1. New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager

2. CONFLICT OF INTEREST: Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager

3. Dr. Antonio Serra Hospital de Sant Pau, Hospital del Mar Barcelona Case as Presented by New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager

4. Patient A 64-yr old male patient Risk factors: Hypertension Ex-smoker Hypercholesterolemia CAD clinical presentation : Inferior AMI 4 hrs of evolution. Non complicated Clinical presentation New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager

5. Coronary angiography Ostial LM + LAD disease Occlusion mid RCA New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager

6. Primary PCI Patient A TIMI 0 flow after wire crossing. New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager

7. Patient B 60-yr old male patient Risk factors: Hypertension Active smoker CAD clinical presentation : Angina Class II in the last 3 months Acute anterior MI of 3 hours of evolution, uncomplicated. Clinical presentation New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager

8. Coronary angiography Normal RCA Occlusion mid LAD New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager

9. Coronary angiography New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager

10. New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager Coronary angiography Patient B TIMI 0 flow after wire crossing.

11. New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager Coronary angiography Patient APatient B Both patients with TIMI 0 flow after wire crossing

12. How would you treat ? A : Balloon dilatation B :Direct Stenting C : Aspiration D :Other alternatives New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager

13. Dr. Antonio Serra Hospital de Sant Pau, Hospital del Mar Barcelona How did I treat ? New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager

14. Option A : Balloon When does distal embolization occur in primary PCI? 400 consecutive patients with primary PCI: Distal embolization 64 / 400 (16%) Napodano M et al. TCT, 2005 New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager

15. Option A : Balloon Impact of distal embolization during primary PCI Henriques JP et al. The Zwolle Group. Eur Heart J 2002;23:1112-1117 Distal embolization 27 / 194 (14%) New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager

16. Option B : Direct Stenting How to choose the stent? TIMI 0-1 flow after crossing the occlusion with the guide wire Stent choice ? : Lenght…………… ? Diameter………… ? Guidance New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager

17. Option C: Aspiration Spanish TAPAS New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager Since the publication of the TAPAS trial, Aspiration in all acute MI became a Gold Standard in primary PCI. However, is aspiration useful in all patients with acute MI?

18. TAPAS trial Svilaas T et al. N Engl J Med 2008;358:557-567 Balloon (n=503) Export (n=502) 1071 Pts with acute MI + Abciximab EXPORT Catheter New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager No visible thrombus on angiogram: 51% EXPORT Catheter did not cross: 11% No material in the aspirate: 27% Amongst those with material in aspirate, 67.7% were platelet thrombi Size of aspirated material < 0.5mm in the majority of cases

19. TAPAS trial : Aspiration arm (n=502) EXPORT Not able to cross (n=54) Nothing in the aspirate (n=123) Thrombus < 0.5 mm (n=179) Thrombus > 0.5 mm (n=146) 11% 24.5% 35.7% 28.8% Thrombus > 2.0 mm : 61 / 331 pts = 18.4% New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager

20. Spanish Registry AMICath crossed the occlusion : 95% 100 consecutive pts with acute MI < 12 h and TIMI flow 0-1 after wire crossing TIMI 2-3 flow after AMICath : 85% Angiographically visible thrombus : 49% Thrombus aspiration : 18% Stent implant without pre-dilatation : 83% New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager

21. Should we routinely aspirate in all primary PCI cases ? In 60.2% of Cases -No aspirate OR -´Mini´ thrombus Catheter big profile - Plaque rupture - Spasm - Distal emboli Option C: Always aspiration first When thrombus is visible on angiography “SELECTIVE ASPIRATION” Guidance NO New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager When should we aspirate in primary PCI ?

22. Option D: Other alternatives New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager Tip profile : 0.017”, like standard PTCA balloon The profile increases up to 1.5 mm 4 Radiopaque markers separated by 10 mm “High flow” distal holes Monorail system Hypotube design for max push Very flexible

23. New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager Patient A AMI Cath advanced distal to the oclusion. Adenosine 1-2 mg injected distally to the occlusion to prevent reperfusion injury

24. New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager Patient A Dye injection through “high flow” distal holes of the AMI Cath allows anatomic characterization of the distal vessel.

25. New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager Patient A TIMI 3 flow is restored by “Dotter effect” with the AMI Cath. Absence of distal embolization. Time to recanalize the artery: 3 minutes

26. Patient A Thrombus ? New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager

27. New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager Patient A Thrombus aspiration with the HUNTER Catheter

28. Patient A BMS (Apolo Bionert) 3.0 x 19 mm Final result New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager

29. New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager Patient A TIMI 3 flow Blush grade 2-3 > 70% ST segment resolution

30. New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager Patient B AMI Cath advanced distal to the oclusion. Adenosine 2-4 mg distally to prevent reperfusion injury

31. New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager Patient B Dye injection through “high flow” distal holes of the AMI Cath allows anatomic characterization of the distal vessel.

32. New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager Patient B TIMI 3 flow is obtained in < 3 minutes since the insertion of the AMI Cath.

33. New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager Patient B Thrombus ?

34. New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager Patient B Second GW in D1 “Direct” BMS 3.0 x 23 mm Final result

35. New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager Patient B TIMI 3 flow Blush grade 2-3 > 70% ST segment resolution

36. New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager Summary Patients of similar age, risk factors Acute uncomplicated MI of < 6 hrs, TIMI 0-1 flow after wire crossing. TIMI 3 flow restored in < 3 minutes - Adenosine distal to the occlusion (prevention of reperfusion injury) - Assessment of the distal vessel ThrombusNO Thrombus A B Manual aspiration “Direct” stenting TIMI 3, Blush 2-3, > 70% STR AMI Cath Strategy GUIDANCEGUIDANCE Manual aspiration

37. New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager THANK YOU Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager