1. Proxis Proximal embolic protection in saphenous vein graft and infarct PCI Dan Blackman Leeds General Infirmary Advanced Angioplasty 2006

2. Conflicts of Interest Speakers HonorariumSt Jude

3. Proxis embolic protection system - short flexible catheter, - attached to a hypertube-catheter shaft -short distal circumferential balloon at the tip -proximal balloon within guide – -- deployed in proximal vessel (10mm landing zone) - balloon inflated at 2/3 atm, causing stasis of flow

4. Do we need another embolic protection device ?

5. Embolic protection in saphenous vein grafts Two key problems remain (1) Residual MACE of c.10% despite distal protection

6. 30-day MACE with distal protection

7. Causes of residual MACE Distal FilterDistal balloonProxis Embolisation on wiring ± pre-dilatation ++- Embolisation on device crossing ++- Failure to capture debris < 100μm +-- Failure to capture soluble mediators +-- Ischaemia during balloon occlusion -++

8. Embolic protection in saphenous vein grafts Two key problems remain (1) Residual MACE of 10% despite distal protection (2) Distal protection cannot be used for distal lesions (25-30mm landing zone required)

16. Proxis in saphenous vein grafts Proximal balloon occlusion embolic protection offers theoretical benefits over distal protection Proxis is at least as effective as distal protection in a large randomised controlled trial Proxis allows protection of distal vein graft lesions not amenable to distal protection

17. 67 year old male CABG x 4 1994 Tn +ve ACS with ST↓ Critical stenosis in tortuous SVG to RCA

20. Embolic protection in acute myocardial infarction Do we need another embolic protection device? Do we need any embolic protection device?

21. Embolic protection in acute myocardial infarction EMERALD no benefit with Guardwire distal balloon occlusion in unselected primary/rescue PCI ASPARAGUS no benefit from FilterWire distal filter in unselected primary PCI PROMISE no benefit from FilterWire distal filter in infarct PCI

22. Why has embolic protection failed to improve outcome in infarct PCI? Distal embolisation does not contribute to adverse outcome Predictive variables for no-reflow include:- –Angiographic heavy thrombus burden –IVUS findings of lipid-rich plaque Loss of plaque volume at the lesion site correlates with occurrence of no-reflow Macroscopic distal embolisation correlates with poor outcome

23. Why has embolic protection failed to improve outcome in infarct PCI? Distal embolisation does not contribute to adverse outcome Study patients were low-risk –Select patients may benefit Heavy thrombus burden Large vessels Lipid-rich plaque Risk/benefit of Embolic protection devices used unfavourable –Increased procedure time and complexity –Embolisation on crossing the lesion –Failure to protect side-branches –Incomplete protection from small particles and soluble mediators

24. Might Proxis provide more effective embolic protection in infarct PCI? Reduced complexityNo need to cross occlusion or visualise distal vessel Reduced riskAvoid embolisation caused by device crossing Improved protectionProtect all stages inc. wire crossing Improved protectionAspiration of thrombus, small particles and soluble mediators Improved protectionProtection of side branches

25. Early experience with Proxis combined embolic protection/ thrombectomy system in acute myocardial infarction Karel T. Koch MD, PhD, Robbert J. de Winter MD, PhD, Jose Henriques MD, PhD, Rene J. vd Schaaf MD, Saskia Rittersma MD, Jan G.P. Tijssen PhD, Allart J. vd Wall MD, PhD, Jan J. Piek MD, PhD Academic Medical Centre Amsterdam, The Netherlands

26. TIMI-flow after PCI:396% 2 3% 1 1% 1 1% MBG-396% ST resolution at 60 minutes: > 50%100% > 70%81% Total MACE at 30 days4% Koch et al. Procedural outcome

27. Proxis in infarct PCI Distal embolic protection is ineffective in unselected patients with acute MI Distal embolisation must contribute to adverse outcome in some patients Proxis proximal protection + aspiration offers convincing theoretical advantages over distal protection with encouraging registry data A randomised controlled trial of Proxis in selected high-risk patients is required

28. Conclusions Proxis is the first proximal embolic protection device In vein graft PCI Proxis is at least as effective as distal protection In vein graft PCI Proxis enables protection of distal lesions not eligible for distal protection In infarct PCI Proxis offers convincing theoretical advantages over distal protection Early registry data of Proxis in AMI are encouraging, but randomised controlled trial data are required

29. 48 year old male First presentation with transient inferior ST  Coronary angiogram 12 hours after presentation

31. 67 year old male CABG x 4 1994 Tn +ve ACS with ST↓ Critical stenosis in tortuous SVG to RCA