Download Rembert Pogge von Strandmann PhD

DCB - V
Drug Eluting Valvuloplasty Balloon
Catheter
Rembert Pogge von Strandmann PhD
Royalty income for this project
from Eurocor GmbH Germany
Valvuloplasty with a PaclitaxelCoated Balloon („DCB-V“) Prevents
Restenosis in an Experimental
Animal Model of Aortic Stenosis
Konstantinos Spargias1*, Mariann Gyöngyösi2*, Dominik Kieselbach3,
Rembert Pogge von Strandmann3+
1 Department of Transcatheter Heart Valves, Hygeia Hospital, Athens, Greece, 2 Department of
Cardiology, Medical University of Vienna, Austria, 5 Eurocor GmbH, Bonn, Germany
*Contributed equally, +Presenting author
Background
• Restenosis rates after balloon valvuloplasty
(BAV) in calcific aortic valve disease (CAVD) is
up to 83% after six months, and almost 100%
within one year after the procedure.
Aim of the Study
• Investigation of the potential role of a
paclitaxel-eluting valvuloplasty balloon to
mitigate the progression of restenosis in an
animal model of CAVD.
Investigational Device – „DCB-V“
• Paclitaxel balloon surface: 3 µg/mm²
• Coating is a 1:1 mixture of paclitaxel and shellac
• Shellac swells in blood and releases paclitaxel under
pressure
• The coating is CE marked
• Shellac is in accordance with the FDA “Inactive
Ingredients Guide“
• DCB-V 8 mm in diameter, 20 mm in length
Study Flow Chart
• A special diet has been
used to induce a
significant decrease in
AVA and to increase
the transvalvular
pressure gradients
• Animals were
randomized 1:1 to
DCB-V vs. POBA
treatment
• Follow-up 1 month
after procedure
Results I
Results II
• Baseline and post-BAV AS severity, as assessed by several
echocardiographic indices, were similar between the groups.
However, at one month after BAV the AVA was significantly
larger, but the SWL loss and aortic valve resistance were
significantly lower, in the paclitaxel-BAV group.
• At follow up, indices of left ventricular systolic performance,
such as fractional shortening and SWL were improved in the
paclitaxel-balloon compared to the plain-balloon group.
Results III
• At one month after BAV, the
reduction in AVA resulted in a
significant increase in the mean
invasive pressure gradient in the
plain-balloon group and a nonsignificant increase in the
paclitaxel-balloon group
• This led to a trend for a lower
mean gradient at follow up in
the DCB-V group
Results IV
• Histology demonstrated a marked decrease in collagen
trichrome staining and cell proliferation in the aortic valve
leaflets in the paclitaxel-balloon group compared to the
plain-balloon group.
Results V
• The paclitaxel-treated balloon substantially decreased the
calcification response as compared to the uncoated balloon.
• This led to a significantly smaller leaflet thickness in the paclitaxelballoon group compared to the plain-balloon group.
• A significant reduction in the mean PCNA stain grade in the
paclitaxel-balloon group was observed.
First publications
• Paclitaxel-eluting balloon in experimental disease K.
Spargias et al. J Heart Valve Dis
Vol. 23. No. 3 May 2014
• Testing Drug Eluting Paclitaxel Balloon Valvuloplasty in
an Experimental Model of Aortic Stenosis; Page 41ff in:
Molecular Biology of Valvular Heart Disease ISBN 9781-4471-6349-7 ISBN 978-1-4471-6350-3 (eBook)
DOI 10.1007/978-1-4471-6350-3
Springer London Heidelberg New York Dordrecht
Edited by Nalini M. Rajamannan
Patents Valvuloplasty
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Europe
Brazil
India
Russia
USA
EP 08737275.1
20090106822
n/a
2 459 634
8/187,233
pending
pending
pending
GRANTED
GRANTED
Conclusion
• Restenosis was less evident in valves dilated with the paclitaxel-eluting
balloon.
• There were also reductions in ECM synthesis, cell proliferation and
calcification in the paclitaxel-balloon treated leaflets
– (i) a decreased leaflet thickness
– (ii) a larger AVA
– (iii) a diminished SWL
– (iv) a decreased aortic valve resistance.
• Together, these observations suggest that local paclitaxel delivery
attenuated the myofibroblast osteogenic differentiation that drives the
restenosis process and is typically seen following BAV with a plain balloon.