Proxis

Proximal embolic protection in saphenous vein graft and infarct PCI

Dan BlackmanLeeds General Infirmary

Advanced Angioplasty 2006

Conflicts of Interest

• Speakers Honorarium St Jude

Proxis embolic protection systemProxis embolic protection system

- short flexible catheter, short flexible catheter,

- attached to a hypertube-catheter attached to a hypertube-catheter shaftshaft

-short distal circumferential short distal circumferential balloon balloon at the tipat the tip

-proximal balloon within guide proximal balloon within guide – –

-- deployed in proximal vessel (10mm - deployed in proximal vessel (10mm landing zone) landing zone)

- balloon inflated at 2/3 atm, causing - balloon inflated at 2/3 atm, causing stasis of flowstasis of flow

Do we need another embolic protection device ?

Embolic protection in saphenous vein grafts

Two key problems remain

(1) Residual MACE of c.10% despite distal

protection

30-day MACE with distal protection

9.6 9.9

11.6 11.210.1

9.18.4

16.5

0

2

4

6

8

10

12

14

16

18

SAFERcontrol

SAFERGW

FIREFW

FIREGW

PRIDETriactiv

PRIDEFW/GW

SPIDER SPIDERFW/GW

30-d

ay M

AC

E

Causes of residual MACE

Distal Filter Distal balloon Proxis

Embolisation on wiring ± pre-dilatation

+ + -

Embolisation on device crossing

+ + -

Failure to capture debris < 100μm

+ - -

Failure to capture soluble mediators

+ - -

Ischaemia during balloon occlusion

- + +

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)

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

• 67 year old male

• CABG x 4 1994

• Tn +ve ACS with ST↓

• Critical stenosis in tortuous SVG to RCA

Embolic protection in acute myocardial infarction

• Do we need another embolic protection device?

• Do we need any embolic protection device?

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

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

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

Might Proxis provide more effective embolic protection in infarct PCI?

• Reduced complexity No need to cross occlusion or visualise distal vessel

• Reduced risk Avoid embolisation caused by device crossing

• Improved protection Protect all stages inc. wire crossing

• Improved protection Aspiration of thrombus, small particles and soluble mediators

• Improved protection Protection of side branches

Early experience with Proxis Early experience with Proxis combined embolic protection/ thrombectomy system combined embolic protection/ thrombectomy system

in ac in acuute myocardial infarctionte myocardial infarction

Karel T. Koch MD, PhD, Robbert J. de Winter MD, PhD, Jose Henriques MD, PhD, 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, Rene J. vd Schaaf MD, Saskia Rittersma MD, Jan G.P. Tijssen PhD,

Allart J. vd Wall MD, PhD, Jan J. Piek MD, PhDAllart J. vd Wall MD, PhD, Jan J. Piek MD, PhD

Academic Medical CentreAcademic Medical Centre

Amsterdam, The NetherlandsAmsterdam, The Netherlands

TIMITIMI--flow flow after PCI:after PCI: 33 96%96%

22 3% 3%

11 1% 1%

MBG-3MBG-3 96%96%

ST resolution at 60 minutes:ST resolution at 60 minutes:> 50%> 50% 100%100%> 70%> 70% 81%81%

Total MACE at 30 daysTotal MACE at 30 days 4%4%

Koch et al. Procedural outcome

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

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

• 48 year old male

• First presentation with transient inferior ST • Coronary angiogram 12 hours after presentation

• 67 year old male

• CABG x 4 1994

• Tn +ve ACS with ST↓

• Critical stenosis in tortuous SVG to RCA