Hybrid approach for harmony transcatheter pulmonary valve replacement

Abstract

The Harmony™ Transcatheter Pulmonary Valve (Medtronic) was recently approved by the Food and Drug Administration for transcatheter pulmonary valve replacement in native right ventricular outflow tracts. Despite this milestone, some patients have main pulmonary arteries that are severely dilated and continue to require surgical pulmonary valve replacement. The hybrid approach combines surgical creation of a landing zone, transcatheter valve deployment, and suture stabilization of the implanted valve. In this case series, we report the first use of a hybrid approach for Harmony™ transcatheter pulmonary valve replacement. Two cases are reported with varying approaches for surgical creation of a landing zone followed by successful placement of a Harmony™ valve.

Keywords: congenital heart disease; pediatrics; percutaneous intervention; pulmonary valve disease (PVD); transcatheter valve implantation (TVI).

Figure 1

(A) Patient 1 Harmony valve fit analysis for the TPV 25. Note that there is inadequate interference superiorly as represented by the red shading, despite having adequate interference inferiorly as represented by the green shading. However, simultaneous adequate interference is required for a secure frame fit. (B) Patient 2 Harmony valve fit analysis for the TPV 25. Note that there is minimal interference superiorly or inferiorly. CT reconstructed images are seen alongside fit analysis for better visualization of the anatomy. Red arrows indicate level of the valve annulus. [Color figure can be viewed at wileyonlinelibrary.com]

Figure 2

(A) Lateral projection at baseline for patient 1 showing dilated main pulmonary artery (B) plication created a choke point measuring 25 mm. (C) Intracardiac echocardiography showing a well‐seated TPV 25. White arrowhead identifies the radiopaque marker placed on the patient's skin. [Color figure can be viewed at wileyonlinelibrary.com]

Figure 3

(A) Artist's rendering, anterior and cranial projection, of the Harmony TPV 25 implanted in the main pulmonary artery after plication to create a landing zone (horizontal black arrow) and placement of stabilizing sutures through the first and last rows of the Harmony valve superiorly (down facing black arrowhead) and inferiorly (up facing black arrowhead). (B) 3D print with Harmony TPV 25 in place demonstrating the placement of a stabilizing suture superiorly. (C) 3D print with suture in place. [Color figure can be viewed at wileyonlinelibrary.com]

Figure 4

(A) Intraoperative fluoroscopy, anterior and cranial projection, demonstrating a 30 mm PTS‐X balloon inflated in the main pulmonary artery (MPA) with a waist (white arrow) noted in the area of surgical plication. (B) Following deployment of the Harmony valve, the white arrow denotes two radio‐opaque clips that identify the region of surgical plication. (C) Transesophageal echocardiography, mid‐esophageal view, demonstrating the Harmony™ valve well seated in the right ventricular outflow tract/MPA. The white arrowheads point to the superior and inferior stent struts into which stabilizing sutures were placed, the white arrow denotes the central waist where the plication of the MPA was performed. RV, right ventricle. [Color figure can be viewed at wileyonlinelibrary.com]