Pancholy SB - AIMRADIAL 2013 - Pulsera hemostasis
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Pulsera first-in-man device
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Pancholy SB - AIMRADIAL 2013 - Pulsera hemostasis
- 1. Pulsera FIM Samir B. Pancholy, MD, FACP, FACC, FSCAI Mauricio G. Cohen, MD, FACC, FSCAI Joseph Korotko, MS
- 2. DISCLOSURES ACCUMED RADIAL Terumo
- 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. 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. 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. 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. Need to monitor radial artery flow Doppler Plethysmography
- 8. Pulsera™ – Current Design Velcro Strap Retention Band Hinged Comfort Cushion Compression Balloon with Reflective Surface, Inflation Tube and Valve
- 9. Application of Pulsera™ Pull sheath 1-2 cm Inflate Pulsera™ Balloon and remove the sheath Deflate balloon until pulsation can be visualized
- 10. Pulsera device
- 11. Pulsera Study 50 volunteers Compare Pulsera device to plethysmography
- 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 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 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 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. Pulsera Clamp FDA listed Available in USA