Pancholy SB - AIMRADIAL 2013 - Pulsera hemostasis

652 views
495 views

Published on

Pulsera first-in-man device

0 Comments
1 Like
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total views
652
On SlideShare
0
From Embeds
0
Number of Embeds
205
Actions
Shares
0
Downloads
0
Comments
0
Likes
1
Embeds 0
No embeds

No notes for slide

Pancholy SB - AIMRADIAL 2013 - Pulsera hemostasis

  1. 1. Pulsera FIM Samir B. Pancholy, MD, FACP, FACC, FSCAI Mauricio G. Cohen, MD, FACC, FSCAI Joseph Korotko, MS
  2. 2. DISCLOSURES  ACCUMED RADIAL  Terumo
  3. 3. Radial Artery Occlusion Rates 12 Pre-Patent hemostasis 10.5 10 9.0 8 % Early 6.9 6 5.3 5.0 4 1.8 2 NR NR 0 Sanmartin Rathore Anticoagulation Courtesy of SV Rao, MD UFH 70-100 u/kg UFH 70 u/kg Plante Pancholy UFH 70 u/kg Or Bivalirudin UFH 50u/kg Late
  4. 4. Radial artery occlusion  2-5% in high quality “radial” labs  Limits ipsilateral radial access  High incidence in patients with flow cessation during hemostasis despite heparin
  5. 5. Radial artery hemostasis Absent radial flow 70 60 50 40 30 20 10 0 At application Sanmartin et al CCI 2007; 70: 185-9 At removal
  6. 6. Patent Hemostasis 14 P < 0.05 12 10 8 % Usual Hold Patent Hold 6 4 2 0 Early RAO Pancholy S et al, CCI 2008;72:335-40 Persistent RAO
  7. 7. Need to monitor radial artery flow  Doppler  Plethysmography
  8. 8. Pulsera™ – Current Design Velcro Strap Retention Band Hinged Comfort Cushion Compression Balloon with Reflective Surface, Inflation Tube and Valve
  9. 9. Application of Pulsera™ Pull sheath 1-2 cm Inflate Pulsera™ Balloon and remove the sheath Deflate balloon until pulsation can be visualized
  10. 10. Pulsera device
  11. 11. Pulsera Study  50 volunteers  Compare Pulsera device to plethysmography
  12. 12. 12 Patient Demographics Variables Age, years, Median [IQR] Male, n (%) BMI, Kg/m2, Median [IQR] Prior PCI, n (%) n=51 68 [76, 57] 29 (58%) 26.3 [33.7, 24.2] 19 (37) • All patients had normal modified Allen’s test 7/29/2013 Accumed Radial, LLC CONFIDENTIAL
  13. 13. 13 Patient Demographics Variables Left Right 126 [110, 136] 130 [118, 140] Diastolic Pressure, mm Hg 70 [70, 77] 72 [70, 80] Pulse Pressure, mmHg 50 [42, 64] 55 [42, 64] Wrist Circumfrence, cm 17 [15, 20] 18 [15, 20] Faint 0 (0) 0 (0) Weak 1 (2) 0 (0) 46 (90) 46 (90) 4 (8) 5 (10) Systolic Pressure, mm Hg Pulse Normal Bounding Continuous variables presented as median [IQR] 7/29/2013 Accumed Radial, LLC CONFIDENTIAL
  14. 14. 14 Indicator Balloon Volume Information Vol to 3+ blink right Vol to 3+ blink - left Vol to no blink (no flow) right Vol to no blink (no flow) - left Vol to restor 3+ blink - right Vol to restor 3+ blink - left
  15. 15. 15 Comparison of Plethysmography to Pulsera™ Sphygmomanometer-induced Flow Cessation • Plethysmography was used as a parameter of true radial flow Pulsera Flow Flow No Flow 102 data points 0 data points (True Positive) (False Negative) 0 data points 102 data points (False Positive) (True Negative) Plethysmography No Flow • The Pulsera device indicated the same flow status as Plethysmography in all 102 cases for both the “Flow” condition and the “No Flow” condition. • The results indicate that PULSERA has 100% sensitivity and 100% specificity for the detection of flow in the radial artery
  16. 16. Pulsera Clamp  FDA listed  Available in USA

×