PMC10099905_01
(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]
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Harmony  valve (Figure 1B). His severely depressed LVEF made him a high-risk candidate for cardiopulmonary bypass in our opinion.
(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]
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Initial angiography showed a severely dilated MPA measuring up to 5 cm (Figure 2A). Angiography performed after the plication confirmed adequacy of MPA size, with the MPA now measuring 25 mm (Figure 2B).
PMC10099905_02
(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]
CCD-101-135-g002.jpg
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Harmony  valve (Figure 1B). His severely depressed LVEF made him a high-risk candidate for cardiopulmonary bypass in our opinion.
(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]
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As such, after extensive discussion with the surgical team and 3D printing of the anatomy (Figure 3), a decision was made to attempt a hybrid approach.
(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]
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Balloon sizing was performed with a 30 mm PTSX balloon to assess the adequacy of the plication, which ultimately had a waist measuring 27 mm on the balloon by fluoroscopy (Figure 4).