Acute evaluation of the Mynx vascular closure device during arterial re-puncture in an ovine model.
BACKGROUND
The Mynx vascular closure device (VCD) (AccessClosure, Inc., Mountain View, California) is used for extravascular closure of the common femoral artery (CFA) after diagnostic or interventional endovascular procedures. Although it is common clinical practice to re-puncture a CFA, for some VCDs, acute repuncture is discouraged, while for other VCDs the safety of direct re-puncture through a previously placed VCD is still in question. The objective of this preclinical study was to evaluate the acute performance of the Mynx device where direct re-puncture has occurred through the hydrogel sealant, followed by delivery of a second Mynx device to close the reaccess puncture site.


METHODS
Two ovine models with a total of 24 punctures (12 sets of puncture and re-puncture) were used for this study. Success was measured utilizing angiographic and observational endpoints.


RESULTS
There was no evidence of hydrogel sealant prolapse into the artery, distal embolization of sealant following repuncture, groin site bleeding or hematoma. Successful hemostasis was achieved in all punctures (mean activated clotting time = 357 secs) with the exception of a minor (non-clinically significant) contrast extravasation in the tissue tract, which resolved with 2 minutes of adjunctive compression.


CONCLUSIONS
Arterial re-puncture in an ovine model directly through a recently placed Mynx closure device and subsequent re-closure with a second Mynx device can be successfully accomplished.
Garasic
Joseph M
JM
Division of Cardiology, Massachusetts General Hospital, 55 Fruit Street, GRB-8, Boston, MA 02114, USA. jgarasic@partners.org
Marin
Linda
L
Anderson
R David
RD
D000818:Animals; D004617:Embolism / Q000517:prevention & control; D004864:Equipment and Supplies / Q000009:adverse effects; D005263:Femoral Artery / Q000601:surgery*; D006406:Hematoma / Q000517:prevention & control; D006470:Hemorrhage / Q000517:prevention & control; D006488:Hemostasis, Surgical / Q000295:instrumentation* / Q000379:methods; D020136:Hydrogel, Polyethylene Glycol Dimethacrylate / Q000009:adverse effects; D008297:Male; D023421:Models, Animal; D012756:Sheep; D014656:Vascular Surgical Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods
D020136:Hydrogel, Polyethylene Glycol Dimethacrylate