First-in-man implantation of a novel percutaneous valve: a new approach to medical device development.
OBJECTIVE
To present our experience of 'first-in-man' implantation of a new percutaneous pulmonary valve into a dilated pulmonary trunk, using patient specific data to influence the design of the device and ensure patient safety.


RESULTS
A 42-year-old with severe pulmonary insufficiency underwent computed tomography assessment of his pulmonary trunk. This information was utilised to create computer and rapid prototyping models that were used to customise and test the device, which was subsequently implanted into the patient. Following the procedure, the clinical, haemodynamic and morphological success of this approach was determined. The new device was safely and successfully implanted as predicted by the pre-procedural modelling. There was excellent device stability, no stent fractures, no pulmonary incompetence and only trivial para-device leak at six months follow-up. The patient described marked symptomatic improvement.


CONCLUSIONS
Safe, effective percutaneous pulmonary valve implantation is possible in a patient with a dilated, native pulmonary trunk. Our methodologies, which have evolved as a direct result of recent advances in four-dimensional imaging techniques, challenge the conventional stepwise pathway of bench and animal testing prior to human application, and may be safer and more relevant, potentially reducing the number of animal experiments necessary for testing new medical devices.
Schievano
Silvia
S
Cardiovascular Unit, UCL Institute of Child Health, London, United Kingdom.
Taylor
Andrew M
AM
Capelli
Claudio
C
Coats
Louise
L
Walker
Fiona
F
Lurz
Philipp
P
Nordmeyer
Johannes
J
Wright
Sue
S
Khambadkone
Sachin
S
Tsang
Victor
V
Carminati
Mario
M
Bonhoeffer
Philipp
P
D000328:Adult; D006328:Cardiac Catheterization / Q000379:methods*; D004867:Equipment Design; D005500:Follow-Up Studies; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation*; D006801:Humans; D008297:Male; D011665:Pulmonary Valve Insufficiency / Q000151:congenital / Q000000981:diagnostic imaging / Q000601:surgery*; D011856:Radiographic Image Enhancement; D014057:Tomography, X-Ray Computed