1. Renal Embolic Protection: When and How ?
Aravinda Nanjundappa, MD, FSCAI, FACC, RVT
Associate Professor of Medicine and Surgery
West Virginia University
Charleston, WV

2. Aravinda Nanjundappa, MD
DISCLOSURES
Aravinda Nanjundappa, MD
Consulting Fees
Cardiva Medical, Inc.
Honoraria
Novartis AG, Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership

3. Why Renal artery Embolic Protection device?
Dark side of Renal artery stenting
Atheroembolism

4. Why atheroembolism

6. Clinical impact on renals

7. Con Argument Plain-old PTRAS is fine Atheroembolization is over-rated
No evidence that DPD’s improve outcomes
Pore size matters
CORAL showed a lot of AE’s for DPD’s
There’s really no science
Closing comments

8. Con Argument
Plain-old PTRAS is fine

9. Renal Artery Stenting for CKD
Only 15-30% experience improved kidney function after revascularization1
Review of 10 stent series
Improvement in 26%, stabilization in 48%, and deterioration in 26%2
1. Zeller T, et al. J Endovasc Ther 2004:11:
2. Isles CG, et al. Q J Med 1999;92:

10. “Acceptable evidence suggested similar kidney-related outcomes…”
AHRQ-Sponsored Systemic Literature Revi ew
Balk E, et al. Ann Intern Med Dec 19;145(12):

11. Con Argument
Atheroembolization is over-rated

12. PercuSurge DPD: Wake Forest/SF VA
27 RA-PTAS with balloon occlusion DPD
Guide catheter aspirate sent for analysis
Average number of particles micron: 2,000
Average number of particles >60 microns:
265
Edwards MS, et al. Presented at Southern Association for Vascular Surgery Meeting, January 2007.

13. Con Argument
No evidence that DPD’s improve outcomes

14. DISTAL EMBOLIC PROTECTION: CORONARY ARTERY RCT’s
Decreased major adverse clinical events by 42% in the 801-patient SAFER Trial
Saphenous Vein Graft Angioplasty Free of Emboli Randomized1
Similar results in a FilterWire RCT2
1. Baim DS, et al. Circulation 2002;105(11):
2. Stone GW, et al. Circulation 2003:108:

15. DISTAL EMBOLIC PROTECTION: CAROTID ARTERIES
1,483 patients from 26 hospitals
A DPD was used in 668 of 1483 patients (45%)
Patients treated with a PD had a lower rate of ipsilateral stroke (1.7% versus 4.1%, p = 0.007)
Zahn R, et al. Eur Heart J 2004;25(17):

16. AngioGuard DPD Filter: New Zealand Experience
63 patients with 83 renal artery stent procedures
94% had improvement or no deterioration in kidney function1 (no DPD—69%2)
65% of Angioguards contained macroscopic debris
1. Holden A, et al. Kidney International 2006;70:
2. Harden PN, et al. Lancet 1997;349:

17. Occlusion Balloon DPD (PercuSurge): Nancy, France, 28 patients
Kidney Function deteriorated in ZERO
100% of aspirated material contained visible debris
Henry M, et al. J Endovasc Ther 2001;8:

18. PercuSurge DPD: Wake Forest, 26 patients
Kidney Function deteriorated in ZERO
Visible debris in 44% of aspirates
Kidney function by MDRD improved or stabilized in 100%
Edwards MS, et al. J Vasc Surg 2006;44:

19. PercuSurge DPD: Wake Forest/SF VA
Significant correlation between number of particles and pre-procedure antiplatelet therapy
Change in eGFR correlated with pre-procedure antiplatelet therapy
Edwards MS, et al. Presented at Southern Association for Vascular Surgery Meeting, January 2007.

20. Con Argument
Pore size matters

21. Embolic Filter Filters have pores of 100 micron size
Efferent arteriole microns
RBC 8 microns
Devices are capable of capturing fragments that are much smaller1,2
1. Grube E, et al. Am J Cardiol 2002;89:941–945.
2. Rogers R, et al. Circulation 2004;109:1735–1740.

22. Rogers R, et al. Embolic protection with filtering or occlusion balloons during saphenous vein graft stenting retrieves identical volumes and sizes of particulate debris. Circulation 2004;109:1735–1740.
(Plaque volumes also similar in the FIRE Trial (FilterWire vs. GuardWire RCT))
Jonas M, et al. Eur Heart J 2006;27:920–928.

23. Con Argument
CORAL showed a lot of AE’s for DPD’s

24. CORAL and DPD AE’s
No clinical outcomes were attributed to DPD AE’s in CORAL roll-in patients
Effect on kidney function or other outcomes in CORAL is not known
may have helped!
Courtesy of Timothy P. Murphy, M.D. Co Principal investigator CORAL study

25. Con Argument
There’s really no science

26. Antiplatelet Agents in PCI
Inhibitors of the platelet glycoprotein IIb/IIIa receptor reduce the incidence of myocardial necrosis after PCI for ACS1,2
Oral antiplatelet agents also reduce adverse events3
1. EPILOG Investigators. N Eng J Med 1997;336:
2. The EPIC Investigators. N Eng J Med 1994;330(14):
3. CURE Study. Mehta SR, Yusuf S, et al. Lancet 2001;358(9281):

27. RESIST: Embolic Protection and Platelet Inhibition During Renal Artery Stenting
Multicenter, prospective, randomized 2 x 2 factorial design study that enrolled a total of 100 patients with atherosclerotic RAS> 50% who were undergoing stenting.
Patients were randomized to either:
Control (n = 28);
Angioguard only (n = 22);
Abciximab only (n = 25); and
Combined Angioguard and abciximab (n = 25).
Endpoints: Change in the Modification of Diet in Renal Disease (MDRD)-derived glomerular filtration rate (GFR) from baseline to 1 month.

28. RESIST Study Angioguard? ReoPro?
Christopher J. Cooper, MD (Medical University of Ohio, Toledo), on Behalf of the RESIST Investigators

29. Results

30. EPD for all renal interventions?

31. When to use EPD ?

32. Renal protection devices
Filters
Angioguard
Accunet
Embolishield EZ
Occlusive
Percusurge
Fibrenet

33. Challenges with Renal EPD
None designed for renal artery
Ability to traverse lesions
Early branching
Inadequate distal landing zone
Poor wire support to deliver stent
Spasm and endothelial damage
Snagging the filter on the stent edge

34. Adjuvant tips for Renal EPD
ASA and Clopidogrel
Pre hydration
Minimal catheter manipulation
No touch or telescoping technique
Ok to say no to hostile aorta

35. Conclusions
EPD does have a limited role in RAS stenting – hazy lesions, low GFR and solitary kidney
Carefull case selection
Beware of EPD complications
Dedicated renal EPD is needed
Large scale RCT for renal EPD