_the_right_ventricular_outflow_tract:_time_to_rewrite_the_label L2 - https://doi.org/10.1002/ccd.24594 DB - PRIME DP - Unbound Medicine ER -