Radial hemostasis: results of the STATSEAL feasibility study - Muhammad Ayyaz Ul Haq

1. INTERIM RESULTS OF
STATSEAL™ FEASIBILITY
STUDY.
KEELE CARDIOVASCULAR RESEARCH GROUP UK
Muhammad Ayyaz Ul Haq, Sheraz A Nazir, Muhammad Rashid, Chun Shing Kwok,
Zaheer Alisiddiq, Ahmed Shoaib, Desiree Suarez, Alison Hardwick, Karim Ratib,
Mamas A Mamas, James Nolan

2. DISCLOSURES
❖ None

3. ❖ 2 mechanisms of action
❖ Hydrophilic polymer – dehydrates blood
❖ Potassium ferrate – agglomerates blood solids to create seal
❖ Beneath the seal the blood clots naturally

4. TRANSRADIAL STATSEAL USE
❖ Helen Condry 2016
 23 pts in each arm / Terumo Band
❖ Time to haemostasis 205 +/-52 versus 77 +/- 20 mins
❖ Matheen A. Khuddus – Cathlab Digest 2017
 Observational study / TR Band, haemostsis 1hr, no increase bleeding/haematoma, less RAO
❖ N. De Korompay JVIR 2017
❖ 323 pts – Interventional Radiology / Safeguard Band
❖ 0.92% haematoma
❖ 0.3% RAO

5. CURRENT STUDY
❖ A single centre, randomized control study
❖ All local patients attending for angiography and/or PCI
❖ Control
❖ Usual haemostasis - Compression time 1 hour for every 2500iu of
Heparin
❖ Helix compression
❖ Study group
❖ Added haemostasis - Statseal
❖ Rapid deflation technique (RDT)
❖ Statseal application using Nolan protocol
❖ Compression time 1 hour independent of Heparin dose

6. OUTCOMES
❖ Primary end point
❖ Time to achieve haemostasis
❖ Secondary out come
❖ Bleeding
❖ Haematoma
❖ Radial artery patency (Barbeaus Test within 24 hours)
Preliminary results – first 121 patients

7. PATIENT AND PROCEDURE CHARACTERISTICS

8. 172.9
68.2
0.
45.
90.
135.
180.
225.
No Statseal Statseal
P<0.001
Minutes TIME TO HAEMOSTASIS

9. BLEEDING
P=0.32
4.9
1.7
0
1
2
3
4
5
6
No Statseal Statseal
%

10. HAEMATOMA
P=0.33
6.6
11.7
0
2
4
6
8
10
12
14
No Statseal Statseal
%

11. RADIAL ARTERY OCCLUSION
P=0.32
4.9
1.7
0
1
2
3
4
5
6
No Statseal Statseal
%

12. CONCLUSION
❖ Use of Statseal with rapid deflation technique feasible
❖ Reduces compression time
❖ No significant additional bleeding or RAO
❖ Improved nursing staff satisfaction
❖ Rapid turn over
❖ Cost effective
❖ Study ongoing – 500 patients