Evidence from clinical trials on high-risk medical devices in children: a scoping review

K Guerlich, B Patro-Golab, P Dworakowski… - Pediatric …, 2024 - nature.com
Background Meeting increased regulatory requirements for clinical evaluation of medical
devices marketed in Europe in accordance with the Medical Device Regulation (EU …

Pulmonary valve stenosis: From diagnosis to current management techniques and future prospects

F Marchini, S Meossi, G Passarini… - Vascular Health and …, 2023 - Taylor & Francis
Pulmonary stenosis (PS) is mainly a congenital defect that accounts for 7–12% of congenital
heart diseases (CHD). It can be isolated or, more frequently, associated with other …

Transcatheter pulmonary valve replacement with the sapien prosthesis

S Shahanavaz, EM Zahn, DS Levi… - Journal of the American …, 2020 - jacc.org
Background There are limited published data focused on outcomes of transcatheter
pulmonary valve replacement (TPVR) with either a Sapien XT or Sapien 3 (S3) valve …

Multicenter study of endocarditis after transcatheter pulmonary valve replacement

DB McElhinney, Y Zhang, JA Aboulhosn… - Journal of the American …, 2021 - jacc.org
Background Endocarditis has emerged as one of the most impactful adverse events after
transcatheter pulmonary valve replacement (TPVR), but there is limited information about …

[HTML][HTML] Pulmonary valve replacement for tetralogy of Fallot

D Balzer - Methodist DeBakey cardiovascular journal, 2019 - ncbi.nlm.nih.gov
Right ventricular outflow tract (RVOT) dysfunction is common following surgical repair of
tetralogy of Fallot and other forms of complex congenital heart disease. This results in …

Pre-and postprocedure imaging of transcatheter pulmonary valve implantation

A Canan, D Ocazionez-Trujillo, D Vargas, TA Foley… - Radiographics, 2022 - pubs.rsna.org
Transcatheter pulmonary valve replacement (TPVR) is a minimally invasive procedure for
treatment of right ventricular outflow tract (RVOT) dysfunction in surgically repaired …

Outcomes of transcatheter pulmonary SAPIEN 3 valve implantation: an international registry

S Hascoët, JR Bentham, L Giugno… - European Heart …, 2024 - academic.oup.com
Abstract Background and Aims Transcatheter pulmonary valve implantation (TPVI) is
indicated to treat right-ventricular outflow tract (RVOT) dysfunction related to congenital heart …

Nationwide registry‐based analysis of infective endocarditis risk after pulmonary valve replacement

C Stammnitz, D Huscher, UMM Bauer… - Journal of the …, 2022 - Am Heart Assoc
Background Infective endocarditis (IE) after pulmonary valve replacements in congenital
heart disease is a significant concern. This study aimed to identify specific long‐term risk …

Long-term outcomes of transcatheter pulmonary valve implantation with melody and SAPIEN valves

A Houeijeh, C Batteux, C Karsenty, N Ramdane… - International Journal of …, 2023 - Elsevier
Background Transcatheter pulmonary valve implantation (TPVI) is effective for treating right
ventricle outflow tract (RVOT) dysfunction. Factors associated with long-term valve durability …

[HTML][HTML] Technical recommendations for computed tomography guidance of intervention in the right ventricular outflow tract: native RVOT, conduits and bioprosthetic …

BK Han, S Garcia, J Aboulhosn, P Blanke… - Journal of the Society for …, 2023 - Elsevier
This consensus document for the performance of cardiovascular computed tomography
(CCT) to guide intervention in the right ventricular outflow tract (RVOT) in patients with …