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Patent Hemostasis is the 
Standard of Care 
Sunil V. Rao 
The Duke Clinical Research Institute 
Duke University Medical Center 
The Durham VA Medical Center
Disclosures 
■ Consultant 
● Terumo Medical, The Medicines Company 
■ Research funding 
● Bellerophon 
■ Off-label uses may be discussed
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?
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.”
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.
Goals of hemostasis 
■ Minimize access site bleeding 
■ Minimize forearm hematomas 
■ Minimize long-term consequences of radial artery 
access 
Yonetsu T, et. al. EHJ 2010
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
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
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
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!
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?

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Rao SV - AIMRADIAL 2014 - Patent hemostasis

  • 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?