Off-label use of percutaneous pulmonary valved stents in the right ventricular outflow tract: Time to rewrite the label?

Authors


  • Conflict of interest: Marc Gewillig is proctor for Numed, Medtronic, and Edwards. The other authors have no conflict of interest.

Correspondence to: Marc Gewillig, E-mail: marc.gewillig@uzleuven.be MD, PhD Pediatric and Congenital Cardiology, UZ Leuven, Herestraat 49, 3000 Leuven, Belgium. E-mail: marc.gewillig@uzleuven.be

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. © 2013 Wiley Periodicals, Inc.

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