Patent hemostasis as standard of care: pro

1. Patent Hemostasis is the
Standard of Care
Sunil V. Rao
The Duke Clinical Research Institute
Duke University Medical Center
The Durham VA Medical Center

2. Disclosures
■ Consultant
● Terumo Medical, The Medicines Company
■ Research funding
● Bellerophon
■ Off-label uses may be discussed

3. Radial Hemostasis
Why not?
■ Fundamental law of cardiovascular medicine: AN
OPEN ARTERY IS BETTER THAN A CLOSED
ONE
■ Why would we adopt a strategy into clinical
practice?
● It is efficacious
● It is effective (not cumbersome to implement)
● It is safe
● It doesn’t cost too much
■ Does patent hemostasis fit this paradigm?

4. Radial Artery Occlusion – who cares?
■ “I don’t care about radial artery occlusion”
■ “Radial artery occlusion is asymptomatic so
who cares?”
■ “Trying to preserve the radial artery is too
complicated.”

5. Why not do patent hemostasis?
■ “I don’t care about radial artery occlusion”
● I can guarantee that your patients do. If you are not
doing patent hemostasis, do you explain the risk of
RAO during the consent process?
■ “Radial artery occlusion is asymptomatic so
who cares?”
● Not all RAO is asymptomatic. Your patient will care
the next time they need a cath and they ask why you
are accessing their femoral artery.
■ “Trying to preserve the radial artery is too
complicated.”
● If patent hemostasis is too complicated, then maybe
you shouldn’t be doing radial procedures.

6. Goals of hemostasis
■ Minimize access site bleeding
■ Minimize forearm hematomas
■ Minimize long-term consequences of radial artery
access
Yonetsu T, et. al. EHJ 2010

7. Patent hemostasis is efficacious at preventing
radial artery occlusion
Diagnostic catheterization
N=480
Patent
hold
Conventional
hold
Hemoband
24 –hour and 30-day
Radial artery patency
Assessed with Reverse
Barbeau test
Pancholy S, et. al. CCI 2008

8. Titration to pressure below MAP – The RACOMAP Study
(N=351)
■ Randomized to MAP guided
pressure vs. 15 cc of air
■ TR-Band left on for 3 hours in
both groups
■ Significant differences in
amount of air (8.8 cc vs. 15
cc, p=0.0001)
■ Enrollment stopped after 50%
of planned sample size
■ Radial occlusion significantly
lower with MAP-guided
compression
● 1.1% vs. 12%, p=0.0001
■ No major bleeds, no
differences in minor bleeds or
re-bleeds

9. Patent hemostasis is effective and safe
■ Applying patent hemostasis takes 10-20 seconds
■ No increase in bleeding in either of the randomized
trials
● PROPHET Trial – no patients developed a
bleeding complication
● RACOMAP – No major bleeding
No difference in minor bleeding compared with
conventional hemostasis

10. Patent hemostasis does not require additional
resources
■ Original trial (PROPHET) was done using the
Hemoband
■ The additional nursing care is not onerous
● Original protocol was to achieve patent
hemostasis in the cath lab
● Leave the hemostasis device in place for 2
hours then remove
● EASY!

11. Radial hemostasis - Summary
■ Radial hemostasis is easy – one reason to adopt
radial
■ Preserving the radial artery has no down side
■ Patent hemostasis is a best practice
■ Patent hemostasis is efficacious, effective, safe,
and requires few resources
■ Why not patent hemostasis?