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Initial assessment of a novel delivery system (NuDEL™ ®) for the covered Cheatham-Platinum stent

Published online by Cambridge University Press:  15 June 2017

Gareth J. Morgan ,
Damien Kenny ,
Christopher Duke ,
Kevin P. Walsh  and
Shakeel A. Qureshi
Gareth J. Morgan*
Affiliation:
Departments of Paediatric and Adult Congenital Cardiology, Evelina London Children’s Hospital, Guy’s and St Thomas’ NHS Foundation Trust, King’s College London, London, United Kingdom
Damien Kenny
Affiliation:
Department of Paediatric Cardiology, Our Lady’s Hospital for Sick Children, Crumlin, Dublin, Ireland
Christopher Duke
Affiliation:
East Midlands Congenital Heart Centre, Glenfield Hospital, Leicester, United Kingdom
Kevin P. Walsh
Affiliation:
Department of Paediatric Cardiology, Our Lady’s Hospital for Sick Children, Crumlin, Dublin, Ireland
Shakeel A. Qureshi
Affiliation:
Departments of Paediatric and Adult Congenital Cardiology, Evelina London Children’s Hospital, Guy’s and St Thomas’ NHS Foundation Trust, King’s College London, London, United Kingdom
*
Correspondence to: Dr G. J. Morgan, Department of Congenital Cardiology, Children’s Hospital of Colorado, University of Colorado, Denver, CO 80045, United States of America. Tel: +1 720 777 3379; Fax: +1 720 777 7177; E-mail: [email protected]
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Abstract

Aims

We sought to evaluate the first-in-man use of a new system for implantation of covered stents in patients with complex structural and CHD.

Methods and results

Retrospective data were collected of the first 13 NuDEL™ delivery systems used in patients. The NuDEL™ comprises a covered Cheatham-Platinum stent mounted on a balloon-in-balloon and pre-loaded in a long delivery sheath. Data were collected from three centres in the United Kingdom and Ireland. A total of 13 covered stents were delivered via 12 NuDEL™ delivery systems in 12 patients. Among them, six patients had coarctation of the aorta, five patients had right ventricular outflow tract stenosis, and one patient had severe stenosis of a Mustard systemic venous baffle. There were no complications, and all the stents were deployed in the desired position with satisfactory haemodynamic results.

Conclusions

The development of a bespoke system of a pre-mounted, pre-loaded covered stent may negate some of the technical challenges that complicate large-calibre stent deployment. Our preliminary results suggest that the NuDEL™ system is a safe and effective means of covered stent deployment in challenging anatomy.

Keywords

Covered stentcoarctationright ventricular outflow tract stentpercutaneous pulmonary valve
Type
Original Articles
Information
Cardiology in the Young , Volume 27 , Issue 8 , October 2017 , pp. 1465 - 1469
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Copyright
© Cambridge University Press 2017 

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