Abstract
Percutaneous pulmonary valve implantation (PPVI) is an innovative, successful alternative to open-heart surgery for the treatment of pulmonary valve dysfunction. However, the current device used in PPVI presents some limitations: stent fractures and availability to a limited group of patients with very specific anatomy. These shortcomings have created the need for a new device that can significantly broaden the number of patients that might benefit from this minimally invasive procedure. In this chapter, we show how engineering methodologies, such as patient-specific 3D imaging elaboration and finite element modeling, were adopted to study the current PPVI device limitations and a new design for the next generation device. These techniques were successfully implemented in the first-in-man application of this new device. The presented combined strategy has the potential to aid and accelerate the design of future percutaneous heart valve devices, and also to contribute to shorter learning curves for patient selection and lower numbers of procedural and device failures, thus enhancing patient safety.
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Abbreviations
- Bib:
-
Balloon-in-balloon
- CT:
-
Computed tomography
- ECG:
-
Electrocardiogram
- FDA:
-
Food and Drug Administration
- FE:
-
Finite element
- HDE:
-
Humanitarian Device Exemption
- MHRA:
-
Medicines and Healthcare Products Regulatory Agency
- MR:
-
Magnetic resonance
- PPVI:
-
Percutaneous pulmonary valve implantation
- PVR:
-
Pulmonary valve replacement
- RVOT:
-
Right ventricular outflow tract
- SG1:
-
First stent-graft
- SG2:
-
Second stent-graft
- SG3:
-
Third stent-graft
References
Marelli AJ, Mackie AS, Ionescu-Ittu R et al (2007) Congenital heart disease in the general population: changing prevalence and age distribution. Circulation 115:163–172
Tweddell JS, Pelech AN, Frommelt PC et al (2000) Factors affecting longevity of homograft valves used in right ventricular outflow tract reconstruction for congenital heart disease. Circulation 102:III130–III135
Powell AJ, Lock JE, Keane JF et al (1995) Prolongation of RV-PA conduit life span by percutaneous stent implantation. Intermediate-term results. Circulation 92:3282–3288
Oosterhof T, Meijboom FJ, Vliegen HW et al (2006) Long-term follow-up of homograft function after pulmonary valve replacement in patients with tetralogy of Fallot. Eur Heart J 27:1478–1484
Gatzoulis MA, Balaji S, Webber SA et al (2000) Risk factors for arrhythmia and sudden cardiac death late after repair of tetralogy of Fallot: a multicentre study. Lancet 356:975–981
Bonhoeffer P, Boudjemline Y, Saliba Z et al (2000) Percutaneous replacement of pulmonary valve in a right-ventricle to pulmonary-artery prosthetic conduit with valve dysfunction. Lancet 356:1403–1405
Lurz P, Coats L, Khambadkone S et al (2008) Percutaneous pulmonary valve implantation—impact of evolving technology and learning curve on clinical outcome. Circulation 117:1964–1972
Cheatham JP (2001) Stenting of coarctation of the aorta. Catheter Cardiovasc Interv 54:112–125
Coats L, Tsang V, Khambadkone S et al (2005) The potential impact of percutaneous pulmonary valve stent implantation on right ventricular outflow tract re-intervention. Eur J Cardiothorac Surg 27:536–543
Coats L, Khambadkone S, Derrick G et al (2006) Physiological and clinical consequences of relief of right ventricular outflow tract obstruction late after repair of congenital heart defects. Circulation 113:2037–2044
McElhinney DB, Hellenbrand WE, Zahn EM et al (2010) Short- and medium-term outcomes after transcatheter pulmonary valve placement in the expanded multicenter US Melody valve trial. Circulation 122:507–516
Nordmeyer J, Khambadkone S, Coats L et al (2007) Risk stratification, systematic classification, and anticipatory management strategies for stent fracture after percutaneous pulmonary valve implantation. Circulation 115:1392–1397
Nordmeyer J, Coats L, Lurz P et al (2008) Percutaneous pulmonary valve-in-valve implantation: a successful treatment concept for early device failure. Eur Heart J 29:810–815
Schievano S, Coats L, Migliavacca F et al (2007) Variations in right ventricular outflow tract morphology following repair of congenital heart disease—implications for percutaneous pulmonary valve implantation. J Cardiovasc Magn Reson 9:687–695
Schievano S, Petrini L, Migliavacca F et al (2007) Finite element analysis of stent deployment: understanding stent fracture in percutaneous pulmonary valve implantation. J Interv Cardiol 20:546–554
Schievano S, Taylor AM, Capelli C et al (2009) Patient specific finite element analysis results in more accurate prediction of stent fractures: application to percutaneous pulmonary valve implantation. J Biomech 43:687–693
Schievano S, Migliavacca F, Coats L et al (2007) Percutaneous pulmonary valve implantation based on rapid prototyping of right ventricular outflow tract and pulmonary trunk from MR data. Radiology 242:490–497
Marrey RV, Burgermeister R, Grishaber RB et al (2006) Fatigue and life prediction for cobalt-chromium stents: a fracture mechanics analysis. Biomaterials 27:1988–2000
Beden SM, Abdullah S, Ariffin AK et al (2009) Fatigue life assessment of different steel-based shell materials under variable amplitude loading. Eur J Sci Res 29:157–169
Nordmeyer J, Lurz P, Khambadkone S et al (2011) Pre-stenting with a bare metal stent before percutaneous pulmonary valve implantation: acute and 1-year outcomes. Heart 97:118–123
Bonhoeffer P, Huynh R, House M et al (2008) Transcatheter pulmonic valve replacement in sheep using a grafted self expanding stent with tissue valve. Circulation 118:S812
Schievano S, Taylor AM, Capelli C et al (2010) First-in-man implantation of a novel percutaneous valve: a new approach to medical device development. EuroIntervention 5:745–750
Schievano S, Capelli C, Young C et al (2011) Four-dimensional computed tomography: a method of assessing right ventricular outflow tract and pulmonary artery deformations throughout the cardiac cycle. Eur Radiol 21:36–45
Capelli C, Taylor AM, Migliavacca F et al (2010) Patient-specific reconstructed anatomies and computer simulations are fundamental for selecting medical device treatment: application to a new percutaneous pulmonary valve. Philos Transact A Math Phys Eng Sci 368:3027–3038
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Schievano, S., Taylor, A.M., Bonhoeffer, P. (2013). Percutaneous Pulmonary Valve Implantation: The First Transcatheter Valve. In: Iaizzo, P., Bianco, R., Hill, A., St. Louis, J. (eds) Heart Valves. Springer, Boston, MA. https://doi.org/10.1007/978-1-4614-6144-9_9
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DOI: https://doi.org/10.1007/978-1-4614-6144-9_9
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