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Congenital heart disease (CHD) affects roughly 9% of babies. Around 20% of babies with congenital heart disease (CHD) have pulmonary valve or right ventricular outflow tract (RVOT) anomalies, such as tetralogy of Fallot, a single common arterial trunk, or pulmonary atresia. Surgical correction within the first month of life enhances the prognosis of this patient group. Transannular patch expansion, bioprosthetic valve implantation, and valved conduits are all surgical techniques for RVOT reconstruction. The acceptability of surgical intervention of the RVOT for complicated CHD varies with age and is tissue-dependent.
Multiple complications, however, including pulmonary regurgitation, self-growth, external ductal stenosis, valvular stenosis, ductal distortion, sternal compression, intimal hyperplasia, external ductal calcification, and aneurysm deformation, result in progressive RVOT dysfunction in these patients. As a result, they require recurring surgical operations throughout their lives. Despite the low death rate associated with surgical operations, complications are substantially more prevalent, particularly in patients undergoing several procedures. Transcatheter pulmonary valve replacement (TPVR) has appeared as a non-surgical, less invasive alternative treatment for RVOT failure. The goals of transcatheter pulmonary valve replacement are to replace the pulmonary valve without surgery and to minimise the number of cardiac procedures required over a patient's lifetime.
Bonhoeffer et al. performed the first transcatheter pulmonary valve replacement (TPVR) in 2000, and it is currently an approved treatment for severe pulmonary regurgitation/stenosis and RV-PA conduit failure. The three balloon-expandable valves utilised for malfunctioning RV-PA conduits are the Medtronic Melody valve, Edwards SAPIEN valve, and Meril Myval.
Medtronic, a world leader in the medical device business, has developed various transcatheter valve therapies. Medtronic has strategically positioned itself to dominate the transcatheter pulmonary valve (TPV) industry, however, its US revenues in the domain have remained stagnant, possibly because pulmonary regurgitation (PR) is frequently asymptomatic. In the past, PR has been addressed symptomatically, with valve repair or replacement seen as a last resort only.
SAPIEN 3, the latest generation of balloon-expandable transcatheter heart valves, is designed to overcome certain limitations of previous generation transcatheter heart valves. Recent trials involving SAPIEN 3 indicate very low rates of vascular complications and paravalvular regurgitation, and lower rates of stroke and mortality as compared to surgical aortic valve replacement (SAVR) in patients with moderate to high surgical risk.
Clearly, firms are striving to offer increasingly sophisticated and efficient TPVs through advancements in technology.
In 2021, doctors from The Department of Cardiology, PGIMER, performed a successful TPVR for the first time in North India. However, TPVR remains a costly alternative and in countries like India, many people might be unable to afford the treatment.
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