Drug-eluting introducer sheath prevents local peripheral complications: pre-clinical evaluation of nitric oxide-coated sheath.
OBJECTIVE
This study evaluated the protective effect of nitric oxide-coating of introducer sheath on the local complications in juvenile porcine femoral arteries with similar size to human radial arteries.


BACKGROUND
Insertion of an introducer sheath induces vasospasm and transient or permanent vessel occlusion of radial arteries.


METHODS
Nitric oxide-coated or control introducer sheaths with or without spasmolytic cocktail (control + C-sheath) were inserted into porcine femoral arteries, followed by percutaneous coronary intervention (PCI). The diameter of the femoral artery at the puncture site, distally and proximally, was measured by quantitative angiography. Histopathological and histomorphometric parameters of the femoral arteries were analyzed 1 h or 1 week after PCI.


RESULTS
Insertion of femoral sheath led to mild or severe spasms, with significantly higher vessel diameter at the access site (2.69 ± 0.81 mm vs. 1.77 ± 0.77 mm and 1.85 ± 0.66 mm, p < 0.001), and proximal and distal to it, during PCI in the nitric oxide-sheath group versus the control-sheath and control + C-sheath groups, respectively. Immediately following PCI, significantly less luminal thrombosis (12% vs. 33% and 31% of all analyzed segments, p < 0.001) was observed in the nitric oxide-sheath arteries. At 1 week, lower intimal inflammation score (0.43 ± 11 vs. 1.03 ± 0.35 and 1.04 ± 0.32, p < 0.05), less luminal thrombosis (8% vs. 21% and 30% p < 0.05), and smaller intimal hyperplasia (0.31 ± 0.31 mm(2) vs. 0.47 ± 1.00 mm(2) and 0.86 ± 0.82 mm(2), p < 0.05) were observed in NO-sheath arteries at the injury site.


CONCLUSIONS
Nitric oxide coating on the introducer sheath prevents local complications during PCI and results in less vascular thrombosis and inflammation at the access site, contributing to patency of the access vessel with similar size to the radial artery.
Department of Cardiology, Medical University of Vienna, Vienna, Austria.
Rayyan
R
Hemetsberger
Aniko
A
Posa
Serdar
S
Farhan
Hani
H
Hemetsberger
Bassam
B
Redwan
Noemi
N
Pavo
Imre J
IJ
Pavo
Christian A
CA
Plass
Ors
O
Petnehazy
Zsolt
Z
Petrasi
Kurt
K
Huber
Dietmar
D
Glogar
Gerald
G
Maurer
Mariann
M
Gyöngyösi
D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D000818:Animals; D001157:Arterial Occlusive Diseases / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D002406:Catheterization, Peripheral / Q000009:adverse effects / Q000295:instrumentation*; D057785:Catheters; D016009:Chi-Square Distribution; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D004867:Equipment Design; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000473:pathology / Q000503:physiopathology; D009569:Nitric Oxide / Q000008:administration & dosage*; D011677:Punctures; D034421:Sus scrofa; D013997:Time Factors; D014654:Vascular Patency / Q000187:drug effects; D014661:Vasoconstriction / Q000187:drug effects*; D014665:Vasodilator Agents / Q000008:administration & dosage*
D020099:Coated Materials, Biocompatible; D014665:Vasodilator Agents; D009569:Nitric Oxide