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Review
. 2023 Nov;51(11):2384-2392.
doi: 10.1007/s10439-023-03328-5. Epub 2023 Aug 5.

Unmet Clinical Needs for Transcatheter Pulmonary Valves

Nnaoma Agwu  1 , Michael R Recto  2 , Arash Kheradvar  3
Affiliations
Review

Unmet Clinical Needs for Transcatheter Pulmonary Valves

Nnaoma Agwu et al. Ann Biomed Eng. 2023 Nov.

Abstract

A common feature of congenital heart disease is the presence of right ventricular outflow tract (RVOT) obstruction that can range from mild to severe and can lead to atresia of the pulmonary valve, in extreme conditions. RVOT abnormalities can frequently be corrected surgically or via interventional means. However, most of these patients will ultimately develop pulmonary valve insufficiency and eventual right ventricular dilation, which will require a pulmonary valve replacement at some point in their life to mitigate the detrimental effects of pulmonary valve regurgitation (PVR) on the right ventricle (RV). The evolution from the studies done by Philip Bonhoeffer to implant a pulmonary valve via transcatheter means, have provided a bedrock for transcatheter pulmonary valve replacement (TPVR). Yet, several areas of unmet need for a demographic of patients still exist. Here, we discuss the clinical unmet needs in children under 20 Kg and expand the use of hybrid and other TPVR approaches along with the current indications and contraindications for pulmonary valve replacement. The constraints and limitations from commercially available pulmonary valves will be discussed from a clinical standpoint. Finally, we explore the use of hybrid and periventricular delivery of transcatheter pulmonary valves in younger patients.

Keywords: Harmony valve; Melody valve; RVOT; SAPIEN valve; TPVR.

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Figures

Fig. 1
Fig. 1
Echocardiographic image of RVOT showing the ideal minimum diameter for TPVR before bifurcation. This view is the parasternal short view
Fig. 2
Fig. 2
The Melody valve. The valve is hand crimped over the Ensemble II delivery system and can be viewed under fluoroscopy given its radiopaque markers
Fig. 3
Fig. 3
The SAPIEN XT. This valve has a low frame height to minimize damage and interference with the conduction system. It is mounted on the Novaflex system with radiopaque markers for determining valve positioning. Provided by Edwards Lifesciences
Fig. 4
Fig. 4
The SAPIEN-3 valve (S3) before mounting on the Commander™ delivery system. The valve includes three radiopaque markers indicating the middle of balloon deployment. Its integrated Flex Catheter has improved operator’s navigation given the increased flexibility of the catheter. Provided by Edwards Lifesciences
Fig. 5
Fig. 5
Harmony Valve in 25 mm (A, B) and 22 mm (C), each with flared inflow and outflow ends. The large, flared inflow and outflow ends allow for a range of pulmonary artery sizes
See this image and copyright information in PMC

References

    1. Abdelghani M, Nassif M, Blom NA, Van Mourik MS, Straver B, Koolbergen DR, Kluin J, Tijssen JG, Mulder BJM, Bouma BJ, and de Winter RJ. Infective endocarditis after melody valve implantation in the pulmonary position: a systematic review. J. Am. Heart Assoc.7:e008163, 2018. - PMC - PubMed
    1. Alkashkari W, Albugami S, Abbadi M, Niyazi A, Alsubei A, and Hijazi ZM. Transcatheter pulmonary valve replacement in pediatric patients. Expert Rev. Med. Devices. 17:541–554, 2020. - PubMed
    1. Armstrong AK, Berger F, Jones TK, Moore JW, Benson LN, Cheatham JP, Turner DR, Rhodes JF, Vincent JA, Zellers T, Lung T-H, Eicken A, and McElhinney DB. Association between patient age at implant and outcomes after transcatheter pulmonary valve replacement in the multicenter Melody valve trials. Catheter. Cardiovasc. Interv. 94(4):607–617, 2019. - PubMed
    1. Bartra S Transcatheter pulmonary valve replacement in patients with congenital heart disease. Critical Care Nurse. 38:30–36, 2018. - PubMed
    1. Benson LN, Gillespie MJ, Bergersen L, Cheatham SL, Hor KN, Horlick EM, Weng S, McHenry BT, Osten MD, Powell AJ, and Cheatham JP. Three-year outcomes from the harmony native outflow tract early feasibility study. Circulation. 13:e008320, 2020. - PubMed

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